2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

PubMed

Song, An; Lee, Anita; Garofolo, Fabio; Kaur, Surinder; Duggan, Jeff; Evans, Christopher; Palandra, Joe; Donato, Lorella Di; Xu, Keyang; Bauer, Ronald; Bustard, Mark; Chen, Linzhi; Cocea, Laurent; Croft, Stephanie; Galliccia, Fabrizio; Haidar, Sam; Hughes, Nicola; Ishii-Watabe, Akiko; Islam, Rafiqul; Jones, Barry; Kadavil, John; Krantz, Carsten; Lima Santos, Gustavo Mendes; Olah, Timothy; Pedras-Vasconcelos, João; Staelens, Ludovicus; Saito, Yoshiro; Savoie, Natasha; Scheibner, Kara; Spitz, Susan; Tampal, Nilufer; Thomas, Eric; Vinter, Stephen; Wakelin-Smith, Jason; Welink, Jan; Zeng, Jianing; Zhou, Shaolian

2016-12-01

The 2016 10th Workshop on Recent Issues in Bioanalysis (10 th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it is specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecules involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This White Paper is published in 3 parts due to length. This part (Part 2) discusses the recommendations for Hybrid LBA/LCMS and regulatory inputs from major global health authorities. Parts 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) have been published in the Bioanalysis journal, issues 22 and 23, respectively.

Regulatory and policy issues for reuse and remanufacture of wood materials coated with lead-based paint

Treesearch

Thomas R. Napier; Robert H. Falk; George B. Guy; Susan Drodz

2005-01-01

At present, there is no regulatory or policy guidance at the Federal level that permits, prohibits, or qualifies practice for salvaging and reusing building materials coated with lead-based paint (LBP). This paper describes the current regulations and standards relative to LBP in buildings (in particular LBP on lumber and timber products), LBP mitigation, and disposal...

Distribution System Residuals – Is “Detectable” Still Acceptable for Chloramines?

EPA Science Inventory

Recently, Roberson (2014) noted that one of the distribution system issues currently on the regulatory radar is, “Should disinfectant residual requirements be a specific number as opposed to the current detectable residual?” As our title suggests, we seek to assess what it means...

The evolution and challenges for the international harmonization of the regulation of pharmaceutical excipients in Taiwan.

PubMed

Chang, Lin-Chau; Kang, Jaw-Jou; Gau, Churn-Shiouh

2015-12-01

Excipients, once considered an inert component, have been shown to greatly influence the characteristics of the drug product, such as quality and safety. Functionality-related characteristics of excipients could affect the performance of the drug product. Moreover, the impact of globalization has complicated the issue and made the supervision of supply chain highly important. Taiwan, a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, makes efforts to harmonize with international regulations and to strengthen the protection of patients through regulatory controls. In order to improve the harmonization and the transparency of regulatory requirements, the aim of the present study was to investigate the regulatory framework and considerations of stringent regulatory authorities and to propose the draft regulatory requirements to the Taiwan Food and Drug Administration for jurisdiction. The proposal which was extensively discussed in the expert committee includes the regulatory considerations to ensure the safety and quality of the excipients and may serve as a platform to facilitate the communication with industries about the current thinking on related issues. Moreover, through the review of the recent guidelines published by the stringent regulatory authorities, the trend of the regulatory considerations was revealed and discussed. Copyright © 2015 Elsevier Inc. All rights reserved.

Upcoming Environmental Modeling in Ground Water Public Meeting

EPA Pesticide Factsheets

This meeting provides a public forum for pesticide registrants, other stakeholders and EPA to discuss current issues related to modeling pesticide fate, transport, and exposure for pesticide risk assessments in a regulatory context.

Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine.

PubMed

Gilbert, Frederic; O'Connell, Cathal D; Mladenovska, Tajanka; Dodds, Susan

2018-02-01

Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

Food irradiation—US regulatory considerations

NASA Astrophysics Data System (ADS)

Morehouse, Kim M.

2002-03-01

The use of ionizing radiation in food processing has received increased interest as a means of reducing the level of foodborne pathogens. This overview discusses the regulatory issues connected with the use of this technology in the United States. Several recent changes in the FDA's review process are discussed. These include the current policy that utilizes an expedited review process for petitions seeking approval of additives and technologies intended to reduce pathogen levels in food, and the recent USDA rule that eliminates the need for a separate rulemaking process by USDA for irradiation of meat and poultry. Recently promulgated rules and pending petitions before the FDA associated with the use of ionizing radiation for the treatment of foods are also discussed along with the current FDA labeling requirements for irradiated foods and the 1999 advanced notice of proposed rule on labeling. Another issue that is presented is the current status of the approval of packaging materials intended for food contact during irradiation treatment of foods.

Leading trends in environmental regulation that affect energy development. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Steele, R V; Attaway, L D; Christerson, J A

1980-01-01

Major environmental issues that are likely to affect the implementation of energy technologies between now and the year 2000 are identified and assessed. The energy technologies specifically addressed are: oil recovery and processing; gas recovery and processing; coal liquefaction; coal gasification (surface); in situ coal gasification; direct coal combustion; advanced power systems; magnetohydrodynamics; surface oil shale retorting; true and modified in situ oil shale retorting; geothermal energy; biomass energy conversion; and nuclear power (fission). Environmental analyses of these technologies included, in addition to the main processing steps, the complete fuel cycle from resource extraction to end use. A comprehensive surveymore » of the environmental community (including environmental groups, researchers, and regulatory agencies) was carried out in parallel with an analysis of the technologies to identify important future environmental issues. Each of the final 20 issues selected by the project staff has the following common attributes: consensus of the environmental community that the issue is important; it is a likely candidate for future regulatory action; it deals with a major environmental aspect of energy development. The analyses of the 20 major issues address their environmental problem areas, current regulatory status, and the impact of future regulations. These analyses are followed by a quantitative assessment of the impact on energy costs and nationwide pollutant emissions of possible future regulations. This is accomplished by employing the Strategic Environmental Assessment System (SEAS) for a subset of the 20 major issues. The report concludes with a more general discussion of the impact of environmental regulatory action on energy development.« less

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).

PubMed

Welink, Jan; Fluhler, Eric; Hughes, Nicola; Arnold, Mark; Garofolo, Fabio; Bustard, Mark; Coppola, Laura; Dhodda, Raj; Evans, Christopher; Gleason, Carol; Haidar, Sam; Hayes, Roger; Heinig, Katja; Katori, Noriko; Blaye, Olivier Le; Li, Wenkui; Liu, Guowen; Lima Santos, Gustavo Mendes; Meng, Min; Nicholson, Bob; Savoie, Natasha; Skelly, Michael; Sojo, Luis; Tampal, Nilufer; de Merbel, Nico van; Verhaeghe, Tom; Vinter, Stephen; Wickremsinhe, Enaksha; Whale, Emma; Wilson, Amanda; Witte, Bärbel; Woolf, Eric

2015-01-01

The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 1 covers the recommendations for small molecule bioanalysis using LCMS. Part 2 (hybrid LBA/LCMS and regulatory agencies' inputs) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will also be published in volume 7 of Bioanalysis, issues 23 and 24, respectively.

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).

PubMed

Richards, Susan; Amaravadi, Lakshmi; Pillutla, Renuka; Birnboeck, Herbert; Torri, Albert; Cowan, Kyra J; Papadimitriou, Apollon; Garofolo, Fabio; Satterwhite, Christina; Piccoli, Steven; Wu, Bonnie; Krinos-Fiorotti, Corinna; Allinson, John; Berisha, Flora; Cocea, Laurent; Croft, Stephanie; Fraser, Stephanie; Galliccia, Fabrizio; Gorovits, Boris; Gupta, Swati; Gupta, Vinita; Haidar, Sam; Hottenstein, Charles; Ishii-Watabe, Akiko; Jani, Darshana; Kadavil, John; Kamerud, John; Kramer, Daniel; Litwin, Virginia; Lima Santos, Gustavo Mendes; Nelson, Robert; Ni, Yan; Pedras-Vasconcelos, João; Qiu, Yongchang; Rhyne, Paul; Safavi, Afshin; Saito, Yoshiro; Savoie, Natasha; Scheibner, Kara; Schick, Eginhard; Siguenza, Patricia Y; Smeraglia, John; Staack, Roland F; Subramanyam, Meena; Sumner, Giane; Thway, Theingi; Uhlinger, David; Ullmann, Martin; Vitaliti, Alessandra; Welink, Jan; Whiting, Chan C; Xue, Li; Zeng, Rong

2016-12-01

The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a weeklong event - A Full Immersion Week of Bioanalysis for PK, Biomarkers and Immunogenicity. As usual, it is specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecules involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on PK, biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This White Paper is published in 3 parts due to length. This part (Part 3) discusses the recommendations for large molecule bioanalysis using LBA, biomarkers and immunogenicity. Parts 1 (small molecule bioanalysis using LCMS) and Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) have been published in the Bioanalysis journal, issues 22 and 23, respectively.

Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions.

PubMed

Wang, Ting; McAuslane, Neil; Liberti, Lawrence; Leufkens, Hubert; Hövels, Anke

2018-06-01

To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy. Two separate questionnaires were developed to assess stakeholders' perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies. The responses were analyzed using descriptive statistics. Seven regulatory and 8 HTA agencies from Australia, Canada, and Europe and 19 international companies developing innovative medicine responded to the survey. This study provided a snapshot of the current regulatory and HTA landscape. Changes made over the past 5 years were reflected in three main areas: there is an increasing interaction between regulatory and HTA agencies; current conditional regulatory approvals are not always linked with flexible HTA approaches; and companies are more supportive of joint scientific advice. Four types of evidentiary requirements were identified as building blocks for better alignment: acceptable primary end points, inclusion of an active comparator, use of patient-reported outcomes, and choice and use of surrogate end point. The study showed that the gap between regulatory and HTA requirements has narrowed over the past 5 years. All respondents supported synergy between regulatory and HTA stakeholders, and the study provided several recommendations on how to further improve evidentiary alignment including the provision of joint scientific advice, which was rated as a key strategy by both agencies and companies. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Current status of herbal product: Regulatory overview

PubMed Central

Sharma, Sanjay

2015-01-01

A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. PMID:26681886

Current status of herbal product: Regulatory overview.

PubMed

Sharma, Sanjay

2015-01-01

A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment.

78 FR 62787 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

... component of its current IRS margin model. The proposed change is reflected in an Advisory Notice issued to... offers clearing for a variety of swaps products under the exclusive jurisdiction of the Commodity Futures... rate swaps (``IRS''). CME proposes to make certain changes to its current IRS margin model in relation...

75 FR 44781 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-29

...; File No. 265-26] Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Commodity... Meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. SUMMARY: The Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues will hold a public meeting on August 11, 2010, from 9 a.m...

75 FR 66362 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-28

...; File No. 265-26] Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Commodity... meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. SUMMARY: The Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues will hold a public meeting on November 5, 2010, from 9 a.m...

Genomics in the land of regulatory science.

PubMed

Tong, Weida; Ostroff, Stephen; Blais, Burton; Silva, Primal; Dubuc, Martine; Healy, Marion; Slikker, William

2015-06-01

Genomics science has played a major role in the generation of new knowledge in the basic research arena, and currently question arises as to its potential to support regulatory processes. However, the integration of genomics in the regulatory decision-making process requires rigorous assessment and would benefit from consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) hosted the fourth Global Summit on Regulatory Science (GSRS2014) to discuss the role of genomics in regulatory decision making, with a specific emphasis on applications in food safety and medical product development. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the analysis, interpretation and reporting of genomics data with an emphasis on transparency, traceability and "fitness for purpose" for the intended application. It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent, reliable, reproducible and auditable processes in the management of food and medical product safety risks. It was also recognized that training is an important mechanism in achieving internationally consistent outcomes. GSRS2014 provided an effective venue for regulators andresearchers to meet, discuss common issues, and develop collaborations to address the challenges posed by the application of genomics to regulatory science, with the ultimate goal of wisely integrating novel technical innovations into regulatory decision-making. Published by Elsevier Inc.

Regulatory Technology Development Plan - Sodium Fast Reactor. Mechanistic Source Term - Trial Calculation. Work Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grabaskas, David; Bucknor, Matthew; Jerden, James

2016-02-01

The overall objective of the SFR Regulatory Technology Development Plan (RTDP) effort is to identify and address potential impediments to the SFR regulatory licensing process. In FY14, an analysis by Argonne identified the development of an SFR-specific MST methodology as an existing licensing gap with high regulatory importance and a potentially long lead-time to closure. This work was followed by an initial examination of the current state-of-knowledge regarding SFR source term development (ANLART-3), which reported several potential gaps. Among these were the potential inadequacies of current computational tools to properly model and assess the transport and retention of radionuclides duringmore » a metal fuel pool-type SFR core damage incident. The objective of the current work is to determine the adequacy of existing computational tools, and the associated knowledge database, for the calculation of an SFR MST. To accomplish this task, a trial MST calculation will be performed using available computational tools to establish their limitations with regard to relevant radionuclide release/retention/transport phenomena. The application of existing modeling tools will provide a definitive test to assess their suitability for an SFR MST calculation, while also identifying potential gaps in the current knowledge base and providing insight into open issues regarding regulatory criteria/requirements. The findings of this analysis will assist in determining future research and development needs.« less

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).

PubMed

Neubert, Hendrik; Song, An; Lee, Anita; Wei, Cong; Duggan, Jeff; Xu, Keyang; Woolf, Eric; Evans, Chris; Palandra, Joe; Laterza, Omar; Amur, Shashi; Berger, Isabella; Bustard, Mark; Cancilla, Mark; Chen, Shang-Chiung; Cho, Seongeun Julia; Ciccimaro, Eugene; Cludts, Isabelle; Cocea, Laurent; D'Arienzo, Celia; Danan-Leon, Lieza; Donato, Lorella Di; Garofolo, Fabio; Haidar, Sam; Ishii-Watabe, Akiko; Jiang, Hao; Kadavil, John; Kassim, Sean; Kurki, Pekka; Blaye, Olivier Le; Liu, Kai; Mathews, Rod; Lima Santos, Gustavo Mendes; Niwa, Makoto; Pedras-Vasconcelos, João; Qian, Mark; Rago, Brian; Saad, Ola; Saito, Yoshiro; Savoie, Natasha; Su, Dian; Szapacs, Matthew; Tampal, Nilufer; Vinter, Stephen; Wang, Jian; Welink, Jan; Whale, Emma; Wilson, Amanda; Xue, Y-J

2017-12-01

The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid ligand binding assay (LBA)/LCMS and LBA approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for biotherapeutics, biomarkers and immunogenicity assays using hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (LCMS for small molecules, peptides and small molecule biomarkers) and Part 3 (LBA: immunogenicity, biomarkers and pharmacokinetic assays) are published in Volume 9 of Bioanalysis, issues 22 and 24 (2017), respectively.

European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs.

PubMed

Hoshino, Tatsuro; Muto, Nanami; Tsukada, Shinsuke; Nakamura, Takatoshi; Maegawa, Hikoichiro

2018-01-06

Since the publication of "Application Guideline for Western Traditional Herbal Medicines as OTC Drugs" in 2007, only two European ethnopharmaceuticals, Vitis vinifera L., folium extract (Antistax) and Vitex agnus-castus L., fructus extract (Prefemin), have been approved as OTC drugs in Japan. In this review, we describe the current regulation of Western ethnopharmaceuticals in Japan, summarize our regulatory experiences and discuss the scientific and regulatory issues involved.

European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs

PubMed Central

Hoshino, Tatsuro; Muto, Nanami; Tsukada, Shinsuke; Nakamura, Takatoshi; Maegawa, Hikoichiro

2018-01-01

Since the publication of “Application Guideline for Western Traditional Herbal Medicines as OTC Drugs” in 2007, only two European ethnopharmaceuticals, Vitis vinifera L., folium extract (Antistax) and Vitex agnus-castus L., fructus extract (Prefemin), have been approved as OTC drugs in Japan. In this review, we describe the current regulation of Western ethnopharmaceuticals in Japan, summarize our regulatory experiences and discuss the scientific and regulatory issues involved. PMID:29316611

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).

PubMed

Yang, Eric; Welink, Jan; Cape, Stephanie; Woolf, Eric; Sydor, Jens; James, Christopher; Goykhman, Dina; Arnold, Mark; Addock, Neil; Bauer, Ronald; Buonarati, Michael; Ciccimaro, Eugene; Dodda, Raj; Evans, Christopher; Garofolo, Fabio; Hughes, Nicola; Islam, Rafiq; Nehls, Corey; Wilson, Amanda; Briscoe, Chad; Bustard, Mark; Coppola, Laura; Croft, Stephanie; Drexler, Dieter; Ferrari, Luca; Fraier, Daniela; Jenkins, Rand; Kadavil, John; King, Lloyd; Li, Wenkui; Lima Santos, Gustavo Mendes; Musuku, Adrien; Ramanathan, Ragu; Saito, Yoshiro; Savoie, Natasha; Summerfield, Scott; Sun, Rachel; Tampal, Nilufer; Vinter, Steve; Wakelin-Smith, Jason; Yue, Qin

2016-10-07

The 2016 10 th Workshop on Recent Issues in Bioanalysis (10 th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This white paper is published in 3 parts due to length. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LCMS. Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in the Bioanalysis journal, issue 23.

ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH

Cancer.gov

ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH, designed to stimulate dialogue on ethical and regulatory issues in cancer research and promote awareness of developing policies and best practices.

Regulatory trends in the battery industry

NASA Astrophysics Data System (ADS)

McColl, K. G.

1994-02-01

The scope of regulations in the battery industry is extensive and also complex. In the future, regulations will become more demanding and will encompass issues not currently considered. Increased focus on environmental issues by government bodies, environmental groups, local communities will result in more strict compliance standards. The USA is currently leading the world's battery industries in the scope and compliance level of regulations. By studying trends in the USA, the rest of the battery industry can prepare itself for the future operating environment. This paper reviews the most critical areas of air pollution, blood-lead levels and recycling. The paper concludes that the battery industry must adopt a culture of exceeding current compliance standards.

Analysis of the performance of the CONTOUR® TS Blood Glucose Monitoring System: when regulatory performance criteria are met, should we have confidence to use a medical device with all patients?

PubMed

Lyon, Martha E; Lyon, Andrew W

2011-01-01

The article entitled, Performance of the CONTOUR® TS Blood Glucose Monitoring System, by Frank and colleagues in this issue of Journal of Diabetes Science and Technology, demonstrates that the CONTOUR® TS glucose meter exceeds current regulatory expectations for glucose meter performance. However, the appropriateness of current regulatory expectations, such as International Organization for Standardization (ISO) 15197:2003, is being reevaluated because of increasing concern regarding the reliability of glucose meters in ambulatory and hospitalized environments. Between 2004 and 2008, 12,673 serious adverse events with glucose meters that met the ISO 15197 expectations were reported in the Food and Drug Administration-Manufacturer and User Facility Device Experience surveillance database. Should different glucose meter performance criteria be applied to ambulatory versus critical care patients? © 2010 Diabetes Technology Society.

Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods.

PubMed

Schechtman, Leonard M

2002-01-01

Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which humans are exposed. That history forms the basis for the testing strategies that have evolved to satisfy the needs of the regulatory bodies that render decisions that affect, for the most part, virtually all phases of premarket product development and evaluation and, to a lesser extent, postmarketing surveillance. Only relatively recently have the levels of awareness of, and responsiveness to, animal welfare issues reached current proportions. That paradigm shift, although sluggish, has nevertheless been progressive. New and alternative toxicological methods for hazard evaluation and risk assessment have now been adopted and are being viewed as a means to address those issues in a manner that considers humane treatment of animals yet maintains scientific credibility and preserves the goal of ensuring human safety. To facilitate this transition, regulatory agencies and regulated industry must work together toward improved approaches. They will need assurance that the methods will be reliable and the results comparable with, or better than, those derived from the current classical methods. That confidence will be a function of the scientific validation and resultant acceptance of any given method. In the United States, to fulfill this need, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its operational center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), have been constituted as prescribed in federal law. Under this mandate, ICCVAM has developed a process and established criteria for the scientific validation and regulatory acceptance of new and alternative methods. The role of ICCVAM in the validation and acceptance process and the criteria instituted toward that end are described. Also discussed are the participation of the US Food and Drug Administration (FDA) in the ICCVAM process and that agency's approach to the application and implementation of ICCVAM-recommended methods.

Chemistry, toxicity, and bioavailability of copper and its relationship to regulation in the marine environment. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Seligman, P.E.; Zirino, A.

1998-11-01

This document details issues addressed at a June 1997 workshop attended by Navy and regulatory representatives and scientific experts. Objectives discussed were: (1) define the current status and future direction of copper (Cu) regulations, (2) define problems and issues associated with the introduction of copper into the estuarine environment, and (3) discuss and evaluate the relationship between copper speciation, bio-availability, and toxicity.

Unlicensed and unshackled : a joint OSP-OET white paper on unlicensed devices and their regulatory issues

DOT National Transportation Integrated Search

2003-05-01

In this paper, the authors present a survey of the origins of unlicensed wireless devices, their governing regulation, the current technological state of the art, an overview of the market with information from publicly available sources, and an anal...

77 FR 52636 - Hazardous Materials: Revision to Fireworks Regulations (RRR)

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... mathematical errors, or denied for safety issues. If an application is rejected, the applicant often resubmits... processing of EX approval applications under the current regulatory scheme. PHMSA proposes an alternative option for Division 1.4G consumer fireworks in which applicants will submit applications for...

Current issues involving screening and identification of chemical contaminants in foods by mass spectrometry

USDA-ARS?s Scientific Manuscript database

Although quantitative analytical methods must be empirically validated prior to their actual use in a variety of applications, including regulatory monitoring of chemical adulterants in foods, validation of qualitative method performance for the analytes and matrices of interest is frequently ignore...

Reading the Tea Leaves: How Utilities in the West Are Managing Carbon Regulatory Risk in their Resource Plans

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barbose, Galen; Wiser, Ryan; Phadke, Amol

2008-02-01

The long economic lifetime and development lead-time of many electric infrastructure investments requires that utility resource planning consider potential costs and risks over a lengthy time horizon. One long-term -- and potentially far-reaching -- risk currently facing the electricity industry is the uncertain cost of future carbon dioxide (CO2) regulations. Recognizing the importance of this issue, many utilities (sometimes spurred by state regulatory requirements) are beginning to actively assess carbon regulatory risk within their resource planning processes, and to evaluate options for mitigating that risk. However, given the relatively recent emergence of this issue and the rapidly changing political landscape,more » methods and assumptions used to analyze carbon regulatory risk, and the impact of this analysis on the selection of a preferred resource portfolio, vary considerably across utilities. In this study, we examine the treatment of carbon regulatory risk in utility resource planning, through a comparison of the most-recent resource plans filed by fifteen investor-owned and publicly-owned utilities in the Western U.S. Together, these utilities account for approximately 60percent of retail electricity sales in the West, and cover nine of eleven Western states. This report has two related elements. First, we compare and assess utilities' approaches to addressing key analytical issues that arise when considering the risk of future carbon regulations. Second, we summarize the composition and carbon intensity of the preferred resource portfolios selected by these fifteen utilities and compare them to potential CO2 emission benchmark levels.« less

WhatsApp in Stroke Systems: Current Use and Regulatory Concerns.

PubMed

Calleja-Castillo, Juan M; Gonzalez-Calderon, Gina

2018-01-01

Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

WhatsApp in Stroke Systems: Current Use and Regulatory Concerns

PubMed Central

Calleja-Castillo, Juan M.; Gonzalez-Calderon, Gina

2018-01-01

Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use. PMID:29904369

International Mutual Recognition: Progress and Prospects. Working Paper.

ERIC Educational Resources Information Center

Hager, Paul

Increasing the mobility of service providers, including professionals, via mutual recognition (of regulatory systems) agreements (MRAs) has become a significant issue worldwide. Despite increasing interest in MRAs, it may be argued that MRAs are but one of a larger range of major developments that have fueled current interest in occupational…

77 FR 25533 - Agency Requests for Approval of a New Information Collection(s): Human Subjects Experiments...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-30

... observational experiments are being conducted in support of current agency regulatory efforts that contemplate... comments [identified by Docket No. NHTSA- 2012-0046] through one of the following methods: Federal e... Information Collection. Background: NHTSA has initiated research and rulemaking to address these issues...

2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).

PubMed

Welink, Jan; Yang, Eric; Hughes, Nicola; Rago, Brian; Woolf, Eric; Sydor, Jens; Coppola, Laura; Ackermann, Brad; Li, Wenkui; Alley, Stephen C; Arnold, Mark; Berger, Isabella; Briscoe, Chad; Buonarati, Michael; Bustard, Mark; Cancilla, Mark; Cho, Seongeun Julia; Duggan, Jeff; Fraier, Daniela; Garofolo, Fabio; Green, Rachel; Haidar, Sam; Hittle, Lucinda; Ishii-Watabe, Akiko; Islam, Rafiq; Jenkins, Rand; Jones, Barry; Kadavil, John; Kassim, Sean; Kavetska, Olga; Blaye, Olivier Le; Lee, Anita; Liu, Hanlan; Mehl, John; Lima Santos, Gustavo Mendes; Musuku, Adrien; Ramanathan, Ragu; Saito, Yoshiro; Savoie, Natasha; Summerfield, Scott; Surapaneni, Sekhar; Szapacs, Matthew; Tampal, Nilufer; Verhaeghe, Tom; Vinter, Stephen; Whale, Emma

2017-11-01

The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis, Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS and ligand-binding assay (LBA) approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for Small Molecules, Peptides and Small Molecule Biomarkers using LCMS. Part 2 (Biotherapeutics, Biomarkers and Immunogenicity Assays using Hybrid LBA/LCMS and Regulatory Agencies' Inputs) and Part 3 (LBA: Immunogenicity, Biomarkers and PK Assays) are published in volume 9 of Bioanalysis, issues 23 and 24 (2017), respectively.

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).

PubMed

Gupta, Shalini; Richards, Susan; Amaravadi, Lakshmi; Piccoli, Steven; Desilva, Binodh; Pillutla, Renuka; Stevenson, Lauren; Mehta, Devangi; Carrasco-Triguero, Montserrat; Neely, Robert; Partridge, Michael; Staack, Roland F; Zhao, Xuemei; Gorovits, Boris; Kolaitis, Gerry; Sumner, Giane; Stubenrauch, Kay-Gunnar; Zou, Linglong; Amur, Shashi; Beaver, Chris; Berger, Isabella; Berisha, Flora; Birnboeck, Herbert; Bower, Joe; Cho, Seongeun Julia; Cludts, Isabelle; Cocea, Laurent; Donato, Lorella Di; Fischer, Saloumeh; Fraser, Stephanie; Garofolo, Fabio; Haidar, Sam; Haulenbeek, Jonathan; Hottenstein, Charles; Hu, Jenny; Ishii-Watabe, Akiko; Islam, Rafiq; Jani, Darshana; Kadavil, John; Kamerud, John; Kramer, Daniel; Kurki, Pekka; MacMannis, Stephen; McNally, Jim; Mullan, Ashley; Papadimitriou, Apollon; Pedras-Vasconcelos, João; Ray, Soma; Safavi, Afshin; Saito, Yoshiro; Savoie, Natasha; Fjording, Marianne Scheel; Scheibner, Kara; Smeraglia, John; Song, An; Stouffer, Bruce; Tampal, Nilufer; der Strate, Barry van; Verch, Thorsten; Welink, Jan; Xu, Yuanxin; Yang, Tong-Yuan; Yengi, Lilian; Zeng, Jianing; Zhang, Yan; Zhang, Yanhua; Zoog, Stephen

2017-12-01

The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule analysis involving LC-MS, hybrid ligand-binding assay (LBA)/LC-MS and LBA approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large-molecule bioanalysis, biomarkers and immunogenicity using LBA. Part 1 (LC-MS for small molecules, peptides and small molecule biomarkers) and Part 2 (hybrid LBA/LC-MS for biotherapeutics and regulatory agencies' inputs) are published in volume 9 of Bioanalysis, issues 22 and 23 (2017), respectively.

Animal Health Ireland: providing national leadership and coordination of non-regulatory animal health issues in Ireland.

PubMed

More, S J; Doherty, M L; Downey, L; McKenzie, K; Devitt, C; O'Flaherty, J

2011-12-01

Livestock production plays an important role in the Irish economy. Regulatory animal health issues are the responsibility of government, but until recently there has been no national coordination of non-regulatory animal health issues. This gap has recently been filled with the establishment of Animal Health Ireland (AHI), a not-for-profit, partnership-based organisation providing national leadership and coordination of non-regulatory animal health issues in Ireland. Animal Health Ireland provides benefits to livestock producers and processors by providing the knowledge, education and coordination required to establish effective control strategies, both on-farm and nationally. This paper presents a brief overview of the context for AHI, and of its establishment and initial activities. Non-regulatory animal health issues have been prioritised. A series of work programmes (each focusing on a high-priority issue) have been established. Partnership is critical to success, both for AHI as an organisation and for effective farm-level transfer of knowledge. This model for national leadership and coordination of non-regulatory animal health issues may be of relevance elsewhere.

Facilities removal working group

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

This working group`s first objective is to identify major economic, technical, and regulatory constraints on operator practices and decisions relevant to offshore facilities removal. Then, the group will try to make recommendations as to regulatory and policy adjustments, additional research, or process improvements and/or technological advances, that may be needed to improve the efficiency and effectiveness of the removal process. The working group will focus primarily on issues dealing with Gulf of Mexico platform abandonments. In order to make the working group sessions as productive as possible, the Facilities Removal Working Group will focus on three topics that address amore » majority of the concerns and/or constraints relevant to facilities removal. The three areas are: (1) Explosive Severing and its Impact on Marine Life, (2) Pile and Conductor Severing, and (3) Deep Water Abandonments This paper will outline the current state of practice in the offshore industry, identifying current regulations and specific issues encountered when addressing each of the three main topics above. The intent of the paper is to highlight potential issues for panel discussion, not to provide a detailed review of all data relevant to the topic. Before each panel discussion, key speakers will review data and information to facilitate development and discussion of the main issues of each topic. Please refer to the attached agenda for the workshop format, key speakers, presentation topics, and panel participants. The goal of the panel discussions is to identify key issues for each of the three topics above. The working group will also make recommendations on how to proceed on these key issues.« less

Strengthening health professions regulation in Cambodia: a rapid assessment.

PubMed

Clarke, David; Duke, Jan; Wuliji, Tana; Smith, Alyson; Phuong, Keat; San, Un

2016-03-10

This paper describes a rapid assessment of Cambodia's current system for regulating its health professions. The assessment forms part of a co-design process to set strategic priorities for strengthening health profession regulation to improve the quality and safety of health services. A health system approach for strengthening health professions' regulation is underway and aims to support the Government of Cambodia's plans for scaling up its health workforce, improving health services' safety and quality, and meeting its Association of South East Asian Nations (ASEAN) obligations to facilitate trade in health care services. The assessment used a mixed methods approach including: A desktop review of key laws, plans, reports and other documents relating to the regulation of the health professions in Cambodia (medicine, dentistry, midwifery, nursing and pharmacy); Key informant interviews with stakeholders in Cambodia (The term "stakeholders" refers to government officials, people working on health professional regulation, people working for the various health worker training institutions and health workers at the national and provincial level); Surveys and questionnaires to assess Cambodian stakeholder knowledge of regulation; Self-assessments by members of the five Cambodian regulatory councils regarding key capacities and activities of high-performing regulatory bodies; and A rapid literature review to identify: The key functions of health professional regulation; The key issues affecting the Cambodian health sector (including relevant developments in the wider ASEAN region); and "Smart" health profession regulation practices of possible relevance to Cambodia. We found that the current regulatory system only partially meets Cambodia's needs. A number of key regulatory functions are being performed, but overall, the current system was not designed with Cambodia's specific needs in mind. The existing system is also overly complex, with considerable duplication and overlap between governance and regulatory arrangements for the five regulated professions. There is considerable scope for reform to the current regulatory system to better align the system to Cambodia's: Current needs and circumstances; Health system strategic priorities; and International obligations. Cambodia is also well placed to base its reformed regulatory system on recent developments of "smart regulatory practices" for health professionals.

Current challenges in bioequivalence, quality, and novel assessment technologies for topical products.

PubMed

Yacobi, Avraham; Shah, Vinod P; Bashaw, Edward D; Benfeldt, Eva; Davit, Barbara; Ganes, Derek; Ghosh, Tapash; Kanfer, Isadore; Kasting, Gerald B; Katz, Lindsey; Lionberger, Robert; Lu, Guang Wei; Maibach, Howard I; Pershing, Lynn K; Rackley, Russell J; Raw, Andre; Shukla, Chinmay G; Thakker, Kailas; Wagner, Nathalie; Zovko, Elizabeta; Lane, Majella E

2014-04-01

This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic topical products. The methods currently available for assessment of BE were reviewed as well as alternatives and the advantages and disadvantages of each method were considered. Guidance on quality and performance of topical products was reviewed and a framework to categorise existing and alternative methods for evaluation of BE was discussed. The outcome of the workshop emphasized both a need for greater attention to quality, possibly, via a Quality-By-Design (QBD) approach and a need to develop a "whole toolkit" approach towards the problem of determination of rate and extent in the assessment of topical bioavailability. The discussion on the BE and clinical equivalence of topical products revealed considerable concerns about the variability present in the current methodologies utilized by the industry and regulatory agencies. It was proposed that academicians, researchers, the pharmaceutical industry and regulators work together to evaluate and validate alternative methods that are based on both the underlying science and are adapted to the drug product itself instead of single "universal" method.

77 FR 40817 - Low-Level Radioactive Waste Regulatory Management Issues

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-11

...-2011-0012] RIN-3150-AI92 Low-Level Radioactive Waste Regulatory Management Issues AGENCY: Nuclear... Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555... State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington...

Regulatory ozone modeling: status, directions, and research needs.

PubMed Central

Georgopoulos, P G

1995-01-01

The Clean Air Act Amendments (CAAA) of 1990 have established selected comprehensive, three-dimensional, Photochemical Air Quality Simulation Models (PAQSMs) as the required regulatory tools for analyzing the urban and regional problem of high ambient ozone levels across the United States. These models are currently applied to study and establish strategies for meeting the National Ambient Air Quality Standard (NAAQS) for ozone in nonattainment areas; State Implementation Plans (SIPs) resulting from these efforts must be submitted to the U.S. Environmental Protection Agency (U.S. EPA) in November 1994. The following presentation provides an overview and discussion of the regulatory ozone modeling process and its implications. First, the PAQSM-based ozone attainment demonstration process is summarized in the framework of the 1994 SIPs. Then, following a brief overview of the representation of physical and chemical processes in PAQSMs, the essential attributes of standard modeling systems currently in regulatory use are presented in a nonmathematical, self-contained format, intended to provide a basic understanding of both model capabilities and limitations. The types of air quality, emission, and meteorological data needed for applying and evaluating PAQSMs are discussed, as well as the sources, availability, and limitations of existing databases. The issue of evaluating a model's performance in order to accept it as a tool for policy making is discussed, and various methodologies for implementing this objective are summarized. Selected interim results from diagnostic analyses, which are performed as a component of the regulatory ozone modeling process for the Philadelphia-New Jersey region, are also presented to provide some specific examples related to the general issues discussed in this work. Finally, research needs related to a) the evaluation and refinement of regulatory ozone modeling, b) the characterization of uncertainty in photochemical modeling, and c) the improvement of the model-based ozone-attainment demonstration process are presented to identify future directions in this area. Images Figure 7. Figure 7. Figure 7. Figure 8. Figure 9. PMID:7614934

Non-animal models of epithelial barriers (skin, intestine and lung) in research, industrial applications and regulatory toxicology.

PubMed

Gordon, Sarah; Daneshian, Mardas; Bouwstra, Joke; Caloni, Francesca; Constant, Samuel; Davies, Donna E; Dandekar, Gudrun; Guzman, Carlos A; Fabian, Eric; Haltner, Eleonore; Hartung, Thomas; Hasiwa, Nina; Hayden, Patrick; Kandarova, Helena; Khare, Sangeeta; Krug, Harald F; Kneuer, Carsten; Leist, Marcel; Lian, Guoping; Marx, Uwe; Metzger, Marco; Ott, Katharina; Prieto, Pilar; Roberts, Michael S; Roggen, Erwin L; Tralau, Tewes; van den Braak, Claudia; Walles, Heike; Lehr, Claus-Michael

2015-01-01

Models of the outer epithelia of the human body - namely the skin, the intestine and the lung - have found valid applications in both research and industrial settings as attractive alternatives to animal testing. A variety of approaches to model these barriers are currently employed in such fields, ranging from the utilization of ex vivo tissue to reconstructed in vitro models, and further to chip-based technologies, synthetic membrane systems and, of increasing current interest, in silico modeling approaches. An international group of experts in the field of epithelial barriers was convened from academia, industry and regulatory bodies to present both the current state of the art of non-animal models of the skin, intestinal and pulmonary barriers in their various fields of application, and to discuss research-based, industry-driven and regulatory-relevant future directions for both the development of new models and the refinement of existing test methods. Issues of model relevance and preference, validation and standardization, acceptance, and the need for simplicity versus complexity were focal themes of the discussions. The outcomes of workshop presentations and discussions, in relation to both current status and future directions in the utilization and development of epithelial barrier models, are presented by the attending experts in the current report.

Comprehensive in vitro Proarrhythmia Assay (CiPA): Pending issues for successful validation and implementation.

PubMed

Cavero, Icilio; Guillon, Jean-Michel; Ballet, Veronique; Clements, Mike; Gerbeau, Jean-Frédéric; Holzgrefe, Henry

2016-01-01

The Comprehensive in vitro Proarrhythmia Assay (CiPA) is a nonclinical Safety Pharmacology paradigm for discovering electrophysiological mechanisms that are likely to confer proarrhythmic liability to drug candidates intended for human use. Key talks delivered at the 'CiPA on my mind' session, held during the 2015 Annual Meeting of the Safety Pharmacology Society (SPS), are summarized. Issues and potential solutions relating to crucial constituents [e.g., biological materials (ion channels and pluripotent stem cell-derived cardiomyocytes), study platforms, drug solutions, and data analysis] of CiPA core assays are critically examined. In order to advance the CiPA paradigm from the current testing and validation stages to a research and regulatory drug development strategy, systematic guidance by CiPA stakeholders is necessary to expedite solutions to pending and newly arising issues. Once a study protocol is proved to yield robust and reproducible results within and across laboratories, it can be implemented as qualified regulatory procedure. Copyright © 2016 Elsevier Inc. All rights reserved.

Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems

PubMed Central

Anderson, Monique L; Califf, Robert M; Sugarman, Jeremy

2015-01-01

Cluster randomized trials (CRTs) randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic CRTs in routine healthcare settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic CRTs but challenges remain, including some arising from the current U.S. research and healthcare regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic CRTs in healthcare settings, the National Institutes of Health (NIH) Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland in July of 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the NIH, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of CRTs, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic CRTs in healthcare settings. PMID:25733677

The Regulatory Challenges of Decommissioning Nuclear Power Plants in Korea - 13101

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Jungjoon; Ahn, Sangmyeon; Choi, Kyungwoo

As of 2012, 23 units of nuclear power plants are in operation, but there is no experience of permanent shutdown and decommissioning of nuclear power plant in Korea. It is realized that, since late 1990's, improvement of the regulatory framework for decommissioning has been emphasized constantly from the point of view of International Atomic Energy Agency (IAEA)'s safety standards. And it is known that now IAEA prepare the safety requirement on decommissioning of facilities, its title is the Safe Decommissioning of Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission tomore » Korea in 2011, it was recommended that the regulatory framework for decommissioning should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became also important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we identify the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is to be established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. After dealing with it, it is expected that the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

The regulatory framework for safe decommissioning of nuclear power plants in Korea

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sangmyeon Ahn; Jungjoon Lee; Chanwoo Jeong

We are having 23 units of nuclear power plants in operation and 5 units of nuclear power plants under construction in Korea as of September 2012. However, we don't have any experience on shutdown permanently and decommissioning of nuclear power plants. There are only two research reactors being decommissioned since 1997. It is realized that improvement of the regulatory framework for decommissioning of nuclear facilities has been emphasized constantly from the point of view of IAEA's safety standards. It is also known that IAEA will prepare the safety requirement on decommissioning of facilities; its title is the Safe Decommissioning ofmore » Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission to Korea in 2011, it was recommended that the regulatory framework should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we focus on identifying the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. It is expected that if the things will go forward as planned, the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

IT Legislative and Regulatory Issues Agenda. Higher Education Information Technology Alliance

ERIC Educational Resources Information Center

National Association of State Universities and Land-Grant Colleges, 2004

2004-01-01

This document represents the higher education and library community's guiding public policy agenda on information technology (IT) for the current year. The Higher Education Information Technology (HEIT) Alliance is a coalition of 11 national higher education and library associations, whose members represent a broad array of stakeholders on college…

77 FR 66850 - Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

...; the U.S. Army Medical Research Institute of Infectious Diseases; the Biomedical Advanced Research and... research needed to advance animal model development and to advance candidate medical countermeasures (MCMs... antibiotics. For example, a 20-year prospective study of melioidosis in northern Australia found an overall...

Battery condenser system total particulate emission factors and rates for cotton gins

USDA-ARS?s Scientific Manuscript database

This manuscript is part of a series of manuscripts that characterize cotton gin emissions from the standpoint of stack sampling. The impetus behind this project was the urgent need to collect additional cotton gin emissions data to address current regulatory issues. A key component of this study was...

Battery condenser system PM10 emission factors and rates for cotton gins

USDA-ARS?s Scientific Manuscript database

This manuscript is part of a series of manuscripts that to characterize cotton gin emissions from the standpoint of stack sampling. The impetus behind this project was the urgent need to collect additional cotton gin emissions data to address current regulatory issues. A key component of this study ...

Battery condenser system total particulate emission factors and rates for cotton gins: Method 17

USDA-ARS?s Scientific Manuscript database

This manuscript is part of a series of manuscripts that characterize cotton gin emissions from the standpoint of stack sampling. The impetus behind this project was the urgent need to collect additional cotton gin emissions data to address current regulatory issues. A key component of this study was...

Environmental damage schedules: community judgments of importance and assessments of losses

Treesearch

Ratana Chuenpagdee; Jack L. Knetsch; Thomas C. Brown

2001-01-01

Available methods of valuing environmental changes are often limited in their applicability to current issues such as damage assessment and implementing regulatory controls, or may otherwise not provide reliable readings of community preferences. An alternative is to base decisions on predetermined fixed schedules of sanctions, restrictions, damage awards, and other...

76 FR 65544 - Standard Format and Content of License Applications for Mixed Oxide Fuel Fabrication Facilities

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-21

...The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision to regulatory guide (RG) 3.39, ``Standard Format and Content of License Applications for Mixed Oxide Fuel Fabrication Facilities.'' This guide endorses the standard format and content for license applications and integrated safety analysis (ISA) summaries described in the current version of NUREG-1718, ``Standard Review Plan for the Review of an Application for a Mixed Oxide (MOX) Fuel Fabrication Facility,'' as a method that the NRC staff finds acceptable for meeting the regulatory requirements of Title 10 of the Code of Federal Regulations (10 CFR) part 70, ``Domestic Licensing of Special Nuclear Material'' for mixed oxide fuel fabrication facilities.

Providing notice to employees on leave: Implications of Ragsdale versus Wolverine Worldwide, Inc.

PubMed

Cossi, David A; McGovern, Patricia M

2003-11-01

Occupational health nurses must develop a perspective on implementation of the Family and Medical Leave Act (FMLA) that supports the provision of quality nursing care to employees and regulatory compliance by the employer. Public policy related to the FMLA continues to evolve with the states acting more rapidly than the federal government as laboratories for social change. Occupational health nurses must identify resources for staying current about new legislation and proposals to advise employers and facilitate regulatory compliance. Occupational health nurses should advise employers to provide written notice to employees designating leave taken under company leave policies as counting as employees' FMLA leave entitlement. These issues are important for regulatory compliance, and also for communication with and fair treatment of employees.

Nanotechnologies in agriculture and food - an overview of different fields of application, risk assessment and public perception.

PubMed

Grobe, Antje; Rissanen, Mikko E

2012-12-01

Nanomaterials in agriculture and food are key issues of public and regulatory interest. Over the past ten years, patents for nanotechnological applications in the field of food and agriculture have become abundant. Uncertainty prevails however regarding their current development status and presence in the consumer market. Thus, the discussion on nanotechnologies in the food sector with its specific public perception of benefits and risks and the patterns of communication are becoming similar to the debate on genetically modified organisms. The food industry's silence in communication increased mistrust of consumer organisations and policy makers. The article discusses the background of the current regulatory debates, starting with the EU recommendation for defining nanomaterials, provides an overview of possible fields of application in agriculture and food industries and discusses risk assessment and the public debate on benefits and risks. Communicative recommendations are directed at researchers, the food industry and regulators in order to increase trust both in stakeholders, risk management and regulatory processes.

Introduction: MicroRNAs in human reproduction: small molecules with crucial regulatory roles.

PubMed

Imbar, Tal; Galliano, Daniela; Pellicer, Antonio; Laufer, Neri

2014-06-01

MicroRNAs constitute a large family of approximately 21-nucleotide-long, noncoding RNAs. They emerged more than 20 years ago as key posttranscriptional regulators of gene expression. The regulatory role of these small RNA molecules has recently begun to be explored in the human reproductive system. In this issue's Views and Reviews, the authors present the current knowledge regarding the involvement of microRNAs in several aspects of human reproduction and discuss its future implications for clinical practice. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Telemental Health for Children and Adolescents: An Overview of Legal, Regulatory, and Risk Management Issues.

PubMed

Kramer, Gregory M; Luxton, David D

2016-04-01

The use of technology to provide telemental healthcare continues to increase; however, little has been written about the legal and regulatory issues involved in providing this form of care to children and adolescents. This article reviews existing laws and regulations to summarize the risk management issues relevant to providing telemental healthcare to children and adolescents. There are several legal and regulatory areas in which telemental health clinicians need to have awareness. These areas include: 1) Licensure, 2) malpractice liability, 3) credentialing and privileging, 4) informed consent, 5) security and privacy, and 6) emergency management. Although legal and regulatory challenges remain in providing telemental healthcare to children and adolescents, it is possible to overcome these challenges with knowledge of the issues and appropriate risk management strategies. We provide general knowledge of these key legal and regulatory issues, along with some risk management recommendations.

Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps?

PubMed

Flanagan, Talia; Van Peer, Achiel; Lindahl, Anders

2016-08-25

Regulatory interactions are an important part of the drug development and licensing process. A survey on the use of biopharmaceutical tools for regulatory purposes has been carried out within the industry community of the EU project OrBiTo within Innovative Medicines Initiative (IMI). The aim was to capture current practice and experience in using in vitro and in silico biopharmaceutics tools at various stages of development, what barriers exist or are perceived, and to understand the current gaps in regulatory biopharmaceutics. The survey indicated that biorelevant dissolution testing and physiologically based modelling and simulation are widely applied throughout development to address a number of biopharmaceutics issues. However, data from these in vitro and in silico predictive biopharmaceutics tools are submitted to regulatory authorities far less often than they are used for internal risk assessment and decision making. This may prevent regulators from becoming familiar with these tools and how they are applied in industry, and limits the opportunities for biopharmaceutics scientists working in industry to understand the acceptability of these tools in the regulatory environment. It is anticipated that the advanced biopharmaceutics tools and understanding delivered in the next years by OrBiTo and other initiatives in the area of predictive tools will also be of value in the regulatory setting, and provide a basis for more informed and confident biopharmaceutics risk assessment and regulatory decision making. To enable the regulatory potential of predictive biopharmaceutics tools to be realized, further scientific dialogue is needed between industry, regulators and scientists in academia, and more examples need to be published to demonstrate the applicability of these tools. Copyright © 2016 Elsevier B.V. All rights reserved.

Steering healthcare service delivery: a regulatory perspective.

PubMed

Prakash, Gyan

2015-01-01

The purpose of this paper is to explore regulation in India's healthcare sector and makes recommendations needed for enhancing the healthcare service. The literature was reviewed to understand healthcare's regulatory context. To understand the current healthcare system, qualitative data were collected from state-level officials, public and private hospital staff. A patient survey was performed to assess service quality (QoS). Regulation plays a central role in driving healthcare QoS. India needs to strengthen market and institutional co-production based approaches for steering its healthcare in which delivery processes are complex and pose different challenges. This study assesses current healthcare regulation in an Indian state and presents a framework for studying and strengthening regulation. Agile regulation should be based on service delivery issues (pull approach) rather than monitoring and sanctions based regulatory environment (push approach). Healthcare pitfalls across the world seem to follow similar follies. India's complexity and experience is useful for emerging and developed economies. The author reviewed around 70 publications and synthesised them in healthcare regulatory contexts. Patient's perception of private providers could be a key input towards steering regulation. Identifying gaps across QoS dimensions would be useful in taking corrective measures.

Cross-Cutting issues in Regulatory Supervision of Spent Fuel Radioactive Waste and Radioactively Contaminated Land in North-West Russia

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sneve, M. K.; Smith, G. M.

2006-07-01

The Norwegian Government is promoting improvements in radiation protection and nuclear safety in North-West Russia. Among priority areas there is the improvement of spent nuclear fuel and radioactive waste management, as well as remediation operations at the Shore Technical Bases operated by Federal Enterprise SevRAO at Andreeva Bay and Gremikha on the Kola Peninsula. The extreme radiological conditions at these sites present novel difficulties for regulatory supervision of operations. The situation at these sites is such that the existing regulations are applicable, and actions to remedy the situation are not permitted under the current regulatory regime. An improved regulatory process,more » including development of special norms and rules, is required to take account of this unusual situation. The Norwegian strategy includes not only support to industrial projects, but also support to Russian Federation regulatory bodies, to ensure that work is carried out in compliance with Russian Federation law, taking account of international recommendations and other national good practice as relevant in the RF. Accordingly, the Norwegian Radiation Protection Authority has set up a programme of cooperation with the Federal Medical-Biological Agency (FMBA), which is the primary radiation protection authority in the RF. The work is carried out with technical input from the Russian Institute of Biophysics and with inputs from western technical support organisations. The overall objective of the work is to promote effective and efficient regulatory supervision of SevRAO activities at Andreeva Bay and Gremikha within the scope of responsibilities of FMBA. This paper describes the results of an initial threat assessment which allows consideration of the cross-cutting issues associated with developing an overall effective site management plan which deals with short- and long-term issues, and protection of workers as well as of the public and the environment, while achieving a timely and effective use of resources in order to solve the problems. (authors)« less

Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

PubMed Central

Russo, Ethan B.

2016-01-01

This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain. PMID:27683558

Regulatory aspects of oncology drug safety evaluation: past practice, current issues, and the challenge of new drugs.

PubMed

Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M Stacey; McGuinn, W David; Verbois, S Leigh

2010-03-01

The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

Overview of Variable Renewable Energy Regulatory Issues: A Clean Energy Regulators Initiative Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Miller, M.; Cox, S.

This CERI report aims to provide an introductory overview of key regulatory issues associated with the deployment of renewable energy -- particularly variable renewable energy (VRE) sources such wind and solar power. The report draws upon the research and experiences from various international contexts, and identifies key ideas that have emerged from the growing body of VRE deployment experience and regulatory knowledge. The report assumes basic familiarity with regulatory concepts, and although it is not written for a technical audience, directs the reader to further reading when available. VRE deployment generates various regulatory issues: substantive, procedural, and public interest issues,more » and the report aims to provide an empirical and technical grounding for all three types of questions as appropriate.« less

Guidelines for Bacteriophage Product Certification.

PubMed

Fauconnier, Alan

2018-01-01

Following decades in the wilderness, bacteriophage therapy is now appearing as a credible antimicrobial strategy. However, this reemerging therapy does not rekindle without raising sensitive regulatory concerns. Indeed, whereas the European regulatory framework has been basically implemented to tackle ready-to-use pharmaceuticals produced on a large scale, bacteriophage therapy relies on a dynamic approach requiring a regulation on personalized medicine, nonexistent at present. Because of this, no guideline are currently available for addressing the scientific and regulatory issues specifically related to phage therapy medicinal products (PTMP).Pending to the implementation of an appropriate regulatory framework and to the development of ensuing guidelines, several avenues which might lead to PTMP regulatory compliance are explored here. Insights might come from the multi-strain dossier approach set up for particular animal vaccines, from the homologous group concept developed for the allergen products or from the licensing process for veterinary autogenous vaccines. Depending on national legislations, customized preparations prescribed as magistral formulas or to be used on a named-patient basis are possible regulatory approaches to be considered. However, these schemes are not optimal and should thus be regarded as transitional.

Ethical Issues and Codes of Ethics: Views of Adult Education Practitioners in Canada and the United States.

ERIC Educational Resources Information Center

Gordon, Wanda; Sork, Thomas J.

2001-01-01

Replicating an Indiana study, 261 responses from British Columbia adult educators revealed a high degree of support for codes of ethics and identified ethical dilemmas in practice. Half currently operated under a code. Responses to whether codes should have a regulatory function were mixed. (Contains 44 references.) (SK)

76 FR 74111 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-30

... that CBSX is not currently the primary listing market for any stocks, and thus, will not be issuing any... Effectiveness of Proposed Rule Change Related to the Individual Stock Trading Pause Pilot Program November 23... Change The Exchange is proposing to amend CBOE Stock Exchange, LLC's (``CBSX'', the CBOE's stock trading...

75 FR 69150 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... Process in Providing Trustee Access to the Security Position Report Service November 4, 2010. I.... The current review process to approve a trustee's access to the SPR service for a security is done... a trustee's access to DTC's SPR service for an issue with an automated approval process, DTC will be...

Battery condenser system PM10 emission factors and rates for cotton gins: Method 201A PM10 sizing cyclones

USDA-ARS?s Scientific Manuscript database

This manuscript is part of a series of manuscripts that to characterize cotton gin emissions from the standpoint of stack sampling. The impetus behind this project was the urgent need to collect additional cotton gin emissions data to address current regulatory issues. A key component of this study ...

Status of market, regulation and research of genetically modified crops in Chile.

PubMed

Sánchez, Miguel A; León, Gabriel

2016-12-25

Agricultural biotechnology and genetically modified (GM) crops are effective tools to substantially increase productivity, quality, and environmental sustainability in agricultural farming. Furthermore, they may contribute to improving the nutritional content of crops, addressing needs related to public health. Chile has become one of the most important global players for GM seed production for counter-season markets and research purposes. It has a comprehensive regulatory framework to carry out this activity, while at the same time there are numerous regulations from different agencies addressing several aspects related to GM crops. Despite imports of GM food/feed or ingredients for the food industry being allowed without restrictions, Chilean farmers are not using GM seeds for farming purposes because of a lack of clear guidelines. Chile is in a rather contradictory situation about GM crops. The country has invested considerable resources to fund research and development on GM crops, but the lack of clarity in the current regulatory situation precludes the use of such research to develop new products for Chilean farmers. Meanwhile, a larger scientific capacity regarding GM crop research continues to build up in the country. The present study maps and analyses the current regulatory environment for research and production of GM crops in Chile, providing an updated overview of the current status of GM seeds production, research and regulatory issues. Copyright © 2016 Elsevier B.V. All rights reserved.

Regulatory Networks Controlling Plant Cold Acclimation or Low Temperature Regulatory Networks Controlling Cold Acclimation in Arabidopsis (2011 JGI User Meeting)

ScienceCinema

Thomashow, Mike

2018-02-06

The U.S. Department of Energy Joint Genome Institute (JGI) invited scientists interested in the application of genomics to bioenergy and environmental issues, as well as all current and prospective users and collaborators, to attend the annual DOE JGI Genomics of Energy & Environment Meeting held March 22-24, 2011 in Walnut Creek, Calif. The emphasis of this meeting was on the genomics of renewable energy strategies, carbon cycling, environmental gene discovery, and engineering of fuel-producing organisms. The meeting features presentations by leading scientists advancing these topics. Mike Thomashow of Michigan State University gives a presentation on on "Low Temperature Regulatory Networks Controlling Cold Acclimation in Arabidopsis" at the 6th annual Genomics of Energy & Environment Meeting on March 23, 2011."

Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape.

PubMed

Benda, Norbert; Brandt, Andreas

2018-01-01

Recently, new draft guidelines on multiplicity issues in clinical trials have been issued by European Medicine Agency (EMA) and Food and Drug Administration (FDA), respectively. Multiplicity is an issue in clinical trials, if the probability of a false-positive decision is increased by insufficiently accounting for testing multiple hypotheses. We outline the regulatory principles related to multiplicity issues in confirmatory clinical trials intended to support a marketing authorization application in the EU, describe the reasons for an increasing complexity regarding multiple hypotheses testing and discuss the specific multiplicity issues emerging within the regulatory context and being relevant for drug approval.

The role of ethics in data governance of large neuro-ICT projects.

PubMed

Stahl, Bernd Carsten; Rainey, Stephen; Harris, Emma; Fothergill, B Tyr

2018-05-14

We describe current practices of ethics-related data governance in large neuro-ICT projects, identify gaps in current practice, and put forward recommendations on how to collaborate ethically in complex regulatory and normative contexts. We undertake a survey of published principles of data governance of large neuro-ICT projects. This grounds an approach to a normative analysis of current data governance approaches. Several ethical issues are well covered in the data governance policies of neuro-ICT projects, notably data protection and attribution of work. Projects use a set of similar policies to ensure users behave appropriately. However, many ethical issues are not covered at all. Implementation and enforcement of policies remain vague. The data governance policies we investigated indicate that the neuro-ICT research community is currently close-knit and that shared assumptions are reflected in infrastructural aspects. This explains why many ethical issues are not explicitly included in data governance policies at present. With neuro-ICT research growing in scale, scope, and international involvement, these shared assumptions should be made explicit and reflected in data governance.

CRISPR, Patents, and the Public Health



PubMed Central

Sherkow, Jacob S.

2017-01-01

Patent issues surrounding CRISPR, the revolutionary genetic editing technology, may have important implications for the public health. Patents maintain high prices for novel therapies, limiting patient access. Relatedly, insurance coverage for expensive therapies is waning. Patents also misallocate research and development resources to profitable disease indications rather than those that necessarily impinge on the public health. And it is unclear how CRISPR therapies will figure into the current regulatory framework for biosimilars. Policy makers and physicians should consider these issues now, before CRISPR therapies become widely adopted—and entrenched—in the marketplace. PMID:29259531

CRISPR, Patents, and the Public Health.

PubMed

Sherkow, Jacob S

2017-12-01

Patent issues surrounding CRISPR, the revolutionary genetic editing technology, may have important implications for the public health. Patents maintain high prices for novel therapies, limiting patient access. Relatedly, insurance coverage for expensive therapies is waning. Patents also misallocate research and development resources to profitable disease indications rather than those that necessarily impinge on the public health. And it is unclear how CRISPR therapies will figure into the current regulatory framework for biosimilars. Policy makers and physicians should consider these issues now, before CRISPR therapies become widely adopted-and entrenched-in the marketplace.

A combined park management framework based on regulatory and behavioral strategies: use of visitors' knowledge to assess effectiveness.

PubMed

Papageorgiou, K

2001-07-01

In light of the increasing mandate for greater efficiency in conservation of natural reserves such as national parks, the present study suggests educational approaches as a tool to achieve conservation purposes. Currently, the management of human-wildlife interactions is dominated by regulatory strategies, but considerable potential exists for environmental education to enhance knowledge in the short run and to prompt attitude change in the long run. A framework for conservation based on both traditional regulatory- and behavior-oriented strategies was proposed whereby the level of knowledge that park visitors have acquired comprises an obvious outcome and establishes a basis upon which the effectiveness of regulatory- and behavior-based regimes could be assessed. The perceptions regarding park-related issues of two distinct visitor groups (locals and nonlocals) are summarized from a survey undertaken in Vikos-Aoos national park. The findings suggest a superficial knowledge for certain concepts but little profound understanding of the content of such concepts, indicating that knowledge-raising efforts should go a long way towards establishing a positive attitude for the resource. Visitors' poor knowledge of the park's operation regulation contest the efficiency of the presently dominant regulatory management regime. While geographical distances did not appear to significantly differentiate knowledge between the two groups, wilderness experience (as certified by visits to other parks) was proved to be an impetus for generating substantial learner interest in critical park issues among nonlocal visitors. School education and media were found to be significant knowledge providers.

77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-28

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0048] Proposed Generic Communication; Regulatory Issue... CFR) Part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants,'' to satisfy the... inservice testing programs during the initial 120-month program interval following nuclear power plant...

Top Tips for Buying Telecommunication Services.

ERIC Educational Resources Information Center

Linder, Jeff

2001-01-01

Examines top regulatory issues and other unique issues resulting from this regulatory overlay when negotiating for corporate telecom services. Issues cover such topics as tariffs, rate negotiation, exclusivity provisions, revenue commitments, mid-term negotiations, service-level agreements, and dispute resolution. (GR)

Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014.

PubMed

Ho, Mei Mei; Baca-Estrada, Maria; Conrad, Christoph; Karikari-Boateng, Eric; Kang, Hye-Na

2015-08-26

The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Regulatory Compliance in Multi-Tier Supplier Networks

NASA Technical Reports Server (NTRS)

Goossen, Emray R.; Buster, Duke A.

2014-01-01

Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

Unique Regulatory Approach for Licensing the Port Hope Remediation Project in Canada - 13315

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kostova, M.; Howard, D.; Elder, P.

2013-07-01

The Port Hope remediation project is a part of a larger initiative of the Canadian Federal Government the Port Hope Area Initiative (PHAI) which is based upon a community proposal. The Government of Canada, through Natural Resources Canada (NRCan) is investing $1.28 billion over 10 years to clean up historic low-level radioactive waste in the Port Hope Area and to provide long-term safe management of the low-level radioactive wastes in the Port Hope Area. These wastes arose from the activities of a former Federal Crown Corporation (Eldorado Nuclear) and its private sector predecessors. In Canada, historic waste are defined asmore » low-level radioactive waste that was managed in a manner no longer considered acceptable, but for which the original producer cannot reasonably be held responsible or no longer exists and for which the Federal Government has accepted responsibility. In Canada, under the current regulatory framework, the environmental remediation is not considered as a distinct phase of the nuclear cycle. The regulatory approach for dealing with existing sites contaminated with radioactive residues is defined on the basis of risk and application of existing regulations. A unique regulatory approach was taken by the Canadian Nuclear Safety Commission (CNSC) to address the various licensing issues and to set out the requirements for licensing of the Port Hope Project within the current regulatory framework. (authors)« less

Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.

PubMed

Lin, Yi-Chu; Wang, Po-Yu; Tsai, Shih-Chih; Lin, Chien-Liang; Tai, Hsuen-Yung; Lo, Chi-Fang; Wu, Shiow-Ing; Chiang, Yu-Mei; Liu, Li-Ling

2015-01-01

Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

PubMed

Stevenson, Lauren; Garofolo, Fabio; DeSilva, Binodh; Dumont, Isabelle; Martinez, Suzanne; Rocci, Mario; Amaravadi, Lakshmi; Brudny-Kloeppel, Margarete; Musuku, Adrien; Booth, Brian; Dicaire, Catherine; Wright, Laura; Mayrand-Provencher, Laurence; Losauro, Mike; Gouty, Dominique; Arnold, Mark; Bansal, Surendra; Dudal, Sherri; Dufield, Dawn; Duggan, Jeff; Evans, Christopher; Fluhler, Eric; Fraser, Stephanie; Gorovits, Boris; Haidar, Sam; Hayes, Roger; Ho, Stacy; Houghton, Richard; Islam, Rafiqul; Jenkins, Rand; Katori, Noriko; Kaur, Surinder; Kelley, Marian; Knutsson, Magnus; Lee, Jean; Liu, Hanlan; Lowes, Steve; Ma, Mark; Mikulskis, Alvydas; Myler, Heather; Nicholson, Bob; Olah, Timothy; Ormsby, Eric; Patel, Shefali; Pucci, Vincenzo; Ray, Chad; Schultz, Gary; Shih, Judy; Shoup, Ronald; Simon, Craig; Song, An; Neto, João Tavares; Theobald, Valerie; Thway, Theingi; Wakelin-Smith, Jason; Wang, Jian; Wang, Laixin; Welink, Jan; Whale, Emma; Woolf, Eric; Xu, Raymond

2013-12-01

The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science. Such as the previous editions, this 2013 White Paper addresses important bioanalytical issues and provides practical answers to the topics presented, discussed and agreed upon by the global bioanalytical community attending the 7th Workshop on Recent Issues in Bioanalysis.

Historical perspective on the medical use of cannabis for epilepsy: Ancient times to the 1980s.

PubMed

Friedman, Daniel; Sirven, Joseph I

2017-05-01

There has been a dramatic surge in the interest of utilizing cannabis for epilepsy treatment in the US. Yet, access to cannabis for research and therapy is mired in conflicting regulatory policies and shifting public opinion. Understanding the current state of affairs in the medical cannabis debate requires an examination of the history of medical cannabis use. From ancient Chinese pharmacopeias to the current Phase III trials of pharmaceutical grade cannabidiol, this review covers the time span of cannabis use for epilepsy therapy so as to better assess the issues surrounding the modern medical opinion of cannabis use. This article is part of a Special Issue titled Cannabinoids and Epilepsy. Copyright © 2016 Elsevier Inc. All rights reserved.

Accounting Profession: Oversight, Auditor Independence, and Financial Reporting Issues

DTIC Science & Technology

2002-05-03

oversight of the accounting profession, auditor independence, and selected financial reporting matters. The sudden and largely unexpected bankruptcy of the...Enron Corporation (Enron) and other large corporations financial reporting restatements have raised questions about the soundness of the current self...regulatory and financial reporting systems and resulted in substantial losses to employees, shareholders, and other investors. These events have also

78 FR 69465 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

...-money strikes. Elimination of the cap would remedy this issue. Currently, the Exchange lists quarterly... additional strikes. Consequently, the Exchange is not able to list important at-the-money strikes due to the... so that it may list strikes that are closer to the money, delisting is not always possible. If all of...

78 FR 68108 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

... for Low-Volume Issues November 6, 2013. Pursuant to Section 19(b)(1) \\1\\ of the Securities Exchange... 100,000 1,500 The Exchange introduced the current lowest-volume LMM rights fee tier on October 1, 2013...-volume LMM rights fee tier, beginning November 1, 2013 the fee for the next highest tier would apply...

International Activities Related to Pesticides

EPA Pesticide Factsheets

Regulating pesticides involves many international issues and working with our regulatory partners in other countries. Learn about EPA's activities, upcoming meetings and workshops, and various regulatory issues.

Study of the regulatory issues affecting truck freight movement in the Midwest : [tech transfer summary].

DOT National Transportation Integrated Search

2014-12-01

This initial study identified the need for and interest in a peer-to-peer event focused on identifying regulatory trends and issues, as : well as the potential for Iowa and other states to find and prioritize : possible regulatory changes to improve ...

17 CFR 30.5 - Alternative procedures for non-domestic persons.

Code of Federal Regulations, 2010 CFR

2010-04-01

... communications issued by or on behalf of the Commission, U.S. Department of Justice, any self-regulatory..., any self-regulatory organization or any foreign futures or foreign options customer, pursuant to such... issued by or on behalf of the Commission, U.S. Department of Justice, any self-regulatory organization...

76 FR 26333 - National Federal Regulatory Enforcement Fairness Hearing Region III Regulatory Fairness Board

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-06

... National Ombudsman is issuing this notice to announce the location, date and time of the National Federal... Visual and Performing Arts Center--Smith Theatre, Howard Community College, 10901 Little Patuxent Parkway... regulatory enforcement issues affecting their members. Free parking is available at the college. Anyone...

Future development of global regulations of Chinese herbal products.

PubMed

Fan, Tai-Ping; Deal, Greer; Koo, Hoi-Lun; Rees, Daryl; Sun, He; Chen, Shaw; Dou, Jin-Hui; Makarov, Valery G; Pozharitskaya, Olga N; Shikov, Alexander N; Kim, Yeong Shik; Huang, Yi-Tsau; Chang, Yuan Shiun; Jia, William; Dias, Alberto; Wong, Vivian Chi-Woon; Chan, Kelvin

2012-04-10

GP-TCM is the first EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. One of the key deliverables of the Work Package 7 in GP-TCM was to investigate information of the existing requirements for registration of TCM products listed by global regulatory bodies. The paper aims to collate data and draw comparison of these regulations. Case studies are also presented to illustrate the problems involved in registering TCM products in different regions worldwide. A collaborative network task force was established during the early stage of the GP-TCM project and operated through exchanges, teleconferences and focused discussions at annual meetings. The task force involved coordinators, academics who are actively involved with R&D of Chinese herbal medicines, experts on monographic standards of Chinese materia medica, representatives from regulatory agencies, experts from industries in marketing Chinese medicines/herbal medicines and natural products. The co-ordinators took turns to chair teleconferences, led discussions on specific issues at AGM discussion sessions, at joint workshops with other work-packages such as WP1 (quality issues), WP3 (toxicology issues) and WP6 (clinical trial issues). Collectively the authors were responsible for collating discussion outcomes and updating written information. A global overview of regulations on herbal registration has been compiled during the three years of the consortium. The regulatory requirements for registration of herbal products in the EU and China were compared, and this is extended to other regions/countries: Africa, Australia, Brazil, Canada, Japan, Russia, South Korea, Taiwan, and the United States. A wide variation of the regulations for the categories of herbal products exists: food (functional food, novel foods, dietary food for special medical purpose, foods for particular nutritional use, food supplement); cosmetic, traditional herbal medicine products; herbal medicines for human use and veterinary use. The regulatory issues for registration of herbal products are complicated among the countries and regions worldwide. The information summarised in the text is for reference only. Some regulations which are presented in this review are still in legislation process and may change in due course. Before taking any regulatory action, readers are advised to consult current official legislation and guidance and/or to seek appropriate professional advice. The lessons learnt from global regulation of TCM will provide valuable insights for regulation of other traditional medicine such as Ayurveda and Unani medicine, as well as other forms of indigenous medicine. The WHO is well placed to co-ordinate a consultation process with the aim of putting forward suggestions for harmonisation to key regulatory agencies. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Unique agricultural safety and health issues of migrant and immigrant children.

PubMed

McLaurin, Jennie A; Liebman, Amy K

2012-01-01

Immigrant and migrant youth who live and work in agricultural settings experience unique agricultural safety and health issues. Mobility, poverty, cultural differences, immigration status, language, education, housing, food security, regulatory standards and enforcement, and access to childcare and health care influence exposure risk and the well-being of this population. Approximately 10% of the migrant agricultural labor force is composed of unaccompanied minors, whose safety and health is further compounded by lack of social supports and additional stresses associated with economic independence. This paper examines the current demographic and health data, regulatory protections, and programs and practices addressing safety and health in this sector of youth in agriculture. Gaps in knowledge and practice are identified, with emphasis on data collection and regulatory limitations. Best practices in programs addressing the special needs of this population are highlighted. Recommendations identify seven priority areas for impact to promote transformative change in the agricultural health and safety concerns of unaccompanied minors and children of immigrant, migrant and seasonal farmworkers. This framework may be used to examine similar needs in other identified subpopulations of children as they merit attention, whether now or in the future.

Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

MULKEY, C.H.

1999-07-06

This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through themore » DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants.« less

18 CFR 2.1a - Public suggestions, comments, proposals on substantial prospective regulatory issues and problems.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL...

18 CFR 2.1a - Public suggestions, comments, proposals on substantial prospective regulatory issues and problems.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL...

18 CFR 2.1a - Public suggestions, comments, proposals on substantial prospective regulatory issues and problems.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL...

18 CFR 2.1a - Public suggestions, comments, proposals on substantial prospective regulatory issues and problems.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL...

Communication Regulatory Science: Mapping a New Field.

PubMed

Noar, Seth M; Cappella, Joseph N; Price, Simani

2017-12-13

Communication regulatory science is an emerging field that uses validated techniques, tools, and models to inform regulatory actions that promote optimal communication outcomes and benefit the public. In the opening article to this special issue on communication and tobacco regulatory science, we 1) describe Food and Drug Administration (FDA) regulation of tobacco products in the US; 2) introduce communication regulatory science and provide examples in the tobacco regulatory science realm; and 3) describe the special issue process and final set of articles. Communication research on tobacco regulatory science is a burgeoning area of inquiry, and this work advances communication science, informs and potentially guides the FDA, and may help to withstand legal challenges brought by the tobacco industry. This research has the potential to have a major impact on the tobacco epidemic and population health by helping implement the most effective communications to prevent tobacco initiation and increase cessation. This special issue provides an example of 10 studies that exemplify tobacco regulatory science and demonstrate how the health communication field can affect regulation and benefit public health.

[Convergence of healthcare regulation in the Americas: history, development, and new challenges].

PubMed

Silva, Ana Paula Jucá; Tagliari, Patrícia Oliveira Pereira

2016-05-01

The present article describes the changing relationship among healthcare regulatory authorities in various international settings, with special emphasis on the Americas. As other sectors, healthcare also faces the need to regulate international practices, while at the same time taking into consideration the specific realities of each country. Regulatory convergence - a movement towards technical alignment to enable the adoption of local regulatory mechanisms that take into account internationally recognized standards and principles to promote a single sanitary goal - has emerged as a means to address this challenge. Organizations that already use this tool, such as the International Conference of Drug Regulatory Authorities (ICDRA), Pan American Network for Drug Regulatory Harmonization (PANDRH), International Generic Drug Regulators Programme (IGDRP), and the International Medical Device Regulators Forum (IMDRF), among others, are currently working to gather knowledge, data, and specialists from different countries to build an international technical and scientific standard that can be used for decision-making by local regulators. This would ensure convergence of national regulations despite the need to adapt international standards to local needs, structure, and capacities. The most recent resolutions issued by the World Health Organization recognize the need to bring regulatory systems closer to the reality of national healthcare systems, and underscore the advantages of using existing local guidelines as input for cooperation with regulatory authorities.

News from the Biological Stain Commission No. 5.

PubMed

Lyon, H O; Dapson, R W

2009-06-01

In this fifth issue of News from the Biological Stain Commission (BSC), under the heading of Regulatory Affairs, the BSC's International Affairs Committee provides more information from the meeting of the International Standards Organization ISO/TC 212 Committee that took place on June 2-4, 2008 at Vancouver, Canada. In addition, we give an update on the current situation regarding the supplies of hematoxylin.

Unmanned Aerial Vehicle Systems for Disaster Relief: Tornado Alley

NASA Technical Reports Server (NTRS)

DeBusk, Wesley M.

2009-01-01

Unmanned aerial vehicle systems are currently in limited use for public service missions worldwide. Development of civil unmanned technology in the United States currently lags behind military unmanned technology development in part because of unresolved regulatory and technological issues. Civil unmanned aerial vehicle systems have potential to augment disaster relief and emergency response efforts. Optimal design of aerial systems for such applications will lead to unmanned vehicles which provide maximum potentiality for relief and emergency response while accounting for public safety concerns and regulatory requirements. A case study is presented that demonstrates application of a civil unmanned system to a disaster relief mission with the intent on saving lives. The concept utilizes unmanned aircraft to obtain advanced warning and damage assessments for tornados and severe thunderstorms. Overview of a tornado watch mission architecture as well as commentary on risk, cost, need for, and design tradeoffs for unmanned aerial systems are provided.

Worldwide legislative challenges related to psychoactive drugs.

PubMed

Negrei, Carolina; Galateanu, Bianca; Stan, Miriana; Balalau, Cristian; Dumitru, Mircea Lucian Bogdan; Ozcagli, Eren; Fenga, Concettina; Kovatsi, Leda; Fragou, Domniki; Tsatsakis, Aristidis

2017-06-02

The discovery of a "new" psychoactive substance is a relatively exceptional event, while the regulatory response usually involved the assessment of risks to public health and inclusion of the novel substance in the national list of controlled substances. However, in recent years we have witnessed the rapid emergence of new chemical substances, which elude international control and pose a challenge to existing processes and a threat to the credibility of control systems. We currently review and present characteristics of these legal and illegal new substances and issues regarding their global monitoring and regulatory measures already taken, or in the process of being taken, for their control. The concept of prohibition applied in active substance-related legislation is rather hazard ridden as balance is required between the ban on substances of potential therapeutic use and the access on the market of high-risk substances. Current and future laws regarding psychoactive compounds.

75 FR 3760 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-22

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0018] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory...) is issuing for public comment a draft guide in the agency's ``Regulatory Guide'' series. This series...

Regulatory Issues and Challenges in Developing Seismic Source Characterizations for New Nuclear Power Plant Applications in the US

NASA Astrophysics Data System (ADS)

Fuller, C. W.; Unruh, J.; Lindvall, S.; Lettis, W.

2009-05-01

An integral component of the safety analysis for proposed nuclear power plants within the US is a probabilistic seismic hazard assessment (PSHA). Most applications currently under NRC review followed guidance provided within NRC Regulatory Guide 1.208 (RG 1.208) for developing seismic source characterizations (SSC) for their PSHA. Three key components of RG 1.208 guidance is that applicants should: (1) use existing PSHA models and SSCs accepted by the NRC as SSC as a starting point for their SSCs; (2) evaluate new information and data developed since acceptance of the starting model to determine if the model should be updated; and (3) follow guidelines set forth by the Senior Seismic Hazard Analysis Committee (SSHAC) (NUREG/CR-6372) in developing significant updates (i.e., updates should capture SSC uncertainty through representing the "center, body, and range of technical interpretations" of the informed technical community). Major motivations for following this guidance are to ensure accurate representations of hazard and regulatory stability in hazard estimates for nuclear power plants. All current applications with the NRC have used the EPRI-SOG source characterizations developed in the 1980s as their starting point model, and all applicants have followed RG 1.208 guidance in updating the EPRI- SOG model. However, there has been considerable variability in how applicants have interpreted the guidance, and thus there has been considerable variability in the methodology used in updating the SSCs. Much of the variability can be attributed to how different applicants have interpreted the implications of new data, new interpretations of new and/or old data, and new "opinions" of members of the informed technical community. For example, many applicants and the NRC have wrestled with the challenge of whether or not to update SSCs in light of new opinions or interpretations of older data put forth by one member of the technical community. This challenge has been further complicated by: (1) a given applicant's uncertainty in how to revise the EPRI-SOG model, which was developed using a process similar to that dictated by SSHAC for a level 3 or 4 study, without conducting a resource-intensive SSHAC level 3 or higher study for their respective application; and (2) a lack of guidance from the NRC on acceptable methods of demonstrating that new data, interpretations, and opinions are adequately represented within the EPRI-SOG model. Partly because of these issues, initiative was taken by the nuclear industry, NRC and DOE to develop a new base PSHA model for the central and eastern US. However, this new SSC model will not be completed for several years and does not resolve many of the fundamental regulatory and philosophical issues that have been raised during the current round of applications. To ensure regulatory stability and to provide accurate estimates of hazard for nuclear power plants, a dialog must be started between regulators and industry to resolve these issues. Two key issues that must be discussed are: (1) should new data and new interpretations or opinions of old data be treated differently in updated SSCs, and if so, how?; and (2) how can new data or interpretations developed by a small subset of the technical community be weighed against and potentially combined with a SSC model that was originally developed to capture the "center, body and range" of the technical community?

The role of consent in medical research: breaking or building walls? A call for legislative reform.

PubMed

Dangata, Yohanna Yanshiyi

2011-12-01

Research has been integral to the practice of medicine for almost as long as the discipline has existed. Until fairly recently research used to be conducted on human subjects without mandatory requirement for their consent. However, over time medical research became associated with significant cruelty resulting in an outcry for regulation of research actives. This resulted in significant legislation in place for monitoring. Today it is mandatory to obtain consent from subjects before embarking on medical research, and indeed treatment. Its significant regulatory role notwithstanding, the issue of consent at times becomes a hindrance to research. This paper examines the issue of consent in relation to medical research in the context of present legislation. It lays out the background to medical research with respect to purpose, scope, standard protocol and related issues; it then addresses the issue of consent in various scenarios, highlighting problems and the need for legislative reform. It is maintained that while regulatory measures have brought a lot of sanity to medical research and the medical profession, some measures are building walls inhibitory to research activities. Research being integral to the development and growth of healthcare delivery, there is need for reformation of current medical law for balance between patient protectionism and progress in medical research for effective patient care.

Let's Get Small: An Introduction to Transitional Issues in Nanotech and Intellectual Property.

PubMed

Koepsell, David

2009-08-01

Much of the discussion regarding nanotechnology centers around perceived and prosphesied harms and risks. While there are real risks that could emerge from futuristic nanotechnology, there are other current risks involved with its development, not involving physical harms, that could prevent its full promise from being realized. Transitional forms of the technology, involving "microfab," or localized, sometimes desk-top, manufacture, pose a good opportunity for case study. How can we develop legal and regulatory institutions, specifically centered around the problems of intellectual property, that both stimulate innovation, and make the best possible use of what will eventually be a market in "types" rather than "tokens"? This paper argues that this is the most critical, current issues facing nanotechnology, and suggests a manner to approach it.

75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0148] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

75 FR 45166 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-02

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0265] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

The logic of the floral transition: Reverse-engineering the switch controlling the identity of lateral organs.

PubMed

Dinh, Jean-Louis; Farcot, Etienne; Hodgman, Charlie

2017-09-01

Much laboratory work has been carried out to determine the gene regulatory network (GRN) that results in plant cells becoming flowers instead of leaves. However, this also involves the spatial distribution of different cell types, and poses the question of whether alternative networks could produce the same set of observed results. This issue has been addressed here through a survey of the published intercellular distribution of expressed regulatory genes and techniques both developed and applied to Boolean network models. This has uncovered a large number of models which are compatible with the currently available data. An exhaustive exploration had some success but proved to be unfeasible due to the massive number of alternative models, so genetic programming algorithms have also been employed. This approach allows exploration on the basis of both data-fitting criteria and parsimony of the regulatory processes, ruling out biologically unrealistic mechanisms. One of the conclusions is that, despite the multiplicity of acceptable models, an overall structure dominates, with differences mostly in alternative fine-grained regulatory interactions. The overall structure confirms the known interactions, including some that were not present in the training set, showing that current data are sufficient to determine the overall structure of the GRN. The model stresses the importance of relative spatial location, through explicit references to this aspect. This approach also provides a quantitative indication of how likely some regulatory interactions might be, and can be applied to the study of other developmental transitions.

75 FR 36715 - Final Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-28

... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision..., Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory...

75 FR 21749 - Spring 2010 Semiannual Agenda of Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

...In compliance with Executive Order 12866, entitled ``Regulatory Planning and Review,'' and the Regulatory Flexibility Act, as amended, the Department of Commerce (Department), in the spring and fall of each year, publishes in the Federal Register an agenda of regulations under development of review over the next 12 months. Rulemaking actions are grouped according to prerulemaking, proposed rules, final rules, long-term actions, and rulemaking actions completed since the fall 2009 agenda. The purpose of the agenda is to provide information to the public on regulations currently under review, being proposed, or issued by the Department. The agenda is intended to facilitate comments and views by interested members of the public.

Assessing the role of regulatory bodies in managing health professional issues and errors in Europe.

PubMed

Risso-Gill, Isabelle; Legido-Quigley, H; Panteli, D; Mckee, M

2014-08-01

This paper explores how medical regulatory bodies in nine European countries manage professional issues involving quality and patient safety, to build on limited existing information on procedures for regulating medical professionals in Europe. Twelve vignettes describing scenarios of concerns about standards of physicians were developed, covering clinical, criminal and administrative matters. Medical regulatory bodies in nine European countries were asked what action they would normally take in each situation. Their responses were related to their regulatory mandate. Responses varied greatly across participating countries. Regulators are always involved where patients are at risk or where a criminal offence is committed within the clinical setting. Non-criminal medical issues were generally handled by the employer, if any, at their discretion. Countries varied in the use of punitive measures, the extent to which they took an interest in issues arising outside professional activities, and whether they dealt with issues themselves or referred cases to another regulatory authority or took no action at all. There is little consistency across Europe on the regulation of medical professionals. There is considerable diversity in the range of topics that regulatory bodies oversee, with almost all covering health care quality and safety and others encompassing issues related to reputation, respect and trust. These inconsistencies have significant implications for professional mobility, patient safety and quality of care. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

76 FR 6085 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

...-2011-0014] RIN 3150-AI49 Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice Availability of Draft Regulatory Guide. SUMMARY: The U.S. Nuclear Regulatory Commission (Commission or NRC) is issuing for public comment Draft Regulatory Guide, DG-5019, ``Reporting and...

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

PubMed

Borg, John Joseph; Tomasi, Paolo; Pani, Luca; Aislaitner, George; Pirozynski, Michal; Leufkens, Hubert; Melchiorri, Daniela

2014-01-01

When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.

Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure.

PubMed

Caneva, Laura; Bonelli, Milton; Papaluca-Amati, Marisa; Vidal, Jean-Marc

2014-04-01

In this article we analyse the Environmental Risk Assessment (ERA) of 59 medicinal products for human use authorised in the EU through the centralised procedure between 2011 and 2012, to establish whether company submissions are compliant with the European Medicines Agency (EMA) guideline and complete in terms of data and study reports provided. The most frequent questions raised by EU regulatory authorities are described, together with an evaluation of the presence and quality of ERA-related information in published regulatory assessment documents. The results of this review show recent improvement in ERA-related data presented in regulatory assessment documents available to the public while also highlighting a need to develop further guidance on environmental issues in order to assist applicants improve their ERA dossiers and overcome current shortcomings. Copyright © 2014 Elsevier Inc. All rights reserved.

Protecting sensitive systems and data in an open agency

NASA Technical Reports Server (NTRS)

Hunt, Douglas B.; Tompkins, Frederick G.

1987-01-01

This paper focuses on the policy and definitional issues associated with providing adequate and reasonable levels of protection for sensitive systems and data in an agency whose basic charter mandates the open sharing of information and transfer of technology into the market economy. An information model based on current Federal regulatory issuances is presented. A scheme for determining sensitivity levels, based on a categorization taxonomy,is provided.

Expanding research to provide an evidence base for nutritional interventions for the management of inborn errors of metabolism.

PubMed

Camp, Kathryn M; Lloyd-Puryear, Michele A; Yao, Lynne; Groft, Stephen C; Parisi, Melissa A; Mulberg, Andrew; Gopal-Srivastava, Rashmi; Cederbaum, Stephen; Enns, Gregory M; Ershow, Abby G; Frazier, Dianne M; Gohagan, John; Harding, Cary; Howell, R Rodney; Regan, Karen; Stacpoole, Peter W; Venditti, Charles; Vockley, Jerry; Watson, Michael; Coates, Paul M

2013-08-01

A trans-National Institutes of Health initiative, Nutrition and Dietary Supplement Interventions for Inborn Errors of Metabolism (NDSI-IEM), was launched in 2010 to identify gaps in knowledge regarding the safety and utility of nutritional interventions for the management of inborn errors of metabolism (IEM) that need to be filled with evidence-based research. IEM include inherited biochemical disorders in which specific enzyme defects interfere with the normal metabolism of exogenous (dietary) or endogenous protein, carbohydrate, or fat. For some of these IEM, effective management depends primarily on nutritional interventions. Further research is needed to demonstrate the impact of nutritional interventions on individual health outcomes and on the psychosocial issues identified by patients and their families. A series of meetings and discussions were convened to explore the current United States' funding and regulatory infrastructure and the challenges to the conduct of research for nutritional interventions for the management of IEM. Although the research and regulatory infrastructure are well-established, a collaborative pathway that includes the professional and advocacy rare disease community and federal regulatory and research agencies will be needed to overcome current barriers. Copyright © 2013. Published by Elsevier Inc. All rights reserved.

Therapeutic gene editing: delivery and regulatory perspectives.

PubMed

Shim, Gayong; Kim, Dongyoon; Park, Gyu Thae; Jin, Hyerim; Suh, Soo-Kyung; Oh, Yu-Kyoung

2017-06-01

Gene-editing technology is an emerging therapeutic modality for manipulating the eukaryotic genome by using target-sequence-specific engineered nucleases. Because of the exceptional advantages that gene-editing technology offers in facilitating the accurate correction of sequences in a genome, gene editing-based therapy is being aggressively developed as a next-generation therapeutic approach to treat a wide range of diseases. However, strategies for precise engineering and delivery of gene-editing nucleases, including zinc finger nucleases, transcription activator-like effector nuclease, and CRISPR/Cas9 (clustered regularly interspaced short palindromic repeats-associated nuclease Cas9), present major obstacles to the development of gene-editing therapies, as with other gene-targeting therapeutics. Currently, viral and non-viral vectors are being studied for the delivery of these nucleases into cells in the form of DNA, mRNA, or proteins. Clinical trials are already ongoing, and in vivo studies are actively investigating the applicability of CRISPR/Cas9 techniques. However, the concept of correcting the genome poses major concerns from a regulatory perspective, especially in terms of safety. This review addresses current research trends and delivery strategies for gene editing-based therapeutics in non-clinical and clinical settings and considers the associated regulatory issues.

Therapeutic gene editing: delivery and regulatory perspectives

PubMed Central

Shim, Gayong; Kim, Dongyoon; Park, Gyu Thae; Jin, Hyerim; Suh, Soo-Kyung; Oh, Yu-Kyoung

2017-01-01

Gene-editing technology is an emerging therapeutic modality for manipulating the eukaryotic genome by using target-sequence-specific engineered nucleases. Because of the exceptional advantages that gene-editing technology offers in facilitating the accurate correction of sequences in a genome, gene editing-based therapy is being aggressively developed as a next-generation therapeutic approach to treat a wide range of diseases. However, strategies for precise engineering and delivery of gene-editing nucleases, including zinc finger nucleases, transcription activator-like effector nuclease, and CRISPR/Cas9 (clustered regularly interspaced short palindromic repeats-associated nuclease Cas9), present major obstacles to the development of gene-editing therapies, as with other gene-targeting therapeutics. Currently, viral and non-viral vectors are being studied for the delivery of these nucleases into cells in the form of DNA, mRNA, or proteins. Clinical trials are already ongoing, and in vivo studies are actively investigating the applicability of CRISPR/Cas9 techniques. However, the concept of correcting the genome poses major concerns from a regulatory perspective, especially in terms of safety. This review addresses current research trends and delivery strategies for gene editing-based therapeutics in non-clinical and clinical settings and considers the associated regulatory issues. PMID:28392568

Setting priorities for non-regulatory animal health in Ireland: results from an expert Policy Delphi study and a farmer priority identification survey.

PubMed

More, Simon J; McKenzie, Ken; O'Flaherty, Joe; Doherty, Michael L; Cromie, Andrew R; Magan, Mike J

2010-07-01

Agriculture is a very important contributor to the Irish economy. In Ireland, national animal health services have been a government, rather than an industry, responsibility. In 2009, Animal Health Ireland (AHI) was established to provide a partnership approach to national leadership of non-regulatory animal health issues (those not subject to national and/or EU regulation). The objectives of this study were to elicit opinion from experts and farmers about non-regulatory animal health issues facing Irish livestock industries, including prioritisation of animal health issues and identification of opportunities to maximise the effective use of AHI resources. The study was conducted with experts using Policy Delphi methodology over three rounds, and with farmers using a priority identification survey. Non-regulatory bovine diseases/conditions were prioritised by both experts and farmers based on impact and international competitiveness. For each high-priority disease/condition, experts were asked to provide an assessment based on cost, impact, international perception, impediment to international market access and current resource usage effectiveness. Further information was also sought from experts about resource allocation preferences, methods to improve education and coordination, and innovative measures to improve prevention and management. There was close agreement between responses from experts and dairy farmers: each gave highest priority to 3 diseases with a biosecurity risk (subsequently termed 'biosecure diseases') (bovine viral diarrhoea [BVD], infectious bovine rhinotracheitis [IBR], paratuberculosis) and 4 diseases/conditions generally without a biosecurity risk ('non-biosecure diseases/conditions') (fertility, udder health/milk quality, lameness, calf health). Beef farmers also prioritised parasitic conditions and weanling pneumonia. The adverse impact of biosecure diseases is currently considered relatively minor by experts, but would increase substantially in time. There are already substantial costs to farms and agribusiness from non-biosecure diseases/conditions. Experts preferred an equal allocation of resources between these biosecure and non-biosecure diseases/conditions, with emphasis on adopting/adapting international models, education and awareness-raising. The results from this study provide robust insights about non-regulatory animal health priorities in Ireland, as perceived by experts and farmers, using methodologies that are both transparent and inclusive. They have already been extremely influential in shaping national policy, as a foundation for interdisciplinary (and multi-agency) cooperation, as a contribution to efforts to encourage stakeholder responsibility-taking, and to ongoing development of postgraduate and undergraduate veterinary education in Ireland. Copyright (c) 2010. Published by Elsevier B.V.

76 FR 65541 - Assuring the Availability of Funds for Decommissioning Nuclear Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-21

... NUCLEAR REGULATORY COMMISSION [NRC-2009-0263] Assuring the Availability of Funds for Decommissioning Nuclear Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision to Regulatory...

Clearing the air and breathing freely: the health politics of air pollution and asthma.

PubMed

Brown, Phil; Mayer, Brian; Zavestoski, Stephen; Luebke, Theo; Mandelbaum, Joshua; McCormick, Sabrina

2004-01-01

This study examines the growing debate around environmental causes of asthma in the context of federal regulatory disputes, scientific controversy, and environmental justice activism. A multifaceted form of social discovery of the effect of air pollution on asthma has resulted from multipartner and multiorganizational approaches and from intersectoral policy that deals with social inequality and environmental justice. Scientists, activists, health voluntary organizations, and some government agencies and officials have identified various elements of the asthma and air pollution connection. To tackle these issues, they have worked through a variety of collaborations and across different sectors of environmental regulation, public health, health services, housing, transportation, and community development. The authors examine the role of activist groups in discovering the increased rates of asthma and framing it as a social and environmental issue; give an overview of the current knowledge base on air pollution and asthma, and the controversies within science; and situate that science in the regulatory debate, discussing the many challenges to the air quality researchers. They then examine the implications of the scientific and regulatory controversies over linking air pollution to increases in asthma. The article concludes with a discussion of how alliances between activists and scientists lead to new research strategies and innovations.

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study.

PubMed

Pires, Carla; Vigário, Marina; Cavaco, Afonso

2015-01-01

Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments.

PubMed

Ciani, Oriana; Wilcher, Britni; van Giessen, Anoukh; Taylor, Rod S

2017-02-01

Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on suboptimal data to make clinical and cost-effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technology submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device-specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licencing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd.

75 FR 79049 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-17

..., Division of Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2010-31731 Filed...

Issues in Peer Review of the Scientific Basis for Regulatory Decisions.

ERIC Educational Resources Information Center

American Chemical Society, Washington, DC.

This document is intended to provide a discussion of the issues that need to be addressed in the development of peer review guidelines, the options for addressing the issues, and a range of views about such options. The document focuses on peer review with regard to regulatory decisions and contains major sections which deal with: (1) what should…

A Canadian Working Group report on fecal microbial therapy: Microbial ecosystems therapeutics

PubMed Central

Allen-Vercoe, Emma; Reid, Gregor; Viner, Norman; Gloor, Gregory B; Hota, Susy; Kim, Peter; Lee, Christine; O’Doherty, Kieran C; Vanner, Stephen J; Weese, J Scott; Petrof, Elaine O

2012-01-01

A working group from across Canada comprised of clinician and basic scientists, epidemiologists, ethicists, Health Canada regulatory authorities and representatives of major funding agencies (Canadian Institutes of Health Research and the Crohn’s and Colitis Foundation of Canada) met to review the current experience with fecal microbial therapy and to identify the key areas of study required to move this field forward. The report highlights the promise of fecal microbial therapy and related synthetic stool therapy (together called ‘microbial ecosystems therapeutics’) for the treatment of Clostridium difficile colitis and, possibly, other disorders. It identifies pressing clinical issues that need to be addressed as well as social, ethical and regulatory barriers to the use of these important therapies. PMID:22803022

Generic immunosuppression in transplantation: current evidence and controversial issues.

PubMed

El Hajj, Sandra; Kim, Miae; Phillips, Karen; Gabardi, Steven

2015-05-01

The overall success of organ transplantation in the 21st century has been predicated, in part, on the use of newer, more potent, and selective immunosuppressive agents. However, the high cost of lifelong immunosuppression represents a financial burden for many patients. In the past 15 years, regulatory agencies in Europe and America have approved several generic immunosuppressants. One concern is whether the conversion between innovator and generic immunosuppressants will prove to be problematic. This manuscript aims to compare and contrast the bioequivalence requirements among regulatory authorities in the USA, Europe, and Canada, evaluate published studies of generic immunosuppressants in transplant recipients, summarize consensus statements made by transplant organizations and discuss how to engage patients in discussion regarding the choice between innovator and generic immunosuppressants.

The Public Utilities Regulatory Policy Act (PURPA) and US Geothermal Industry: Current controversies and trends in federal and state implementation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

This report is an analysis of the issues confronting US energy policymakers and the US geothermal industry as the result of the implementation and interpretation of the 1978 Public Utility Regulatory Policies Act, commonly known as PURPA. It seeks to answer four sets of questions about PURPA: (1) What has the existence of PURPA meant to the US geothermal industry. (2) How has the interpretation of PURPA evolved over the past decade. (3) What particular portions of PURPA rule making have been most crucial to the growth and development of the geothermal industry. (4) What aspects of PURPA have beenmore » most troubling to utilities purchasing or developing geothermal energy.« less

The balance between innovation and competition: the Hatch-Waxman Act, the 2003 Amendments, and beyond.

PubMed

Kelly, Colleen

2011-01-01

In 1984, Congress passed the Hatch-Waxman Act, a landmark statute designed both to encourage innovation by pioneer drug companies and to increase competition by generic drug companies. After its enactment, drug companies attempted to "ga the regulatory regime to their respective economic advantage. In 2003, in an effort to address these issues, FDA promulgated a final rule and Congress passed the Medicare Modernization Act, amending the Hatch-Waxman Act. This article provides a comprehensive look at the 2003 statutory and regulatory changes. First, the article analyzes the history and provisions of the original Hatch-Waxman Act and the issues that arose after its enactment. Second, the article discusses the passage of the 2003 FDA rule and the 2003 Medicare Modernization Act. Next, the article demonstrates that, although the 2003 amendments may have definitively resolved some issues, the amendments did not resolve all interpretive issues and have even led to unintended consequences. In particular, the article discusses several areas of current controversy, including the effect of patent delisting and patent expiration on 180-day exclusivity, the patent delisting counterclaim provision, the declaratory judgment action provision, patent settlement agreements, and authorized generics. Finally, the article assesses the potential for future reform of the Hatch-Waxman Act. The article concludes that maintaining the balance between innovation and competition will likely remain a daunting task for legislators and regulators in the future.

Key anticipated regulatory issues for clinical use of human induced pluripotent stem cells.

PubMed

Knoepfler, Paul S

2012-09-01

The production of human induced pluripotent stem cells (hiPSCs) has greatly expanded the realm of possible stem cell-based regenerative medicine therapies and has particularly exciting potential for autologous therapies. However, future therapies based on hiPSCs will first have to address not only similar regulatory issues as those facing human embryonic stem cells with the US FDA and international regulatory agencies, but also hiPSCs have raised unique concerns as well. While the first possible clinical use of hiPSCs remains down the road, as a field it would be wise for us to anticipate potential roadblocks and begin formulating solutions. In this article, I discuss the potential regulatory issues facing hiPSCs and propose some potential changes in the direction of the field in response.

Summary of SMIRT20 Preconference Topical Workshop – Identifying Structural Issues in Advanced Reactors

DOE Office of Scientific and Technical Information (OSTI.GOV)

William Richins; Stephen Novascone; Cheryl O'Brien

Summary of SMIRT20 Preconference Topical Workshop – Identifying Structural Issues in Advanced Reactors William Richins1, Stephen Novascone1, and Cheryl O’Brien1 1Idaho National Laboratory, US Dept. of Energy, Idaho Falls, Idaho, USA, e-mail: William.Richins@inl.gov The Idaho National Laboratory (INL, USA) and IASMiRT sponsored an international forum Nov 5-6, 2008 in Porvoo, Finland for nuclear industry, academic, and regulatory representatives to identify structural issues in current and future advanced reactor design, especially for extreme conditions and external threats. The purpose of this Topical Workshop was to articulate research, engineering, and regulatory Code development needs. The topics addressed by the Workshop were selectedmore » to address critical industry needs specific to advanced reactor structures that have long lead times and can be the subject of future SMiRT technical sessions. The topics were; 1) structural/materials needs for extreme conditions and external threats in contemporary (Gen. III) and future (Gen. IV and NGNP) advanced reactors and 2) calibrating simulation software and methods that address topic 1 The workshop discussions and research needs identified are presented. The Workshop successfully produced interactive discussion on the two topics resulting in a list of research and technology needs. It is recommended that IASMiRT communicate the results of the discussion to industry and researchers to encourage new ideas and projects. In addition, opportunities exist to retrieve research reports and information that currently exists, and encourage more international cooperation and collaboration. It is recommended that IASMiRT continue with an off-year workshop series on select topics.« less

Analysis of pharmaceutical safety-related regulatory actions in Japan: do tradeoffs exist between safer drugs and launch delay?

PubMed

Yamada, Toru; Kusama, Makiko; Hirai, Yuka; Arnold, Frank; Sugiyama, Yuichi; Ono, Shunsuke

2010-12-01

Prediction and management of drug safety is a global regulatory issue. Safety-related regulatory actions (SRRAs) are taken mostly when unexpected adverse drug reactions occur. Currently, Japan is reconciled to delayed access to new drugs (ie, launch delay compared to Western countries), but may have been benefiting by free-riding on safety data accumulated in other countries prior to Japanese launch. To identify factors that are significantly associated with SRRAs, and to discuss the challenges that Japan might have to face with increasing access to new drugs. The SRRAs of 135 new drugs approved from January 2000 to December 2005 were analyzed to investigate association with launch lag, company and drug characteristics, market size, submission data, and regulatory status. SRRAs were measured in terms of the number of emergency safety information notifications and official safety instructions issued by the Japanese regulatory agency within 3 years after approval. A negative binomial distribution model was used for regression analysis. Longer launch lags and presence of drugs with similar modes of action were associated with fewer SRRAs. Bridging strategy showed increased SRRAs. No significant association was observed between SRRAs and the subject number in clinical data packages. Occurrence of SRRAs was varied among development strategy, preceding products, and regional regulations. The occurrence of SRRAs was associated with the accumulation of both foreign and domestic postmarketing evidence rather than with clinical trial data upon launch. Considering the paradigm shift to simultaneous global drug development and filing for regulatory approval, this study indicates the importance of intensive data collection in the early postmarketing phase and use of safety information in early markets. However, even if we would be sufficiently cautious about safety risks of new drugs, a population that enjoys first-in-class drugs probably has to bear the risks.

Hazard and risk assessment of industrial chemicals in the occupational context in Europe: some current issues.

PubMed

Fairhurst, S

2003-11-01

This paper is about industrial chemicals, the manner in which their toxicity is assessed and the use of such assessments in regulatory decision-making. It begins with general points concerning toxicological data availability and hazard identification, then moves on to risk assessment and occupational exposure limits, and finally looks briefly at three specific toxicological issues, asthma, chronic toxic encephalopathy, and "low toxicity" dust effects on the lung, where the science is far from resolved. The overall purpose of the paper is to raise, or perhaps to act as a reminder of a number of issues of particular relevance to industrial chemicals and the occupational setting, and hopefully to prompt further thinking and perhaps some new initiatives directed at the areas in question.

76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-04

... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the... regulatory guidance concerning the use of electronic signatures and documents to comply with FMCSA...

Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

PubMed

Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Abadie, Eric; Barnett, David; König, Franz; Pearson, Steven

2010-04-01

Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address RE during the pre-marketing stages. This article describes the current political background to the RE debate and presents the scientific and methodological challenges as they relate to RE assessment. In addition, we explain the impact of RE on drug development, and speculate on future developments and actions that are likely to be required from key players.

Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.

PubMed

Seabroke, Suzie; Wise, Lesley; Waller, Patrick

2013-10-01

The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA). An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year. The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %. Following the pilot study and implementation at the UK MHRA, the RPPS has provided a systematic approach to drug safety issue prioritisation that should help to reduce the subjectivity of reliance on individual judgement.

Reinventing clinical trials: a review of innovative biomarker trial designs in cancer therapies.

PubMed

Lin, Ja-An; He, Pei

2015-06-01

Recently, new clinical trial designs involving biomarkers have been studied and proposed in cancer clinical research, in the hope of incorporating the rapid growing basic research into clinical practices. Journal articles related to various biomarkers and their role in cancer clinical trial, articles and books about statistical issues in trial design, and regulatory website, documents, and guidance for submission of targeted cancer therapies. The drug development process involves four phases. The confirmatory Phase III is essential in regulatory approval of a special treatment. Regulatory agency has restrictions on confirmatory trials 'using adaptive designs'. No rule of thumb to pick the most appropriate design for biomarker-related trials. Statistical issues to solve in new designs. Regulatory acceptance of the 'newly proposed trial designs'. Biomarker-related trial designs that can resolve the statistical issues and satisfy the regulatory requirement. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Pre-anthropocene mercury residues in North American freshwater fish.

PubMed

Hope, Bruce K; Louch, Jeff

2014-04-01

Mercury (Hg) has been entering the environment from both natural and anthropogenic sources for millennia, and humans have been influencing its environmental transport and fate from well before the Industrial Revolution. Exposure to Hg (as neurotoxic monomethylmercury [MeHg]) occurs primarily through consumption of finfish, shellfish, and marine mammals, and regulatory limits for MeHg concentrations in fish tissue have steadily decreased as information on its health impacts has become available. These facts prompted us to consider 2 questions: 1) What might the MeHg levels in fish tissue have been in the pre-Anthropocene, before significant human impacts on the environment? and 2) How would these pre-Anthropocene levels have compared with current regulatory criteria for MeHg residues in fish tissue? We addressed the first question by estimating pre-Anthropocene concentrations of MeHg in the tissues of prey and predatory fish with an integrated Hg speciation, transport, fate, and food web model (SERAFM), using estimated Hg concentrations in soil, sediment, and atmospheric deposition before the onset of significant human activity (i.e., ≤2000 BCE). Model results show MeHg residues in fish varying depending on the characteristics of the modeled water body, which suggests that Hg in fish tissue is best considered at the scale of individual watersheds or water bodies. We addressed the second question by comparing these model estimates with current regulatory criteria and found that MeHg residues in predatory (but not prey) fish could have approached or exceeded these criteria in some water bodies during the pre-Anthropocene. This suggests that the possibility of naturally occurring levels of Hg in fish below which it is not possible to descend, regardless of where those levels stand with respect to current regulatory limits. Risk management decisions made under these circumstances have the potential to be ineffectual, frustrating, and costly for decision makers and stakeholders alike, suggesting the need for regulatory flexibility when addressing the issue of Hg in fish. © 2013 SETAC.

Considerations on the EU definition of a nanomaterial: science to support policy making.

PubMed

Bleeker, Eric A J; de Jong, Wim H; Geertsma, Robert E; Groenewold, Monique; Heugens, Evelyn H W; Koers-Jacquemijns, Marjorie; van de Meent, Dik; Popma, Jan R; Rietveld, Anton G; Wijnhoven, Susan W P; Cassee, Flemming R; Oomen, Agnes G

2013-02-01

In recent years, an increasing number of applications and products containing or using nanomaterials have become available. This has raised concerns that some of these materials may introduce new risks for humans or the environment. A clear definition to discriminate nanomaterials from other materials is prerequisite to include provisions for nanomaterials in legislation. In October 2011 the European Commission published the 'Recommendation on the definition of a nanomaterial', primarily intended to provide unambiguous criteria to identify materials for which special regulatory provisions might apply, but also to promote consistency on the interpretation of the term 'nanomaterial'. In this paper, the current status of various regulatory frameworks of the European Union with regard to nanomaterials is described, and major issues relevant for regulation of nanomaterials are discussed. This will contribute to better understanding the implications of the choices policy makers have to make in further regulation of nanomaterials. Potential issues that need to be addressed and areas of research in which science can contribute are indicated. These issues include awareness on situations in which nano-related risks may occur for materials that fall outside the definition, guidance and further development of measurement techniques, and dealing with changes during the life cycle. Copyright © 2012 Elsevier Inc. All rights reserved.

Regulatory Forum Opinion Piece*: Use and Utility of Animal Models of Disease for Nonclinical Safety Assessment: A Pharmaceutical Industry Survey.

PubMed

Morgan, Sherry J; Couch, Jessica; Guzzie-Peck, Peggy; Keller, Douglas A; Kemper, Ray; Otieno, Monicah A; Schulingkamp, Robert J; Jones, Thomas W

2017-04-01

An Innovation and Quality (IQ) Consortium focus group conducted a cross-company survey to evaluate current practices and perceptions around the use of animal models of disease (AMDs) in nonclinical safety assessment of molecules in clinical development. The IQ Consortium group is an organization of pharmaceutical and biotechnology companies with the mission of advancing science and technology. The survey queried the utilization of AMDs during drug discovery in which drug candidates are evaluated in efficacy models and limited short-duration non-Good Laboratory Practices (GLP) toxicology testing and during drug development in which drug candidates are evaluated in GLP toxicology studies. The survey determined that the majority of companies used AMDs during drug discovery primarily as a means for proactively assessing potential nonclinical safety issues prior to the conduct of toxicology studies, followed closely by the use of AMDs to better understand toxicities associated with exaggerated pharmacology in traditional toxicology models or to derisk issues when the target is only expressed in the disease state. In contrast, the survey results indicated that the use of AMDs in development is infrequent, being used primarily to investigate nonclinical safety issues associated with targets expressed only in disease states and/or in response to requests from global regulatory authorities.

An Asian perspective on GMO and biotechnology issues.

PubMed

Teng, Paul P S

2008-01-01

Of the 102 million hectares that made up the global area of biotech crops in 2006, less than 8% (7.6 million ha) were in Asia. Three biotech crops are currently planted in significant areas in four Asian countries with government regulatory approval; namely, cotton, corn (maize), and canola. However, the amount of GM crop material imported into the Asian region for processing into food and animal feed is very substantial, and almost every country imports GM food. The issues which concern Asian scientists, regulators, and the lay public resemble those of other regions - biosafety, food safety, ethics and social justice, competitiveness, and the "EU" trade question. Most Asian countries now have regulatory systems for approving the commercialization of GM crops, and for approving food safety of GM crops. In Asia, because of the varied cultures, issues concerning the use of genes derived from animals arouse much emotion for religious and diet choice reasons. Because many Asian producers and farmers are small-scale, there is also concern about technology dependency and to whom the benefits accrue. All consumers surveyed have expressed concern about potential allergenic and long-term toxic effects, neither of which is grounded on scientific facts. Because of Asia's growing demand for high volumes of quality food, it is likely that GM crops will become an increasing feature of our diet.

75 FR 43207 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-23

... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing.... Jervey, Acting Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear...

When organ donation from living donors serves as the main source of organ procurement: a critical examination of the ethical and legal challenges to Turkey's recent efforts to overcome organ shortage.

PubMed

Sert, G; Guven, T; Gorkey, S

2013-01-01

Despite the fact that Turkey has implemented a number of legislative and regulatory efforts to increase cadaveric donations, live donors still serve as the main source of organ procurement in this country. To address this problem, Turkey's regulatory authorities have sought to increase the number of brain death declarations. A new regulation issued in 2012 repeats the criteria for brain death that were first issued in 1993. This paper argues that these efforts are far from adequate owing to a number of complicated, ethical, and legal challenges that must be addressed to increase cadaveric organ donations. After examining these factors, which are completely neglected in current policies, we conclude that Turkey needs a realistic ethically justifiable organ procurement policy that must be supported by a framework of patient rights to implement the concept of patient autonomy and respect for human dignity in health care services as the primary goal. Copyright © 2013 Elsevier Inc. All rights reserved.

75 FR 20868 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-21

...: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.68.2... Water-Cooled Nuclear Power Plants.'' FOR FURTHER INFORMATION CONTACT: Mark P. Orr, Regulatory Guide... Shutdown Capability for Water-Cooled Nuclear Power Plants,'' was issued with a temporary identification as...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Boing, L.E.

This paper presents an overview of the US experiences in the decommissioning technical area. Sections included are: (1) an overview of the magnitude of the problem, (2) a review of the US decommissioning process, (3) regulation of decommissioning, (4) regulatory and funding requirements for decommissioning, and (5) a general overview of all on-going and completed decommissioning projects to date in the US. The final section presents a review of some issues in the decommissioning area currently being debated in the technical specialists community.

Self-regulatory processes mediate the intention-behavior relation for adherence and exercise behaviors.

PubMed

de Bruin, Marijn; Sheeran, Paschal; Kok, Gerjo; Hiemstra, Anneke; Prins, Jan M; Hospers, Harm J; van Breukelen, Gerard J P

2012-11-01

Understanding the gap between people's intentions and actual health behavior is an important issue in health psychology. Our aim in this study was to investigate whether self-regulatory processes (monitoring goal progress and responding to discrepancies) mediate the intention-behavior relation in relation to HIV medication adherence (Study 1) and intensive exercise behavior (Study 2). In Study 1, questionnaire and electronically monitored adherence data were collected at baseline and 3 months later from patients in the control arm of an HIV-adherence intervention study. In Study 2, questionnaire data was collected at 3 time points 6-weeks apart in a cohort study of physical activity. Complete data at all time points were obtained from 51 HIV-infected patients and 499 intensive exercise participants. Intentions were good predictors of behavior and explained 25 to 30% of the variance. Self-regulatory processes explained an additional 11% (Study 1) and 6% (Study 2) of variance in behavior on top of intentions. Regression and bootstrap analyses revealed at least partial, and possibly full, mediation of the intention-behavior relation by self-regulatory processes. The present studies indicate that self-regulatory processes may explain how intentions drive behavior. Future tests, using different health behaviors and experimental designs, could firmly establish whether self-regulatory processes complement current health behavior theories and should become routine targets for intervention. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

Stress spillover in early marriage: the role of self-regulatory depletion.

PubMed

Buck, April A; Neff, Lisa A

2012-10-01

Stressful experiences external to a marriage (e.g., work stress, finances) are often associated with poor relationship functioning and lowered marital satisfaction, a phenomenon called stress spillover. To date, however, little attention has been devoted to understanding the specific mechanisms through which stress may lead to maladaptive relationship patterns. Drawing from theories of self-regulatory depletion, it was predicted that coping with external stress is an effortful process that consumes spouses' regulatory resources, leaving spouses with less energy to effectively respond to their relationship issues. The current study relied on a sample of newly married couples to examine whether self-regulatory depletion may account for the link between external stress and relationship well-being. Couples were asked to complete a 14-day daily diary that assessed their daily stress, their state of self-regulatory depletion, their marital behaviors, and their daily marital appraisals. Within-person analyses revealed that, on average, couples experienced stress spillover, such that on days when their stress was higher than usual they reported enacting more negative behaviors toward their partner and endorsed less positive appraisals of the relationship. Further analyses confirmed that self-regulatory depletion accounted for a majority of these spillover effects. These findings suggest that even happy couples may find it difficult to engage in adaptive relationship processes under conditions of stress. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

Quality measurement and improvement in liver transplantation.

PubMed

Mathur, Amit K; Talwalkar, Jayant

2018-06-01

There is growing interest in the quality of health care delivery in liver transplantation. Multiple stakeholders, including patients, transplant providers and their hospitals, payers, and regulatory bodies have an interest in measuring and monitoring quality in the liver transplant process, and understanding differences in quality across centres. This article aims to provide an overview of quality measurement and regulatory issues in liver transplantation performed within the United States. We review how broader definitions of health care quality should be applied to liver transplant care models. We outline the status quo including the current regulatory agencies, public reporting mechanisms, and requirements around quality assurance and performance improvement (QAPI) activities. Additionally, we further discuss unintended consequences and opportunities for growth in quality measurement. Quality measurement and the integration of quality improvement strategies into liver transplant programmes hold significant promise, but multiple challenges to successful implementation must be addressed to optimise value. Copyright © 2018 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

78 FR 68101 - Environmental Issues Associated With New Reactors and Specific Environmental Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

... October 15, 2013. The Nuclear Energy Institute (NEI) submitted a letter on September 17, 2013 (Agencywide... NUCLEAR REGULATORY COMMISSION [NRC-2013-0212: NRC-2013-0211] Environmental Issues Associated With... AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; re-opening of comment period...

76 FR 60939 - Metal Fatigue Analysis Performed by Computer Software

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... Nuclear Power Plants,'' Revision 2, issued December 2010, which recommends that the effects of the reactor... design control in accordance with Appendix B, ``Quality Assurance Criteria for Nuclear Power Plants and... Nuclear Power Plants.'' Intent The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory...

Innovative Legal Approaches to Address Obesity

PubMed Central

Pomeranz, Jennifer L; Teret, Stephen P; Sugarman, Stephen D; Rutkow, Lainie; Brownell, Kelly D

2009-01-01

Context: The law is a powerful public health tool with considerable potential to address the obesity issue. Scientific advances, gaps in the current regulatory environment, and new ways of conceptualizing rights and responsibilities offer a foundation for legal innovation. Methods: This article connects developments in public health and nutrition with legal advances to define promising avenues for preventing obesity through the application of the law. Findings: Two sets of approaches are defined: (1) direct application of the law to factors known to contribute to obesity and (2) original and innovative legal solutions that address the weak regulatory stance of government and the ineffectiveness of existing policies used to control obesity. Specific legal strategies are discussed for limiting children's food marketing, confronting the potential addictive properties of food, compelling industry speech, increasing government speech, regulating conduct, using tort litigation, applying nuisance law as a litigation strategy, and considering performance-based regulation as an alternative to typical regulatory actions. Finally, preemption is an overriding issue and can play both a facilitative and a hindering role in obesity policy. Conclusions: Legal solutions are immediately available to the government to address obesity and should be considered at the federal, state, and local levels. New and innovative legal solutions represent opportunities to take the law in creative directions and to link legal, nutrition, and public health communities in constructive ways. PMID:19298420

Regulatory Approval of Cancer Risk-reducing (Chemopreventive) Drugs: Moving What We Have Learned into the Clinic

PubMed Central

Meyskens, Frank L.; Curt, Gregory A.; Brenner, Dean E.; Gordon, Gary; Herberman, Ronald B.; Finn, Olivera; Kelloff, Gary J.; Khleif, Samir N.; Sigman, Caroline C.; Szabo, Eva

2010-01-01

This paper endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of non-scientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical-industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs. PMID:21372031

Identifying viable regulatory and innovation pathways for regenerative medicine: a case study of cultured red blood cells.

PubMed

Mittra, J; Tait, J; Mastroeni, M; Turner, M L; Mountford, J C; Bruce, K

2015-01-25

The creation of red blood cells for the blood transfusion markets represents a highly innovative application of regenerative medicine with a medium term (5-10 year) prospect for first clinical studies. This article describes a case study analysis of a project to derive red blood cells from human embryonic stem cells, including the systemic challenges arising from (i) the selection of appropriate and viable regulatory protocols and (ii) technological constraints related to stem cell manufacture and scale up to clinical Good Manufacturing Practice (GMP) standard. The method used for case study analysis (Analysis of Life Science Innovation Systems (ALSIS)) is also innovative, demonstrating a new approach to social and natural science collaboration to foresight product development pathways. Issues arising along the development pathway include cell manufacture and scale-up challenges, affected by regulatory demands emerging from the innovation ecosystem (preclinical testing and clinical trials). Our discussion reflects on the efforts being made by regulators to adapt the current pharmaceuticals-based regulatory model to an allogeneic regenerative medicine product and the broader lessons from this case study for successful innovation and translation of regenerative medicine therapies, including the role of methodological and regulatory innovation in future development in the field. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

The current status and future potential of personalized diagnostics: Streamlining a customized process.

PubMed

Richmond, Terri D

2008-01-01

Recent genetic discoveries and related developments in genomic techniques have led to the commercialization of novel diagnostic platforms for studying disease or gauging therapeutic outcomes in individual patients. This newly emerging field is called "personalized medicine," and uses the patient's genetic composition to tailor strategies for patient-specific disease detection, treatment, or prevention. Personalized diagnostic tests are used to detect patient-to-patient variations in gene or protein expression levels, which act as indicators for drug treatments or disease prognosis. In turn, medical professionals can better answer questions such as: "Who should be treated with which drug?" and "How should the treatment be administered?" The regulations governing personalized medicine can be complicated because they encompass in vitro diagnostic systems and laboratory tests as well as methods of disease treatment and patient care. Industry, academia, medicine, and the Food and Drug Administration (FDA) are all involved in the cultivation of the field: substantial collaborations between drug developers and regulatory authorities are required to consider and shape emerging regulations as personalized drug strategies mature. Some of the regulatory issues identified by industry and the FDA about personalized medicine and personalized diagnostics will be addressed. In addition, relevant collaborations, advances, and current and draft regulatory guidances will be discussed with respect to the future of personalized medicine.

Evidence-based guidelines for use of probiotics in preterm neonates.

PubMed

Deshpande, Girish C; Rao, Shripada C; Keil, Anthony D; Patole, Sanjay K

2011-08-02

Current evidence indicates that probiotic supplementation significantly reduces all-cause mortality and definite necrotising enterocolitis without significant adverse effects in preterm neonates. As the debate about the pros and cons of routine probiotic supplementation continues, many institutions are satisfied with the current evidence and wish to use probiotics routinely. Because of the lack of detail on many practical aspects of probiotic supplementation, clinician-friendly guidelines are urgently needed to optimise use of probiotics in preterm neonates. To develop evidence-based guidelines for probiotic supplementation in preterm neonates. To develop core guidelines on use of probiotics, including strain selection, dose and duration of supplementation, we primarily used the data from our recent updated systematic review of randomised controlled trials. For equally important issues including strain identification, monitoring for adverse effects, product format, storage and transport, and regulatory hurdles, a comprehensive literature search, covering the period 1966-2010 without restriction on the study design, was conducted, using the databases PubMed and EMBASE, and the proceedings of scientific conferences; these data were used in our updated systematic review. In this review, we present guidelines, including level of evidence, for the practical aspects (for example, strain selection, dose, duration, clinical and laboratory surveillance) of probiotic supplementation, and for dealing with non-clinical but important issues (for example, regulatory requirements, product format). Evidence was inadequate in some areas, and these should be a target for further research. We hope that these evidence-based guidelines will help to optimise the use of probiotics in preterm neonates. Continued research is essential to provide answers to the current gaps in knowledge about probiotics.

78 FR 23507 - Notice of Regulatory Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-19

.... 2013-N-06] Notice of Regulatory Review AGENCY: Federal Housing Finance Agency. ACTION: Request for comment. SUMMARY: The Federal Housing Finance Agency (FHFA) is issuing a notice of a regulatory review that will be conducted in accordance with the process set forth in the regulatory review plan published...

Marine current energy conversion: the dawn of a new era in electricity production.

PubMed

Bahaj, AbuBakr S

2013-02-28

Marine currents can carry large amounts of energy, largely driven by the tides, which are a consequence of the gravitational effects of the planetary motion of the Earth, the Moon and the Sun. Augmented flow velocities can be found where the underwater topography (bathymetry) in straits between islands and the mainland or in shallows around headlands plays a major role in enhancing the flow velocities, resulting in appreciable kinetic energy. At some of these sites where practical flows are more than 1 m s(-1), marine current energy conversion is considered to be economically viable. This study describes the salient issues related to the exploitation of marine currents for electricity production, resource assessment, the conversion technologies and the status of leading projects in the field. This study also summarizes important issues related to site development and some of the approaches currently being undertaken to inform device and array development. This study concludes that, given the highlighted commitments to establish favourable regulatory and incentive regimes as well as the aspiration for energy independence and combating climate change, the progress to multi-megawatt arrays will be much faster than that achieved for wind energy development.

Pharmaceuticals--strategic considerations in health reforms in Pakistan.

PubMed

Nishtar, Sania

2006-12-01

Pharmaceuticals are critical to the functioning of healthcare systems which require a sustainable supply of quality, efficacious, and safe essential medicines. With this as a context, the Gateway Paper in its capacity as a suggested roadmap for health reforms within Pakistan stressed on the need for a pharmaceutical policy to be directed towards improving people's access to medicines; within this framework a number of issues have been highlighted. Weaknesses in the current legislation on drugs, in particular gaps, which have emerged contemporaneously with reference to the post WTO situation and the technology boom, have been discussed and the incongruity between the drug policies and policies in the other sectors addressed. The Gateway Paper makes a strong case to establish a statutory semi-autonomous drug regulatory authority in order to ensure stricter implementation of the Drug Law, which needs to be amended to bridge the current gaps. The paper lays emphasis on a formal quality assurance mechanism and the need to build capacity to implement regulation in this regard. Lack of clarity in the current pricing formula has been flagged as a key issue and the need highlighted to develop a pricing formula that is predictable, transparent and acceptable to the stakeholders, yet one that does not create access and affordability issues for the poor and disadvantaged. The paper addresses gaps in the process of drug registration in Pakistan and stresses on the need to redefine its scope and ensure its stricter enforcement. Unethical market practices and irrational use of drugs have been discussed and the need for transparently implementing standard operating procedures for drug selecting, procurement, storage, dispensing and rational prescribing and the introduction of appropriate evidence based education, managerial and regulatory interventions in this regard, highlighted. The myriad of reasons which lead to the shortage of drugs and to the mushrooming of spurious, counterfeit and sub-standard drugs in the market have also been the subject of discussion as have been issues relating to the present size and utilization of the National Essential Drug List.

76 FR 14107 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision... Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2011-5967 Filed 3-14-11...

Commissioning through competition and cooperation in the English NHS under the Health and Social Care Act 2012: evidence from a qualitative study of four clinical commissioning groups

PubMed Central

Allen, Pauline; Osipovič, Dorota; Shepherd, Elizabeth; Coleman, Anna; Perkins, Neil; Garnett, Emma; Williams, Lorraine

2017-01-01

Objective The Health and Social Care Act 2012 (‘HSCA 2012’) introduced a new, statutory, form of regulation of competition into the National Health Service (NHS), while at the same time recognising that cooperation was necessary. NHS England's policy document, The Five Year Forward View (‘5YFV’) of 2014 placed less emphasis on competition without altering the legislation. We explored how commissioners and providers understand the complex regulatory framework, and how they behave in relation to competition and cooperation. Design We carried out detailed case studies in four clinical commissioning groups, using interviews and documentary analysis to explore the commissioners’ and providers’ understanding and experience of competition and cooperation. Setting/participants We conducted 42 interviews with senior managers in commissioning organisations and senior managers in NHS and independent provider organisations (acute and community services). Results Neither commissioners nor providers fully understand the regulatory regime in respect of competition in the NHS, and have not found that the regulatory authorities have provided adequate guidance. Despite the HSCA 2012 promoting competition, commissioners chose mainly to use collaborative strategies to effect major service reconfigurations, which is endorsed as a suitable approach by providers. Nevertheless, commissioners are using competitive tendering in respect of more peripheral services in order to improve quality of care and value for money. Conclusions Commissioners regard the use of competition and cooperation as appropriate in the NHS currently, although collaborative strategies appear more helpful in respect of large-scale changes. However, the current regulatory framework contained in the HSCA 2012, particularly since the publication of the 5YFV, is not clear. Better guidance should be issued by the regulatory authorities. PMID:28183806

Cerebrospinal fluid protein and glucose examinations and tuberculosis:
Will laboratory safety regulations force a change of practice?

PubMed

Tormey, William P; O'Hagan, Christopher

2015-01-01

Cerebrospinal fluid (CSF) protein and glucose examinations are usually performed in chemical pathology departments on autoanalysers. Tuberculosis (TB) is a group 3 biological agent under Directive 2000/54/EC of the European Parliament but in the biochemistry laboratory, no extra precautions are taken in its analysis in possible TB cases. The issue of laboratory practice and safety in the biochemical analyses of CSF specimens, when tuberculosis infection is in question is addressed in the context of ambiguity in the implementation of current national and international health and safety regulations. Additional protective measures for laboratory staff during the analysis of CSF TB samples should force a change in current laboratory practice and become a regulatory issue under ISO 15189. Annual Mantoux skin test or an interferon-γ release assay for TB should be mandatory for relevant staff. This manuscript addresses the issue of biochemistry laboratory practice and safety in the biochemical analyses of CSF specimens when tuberculosis infection is in question in the context of the ambiguity of statutory health and safety regulations.

78 FR 61999 - Hydropower Regulatory Efficiency Act of 2013; Supplemental Notice of Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD13-9-000] Hydropower Regulatory Efficiency Act of 2013; Supplemental Notice of Workshop As announced in the Notices issued on September 3, 2013 and September 18, 2013, the Federal Energy Regulatory Commission (FERC or Commission...

Translating PrEP effectiveness into public health impact: key considerations for decision-makers on cost-effectiveness, price, regulatory issues, distributive justice and advocacy for access.

PubMed

Hankins, Catherine; Macklin, Ruth; Warren, Mitchell

2015-01-01

The extraordinary feat of proving the effectiveness of oral pre-exposure prophylaxis (PrEP) in clinical trials in different populations in a variety of settings may prove to have been easier than ensuring it is used well. Decision-makers must make difficult choices to realize the promise of antiretroviral prophylaxis for their countries. This paper outlines key economic, regulatory and distributive justice issues that must be addressed for effective and acceptable PrEP implementation. In considering the role that PrEP can play in combination prevention programmes, decision-makers must determine who can benefit most from PrEP, how PrEP can be provided safely and efficiently, and what kind of health system support will ensure successful implementation. To do this, they need contextualized information on disease burden by population, analyses of how PrEP services might best be delivered, and projections of the human resource and infrastructure requirements for each potential delivery model. There are cost considerations, varying cost-effectiveness results and regulatory challenges. The principles of ethics can inform thorny discussions about who should be prioritized for oral PrEP and how best to introduce it fairly. We describe the cost-effectiveness of PrEP in different populations at higher risk of HIV exposure, its price in low- and middle-income countries, and the current regulatory situation. We explore the principles of ethics that can inform resource allocation decision-making about PrEP anchored in distributive justice, at a time when universal access to antiretroviral treatment remains to be assured. We then highlight the role of advocacy in moving the PrEP agenda forward. The time is ripe now for decisions about whether, how and for whom PrEP should be introduced into a country's HIV response. It has the potential to contribute significantly to high impact HIV prevention if it is tailored to those who can most benefit from it and if current regulatory and pricing barriers can be overcome. Advocacy at all levels can help inform decision-making and push the access agenda to avert HIV infections among those at highest risk of HIV exposure. The benefits will accrue beyond the individual level to slow HIV transmission at the population level.

PURPA 210 avoided cost rates: Economic and implementation issues

DOE Office of Scientific and Technical Information (OSTI.GOV)

Devine, M.D.; Chartock, M.A.; Gunn, E.M.

The purpose of Section 210 of the Public Utilities Regulatory Policies Act (PURPA) was to promote the utilization of waste and renewable fuels and cogeneration processes for increasing electric power supplies. It represents a radical change in policy by allowing financially unregulated parties to generate power in ''qualifying facilities'' and by requiring utilities to purchase this power at the utilities' marginal (or ''avoided'') cost. PURPA 210 has clearly had a major impact as measured by the actual and proposed number of new qualifying facilities; however, implementation has been difficult due to the adversarial nature of the process for negotiating ormore » setting the avoided cost rates. This paper reviews the pertinent PURPA rules and regulations, analyzes the status of current avoided cost rates that have been established, and discusses implementation issues and options for resolving those issues.« less

30 CFR 773.21 - Initial review and finding requirements for improvidently issued permits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... EXPLORATION SYSTEMS UNDER REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.21 Initial review and finding requirements for improvidently issued permits. (a) If we, the regulatory authority... paragraph (c) of this section, you may challenge the preliminary finding by providing us with evidence as to...

77 FR 59427 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-27

...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of a Proposed Rule Change To Amend Rule G-34 on CUSIP Numbers, New Issue, and Market Information Requirements September 21... consisting of amendments to Rule G-34 on CUSIP numbers, new issue, and market information requirements. The...

Common Carrier Access to Cable Communications: Regulatory and Economic Issues.

ERIC Educational Resources Information Center

Kestenbaum, Lionel

The implications of cable television (CATV) common carrier access and economic and regulatory issues associated with it are examined in this paper. The first section provides a discussion of the feasibility and legal basis of common carrier access; the next section contrasts common carrier access with existing over-the-air television broadcasting…

77 FR 56694 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-13

... documents, instead of issuing subpoenas. The proposed rule change would add procedures for non-parties to... documents, instead of issuing subpoenas, and to standardize certain procedures relating to subpoenas and.... Finally, the Subpoena Rules describe how parties must share documents produced under a subpoena. The...

78 FR 29392 - Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital... requirements for the quality and reliability of basic components with embedded digital devices. DATES: Submit...

Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues.

PubMed

Sanders, M E; Huis in't Veld, J

1999-01-01

Properly formulated probiotic-containing foods offer consumers a low risk, low cost dietary component that has the potential to promote health in a variety of ways. Several such products are available commercially, although markets in Japan and Europe are more developed than in the USA. Once healthful attributes of a probiotic product have been identified, there remain microbiological, product, regulatory and labeling issues to be addressed prior to marketing. Microbiological and product issues include safety, effective scale-up for manufacturing, definition of probiotic activity, probiotic stability in the product over the course of product manufacture, shelf-life and consumption, definition of effective dose and target population(s), and development of quality assurance approaches. Examples of probiotic-containing foods are given. Regulatory and labeling issues are complicated because they differ for each country, but are likewise critical because they provide the means for communication of the product benefits to the consumer. The regulatory climate worldwide appears to be one of caution about overstating the benefits of such products but at the same time not preventing corporate commitment to marketing.

A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

PubMed

Mol, Peter G M; Straus, Sabine M J M; Piening, Sigrid; de Vries, Jonie T N; de Graeff, Pieter A; Haaijer-Ruskamp, Flora M

2010-06-01

As pre-approval trials are inherently limited in assessing the complete benefit-risk profile of a new drug, serious safety issues may emerge once a drug gains widespread use after approval. Regulators face the dilemma of balancing timely market access with the need for complete data on risks. This challenge has led to a life-cycle approach but, so far, few data are available on post-approval safety issues requiring regulatory action. The aim of this study is to determine the frequency, timing and nature of safety issues that necessitated safety-related regulatory action in the form of a Direct Healthcare Professional Communication (DHPC) issued by pharmaceutical companies in collaboration with the Dutch Medicines Evaluation Board during the past decade. All DHPCs issued in the Netherlands from 1 January 1999 to 1 January 2009 were retrospectively collected from the national regulatory authorities. Elapsed time between the approval date and the issue of the DHPC was determined. Characteristics of the action including the nature of the safety issue (according to Medical Dictionary for Regulatory Activities [MedDRA] terminology), type of drug and procedural aspects of the regulatory action taken were reviewed. DHPC characteristics were tabulated and explorative non-parametric tests were performed to study the effect of safety issue, drug class, drug type, orphan drug and first-in-class status on elapsed time from approval to the DHPC. 157 DHPCs were issued concerning 112 different active substances, approximately 9% (112/1200) of active substances available in the Netherlands in 2007. The number of DHPCs issued increased by 2.1 (95% CI 1.2, 3.1; p < 0.001) DHPCs per year over the past decade, reaching a total of 25 in 2008. The median time between approval and DHPC was 5.3 years (range 0.13-48 years). No significant trend in elapsed time to DHPC was observed in relation to the studied years (p = 0.06). One-third of all DHPCs were issued in the first 3 years after approval, but 27% (n = 43/157) of the DHPCs were issued 10 or more years after approval. Timing of DHPCs differed depending on safety issue, drug class, drug type and orphan drug status. DHPCs mostly concerned adverse events in the system organ class of 'cardiac disorders' (15%), 'injury, poisoning and procedural complications' (13%) and 'general disorders and administration site conditions' (10%). In ten cases the drug was eventually withdrawn. Withdrawal occurred a median duration of 2.4 years after registration (range of 1.5-48 years) and was most frequently due to cardiac disorders (including QT interval prolongation; four occasions) and hepatobiliary disorders (two occasions). In the past decade, the number of DHPCs has increased over time. This is likely caused by a multitude of factors: increased risk awareness by the public, media, regulators and other stakeholders; the type of drugs approved, such as orphan drugs and biologicals; and the regulatory process, including conditional approvals. The number of DHPCs may in the future increase further with the possibility of screening large epidemiological databases proactively for adverse drug events. Nine percent of all marketed drugs required a safety-related action. Regulatory action is taken shortly (<3 years) after market approval nearly as often as after intermediate (3-10 years) and long-term (>10 years) market exposure. These findings underline the need for risk management during the whole life cycle of a drug.

Patient safety issues in office-based surgery and anaesthesia in Switzerland: a qualitative study.

PubMed

McLennan, Stuart; Schwappach, David; Harder, Yves; Staender, Sven; Elger, Bernice

2017-08-01

To identify the spectrum of patient safety issues in office-based surgery and anaesthesia in Switzerland. Purposive sample of 23 experts in surgery and anaesthesia and quality and regulation in Switzerland. Data were collected via individual qualitative interviews using a researcher-developed semi-structured interview guide between March 2016 and September 2016. Interviews were transcribed and analysed using conventional content analysis. Issues were categorised under the headings "structure", "process", and "outcome". Experts identified two key overarching patient safety and regulatory issues in relation to office-based surgery and anaesthesia in Switzerland. First, experts repeatedly raised the current lack of data and transparency of the setting. It is unknown how many surgeons are operating in offices, how many and what types of operations are being done, and what the outcomes are. Secondly, experts also noted the limited oversight and regulation of the setting. While some standards exists, most experts felt that more minimal safety standards are needed regarding the requirements that must be met to do office-based surgery and what can and cannot be done in the office-based setting are needed, but they advocated a self-regulatory approach. There is a lack of empirical data regarding the quantity and quality office-based surgery and anaesthesia in Switzerland. Further research is needed to address these research gaps and inform health policy in relation to patient safety in office-based surgery and anaesthesia in Switzerland. Copyright © 2017. Published by Elsevier GmbH.

In search of the silver bullet: regulatory models to address childhood obesity.

PubMed

Rothenberg, Joan R

2010-01-01

The concern over obesity today has evolved beyond an issue of personal vanity to a serious national health issue affecting millions of Americans. Obesity in children is especially alarming. Overweight children and adolescents are at risk for health problems throughout their lives. While under-nutrition or diet insufficiencies were once major obstacles in the development of healthy infants and children, the epidemic of childhood obesity marks the start of the 21st century with equally menacing health consequences. Childhood obesity creates an increased burden of disease on our economy with increased indirect economic costs of time lost from work for parents and time lost from school for the child. Data raise the possibility that the current generation of children could suffer greater illness or experience a shorter lifespan than that of their parents. Some experts believe that government mandated restrictions on dietary choices would alleviate the obesity problem, while others find such actions to be an unwarranted government intrusion. Still, as concerns about obesity continue to grow, especially regarding children, some say government intervention of some type is necessary to solve the problem. This paper examines the history and factors involved in the childhood obesity epidemic, explores regulatory options for its resolution, and provides an overview of obesity as a serious challenge to public health, and the health of children in particular. The federal agencies who share the responsibility for regulating food in the United States and their efforts to address the obesity problem are discussed as a background to various state and federal regulatory models influencing dietary choices. The effectiveness of proposed regulations and alternatives to government intervention suggest that the resolution of the childhood obesity issue requires a coordinated, multilevel approach.

Understanding regulatory networks requires more than computing a multitude of graph statistics. Comment on "Drivers of structural features in gene regulatory networks: From biophysical constraints to biological function" by O.C. Martin et al.

NASA Astrophysics Data System (ADS)

Tkačik, Gašper

2016-07-01

The article by O. Martin and colleagues provides a much needed systematic review of a body of work that relates the topological structure of genetic regulatory networks to evolutionary selection for function. This connection is very important. Using the current wealth of genomic data, statistical features of regulatory networks (e.g., degree distributions, motif composition, etc.) can be quantified rather easily; it is, however, often unclear how to interpret the results. On a graph theoretic level the statistical significance of the results can be evaluated by comparing observed graphs to ;randomized; ones (bravely ignoring the issue of how precisely to randomize!) and comparing the frequency of appearance of a particular network structure relative to a randomized null expectation. While this is a convenient operational test for statistical significance, its biological meaning is questionable. In contrast, an in-silico genotype-to-phenotype model makes explicit the assumptions about the network function, and thus clearly defines the expected network structures that can be compared to the case of no selection for function and, ultimately, to data.

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

PubMed

Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

2007-01-01

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

Meeting the challenges of medical countermeasure development

PubMed Central

Maher, Carmen; Hu‐Primmer, Jean; MacGill, Tracy; Courtney, Brooke; Borio, Luciana

2012-01-01

Summary Despite substantial investments since the events of 2001, much work remains to prepare the nation for a chemical, biological, radiological or nuclear (CBRN) attack or to respond to an emerging infectious disease threat. Following a 2010 review of the US Public Health Emergency Medical Countermeasures Enterprise, FDA launched its Medical Countermeasures initiative (MCMi) to facilitate the development and availability of medical products to counter CBRN and emerging disease threats. As a regulatory agency, FDA has a unique and critical part to play in this national undertaking. Using a three‐pillar approach, FDA is addressing key challenges associated with the regulatory review process for medical countermeasures; gaps in regulatory science for MCM development and evaluation; and issues related to the legal, regulatory and policy framework for an effective public health response. Filling the gaps in the MCM Enterprise is a huge national undertaking, requiring the collaboration of all stakeholders, including federal partners, current and prospective developers of medical countermeasures, relevant research organizations, and state and local responders. Especially critical to success are an appreciation of the long timelines, risks and high costs associated with developing medical countermeasures – and the systems to deliver them – and the requisite support of all stakeholders, including national leadership. PMID:22925432

Regulating genomics in the 21st century: from logos to pathos?

PubMed

Gottweis, Herbert

2005-03-01

There is currently an important change in the governance of genomics. In the past, much of the regulatory discussion about genomics has focused on issues of risk. Today, a new discussion is evolving that emphasizes the uncertainties involved in the development and diffusion of genomics into society. The increasing importance of emotional language and the focus on trust in the discussion about genomics reflects the attempt to substitute for the shortcomings of logos with ethos and pathos.

Cybersecurity in Artificial Pancreas Experiments.

PubMed

O'Keeffe, Derek T; Maraka, Spyridoula; Basu, Ananda; Keith-Hynes, Patrick; Kudva, Yogish C

2015-09-01

Medical devices have transformed modern health care, and ongoing experimental medical technology trials (such as the artificial pancreas) have the potential to significantly improve the treatment of several chronic conditions, including diabetes mellitus. However, we suggest that, to date, the essential concept of cybersecurity has not been adequately addressed in this field. This article discusses several key issues of cybersecurity in medical devices and proposes some solutions. In addition, it outlines the current requirements and efforts of regulatory agencies to increase awareness of this topic and to improve cybersecurity.

Regulatory alerts for dietary supplements in Canada and the United States, 2005-13.

PubMed

Abe, Andrew M; Hein, Darren J; Gregory, Philip J

2015-06-01

Dietary supplement regulatory alerts published by the Food and Drug Administration (FDA) and Health Canada were evaluated and characterized. FDA MedWatch and Health Canada websites were reviewed to identify regulatory alerts regarding dietary supplements from January 1, 2005, through December 31, 2013. Alerts were analyzed to identify product characteristics that may be predictive of product quality issues and potential patient harm. A total of 1560 dietary supplement-related regulatory alerts were identified. Of those, 1287 (83%) were identified through Health Canada, and 273 (18%) were identified through FDA MedWatch. The country of origin of dietary supplements associated with regulatory alerts was not provided in most regulatory alerts; however, when their origin was provided, the United States was the most common. Dietary supplements intended for sexual enhancement were the subject of 33% of all regulatory alerts identified. Products purchased online were the most likely to be associated with a regulatory alert. Dietary supplements intended for sexual enhancement, weight loss, and bodybuilding or athletic performance appeared to pose the greatest risk for patient harm due to product contamination with a pharmaceutical such as a phosphodiesterase-5 inhibitor or sibutramine. Analysis of Canadian and U.S. regulatory alerts concerning dietary supplements revealed that more than 80% of the composite alerts were issued by Health Canada. The most common intended uses of supplements for which alerts were issued were sexual enhancement, weight loss, and bodybuilding or athletic performance. The most common reason for alerts was the presence of a pharmaceutical contaminant. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Regulatory and technical reports (abstract index journal): Annual compilation for 1996, Volume 21, No. 4

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sheehan, M.A.

1997-04-01

This compilation is the annual cumulation of bibliographic data and abstracts for the formal regulatory and technical reports issued by the U.S. Nuclear Regulatory Commission (NRC) Staff and its contractors.

17 CFR 1.63 - Service on self-regulatory organization governing boards or committees by persons with...

Code of Federal Regulations, 2014 CFR

2014-04-01

... EXCHANGE ACT Miscellaneous § 1.63 Service on self-regulatory organization governing boards or committees by... organization means a “self-regulatory organization” as defined in § 1.3(ee), and includes a “clearing... self-regulatory organization to issue disciplinary charges, to conduct disciplinary proceedings, to...

17 CFR 1.63 - Service on self-regulatory organization governing boards or committees by persons with...

Code of Federal Regulations, 2013 CFR

2013-04-01

... EXCHANGE ACT Miscellaneous § 1.63 Service on self-regulatory organization governing boards or committees by... organization means a “self-regulatory organization” as defined in § 1.3(ee), and includes a “clearing... self-regulatory organization to issue disciplinary charges, to conduct disciplinary proceedings, to...

Securities and Exchange Commission Rule 151A and Annuities: Issues and Legislation

DTIC Science & Technology

2010-07-01

brokers are required to be members of the Financial Industry Regulatory Authority (FINRA), a non -governmental self-regulatory organization for the...Issues and Legislation Baird Webel Specialist in Financial Economics Rena S. Miller Analyst in Financial Economics July 1, 2010 Congressional...4173) and the Restoring American Financial Stability Act (S. 3217)....................................................................... 12

Giants That Occasionally Roar: Broadcast Regulatory Policy in the United States.

ERIC Educational Resources Information Center

Busby, Linda J.

In this document, broadcast regulatory issues since 1940 are outlined and discussed in relation to social forces. The 1940s saw open warfare between the Federal Communications Commission (FCC) and broadcasters, as a result of the FCC expanding its powers. In 1946, the FCC issued its "Public Service Responsibility of Broadcast Licensees,"…

75 FR 1439 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Rescinding...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

...-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Rescinding NYSE Information Memoranda 04-27 and 07-66 and Issuing a New Information Memo Concerning the Exchange's Gap Quote Policy... NYSE Information Memoranda 04-27 and 07-66 and issue a new Information Memo that provides updated...

75 FR 1438 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule Change Rescinding Information Memoranda 04-27 and 07-66 and Issuing a New Information Memo Concerning the Exchange's Gap Quote... proposed rule change to rescind NYSE Information Memoranda 04-27 and 07-66 and issue a new Information Memo...

International Approaches for Nuclear Waste Disposal in Geological Formations: Geological Challenges in Radioactive Waste Isolation—Fifth Worldwide Review

DOE Office of Scientific and Technical Information (OSTI.GOV)

Faybishenko, Boris; Birkholzer, Jens; Sassani, David

The overall objective of the Fifth Worldwide Review (WWR-5) is to document the current state-of-the-art of major developments in a number of nations throughout the World pursuing geological disposal programs, and to summarize challenging problems and experience that have been obtained in siting, preparing and reviewing cases for the operational and long-term safety of proposed and operating nuclear waste repositories. The scope of the Review is to address current specific technical issues and challenges in safety case development along with the interplay of technical feasibility, siting, engineering design issues, and operational and post-closure safety. In particular, the chapters included inmore » the report present the following types of information: the current status of the deep geological repository programs for high level nuclear waste and low- and intermediate level nuclear waste in each country, concepts of siting and radioactive waste and spent nuclear fuel management in different countries (with the emphasis of nuclear waste disposal under different climatic conditions and different geological formations), progress in repository site selection and site characterization, technology development, buffer/backfill materials studies and testing, support activities, programs, and projects, international cooperation, and future plans, as well as regulatory issues and transboundary problems.« less

78 FR 26090 - Content Specifications and Shielding Evaluations for Type B Transportation Packages

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-03

...The U.S. Nuclear Regulatory Commission (NRC) is issuing Regulatory Issue Summary (RIS) 2013-04, ``Content Specifications and Shielding Evaluations for Type B Transportation Packages.'' This RIS clarifies the NRC's use of staff guidance in NUREG-1609, ``Standard Review Plan for Transport Packages for Radioactive Material,'' for the review of content specifications and shielding evaluations included in the Certificates of Compliance (CoC) and safety analysis reports (SARs) for Type B transportation packages. The RIS does not impose any additional regulatory requirements on NRC licensees.

Flight training efforts would benefit from more flexible aviation regulatory structures.

PubMed

Bent, J

1996-10-01

Training and regulatory issues related to modern flight deck systems are reviewed. Philosophical differences in regulatory bodies in the United States and Europe are highlighted. Methods of changing regulations in Europe and the United States are discussed.

78 FR 37850 - Quality Assurance Program Requirements (Operations)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0021] Quality Assurance Program Requirements (Operations... Regulatory Commission (NRC) is issuing a revision to Regulatory Guide (RG) 1.33, ``Quality Assurance Program... managerial and administrative Quality Assurance (QA) controls for nuclear power plants during operations...

A Preliminary Assessment of the Benefits of Reducing Formaldehyde Exposures (1984)

EPA Pesticide Factsheets

The report reviews a variety of regulatory responses that EPA might consider in developing regulatory strategies for controlling human exposures under the Toxic Substance Control Act and previewed issues that may arise in a regulatory impact analysis.

Current Status and Prospects for Cannabidiol Preparations as New Therapeutic Agents.

PubMed

Fasinu, Pius S; Phillips, Sarah; ElSohly, Mahmoud A; Walker, Larry A

2016-07-01

States and the federal government are under growing pressure to legalize the use of cannabis products for medical purposes in the United States. Sixteen states have legalized (or decriminalized possession of) products high in cannabidiol (CBD) and with restricted ∆(9) -tetrahydrocannabinol (∆(9) -THC) content. In most of these states, the intent is for use in refractory epileptic seizures in children, but in a few states, the indications are broader. This review provides an overview of the pharmacology and toxicology of CBD; summarizes some of the regulatory, safety, and cultural issues relevant to the further exploitation of its antiepileptic or other pharmacologic activities; and assesses the current status and prospects for clinical development of CBD and CBD-rich preparations for medical use in the United States. Unlike Δ(9) -THC, CBD elicits its pharmacologic effects without exerting any significant intrinsic activity on the cannabinoid receptors, whose activation results in the psychotropic effects characteristic of Δ(9) -THC, and CBD possesses several pharmacologic activities that give it a high potential for therapeutic use. CBD exhibits neuroprotective, antiepileptic, anxiolytic, antipsychotic, and antiinflammatory properties. In combination with Δ(9) -THC, CBD has received regulatory approvals in several European countries and is currently under study in trials registered by the U.S. Food and Drug Administration in the United States. A number of states have passed legislation to allow for the use of CBD-rich, limited Δ(9) -THC-content preparations of cannabis for certain pathologic conditions. CBD is currently being studied in several clinical trials and is at different stages of clinical development for various medical indications. Judging from clinical findings reported so far, CBD and CBD-enriched preparations have great potential utility, but uncertainties regarding sourcing, long-term safety, abuse potential, and regulatory dilemmas remain. © 2016 Pharmacotherapy Publications, Inc.

The management of household hazardous waste in the United Kingdom.

PubMed

Slack, R J; Gronow, J R; Voulvoulis, N

2009-01-01

Waste legislation in the United Kingdom (UK) implements European Union (EU) Directives and Regulations. However, the term used to refer to hazardous waste generated in household or municipal situations, household hazardous waste (HHW), does not occur in UK, or EU, legislation. The EU's Hazardous Waste Directive and European Waste Catalogue are the principal legislation influencing HHW, although the waste categories described are difficult to interpret. Other legislation also have impacts on HHW definition and disposal, some of which will alter current HHW disposal practices, leading to a variety of potential consequences. This paper discusses the issues affecting the management of HHW in the UK, including the apparent absence of a HHW-specific regulatory structure. Policy and regulatory measures that influence HHW management before disposal and after disposal are considered, with particular emphasis placed on disposal to landfill.

Liver safety assessment in special populations (hepatitis B, C, and oncology trials).

PubMed

Kullak-Ublick, Gerd A; Merz, Michael; Griffel, Louis; Kaplowitz, Neil; Watkins, Paul B

2014-11-01

The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver disorders. However, liver safety assessment faces challenges in populations with underlying liver disease, such as viral hepatitis or metastatic cancer. This is an important issue because there are currently many promising anti-viral and oncologic therapies in clinical development, with a trend toward oral therapies with reduced side effects. Without clearer guidelines, questions regarding liver safety may become a major factor in regulatory approval and ultimately physician uptake of the new treatments. The lack of consensus in defining stopping rules based on serum alanine aminotransferase (ALT) levels underscores the need for precompetitive data sharing to improve our understanding of DILI in these populations and to allow evidence-based rather than empirical definition of stopping rules. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moe, Wayne L.

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However,more » it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.« less

Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moe, Wayne Leland

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However,more » it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.« less

Evidence-based guidelines for use of probiotics in preterm neonates

PubMed Central

2011-01-01

Background Current evidence indicates that probiotic supplementation significantly reduces all-cause mortality and definite necrotising enterocolitis without significant adverse effects in preterm neonates. As the debate about the pros and cons of routine probiotic supplementation continues, many institutions are satisfied with the current evidence and wish to use probiotics routinely. Because of the lack of detail on many practical aspects of probiotic supplementation, clinician-friendly guidelines are urgently needed to optimise use of probiotics in preterm neonates. Aim To develop evidence-based guidelines for probiotic supplementation in preterm neonates. Methods To develop core guidelines on use of probiotics, including strain selection, dose and duration of supplementation, we primarily used the data from our recent updated systematic review of randomised controlled trials. For equally important issues including strain identification, monitoring for adverse effects, product format, storage and transport, and regulatory hurdles, a comprehensive literature search, covering the period 1966-2010 without restriction on the study design, was conducted, using the databases PubMed and EMBASE, and the proceedings of scientific conferences; these data were used in our updated systematic review. Results In this review, we present guidelines, including level of evidence, for the practical aspects (for example, strain selection, dose, duration, clinical and laboratory surveillance) of probiotic supplementation, and for dealing with non-clinical but important issues (for example, regulatory requirements, product format). Evidence was inadequate in some areas, and these should be a target for further research. Conclusion We hope that these evidence-based guidelines will help to optimise the use of probiotics in preterm neonates. Continued research is essential to provide answers to the current gaps in knowledge about probiotics. PMID:21806843

International challenges and public policy issues.

PubMed

Morris, N

1999-01-01

The paper presents an overview of current public policy issues relating to biological standardisation and control, drawing on the extensive background material assembled for two recent international reviews, and previously published work. It identifies a number of factors which are destabilising the current system and promoting a climate for change. These include the squeeze on public sector resources, the growth in volume and complexity of biologicals, developing world needs, concerns about harmonisation and new social and ethical issues. It is argued that this situation presents important opportunities for reviewing the existing boundaries between regulatory scientists, industry, and the public, for international agreement on priorities and for harmonisation and mutual recognition. While considerable progress has already been made on these issues at national, regional and global level, there is a need for fuller international participation and the additional impetus that would come from a higher-profile commitment by governments. Such commitment will also be important for the vital questions of sustaining the scientific base and securing the resource for an effective, truly worldwide programme of standardisation and control. An international approach will also be essential in steering biologicals control through the difficult social and ethical questions of the future. WHO, in collaboration with national authorities, has a key role to play in these developments.

Parental supervision for their children's toothbrushing: Mediating effects of planning, self-efficacy, and action control.

PubMed

Hamilton, Kyra; Cornish, Stephen; Kirkpatrick, Aaron; Kroon, Jeroen; Schwarzer, Ralf

2018-05-01

With 60-90% of children worldwide reportedly experiencing dental caries, poor oral health in the younger years is a major public health issue. As parents are important to children's oral hygiene practices, we examined the key self-regulatory behaviours of parents for supervising their children's toothbrushing using the health action process approach. Participants (N = 281, 197 mothers) comprised Australian parents of 2- to 5-year-olds. A longitudinal design was used to investigate the sequential mediation chain for the effect of intention (Time 1) on parental supervision for their youngest child's toothbrushing (Time 3), via self-efficacy and planning (Time 2), and action control (Time 3). A latent-variable structural equation model, controlling for baseline behaviour and habit, revealed significant indirect effects from intention via self-efficacy and action control and intention via planning and action control, on parental supervision behaviour. The model was a good fit to the data, explaining 74% of the variance in parents' supervising behaviour for their children's toothbrushing. While national recommendations are provided to guide parents in promoting good oral hygiene practices with their children, current results show the importance of going beyond simple knowledge transmission to support parents' intentions to supervise their children's toothbrushing actually materialize. Current findings make a significant contribution to the cumulative empirical evidence regarding self-regulatory components in health behaviour change and can inform intervention development to increase parents' participation in childhood oral hygiene practices, thus helping to curb rising oral health conditions and diseases. Statement of contribution What is already known on this subject? Self-regulatory skills are important to translate intentions into behaviour. Self-efficacy, planning, and action control are key self-regulatory skills for behaviour change. What does this study add? Self-regulatory skills are needed for parents to supervise their children's toothbrushings. Self-efficacy, planning, and action control are important self-regulatory skills in this context. Future interventions should map these self-regulatory predictors onto behaviour change techniques. © 2018 The British Psychological Society.

Radiation Safety System for SPIDER Neutral Beam Accelerator

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sandri, S.; Poggi, C.; Coniglio, A.

2011-12-13

SPIDER (Source for Production of Ion of Deuterium Extracted from RF Plasma only) and MITICA (Megavolt ITER Injector Concept Advanced) are the ITER neutral beam injector (NBI) testing facilities of the PRIMA (Padova Research Injector Megavolt Accelerated) Center. Both injectors accelerate negative deuterium ions with a maximum energy of 1 MeV for MITICA and 100 keV for SPIDER with a maximum beam current of 40 A for both experiments. The SPIDER facility is classified in Italy as a particle accelerator. At present, the design of the radiation safety system for the facility has been completed and the relevant reports havemore » been presented to the Italian regulatory authorities. Before SPIDER can operate, approval must be obtained from the Italian Regulatory Authority Board (IRAB) following a detailed licensing process. In the present work, the main project information and criteria for the SPIDER injector source are reported together with the analysis of hypothetical accidental situations and safety issues considerations. Neutron and photon nuclear analysis is presented, along with special shielding solutions designed to meet Italian regulatory dose limits. The contribution of activated corrosion products (ACP) to external exposure of workers has also been assessed. Nuclear analysis indicates that the photon contribution to worker external exposure is negligible, and the neutron dose can be considered by far the main radiation protection issue. Our results confirm that the injector has no important radiological impact on the population living around the facility.« less

Industry Perspective on Contemporary Protein-Binding Methodologies: Considerations for Regulatory Drug-Drug Interaction and Related Guidelines on Highly Bound Drugs.

PubMed

Di, Li; Breen, Christopher; Chambers, Rob; Eckley, Sean T; Fricke, Robert; Ghosh, Avijit; Harradine, Paul; Kalvass, J Cory; Ho, Stacy; Lee, Caroline A; Marathe, Punit; Perkins, Everett J; Qian, Mark; Tse, Susanna; Yan, Zhengyin; Zamek-Gliszczynski, Maciej J

2017-12-01

Regulatory agencies have recently issued drug-drug interaction guidelines, which require determination of plasma protein binding (PPB). To err on the conservative side, the agencies recommend that a 0.01 lower limit of fraction unbound (f u ) be used for highly bound compounds (>99%), irrespective of the actual measured values. While this may avoid false negatives, the recommendation would likely result in a high rate of false positive predictions, resulting in unnecessary clinical studies and more stringent inclusion/exclusion criteria, which may add cost and time in delivery of new medicines to patients. In this perspective, we provide a review of current approaches to measure PPB, and important determinants in enabling the accuracy and precision in these measurements. The ability to measure f u is further illustrated by a cross-company data comparison of PPB for warfarin and itraconazole, demonstrating good concordance of the measured f u values. The data indicate that f u values of ≤0.01 may be determined accurately across laboratories when appropriate methods are used. These data, along with numerous other examples presented in the literature, support the use of experimentally measured f u values for drug-drug interaction predictions, rather than using the arbitrary cutoff value of 0.01 as recommended in current regulatory guidelines. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Methodological issues associated with clinical trials in epilepsy.

PubMed

Ferlazzo, Edoardo; Sueri, Chiara; Gasparini, Sara; Russo, Emilio; Cianci, Vittoria; Ascoli, Michele; De Sarro, Giovambattista; Aguglia, Umberto

2017-10-01

despite methodological advances in epilepsy clinical trials, the proportion of patients reaching seizure-freedom has not substantially changed over the years. We review the main methodological limitations of current trials, the possible strategies to overcome these limits, and the issues that need to be addressed in next future. Area covered: references were identified by PubMed search until March 2017 and unpublished literature was searched on ClinicalTrials.gov. Add-on trials mainly involve refractory epilepsy subjects, reducing overall response to the investigational drug. The inclusion of subjects with earlier disease from less developed countries has partially allowed overcoming this limitation, but has introduced more random variability of results. Monotherapy trials rise methodological, economical, and ethical concerns with different regulatory requirements in European Union and in the United States of America. Newer trial designs, such as futility trials or 'time-to-event' design, have been implemented. Moreover, both add-on and monotherapy trials results might be affected by patient's ability to recognize and record seizures, and by randomness of seizures occurrence over time. Possible strategies to achieve more reliable outcomes are detailed. Expert commentary: clinical trial methodology needs to be optimized to better address regulatory agencies requirements and to encounter both patients' and clinicians' needs.

Monitoring ethical, legal, and social issues in developing population genetic databases.

PubMed

Austin, Melissa A; Harding, Sarah E; McElroy, Courtney E

2003-01-01

To characterize ethical, legal, and social issues unique to population genetic database research and to determine the relevance of international recommendations and guidelines for addressing these issues in the development of "genebank" projects globally. Building on our previous description of eight international genebanks, we conducted a comprehensive electronic search and literature review of relevant publications and consulted national and international documents applicable to genebank research. We identified and characterized five categories of ethical, legal, and social issues unique to genebank development: sponsorship and benefit-sharing, neutrality and regulatory power of ethics committees, public engagement, consent, and data protection. We illustrate these issues with examples from specific genebanks. Not all of the issues are addressed in current international guidelines, many of which are nonspecific and unenforceable. The trend of genebank development promises to provide new discoveries to the field of medical science and to greatly improve public health. However, there is a growing need for more explicit, enforceable, and coordinated international guidelines relevant to the development and implementation of genebanks. By comparing ethical, legal and social issues as they arise in genebanks, researchers can better evaluate how to best use these projects to improve public health while protecting participating populations.

Implications for current regulatory waste toxicity characterisation methods from analysing metal and metalloid leaching from photovoltaic modules

NASA Astrophysics Data System (ADS)

Collins, Mary Kayla; Anctil, Annick

2017-07-01

The appropriateness of regulatory methods to characterise the toxicity of photovoltaic (PV) modules was investigated to quantify potential environmental impacts for modules disposed of in landfills. Because solar energy is perceived as a green technology, it is important to ensure that end-of-life issues will not be detrimental to solar energy's success. United States Environmental Protection Agency Method 1311, California waste extraction test, and modified versions of both were performed on a multi-crystalline silicon module and cells and a copper indium gallium diselenide (CIGS) module. Variations in metal leachate concentrations were found with changes in testing parameters. Lead concentrations from the multi-crystalline module ranged from 16.2 to 50.2 mg/L. Cadmium concentrations from the CIGS module ranged from 0.1 to 3.52 mg/L. This raises doubt that regulatory methods can adequately characterise PV modules. The results are useful for developing end-of-life procedures, which is a positive step towards avoiding an e-waste problem and continuing trends of increasing installation and cost reduction in the PV market.

Underground storage tank management plan, Oak Ridge Y-12 Plant, Oak Ridge, Tennessee

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1997-09-01

The Underground Storage Tank (UST) Program at the Oak Ridge Y-12 Plant was established to locate UST systems at the facility and to ensure that all operating UST systems are free of leaks. UST systems have been removed or upgraded in accordance with Tennessee Department of Environment and Conservation (TDEC) regulations and guidance. With the closure of a significant portion of the USTs, the continuing mission of the UST Management Program is to manage the remaining active UST systems and continue corrective actions in a safe regulatory compliant manner. This Program outlines the compliance issues that must be addressed, reviewsmore » the current UST inventory and compliance approach, and presents the status and planned activities associated with each UST system. The UST Program provides guidance for implementing TDEC regulations and guidelines for petroleum UST systems. The plan is divided into three major sections: (1) regulatory requirements, (2) active UST sites, and (3) out-of-service UST sites. These sections describe in detail the applicable regulatory drivers, the UST sites addressed under the Program, and the procedures and guidance for compliance.« less

Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

PubMed Central

Sabata, Roger; Verges, Josep; Zugaza, José L.; Ruiz, Adolfina; Clares, Beatriz

2016-01-01

Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs. PMID:27999600

Transcriptional and posttranscriptional regulation of cyanobacterial photosynthesis.

PubMed

Wilde, Annegret; Hihara, Yukako

2016-03-01

Cyanobacteria are well established model organisms for the study of oxygenic photosynthesis, nitrogen metabolism, toxin biosynthesis, and salt acclimation. However, in comparison to other model bacteria little is known about regulatory networks, which allow cyanobacteria to acclimate to changing environmental conditions. The current work has begun to illuminate how transcription factors modulate expression of different photosynthetic regulons. During the past few years, the research on other regulatory principles like RNA-based regulation showed the importance of non-protein regulators for bacterial lifestyle. Investigations on modulation of photosynthetic components should elucidate the contributions of all factors within the context of a larger regulatory network. Here, we focus on regulation of photosynthetic processes including transcriptional and posttranscriptional mechanisms, citing examples from a limited number of cyanobacterial species. Though, the general idea holds true for most species, important differences exist between various organisms, illustrating diversity of acclimation strategies in the very heterogeneous cyanobacterial clade. This article is part of a Special Issue entitled Organization and dynamics of bioenergetic systems in bacteria, edited by Prof Conrad Mullineaux. Copyright © 2015 Elsevier B.V. All rights reserved.

Regulatory issues in accreditation of toxicology laboratories.

PubMed

Bissell, Michael G

2012-09-01

Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.

Heterogeneous but “Standard” Coding Systems for Adverse Events: Issues in Achieving Interoperability between Apples and Oranges

PubMed Central

Richesson, Rachel L.; Fung, Kin Wah; Krischer, Jeffrey P.

2008-01-01

Monitoring adverse events (AEs) is an important part of clinical research and a crucial target for data standards. The representation of adverse events themselves requires the use of controlled vocabularies with thousands of needed clinical concepts. Several data standards for adverse events currently exist, each with a strong user base. The structure and features of these current adverse event data standards (including terminologies and classifications) are different, so comparisons and evaluations are not straightforward, nor are strategies for their harmonization. Three different data standards - the Medical Dictionary for Regulatory Activities (MedDRA) and the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) terminologies, and Common Terminology Criteria for Adverse Events (CTCAE) classification - are explored as candidate representations for AEs. This paper describes the structural features of each coding system, their content and relationship to the Unified Medical Language System (UMLS), and unsettled issues for future interoperability of these standards. PMID:18406213

Biosimilars in Dermatology: Current Situation (Part I).

PubMed

Puig, L; Carretero, G; Daudén, E; Ferrándiz, C; Marrón, S E; Martorell, A; Pérez-Suárez, B; Rodriguez-Cerdeira, C; Ruiz-Villaverde, R; Sánchez-Carazo, J L; Velasco, M

2015-09-01

The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this article, we review regulatory issues related to the approval of biosimilars, with a particular focus on the situation in the European Union. We will examine analytical characterization studies and special considerations for clinical trials with biosimilars, and also look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. Finally, we will review the biosimilars with indications for psoriasis currently in the clinical development pipeline and assess their potential to offer comparable efficacy and safety to the reference product while contributing to the sustainability of the public health care system. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

Why do patients engage in medical tourism?

PubMed

Runnels, Vivien; Carrera, P M

2012-12-01

Medical tourism is commonly perceived and popularly depicted as an economic issue, both at the system and individual levels. The decision to engage in medical tourism, however, is more complex, driven by patients' unmet need, the nature of services sought and the manner by which treatment is accessed. In order to beneficially employ the opportunities medical tourism offers, and address and contain possible threats and harms, an informed decision is crucial. This paper aims to enhance the current knowledge on medical tourism by isolating the focal content of the decisions that patients make. Based on the existing literature, it proposes a sequential decision-making process in opting for or against medical care abroad, and engaging in medical tourism, including considerations of the required treatments, location of treatment, and quality and safety issues attendant to seeking care. Accordingly, it comments on the imperative of access to health information and the current regulatory environment which impact on this increasingly popular and complex form of accessing and providing medical care. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Urban science education: examining current issues through a historical lens

NASA Astrophysics Data System (ADS)

McLaughlin, Cheryl A.

2014-12-01

This paper reviews and synthesizes urban science education studies published between 2000 and 2013 with a view to identifying current challenges faced by both teachers and students in urban classrooms. Additionally, this paper considers the historical events that have shaped the conditions, bureaucracies, and interactions of urban institutions. When the findings from these urban science education studies were consolidated with the historical overview provided, it was revealed that the basic design and regulatory policies of urban schools have not substantively changed since their establishment in the nineteenth century. Teachers in urban science classrooms continue to face issues of inequality, poverty, and social injustice as they struggle to meet the needs of an increasingly diverse student population. Furthermore, persistent concerns of conflicting Discourses, cultural dissonance, and oppression create formidable barriers to science learning. Despite the many modifications in structure and organization, urban students are still subjugated and marginalized in systems that emphasize control and order over high-quality science education.

76 FR 14108 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

..., Revision 1, ``Control of Preheat Temperature for Welding of Low-Alloy Steel.'' FOR FURTHER INFORMATION... for Welding of Low-Alloy Steel,'' was issued with a temporary identification as Draft Regulatory Guide... implementing regulatory requirements related to the control of welding for low-alloy steel components during...

78 FR 75579 - License Renewal Application for Grand Gulf Nuclear Station, Unit 1

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-12

... NUCLEAR REGULATORY COMMISSION [Docket No. 50-416; NRC-2011-0262] License Renewal Application for Grand Gulf Nuclear Station, Unit 1 AGENCY: Nuclear Regulatory Commission. ACTION: Draft supplemental....S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft, plant-specific...

Biosimilars--global issues, national solutions.

PubMed

Knezevic, Ivana; Griffiths, Elwyn

2011-09-01

Biotechnology derived medicinal products are presently the best characterized biologicals with considerable production and clinical experience, and have revolutionized the treatment of some of the most difficult-to-treat diseases, prolonging and improving the quality of life and patient care. They are also currently one of the fastest growing segments of the pharmaceutical industry market. The critical challenge that the biopharmaceutical industry is facing is the expiry of patents for the first generation of biopharmaceuticals, mainly recombinant DNA derived products, such as interferons, growth hormone and erythropoetin. The question that immediately arose was how should such copies of the originator products be licensed, bearing in mind that they are highly complex biological molecules produced by equally complex biological production processes with their inherent problem of biological variability. Copying biologicals is much more complex than copying small molecules and the critical issue was how to handle the licensing of products if relying in part on data from an innovator product. Since 2004 there has been considerable international consultation on how to deal with biosimilars and biological copy products. This has led to a better understanding of the challenges in the regulatory evaluation of the quality, safety and efficacy of "biosimilars", to the exchange of information between regulators, as well as to the identification of key issues. The aim of this article is to provide a brief overview of the scientific and regulatory challenges faced in developing and evaluating similar biotherapeutic products for global use. It is intended as an introduction to the series of articles in this special issue of Biologicals devoted to similar biotherapeutic products. Copyright © 2011. Published by Elsevier Ltd.

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

PubMed

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically required by other documents. The author has identified signal detection (intended not only as adverse event disproportionate reporting, but including non-clinical, laboratory, clinical analysis data and literature screening) and characterization as the basis for the preparation of all drug safety documents, which can be viewed as different ways of presenting the results of this activity. Therefore, the author proposes to merge all the aggregate reports required by current regulations into a single document - the Drug Safety Master File. This report should contain all the available information, from any source, regarding the potential and identified risks of a drug. It should be a living document updated and submitted to regulatory authorities on an ongoing basis.

Evolution of transcriptional enhancers and animal diversity

PubMed Central

Rubinstein, Marcelo; de Souza, Flávio S. J.

2013-01-01

Deciphering the genetic bases that drive animal diversity is one of the major challenges of modern biology. Although four decades ago it was proposed that animal evolution was mainly driven by changes in cis-regulatory DNA elements controlling gene expression rather than in protein-coding sequences, only now are powerful bioinformatics and experimental approaches available to accelerate studies into how the evolution of transcriptional enhancers contributes to novel forms and functions. In the introduction to this Theme Issue, we start by defining the general properties of transcriptional enhancers, such as modularity and the coexistence of tight sequence conservation with transcription factor-binding site shuffling as different mechanisms that maintain the enhancer grammar over evolutionary time. We discuss past and current methods used to identify cell-type-specific enhancers and provide examples of how enhancers originate de novo, change and are lost in particular lineages. We then focus in the central part of this Theme Issue on analysing examples of how the molecular evolution of enhancers may change form and function. Throughout this introduction, we present the main findings of the articles, reviews and perspectives contributed to this Theme Issue that together illustrate some of the great advances and current frontiers in the field. PMID:24218630

Regulating the for-profit private healthcare providers towards universal health coverage: A qualitative study of legal and organizational framework in Mongolia.

PubMed

Tsevelvaanchig, Uranchimeg; Narula, Indermohan S; Gouda, Hebe; Hill, Peter S

2018-01-01

Regulating the behavior of private providers in the context of mixed health systems has become increasingly important and challenging in many developing countries moving towards universal health coverage including Mongolia. This study examines the current regulatory architecture for private healthcare in Mongolia exploring its role for improving accessibility, affordability, and quality of private care and identifies gaps in policy design and implementation. Qualitative research methods were used including documentary review, analysis, and in-depth interviews with 45 representatives of key actors involved in and affected by regulations in Mongolia's mixed health system, along with long-term participant observation. There has been extensive legal documentation developed regulating private healthcare, with specific organizations assigned to conduct health regulations and inspections. However, the regulatory architecture for healthcare in Mongolia is not optimally designed to improve affordability and quality of private care. This is not limited only to private care: important regulatory functions targeted to quality of care do not exist at the national level. The imprecise content and details of regulations in laws inviting increased political interference, governance issues, unclear roles, and responsibilities of different government regulatory bodies have contributed to failures in implementation of existing regulations. Copyright © 2017 John Wiley & Sons, Ltd.

Meeting the challenges of medical countermeasure development.

PubMed

Maher, Carmen; Hu-Primmer, Jean; MacGill, Tracy; Courtney, Brooke; Borio, Luciana

2012-09-01

Despite substantial investments since the events of 2001, much work remains to prepare the nation for a chemical, biological, radiological or nuclear (CBRN) attack or to respond to an emerging infectious disease threat. Following a 2010 review of the US Public Health Emergency Medical Countermeasures Enterprise, FDA launched its Medical Countermeasures initiative (MCMi) to facilitate the development and availability of medical products to counter CBRN and emerging disease threats. As a regulatory agency, FDA has a unique and critical part to play in this national undertaking. Using a three-pillar approach, FDA is addressing key challenges associated with the regulatory review process for medical countermeasures; gaps in regulatory science for MCM development and evaluation; and issues related to the legal, regulatory and policy framework for an effective public health response. Filling the gaps in the MCM Enterprise is a huge national undertaking, requiring the collaboration of all stakeholders, including federal partners, current and prospective developers of medical countermeasures, relevant research organizations, and state and local responders. Especially critical to success are an appreciation of the long timelines, risks and high costs associated with developing medical countermeasures - and the systems to deliver them - and the requisite support of all stakeholders, including national leadership. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

78 FR 63501 - Request To Submit a Two-Part Application-Northwest Medical Isotopes, LLC

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... NUCLEAR REGULATORY COMMISSION [Project No. 0803; NRC-2013-0235] Request To Submit a Two-Part Application--Northwest Medical Isotopes, LLC AGENCY: Nuclear Regulatory Commission. ACTION: Exemption. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to an August 9, 2013...

78 FR 47015 - Software Requirement Specifications for Digital Computer Software Used in Safety Systems of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Requirement Specifications for Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory Commission... issuing a revised regulatory guide (RG), revision 1 of RG 1.172, ``Software Requirement Specifications for...

78 FR 36278 - Fuel Oil Systems for Emergency Power Supplies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... this notice (if that document is available in ADAMS) is provided the first time that a document is..., Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001... issuing a revision to an existing guide in the NRC's ``Regulatory Guide'' series. This series was...

77 FR 2556 - Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

...] Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public Workshop... Administration (FDA), Office of Pediatric Therapeutics, is announcing a public workshop entitled ``Ethical and... provide a forum for careful consideration of scientific, ethical, and regulatory issues confronting FDA...

78 FR 70354 - Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0254] Conceptual Example of a Proposed Risk Management... issuing a document entitled: ``White Paper on a Conceptual Example of a Proposed Risk Management... ``openness,'' a white paper on a Conceptual Example of a Proposed Risk Management Regulatory Framework (RMRF...

Ethical issues in neonatal and pediatric clinical trials.

PubMed

Laventhal, Naomi; Tarini, Beth A; Lantos, John

2012-10-01

Children have been identified as uniquely vulnerable clinical research subjects since the early 1970s. This article reviews the historical underpinnings of this designation, the current regulatory framework for pediatric and neonatal research, and common problems in pediatric research oversight. It also presents 3 areas of pediatric and neonatal research (genomic screening, healthy children donating stem cells, and therapeutic hypothermia for neonates with hypoxic-ischemic encephalopathy) that highlight contemporary challenges in pediatric research ethics, including balancing risk and benefit, informed consent and assent, and clinical equipoise. Copyright © 2012 Elsevier Inc. All rights reserved.

Effects of food marketing to kids: I'm lovin' it?

PubMed

Salinsky, Eileen

2006-08-15

This issue brief reviews key findings and recommendations from the Institute of Medicine study on food marketing and its effects on childhood obesity. The brief describes the childhood obesity epidemic, discusses key trends associated with rising childhood obesity rates, and considers the relative role of marketing practices on diet and obesity within the broader context of complex contributory factors. The brief also summarizes the current legal framework for regulating marketing directed at children;discusses voluntary, self-regulatory mechanisms; and highlights proposals to re-orient marketing practices to combat childhood obesity.

Cybersecurity in Artificial Pancreas Experiments

PubMed Central

O'Keeffe, Derek T.; Maraka, Spyridoula; Basu, Ananda; Keith-Hynes, Patrick

2015-01-01

Abstract Medical devices have transformed modern health care, and ongoing experimental medical technology trials (such as the artificial pancreas) have the potential to significantly improve the treatment of several chronic conditions, including diabetes mellitus. However, we suggest that, to date, the essential concept of cybersecurity has not been adequately addressed in this field. This article discusses several key issues of cybersecurity in medical devices and proposes some solutions. In addition, it outlines the current requirements and efforts of regulatory agencies to increase awareness of this topic and to improve cybersecurity. PMID:25923544

[To the issue on the optimization and regulation of microclimate in the subway trains and stations].

PubMed

Leksin, A G; Beresneva, T G; Kaptsov, V A; Korotich, L P; Evlampieva, M N; Timoshenkova, E V

2014-01-01

There is presented an overview of currently existing regulatory framework governing the parameters of the microclimate in the salons of subway passenger cars and stations. Analysis of the normative documents indicated that they contain very incomplete, contradictory, often unfounded information about the parameters of microclimate parameters in salons of subway rolling stock. Also, there are no clear cut hygienically-sound requirements for the work of imposed on the rolling stock subway systems provide microclimate, including new systems for air conditioning and disinfection.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barker, J. Jr.; Tenenbaum, B.; Woolf, F.

This paper focuses on the governance and regulation of power pools outside the United States. The current governance and regulatory arrangements for four power pools, as developed in pool documents and government regulations and laws, are compared and contrasted. The power pools analyzed are located in England and Wales, Australia, Canada, and Scandinavia. Topics discussed in relation to these pools are the effects of structure on governance, how each pool has dealt with a number of basic governance decisions, how the pools monitor the markets, ways in which regulators and other institutions control pools, and self-governance issues.

Translational Challenges in Cardiovascular Tissue Engineering.

PubMed

Emmert, Maximilian Y; Fioretta, Emanuela S; Hoerstrup, Simon P

2017-04-01

Valvular heart disease and congenital heart defects represent a major cause of death around the globe. Although current therapy strategies have rapidly evolved over the decades and are nowadays safe, effective, and applicable to many affected patients, the currently used artificial prostheses are still suboptimal. They do not promote regeneration, physiological remodeling, or growth (particularly important aspects for children) as their native counterparts. This results in the continuous degeneration and subsequent failure of these prostheses which is often associated with an increased morbidity and mortality as well as the need for multiple re-interventions. To overcome this problem, the concept of tissue engineering (TE) has been repeatedly suggested as a potential technology to enable native-like cardiovascular replacements with regenerative and growth capacities, suitable for young adults and children. However, despite promising data from pre-clinical and first clinical pilot trials, the translation and clinical relevance of such TE technologies is still very limited. The reasons that currently limit broad clinical adoption are multifaceted and comprise of scientific, clinical, logistical, technical, and regulatory challenges which need to be overcome. The aim of this review is to provide an overview about the translational problems and challenges in current TE approaches. It further suggests directions and potential solutions on how these issues may be efficiently addressed in the future to accelerate clinical translation. In addition, a particular focus is put on the current regulatory guidelines and the associated challenges for these promising TE technologies.

Oceans and Coasts

EPA Pesticide Factsheets

An overview of EPA’s oceans, coasts, estuaries and beaches programs and the regulatory (permits/rules) and non-regulatory approaches for managing their associated environmental issues, such as water pollution and climate change.

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

PubMed

Garofolo, Fabio; Rocci, Mario L; Dumont, Isabelle; Martinez, Suzanne; Lowes, Steve; Woolf, Eric; van Amsterdam, Peter; Bansal, Surendra; Barra, Ariadna Cristina Gomes; Bauer, Ronald; Booth, Brian P; Carrasco-Triguero, Montserrat; DeSilva, Binodh; Dunn, John; Gallicano, Keith; Gouty, Dominique; Ho, Stacy; Hucker, Richard; Jemal, Mohammed; Katori, Noriko; Le Blaye, Olivier; Lee, Jean; Li, Wenkui; Michael, Steve; Nehls, Corey; Nicholson, Robert; Ormsby, Eric; Tang, Daniel; Viswanathan, C T; Weiner, Russell; Young, Graeme

2011-09-01

The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.

International Conference on Harmonisation; guidance on the M4 Common Technical Document--Quality: Questions and Answers/Location Issues; availability. Notice.

PubMed

2004-06-09

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M4: The CTD--Quality: Questions and Answers/Location Issues." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance provides further clarification for preparing the quality components of an application file in the common technical document (CTD) format. The guidance addresses the relationship between linked sections for certain parameters (such as polymorphism and particle size), and it addresses location issues (by indicating the section in which to place requested information). The guidance is intended to ease the preparation of paper and electronic submissions, facilitate regulatory reviews, and simplify the exchange of regulatory information among regulatory authorities.

California state information handbook: formerly utilized sites remedial action program

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

This volume is one of a series produced under contract with the DOE, by Politech Corporation to develop a legislative and regulatory data base to assist the FUSRAP management in addressing the institutional and socioeconomic issues involved in carrying out the Formerly Utilized Sites Remedial Action Program. This Information Handbook series contains information about all relevant government agencies at the Federal and state levels, the pertinent programs they administer, each affected state legislature, and current Federal and state legislative and regulatory initiatives. This volume is a compilation of information about the state of California. It contains: a description of themore » state executive branch structure; a summary of relevant state statutes and regulations; a description of the structure of the state legislature, identification of the officers and committee chairmen, and a summary of recent relevant legislative action; the full text of relevant statutes and regulations.« less

Oregon state information handbook formerly utilized sites remedial action program

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

This volume is one of a series produced under contract with the DOE, by Politech Corporation to develop a legislative and regulatory data base to assist the FUSRAP management in addressing the institutional and socioeconomic issues involved in carrying out the Formerly Utilized Sites Remedial Action Program. This Information Handbook series contains information about all relevant government agencies at the Federal and state levels, the pertinent programs they administater, each affected state legislature, and current Federal and state legislative and regulatory initiatives. This volume is a compilation of information about the State of Oregon. It contains: a description of themore » state executive branch structure; a summary of relevant state statutes and regulations; a description of the structure of the state legislature, identification of the officers and committee chairmen, and a summary of recent relevant legislative action; and the full text of relevant statutes and regulations.« less

Iowa state information handbook: formerly utilized sites remedial action program

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

This volume is one of a series produced under contract with the DOE, By Politech Corporation to develop a legislative and regulatory data base to assist the FUSRAP management in addressing the institutional and socioeconomic issues involved in carrying out the Formerly Utilized Sites Remedial Action Program. This Information Handbook series contains information about all relevant government agencies at the Federal and state levels, the pertinent programs they administer, each affected state legislature, and current Federal and state legislative and regulatory initiatives. This volume is a compilation of information about the state of Iowa. It contains: a description of themore » state executive branch structure; a summary of relevant state statutes and regulations; a description of the structure of the state legislature, identification of the officers and committee chairmen, and a summary of recent relevant legislative action; the full test of relevant statutes and regulations.« less

Oregon state information handbook: formerly utilized sites remedial action program

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

This volume is one of a series produced under contract with the DOE, by Politech Corporation to develop a legislative and regulatory data base to assist the FUSRAP management in addressing the institutional and socioeconomic issues involved in carrying out the Formerly Utilized Sites Remedial Action Program. This Information Handbook series contains information about all relevant government agencies at the Federal and state levels, the pertinent programs they administer, each affected state legislature, and current Federal and state legislative and regulatory initiatives. This volume is a compilation of information about the State of Oregon. It contains a description of themore » state executive branch structure; a summary of relevant state statutes and regulations; a description of the structure of the state legislature, identification of the officers and committee chairmen, and a summary of recent relevant legislative action; and the full text of relevant statutes and regulations.« less

Pennsylvania state information handbook: formerly utilized sites remedial action program

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

This volume is one of a series produced under contract with the DOE, by Politech Corporation to develop a legislative and regulatory data base to assist the FUSRAP management in addressing the institutional and socioeconomic issues involved in carrying out the Formerly Utilized Sites Remedial Action Program. This Information Handbook series contains information about all relevant government agencies at the Federal and State levels, the pertinent programs they administer, each affected state legislature, and current Federal and state legislative and regulatory initiatives. This volume is a compilation of information about the State of Pennsylvania. It contains a description of themore » state executive branch structure; a summary of relevant state statutes and regulations; a description of the structure of the state legislature, identification of the officers and committee chairmen, and a summary of recent relevant legislative action; and the full text of relevant statutes and regulations.« less

Florida state information handbook: formerly utilized sites remedial action program

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

This volume is one of a series produced under contract with DOE, Office of Nuclear Waste Management, by Politech Corporation to develop a legislative and regulatory data base to assist the FUSRAP management in addressing the institutional and socioeconomic issues involved in carrying out the Remedial Action Program. This Information Handbook series contains information about all relevant government agencies at the federal and state levels, the pertinent programs they administer, each affected state legislature, and current federal and state legislative and regulatory initiatives. This volume is a compilation of information about the State of Florida. It contains a description ofmore » the state executive branch structure; a summary of relevant state statutes and regulations; a description of the structure of the state legislature, identification of the officers and committee chairmen, and a summary of recent relevant legislative action; and the full text of relevant statutes and regulations.« less

Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

PubMed Central

Venkatesh, M.; Bairavi, V. G.; Sasikumar, K. C.

2011-01-01

Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. PMID:21430959

New Mexico state information handbook: formerly utilized sites remedial action program

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

This volume is one of a series produced under contract with the DOE, by Politech Corporation to develop a legislative and regulatory data base to assist the FUSRAP management in addressing the institutional and socioeconomic issues involved in carrying out the Formerly Utilized Sites Remedial Action Program. This information Handbook series contains information about all relevant government agencies at the Federal and state levels, the pertinent programs they administer, each affected state legislature, and current Federal and state legislative and regulatory initiatives. This volume is a compilation of information about the State of New Mexico. It contains a description ofmore » the state executive branch structure; a summary of relevant state statutes and regulations; a description of the structure of the state legislature, identification of the officers and committee chairmen, and a summary of recent relevant legislative action; and the full text of relevant statutes and regulations.« less

Animal models to detect allergenicity to foods and genetically modified products: workshop summary.

PubMed Central

Tryphonas, Helen; Arvanitakis, George; Vavasour, Elizabeth; Bondy, Genevieve

2003-01-01

Respiratory allergy and allergy to foods continue to be important health issues. There is evidence to indicate that the incidence of food allergy around the world is on the rise. Current estimates indicate that approximately 5% of young children and 1-2% of adults suffer from true food allergy (Kagan 2003). Although a large number of in vivo and in vitro tests exist for the clinical diagnosis of allergy in humans, we lack validated animal models of allergenicity. This deficiency creates serious problems for regulatory agencies and industries that must define the potential allergenicity of foods before marketing. The emergence of several biotechnologically derived foods and industrial proteins, as well as their potential to sensitize genetically predisposed populations to develop allergy, has prompted health officials and regulatory agencies around the world to seek approaches and methodologies to screen novel proteins for allergenicity. PMID:12573909

Safety and Regulatory Issues of the Thorium Fuel Cycle

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ade, Brian; Worrall, Andrew; Powers, Jeffrey

2014-02-01

Thorium has been widely considered an alternative to uranium fuel because of its relatively large natural abundance and its ability to breed fissile fuel (233U) from natural thorium (232Th). Possible scenarios for using thorium in the nuclear fuel cycle include use in different nuclear reactor types (light water, high temperature gas cooled, fast spectrum sodium, molten salt, etc.), advanced accelerator-driven systems, or even fission-fusion hybrid systems. The most likely near-term application of thorium in the United States is in currently operating light water reactors (LWRs). This use is primarily based on concepts that mix thorium with uranium (UO2 + ThO2),more » add fertile thorium (ThO2) fuel pins to LWR fuel assemblies, or use mixed plutonium and thorium (PuO2 + ThO2) fuel assemblies. The addition of thorium to currently operating LWRs would result in a number of different phenomenological impacts on the nuclear fuel. Thorium and its irradiation products have nuclear characteristics that are different from those of uranium. In addition, ThO2, alone or mixed with UO2 fuel, leads to different chemical and physical properties of the fuel. These aspects are key to reactor safety-related issues. The primary objectives of this report are to summarize historical, current, and proposed uses of thorium in nuclear reactors; provide some important properties of thorium fuel; perform qualitative and quantitative evaluations of both in-reactor and out-of-reactor safety issues and requirements specific to a thorium-based fuel cycle for current LWR reactor designs; and identify key knowledge gaps and technical issues that need to be addressed for the licensing of thorium LWR fuel in the United States.« less

Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America.

PubMed

de la Cruz, Claudia; de Carvalho, André V E; Dorantes, Gladys L; Londoño Garcia, Angela M; Gonzalez, Cesar; Maskin, Matías; Podoswa, Nancy; Redfern, Jan S; Valenzuela, Fernando; van der Walt, Joelle; Romiti, Ricardo

2017-01-01

Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes. © 2016 Japanese Dermatological Association.

Follow-on biologics: data exclusivity and the balance between innovation and competition.

PubMed

Grabowski, Henry

2008-06-01

Legislation to create a regulatory pathway for follow-on biologics is currently being considered by the United States Congress. A critical issue in this respect is the period of data exclusivity for innovator companies before a follow-on competitor can rely in part on data obtained for an original biologic for an abbreviated approval. Given the nature of patents on biologics, the period of data exclusivity is anticipated to have a key role in determining how quickly follow-on competitors emerge, and consequently also on the time available for originator companies to recoup their investment. With this issue in mind, this article discusses factors influencing return on investment on biologic research and development. A break-even analysis for a representative portfolio of biologics provides support for a substantial data exclusivity period.

The Potential of Cold Plasma for Safe and Sustainable Food Production.

PubMed

Bourke, Paula; Ziuzina, Dana; Boehm, Daniela; Cullen, Patrick J; Keener, Kevin

2018-06-01

Cold plasma science and technology is increasingly investigated for translation to a plethora of issues in the agriculture and food sectors. The diversity of the mechanisms of action of cold plasma, and the flexibility as a standalone technology or one that can integrate with other technologies, provide a rich resource for driving innovative solutions. The emerging understanding of the longer-term role of cold plasma reactive species and follow-on effects across a range of systems will suggest how cold plasma may be optimally applied to biological systems in the agricultural and food sectors. Here we present the current status, emerging issues, regulatory context, and opportunities of cold plasma with respect to the broad stages of primary and secondary food production. Copyright © 2017 Elsevier Ltd. All rights reserved.

Ethics and biobanks

PubMed Central

Hansson, M G

2008-01-01

Biobank research has been the focus of great interest of scholars and regulatory bodies who have addressed different ethical issues. On the basis of a review of the literature it may be concluded that, regarding some major themes in this discussion, a consensus seems to emerge on the international scene after the regular exchange of arguments in scientific journals. Broad or general consent is emerging as the generally preferred solution for biobank studies and straightforward instructions for coding will optimise privacy while facilitating research that may result in new methods for the prevention of disease and for medical treatment. The difficult question regarding the return of information to research subjects is the focus of the current research, but a helpful analysis of some of the issues at stake and concrete recommendations have recently been suggested. PMID:19034276

Who owns Australia's water--elements of an effective regulatory model.

PubMed

McKay, J

2003-01-01

This paper identifies and describes a number of global trends in regulatory theory and legal scholarship. It points out the huge level of complexity demanded by globalisation and the unfortunate complication of this is that there is legal indeterminacy. The legal indeterminacy springs from the desire to amend and alter existing models. That has been the thrust of the Council of Australian Governments changes to adapt and add huge amounts of complexity to a flawed system. This paper argues that an effective water regulatory model requires a fundamental re-examination of the concept of water ownership and a capturing by the State of the right to allocate rainfall. This foundation is effective and the way forward to deal with the key issues in this transition phase. The second key element to an effective regulatory model is the concept of performance-based assessment. This requires information and schemes to be set up to work out ways to monitor and evaluate the performance of the utility on selected criteria. For Australia at present there is a dire lack of agreed criteria on these key issues and these have the potential to pull apart the whole process. The key issues are indigenous rights, governance issues, public participation, alteration of pre-existing rights and incorporation of environmental requirements.

Shaping nursing profession regulation through history - a systematic review.

PubMed

Stievano, A; Caruso, R; Pittella, F; Shaffer, F A; Rocco, G; Fairman, J

2018-03-23

The aim of this systematic review was to provide a critical synthesis of the factors that historically shaped the advancements of nursing regulators worldwide. An in-depth examination of the different factors that moulded regulatory changes over time is pivotal to comprehend current issues in nursing. In the light of global health scenarios, the researchers explored the factors that historically influenced the socio-contextual circumstances upon which governments made regulatory changes. A systematic search was performed on the following databases: PubMed, CINAHL, Scopus, OpenGrey and ScienceDirect. The review included papers from January 2000 to October 2016 published in English. The authors used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and an inductive thematic approach for synthesis. Two main themes were identified: factors underpinning current challenges and historical and contextual triggers of regulation. The first theme was composed of three aspects: education, migration and internationalization, and policy and regulation; the second theme consisted of four attributes: demographics, economics, history of registration and wars, and historical changes in nursing practice. Factors that shaped nursing regulation were linked to changing demographics and economics, education, history of nursing registration, shifting patterns of migration and internationalization, nursing practice, policy and regulation and significant societal turns often prompted by wars. A deeper understanding of the developments of the nursing regulatory institutions provides the foundation for portable standards that can be applied across an array of jurisdictions to guarantee a better public safety. Understanding factors that socially, legislatively and politically have influenced the development of regulatory bodies over time helps to mould local, national and international policies that have a stronger impact on health worldwide. To achieve this, there must be effective cooperation among systems of nursing regulations globally. © 2018 International Council of Nurses.

Adipose-Derived Stem Cells in Aesthetic Surgery: A Mixed Methods Evaluation of the Current Clinical Trial, Intellectual Property, and Regulatory Landscape.

PubMed

Arshad, Zeeshaan; Halioua-Haubold, Celine-Lea; Roberts, Mackenna; Urso-Baiarda, Fulvio; Branford, Oliver A; Brindley, David A; Davies, Benjamin M; Pettitt, David

2018-02-17

Adipose tissue, which can be readily harvested via a number of liposuction techniques, offers an easily accessible and abundant source of adipose-derived stem cells (ASCs). Consequently, ASCs have become an increasingly popular reconstructive option and a novel means of aesthetic soft tissue augmentation. This paper examines recent advances in the aesthetic surgery field, extending beyond traditional review formats to incorporate a comprehensive analysis of current clinical trials, adoption status, and the commercialization pathway. Keyword searches were carried out on clinical trial databases to search for trials using ASCs for aesthetic indications. An intellectual property landscape was created using commercial software (Thomson Reuters Thomson Innovation, New York, NY). Analysis of who is claiming what in respect of ASC use in aesthetic surgery for commercial purposes was analyzed by reviewing the patent landscape in relation to these techniques. Key international regulatory guidelines were also summarized. Completed clinical trials lacked robust controls, employed small sample sizes, and lacked long-term follow-up data. Ongoing clinical trials still do not address such issues. In recent years, claims to intellectual property ownership have increased in the "aesthetic stem cell" domain, reflecting commercial interest in the area. However, significant translational barriers remain including regulatory challenges and ethical considerations. Further rigorous randomized controlled trials are required to delineate long-term clinical efficacy and safety. Providers should consider the introduction of patient reported outcome metrics to facilitate clinical adoption. Robust regulatory and ethical policies concerning stem cells and aesthetic surgery should be devised to discourage further growth of "stem cell tourism." © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

Overview of cancer vaccines

PubMed Central

Kudrin, Alex

2012-01-01

Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This is a review dedicated to determine major regulatory and developmental issues around cancer immunotherapeutics. A three pillar approach should be used in setting a development path: discovery platforms and sufficient pool of validated tumor antigens, product development strategy enabling to bring the product closer to the patient and clinical development strategy accounting for competitive landscape, treatment paradigm, technical and commercial risks. Regulatory framework existing around cancer vaccines in the EU, US, Japan and some developing countries is outlined. In addition, the review covers some specific issues on the design and conduct of clinical trials with cancer vaccines. PMID:22894970

Enhancing the development and approval of acute stroke therapies: Stroke Therapy Academic Industry roundtable.

PubMed

Fisher, Marc; Albers, Gregory W; Donnan, Geoffrey A; Furlan, Anthony J; Grotta, James C; Kidwell, Chelsea S; Sacco, Ralph L; Wechsler, Lawrence R

2005-08-01

Previous Stroke Therapy Academic Industry Roundtable (STAIR) meetings focused on preclinical evidence of drug efficacy and enhancing acute stroke trial design and performance. A fourth (STAIR-IV) was held to discuss relevant issues related to acute stroke drug development and regulatory approval. The STAIR-IV meeting had 3 main focus areas. The first topic was novel approaches to statistical design of acute stroke trials and appropriate outcome measures. The second focus was the need for better cooperation among participants in stroke therapy development that may be addressed through a national consortium of stroke trial centers in the United States and elsewhere. Lastly, regulatory issues related to the approval of novel mono and multiple acute stroke therapies were discussed. The development of additional acute stroke therapies represents a large unmet need with many remaining challenges and also opportunities to incorporate novel approaches to clinical trial design that will lead to regulatory approval. The STAIR-IV meeting explored new concepts of trial methodology and data analysis, initiatives for implementing a US clinical trialist consortium, and pertinent regulatory issues to expedite approval of novel therapies.

78 FR 9743 - Event Reporting Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0237] Event Reporting Guidelines AGENCY: Nuclear... Regulatory Commission (NRC) has issued NUREG- 1022, Revision 3, ``Event Reporting Guidelines: 10 CFR 50.72 and 50.73.'' [[Page 9744

Improving medical device regulation: the United States and Europe in perspective.

PubMed

Sorenson, Corinna; Drummond, Michael

2014-03-01

Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium- and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices. © 2014 Milbank Memorial Fund.

Improving Medical Device Regulation: The United States and Europe in Perspective

PubMed Central

SORENSON, CORINNA; DRUMMOND, MICHAEL

2014-01-01

Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. Methods: We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. Findings: The two regulatory systems differ in their mandate and orientation, organization, pre-and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Conclusions: Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium-and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices. PMID:24597558

Commissioning through competition and cooperation in the English NHS under the Health and Social Care Act 2012: evidence from a qualitative study of four clinical commissioning groups.

PubMed

Allen, Pauline; Osipovič, Dorota; Shepherd, Elizabeth; Coleman, Anna; Perkins, Neil; Garnett, Emma; Williams, Lorraine

2017-02-09

The Health and Social Care Act 2012 ('HSCA 2012') introduced a new, statutory, form of regulation of competition into the National Health Service (NHS), while at the same time recognising that cooperation was necessary. NHS England's policy document, The Five Year Forward View ('5YFV') of 2014 placed less emphasis on competition without altering the legislation. We explored how commissioners and providers understand the complex regulatory framework, and how they behave in relation to competition and cooperation. We carried out detailed case studies in four clinical commissioning groups, using interviews and documentary analysis to explore the commissioners' and providers' understanding and experience of competition and cooperation. We conducted 42 interviews with senior managers in commissioning organisations and senior managers in NHS and independent provider organisations (acute and community services). Neither commissioners nor providers fully understand the regulatory regime in respect of competition in the NHS, and have not found that the regulatory authorities have provided adequate guidance. Despite the HSCA 2012 promoting competition, commissioners chose mainly to use collaborative strategies to effect major service reconfigurations, which is endorsed as a suitable approach by providers. Nevertheless, commissioners are using competitive tendering in respect of more peripheral services in order to improve quality of care and value for money. Commissioners regard the use of competition and cooperation as appropriate in the NHS currently, although collaborative strategies appear more helpful in respect of large-scale changes. However, the current regulatory framework contained in the HSCA 2012, particularly since the publication of the 5YFV, is not clear. Better guidance should be issued by the regulatory authorities. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Regulatory framework on bioequivalence criteria for locally acting gastrointestinal drugs: the case for oral modified release mesalamine formulations.

PubMed

Sferrazza, Gianluca; Siviero, Paolo D; Nicotera, Giuseppe; Turella, Paola; Serafino, Annalucia; Blandizzi, Corrado; Pierimarchi, Pasquale

2017-09-01

Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issue for both regulatory authorities and pharmaceutical industries. The international regulatory framework has been characterized by the lack of specific bioequivalence tests that has generated a negative impact on the market competition and drug use in clinical practice. Areas covered: This review article provides an overview of the European Union and United States regulatory frameworks on bioequivalence criteria for locally acting gastrointestinal drugs, also discussing the most prominent scientific issues and advances that has been made in this field. A focus on oral modified release mesalamine formulations will be also provided, with practical examples of the regulatory pathways followed by pharmaceutical companies to determine bioequivalence. Expert commentary: The development of a scientific rationale to demonstrate bioequivalence in this field has been complex and often associated with uncertainties related to scientific and regulatory aspects. Only in recent years, thanks to advanced knowledge in this field, the criteria for bioequivalence assessment are undergoing substantial changes. This new scenario will likely result in a significant impact on pharmaceutical companies, promoting more competition through a clearer regulatory approach, conceived for streamlining the demonstration of therapeutic equivalence for locally acting gastrointestinal drugs.

47 CFR 63.10 - Regulatory classification of U.S. international carriers.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 3 2010-10-01 2010-10-01 false Regulatory classification of U.S. international... and Supplements § 63.10 Regulatory classification of U.S. international carriers. (a) Unless otherwise... issue it raises as to the proper classification of the U.S. carrier. (c) Any carrier classified as...

47 CFR 63.10 - Regulatory classification of U.S. international carriers.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 3 2011-10-01 2011-10-01 false Regulatory classification of U.S. international... and Supplements § 63.10 Regulatory classification of U.S. international carriers. (a) Unless otherwise... issue it raises as to the proper classification of the U.S. carrier. (c) Any carrier classified as...

77 FR 33253 - Regulatory Guide 8.24, Revision 2, Health Physics Surveys During Enriched Uranium-235 Processing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-05

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0115] Regulatory Guide 8.24, Revision 2, Health Physics..., ``Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication'' was issued with a... specifically with the following aspects of an acceptable occupational health physics program that are closely...

78 FR 37848 - ASME Code Cases Not Approved for Use

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

...The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1233, ``ASME Code Cases not Approved for Use.'' This regulatory guide lists the American Society of Mechanical Engineers (ASME) Code Cases that the NRC has determined not to be acceptable for use on a generic basis.

78 FR 47574 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery Off the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-06

...-Grouper Fishery Off the Southern Atlantic States; Regulatory Amendment 18 AGENCY: National Marine... rule. SUMMARY: NMFS issues this final rule to implement Regulatory Amendment 18 to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP) (Regulatory Amendment 18...

Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".

PubMed

O'Reilly, Erin K; Blair Holbein, M E; Berglund, Jelena P; Parrish, Amanda B; Roth, Mary-Tara; Burnett, Bruce K

2013-12-01

This study highlights Warning Letter (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to 'clinical investigators', 'sponsors' or 'sponsor-investigators'. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. A review of FDA WLs issued over a five-year period (FDA Fiscal Years 2008-2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware of, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]; thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research.

Regulatory perspectives on acceptability testing of dosage forms in children.

PubMed

Kozarewicz, Piotr

2014-08-05

Current knowledge about the age-appropriateness of different dosage forms is still fragmented or limited. Applicants are asked to demonstrate that the target age group(s) can manage the dosage form or propose an alternative strategy. However, questions remain about how far the applicant must go and what percentage of patients must find the strategy 'acceptable'. The aim of this overview is to provide an update on current thinking and understanding of the problem, and discuss issues relating to the acceptability testing. This overview should be considered as means to start a wider discussion which hopefully will result in a harmonised, globally acceptable approach for confirmation of the acceptability in the future. Copyright © 2014 Elsevier B.V. All rights reserved.

Nutrition issues in Codex: health claims, nutrient reference values and WTO agreements: a conference report.

PubMed

Aggett, Peter J; Hathcock, John; Jukes, David; Richardson, David P; Calder, Philip C; Bischoff-Ferrari, Heike; Nicklas, Theresa; Mühlebach, Stefan; Kwon, Oran; Lewis, Janine; Lugard, Maurits J F; Prock, Peter

2012-03-01

Codex documents may be used as educational and consensus materials for member governments. Also, the WTO SPS Agreement recognizes Codex as the presumptive international authority on food issues. Nutrient bioavailability is a critical factor in determining the ability of nutrients to provide beneficial effects. Bioavailability also influences the quantitative dietary requirements that are the basis of nutrient intake recommendations and NRVs. Codex, EFSA and some national regulatory authorities have established guidelines or regulations that will permit several types of health claims. The scientific basis for claims has been established by the US FDA and EFSA, but not yet by Codex. Evidence-based nutrition differs from evidence-based medicine, but the differences are only recently gaining recognition. Health claims on foods may provide useful information to consumers, but many will interpret the information to mean that they can rely upon the food or nutrient to eliminate a disease risk. NRVs are designed to provide a quantitative basis for comparing the nutritive values of foods, helping to illustrate how specific foods fit into the overall diet. The INL-98 and the mean of adult male and female values provide NRVs that are sufficient when used as targets for individual intakes by most adults. WTO recognizes Codex as the primary international authority on food issues. Current regulatory schemes based on recommended dietary allowances are trade restrictive. A substantial number of decisions by the EFSA could lead to violation of WTO agreements.

Structural marsh management research priorities

USGS Publications Warehouse

Cahoon, Donald R.; Groat, Charles G.

1989-01-01

The paper presents a prioritized list of research issues related to structural marsh management developed by a multidisciplinary panel of regulatory agency representatives, landowners, and scientists. More than 75 issues were identified concerning landscape changes, influence on ecological processes (i.e., hydrologic, biologic, and edaphic factors), habitat quality, cumulative impacts, and management approach. These issues were prioritized and organized around six basic questions regulatory personnel must try to answer for each marsh management plan application. The six questions deal with the influence of marsh management on, in order of most immediate need, marsh loss and health, fisheries, wildlife, habitat change, water quality, and cumulative effects.

Recommendations for harmonization of data collection and analysis of developmental neurotoxicity endpoints in regulatory guideline studies: Proceedings of workshops presented at Society of Toxicology and joint Teratology Society and Neurobehavioral Teratology Society meetings.

PubMed

Li, Abby A; Sheets, Larry P; Raffaele, Kathleen; Moser, Virginia; Hofstra, Angela; Hoberman, Alan; Makris, Susan L; Garman, Robert; Bolon, Brad; Kaufmann, Wolfgang; Auer, Roland; Lau, Edmund; Vidmar, Thomas; Bowers, Wayne J

2017-09-01

The potential for developmental neurotoxicity (DNT) of environmental chemicals may be evaluated using specific test guidelines from the US Environmental Protection Agency or the Organisation for Economic Cooperation and Development (OECD). These guidelines generate neurobehavioral, neuropathological, and morphometric data that are evaluated by regulatory agencies globally. Data from these DNT guideline studies, or the more recent OECD extended one-generation reproductive toxicity guideline, play a pivotal role in children's health risk assessment in different world areas. Data from the same study may be interpreted differently by regulatory authorities in different countries resulting in inconsistent evaluations that may lead to inconsistencies in risk assessment decisions internationally, resulting in regional differences in public health protection or in commercial trade barriers. These issues of data interpretation and reporting are also relevant to juvenile and pre-postnatal studies conducted more routinely for pharmaceuticals and veterinary medicines. There is a need for development of recommendations geared toward the operational needs of the regulatory scientific reviewers who apply these studies in risk assessments, as well as the scientists who generate DNT data sets. The workshops summarized here draw upon the experience of the authors representing government, industry, contract research organizations, and academia to discuss the scientific issues that have emerged from diverse regulatory evaluations. Although various regulatory bodies have different risk management decisions and labeling requirements that are difficult to harmonize, the workshops provided an opportunity to work toward more harmonized scientific approaches for evaluating DNT data within the context of different regulatory frameworks. Five speakers and their coauthors with neurotoxicology, neuropathology, and regulatory toxicology expertise discussed issues of variability, data reporting and analysis, and expectations in DNT data that are encountered by regulatory authorities. In addition, principles for harmonized evaluation of data were suggested using guideline DNT data as case studies. Copyright © 2017. Published by Elsevier Inc.

Issue Paper on the Environmental Chemistry of Metals

EPA Pesticide Factsheets

EPA has identified three types of regulatory risk assessments where information regarding speciation of metals is useful and desirable: national hazard/risk ranking and characterization, site-specific assessments, and National Regulatory Assessments.

Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

How health technology assessment agencies address the issue of unpublished data.

PubMed

Kreis, Julia; Panteli, Dimitra; Busse, Reinhard

2014-01-01

Reporting bias potentially threatens the validity of results in health technology assessment (HTA) reports. Our study aimed to explore policies and practices of HTA agencies regarding strategies to include previously unpublished data in their assessments, focusing on requests to industry for unpublished data. We included international HTA agencies with publicly available methods papers as well as HTA reports. From the methods papers and recent reports we extracted information on requests to industry and on searches in trial registries, regulatory authority Web sites and for conference abstracts. Eighteen HTA agencies and seventy-three reports were included. Agencies' methods papers showed variability regarding requests to industry (requests are routinely carried out in seven cases, not mentioned in six, at the discretion of HTA authors in three, and based on manufacturer applications in two), which were reflected in the reports investigated. As reporting of requests was limited, it often remained unclear whether unpublished data had been received. Searches in trial registries, at regulatory authorities or for conference abstracts are described as a routine or optional part of the search strategy in the methods papers of 9, 11, and 8 included agencies, respectively. A total of 52 percent, 39 percent, and 16 percent of reports described searches in trial registries, at regulatory agencies, and hand searching of conference proceedings. International HTA agencies currently differ considerably in their efforts to address the issue of unpublished data. Requests to industry may constitute one strategy to access and include unpublished data, while agencies can learn from each other concerning successful practice.

[Collections of human biological resources for research purposes: from regulations to the need of a guide of good collection practices].

PubMed

Le Roux, N; de Montgolfier, S; di Donato, J-H; Boccon-Gibod, L; Teillac, P; Hervé, C; Berthon, P

2003-12-01

In France, collections of human biological resources are regulated by the "Bioethics Law", currently in revision. Hence, we analyse the regulatory and ethical issues of these practices in the context of scientific research. The ultimate aim of such collections is to improve biological and medical knowledge. We think that the French regulatory system is quite complicated and non-explicit for "collection holders". The multiplicity of legal texts concerning this activity has made their application difficult, especially in the absence of application decrees. The project amending the actual law has clarified the legal status of collections but it did not shed light on the status of human body detached parts. Furthermore, the text is still very far from the international bioethical recommendations, and does not reflect the actual collection's implementation. The establishment of a guideline of Good Collection Practices, based on clear principles, should help to simplify the situation, especially when it is imbedded in the regulation and linked to control procedures. It would allow a balance between collective interests and the protection of individuals, taking into account of the international highly competitive scientific and economical constraints. The major issue is to preserve and to perpetuate the existing and future collections because of their precious value as an important tool for biomedical knowledge. The efficiency of a regulation depends on its legibility and accessibility, two requirements that seem to determine the acceptance of the regulatory tool and its application allowing subsequently to reach fairness in proceedings.

The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites, and Sponsors.

PubMed

Smith-Gick, Jodi; Barnes, Nicola; Barone, Rocco; Bedford, Jeff; James, Jason R; Reisner, Stacy Frankovitz; Stephenson, Michael

2018-01-01

Current clinical trial labels are designed primarily to meet regulatory requirements. These labels have low patient and site utility, few are opened, and they have limited space and small fonts. As our world transitions from paper to electronic, an opportunity exists to provide patients with information about their investigational clinical trial product in a way that is more easily accessible, meets Health Authority requirements, and provides valuable additional information for the patient and caregiver. A TransCelerate initiative was launched to understand the current regulatory and technology landscape for the potential use an electronic label (eLabel) for investigational medicinal products (IMPs). Concepts and an example proof of concept were developed intended to show the "art of the possible" for a foundational eLabel and a "universal printed label." In addition, possible patient-centric enhancements were captured in the eLabel proof of concept. These concepts were shared with Health Authorities as well as patient and site advisory groups to gather feedback and subsequently enhance the concepts. Feedback indicated that the concept of an eLabel provides value and concepts should continue to be pursued. While the Health Authorities engaged with did not express issues with the use of an eLabel per se, the reduction in the content on the paper label is not possible in some geographic locations due to existing regulations. There is nothing that prevents transmitting the label electronically in conjunction with current conventional labeling. While there are still some regulatory barriers that need to be addressed for reducing what is on the paper label, advancement toward a more patient-centric approach benefits stakeholders and will enable a fully connected patient-centric experience. The industry must start now to build the foundation.

Analysis of federal and state policies and environmental issues for bioethanol production facilities.

PubMed

McGee, Chandra; Chan Hilton, Amy B

2011-03-01

The purpose of this work was to investigate incentives and barriers to fuel ethanol production from biomass in the U.S. during the past decade (2000-2010). In particular, we examine the results of policies and economic conditions during this period by way of cellulosic ethanol activity in four selected states with the potential to produce different types of feedstocks (i.e., sugar, starch, and cellulosic crops) for ethanol production (Florida, California, Hawaii, and Iowa). Two of the four states, Iowa and California, currently have commercial ethanol production facilities in operation using corn feedstocks. While several companies have proposed commercial scale facilities in Florida and Hawaii, none are operating to date. Federal and state policies and incentives, potential for feedstock production and conversion to ethanol and associated potential environmental impacts, and environmental regulatory conditions among the states were investigated. Additionally, an analysis of proposed and operational ethanol production facilities provided evidence that a combination of these policies and incentives along with the ability to address environmental issues and regulatory environment and positive economic conditions all impact ethanol production. The 2000-2010 decade saw the rise of the promise of cellulosic ethanol. Federal and state policies were enacted to increase ethanol production. Since the initial push for development, expansion of cellulosic ethanol production has not happened as quickly as predicted. Government and private funding supported the development of ethanol production facilities, which peaked and then declined by the end of the decade. Although there are technical issues that remain to be solved to more efficiently convert cellulosic material to ethanol while reducing environmental impacts, the largest barriers to increasing ethanol production appear to be related to government policies, economics, and logistical issues. The numerous federal and state policies do not effectively give investors confidence to commit to the construction and long-term operation of facilities under current economic conditions. Additional changes in policy and breakthroughs in technology and logistics will be required to address these hurdles to increases in ethanol production in the U.S. in the next decade.

78 FR 35117 - Orphan Drug Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-12

...The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.

[Current situation of and the political measures for drug abuse/dependence].

PubMed

Wada, Kiyoshi; Ozaki, Shigeru; Kondo, Ayumi

2008-04-01

More than 10 years has passed since 1995 when the third epidemic of methamphetamine abuse started in Japan. We are now still in the third epidemic of methamphetamine abuse, thought the current situation of drug abuse/dependence has obviously changed from previously. Considering several kinds of nationwide surveys and censuses, the authors summarized the change as follows: a) obvious decrease in solvent abuse/dependence, b) stabilization of methamphetamine abuse/dependence, c) increase in abuse of such drugs as cannabis or MDMA which don't have high potential to cause drug-induced psychosis, and d) emergence of non-regulatory drugs represented by designer drugs. These imply the change a) from "hard drugs" to "soft drugs", b) from Japanese unique situation which is symbolized by solvent abuse to Western situation which is symbolized by cannabis abuse, and c) from "illicit drugs" to "non-regulatory drugs". These characteristics reveal that there is the limitation to the Japanese Government policy which has tried to control the drug issue mainly as criminal cases for many years and that it is time now to change its policy. The authors stress the necessities of development of medical treatment targeting drug dependence and of its social support system.

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project.

PubMed

Merle, Corinne S C; Sismanidis, Charalambos; Sow, Oumou Bah; Gninafon, Martin; Horton, John; Lapujade, Olivier; Lo, Mame Bocar; Mitchinson, Denis A; Perronne, Christian; Portaels, Francoise; Odhiambo, Joseph; Olliaro, Piero; Rustomjee, Roxana; Lienhardt, Christian; Fielding, Katherine

2012-05-18

There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize endpoint unavailability; and (2) distinguish between relapse and re-infection.

Uranium-Loaded Water Treatment Resins: 'Equivalent Feed' at NRC and Agreement State-Licensed Uranium Recovery Facilities - 12094

DOE Office of Scientific and Technical Information (OSTI.GOV)

Camper, Larry W.; Michalak, Paul; Cohen, Stephen

Community Water Systems (CWSs) are required to remove uranium from drinking water to meet EPA standards. Similarly, mining operations are required to remove uranium from their dewatering discharges to meet permitted surface water discharge limits. Ion exchange (IX) is the primary treatment strategy used by these operations, which loads uranium onto resin beads. Presently, uranium-loaded resin from CWSs and mining operations can be disposed as a waste product or processed by NRC- or Agreement State-licensed uranium recovery facilities if that licensed facility has applied for and received permission to process 'alternate feed'. The disposal of uranium-loaded resin is costly andmore » the cost to amend a uranium recovery license to accept alternate feed can be a strong disincentive to commercial uranium recovery facilities. In response to this issue, the NRC issued a Regulatory Issue Summary (RIS) to clarify the agency's policy that uranium-loaded resin from CWSs and mining operations can be processed by NRC- or Agreement State-licensed uranium recovery facilities without the need for an alternate feed license amendment when these resins are essentially the same, chemically and physically, to resins that licensed uranium recovery facilities currently use (i.e., equivalent feed). NRC staff is clarifying its current alternate feed policy to declare IX resins as equivalent feed. This clarification is necessary to alleviate a regulatory and financial burden on facilities that filter uranium using IX resin, such as CWSs and mine dewatering operations. Disposing of those resins in a licensed facility could be 40 to 50 percent of the total operations and maintenance (O and M) cost for a CWS. Allowing uranium recovery facilities to treat these resins without requiring a license amendment lowers O and M costs and captures a valuable natural resource. (authors)« less

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

PubMed Central

2012-01-01

Background There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Methods Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). Results In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. Conclusion When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize endpoint unavailability; and (2) distinguish between relapse and re-infection. PMID:22607233

77 FR 40668 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

...-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of Proposed Rule Change To Amend Rule G-34, on CUSIP Numbers, New Issue, and Market Information Requirements July 3, 2012. Pursuant.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance...

Regulatory issues in international maritime transport

DOT National Transportation Integrated Search

2001-08-11

This report focuses on regulations governing international liner and bulk shipping. The report discusses the web of regulatory measures that surround these two segments of the shipping industry, and which have a considerable impact on its performance...

Human-animal chimera: a neuro driven discussion? Comparison of three leading European research countries.

PubMed

Cabrera Trujillo, Laura Yenisa; Engel-Glatter, Sabrina

2015-06-01

Research with human-animal chimera raises a number of ethical concerns, especially when neural stem cells are transplanted into the brains of non-human primates (NHPs). Besides animal welfare concerns and ethical issues associated with the use of embryonic stem cells, the research is also regarded as controversial from the standpoint of NHPs developing cognitive or behavioural capabilities that are regarded as "unique" to humans. However, scientists are urging to test new therapeutic approaches for neurological diseases in primate models as they better mimic human physiology than all current animal models. As a response, various countries have issued reports on the topic. Our paper summarizes the ethical issues raised by research with human-animal brain chimeras and compares the relevant regulatory instruments and different recommendations issued in national reports from three important European research nations: Germany, Switzerland and the United Kingdom. We assess and discuss the focus and priorities set by the different reports, review various reasons for and perspectives on the importance of the brain in chimera research, and identify critical points in the reports that warrant further specification and debate.

Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

PubMed

Tohkin, Masahiro

2017-01-01

I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

Meeting report: international workshop on endocrine disruptors: exposure and potential impact on consumers health.

PubMed

Rousselle, C; Ormsby, J N; Schaefer, B; Lampen, A; Platzek, T; Hirsch-Ernst, K; Warholm, M; Oskarsson, A; Nielsen, P J; Holmer, M L; Emond, C

2013-02-01

The French Agency for Food, Environmental and Occupational Health and Safety (Anses) hosted a two-day workshop on Endocrine Disruptors: Exposure and Potential Impact on Consumers Health, bringing together participants from international organizations, academia, research institutes and from German, Swedish, Danish and French governmental agencies. The main objective of the workshop was to share knowledge and experiences on endocrine disruptors (ED) exposure and potential impact on consumers' health, to identify current risk assessment practices and knowledge gaps and issue recommendations on research needs and future collaboration. The following topics were reviewed: (1) Definition of ED, (2) endpoints to be considered for Risk assessment (RA) of ED, (3) non-monotonic dose response curves, (4) studies to be considered for RA (regulatory versus academic studies), (5) point of departure and uncertainty factors, (6) exposure assessment, (7) regulatory issues related to ED. The opinions expressed during this workshop reflect day-to-day experiences from scientists, regulators, researchers, and others from many different countries in the fields of risk assessment, and were regarded by the attendees as an important basis for further discussions. Accordingly, the participants underlined the need for more exchange in the future to share experiences and improve the methodology related to risk assessment for endocrine disrupters. Copyright © 2012 Elsevier Inc. All rights reserved.

Means and ENDS - e-cigarettes, the Framework Convention on Tobacco Control, and global health diplomacy in action.

PubMed

Russell, Andrew; Wainwright, Megan; Tilson, Melodie

2018-01-01

E-cigarettes are a new and disruptive element in global health diplomacy (GHD) and policy-making. This is an ethnographic account of how e-cigarettes and other Electronic Nicotine Delivery Systems (ENDS) were tackled at the 6th Conference of the Parties to the World Health Organization's Framework Convention on Tobacco Control. It demonstrates how uncertainty about ENDS and differences of opinion are currently so great that 'agreeing to disagree' as a consensus position and 'strategic use of time' were the principles that ensured effective GHD in this case. Observers representing accredited non-governmental organisations were active in briefing and lobbying country delegates not to spend too much time debating an issue for which insufficient evidence exists, and for which countries were unlikely to reach a consensus on a specific regulatory approach or universally applicable regulatory measures. Equally, the work of Costa Rica in preparing and re-negotiating the draft decision, and the work of the relevant Committee Chair in managing the discussion, contributed to effectively reining in lengthy statements from Parties and focusing on points of consensus. As well as summarising the debate itself and analysing the issues surrounding it, this account offers an example of GHD working effectively in a situation of epistemic uncertainty.

Health Effects and Public Health Concerns of Energy Drink Consumption in the United States: A Mini-Review.

PubMed

Al-Shaar, Laila; Vercammen, Kelsey; Lu, Chang; Richardson, Scott; Tamez, Martha; Mattei, Josiemer

2017-01-01

As energy drink consumption continues to grow worldwide and within the United States, it is important to critically examine the nutritional content and effects on population health of these beverages. This mini-review summarizes the current scientific evidence on health consequences from energy drink consumption, presents relevant public health challenges, and proposes recommendations to mitigate these issues. Emerging evidence has linked energy drink consumption with a number of negative health consequences such as risk-seeking behaviors, poor mental health, adverse cardiovascular effects, and metabolic, renal, or dental conditions. Despite the consistency in evidence, most studies are of cross-sectional design or focus almost exclusively on the effect of caffeine and sugar, failing to address potentially harmful effects of other ingredients. The negative health effects associated with energy drinks (ED) are compounded by a lack of regulatory oversight and aggressive marketing by the industry toward adolescents. Moreover, the rising trend of mixing ED with alcohol presents a new challenge that researchers and public health practitioners must address further. To curb this growing public health issue, policy makers should consider creating a separate regulatory category for ED, setting an evidence-based upper limit on caffeine, restricting sales of ED, and regulating existing ED marketing strategies, especially among children and adolescents.

Legal and ethical issues in the international transaction of donor sperm and eggs.

PubMed

Heng, Boon Chin

2007-04-01

Pertinent ethical and legal issues in the international transaction of donor sperm and eggs are discussed. Firstly, there may be legislative and ethical "contradiction" by the local health authority in permitting import of donor gametes, due to varying policies on donor reimbursement in different countries. This is particularly significant in countries where the underlying principle of gamete donation is altruistic motivation, and where reimbursement is given only for direct "out-of-pocket" expenses i.e. traveling costs. Secondly, there is a lack of clear and coherent internationally-binding legislation and regulatory guidelines overseeing the exchange of donor gametes across international borders. In particular, provisions should be made for donor traceability if gametes are sourced from abroad. Thirdly, in the case of "frozen-egg donation" from abroad, patients must rightfully be informed that current cryopreservation technology is still sub-optimal, and all studies have consistently shown that the chances of conception are always lower with "frozen-eggs" compared to freshly-retrieved eggs. Finally, regulatory safeguards should be put in place to prevent fertility clinics and medical professionals from "re-selling" imported donor gametes at a profit to the patient, since it would be thoroughly unprofessional for them to earn a profit simply through the 'brokerage' of donated human material.

(PURPA grants to state utility regulatory commissions and electric utilities). Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lambert, E.S.

The Utah Commission considered fully in hearings each of the eleven regulatory and ratemaking standards. In addition, the Commission held hearings concerning the lifeline rates provision of PURPA and the cogeneration and small power production provision. The Utah Commission has taken action with respect to each of these standards. In its Order concerning cases numbered 80-999-09 and 81-999-01, 02, 03, 04, and 05, issued May 14, 1982, and appended to this report, the Utah Commission adopted each of the ratemaking standards. Its actions concerning adoption of the regulatory standards have been the subject of hearings and orders issued during themore » period of time prior to the issuance of the May 14, 1982 Order. After full hearing on the subject, the Utah Commission declined to adopt lifeline rates. In an Order issued April 9, 1981, the Commission implemented the FERC regulations issued pursuant to PURPA Sections 201 and 210. Contained in that Order were interim rates based upon the avoided costs of the electric utilities under this Commission's jurisdiction that are subject to PURPA.« less

Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Clinical Research with Transcranial Direct Current Stimulation (tDCS): Challenges and Future Directions

PubMed Central

Brunoni, Andre Russowsky; Nitsche, Michael A.; Bolognini, Nadia; Bikson, Marom; Wagner, Tim; Merabet, Lotfi; Edwards, Dylan J.; Valero-Cabre, Antoni; Rotenberg, Alexander; Pascual-Leone, Alvaro; Ferrucci, Roberta; Priori, Alberto; Boggio, Paulo; Fregni, Felipe

2011-01-01

Background Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In the past ten years, tDCS physiological mechanisms of action have been intensively investigated giving support for the investigation of its applications in clinical neuropsychiatry and rehabilitation. However, new methodological, ethical, and regulatory issues emerge when translating the findings of preclinical and phase I studies into phase II and III clinical studies. The aim of this comprehensive review is to discuss the key challenges of this process and possible methods to address them. Methods We convened a workgroup of researchers in the field to review, discuss and provide updates and key challenges of neuromodulation use for clinical research. Main Findings/Discussion We reviewed several basic and clinical studies in the field and identified potential limitations, taking into account the particularities of the technique. We review and discuss the findings into four topics: (i) mechanisms of action of tDCS, parameters of use and computer-based human brain modeling investigating electric current fields and magnitude induced by tDCS; (ii) methodological aspects related to the clinical research of tDCS as divided according to study phase (i.e., preclinical, phase I, phase II and phase III studies); (iii) ethical and regulatory concerns; (iv) future directions regarding novel approaches, novel devices, and future studies involving tDCS. Finally, we propose some alternative methods to facilitate clinical research on tDCS. PMID:22037126

A Qualitative Assessment of Current CCF Guidance Based on a Review of Safety System Digital Implementation Changes with Evolving Technology

DOE Office of Scientific and Technical Information (OSTI.GOV)

Korsah, Kofi; Muhlheim, Michael David; Wood, Richard

The US Nuclear Regulatory Commission (NRC) is initiating a new rulemaking project to develop a digital system common-cause failure (CCF) rule. This rulemaking will review and modify or affirm the NRC's current digital system CCF policy as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, Instrumentation and Controls, in NRCmore » Regulatory Guide (NUREG)-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants (ML033580677). The Oak Ridge National Laboratory (ORNL) is providing technical support to the NRC staff on the CCF rulemaking, and this report is one of several providing the technical basis to inform NRC staff members. For the task described in this report, ORNL examined instrumentation and controls (I&C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF is adequate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed.« less

Towards an understanding of the molecular regulation of carbon allocation in diatoms: the interaction of energy and carbon allocation.

PubMed

Wagner, Heiko; Jakob, Torsten; Fanesi, Andrea; Wilhelm, Christian

2017-09-05

In microalgae, the photosynthesis-driven CO 2 assimilation delivers cell building blocks that are used in different biosynthetic pathways. Little is known about how the cell regulates the subsequent carbon allocation to, for example, cell growth or for storage. However, knowledge about these regulatory mechanisms is of high biotechnological and ecological importance. In diatoms, the situation becomes even more complex because, as a consequence of their secondary endosymbiotic origin, the compartmentation of the pathways for the primary metabolic routes is different from green algae. Therefore, the mechanisms to manipulate the carbon allocation pattern cannot be adopted from the green lineage. This review describes the general pathways of cellular energy distribution from light absorption towards the final allocation of carbon into macromolecules and summarizes the current knowledge of diatom-specific allocation patterns. We further describe the (limited) knowledge of regulatory mechanisms of carbon partitioning between lipids, carbohydrates and proteins in diatoms. We present solutions to overcome the problems that hinder the identification of regulatory elements of carbon metabolism.This article is part of the themed issue 'The peculiar carbon metabolism in diatoms'. © 2017 The Author(s).

Current and new developments in transport and regulatory issues concerning radioisotopes: managing change for minimum business impact

NASA Astrophysics Data System (ADS)

Bennett, Neil; Coppell, David; Rogers, David; Schrader, John

2004-09-01

Changes in the regulatory framework governing the Radiation Processing Industry have the potential to make a real business impact on day-to-day profitability. Many areas of the Radiation Processing Industry are affected by changes in the regulatory framework within which these areas are managed. When planning for such changes the transportation element in the shipment of sealed cobalt radiation sources is an area that is often neglected by some parts of the distribution chain. A balance must be struck between the cobalt supplier and the facility operator/customer that rests upon how much the customer needs to know about the intricacies of cobalt shipment. The objective of this paper is to highlight areas of possible business impact and reassure the users of sealed radiation sources that the global suppliers of these products are used to negotiating local variations in regulations governing the physical transportation of radiation sources, changes in regulations governing the design, manufacture and use of transportation containers and changes in the availability of commercial shippers and shipping routes. The major suppliers of industrial quantities of cobalt-60 are well placed to lead their customers through this complex process as a matter of routine.

Incrementally developing a cultural and regulatory infrastructure for reusable launch vehicles

NASA Astrophysics Data System (ADS)

Simberg, Rand

1998-01-01

At this point in time, technology is perhaps the least significant barrier to the development of high-flight-rate, reusable launchers, necessary for low-cost space access. Much more daunting are the issues of regulatory regimes, needed markets, and public/investor perception of their feasibility. The approach currently the focus of the government (X-33) assumes that the necessary conditions will be in place to support a new reusable launch vehicle in the Shuttle class at the end of the X-33 development. For a number of reasons (market size, lack of confidence in the technology, regulations designed for expendable vehicles, difficulties in capital formation) such an approach may prove too rapid a leap for success. More incremental steps, both experimental and operational, could be a higher-probability path to achieving the goal of cheap access through reusables. Such incrementalism, via intermediate vehicles (possibly multi-stage) exploiting suborbital and smaller-payload markets, could provide the gradual acclimatization of the public, regulatory and investment communities to reusable launchers, and build the confidence necessary to go on to subsequent steps to provide truly cheap access, while providing lower-cost access much sooner.

International and domestic regulator issues facing the Canadian MSAT system

NASA Technical Reports Server (NTRS)

Bahman, Azarbar; Langlois, Jacques R.; Frank, Christopher J.

1988-01-01

International and domestic regulatory issues which affect the implementation of a mobile satellite system (MSAT) over North America are addressed. WARC-MOB-87, MSAT frequency co-ordination, frequency sharing and key Canadian domestic issues are discussed.

Guidelines for Performing Regulatory Impact Analysis (1983/1991)

EPA Pesticide Factsheets

These 1983 guidelines as modified in 1991 provide guidance for preparing EPA Regulatory Impact Analyses including benefit-cost analyses. These guidelines have been superseded by the Guidelines for Preparing Economic Analyses issued in 2000 (see EE-0568).

Development of Regulatory Documents for Creation (Upgrade) of Physical Protection Systems under the Russian/American MPC&A Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Izmaylov, Alexandr V.; Babkin, Vladimir; Kurov, Valeriy

2009-10-07

The development of new or the upgrade of existing physical protection systems (PPS) for nuclear facilities involves a multi-step and multidimensional process. The process consists of conceptual design, design, and commissioning stages. The activities associated with each of these stages are governed by Russian government and agency regulations. To ensure a uniform approach to development or upgrading of PPS at Russian nuclear facilities, the development of a range of regulatory and methodological documents is necessary. Some issues of PPS development are covered by the regulatory documents developed by Rosatom, as well as other Russian agencies with nuclear facilities under theirmore » control. This regulatory development has been accomplished as part of the U.S.-Russian MPC&A cooperation or independently by the Russian Federation. While regulatory coverage is extensive, there are a number of issues such as vulnerability analysis, effectiveness assessment, upgrading PPS, and protection of information systems for PPS that require additional regulations be developed. This paper reports on the status of regulatory coverage for PPS development or upgrade, and outlines a new approach to regulatory document development. It describes the evolutionary process of regulatory development through experience gained in the design, development and implementation of PPS as well as experience gained through the cooperative efforts of Russian and U.S. experts involved the development of MPC&A regulations.« less

Comparative regulatory approaches for groups of new plant breeding techniques.

PubMed

Lusser, Maria; Davies, Howard V

2013-06-25

This manuscript provides insights into ongoing debates on the regulatory issues surrounding groups of biotechnology-driven 'New Plant Breeding Techniques' (NPBTs). It presents the outcomes of preliminary discussions and in some cases the initial decisions taken by regulators in the following countries: Argentina, Australia, Canada, EU, Japan, South Africa and USA. In the light of these discussions we suggest in this manuscript a structured approach to make the evaluation more consistent and efficient. The issue appears to be complex as these groups of new technologies vary widely in both the technologies deployed and their impact on heritable changes in the plant genome. An added complication is that the legislation, definitions and regulatory approaches for biotechnology-derived crops differ significantly between these countries. There are therefore concerns that this situation will lead to non-harmonised regulatory approaches and asynchronous development and marketing of such crops resulting in trade disruptions. Copyright © 2013 Elsevier B.V. All rights reserved.

Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network.

PubMed

Ali, Joseph; Califf, Robert; Sugarman, Jeremy

2016-01-01

PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.

Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients.

PubMed

Monera-Penduka, Tsitsi G; Maponga, Charles C; Morse, Gene D; Nhachi, Charles F B

2017-01-01

Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. The national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized. There was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks. In the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries. The study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).

Development and testing of the VITAMIN-B7/BUGLE-B7 coupled neutron-gamma multigroup cross-section libraries

DOE Office of Scientific and Technical Information (OSTI.GOV)

Risner, J.M.; Wiarda, D.; Miller, T.M.

2011-07-01

The U.S. Nuclear Regulatory Commission's Regulatory Guide 1.190 states that calculational methods used to estimate reactor pressure vessel (RPV) fluence should use the latest version of the evaluated nuclear data file (ENDF). The VITAMIN-B6 fine-group library and BUGLE-96 broad-group library, which are widely used for RPV fluence calculations, were generated using ENDF/B-VI.3 data, which was the most current data when Regulatory Guide 1.190 was issued. We have developed new fine-group (VITAMIN-B7) and broad-group (BUGLE-B7) libraries based on ENDF/B-VII.0. These new libraries, which were processed using the AMPX code system, maintain the same group structures as the VITAMIN-B6 and BUGLE-96 libraries.more » Verification and validation of the new libraries were accomplished using diagnostic checks in AMPX, 'unit tests' for each element in VITAMIN-B7, and a diverse set of benchmark experiments including critical evaluations for fast and thermal systems, a set of experimental benchmarks that are used for SCALE regression tests, and three RPV fluence benchmarks. The benchmark evaluation results demonstrate that VITAMIN-B7 and BUGLE-B7 are appropriate for use in RPV fluence calculations and meet the calculational uncertainty criterion in Regulatory Guide 1.190. (authors)« less

Regulatory Myeloid Cells in Transplantation

PubMed Central

Rosborough, Brian R.; Raïch-Regué, Dàlia; Turnquist, Heth R.; Thomson, Angus W.

2013-01-01

Regulatory myeloid cells (RMC) are emerging as novel targets for immunosuppressive (IS) agents and hold considerable promise as cellular therapeutic agents. Herein, we discuss the ability of regulatory macrophages (Mreg), regulatory dendritic cells (DCreg) and myeloid-derived suppressor cells (MDSC) to regulate alloimmunity, their potential as cellular therapeutic agents and the IS agents that target their function. We consider protocols for the generation of RMC and the selection of donor- or recipient-derived cells for adoptive cell therapy. Additionally, the issues of cell trafficking and antigen (Ag) specificity following RMC transfer are discussed. Improved understanding of the immunobiology of these cells has increased the possibility of moving RMC into the clinic to reduce the burden of current IS agents and promote Ag-specific tolerance. In the second half of this review, we discuss the influence of established and experimental IS agents on myeloid cell populations. IS agents believed historically to act primarily on T cell activation and proliferation are emerging as important regulators of RMC function. Better insights into the influence of IS agents on RMC will enhance our ability to develop cell therapy protocols to promote the function of these cells. Moreover, novel IS agents may be designed to target RMC in situ to promote Ag-specific immune regulation in transplantation and usher in a new era of immune modulation exploiting cells of myeloid origin. PMID:24092382

Development and Testing of the VITAMIN-B7/BUGLE-B7 Coupled Neutron-Gamma Multigroup Cross-Section Libraries

DOE Office of Scientific and Technical Information (OSTI.GOV)

Risner, Joel M; Wiarda, Dorothea; Miller, Thomas Martin

2011-01-01

The U.S. Nuclear Regulatory Commission s Regulatory Guide 1.190 states that calculational methods used to estimate reactor pressure vessel (RPV) fluence should use the latest version of the Evaluated Nuclear Data File (ENDF). The VITAMIN-B6 fine-group library and BUGLE-96 broad-group library, which are widely used for RPV fluence calculations, were generated using ENDF/B-VI data, which was the most current data when Regulatory Guide 1.190 was issued. We have developed new fine-group (VITAMIN-B7) and broad-group (BUGLE-B7) libraries based on ENDF/B-VII. These new libraries, which were processed using the AMPX code system, maintain the same group structures as the VITAMIN-B6 and BUGLE-96more » libraries. Verification and validation of the new libraries was accomplished using diagnostic checks in AMPX, unit tests for each element in VITAMIN-B7, and a diverse set of benchmark experiments including critical evaluations for fast and thermal systems, a set of experimental benchmarks that are used for SCALE regression tests, and three RPV fluence benchmarks. The benchmark evaluation results demonstrate that VITAMIN-B7 and BUGLE-B7 are appropriate for use in LWR shielding applications, and meet the calculational uncertainty criterion in Regulatory Guide 1.190.« less

[Big Data- challenges and risks].

PubMed

Krauß, Manuela; Tóth, Tamás; Hanika, Heinrich; Kozlovszky, Miklós; Dinya, Elek

2015-12-06

The term "Big Data" is commonly used to describe the growing mass of information being created recently. New conclusions can be drawn and new services can be developed by the connection, processing and analysis of these information. This affects all aspects of life, including health and medicine. The authors review the application areas of Big Data, and present examples from health and other areas. However, there are several preconditions of the effective use of the opportunities: proper infrastructure, well defined regulatory environment with particular emphasis on data protection and privacy. These issues and the current actions for solution are also presented.

Summary Analysis: Hanford Site Composite Analysis Update

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nichols, W. E.; Lehman, L. L.

2017-06-05

The Hanford Site’s currently maintained Composite Analysis, originally completed in 1998, requires an update. A previous update effort was undertaken by the U.S. Department of Energy (DOE) in 2001-2005, but was ended before completion to allow the Tank Closure & Waste Management Environmental Impact Statement (TC&WM EIS) (DOE/EIS-0391) to be prepared without potential for conflicting sitewide models. This EIS was issued in 2012, and the deferral was ended with guidance in memorandum “Modeling to Support Regulatory Decision Making at Hanford” (Williams, 2012) provided with the aim of ensuring subsequent modeling is consistent with the EIS.

Major regulatory changes and the impact on diagnostic imaging in the United States 2005 to 2012∗: ∗effective May 15, 2013.

PubMed

Relyea-Chew, Annemarie

2013-09-01

Federal regulation of diagnostic imaging in the United States has increased dramatically in recent years. The primary statutes aimed at curbing escalating costs and reorienting the national priorities of health care have a direct effect on the specialty of diagnostic imaging. This paper surveys the major regulations and current issues that pose challenges to the practice of diagnostic imaging in the United States, from the Deficit Reduction Act of 2005 through the American Taxpayer Relief Act of 2012. Copyright © 2013 AUR. Published by Elsevier Inc. All rights reserved.

[Current status of DNA databases in the forensic field: new progress, new legal needs].

PubMed

Baeta, Miriam; Martínez-Jarreta, Begoña

2009-01-01

One of the most polemic issues regarding the use of deoxyribonucleic acid (DNA) in the legal sphere, refers to the creation of DNA databases. Until relatively recently, Spain did not have a law to support the establishment of a national DNA profile bank for forensic purposes, and preserve the fundamental rights of subjects whose data are archived therein. The regulatory law of police databases regarding identifiers obtained from DNA approved in 2007, covers this void in the Spanish legislation and responds to the incessant need to adapt the laws to continuous scientific and technological progress.

Infectious diseases of animals and plants: an interdisciplinary approach.

PubMed

Wilkinson, Katy; Grant, Wyn P; Green, Laura E; Hunter, Stephen; Jeger, Michael J; Lowe, Philip; Medley, Graham F; Mills, Peter; Phillipson, Jeremy; Poppy, Guy M; Waage, Jeff

2011-07-12

Animal and plant diseases pose a serious and continuing threat to food security, food safety, national economies, biodiversity and the rural environment. New challenges, including climate change, regulatory developments, changes in the geographical concentration and size of livestock holdings, and increasing trade make this an appropriate time to assess the state of knowledge about the impact that diseases have and the ways in which they are managed and controlled. In this paper, the case is explored for an interdisciplinary approach to studying the management of infectious animal and plant diseases. Reframing the key issues through incorporating both social and natural science research can provide a holistic understanding of disease and increase the policy relevance and impact of research. Finally, in setting out the papers in this Theme Issue, a picture of current and future animal and plant disease threats is presented.

Scientific and Legal Perspectives on Science Generated for Regulatory Activities

PubMed Central

Henry, Carol J.; Conrad, James W.

2008-01-01

This article originated from a conference that asked “Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?” In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at “external” information. PMID:18197313

Scientific and legal perspectives on science generated for regulatory activities.

PubMed

Henry, Carol J; Conrad, James W

2008-01-01

This article originated from a conference that asked "Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?" In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at "external" information.

Regulatory system reform of occupational health and safety in China.

PubMed

Wu, Fenghong; Chi, Yan

2015-01-01

With the explosive economic growth and social development, China's regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined.

Regulatory system reform of occupational health and safety in China

PubMed Central

WU, Fenghong; CHI, Yan

2015-01-01

With the explosive economic growth and social development, China’s regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined. PMID:25843565

78 FR 58574 - Maintenance, Testing, and Replacement of Vented Lead-Acid Storage Batteries for Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-24

... time that a document is referenced. Revision 3 of Regulatory Guide 1.129 is available in ADAMS under...-251-7455; email: [email protected] . Both of the Office of Nuclear Regulatory Research, U.S... NRC is issuing a revision to an existing guide in the NRC's ``Regulatory Guide'' series. This series...

Biosimilar safety considerations in clinical practice.

PubMed

Choy, Edwin; Jacobs, Ira Allen

2014-02-01

Biologics are important treatments for a number of cancers. Patents for several biologics will expire over the next decade, removing a barrier to the development and commercialization of biosimilars. As biologics differ from small-molecule drugs due to their size and complexity, multifaceted manufacturing process, and their potential for immunogenicity, biosimilars cannot be considered "generic versions" of currently approved biologics. In highly regulated markets, biosimilars can be authorized only if they are demonstrated to be highly similar to the original drug from an analytical and clinical perspective. Any differences must be justified and shown to have no clinically meaningful effect on the safety and efficacy of the biosimilar. The European Medicines Agency has approved a number of biosimilars and the recent approval of the biosimilar infliximab monoclonal antibody is another regulatory milestone. This article will provide context regarding key safety issues addressed in biosimilar development, approval, and delivery, as well as inform oncologists on matters of safety to consider when prescribing biosimilars. Pertinent issues about safety from countries or regions where biosimilars are currently in use also will be reviewed. © 2014 Elsevier Inc. All rights reserved.

'Only a click away - DTC genetics for ancestry, health, love…and more: A view of the business and regulatory landscape'.

PubMed

Phillips, Andelka M

2016-03-01

I provide an overview of the current state of the direct-to-consumer (DTC) genetic testing industry and the challenges that different types of testing pose for regulation. I consider the variety of services currently available. These range from health and ancestry tests to those for child talent, paternity, and infidelity. In light of the increasingly blurred lines among different categories of testing, I call for a broader discussion of DTC governance. I stress the importance of shifting our attention from the activities of the most prominent companies to viewing DTC genetics as an industry with a wide spectrum of services and raising a wide variety of issues. These issues go beyond questions of clinical utility and validity to those of data security, personal identity, race, and the nature of the family. Robust DTC testing has the power to provide meaningful clinical, genealogical and even forensic information to those who want it; in unscrupulous hands, however, it also has the power to deceive and exploit. I consider approaches to help ensure the former and minimize the latter.

PathCase-SB architecture and database design

PubMed Central

2011-01-01

Background Integration of metabolic pathways resources and regulatory metabolic network models, and deploying new tools on the integrated platform can help perform more effective and more efficient systems biology research on understanding the regulation in metabolic networks. Therefore, the tasks of (a) integrating under a single database environment regulatory metabolic networks and existing models, and (b) building tools to help with modeling and analysis are desirable and intellectually challenging computational tasks. Description PathCase Systems Biology (PathCase-SB) is built and released. The PathCase-SB database provides data and API for multiple user interfaces and software tools. The current PathCase-SB system provides a database-enabled framework and web-based computational tools towards facilitating the development of kinetic models for biological systems. PathCase-SB aims to integrate data of selected biological data sources on the web (currently, BioModels database and KEGG), and to provide more powerful and/or new capabilities via the new web-based integrative framework. This paper describes architecture and database design issues encountered in PathCase-SB's design and implementation, and presents the current design of PathCase-SB's architecture and database. Conclusions PathCase-SB architecture and database provide a highly extensible and scalable environment with easy and fast (real-time) access to the data in the database. PathCase-SB itself is already being used by researchers across the world. PMID:22070889

77 FR 3514 - Protection Against Turbine Missiles

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-24

... NUCLEAR REGULATORY COMMISSION [NRC-2009-0481] Protection Against Turbine Missiles AGENCY: Nuclear... (NRC or Commission) is issuing a revision to Regulatory Guide 1.115, ``Protection Against Turbine... structures, systems, and components against missiles resulting from turbine failure by the appropriate...

75 FR 11970 - Self-Regulatory Organizations; Notice of Filing of Proposed Rule Change by New York Stock...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-12

... Program, the Exchange had considerable historical experience with the continued listing of companies that... does not raise any novel regulatory issues. In addition, the Exchange notes that the Commission stated...

Evolving PBPK applications in regulatory risk assessment: current situation and future goals

EPA Science Inventory

The presentation includes current applications of PBPK modeling in regulatory risk assessment and discussions on conflicts between assuring consistency with experimental data in current situation and the desire for animal-free model development.

77 FR 67678 - Content Specifications and Shielding Evaluations for Type B Transportation Packages

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-13

...The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2012-XX, ``Content Specifications and Shielding Evaluations for Type B Transportation Packages.'' This RIS clarifies the NRC's use of staff guidance in NUREG-1609, ``Standard Review Plan for Transport Packages for Radioactive Material,'' for the review of content specifications and shielding evaluations included in the Certificates of Compliance (CoC) and safety analysis reports (SARs) for Type B transportation packages.

Business management for biodiesel producers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gerpen, Jon Van

2004-07-01

The material in this book is intended to provide the reader with information about the biodiesel and liquid fuels industry, biodiesel start-up issues, legal and regulatory issues, and operational concerns.

Trends affecting the future of vaccine development and delivery: The role of demographics, regulatory science, the anti-vaccine movement, and vaccinomics

PubMed Central

Poland, Gregory A.; Jacobson, Robert M.; Ovsyannikova, Inna G.

2009-01-01

Important scientific, cultural, temporal, and secular issues impact the development of, and delivery of vaccines. In this paper we discuss the impact of demographics, regulatory science, the anti-vaccine movement, and finally the impact of the new biology and individualized medicine, which we call vaccinomics, on vaccine development and delivery. A description of the issues and how they have, are, or should be impacting vaccinology is provided, and hopefully will result in increased attention and discussion among vaccinologists. These issues have been under-valued, under-discussed, and in some cases, ignored. We hope that discussion of these issues will result in changes in how we develop, and how we communicate those developments, to the public. PMID:19200833

Regulatory cross-cutting topics for fuel cycle facilities.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Denman, Matthew R.; Brown, Jason; Goldmann, Andrew Scott

This report overviews crosscutting regulatory topics for nuclear fuel cycle facilities for use in the Fuel Cycle Research & Development Nuclear Fuel Cycle Evaluation and Screening study. In particular, the regulatory infrastructure and analysis capability is assessed for the following topical areas: Fire Regulations (i.e., how applicable are current Nuclear Regulatory Commission (NRC) and/or International Atomic Energy Agency (IAEA) fire regulations to advance fuel cycle facilities) Consequence Assessment (i.e., how applicable are current radionuclide transportation tools to support risk-informed regulations and Level 2 and/or 3 PRA) While not addressed in detail, the following regulatory topic is also discussed: Integrated Security,more » Safeguard and Safety Requirement (i.e., how applicable are current Nuclear Regulatory Commission (NRC) regulations to future fuel cycle facilities which will likely be required to balance the sometimes conflicting Material Accountability, Security, and Safety requirements.)« less

Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.

PubMed

Lesko, Lawrence J; Salerno, Ronald A; Spear, Brian B; Anderson, Donald C; Anderson, Timothy; Brazell, Celia; Collins, Jerry; Dorner, Andrew; Essayan, David; Gomez-Mancilla, Baltazar; Hackett, Joseph; Huang, Shiew-Mei; Ide, Susan; Killinger, Joanne; Leighton, John; Mansfield, Elizabeth; Meyer, Robert; Ryan, Stephen G; Schmith, Virginia; Shaw, Peter; Sistare, Frank; Watson, Mark; Worobec, Alexandra

2003-04-01

The use of pharmacogenetics and pharmacogenomics in the drug development process, and in the assessment of such data submitted to regulatory agencies by industry, has generated significant enthusiasm as well as important reservations within the scientific and medical communities. This situation has arisen because of the increasing number of exploratory and confirmatory investigations into variations in RNA expression patterns and DNA sequences being conducted in the preclinical and clinical phases of drug development, and the uncertainty surrounding the acceptance of these data by regulatory agencies. This report summarizes the outcome of a workshop cosponsored by the Food and Drug Administration (FDA), the Pharmacogenetics Working Group (PWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the PhRMA Preclinical Safety Committee (DruSafe). The specific aim of the workshop was to identify key issues associated with the application of pharmacogenetics and pharmacogenomics, including the feasibility of a regulatory "safe harbor" for exploratory genome-based data, and to provide a forum for industry-regulatory agency dialogue on these important issues.

Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge?

PubMed

Breyer, Didier; Herman, Philippe; Brandenburger, Annick; Gheysen, Godelieve; Remaut, Erik; Soumillion, Patrice; Van Doorsselaere, Jan; Custers, René; Pauwels, Katia; Sneyers, Myriam; Reheul, Dirk

2009-01-01

In the European Union, the definition of a GMO is technology-based. This means that a novel organism will be regulated under the GMO regulatory framework only if it has been developed with the use of defined techniques. This approach is now challenged with the emergence of new techniques. In this paper, we describe regulatory and safety issues associated with the use of oligonucleotide-mediated mutagenesis to develop novel organisms. We present scientific arguments for not having organisms developed through this technique fall within the scope of the EU regulation on GMOs. We conclude that any political decision on this issue should be taken on the basis of a broad reflection at EU level, while avoiding discrepancies at international level.

Scalable human ES culture for therapeutic use: propagation, differentiation, genetic modification and regulatory issues.

PubMed

Rao, M

2008-01-01

Embryonic stem cells unlike most adult stem cell populations can replicate indefinitely while preserving genetic, epigenetic, mitochondrial and functional profiles. ESCs are therefore an excellent candidate cell type for providing a bank of cells for allogenic therapy and for introducing targeted genetic modifications for therapeutic intervention. This ability of prolonged self-renewal of stem cells and the unique advantages that this offers for gene therapy, discovery efforts, cell replacement, personalized medicine and other more direct applications requires the resolution of several important manufacturing, gene targeting and regulatory issues. In this review, we assess some of the advance made in developing scalable culture systems, improvement in vector design and gene insertion technology and the changing regulatory landscape.

76 FR 40777 - Interim Enforcement Policy for Certain Fire Protection Issues

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-12

... Certain Fire Protection Issues AGENCY: Nuclear Regulatory Commission. ACTION: Policy statement; revision... Enforcement Policy on enforcement discretion for certain fire protection issues to extend the enforcement... policy affects licensees that are transitioning to use the National Fire Protection Association Standard...

10 CFR 13.6 - Prerequisities for issuing a complaint.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Prerequisities for issuing a complaint. 13.6 Section 13.6 Energy NUCLEAR REGULATORY COMMISSION PROGRAM FRAUD CIVIL REMEDIES § 13.6 Prerequisities for issuing a complaint. (a) The reviewing official may issue a complaint under § 13.7 only if— (1) The Department of...

78 FR 60352 - Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-01

... computations also factor in their market risk models. It is the Exchange's understanding that for some Market... raises no novel regulatory issues. Accordingly, the Commission hereby waives the 30-day operative delay...

75 FR 10336 - Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

... considerable historical experience with the continued listing of companies that had continued to trade on the... protection of investors and the public interest and does not raise any novel regulatory issues. In addition...

76 FR 55278 - Assistance to Foreign Atomic Energy Activities

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... nor an environmental impact statement is required. C. Regulatory Flexibility Act The Regulatory... Foreign relations, Nuclear energy, Reporting and recordkeeping requirements. Issued in Washington, DC, on.... Moreover, they will benefit from a clarified request process. Generally, small businesses reported that...

Federal control of Indian Lands v. State control of Gaming - Cabazon Bingo and the Indian Gaming regulatory act.

PubMed

Strate, L D; Mayo, A M

1990-03-01

In September, 1988, the 100th Congress passed the Indian Gaming Regulatory Act, concluding five years of debate over the Indian Gaming issue - brought to a head by a Supreme Court decision in February, 1987, that barred states from regulating Indian Gaming. That case (State of California v. Cabazon Band of Mission Indians) forced the legislature to take a serious look at issues of gaming on Indian lands. The result was the creation of a three-tiered system whereby tribes will control ceremonial games, the federal government will control bingo, and the states and tribes will negotiate agreements to cover casino games, parimutuel racing, and jai alai, if such games are legal in that particular state. In light of the case of the Cabazon Indians and the passage of the Indian Gaming Regulatory Act, this paper will address the following competing issues: tribal sovereignty, state interests, federal interests, and states like Nevada, which have a regulated gaming industry.

The evolving role of biosimilars in haematology–oncology: a practical perspective

PubMed Central

Gascon, Pere

2015-01-01

The loss of patents covering many biopharmaceutical/biological agents in the mid 1990s led to the introduction of a new generation of drugs: biosimilars. These new agents, produced by living cells just as the originator drugs, are chemically highly similar to endogenous human proteins; characterized by three-dimensionally complex, high molecular weight compounds. Among the first biosimilars used in haematology–oncology were erythropoietin and granulocyte colony-stimulating factor. After five years of use in clinical practice, the efficacy and safety profile of biosimilars approved by the European Medicines Agency is excellent. Over the next year or two, biosimilar monoclonal antibodies (MoAbs) will become available; the first will be rituximab and trastuzumab. Not only are MoAbs more complex in terms of molecular weight and number of amino acids than the first biosimilars, but they are also anticancer drugs, not merely supportive treatments like their predecessors. This opens up important questions. How are regulatory agencies to assess their clinical efficacy, immunogenicity and safety? Is the neoadjuvant clinical setting the best to evaluate them? What will regulatory agencies decide in terms of switching an originator molecule for a biosimilar or extrapolating efficacy results from one pathology to another? Once biosimilars of rituximab and trastuzumab are approved, several challenging issues will need to be addressed such as how to maintain appropriate pharmacovigilance, how to extrapolate across indications, and issues concerning automatic substitution. There is currently no consensus in any of these areas. This review addresses all these issues: new challenges that the oncology community will face in the near future. PMID:26622996

Sulfenic acid chemistry, detection and cellular lifetime☆

PubMed Central

Gupta, Vinayak; Carroll, Kate S.

2014-01-01

Background Reactive oxygen species-mediated cysteine sulfenic acid modification has emerged as an important regulatory mechanism in cell signaling. The stability of sulfenic acid in proteins is dictated by the local microenvironment and ability of antioxidants to reduce this modification. Several techniques for detecting this cysteine modification have been developed, including direct and in situ methods. Scope of review This review presents a historical discussion of sulfenic acid chemistry and highlights key examples of this modification in proteins. A comprehensive survey of available detection techniques with advantages and limitations is discussed. Finally, issues pertaining to rates of sulfenic acid formation, reduction, and chemical trapping methods are also covered. Major conclusions Early chemical models of sulfenic acid yielded important insights into the unique reactivity of this species. Subsequent pioneering studies led to the characterization of sulfenic acid formation in proteins. In parallel, the discovery of oxidant-mediated cell signaling pathways and pathological oxidative stress has led to significant interest in methods to detect these modifications. Advanced methods allow for direct chemical trapping of protein sulfenic acids directly in cells and tissues. At the same time, many sulfenic acids are short-lived and the reactivity of current probes must be improved to sample these species, while at the same time, preserving their chemical selectivity. Inhibitors with binding scaffolds can be rationally designed to target sulfenic acid modifications in specific proteins. General significance Ever increasing roles for protein sulfenic acids have been uncovered in physiology and pathology. A more complete understanding of sulfenic acid-mediated regulatory mechanisms will continue to require rigorous and new chemical insights. This article is part of a Special Issue entitled Current methods to study reactive oxygen species - pros and cons and biophysics of membrane proteins. Guest Editor: Christine Winterbourn. PMID:23748139

Safety system augmentation at Russian nuclear power plants

DOE Office of Scientific and Technical Information (OSTI.GOV)

Scerbo, J.A.; Satpute, S.N.; Donkin, J.Y.

1996-12-31

This paper describes the design and procurement of a Class IE DC power supply system to upgrade plant safety at the Kola Nuclear Power Plant (NPP). Kola NPP is located above the Arctic circle at Polyarnie Zorie, Murmansk, Russia. Kola NPP consists of four units. Units 1 and 2 have VVER-440/230 type reactors: Units 3 and 4 have VVER-440/213 type reactors. The VVER-440 reactor design is similar to the pressurized water reactor design used in the US. This project provided redundant, Class 1E DC station batteries and DC switchboards for Kola NPP, Units 1 and 2. The new DC powermore » supply system was designed and procured in compliance with current nuclear design practices and requirements. Technical issues that needed to be addressed included reconciling the requirements in both US and Russian codes and satisfying the requirements of the Russian nuclear regulatory authority. Close interface with ATOMENERGOPROEKT (AEP), the Russian design organization, KOLA NPP plant personnel, and GOSATOMNADZOR (GAN), the Russian version of US Nuclear Regulatory Commission, was necessary to develop a design that would assure compliance with current Russian design requirements. Hence, this project was expected to serve as an example for plant upgrades at other similar VVER-440 nuclear plants. In addition to technical issues, the project needed to address language barriers and the logistics of shipping equipment to a remote section of the Former Soviet Union (FSU). This project was executed by Burns and Roe under the sponsorship of the US DOE as part of the International Safety Program (INSP). The INSP is a comprehensive effort, in cooperation with partners in other countries, to improve nuclear safety worldwide. A major element within the INSP is the improvement of the safety of Soviet-designed nuclear reactors.« less

Alternatives to antibiotics: bacteriocins, antimicrobial peptides and bacteriophages.

PubMed

Joerger, R D

2003-04-01

Bacteriocins, antimicrobial peptides, and bacteriophage have attracted attention as potential substitutes for, or as additions to, currently used antimicrobial compounds. This publication will review research on the potential application of these alternative antimicrobial agents to poultry production and processing. Bacteriocins are proteinaceous compounds of bacterial origin that are lethal to bacteria other than the producing strain. It is assumed that some of the bacteria in the intestinal tract produce bacteriocins as a means to achieve a competitive advantage, and bacteriocin-producing bacteria might be a desirable part of competitive exclusion preparations. Purified or partially purified bacteriocins could be used as preservatives or for the reduction or elimination of certain pathogens. Currently only nisin, produced by certain strains of Lactococcus lactis subsp. lactis, has regulatory approval for use in certain foods, and its use for poultry products has been studied extensively. Exploration of the application of antimicrobial peptides from sources other than bacteria to poultry has not yet commenced to a significant extent. Evidence for the ability of chickens to produce such antimicrobial peptides has been provided, and it is likely that these peptides play an important role in the defense against various pathogens. Bacteriophages have received renewed attention as possible agents against infecting bacteria. Evidence from several trials indicates that phage therapy can be effective under certain circumstances. Numerous obstacles for the use of phage as antimicrobials for poultry or poultry products remain. Chiefly among them are the narrow host range of many phages, the issue of phage resistance, and the possibility of phage-mediated transfer of genetic material to bacterial hosts. Regulatory issues and the high cost of producing such alternative antimicrobial agents are also factors that might prevent application of these agents in the near future.

Evolution of pharmacological obesity treatments: focus on adverse side-effect profiles.

PubMed

Krentz, A J; Fujioka, K; Hompesch, M

2016-06-01

Pharmacotherapy directed toward reducing body weight may provide benefits for both curbing obesity and lowering the risk of obesity-associated comorbidities; however, many weight loss medications have been withdrawn from the market because of serious adverse effects. Examples include pulmonary hypertension (aminorex), cardiovascular toxicity, e.g. flenfluramine-induced valvopathy, stroke [phenylpropanolamine (PPA)], excess non-fatal cardiovascular events (sibutramine), and neuro-psychiatric issues (rimonabant; approved in Europe, but not in the USA). This negative experience has helped mould the current drug development and approval process for new anti-obesity drugs. Differences between the US Food and Drug Administration (FDA) and the European Medicines Agency, however, in perceptions of risk-benefit considerations for individual drugs have resulted in discrepancies in approval and/or withdrawal of weight-reducing medications. Thus, two drugs recently approved by the FDA, i.e. lorcaserin and phentermine + topiramate extended release, are not available in Europe. In contrast, naltrexone sustained release (SR)/bupropion SR received FDA approval, and liraglutide 3.0 mg was recently approved in both the USA and Europe. Regulatory strategies adopted by the FDA to manage the potential for uncommon but potentially serious post-marketing toxicity include: (i) risk evaluation and mitigation strategy programmes; (ii) stipulating post-marketing safety trials; (iii) considering responder rates and limiting cumulative exposure by discontinuation if weight loss is not attained within a reasonable timeframe; and (iv) requiring large cardiovascular outcome trials before or after approval. We chronicle the adverse effects of anti-obesity pharmacotherapy and consider how the history of high-profile toxicity issues has shaped the current regulatory landscape for new and future weight-reducing drugs. © 2016 John Wiley & Sons Ltd.

75 FR 62534 - Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD11-1-000] Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference October 1, 2010. The Federal...-referenced proceeding to explore issues associated with reliability monitoring, enforcement and compliance...

[Biosimilars--opportunity or threat?].

PubMed

Swierkot, Jerzy

2013-01-01

Strong interest in biosimilars dates back several years. In the coming years the patent protection ends for subsequent biological drugs, including monoclonal antibodies. This paper organizes the most important facts related to the issue of biosimilars. A biosimilar is a biotherapeutic product which is similar in terms of quality, efficacy and safety to an already licensed reference biotherapeutic product'. It should be noted that biosimilars approved underthe current regulations of the European Medicines Agency (EMA) meet the stringent standards of safety, efficacy and immunogenicity. It is also important to realize that the biosimilar has the right to that name, if it is registered by regulatory authorities like EMA or FDA. One should not confuse biosimilar drugs with those which counterfeit or imitate. Clinical trials on the convertibility of innovative and biosimilar drugs are ongoing. Nevertheless,there is no regulatory framework and clear guidelines of conduct in this regard. In the near future, thanks to the registration of the first biosimilar monoclonal antibodies in rheumatology and gastroenterology the availability of biological treatment for patients should increase.

Direct broadcast satellite-radio market, legal, regulatory, and business considerations

NASA Technical Reports Server (NTRS)

Sood, Des R.

1991-01-01

A Direct Broadcast Satellite-Radio (DBS-R) System offers the prospect of delivering high quality audio broadcasts to large audiences at costs lower than or comparable to those incurred using the current means of broadcasting. The maturation of mobile communications technologies, and advances in microelectronics and digital signal processing now make it possible to bring this technology to the marketplace. Heightened consumer interest in improved audio quality coupled with the technological and economic feasibility of meeting this demand via DBS-R make it opportune to start planning for implementation of DBS-R Systems. NASA-Lewis and the Voice of America as part of their on-going efforts to improve the quality of international audio broadcasts, have undertaken a number of tasks to more clearly define the technical, marketing, organizational, legal, and regulatory issues underlying implementation of DBS-R Systems. The results and an assessment is presented of the business considerations underlying the construction, launch, and operation of DBS-R Systems.

A report from CPhI Worldwide 2013, Fifth Annual Pre-Connect Conference (October 22-24, 2013 - Frankfurt, Germany).

PubMed

Kuhrt, K; Gilpatrick, J

2013-11-01

A day before the start of the 2013 Conference on Pharmaceutical Ingredients (CPhI) Worldwide, the world's leading pharmaceutical networking event, a number of attendees gathered for the Fifth Annual Pre-Connect Conference to discuss trends in business development, manufacturing and regulatory arenas. Of the six modules presented at the meeting, one was dedicated to the sourcing environment in emerging markets, with special attention paid to developments in India and China. Other modules evaluated the current trends in the creation of generics and supergenerics in emerging markets. Additionally, there were updates on issues surrounding the regulatory and development hurdles that biosimilars and biobetters are facing today. Common themes for both discussions include appropriate pricing and erosion demographics for generics and biosimilars, licensing scenarios, commercialization strategies, and how to stay competitive and find novel innovations within new delivery systems, improved formulations and modifications to create better quality active pharmaceutical ingredients. Copyright 2013 Prous Science, S.A.U. or its licensors. All rights reserved.

Validation of gamma irradiator controls for quality and regulatory compliance

NASA Astrophysics Data System (ADS)

Harding, Rorry B.; Pinteric, Francis J. A.

1995-09-01

Since 1978 the U.S. Food and Drug Administration (FDA) has had both the legal authority and the Current Good Manufacturing Practice (CGMP) regulations in place to require irradiator owners who process medical devices to produce evidence of Irradiation Process Validation. One of the key components of Irradiation Process Validation is the validation of the irradiator controls. However, it is only recently that FDA audits have focused on this component of the process validation. What is Irradiator Control System Validation? What constitutes evidence of control? How do owners obtain evidence? What is the irradiator supplier's role in validation? How does the ISO 9000 Quality Standard relate to the FDA's CGMP requirement for evidence of Control System Validation? This paper presents answers to these questions based on the recent experiences of Nordion's engineering and product management staff who have worked with several US-based irradiator owners. This topic — Validation of Irradiator Controls — is a significant regulatory compliance and operations issue within the irradiator suppliers' and users' community.

Direct broadcast satellite-radio market, legal, regulatory, and business considerations

NASA Astrophysics Data System (ADS)

Sood, Des R.

1991-03-01

A Direct Broadcast Satellite-Radio (DBS-R) System offers the prospect of delivering high quality audio broadcasts to large audiences at costs lower than or comparable to those incurred using the current means of broadcasting. The maturation of mobile communications technologies, and advances in microelectronics and digital signal processing now make it possible to bring this technology to the marketplace. Heightened consumer interest in improved audio quality coupled with the technological and economic feasibility of meeting this demand via DBS-R make it opportune to start planning for implementation of DBS-R Systems. NASA-Lewis and the Voice of America as part of their on-going efforts to improve the quality of international audio broadcasts, have undertaken a number of tasks to more clearly define the technical, marketing, organizational, legal, and regulatory issues underlying implementation of DBS-R Systems. The results and an assessment is presented of the business considerations underlying the construction, launch, and operation of DBS-R Systems.

[The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].

PubMed

Berger, A; Schüle, S; Flory, E

2011-07-01

Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.

Are Lead Exposures a Risk in European Fresh Waters? A Regulatory Assessment Accounting for Bioavailability.

PubMed

Peters, Adam; Wilson, Iain; Merrington, Graham; Chowdhury, M Jasim

2018-01-01

An indicative compliance assessment of the Europe-wide bioavailable lead Environmental Quality Standard of 1.2 µg L -1 (EQS) was undertaken against regulatory freshwater monitoring data from six European member states and FOREGS database. Bio-met, a user-friendly tool based upon Biotic Ligand Models (BLMs) was used to account for bioavailability, along with the current European Water Framework Directive lead dissolved organic carbon correction approach. The outputs from both approaches were compared to the BLM. Of the 9054 freshwater samples assessed only 0.6% exceeded the EQS of 1.2 µg L -1 after accounting for bioavailability. The data showed that ambient background concentrations of lead across Europe are unlikely to influence general compliance with the EQS, although there may be isolated local issues. The waters showing the greatest sensitivity to potential lead exposures are characterized by relatively low DOC (< 0.5 mg L -1 ), regardless of the pH and calcium concentrations.

The introduction of new vaccines into developing countries. III. The role of intellectual property.

PubMed

Mahoney, Richard T; Pablos-Mendez, Ariel; Ramachandran, S

2004-01-26

The development of new vaccines that address the particular needs of developing countries has been proceeding slowly. A number of new public sector vaccine research and development initiatives have been launched to address this problem. These new initiatives find that they often wish to collaborate with the private sector and, in collaborating with the private sector, they must address issues of intellectual property (IP) management. It has not been well understood why IP management is important and how such management by public sector groups can best be conducted. IP management has become very important because vaccine research and development is driven by the regulatory process. The regulatory process has increased the cost of vaccine development to very high levels especially for the highly sophisticated new vaccines currently under development. Thus, investors seek IP protection for the required large investments. Conversely, we assert this concept as a new insight, IP rights are essential for mobilizing the significant funds necessary to meet regulatory requirements. Thus, IP rights are of value not only for investors but also for the public at large. In the absence of public sector mechanisms to carry out the functions that the private sector currently conducts, the public sector needs to increase its sophistication in IP management and needs to identify and implement strategies that will help the public sector to achieve its public health goals, especially for the poor and, among these individuals, the poor in developing countries. This paper suggests some strategies that might be used by the public sector to help achieve its public health goals, especially for the poor.

Pharmaceutical company perspectives on current safety risk communications in Japan.

PubMed

Urushihara, Hisashi; Kobashi, Gen; Masuda, Hideaki; Taneichi, Setsuko; Yamamoto, Michiko; Nakayama, Takeo; Kawakami, Koji; Matsuda, Tsutomu; Ohta, Kaori; Sugimori, Hiroki

2014-01-01

In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer's Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.

78 FR 59729 - Final Comparative Environmental Evaluation of Alternatives for Handling Low-Level Radioactive...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-27

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0218] Final Comparative Environmental Evaluation of... Regulatory Commission (NRC) is issuing the Final Comparative Environmental Evaluation of Alternatives for... commercial nuclear power plants (NPPs). This comparative environmental evaluation has been conducted...

75 FR 48319 - Notice of Proposed Information Collection Requests; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-10

... collection, ``Application for Grants under the Talent Search Program.'' This notice hereby corrects the 60..., Regulatory Information Management Services, Office of Management, hereby issues a correction notice as..., Information Collection Clearance Division, Regulatory Information Management Services, Office of Management...

78 FR 64028 - Decommissioning of Nuclear Power Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0035] Decommissioning of Nuclear Power Reactors AGENCY... Commission (NRC) is issuing Revision 1 of regulatory guide (RG) 1.184 ``Decommissioning of Nuclear Power... the NRC's regulations relating to the decommissioning process for nuclear power reactors. The revision...

The expanding universe of regulatory T cell subsets in cancer.

PubMed

Gajewski, Thomas F

2007-08-01

Evidence has indicated that failed antitumor immunity is dominated by immunosuppressive mechanisms within the tumor microenvironment. In this issue of Immunity, Peng et al. (2007) add to this list by describing tumor-infiltrating gammadelta T cells that have regulatory function.

Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation.

PubMed

Pietrobon, Ricardo; Shah, Anand; Kuo, Paul; Harker, Matthew; McCready, Mariana; Butler, Christeen; Martins, Henrique; Moorman, C T; Jacobs, Danny O

2006-07-27

Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved and streamlined regulatory processes for individual academic centers as well as larger research networks.

Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation

PubMed Central

Pietrobon, Ricardo; Shah, Anand; Kuo, Paul; Harker, Matthew; McCready, Mariana; Butler, Christeen; Martins, Henrique; Moorman, CT; Jacobs, Danny O

2006-01-01

Background Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. Results The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). Conclusion The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved and streamlined regulatory processes for individual academic centers as well as larger research networks. PMID:16872540

Four essays on offshore wind power potential, development, regulatory framework, and integration

NASA Astrophysics Data System (ADS)

Dhanju, Amardeep

Offshore wind power is an energy resource whose potential in the US has been recognized only recently. There is now growing interest among the coastal states to harness the resource, particularly in states adjacent to the Mid-Atlantic Bight where the shallow continental shelf allows installation of wind turbines using the existing foundation technology. But the promise of bountiful clean energy from offshore wind could be delayed or forestalled due to policy and regulatory challenges. This dissertation is an effort to identify and address some of the important challenges. Focusing on Delaware as a case study it calculates the extent of the wind resource; considers one means to facilitate resource development---the establishment of statewide and regional public power authorities; analyzes possible regulatory frameworks to manage the resource in state-controlled waters; and assesses the use of distributed storage to manage intermittent output from wind turbines. In order to cover a diversity of topics, this research uses a multi-paper format with four essays forming the body of work. The first essay lays out an accessible methodology to calculate offshore wind resource potential using publicly available data, and uses this methodology to access wind resources off Delaware. The assessment suggests a wind resource approximately four times the average electrical load in Delaware. The second essay examines the potential role of a power authority, a quasi-public institution, in lowering the cost of capital, reducing financial risk of developing and operating a wind farm, and enhancing regional collaboration on resource development and management issues. The analysis suggests that a power authority can lower the cost of offshore wind power by as much as 1/3, thereby preserving the ability to pursue cost-competitive development even if the current federal incentives are removed. The third essay addresses the existing regulatory void in state-controlled waters of Delaware. It outlines a regulatory framework touching on key elements such as the leasing system, length of tenure, and financial terms for allocating property rights. In addition, the framework also provides recommendations on environmental assessment that would be required prior to lease issuance. The fourth essay analyzes offshore wind power integration using electric thermal storage in housing units. It presents a model of wind generation, heating load and wind driven thermal storage to assess the potential of storage to buffer wind intermittency. The analysis suggests that thermal load matches the seasonal excess of offshore wind during winter months, and that electric thermal storage could provide significant temporal, spatial, and cost advantages for balancing output from offshore wind generation, while also converting a major residential load (space heating) now met by fossil fuels to low carbon energy resources. Together, the four essays provide new analyses of policy, regulatory, and system integration issues that could impede resource development, and also analyze and recommend strategies to manage these issues.

Economic analysis requirements in support of orbital debris regulatory policy

NASA Astrophysics Data System (ADS)

Greenberg, Joel S.

1996-10-01

As the number of Earth orbiting objects increases so does the potential for generating orbital debris with the consequent increase in the likelihood of impacting and damaging operating satellites. Various debris remediation approaches are being considered that encompass both in-orbit and return-to-Earth schema and have varying degrees of operations, cost, international competitiveness, and safety implications. Because of the diversity of issues, concerns and long-term impacts, there is a clear need for the setting of government policies that will lead to an orderly abatement of the potential orbital debris hazards. These policies may require the establishment of a supportive regulatory regime. The Department of Transportation is likely to have regulatory responsibilities relating to orbital debris stemming from its charge to protect the public health and safety, safety of property, and national security interests and foreign policy interests of the United States. This paper describes DOT's potential regulatory role relating to orbital debris remediation, the myriad of issues concerning the need for establishing government policies relating to orbital debris remediation and their regulatory implications, the proposed technological solutions and their economic and safety implications. Particular emphasis is placed upon addressing cost-effectiveness and economic analyses as they relate to economic impact analysis in support of regulatory impact analysis.

Instream sand and gravel mining: Environmental issues and regulatory process in the United States

USGS Publications Warehouse

Meador, M.R.; Layher, A.O.

1998-01-01

Sand and gravel are widely used throughout the U.S. construction industry, but their extraction can significantly affect the physical, chemical, and biological characteristics of mined streams. Fisheries biologists often find themselves involved in the complex environmental and regulatory issues related to instream sand and gravel mining. This paper provides an overview of information presented in a symposium held at the 1997 midyear meeting of the Southern Division of the American Fisheries Society in San Antonio, Texas, to discuss environmental issues and regulatory procedures related to instream mining. Conclusions from the symposium suggest that complex physicochemical and biotic responses to disturbance such as channel incision and alteration of riparian vegetation ultimately determine the effects of instream mining. An understanding of geomorphic processes can provide insight into the effects of mining operations on stream function, and multidisciplinary empirical studies are needed to determine the relative effects of mining versus other natural and human-induced stream alterations. Mining regulations often result in a confusing regulatory process complicated, for example, by the role of the U.S. Army Corps of Engineers, which has undergone numerous changes and remains unclear. Dialogue among scientists, miners, and regulators can provide an important first step toward developing a plan that integrates biology and politics to protect aquatic resources.

Applying Definitions of “Asbestos” to Environmental and “Low-Dose” Exposure Levels and Health Effects, Particularly Malignant Mesothelioma

PubMed Central

Case, B. W.; Abraham, J. L.; Meeker, G.; Pooley, F. D.; Pinkerton, K. E.

2011-01-01

Although asbestos research has been ongoing for decades, this increased knowledge has not led to consensus in many areas of the field. Two such areas of controversy include the specific definitions of asbestos, and limitations in understanding exposure-response relationships for various asbestos types and exposure levels and disease. This document reviews the current regulatory and mineralogical definitions and how variability in these definitions has led to difficulties in the discussion and comparison of both experimental laboratory and human epidemiological studies for asbestos. This review also examines the issues of exposure measurement in both animal and human studies, and discusses the impact of these issues on determination of cause for asbestos-related diseases. Limitations include the lack of detailed characterization and limited quantification of the fibers in most studies. Associated data gaps and research needs are also enumerated in this review. PMID:21534084

Applying definitions of “asbestos” to environmental and “low-dose” exposure Levels and health effects, particularly malignant mesothelioma

USGS Publications Warehouse

Case, B.W.; Abraham, J.L.; Meeker, G.; Pooley, F.D.; Pinkerton, K.E.

2011-01-01

Although asbestos research has been ongoing for decades, this increased knowledge has not led to consensus in many areas of the field. Two such areas of controversy include the specific definitions of asbestos, and limitations in understanding exposure-response relationships for various asbestos types and exposure levels and disease. This document reviews the current regulatory and mineralogical definitions and how variability in these definitions has led to difficulties in the discussion and comparison of both experimental laboratory and human epidemiological studies for asbestos. This review also examines the issues of exposure measurement in both animal and human studies, and discusses the impact of these issues on determination of cause for asbestos-related diseases. Limitations include the lack of detailed characterization and limited quantification of the fibers in most studies. Associated data gaps and research needs are also enumerated in this review.

Infectious diseases of animals and plants: an interdisciplinary approach

PubMed Central

Wilkinson, Katy; Grant, Wyn P.; Green, Laura E.; Hunter, Stephen; Jeger, Michael J.; Lowe, Philip; Medley, Graham F.; Mills, Peter; Phillipson, Jeremy; Poppy, Guy M.; Waage, Jeff

2011-01-01

Animal and plant diseases pose a serious and continuing threat to food security, food safety, national economies, biodiversity and the rural environment. New challenges, including climate change, regulatory developments, changes in the geographical concentration and size of livestock holdings, and increasing trade make this an appropriate time to assess the state of knowledge about the impact that diseases have and the ways in which they are managed and controlled. In this paper, the case is explored for an interdisciplinary approach to studying the management of infectious animal and plant diseases. Reframing the key issues through incorporating both social and natural science research can provide a holistic understanding of disease and increase the policy relevance and impact of research. Finally, in setting out the papers in this Theme Issue, a picture of current and future animal and plant disease threats is presented. PMID:21624914

The debate over robotics in benign gynecology.

PubMed

Rardin, Charles R

2014-05-01

The debate over the role of the da Vinci surgical robotic platform in benign gynecology is raging with increasing fervor and, as product liability issues arise, greater financial stakes. Although the best currently available science suggests that, in the hands of experts, robotics offers little in surgical advantage over laparoscopy, at increased expense, the observed decrease in laparotomy for hysterectomy is almost certainly, at least in part, attributable to the availability of the robot. In this author's opinion, the issue is not whether the robot has any role but rather to define the role in an institutional environment that also supports the safe use of vaginal and laparoscopic approaches in an integrated minimally invasive surgery program. Programs engaging robotic surgery should have a clear and self-determined regulatory process and should resist pressures in place that may preferentially support robotics over other forms of minimally invasive surgery. Copyright © 2014 Mosby, Inc. All rights reserved.

Transmission Pricing Issues for Electricity Generation From Renewable Resources

EIA Publications

1999-01-01

This article discusses how the resolution of transmission pricing issues which have arisen under the Federal Energy Regulatory Commission's (FERC) open access environment may affect the prospects for renewable-based electricity.

Business Management for Biodiesel Producers: August 2002--January 2004

DOE Office of Scientific and Technical Information (OSTI.GOV)

Van Gerpen, J.

2004-07-01

The material in this book is intended to provide the reader with information about the biodiesel and liquid fuels industry, biodiesel start-up issues, legal and regulatory issues, and operational concerns.

77 FR 76146 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Approving a Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Approving a Proposed Rule Change Consisting of Amendments To Streamline New Issue Information Submission Requirements Under MSRB Rules G-32..., and market information requirements); and the Electronic Municipal Market Access (``EMMA[supreg...

76 FR 47089 - Regulatory Review Schedule; Cancellation of Consultation Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule; Cancellation of Consultation Meetings AGENCY: National Indian Gaming Commission. ACTION: Notice. SUMMARY: On November 18, 2010, the National Indian Gaming Commission (NIGC) issued a Notice of Inquiry and...

77 FR 73911 - Flightcrew Member Duty and Rest Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-12

... discussion of the methodology and information sources used in the rulemaking analysis, corrects reporting and... Aviation Administration (FAA), DOT. ACTION: Availability of Initial Supplemental Regulatory Impact Analysis. SUMMARY: The FAA is issuing an Initial Supplemental Regulatory Impact Analysis of its final rule amending...

77 FR 8095 - Technical Corrections to Commission Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 2 [Docket No. RM11-30-000; Order No. 756] Technical Corrections to Commission Regulations Issued February 8, 2012. AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Final rule: correcting amendment. SUMMARY: This document adds...

78 FR 73566 - Standard Format and Content for a License Application for an Independent Spent Fuel Storage...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-06

...The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-3042, ``Standard Format and Content for a License Application for an Independent Spent Fuel Storage Installation or a Monitored Retrievable Storage Facility.'' This draft regulatory guide is proposed revision 2 of Regulatory Guide 3.50, which provides a format that the NRC considers acceptable for submitting the information for license applications to store spent nuclear fuel, high-level radioactive waste, and/or reactor-related Greater than Class C waste.

"Must-know" legal issues for healthcare CFOS.

PubMed

Peregrine, Michael W; Schwartz, James R

2002-03-01

Healthcare financial managers are finding that regulatory agencies' customary focus on Medicare and tax-exemption concerns is shifting to other issues directly related to financial management. Regulatory agencies, such as the Securities and Exchange Commission, are scrutinizing not-for-profit and charitable trust law matters. Because of this renewed attention to existing regulations, healthcare financial managers need to increase their diligence in ensuring their organizations' compliance with those laws governing areas for which they traditionally have been accountable, including auditor relationships, restricted gifts, consulting arrangements, investment management, and financial reporting.

The political context of health service regulation.

PubMed

Krause, E A

1975-01-01

Can regulation work in health services, given the present political context? General issues in the regulatory process are discussed, followed by a consideration of the relevance of these issues to the health care field. Regulatory processes are reviewed for the United States in four areas: credentialling of people, surveillance of delivery systems, quality of materials and technology, and rate-setting or cost control. It is concluded that the process cannot work. Four alternatives are presented and briefly evaluated: tinkering, centralized regulation, national health service, and general nationalization of most major economic sectors.

The current role and limitations of surrogate endpoints in advanced prostate cancer.

PubMed

Gomella, Leonard G; Oliver Sartor, A

2014-01-01

The identification of appropriate surrogate endpoints for evaluating cancer therapeutics has been of ongoing interest across various tumor types. Metastatic castrate-resistant prostate cancer (mCRPC) has been a particularly challenging area. As more targeted and novel therapies are being developed in this disease space, an urgent need exists to identify surrogate endpoints in mCRPC. The ability to discern patient benefit in the absence of patient death or other complications would facilitate both drug development and more appropriate patient care. We reviewed the available literature and guidelines used in the development and approval of recent agents for mCRPC. The majority of regulatory approvals of new medications have relied on overall survival (OS) or prevention of complications such as skeletal related events (SRE's). Progression-free survival measures, such as bone scans, computed tomography scans, and prostate-specific antigen related changes, have not been validated nor uniformly accepted as outcome surrogates. All of the successful recent pivotal Phase III trials designed to achieve regulatory approval in mCRPC have used either OS or SRE's as the primary endpoint. There are significant problematic issues that exist associated with defining and implementing surrogate markers in mCRPC beyond survival and complications. Suggestions are made as to how the current situation might be improved. Copyright © 2014 Elsevier Inc. All rights reserved.

Smokers' attitudes and support for e-cigarette policies and regulation in the USA.

PubMed

Wackowski, Olivia A; Delnevo, Cristine D

2015-11-01

In April 2014, the Food and Drug Administration (FDA) proposed a rule to extend its tobacco regulatory authority to e-cigarettes, which have been unregulated and growing in use since their 2006-2007 US introduction. The FDA will issue a final rule based on comments and data received from researchers, tobacco companies and the public. We aimed to present data about current smokers' awareness of and attitudes towards potential e-cigarette regulation and various policies in the USA. We conducted a cross-sectional online e-cigarette focused survey of 519 adult current smokers in April 2014, before the FDA's proposed rule was announced. Participants were recruited from a private research panel (GFK's Knowledge Networks) designed to be representative of the US population. The majority of respondents (62.5%) did not know that e-cigarettes are unregulated by the FDA but agreed that e-cigarettes should be regulated by the FDA for safety and quality (83.5%), carry warning labels about their potential risks (86.6%) and have the same legal age of sale as other tobacco (87.7%). Support was similarly high among current e-cigarette users. Support was substantial though lower overall for policies to restrict e-cigarette indoor use (41.2%), flavouring (44.3%) and advertising (55.5%), and was negatively associated with current e-cigarette use. Support for many e-cigarette regulatory policies is strong among smokers, including for policies that the FDA has recently proposed and potential future regulations. States considering indoor e-cigarette restrictions should know that a substantial number of current smokers support such regulations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Advancing the practice of health impact assessment in Canada: Obstacles and opportunities

DOE Office of Scientific and Technical Information (OSTI.GOV)

McCallum, Lindsay C., E-mail: lindsay.mccallum@mail.utoronto.ca; Intrinsik Environmental Sciences Inc., 6605 Hurontario Street, Mississauga, Ontario L5T0A3; Ollson, Christopher A., E-mail: collson@intrinsik.com

Health Impact Assessment (HIA) is recognized as a useful tool that can identify potential health impacts resulting from projects or policy initiatives. Although HIA has become an established practice in some countries, it is not yet an established practice in Canada. In order to enable broader support for HIA, this study provides a comprehensive review and analysis of the peer-reviewed and gray literature on the state of HIA practice. The results of this review revealed that, although there is an abundance of publications relating to HIA, there remains a lack of transparent, consistent and reproducible approaches and methods throughout themore » process. Findings indicate a need for further research and development on a number of fronts, including: 1) the nature of HIA triggers; 2) consistent scoping and stakeholder engagement approaches; 3) use of evidence and transparency of decision-making; 4) reproducibility of assessment methods; 5) monitoring and evaluation protocols; and, 6) integration within existing regulatory frameworks. Addressing these issues will aid in advancing the more widespread use of HIA in Canada. - Highlights: • Reviewed current state of practice in the field of HIA • Identified key obstacles and opportunities for HIA advancement • Major issues include lack of consistent approach and methodology. • No national regulatory driver hinders opportunity for widespread use of HIA. • Identified research opportunities vital to developing HIA practice in Canada.« less

Legal principles of confidentiality and other public interests: Part 1.

PubMed

Fullbrook, Suzanne

The principles of confidentiality are of paramount importance to nurses and all health professionals. This is explicitly so as the Common Law recognizes confidentiality and supports its importance. However, current practice must take cognizance of the realities of 21st century healthcare delivery - we live in an age of electronic data that is potentially very difficult to keep secret. New rules, protocols and guidelines are being formulated, and regulatory bodies such as the Nursing and Midwifery Council (NMC) reflect such rules in their codes of professional conduct. There is, however, a debate that is suggesting that the rules that relate to confidentiality may need to expand or even bend a little as innovate ways of obtaining, storing, utilizing and communicating data continue to occupy the minds of government and those who formulate legal principles (British Medical Association, 2005). This series of three articles will explore these issues. The first part is a review of case law that explores the fundamental legal principles that underpin confidentiality. The second will concentrate on a review of the guidelines that are to be found in professional regulatory documentation - the NMC and the General Medical Council as they relate to the legal principles. The third and last part will review and reflect on issues that relate expressly to the implementation of electronic patient records, with a review of appropriate statutory legislation and principles of common law.

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

PubMed Central

Antal, A.; Alekseichuk, I.; Bikson, M.; Brockmöller, J.; Brunoni, A.R.; Chen, R.; Cohen, L.G.; Dowthwaite, G.; Ellrich, J.; Flöel, A.; Fregni, F.; George, M.S.; Hamilton, R.; Haueisen, J.; Herrmann, C.S.; Hummel, F.C.; Lefaucheur, J.P.; Liebetanz, D.; Loo, C.K.; McCaig, C.D.; Miniussi, C.; Miranda, P.C.; Moliadze, V.; Nitsche, M.A.; Nowak, R.; Padberg, F.; Pascual-Leone, A.; Poppendieck, W.; Priori, A.; Rossi, S.; Rossini, P.M.; Rothwell, J.; Rueger, M.A.; Ruffini, G.; Schellhorn, K.; Siebner, H.R.; Ugawa, Y.; Wexler, A.; Ziemann, U.; Hallett, M.; Paulus, W.

2018-01-01

Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1–2 mA and during tACS at higher peak-to-peak intensities above 2 mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity ‘conventional’ TES defined as <4 mA, up to 60 min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3–13 A/m2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10 mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6–7, 2016 and were refined thereafter by email correspondence. PMID:28709880

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines.

PubMed

Antal, A; Alekseichuk, I; Bikson, M; Brockmöller, J; Brunoni, A R; Chen, R; Cohen, L G; Dowthwaite, G; Ellrich, J; Flöel, A; Fregni, F; George, M S; Hamilton, R; Haueisen, J; Herrmann, C S; Hummel, F C; Lefaucheur, J P; Liebetanz, D; Loo, C K; McCaig, C D; Miniussi, C; Miranda, P C; Moliadze, V; Nitsche, M A; Nowak, R; Padberg, F; Pascual-Leone, A; Poppendieck, W; Priori, A; Rossi, S; Rossini, P M; Rothwell, J; Rueger, M A; Ruffini, G; Schellhorn, K; Siebner, H R; Ugawa, Y; Wexler, A; Ziemann, U; Hallett, M; Paulus, W

2017-09-01

Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1-2mA and during tACS at higher peak-to-peak intensities above 2mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity 'conventional' TES defined as <4mA, up to 60min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3-13A/m 2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6-7, 2016 and were refined thereafter by email correspondence. Copyright © 2017 International Federation of Clinical Neurophysiology. All rights reserved.

Establishing a laboratory animal model from a transgenic animal: RasH2 mice as a model for carcinogenicity studies in regulatory science.

PubMed

Urano, K; Tamaoki, N; Nomura, T

2012-01-01

Transgenic animal models have been used in small numbers in gene function studies in vivo for a period of time, but more recently, the use of a single transgenic animal model has been approved as a second species, 6-month alternative (to the routine 2-year, 2-animal model) used in short-term carcinogenicity studies for generating regulatory application data of new drugs. This article addresses many of the issues associated with the creation and use of one of these transgenic models, the rasH2 mouse, for regulatory science. The discussion includes strategies for mass producing mice with the same stable phenotype, including constructing the transgene, choosing a founder mouse, and controlling both the transgene and background genes; strategies for developing the model for regulatory science, including measurements of carcinogen susceptibility, stability of a large-scale production system, and monitoring for uniform carcinogenicity responses; and finally, efficient use of the transgenic animal model on study. Approximately 20% of mouse carcinogenicity studies for new drug applications in the United States currently use transgenic models, typically the rasH2 mouse. The rasH2 mouse could contribute to animal welfare by reducing the numbers of animals used as well as reducing the cost of carcinogenicity studies. A better understanding of the advantages and disadvantages of the transgenic rasH2 mouse will result in greater and more efficient use of this animal model in the future.

Validation of biomarkers to predict response to immunotherapy in cancer: Volume II - clinical validation and regulatory considerations.

PubMed

Dobbin, Kevin K; Cesano, Alessandra; Alvarez, John; Hawtin, Rachael; Janetzki, Sylvia; Kirsch, Ilan; Masucci, Giuseppe V; Robbins, Paul B; Selvan, Senthamil R; Streicher, Howard Z; Zhang, Jenny; Butterfield, Lisa H; Thurin, Magdalena

2016-01-01

There is growing recognition that immunotherapy is likely to significantly improve health outcomes for cancer patients in the coming years. Currently, while a subset of patients experience substantial clinical benefit in response to different immunotherapeutic approaches, the majority of patients do not but are still exposed to the significant drug toxicities. Therefore, a growing need for the development and clinical use of predictive biomarkers exists in the field of cancer immunotherapy. Predictive cancer biomarkers can be used to identify the patients who are or who are not likely to derive benefit from specific therapeutic approaches. In order to be applicable in a clinical setting, predictive biomarkers must be carefully shepherded through a step-wise, highly regulated developmental process. Volume I of this two-volume document focused on the pre-analytical and analytical phases of the biomarker development process, by providing background, examples and "good practice" recommendations. In the current Volume II, the focus is on the clinical validation, validation of clinical utility and regulatory considerations for biomarker development. Together, this two volume series is meant to provide guidance on the entire biomarker development process, with a particular focus on the unique aspects of developing immune-based biomarkers. Specifically, knowledge about the challenges to clinical validation of predictive biomarkers, which has been gained from numerous successes and failures in other contexts, will be reviewed together with statistical methodological issues related to bias and overfitting. The different trial designs used for the clinical validation of biomarkers will also be discussed, as the selection of clinical metrics and endpoints becomes critical to establish the clinical utility of the biomarker during the clinical validation phase of the biomarker development. Finally, the regulatory aspects of submission of biomarker assays to the U.S. Food and Drug Administration as well as regulatory considerations in the European Union will be covered.

Energy Efficiency Collaboratives

DOE Office of Scientific and Technical Information (OSTI.GOV)

Li, Michael; Bryson, Joe

2015-09-01

Collaboratives for energy efficiency have a long and successful history and are currently used, in some form, in more than half of the states. Historically, many state utility commissions have used some form of collaborative group process to resolve complex issues that emerge during a rate proceeding. Rather than debate the issues through the formality of a commission proceeding, disagreeing parties are sent to discuss issues in a less-formal setting and bring back resolutions to the commission. Energy efficiency collaboratives take this concept and apply it specifically to energy efficiency programs—often in anticipation of future issues as opposed to reactingmore » to a present disagreement. Energy efficiency collaboratives can operate long term and can address the full suite of issues associated with designing, implementing, and improving energy efficiency programs. Collaboratives can be useful to gather stakeholder input on changing program budgets and program changes in response to performance or market shifts, as well as to provide continuity while regulators come and go, identify additional energy efficiency opportunities and innovations, assess the role of energy efficiency in new regulatory contexts, and draw on lessons learned and best practices from a diverse group. Details about specific collaboratives in the United States are in the appendix to this guide. Collectively, they demonstrate the value of collaborative stakeholder processes in producing successful energy efficiency programs.« less

77 FR 39763 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-05

... financial markets generally; operational issues causing dissemination of inaccurate market information; or... issues causing dissemination of inaccurate market information; or force majeure type events such as...

75 FR 5845 - Agency Information Collection Activity Seeking OMB Approval

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-04

... collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments... Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th... use of automated collection techniques or other forms of information technology. Issued in Washington...

76 FR 65753 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0212] Monitoring the Effectiveness of Maintenance at...) re-issued Draft Regulatory Guide, DG-1278, ``Monitoring the Effectiveness of Maintenance at Nuclear... Revision 4A to Nuclear Management and Resources Council (NUMARC) 93-01, ``Industry Guideline for Monitoring...

75 FR 36211 - Requirements for Distribution of Byproduct Material

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-24

.... Submitting Comments and Accessing Information II. Background A. Introduction B. Regulatory Framework III.... Introduction The Commission has authority to issue both general and specific licenses for the use of byproduct... Products As noted in the introduction on regulatory framework, class exemptions allow the Commission to...

The regulator's perspective: How should new therapies and follow-on products for MS be clinically evaluated in the future?

PubMed

Crommelin, Daan Ja; Broich, Karl; Holloway, Chris; Meesen, Bianca; Lizrova Preiningerova, Jana; Prugnaud, Jean-Louis; Silva-Lima, Beatriz

2016-08-01

Although there is still no cure for multiple sclerosis (MS), the introduction of several innovative drugs with modes of action different from that of the existing drug arsenal and the progress in monitoring disease progression by imaging and using biomarkers are currently causing a knowledge surge. This provides opportunities for improving patient disease management. New therapies are also under development and pose challenges to the regulatory bodies regarding the optimal design of clinical trials with more patient-focused clinical endpoints. Moreover, with the upcoming patent expiry of some of the key first-line MS treatments in Europe, regulatory bodies will also face the challenge of recommending marketing authorisation for generic and abridged versions based on appropriate requirements for demonstrating equality/similarity to the innovator's product. The goal of this article is to improve the understanding of the relevant guidance documents of the European Medicines Agency (EMA) on clinical investigation of medicinal products and to highlight the issues that the agency will need to clarify regarding follow-on products of first-line MS treatments. Today, it is clear that close collaboration between patients, healthcare professionals, regulatory bodies and industry is crucial for developing new safe and effective drugs, which satisfy the needs of MS patients. © The Author(s), 2016.

If I were in charge of electric industry restructuring and regulatory reform: A grim fairy tale

DOE Office of Scientific and Technical Information (OSTI.GOV)

Burns, R.E.

1995-12-31

Imagine for a few minutes what it would be like to be made emperor or empress over the current debate on electric industry restructuring. You could cloak yourself with a robe of authority and issue decrees that would be followed. However, a wise ruler would use his or her powers with a light-hand to fashion and move the debate forward. The following shows what I would do if I were emperor {hor_ellipsis}if I were in charge of the electric industry restructuring and regulatory reform. The recommended decrees include: (1) immediate cessation of the debate over retail competition, (2) recognition ofmore » the regulatory authority needed in this period, (3) coordination of federal-state actions to achieve a common goal, (4) abandonment of fuel adjustment clauses, rate base, and rate-of-return regulation for the gnerating sector, (5) FERC will recognize that state commissions are not bound by the Sierra-Mobile doctrine, (6) efficiencies achieved from performance-based regulations may be credited against stranded costs, (7) the debate over standed benefits will cease, (8) state commissions will reward utilities for engaging in cost-effective emission reduction, (9) the repeal of PURPA and PUHCA will go forward, and (10) an end to the poolco-bilateral contract debate.« less

Quantitative impact of thymic selection on Foxp3+ and Foxp3- subsets of self-peptide/MHC class II-specific CD4+ T cells.

PubMed

Moon, James J; Dash, Pradyot; Oguin, Thomas H; McClaren, Jennifer L; Chu, H Hamlet; Thomas, Paul G; Jenkins, Marc K

2011-08-30

It is currently thought that T cells with specificity for self-peptide/MHC (pMHC) ligands are deleted during thymic development, thereby preventing autoimmunity. In the case of CD4(+) T cells, what is unclear is the extent to which self-peptide/MHC class II (pMHCII)-specific T cells are deleted or become Foxp3(+) regulatory T cells. We addressed this issue by characterizing a natural polyclonal pMHCII-specific CD4(+) T-cell population in mice that either lacked or expressed the relevant antigen in a ubiquitous pattern. Mice expressing the antigen contained one-third the number of pMHCII-specific T cells as mice lacking the antigen, and the remaining cells exhibited low TCR avidity. In mice lacking the antigen, the pMHCII-specific T-cell population was dominated by phenotypically naive Foxp3(-) cells, but also contained a subset of Foxp3(+) regulatory cells. Both Foxp3(-) and Foxp3(+) pMHCII-specific T-cell numbers were reduced in mice expressing the antigen, but the Foxp3(+) subset was more resistant to changes in number and TCR repertoire. Therefore, thymic selection of self-pMHCII-specific CD4(+) T cells results in incomplete deletion within the normal polyclonal repertoire, especially among regulatory T cells.

Interpreting MSHA citations through the lens of occupational health and safety management systems: investigating their impact on mine injuries and illnesses 2003-2010.

PubMed

Yorio, Patrick L; Willmer, Dana R; Haight, Joel M

2014-08-01

Since the late 1980s, the U.S. Department of Labor has considered regulating a systems approach to occupational health and safety management. Recently, a health and safety management systems (HSMS) standard has returned to the regulatory agenda of both the Occupational Safety and Health Administration (OSHA) and the Mine Safety and Health Administration (MSHA). Because a mandated standard has implications for both industry and regulating bodies alike, it is imperative to gain a greater understanding of the potential effects that an HSMS regulatory approach can have on establishment-level injuries and illnesses. Through the lens of MSHA's regulatory framework, we first explore how current enforcement activities align with HSMS elements. Using MSHA data for the years 2003-2010, we then analyze the relationship between various types of enforcement activities (e.g., total number of citations, total penalty amount, and HSMS-aligned citations) and mine reportable injuries. Our findings show that the reduction in mine reportable injuries predicted by increases in MSHA enforcement ranges from negligible to 18%. The results suggest that the type and focus of the enforcement activity may be more important for accident reduction than the total number of citations issued and the associated penalty amount. © 2014 Society for Risk Analysis.

Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.

PubMed

2004-11-24

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.

Nutritional supplements in age-related macular degeneration.

PubMed

Schmidl, Doreen; Garhöfer, Gerhard; Schmetterer, Leopold

2015-03-01

Age-related macular degeneration (AMD) is the most frequent cause of blindness in the Western World. While with new therapies that are directed towards vascular endothelial growth factor (VEGF), a potentially efficient treatment option for the wet form of the disease has been introduced, a therapeutic regimen for dry AMD is still lacking. There is evidence from several studies that oral intake of supplements is beneficial in preventing progression of the disease. Several formulations of micronutrients are currently available. The present review focuses on the role of supplements in the treatment and prevention of AMD and sums up the current knowledge about the most frequently used micronutrients. In addition, regulatory issues are discussed, and future directions for the role of supplementation in AMD are highlighted. © 2015 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

75 FR 45685 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... list (see current List 7 titled Misrepresentation/Omissions, List 9 titled Negligence/Breach of... claims alleging misrepresentation/ omissions (see current List 8, Item 1), negligence/breach of fiduciary... claims alleging misrepresentation/ omission (see current List 8, Item 2), negligence/breach of fiduciary...

Personal genome testing: Test characteristics to clarify the discourse on ethical, legal and societal issues

PubMed Central

2011-01-01

Background As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI) surrounding genetic testing, which must evolve to encompass these differences. One important development is the rise of personal genome testing on the basis of genetic profiling: the testing of multiple genetic variants simultaneously for the prediction of common multifactorial diseases. Currently, an increasing number of companies are offering personal genome tests directly to consumers and are spurring ELSI-discussions, which stand in need of clarification. This paper presents a systematic approach to the ELSI-evaluation of personal genome testing for multifactorial diseases along the lines of its test characteristics. Discussion This paper addresses four test characteristics of personal genome testing: its being a non-targeted type of testing, its high analytical validity, low clinical validity and problematic clinical utility. These characteristics raise their own specific ELSI, for example: non-targeted genetic profiling poses serious problems for information provision and informed consent. Questions about the quantity and quality of the necessary information, as well as about moral responsibilities with regard to the provision of information are therefore becoming central themes within ELSI-discussions of personal genome testing. Further, the current low level of clinical validity of genetic profiles raises questions concerning societal risks and regulatory requirements, whereas simultaneously it causes traditional ELSI-issues of clinical genetics, such as psychological and health risks, discrimination, and stigmatization, to lose part of their relevance. Also, classic notions of clinical utility are challenged by the newer notion of 'personal utility.' Summary Consideration of test characteristics is essential to any valuable discourse on the ELSI of personal genome testing for multifactorial diseases. Four key characteristics of the test - targeted/non-targeted testing, analytical validity, clinical validity and clinical utility - together determine the applicability and the relevance of ELSI to specific tests. The paper identifies and discusses four areas of interest for the ELSI-debate on personal genome testing: informational problems, risks, regulatory issues, and the notion of personal utility. PMID:21672210

Tune yourself in: Valence and arousal preferences in music-listening choices from adolescence to old age.

PubMed

Cohrdes, Caroline; Wrzus, Cornelia; Frisch, Simon; Riediger, Michaela

2017-09-01

In previous studies, older as compared with younger individuals were more strongly motivated to regulate their momentary affect toward pleasant and calm states. Whether these motivational differences are also reflected in regulatory behavior and whether this behavior is efficient in terms of affect change, however, is unclear. To address these issues, we conducted 3 studies with samples ranging in age from adolescence to old adulthood. In Study 1, we developed a novel and age-fair music browsing paradigm for music of diverse musical styles, dates of origin, and affective characteristics. The time spent listening to self-selected music with varying levels of valence and arousal served as an indicator of affect-regulatory preferences in 2 different affectively relevant situations, namely after mood induction in Study 2 and before an upcoming discussion with a stranger in Study 3. As predicted, we found a higher preference for music with positive valence and low arousal in older as compared with younger individuals in both studies. Additionally, the efficacy of music listening as an affect-regulatory strategy was supported because individuals' current affect significantly changed from before to after music listening (Studies 2 and 3), whereas that was not the case in an active control group listening to neutral nonmusical sounds (Study 3). These results extend previous research on affect regulation by demonstrating the utility of the music browsing paradigm as a behavioral indicator of affect-regulatory preferences in individuals from various age groups. They also provide evidence for age differences in, and affect-regulatory effects of, music-choice behavior. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Detection and traceability of genetically modified organisms in the food production chain.

PubMed

Miraglia, M; Berdal, K G; Brera, C; Corbisier, P; Holst-Jensen, A; Kok, E J; Marvin, H J P; Schimmel, H; Rentsch, J; van Rie, J P P F; Zagon, J

2004-07-01

Both labelling and traceability of genetically modified organisms are current issues that are considered in trade and regulation. Currently, labelling of genetically modified foods containing detectable transgenic material is required by EU legislation. A proposed package of legislation would extend this labelling to foods without any traces of transgenics. These new legislations would also impose labelling and a traceability system based on documentation throughout the food and feed manufacture system. The regulatory issues of risk analysis and labelling are currently harmonised by Codex Alimentarius. The implementation and maintenance of the regulations necessitates sampling protocols and analytical methodologies that allow for accurate determination of the content of genetically modified organisms within a food and feed sample. Current methodologies for the analysis of genetically modified organisms are focused on either one of two targets, the transgenic DNA inserted- or the novel protein(s) expressed- in a genetically modified product. For most DNA-based detection methods, the polymerase chain reaction is employed. Items that need consideration in the use of DNA-based detection methods include the specificity, sensitivity, matrix effects, internal reference DNA, availability of external reference materials, hemizygosity versus homozygosity, extrachromosomal DNA, and international harmonisation. For most protein-based methods, enzyme-linked immunosorbent assays with antibodies binding the novel protein are employed. Consideration should be given to the selection of the antigen bound by the antibody, accuracy, validation, and matrix effects. Currently, validation of detection methods for analysis of genetically modified organisms is taking place. In addition, new methodologies are developed, including the use of microarrays, mass spectrometry, and surface plasmon resonance. Challenges for GMO detection include the detection of transgenic material in materials with varying chromosome numbers. The existing and proposed regulatory EU requirements for traceability of genetically modified products fit within a broader tendency towards traceability of foods in general and, commercially, towards products that can be distinguished from each other. Traceability systems document the history of a product and may serve the purpose of both marketing and health protection. In this framework, segregation and identity preservation systems allow for the separation of genetically modified and non-modified products from "farm to fork". Implementation of these systems comes with specific technical requirements for each particular step of the food processing chain. In addition, the feasibility of traceability systems depends on a number of factors, including unique identifiers for each genetically modified product, detection methods, permissible levels of contamination, and financial costs. In conclusion, progress has been achieved in the field of sampling, detection, and traceability of genetically modified products, while some issues remain to be solved. For success, much will depend on the threshold level for adventitious contamination set by legislation. Copryright 2004 Elsevier Ltd.

75 FR 29787 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Granting...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Granting Accelerated Approval of Proposed Rule Change To Permit $1 Strikes for Options on Trust Issued Receipts May 20, 2010. I. Introduction On April 13, 2010, the Chicago Board Options Exchange, Incorporated (``CBOE'' or ``Exchange...

78 FR 27963 - Reliability Technical Conference; Notice of Technical Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD13-6-000] Reliability Technical Conference; Notice of Technical Conference Take notice that the Federal Energy Regulatory... related to the reliability of the Bulk-Power System. A more formal agenda will be issued at a later date...

78 FR 37261 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

... Change Relating to Amendments to the Discovery Guide Used in Customer Arbitration Proceedings June 13... Discovery Guide (``Guide'') used in customer arbitration proceedings to provide general guidance on electronic discovery (``e-discovery'') issues and product cases and to clarify the existing provision...

76 FR 77855 - Criteria for Identifying Material Licensees for the U. S. Nuclear Regulatory Commission's Agency...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-14

... Agencywide Documents Access and Management System (ADAMS) Accession Number: ML112280111) or in the... Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6272... ineffective in correcting their underlying issues. Discussion Criteria for Identifying Nuclear Material...

10 CFR 51.108 - Public hearings on Commission findings that inspections, tests, analyses, and acceptance criteria...

Code of Federal Regulations, 2010 CFR

2010-01-01

... CFR 52.103(b), the Commission will not admit any contentions on environmental issues, the adequacy of... NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2...

77 FR 18872 - Availability of Electric Power Sources

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... the first time that document is referenced. Revision 1 of Regulatory Guide 1.93 is available.... Introduction The NRC is issuing a revision to an existing guide in the NRC's ``Regulatory Guide'' series. This series was developed to describe and make available to the public information such as methods that are...

75 FR 48553 - Supplement to Commission Procedures During Periods of Emergency Operations Requiring Activation...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-11

... electric energy from qualifying cogeneration facilities and qualifying small power production facilities... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 376 [Docket No. RM10-28-000... Activation of Continuity of Operations Plan Issued August 5, 2010. AGENCY: Federal Energy Regulatory...

77 FR 50720 - Test Documentation for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Test Documentation for Digital Computer Software...) is issuing for public comment draft regulatory guide (DG), DG-1207, ``Test Documentation for Digital... practices for test documentation for software and computer systems as described in the Institute of...

76 FR 50537 - Regulatory Guidance Concerning Household Goods Carriers Requiring Shippers To Sign Blank or...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... Concerning Household Goods Carriers Requiring Shippers To Sign Blank or Incomplete Documents AGENCY: Federal.... Basis for This Notice The Agency has received numerous consumer complaints concerning household goods.... The FMCSA is issuing this regulatory guidance to eliminate any ambiguity or confusion concerning the...

78 FR 22349 - Guidance on the Treatment of Uncertainties Associated With PRA in Risk-Informed Decisionmaking

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-15

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0066] Guidance on the Treatment of Uncertainties Associated With PRA in Risk-Informed Decisionmaking AGENCY: Nuclear Regulatory Commission. ACTION... issued for public comment a document entitled: NUREG-1855, Revision 1, ``Guidance on the Treatment of...

77 FR 25760 - Low-Level Radioactive Waste Management and Volume Reduction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-01

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0183] Low-Level Radioactive Waste Management and Volume.... Nuclear Regulatory Commission (NRC or the Commission) is revising its 1981 Policy Statement on Low-Level..., the NRC staff issued SECY-10-0043, ``Blending of Low-Level Radioactive Waste'' (ADAMS Accession No...

77 FR 55232 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-03; Compliance With...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-07

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0067] Japan Lessons-Learned Project Directorate Interim...-Learned Project Directorate Interim Staff Guidance; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing the Final Japan Lessons-Learned Project Directorate (JLD...

77 FR 55231 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-02; Compliance With...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-07

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0069] Japan Lessons-Learned Project Directorate Interim...-Learned Project Directorate interim staff guidance; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing the Final Japan Lessons-Learned Project Directorate Interim...

78 FR 25484 - License Amendment for Anadarko Petroleum Corporation, Bear Creek Facility, Converse County, Wyoming

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

... NUCLEAR REGULATORY COMMISSION [Docket No.: 40-8452; NRC-2012-0095] License Amendment for Anadarko Petroleum Corporation, Bear Creek Facility, Converse County, Wyoming AGENCY: Nuclear Regulatory Commission... License SUA- 1310 issued to Anadarko Petroleum Corporation (APC or the licensee) to authorize alternate...

76 FR 44049 - Guidance for Fuel Cycle Facility Change Processes

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

... NUCLEAR REGULATORY COMMISSION [NRC-2009-0262] Guidance for Fuel Cycle Facility Change Processes...-issued Draft Regulatory Guide, DG- 3037, ``Guidance for Fuel Cycle Facility Change Processes'' in the...-3037 from August 12, 2011 to September 16, 2011. DG-3037 describes the types of changes for fuel cycle...

Workshop: Improving the Assessment and Valuation of Climate Change Impacts for Policy and Regulatory Analysis: Modeling Climate Change Impacts and Associated Economic Damages (2010 - part 1)

EPA Pesticide Factsheets

The purpose of this workshop Improving the Assessment and Valuation of Climate Change Impacts for Policy and Regulatory Analysis. focused on conceptual and methodological issues - integrated assessment modeling and valuation.

78 FR 62360 - PJM Interconnection, L.L.C.; Notice of Technical Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-21

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER13-2108-000] PJM Interconnection, L.L.C.; Notice of Technical Conference Federal Energy Regulatory Commission (Commission) staff... consider issues related to PJM Interconnection, L.L.C.'s (PJM) proposed demand response plan enhancements...

REGULATING THE ULTIMATE SINK: MANAGING THE RISKS OF GEOLOGIC CO2 STORAGE

EPA Science Inventory

The paper addresses the issue of geologic storage (GS) of carbon dioxide (CO2) and discusses the risks and regulatory history of deep underground waste injection on the U.S. mainland and surrounding continental shelf. The treatment focuses on the technical and regulatory aspects ...

76 FR 72009 - Receipt of Request for Action

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0267] Receipt of Request for Action Notice is hereby given... Regulatory Commission (NRC or the Commission) take action to issue a Demand for Information (DFI) of all..., appropriate action will be taken on this petition within a reasonable time. The petitioner declined an...

75 FR 16202 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-31

..., Revision 2, ``An Acceptable Model and Related Statistical Methods for the Analysis of Fuel Densification.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing guide in the... nuclear power reactors. To meet these objectives, the guide describes statistical methods related to...

Workshop on problem areas associated with developing carcinogen guidelines

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1984-06-01

A workshop was conducted to discuss problem areas associated with developing carcinogen guidelines. Session topics included (1) definition of a carcinogen for regulatory purposes; (2) potency; (3) risk assessment; (4) uncertainties; (5) de minimis quantity; and (6) legal and regulatory issues. Separate abstracts have been prepared for individual papers. (ACR)

Bulimia: A Self-Psychological and Ego-Developmental View.

ERIC Educational Resources Information Center

Brenner-Liss, Deborah

1986-01-01

Discusses key clinical issues in the treatment of bulimia with clinical examples from a self-psychological and ego-developmental point of view. Identifies three developmental issues for bulimia: self-regulatory, differentiation, and self-esteem. (Author/ABB)

A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part III. Countermeasures under early stages of development along with 'standard of care' medicinal and procedures not requiring regulatory approval for use.

PubMed

Singh, Vijay K; Hanlon, Briana K; Santiago, Paola T; Seed, Thomas M

2017-09-01

Terrorist attacks, with their intent to maximize psychological and economic damage as well as inflicting sickness and death on given targeted populations, are an ever-growing worldwide concern in government and public sectors as they become more frequent, violent, and sensational. If given the chance, it is likely that terrorists will use radiological or nuclear weapons. To thwart these sinister efforts, both physical and medical countermeasures against these weapons are currently being researched and developed so that they can be utilized by the first responders, military, and medical providers alike. This is the third article of a three-part series in which we have reviewed additional radiation countermeasures that are currently under early preclinical phases of development using largely animal models and have listed and discussed clinical support measures, including agents used for radiation-induced emesis, as well as countermeasures not requiring Food and Drug Administration approval. Despite the significant progress that has been made in this area during the last several years, additional effort is needed in order to push promising new agents, currently under development, through the regulatory pipeline. This pipeline for new promising drugs appears to be unreasonably slow and cumbersome; possible reasons for this inefficiency are briefly discussed. Significant and continued effort needs to be afforded to this research and development area, as to date, there is no approved radioprotector that can be administered prior to high dose radiation exposure. This represents a very significant, unmet medical need and a significant security issue. A large number of agents with potential to interact with different biological targets are under development. In the next few years, several additional radiation countermeasures will likely receive Food and Drug Administration approval, increasing treatment options for victims exposed to unwanted ionizing irradiation.

Comparative assessment of status and opportunities for carbon Dioxide Capture and storage and Radioactive Waste Disposal In North America

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oldenburg, C.; Birkholzer, J.T.

Aside from the target storage regions being underground, geologic carbon sequestration (GCS) and radioactive waste disposal (RWD) share little in common in North America. The large volume of carbon dioxide (CO{sub 2}) needed to be sequestered along with its relatively benign health effects present a sharp contrast to the limited volumes and hazardous nature of high-level radioactive waste (RW). There is well-documented capacity in North America for 100 years or more of sequestration of CO{sub 2} from coal-fired power plants. Aside from economics, the challenges of GCS include lack of fully established legal and regulatory framework for ownership of injectedmore » CO{sub 2}, the need for an expanded pipeline infrastructure, and public acceptance of the technology. As for RW, the USA had proposed the unsaturated tuffs of Yucca Mountain, Nevada, as the region's first high-level RWD site before removing it from consideration in early 2009. The Canadian RW program is currently evolving with options that range from geologic disposal to both decentralized and centralized permanent storage in surface facilities. Both the USA and Canada have established legal and regulatory frameworks for RWD. The most challenging technical issue for RWD is the need to predict repository performance on extremely long time scales (10{sup 4}-10{sup 6} years). While attitudes toward nuclear power are rapidly changing as fossil-fuel costs soar and changes in climate occur, public perception remains the most serious challenge to opening RW repositories. Because of the many significant differences between RWD and GCS, there is little that can be shared between them from regulatory, legal, transportation, or economic perspectives. As for public perception, there is currently an opportunity to engage the public on the benefits and risks of both GCS and RWD as they learn more about the urgent energy-climate crisis created by greenhouse gas emissions from current fossil-fuel combustion practices.« less

75 FR 39720 - Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-12

..., Inc. To List Options on Trust Issued Receipts in $1 Strike Intervals July 6, 2010. Pursuant to Section... strike price intervals for options on Trust Issued Receipts. The text of the proposed rule change is... strike price intervals for options on Trust Issued Receipts (``TIRs''), including Holding Company...

77 FR 63380 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-16

... purchase fixed income securities issued by U.S. or foreign corporations \\6\\ or financial institutions... also may purchase securities issued or guaranteed by the U.S. Government or foreign governments... (``CMOs'').\\8\\ The Fund may purchase or sell securities on a when issued, delayed delivery or forward...

Ethical issues in perinatal mental health research.

PubMed

Brandon, Anna R; Shivakumar, Geetha; Lee, Simon Craddock; Inrig, Stephen J; Sadler, John Z

2009-11-01

To review the background of current ethical standards for the conduct of perinatal mental health research and describe the ethical challenges in this research domain. Current literature reflects a growing sentiment in the scientific community that having no information regarding the impact of psychiatric treatment on the mother and developing fetus/infant poses dangers that may exceed the risks involved in research. However, without sufficient consensus across the scientific community, both regulatory bodies and perinatal researchers find themselves without a framework for decision making that satisfactorily limits the risks and facilitates the benefits of participation of pregnant and lactating women in clinical research. Psychiatric research in perinatal mental health is critically important as it enables clinicians and patients to participate in informed decision-making concerning treatment for psychiatric disorders. Specific areas of concern include fetal safety, maternal risk, the therapeutic misconception, commercial interests, forensic/legal issues, the informed consent process, and study design. Developing guidelines that address ethical challenges and include the views and concerns of multiple stakeholders could improve the access of perinatal women to the benefits of participation in mental health research in addition to providing evidence-based mental healthcare for this subpopulation.

‘Only a click away — DTC genetics for ancestry, health, love…and more: A view of the business and regulatory landscape’

PubMed Central

Phillips, Andelka M.

2016-01-01

I provide an overview of the current state of the direct-to-consumer (DTC) genetic testing industry and the challenges that different types of testing pose for regulation. I consider the variety of services currently available. These range from health and ancestry tests to those for child talent, paternity, and infidelity. In light of the increasingly blurred lines among different categories of testing, I call for a broader discussion of DTC governance. I stress the importance of shifting our attention from the activities of the most prominent companies to viewing DTC genetics as an industry with a wide spectrum of services and raising a wide variety of issues. These issues go beyond questions of clinical utility and validity to those of data security, personal identity, race, and the nature of the family. Robust DTC testing has the power to provide meaningful clinical, genealogical and even forensic information to those who want it; in unscrupulous hands, however, it also has the power to deceive and exploit. I consider approaches to help ensure the former and minimize the latter. PMID:27047755

Mesenchymal stromal cell-based therapy: Regulatory and translational aspects in gastroenterology.

PubMed

Dothel, Giovanni; Raschi, Emanuel; Rimondini, Roberto; De Ponti, Fabrizio

2016-11-07

The past decade has witnessed an outstanding scientific production focused towards the possible clinical applications of mesenchymal stromal cells (MSCs) in autoimmune and chronic inflammatory diseases. This raised the need of novel standards to adequately address quality, efficacy and safety issues of this advanced therapy. The development of a streamlined regulation is currently hampered by the complexity of analyzing dynamic biological entities rather than chemicals. Although numerous pieces of evidence show efficacy in reducing intestinal inflammation, some inconsistencies between the mechanisms of action of rodent vs human MSCs suggest caution before assigning translational value to preclinical studies. Preliminary evidence from clinical trials showed efficacy of MSCs in the treatment of fistulizing Crohn's disease (CD), and preparations of heterologous MSCs for CD treatment are currently tested in ongoing clinical trials. However, safety issues, especially in long-term treatment, still require solid clinical data. In this regard, standardized guidelines for appropriate dosing and methods of infusion could enhance the likelihood to predict more accurately the number of responders and the duration of remission periods. In addition, elucidating MSC mechanisms of action could lead to novel and more reliable formulations such as those derived from the MSCs themselves ( e.g ., supernatants).

Introduction to tobacco control supplement.

PubMed

Chen, Ii-Lun; Husten, Corinne G

2014-05-01

Electronic cigarettes (e-cigarettes) have recently gained significant attention in the marketplace and in the media. However, limited information is available about the worldwide impact of e-cigarettes; most public health officials are calling for more data so they can more fully understand the potential risks and benefits of e-cigarettes in order to inform regulatory action. In the USA, e-cigarettes that are marketed as tobacco products are not currently regulated by the Food and Drug Administration (FDA). However, having a continuum of nicotine-containing products that cross jurisdictional lines within the FDA in the future would create the potential (and the need) for a comprehensive nicotine strategy at the FDA. As part of developing the most appropriate approach to e-cigarette regulation, FDA Center for Tobacco Products scientists have been reviewing the available literature to determine the state of e-cigarette knowledge and have identified research areas that could be addressed. This supplement provides a summary of the current knowledge and research gaps pertaining to e-cigarettes with regards to product design, chemistry and toxicology of e-liquid and aerosol constituents, human factor-based risk factors, abuse liability, clinical pharmacology and human health effects, paediatric issues, and environmental issues.

Environmental Regulatory Update Table, May/June 1992

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number_sign}.

Environmental Regulatory Update Table, May/June 1992

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number sign}.

NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

NASA Technical Reports Server (NTRS)

Scroggins, Sharon

2008-01-01

NASA's Agency-wide.resource for identifying and managing risks associated with changing environmental regulations Goals of the RRAC PC: 1) Proactively. detect, analyze and communicate environmental regulatory risks to NASA Programs and facilities; 2) Communicate with regulators and participate in the mitigation of such risks; and 3) Provide centralized support on emerging regulations to NASA HQ Environmental Management Division. When significant regulatory changes are identified, timely communication is essential. Communication of changing requirements to the regulatory stakeholders - NASA Programs and Facilities. Communication of potential issues to management and, when appropriate, back to the regulating agency.

Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges.

PubMed

Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

2018-02-01

Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians. Based on these arguments, the present article was intended to review information on the main differences between first- and second-generation biosimilars for treatment of immune-mediated inflammatory diseases, as well as their impact on immunogenicity, the design of clinical trials and the critical issue of extrapolation of therapeutic indications. The positions taken by relevant medical associations and the crucial role of pharmacovigilance are also reviewed. According to current knowledge, the initial post-marketing clinical experience with second-generation biosimilars is providing encouraging results, though their long-term safety and efficacy as well as the scientific basis underlying the extrapolation of therapeutic indications are still matter of discussion. There is some consensus that marketing applications should rely on studies supporting the clinical use of biosimilars in their different target diseases and patient populations. In parallel, clinical safety must be ensured by a strict control of the manufacturing processes and a solid pharmacovigilance program. It remains then a responsibility of the physician to drive a proper use of second-generation biosimilars into clinical practice, in accordance with guidelines issued by scientific societies. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Anaerobic stabilization and conversion of transformed intermediates of antibiotic pharmaceutical effluent in a fluidized bed reactor.

PubMed

Tamijevendane, S; Saravanane, R; Rajesh, R; Sivacoumar, R

2011-07-01

The formulation and implementation of regulatory standards for the ultimate disposal and reuse of transformed products of antibiotic drugs and solvents have been a pending issue in the waste management of pharmaceutical industries especially in the developing countries like India. A case study has been identified and the current issues in one of the major pharmaceutical industry (manufacturing cephalosporin drugs) located in Chennai, India, has been discussed for the possible implementation of anaerobically transformed intermediates of antibiotic pharmaceutical waste sludge. The objective of the study was to determine the effect of bioaugmentation on the convertibility of anaerobically transformed intermediates of antibiotic pharmaceutical waste sludge into residuals and biocompost. Cephalosporin is a common name refers to cephradine (C16H19N3O4S) and cephalexin (C16H17N3O4S.H2O). Based on the critical examination of results, the industry is looking for the alternatives of either direct disposal of 7-amino-3-deacetoxycephalosporanic acid (7-ADCA) and phenyl acetic acid or for further degradation and disposal, which will essentially require additional cost and maintenance. The present regulatory standard implemented in India does not envisage such disposal alternatives and hence this would invite suggestions and recommendations of the expertise for the possible implementation on the pending issue in the antibiotic based pharmaceutical industries. The presence of cephalosporin increases total strength (Chemical Oxygen Demand) of the effluent and indirectly increases the cost of the treatment. Hence the biotransformation of cephalosporin either alone or in combination with other energetic compounds, offers the potential for an economical and environment friendly disposal alternative for the anaerobically transformed intermediates of antibiotic pharmaceutical waste sludge.

Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.

PubMed

Tazawa, Yoshiaki

2016-01-01

On July 1st, 2013, the Ministry of Health, Labor and Welfare (MHLW) issued an official notification regarding the co-development of companion diagnostics (CDx) with a drug which requires any exclusive diagnostic test or medical device to predict efficacy or adverse reactions to the drug. The main frame and contents in the MHLW's notification are quite similar to the summaries in the final guidance issued by the US Food and Drug Administration (FDA) on August 6th, 2014 Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic Devices, [2014] ), and these recommend industries to develop, study and submit CDx and the corresponding drug contemporaneously as much as possible. Following the MHLW's notification, the Pharmaceutical and Medical Device Agency (PMDA) notified on December 26th, 2013, "the technical guidance for co-development of CDx and the drug" that mentioned the regulatory requirements for clinical trial of the drug and CDx as well as analytical validity of CDx required for the trials. These official notifications from the Ministry and the Agency may be useful for pharmaceutical and diagnostics makers to understand how they should co-develop and validate CDx for clinical trials and regulatory submission. However, since the most anticipated technologies such as the next generation sequencer (NGS) are more complex and its medical risks could be high level, the existing regulatory system focusing on only diagnostics reagents and devices that are developed and manufactured by in vitro diagnostics (IVD) makers may be no longer suitable for the characteristics of CDx for the future.As an increase of clinical needs for multiple biomarkers assay by DNA sequencer, on November 19th, 2013, the FDA cleared 510 K for NGS and its universal kit. On October 3rd, 2014, moreover, the agency notified two drafts of guidance (Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), [2014]; Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDT), [2014]) for oversight of laboratory developed tests (LDTs) with medium or high medical risks. These FDA's strategic decisions and new regulatory frameworks may allow the clinical laboratories to develop and perform more easily NGS-based CDx under the certification of Clinical Laboratory Improvement Amendments (CLIA). However, neither law nor regulated quality management system similar to the CLIA exists in Japan. To effectively validate LDTs and NGS for medical practice, Japan should learn more the current regulatory changes and initiatives in the US, as well as to reform the regulatory frameworks and create any regulated quality management system for clinical laboratory testing to be reimbursed.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wood, Richard Thomas; Ewing, Paul D.

The U.S. Nuclear Regulatory Commission’s (NRC’s) regulations in Part 50, “Domestic Licensing of Production and Utilization Facilities,” of Title 10 of the Code of Federal Regulations (10 CFR Part 50) state that structures, systems, and components important to safety in a nuclear power plant are to be designed to accommodate the effects of environmental conditions (i.e., remain functional under all postulated service conditions) and that design control measures such as testing are to be used to check the adequacy of design. Regulatory Guide (RG) 1.180 was developed to provide guidance to licensees and applicants on methods acceptable to the NRCmore » staff for complying with the NRC’s regulations on design, installation, and testing practices for addressing the effects of electromagnetic and radio-frequency interference (EMI/RFI) and power surges on safety-related instrumentation and control (I&C) systems. The first revision of RG 1.180 was issued in January 2000 and a second revision was issued in October 2003*. The second revision differed from the first revision in endorsing Military Standard (MIL-STD)-461E and the International Electrotechnical Commission (IEC) Standard (Std) 61000 series of EMI/RFI test methods, extending the guidance to cover signal line testing, incorporating frequency ranges where portable communications devices are experiencing increasing use, and relaxing the operating envelopes (test levels) when experience and confirmatory research warranted. It also offered exemptions from specific test criteria based on technical considerations such as plant conditions and the intended location of the safety-related I&C equipment. Since the last revision, new requirements have been identified, associated RGs have been created and updated, and additional industry guidance has been developed. Additionally, the operational environment has changed with the increase in wireless communication technology for both personal (smartphone) and industrial (remote I&C) purposes. Also, specific concerns and issues with testing methods and methodologies have been identified that must be addressed. Further, most of the standards that serve as the basis for the RG have been revised. Therefore, the NRC’s Office of Regulatory Research has contracted with Oak Ridge National Laboratory (ORNL) to incorporate new information and resolve the identified issues under NRC-HQ-60-14-D-0015, “Update to RG 1.180, Revision 2, Guidelines for Evaluating Electromagnetic and Radio-Frequency Interference in Safety-Related Instrumentation and Control Systems.” The ultimate goal of this project is to provide NRC the technical basis for developing and publishing a new revision of the RG. The focus of Task 4 was for ORNL to identify and address any new or additional EMI/RFI issues that could potentially impact the EMC of I&C systems. More specifically, ORNL was to evaluate the impact of any new issue on safety equipment in their local environments and then determine whether the issues should be included and discussed in the revision to RG 1.180 that is currently under way.« less

77 FR 35844 - Safety Zone; Olde Ellison Bay Days Fireworks Display, Ellison Bay, WI

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... of Proposed Rulemaking A. Regulatory History and Information The Coast Guard is issuing this... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone...

Participatory Workplace Wellness Programs: Reward, Penalty, and Regulatory Conflict

PubMed Central

Pomeranz, Jennifer L

2015-01-01

Context In keeping with the Patient Protection and Affordable Care Act, Congress revised the law related to workplace wellness programs. In June 2013, the Departments of Treasury, Labor, and Health and Human Services passed the final regulations, updating their 2006 regulatory framework. Participatory programs that reward the completion of a health risk assessment are now the most common type of wellness program in the United States. However, legal and ethical concerns emerge when employers utilize incentives that raise questions about the voluntariness of such programs. At issue is that under the Americans with Disabilities Act (ADA) of 1990, employers cannot require health-related inquiries and exams. Methods To analyze the current interpretation of the ADA, I conducted research on both LexisNexis and federal agency websites. The resulting article evaluates the differences in the language of Congress's enabling legislation and the federal departments’ regulations and how they may conflict with the ADA. It also reviews the federal government's authority to address both the legal conflict and ethical concerns related to nonvoluntary participatory programs. Findings Employers’ practices and the federal departments’ regulations conflict with the current interpretation of the ADA by permitting employers to penalize employees who do not complete a health risk assessment. The departments’ regulations may be interpreted as conflicting with Congress's legislation, which mentions penalties only for health-contingent wellness programs. Furthermore, the regulatory protections for employees applicable to health-contingent wellness programs do not apply to participatory programs. Conclusions Either Congress or the federal agencies should address the conflict among employers’ practices, the wellness regulations, and the ADA and also consider additional protections for employees. Employers can avoid ethical and legal complications by offering voluntary programs with positive incentives. PMID:26044631

Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls - A review.

PubMed

Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J Pablo; Garcia-Jares, Carmen

2016-04-07

Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005-2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. Copyright © 2016 Elsevier B.V. All rights reserved.

Recommendations for the ethical use and design of artificial intelligent care providers.

PubMed

Luxton, David D

2014-09-01

This paper identifies and reviews ethical issues associated with artificial intelligent care providers (AICPs) in mental health care and other helping professions. Specific recommendations are made for the development of ethical codes, guidelines, and the design of AICPs. Current developments in the application of AICPs and associated technologies are reviewed and a foundational overview of applicable ethical principles in mental health care is provided. Emerging ethical issues regarding the use of AICPs are then reviewed in detail. Recommendations for ethical codes and guidelines as well as for the development of semi-autonomous and autonomous AICP systems are described. The benefits of AICPs and implications for the helping professions are discussed in order to weigh the pros and cons of their use. Existing ethics codes and practice guidelines do not presently consider the current or the future use of interactive artificial intelligent agents to assist and to potentially replace mental health care professionals. AICPs present new ethical issues that will have significant ramifications for the mental health care and other helping professions. Primary issues involve the therapeutic relationship, competence, liability, trust, privacy, and patient safety. Many of the same ethical and philosophical considerations are applicable to use and design of AICPs in medicine, nursing, social work, education, and ministry. The ethical and moral aspects regarding the use of AICP systems must be well thought-out today as this will help to guide the use and development of these systems in the future. Topics presented are relevant to end users, AI developers, and researchers, as well as policy makers and regulatory boards. Published by Elsevier B.V.

The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework.

PubMed

Cozzi, Emanuele; Tallacchini, Mariachiara; Flanagan, Enda B; Pierson, Richard N; Sykes, Megan; Vanderpool, Harold Y

2009-01-01

The outstanding results recently obtained in islet xenotransplantation suggest that porcine islet clinical trials may soon be scientifically appropriate. Before the initiation of such clinical studies, however, it is essential that a series of key ethical and regulatory conditions are satisfied. As far as ethics is concerned, the fundamental requirements have been previously reported in a position paper of the Ethics Committee of the International Xenotransplantation Association. These include aspects related to the selection of adequately informed, appropriate recipients; animal breeding and welfare; safety issues and the need for a favorable risk/benefit assessment based on strong efficacy data in relevant xenotransplantation studies in the primate. As most diabetic patients are not at risk of short-term mortality without islet transplantation, only a small subset of patients could currently be considered for any type of islet transplant. However, there are potential advantages to xenotransplantation that could result in a favorable benefit-over-harm determination for islet xenotransplantation in this subpopulation and ultimately in a broader population of diabetic patients. With regard to regulatory aspects, the key concepts underlying the development of the regulatory models in existence in the United States, Europe and New Zealand are discussed. Each of these models provides an example of a well-defined regulatory approach to ensure the initiation of well-regulated and ethically acceptable clinical islet xenotransplantation trials. At this stage, it becomes apparent that only a well-coordinated international effort such as that initiated by the World Health Organization, aimed at harmonizing xenotransplantation procedures according to the highest ethical and regulatory standards on a global scale, will enable the initiation of clinical xenotransplantation trials under the best auspices for its success and minimize any risk of failure.

75 FR 21373 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-23

...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed Rule Change To Permit $1 Strikes for Options on Trust Issued Receipts April 16, 2010. Pursuant to Section 19(b)(1) of... that on April 13, 2010, Chicago Board Options Exchange, Incorporated (the ``Exchange'' or ``CBOE...

77 FR 35271 - Safety Zone; NOAA Vessel Rueben Lasker Launch, Marinette, WI

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

.... Regulatory History and Information The Coast Guard is issuing this temporary final rule without prior notice... section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business...

75 FR 52558 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-26

...-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed... costs associated with system issues that are attributable to cancelled AON orders. A Professional order... organization in order for a member organization to be assessed the Cancellation Fee (``500 Threshold''). The...

78 FR 41835 - Inflation Adjustments to the Price-Anderson Act Financial Protection Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-12

...;Prices of new books are listed in the first FEDERAL REGISTER issue of each #0;week. #0; #0; #0; #0;#0... Price-Anderson Act Financial Protection Regulations AGENCY: Nuclear Regulatory Commission. ACTION: Final rule. SUMMARY: The Atomic Energy Act of 1954, as amended (AEA), requires the U.S. Nuclear Regulatory...

78 FR 47012 - Developing Software Life Cycle Processes Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Developing Software Life Cycle Processes Used in... revised regulatory guide (RG), revision 1 of RG 1.173, ``Developing Software Life Cycle Processes for... Developing a Software Project Life Cycle Process,'' issued 2006, with the clarifications and exceptions as...

77 FR 67047 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-08

...-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of Proposed Rule Change Consisting of Amendments to Streamline New Issue Information Submission Requirements Under MSRB Rules G-32... Organization's Statement of the Terms of Substance of the Proposed Rule Change The MSRB is filing with the...

Workshop: Improving the Assessment and Valuation of Climate Change Impacts for Policy and Regulatory Analysis: Modeling Climate Change Impacts and Associated Economic Damages (2011 - part 2)

EPA Pesticide Factsheets

The purpose of this workshop Improving the Assessment and Valuation of Climate Change Impacts for Policy and Regulatory Analysis. focused on conceptual and methodological issues - estimating impacts and valuing damages on a sectoral basis.

ACTIVITIES TO DEVELOP AN INTERIM GUIDANCE FOR MICROARRAY-BASED ASSAYS FOR REGULATORY AND RISK ASSESSMENT APPLICATIONS AT EPA

EPA Science Inventory

Abstract for presentation. Advances in genomics will have significant implications for risk assessment policies and regulatory decision making. In 2002, EPA issued its lnterim Policy on Genomics which stated that such data may be considered in the decision making process, but tha...

Excerpts from U.S. Coast Guard Regulations and Policies Related to the Edible Oil Regulatory Reform Act -- P.L. 104-55

DOT National Transportation Integrated Search

1997-04-11

The Edible Oil Regulatory Reform Act (P.L. 104-55) requires "the head of any Federal agency to differentiate between fats, oils, and greases of animal, marine, or vegetable origin, and other oils and : greases, in issuing certain regulations, and for...

18 CFR 375.104 - Transfer of proceedings from other agencies to the Commission.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REVISED GENERAL RULES THE COMMISSION... regulations issued by the Commission and the Secretary of Energy on October 1, 1977. Those joint regulations... SECRETARY OF ENERGY AND THE FEDERAL ENERGY REGULATORY COMMISSION § 1000.1 Transfer of proceedings. (a)Scope...

18 CFR 375.104 - Transfer of proceedings from other agencies to the Commission.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REVISED GENERAL RULES THE COMMISSION... regulations issued by the Commission and the Secretary of Energy on October 1, 1977. Those joint regulations... SECRETARY OF ENERGY AND THE FEDERAL ENERGY REGULATORY COMMISSION § 1000.1 Transfer of proceedings. (a)Scope...

78 FR 8295 - Guarantees for Bonds Issued for Community or Economic Development Purposes

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-05

.... V. Rulemaking Analysis A. Executive Order (E.O.) 12866; Regulatory Impact Analysis It has been... Budget. The Regulatory Impact Analysis prepared by the CDFI Fund for the interim rule is provided below... Community Investment Impact System (CIIS), which collects data from CDFIs that have received awards from the...

77 FR 50722 - Software Unit Testing for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Unit Testing for Digital Computer Software...) is issuing for public comment draft regulatory guide (DG), DG-1208, ``Software Unit Testing for Digital Computer Software used in Safety Systems of Nuclear Power Plants.'' The DG-1208 is proposed...

76 FR 1335 - Supplemental Standards of Ethical Conduct for Employees of the Federal Energy Regulatory Commission

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-10

.... 744] Supplemental Standards of Ethical Conduct for Employees of the Federal Energy Regulatory... Government Ethics (OGE), is amending the Supplemental Standards of Ethical Conduct for Employees of the.... I. Background 1. The Office of Government Ethics (OGE) has issued rules setting out the Standards of...

76 FR 62868 - Washington State University; Notice of Issuance of Renewed Facility Operating License No. R-76

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-11

...; Notice of Issuance of Renewed Facility Operating License No. R-76 AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance of renewed facility operating license No. R- 76. ADDRESSES: You can access.... Nuclear Regulatory Commission (NRC, the Commission) has issued renewed Facility Operating License No. R-76...

75 FR 34183 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-16

... listing market has resolved any imbalances. See, e.g., BlackRock Letter, Credit Suisse Letter, Knight... to Proposed Rule Change To Amend FINRA Rule 6121 (Trading Halts Due to Extraordinary Market... Listing Market Has Issued a Trading Pause Due to Extraordinary Market Conditions June 10, 2010. I...

75 FR 18091 - Final Flood Elevation Determinations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C... within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601- 612, a regulatory flexibility analysis.... This final rule meets the applicable standards of Executive Order 12988. List of Subjects in 44 CFR...

78 FR 64027 - Preoperational Testing of Emergency Core Cooling Systems for Pressurized-Water Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

...The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to regulatory guide (RG), 1.79, ``Preoperational Testing of Emergency Core Cooling Systems for Pressurized-Water Reactors.'' This RG is being revised to incorporate guidance for preoperational testing of new pressurized water reactor (PWR) designs.

75 FR 63725 - Nuclear Energy Institute; Consideration of Petition in the Rulemaking Process

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

... NUCLEAR REGULATORY COMMISSION 10 CFR Part 70 [Docket No. PRM-70-8; NRC-2009-0184] Nuclear Energy Institute; Consideration of Petition in the Rulemaking Process AGENCY: Nuclear Regulatory Commission. ACTION... Commission (NRC) will consider five of the issues raised in a petition submitted by the Nuclear Energy...

76 FR 14437 - Economic Simplified Boiling Water Reactor Standard Design: GE Hitachi Nuclear Energy; Issuance of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-16

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0055] Economic Simplified Boiling Water Reactor Standard Design: GE Hitachi Nuclear Energy; Issuance of Final Design Approval The U.S. Nuclear Regulatory Commission has issued a final design approval (FDA) to GE Hitachi Nuclear Energy (GEH) for the economic...

77 FR 58591 - Report on Waste Burial Charges: Changes in Decommissioning Waste Disposal Costs at Low-Level...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0362] Report on Waste Burial Charges: Changes in Decommissioning Waste Disposal Costs at Low-Level Waste Burial Facilities AGENCY: Nuclear Regulatory Commission... Commission) has issued for public comment a document entitled: NUREG-1307 Revision 15, ``Report on Waste...

14 CFR 413.5 - Pre-application consultation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 413.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... process and possible issues relevant to the FAA's licensing or permitting decision. Early consultation helps an applicant to identify possible regulatory issues at the planning stage when changes to an...

14 CFR 413.5 - Pre-application consultation.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 413.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... process and possible issues relevant to the FAA's licensing or permitting decision. Early consultation helps an applicant to identify possible regulatory issues at the planning stage when changes to an...

14 CFR 413.5 - Pre-application consultation.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 413.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... process and possible issues relevant to the FAA's licensing or permitting decision. Early consultation helps an applicant to identify possible regulatory issues at the planning stage when changes to an...

10 CFR 590.311 - Conferences.

Code of Federal Regulations, 2013 CFR

2013-01-01

... ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS Procedures § 590.311 Conferences. (a) Upon motion by a..., delineate issues, stipulate certain issues of fact or law, set procedures, and consider other relevant...

10 CFR 590.311 - Conferences.

Code of Federal Regulations, 2014 CFR

2014-01-01

... ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS Procedures § 590.311 Conferences. (a) Upon motion by a..., delineate issues, stipulate certain issues of fact or law, set procedures, and consider other relevant...

78 FR 19478 - National and Governmental Advisory Committees to the U.S. Representative to the Commission for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

.... Representative on a wide range of strategic, scientific, technological, regulatory, and economic issues related... environment issues related to the NAAEC. The meeting will also include a public comment session. The agenda...

77 FR 13115 - Florida Gas Transmission Company; Notice of Intent To Prepare an Environmental Assessment for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-05

... Project and Request for Comments on Environmental Issues The staff of the Federal Energy Regulatory... analysis in the EA on the important environmental issues. By this notice, the Commission requests public... environmental issues related to this project to formally cooperate with us in the preparation of the EA.\\3...

75 FR 40011 - Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-13

... LLC To List Options on Trust Issued Receipts in $1 Strike Intervals July 6, 2010. Pursuant to section... strike price intervals for options on Trust Issued Receipts. The text of the proposed rule change is... establish strike price intervals for options on Trust Issued Receipts (``TIRs''), including Holding Company...

76 FR 40282 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; NRC Regulation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-08

... Commission (NRC) is proposing to issue a RIS that clarifies those discrete sources of radium-226 under... Officers. Intent The NRC is issuing this RIS to clarify which discrete sources of radium-226 under military... definition of byproduct material to include discrete sources of radium-226, discrete sources of naturally...

76 FR 79247 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... Change Relating to Extension of the Exchange's Penny Pilot Program and Replacement of Penny Pilot Issues... Increments) to: Extend through June 30, 2012, the Penny Pilot Program in options classes in certain issues (``Penny Pilot'' or ``Pilot''); and replace any Penny Pilot issues that have been delisted.\\3\\ \\3\\ The...

77 FR 40126 - Self-Regulatory Organizations; NASDAQ OMX Phlx, LLC; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... Change Relating to Extension of the Exchange's Penny Pilot Program and Replacement of Penny Pilot Issues...) to: extend through December 31, 2012, the Penny Pilot Program in options classes in certain issues (``Penny Pilot'' or ``Pilot''); and provide for or allow replacement of any Penny Pilot issues that have...

Rationales for regulatory activity

DOE Office of Scientific and Technical Information (OSTI.GOV)

Perhac, R.M.

1997-02-01

The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

Workshop on the Application of Genomic Tools for the Rapid Molecular Characterization of Bacterial Isolates in Food-borne Disease Outbreak Investigations Ottawa, ON, February 24-25, 2014

DTIC Science & Technology

2014-05-01

techniques in regulatory food microbiology testing. When testing is conducted to verify compliance with food regulations, detection and typing are...8 Implementation of Molecular Techniques in Regulatory Food Microbiology Testing ................................ 8 From A,C,G,T to PFGE, to MLST... food -borne isolates, as well as some case studies highlighting the role of genomics in the resolution of critical regulatory food microbiology issues

Health physics aspects of advanced reactor licensing reviews

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hinson, C.S.

1995-03-01

The last Construction Permit to be issued by the U.S. Nuclear Regulatory Commission (NRC) for a U.S. light water reactor (LWR) was granted in the late 1970s. In 1989 the NRC issued 10 CFR Part 52 which is intended to serve as a framework for the licensing of future reactor designs. The NRC is currently reviewing four different future on {open_quotes}next-generation{close_quotes} reactor designs. Two of these designs are classified as evolutionary designs (modified versions of current generation LWRs) and two are advanced designs (reactors incorporating simplified designs and passive means for accident mitigation). These {open_quotes}next-generation{close_quotes} reactor designs incorporate many innovativemore » design features which are intended to maintain personnel doses ALARA and ensure that the annual average collective dose at these reactors does not exceed 100 person-rems (1 person-sievert) per year. This paper discusses some of the ALARA design features which are incorporated in the four {open_quotes}next-generation{close_quotes} reactor designs incorporate many innovative design features which are intended to maintain personnel doses ALARA and ensure that the annual average collective dose at these reactors does not exceed 100 person-rems (1 person-sievert) per year. This paper discusses some of the ALARA design features which are incorporated in the four {open_quotes}next-generation{close_quotes} reactor designs currently being reviewed by the NRC.« less

Adaptive trial designs: a review of barriers and opportunities

PubMed Central

2012-01-01

Adaptive designs allow planned modifications based on data accumulating within a study. The promise of greater flexibility and efficiency stimulates increasing interest in adaptive designs from clinical, academic, and regulatory parties. When adaptive designs are used properly, efficiencies can include a smaller sample size, a more efficient treatment development process, and an increased chance of correctly answering the clinical question of interest. However, improper adaptations can lead to biased studies. A broad definition of adaptive designs allows for countless variations, which creates confusion as to the statistical validity and practical feasibility of many designs. Determining properties of a particular adaptive design requires careful consideration of the scientific context and statistical assumptions. We first review several adaptive designs that garner the most current interest. We focus on the design principles and research issues that lead to particular designs being appealing or unappealing in particular applications. We separately discuss exploratory and confirmatory stage designs in order to account for the differences in regulatory concerns. We include adaptive seamless designs, which combine stages in a unified approach. We also highlight a number of applied areas, such as comparative effectiveness research, that would benefit from the use of adaptive designs. Finally, we describe a number of current barriers and provide initial suggestions for overcoming them in order to promote wider use of appropriate adaptive designs. Given the breadth of the coverage all mathematical and most implementation details are omitted for the sake of brevity. However, the interested reader will find that we provide current references to focused reviews and original theoretical sources which lead to details of the current state of the art in theory and practice. PMID:22917111

Unbundling in Current Broadband and Next-Generation Ultra-Broadband Access Networks

NASA Astrophysics Data System (ADS)

Gaudino, Roberto; Giuliano, Romeo; Mazzenga, Franco; Valcarenghi, Luca; Vatalaro, Francesco

2014-05-01

This article overviews the methods that are currently under investigation for implementing multi-operator open-access/shared-access techniques in next-generation access ultra-broadband architectures, starting from the traditional "unbundling-of-the-local-loop" techniques implemented in legacy twisted-pair digital subscriber line access networks. A straightforward replication of these copper-based unbundling-of-the-local-loop techniques is usually not feasible on next-generation access networks, including fiber-to-the-home point-to-multipoint passive optical networks. To investigate this issue, the article first gives a concise description of traditional copper-based unbundling-of-the-local-loop solutions, then focalizes on both next-generation access hybrid fiber-copper digital subscriber line fiber-to-the-cabinet scenarios and on fiber to the home by accounting for the mix of regulatory and technological reasons driving the next-generation access migration path, focusing mostly on the European situation.

Quality management for the international transport of laboratory animals.

PubMed

Leary, Steven L

2008-01-01

Increased collaboration between investigators at different institutions has increased the number of laboratory animals being transported. The current system of laws and regulations governing animal shipments is inconsistent and government agencies often have areas of overlapping regulatory management. Furthermore, the lack of industry-wide shipping standards and good practices contributes to confusion among those responsible for shipment. One answer to these quality control issues would be the establishment of independent, industry-regulated 'good practices' for animal transport, similar to those used in laboratories for experimental design. These good practices could be based on the existing International Air Transport Association Live Animals Regulations, with contributions from representatives of the specialties involved. Additionally, quality control under the current system of patchwork regulations could be improved if each institution, both academic and commercial, would designate a single point of contact to follow each shipment from start to finish.

Harnessing science for environmental regulation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Graham, J.D.

1991-01-01

An introductory chapter by Graham frames the issues to be discussed; then the following three chapters describe the formation and character of three organizations. These chapters are written by authors who have each had an active management role in the organization they are writing about: Terry F. Yosie, now at the American Petroleum Institute, who staffed the SAB (Science Advisory Board) while he was at EPA; Robert A. Neal, who headed CIIT (Chemical Industry Institute of Toxicology) before leaving for a position at Vanderbilt University; and Thomas P. Grumbly, former executive director of HEI (Health Effects Institute) now president ofmore » Clean Sites, Inc. While these chapters are well written and make a vital contribution to the overall development of the book's themes, the most valuable and enjoyable parts of the book are the succeeding five chapters, which present case studies dealing with EPA's regulatory efforts on unleaded gasoline, perchloroethylene, formaldehyde, nitrates in drinking water, and carbon monoxide. Each of these case studies, nominally historical accounts of how one or more of these (three) organizations participated in the regulatory controversy, offer insight into the broader issues of dealing with, and incorporating into regulations scientific information that has high uncertainty. One of the richest aspects of the five case studies is the extensive use of referenced interviews with identified participants from all aspects of the regulatory process. This material illuminates the motivation, emotions, and goals of the different players, helping the reader to understand their positions and other issues, such as why industry pursues, and EPA and the environmental movement appear to resist, good science; what underlies EPA's preferences for one regulatory option over another; and why scientists are histant to give yes-or-no answers in accord with the real time needs of the regulatory agency.« less

Toxicogenomics and the Regulatory Framework

EPA Science Inventory

Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expec...

ARTIST (Asian regional tobacco industry scientist team): Philip Morris' attempt to exert a scientific and regulatory agenda on Asia

PubMed Central

Tong, E; Glantz, S

2004-01-01

Objective: To describe how the transnational tobacco industry has collaborated with local Asian tobacco monopolies and companies to promote a scientific and regulatory agenda. Methods: Analysis of previously secret tobacco industry documents. Results: Transnational tobacco companies began aggressively entering the Asia market in the 1980s, and the current tobacco industry in Asia is a mix of transnational and local monopolies or private companies. Tobacco industry documents demonstrate that, in 1996, Philip Morris led an organisation of scientific representatives from different tobacco companies called the Asian Regional Tobacco Industry Science Team (ARTIST), whose membership grew to include monopolies from Korea, China, Thailand, and Taiwan and a company from Indonesia. ARTIST was initially a vehicle for PM's strategies against anticipated calls for global smoke-free areas from a World Health Organization secondhand smoke study. ARTIST evolved through 2001 into a forum to present scientific and regulatory issues faced primarily by Philip Morris and other transnational tobacco companies. Philip Morris' goal for the organisation became to reach the external scientific and public health community and regulators in Asia. Conclusion: The Asian tobacco industry has changed from an environment of invasion by transnational tobacco companies to an environment of participation with Philip Morris' initiated activities. With this participation, tobacco control efforts in Asia face new challenges as Philip Morris promotes and integrates its scientific and regulatory agenda into the local Asian tobacco industry. As the local Asian tobacco monopolies and companies can have direct links with their governments, future implementation of effective tobacco control may be at odds with national priorities. PMID:15564214

ARTIST (Asian regional tobacco industry scientist team): Philip Morris' attempt to exert a scientific and regulatory agenda on Asia.

PubMed

Tong, E K; Glantz, S A

2004-12-01

To describe how the transnational tobacco industry has collaborated with local Asian tobacco monopolies and companies to promote a scientific and regulatory agenda. Analysis of previously secret tobacco industry documents. Transnational tobacco companies began aggressively entering the Asia market in the 1980s, and the current tobacco industry in Asia is a mix of transnational and local monopolies or private companies. Tobacco industry documents demonstrate that, in 1996, Philip Morris led an organisation of scientific representatives from different tobacco companies called the Asian Regional Tobacco Industry Science Team (ARTIST), whose membership grew to include monopolies from Korea, China, Thailand, and Taiwan and a company from Indonesia. ARTIST was initially a vehicle for PM's strategies against anticipated calls for global smoke-free areas from a World Health Organization secondhand smoke study. ARTIST evolved through 2001 into a forum to present scientific and regulatory issues faced primarily by Philip Morris and other transnational tobacco companies. Philip Morris' goal for the organisation became to reach the external scientific and public health community and regulators in Asia. The Asian tobacco industry has changed from an environment of invasion by transnational tobacco companies to an environment of participation with Philip Morris' initiated activities. With this participation, tobacco control efforts in Asia face new challenges as Philip Morris promotes and integrates its scientific and regulatory agenda into the local Asian tobacco industry. As the local Asian tobacco monopolies and companies can have direct links with their governments, future implementation of effective tobacco control may be at odds with national priorities.

Pilot-Induced Oscillation Research: Status at the End of the Century. Volume 2

NASA Technical Reports Server (NTRS)

Shafer, Mary F. (Compiler); Steinmetz, Paul (Compiler)

2001-01-01

The workshop "Pilot-Induced Oscillation Research: The Status at the End of the Century," was held at NASA Dryden Flight Research Center on 6-8 April 1999. The presentations at this conference addressed the most current information available, addressing regulatory issues, flight test, safety, modeling, prediction, simulation, mitigation or prevention, and areas that require further research. All presentations were approved for publication as unclassified documents with no limits on their distribution. This proceedings includes the viewgraphs (some with author's notes) used for thirty presentations that were actually given and two presentations that were not given because of time limitations. Four technical papers on this subject are also included.

Pilot-Induced Oscillation Research: Status at the End of the Century. Volume 3

NASA Technical Reports Server (NTRS)

Shafer, Mary F. (Compiler); Steinmetz, Paul (Compiler)

2001-01-01

The workshop "Pilot-Induced Oscillation Research: The Status at the End of the Century," was held at NASA Dryden Flight Research Center on 6-8 April 1999. The presentations at this conference addressed the most current information available, addressing regulatory issues, flight test, safety, modeling, prediction, simulation, mitigation or prevention, and areas that require further research. All presentations were approved for publication as unclassified documents with no limits on their distribution. This proceedings includes the viewgraphs (some with author's notes) used for thirty presentations that were actually given and two presentations that were not given because of time limitations. Four technical papers on this subject are also included.