30 CFR 934.15 - Approval of North Dakota regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... dates amendments were submitted to OSM, the dates when the Director's decision approving all, or..., Wetlands standards. II-I, Recreational land use standards for tree and shrub stocking. III-D, Methods for...

Laser safety: regulations, standards, and recommendations

NASA Astrophysics Data System (ADS)

Smalley, Penny J.

1993-07-01

All healthcare professionals involved in the delivery of laser technology to patients, must develop and monitor clinical laser safety programs that ensure compliance with national, state, and local regulations, professional standards of practice, and national consensus standards. Laser safe treatment environments for patients and for personnel can be established and maintained through understanding the impact of both regulatory and advisory guidelines, comprehensive program planning, appropriate continuing education, and routine safety audits.

34 CFR Appendix B to Subpart B of... - Appendix I, Standards for Audit of Governmental Organizations, Programs, Activities, and...

Code of Federal Regulations, 2013 CFR

2013-07-01

... Organizations, Programs, Activities, and Functions (GAO) B Appendix B to Subpart B of Part 668 Education... Programs Pt. 668, Subpt. B, App. B Appendix B to Subpart B of Part 668—Appendix I, Standards for Audit of... required for the practice of public accountancy by the regulatory authorities of the States.” 1 1 Letter (B...

34 CFR Appendix B to Subpart B of... - Appendix I, Standards for Audit of Governmental Organizations, Programs, Activities, and...

Code of Federal Regulations, 2014 CFR

2014-07-01

... Organizations, Programs, Activities, and Functions (GAO) B Appendix B to Subpart B of Part 668 Education... Programs Pt. 668, Subpt. B, App. B Appendix B to Subpart B of Part 668—Appendix I, Standards for Audit of... required for the practice of public accountancy by the regulatory authorities of the States.” 1 1 Letter (B...

34 CFR Appendix B to Subpart B of... - Appendix I, Standards for Audit of Governmental Organizations, Programs, Activities, and...

Code of Federal Regulations, 2012 CFR

2012-07-01

... Organizations, Programs, Activities, and Functions (GAO) B Appendix B to Subpart B of Part 668 Education... Programs Pt. 668, Subpt. B, App. B Appendix B to Subpart B of Part 668—Appendix I, Standards for Audit of... required for the practice of public accountancy by the regulatory authorities of the States.” 1 1 Letter (B...

[Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

PubMed

Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

2016-05-01

Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

75 FR 6332 - Wyoming Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... practices, shrub reclamation standards, fish and wildlife enhancement measures, cultural and historic... normal husbandry practices, reorganize and clarify species diversity and shrub density requirements, and... vegetation sampling methods and reclamation success standards for shrubs on reclaimed lands. In August of...

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... 63.851 Section 63.851 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

78 FR 1636 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... Business Size 3245-AG51 Standards for Other Industries With Employee- Based Size Standards not Part of... applicants that do not meet the small business size standards for their industries. For the 504 Program, the... U.S.C. 632(a) Abstract: SBA has received numerous comments from businesses, industry associations...

10 CFR 20.2102 - Records of radiation protection programs.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Records of radiation protection programs. 20.2102 Section 20.2102 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2102 Records of radiation protection programs. (a) Each licensee shall maintain records of the...

10 CFR 20.2102 - Records of radiation protection programs.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Records of radiation protection programs. 20.2102 Section 20.2102 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2102 Records of radiation protection programs. (a) Each licensee shall maintain records of the...

10 CFR 20.2102 - Records of radiation protection programs.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Records of radiation protection programs. 20.2102 Section 20.2102 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2102 Records of radiation protection programs. (a) Each licensee shall maintain records of the...

10 CFR 20.2102 - Records of radiation protection programs.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Records of radiation protection programs. 20.2102 Section 20.2102 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2102 Records of radiation protection programs. (a) Each licensee shall maintain records of the...

10 CFR 20.2102 - Records of radiation protection programs.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Records of radiation protection programs. 20.2102 Section 20.2102 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Records § 20.2102 Records of radiation protection programs. (a) Each licensee shall maintain records of the...

CURRENT STATUS OF THE EPA PROTOCOL GAS PROGRAM

EPA Science Inventory

Accurate compressed gas calibration standards are needed to calibrate continuous emission monitors (CEMs) and ambient air quality monitors that are being used for regulatory purposes. EPA has published a protocol to establish the traceability of these standards to national refer...

30 CFR 810.4 - Responsibility.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PERMANENT PROGRAM...) The Director shall ensure that performance standards and design requirements at least as stringent as... State regulatory authority shall ensure that performance standards and design requirements at least as...

A Review of Federal and State Regulations for Day Care Programs and Facilities. Center for Human Services Development Report No. 10.

ERIC Educational Resources Information Center

Hollick, Rosemary; And Others

This report provides a review of U.S. regulatory standards for day care programs and facilities and makes recommendations for the revision of day care regulations in Pennsylvania. Following a brief discussion of federal interagency requirements, a number of short descriptive analyses compare individual state standards in the areas of licensing,…

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 science: modern trends in science and education for pharmaceutical products].

PubMed

Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

2012-01-01

This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

Applying your corporate compliance skills to the HIPAA security standard.

PubMed

Carter, P I

2000-01-01

Compliance programs are an increasingly hot topic among healthcare providers. These programs establish policies and procedures covering billing, referrals, gifts, confidentiality of patient records, and many other areas. The purpose is to help providers prevent and detect violations of the law. These programs are voluntary, but are also simply good business practice. Any compliance program should now incorporate the Health Insurance Portability and Accountability Act (HIPAA) security standard. Several sets of guidelines for development of compliance programs have been issued by the federal government, and each is directed toward a different type of healthcare provider. These guidelines share certain key features with the HIPAA security standard. This article examines the common areas between compliance programs and the HIPAA security standard to help you to do two very important things: (1) Leverage your resources by combining compliance with the security standard with other legal and regulatory compliance efforts, and (2) apply the lessons learned in developing your corporate compliance program to developing strategies for compliance with the HIPAA security standard.

Final Rule for Control of Air Pollution From New Motor Vehicles and New Motor Vehicle Engines: Voluntary Standards for Light-Duty Vehicles

EPA Pesticide Factsheets

The National LEV program demonstrates how cooperative, partnership efforts can produce a smarter, cheaper program that reduces regulatory burden while increasing protection of the environment and public health.

30 CFR 810.3 - Authority.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Authority. 810.3 Section 810.3 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PERMANENT PROGRAM... operations performance standards and design requirements applicable under regulatory programs which are at...

77 FR 62216 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-12

...: National Institute of Standards and Technology (NIST). Title: Generic Clearance for Program Evaluation Data... National Institute of Standards and Technology (NIST), a non-regulatory agency of the Department of Commerce, proposes to conduct surveys--both quantitative and qualitative--designed to evaluate our current...

75 FR 81120 - North Dakota Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-27

... North Dakota's program and program amendments at 30 CFR 934.15, 934.16, and 934.30. II. Submission of... proposes revisions to the North Dakota Century Code at Chapter 38-14.1-24(18) (Environmental protection... applications--operation plans--maps and plans) and Article 69-05.2-22-07(2) and (4)(i) (Performance standards...

Comparisons of ANS, ASME, AWS, and NFPA standards cited in the NRC standard review plan, NUREG-0800, and related documents

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

Ankrum, A.R.; Bohlander, K.L.; Gilbert, E.R.

This report provides the results of comparisons of the cited and latest versions of ANS, ASME, AWS and NFPA standards cited in the NRC Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants (NUREG 0800) and related documents. The comparisons were performed by Battelle Pacific Northwest Laboratories in support of the NRC`s Standard Review Plan Update and Development Program. Significant changes to the standards, from the cited version to the latest version, are described and discussed in a tabular format for each standard. Recommendations for updating each citation in the Standard Review Plan are presented.more » Technical considerations and suggested changes are included for related regulatory documents (i.e., Regulatory Guides and the Code of Federal Regulations) citing the standard. The results and recommendations presented in this document have not been subjected to NRC staff review.« less

The DoD Environmental Restoration Program: An Air Force Perspective and Status Update

DTIC Science & Technology

2011-11-01

PFCs of interest Perfluorooctane sulfonate ( PFOS ) Perfluorooctanoic acid ( PFOA ) C8HF17O3S C8HF15O2 I n t e g r i t y - S...Mixtures Change in science/methods Evaluation in progress Perchlorate Lower regulatory standards Continue to monitor PFCs ( PFOS / PFOA ) Regulatory interest...e 25 DoD Activities: PFCs PFOA / PFOS on the DoD Emerging Contaminant Watch List for continued surveillance of regulatory actions SERDP

77 FR 25868 - Iowa Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... and program and 702. exemption for coal extraction incidental to the extraction of other minerals. 27... for coal Part 707. extraction incident to government-- financed highway or other constructions. 27-40... standards--coal preparation plants not located within the permit area of a mine. 27-40.71 (207) State...

76 FR 34815 - Wyoming Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-14

...We are issuing a final decision on an amendment to the Wyoming regulatory program (the ``Wyoming program'') under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or ``the Act''). Our decision approves in part, disapproves in part and defers in part the amendment. Wyoming proposed to amend Chapters 1, 2, 4, 5, and Appendix A of the Land Quality Division (LQD) Coal Rules and Regulations to address required program amendments and other deficiencies identified by OSMRE, and to improve and clarify rules relating to requirements for vegetation measurements and performance standards. Specifically, the proposed changes clarify baseline vegetation requirements and revegetation reclamation plan requirements, clarify revegetation success standards and codify normal husbandry practices, reorganize and clarify species diversity and shrub density requirements, and revise and add definitions supporting those proposed changes. Wyoming also proposed changes to its rules in Chapters 2, 4, and 5 regarding cultural and historic resources, prime farmland, siltation structures and impoundments, and operator information. Wyoming revised its program to be consistent with the corresponding Federal regulations and SMCRA, clarify ambiguities, and improve operational efficiency.

75 FR 1552 - Chemical Facility Anti-Terrorism Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-12

... Protection Agency RMP--Risk Management Program SSP--Site Security Plan STQ--Screening Threshold Quantity SVA... Protection Agency (EPA) under the Clean Air Act's Risk Management Program (RMP) for counting-- or excluding... Safety, Information, Site Security and Fuels Regulatory Relief Act, Public Law 106-40. Cf. 72 FR 65410...

30 CFR 710.12 - Special exemption for small operators.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Special exemption for small operators. 710.12... INTERIOR INITIAL PROGRAM REGULATIONS INITIAL REGULATORY PROGRAM § 710.12 Special exemption for small... the Director a limited exemption from the performance standards of this chapter. The exemption shall...

76 FR 22058 - Reducing Regulatory Burden; Retrospective Review Under Executive Order 13563

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-20

... program data that is common across agencies to be collected once and utilized or redistributed to agency... operating costs by sharing similar data across participating agencies. DATES: Comments and information are... simplify and standardize, to the extent practical, acreage reporting processes, program dates, and data...

Water Quality Standards for Coral Reef Protection | Science ...

EPA Pesticide Factsheets

The U.S. Clean Water Act provides a legal framework to protect coastal biological resources such as coral reefs, mangrove forests, and seagrass meadows from the damaging effects of human activities. Even though many resources are protected under this authority, water quality standards have not been effectively applied to coral reefs. The Environmental Protection Agency is promoting biocriteria and other water quality standards through collaborative development of bioassessment procedures, indicators and monitoring strategies. To support regulatory action, bioassessment indicators must be biologically meaningful, relevant to management, responsive to human disturbance, and relatively immune to natural variability. A rapid bioassessment protocol for reef-building stony corals was developed and tested for regulatory applicability. Preliminary testing in the Florida Keys found indicators had sufficient precision and provided information relevant to coral reef management. Sensitivity to human disturbance was demonstrated in the U.S. Virgin Islands for five of eight indicators tested. Once established, monitoring programs using these indicators can provide valuable, long-term records of coral condition and regulatory compliance. Development of a rapid bioassement protocol for reef-building stony corals was tested for regulatory applicability.

78 FR 42558 - Proposed Revision 0 to Fitness-for-Duty Standard Review Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0149] Proposed Revision 0 to Fitness-for-Duty Standard...: Section 13.7 ``Fitness-for-Duty,'' and Section 13.7.1 ``Fitness-for-Duty--Operational [[Page 42559...), concerning implementation of a Fitness-for- Duty (FFD) program. The current SRP does not contain guidance on...

A Global Review of Incentive Programs to Accelerate Energy-Efficient Appliances and Equipment

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

de la Rue du Can, Stephane; Phadke, Amol; Leventis, Greg

Incentive programs are an essential policy tool to move the market toward energy-efficient products. They offer a favorable complement to mandatory standards and labeling policies by accelerating the market penetration of energy-efficient products above equipment standard requirements and by preparing the market for increased future mandatory requirements. They sway purchase decisions and in some cases production decisions and retail stocking decisions toward energy-efficient products. Incentive programs are structured according to their regulatory environment, the way they are financed, by how the incentive is targeted, and by who administers them. This report categorizes the main elements of incentive programs, using casemore » studies from the Major Economies Forum to illustrate their characteristics. To inform future policy and program design, it seeks to recognize design advantages and disadvantages through a qualitative overview of the variety of programs in use around the globe. Examples range from rebate programs administered by utilities under an Energy-Efficiency Resource Standards (EERS) regulatory framework (California, USA) to the distribution of Eco-Points that reward customers for buying efficient appliances under a government recovery program (Japan). We found that evaluations have demonstrated that financial incentives programs have greater impact when they target highly efficient technologies that have a small market share. We also found that the benefits and drawbacks of different program design aspects depend on the market barriers addressed, the target equipment, and the local market context and that no program design surpasses the others. The key to successful program design and implementation is a thorough understanding of the market and effective identification of the most important local factors hindering the penetration of energy-efficient technologies.« less

EPA Protocol Gas Verification Program

EPA Science Inventory

Accurate compressed gas calibration standards are needed to calibrate continuous emission monitors (CEMs) and ambient air quality monitors that are being used for regulatory purposes. US Environmental Protection Agency (EPA) established its traceability protocol to ensure that co...

Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia.

PubMed

Sneve, M K; Kiselev, M; Shandala, N K

2014-05-01

The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support regulatory analysis of management options. For assessments of the current radiological situation, the types of data needed include information about the distribution of radionuclides in environmental media. For prognostic assessments, additional data are needed about the landscape features, on-shore and off-shore hydrology, geochemical properties of soils and sediments, and possible continuing source terms from continuing operations and on-site disposal. It is anticipated that shared international experience in legacy site characterization can be useful in the next steps. Although the output has been designed to support regulatory evaluation of these particular sites in northwest Russia, the methods and techniques are considered useful examples for application elsewhere, as well as providing relevant input to the International Atomic Energy Agency's international Working Forum for the Regulatory Supervision of Legacy Sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

7 CFR 1726.302 - Notice and publication of listed contract forms.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Utilities Service, Program Development and Regulatory Analysis, U.S. Department of Agriculture, Stop 1522... standard forms of contract are also available on the RUS Web site at: http://www.usda.gov/rus/electric...

Biosafety- A Regulatory Primer for DOE/NNSA Sites

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

Siegel, Dina Mary

2017-05-04

The objectives of a biological safety program, and this are to ensure that work with biological materials are conducted in compliance with applicable biosafety standards and ensure that protection of workers, facilities, the public, and the environment.

75 FR 34499 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... maker/taker pricing program. The text of the proposed rule change is available on the Exchange's Web... qualification standards for market makers to receive a rebate under the Exchange's maker/taker pricing program... trading month for series trading between $0.03 and $5.00 in premium. \\8\\ The concept of incenting market...

Self-Regulation in Broadcasting Revisited.

ERIC Educational Resources Information Center

Linton, Bruce A.

1987-01-01

Discusses the self-regulatory processes of the broadcast industry as related to advertising and programing standards after the elimination of the National Association of Broadcasters (NAB) "Code." Asserts that, even though the code is gone, the process of self-regulation continues. (MM)

REGULATORY METHODS PROGRAM SUPPORT FOR NAAQSS

EPA Science Inventory

This task supports attainment determinations of the National Ambient Air Quality Standards (NAAQS) for particulate matter (PM) in the areas of development, testing, and improvement of new and current PM Federal Reference Methods (FRMs) and Federal Equivalent Methods (FEMs). The ...

Current Status of EPA Protocol Gas Verification Program

EPA Science Inventory

Accurate compressed gas reference standards are needed to calibrate and audit continuous emission monitors (CEMs) and ambient air quality monitors that are being used for regulatory purposes. US Environmental Protection Agency (EPA) established its traceability protocol to ensur...

Potential Implications of Recent and Proposed Changes in the Regulatory Oversight of Solid Organ Transplantation in the United States

PubMed Central

Kasiske, BL; Salkowski, N; Wey, A; Israni, AK; Snyder, JJ

2016-01-01

Every 6 months, the Scientific Registry of Transplant Recipients (SRTR) publishes evaluations of every solid organ transplant program in the US, including evaluations of 1-year patient and graft survival. The Centers for Medicare & Medicaid Services (CMS) and the Organ Procurement and Transplantation Network (OPTN) Membership and Professional Standards Committee (MPSC) use SRTR’s 1-year evaluations for regulatory review of transplant programs. Concern has been growing that the regulatory scrutiny of transplant programs with lower than expected outcomes is harmful, causing programs to undertake fewer high-risk transplants and leading to unnecessary organ discards. As a result, CMS raised its threshold for a “Condition-Level Deficiency” designation of observed relative to expected 1-year graft or patient survival from 1.50 to 1.85. Exceeding this threshold in the current SRTR outcomes report and in one of the four previous reports leads to scrutiny that may result in loss of Medicare funding. For its part, OPTN is reviewing a proposal from the MPSC to also change its performance criteria thresholds for program review, to review programs with “substantive clinical differences.” We review the details and implications of these changes in transplant program oversight. PMID:27401597

Development and implementation of energy efficiency standards and labeling programs in China: Progress and challenges

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

Zhou, Nan; Khanna, Nina Zheng; Fridley, David

Over the last twenty years, with growing policy emphasis on improving energy efficiency and reducing environmental pollution and carbon emissions, China has implemented a series of new minimum energy performance standards (MEPS) and mandatory and voluntary energy labels to improve appliance energy efficiency. As China begins planning for the next phase of standards and labeling (S&L) program development under the 12th Five Year Plan, an evaluation of recent program developments and future directions is needed to identify gaps that still exist when compared with international best practices. The review of China’s S&L program development and implementation in comparison with majormore » findings from international experiences reveal that there are still areas of improvement, particularly when compared to success factors observed across leading international S&L program. China currently lacks a formalized regulatory process for standard-setting and do not have any legal or regulatory guidance on elements of S&L development such as stakeholder participation or the issue of legal precedence between conflicting national, industrial and local standards. Consequently, China’s laws regarding standard-setting and management of the mandatory energy label program could be updated, as they have not been amended or revised recently and no longer reflects the current situation. While China uses similar principles for choosing target products as the U.S., Australia, EU and Japan, including high energy-consumption, mature industry and testing procedure and stakeholder support, recent MEPS revisions have generally aimed at only eliminating the bottom 20% efficiency of the market. Setting a firm principle based on maximizing energy savings that are technically feasible and economically justified may help improve the stringency of China’s MEPS program and reduce the need for frequent revisions. China also lacks robust survey data and relies primarily on market research data in relatively simple techno-economic analyses used to determine its efficiency standards levels rather than the specific sets of analyses and tools used internationally. Based on international experiences, inclusion of more detailed energy consumption surveys in the Chinese national census surveys and statistical reporting systems could help provide the necessary data for more comprehensive standard-setting analyses. In terms of stakeholder participation in the standards development process, stakeholder participation in China is limited to membership on technical committees responsible for developing or revising standards and generally do not include environmental groups, consumer associations, utilities and other NGOs. Increasing stakeholder involvement to broader interest groups could help garner more support and feedback in the S&L implementation process. China has emerged as a leader in a national verification testing scheme with complementary pilot checktesting projects, but it still faces challenges with insufficient funding, low local awareness amongst some regulatory agencies and resistance to check-testing by some manufacturers, limited product sampling scope, and testing inconsistency and incomparability of results. Thus, further financial and staff resources and capacity building will be needed to overcome these remaining challenges and to expand impacts evaluations to assess the actual effectiveness of implementation and enforcement.« less

Renewable Fuel Standard (RFS2): Program Amendments Additional Resources

EPA Pesticide Factsheets

The final rule amends the RFS2 regulations of 40 CFR Part 80 Subpart M to correct regulatory language that was inconsistent or that inadvertently misrepresented EPA’s intent as reflected in the preamble to the final RFS2 regulations.

Priorities for Water Quality Criteria and Standards Programs FY 2017-2018

EPA Pesticide Factsheets

This document recommends priorities for states and authorized tribes as they plan WQS actions and updates in the upcoming two fiscal years. The document addresses new regulatory requirements in 40 CFR part 131 issued in August 2015.

Current Status of EPA Verification Program for EPA Protocol Gases

EPA Science Inventory

Accurate compressed gas calibration standards are needed to calibrate continuous emission monitors (CEMs) and ambient air quality monitors that are being used for regulatory purposes. US Environmental Protection Agency (EPA) established its traceability protocol to ensure that c...

EPA Protocol Gas Verification Program - Presented at NIST Gas Panel Meeting

EPA Science Inventory

Accurate compressed gas calibration standards are needed to calibrate continuous emission monitors (CEMs) and ambient air quality monitors that are being used for regulatory purposes. US Environmental Protection Agency (EPA) established its traceability protocol to ensure that c...

75 FR 74151 - Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

...EPA and NHTSA, on behalf of the Department of Transportation, are each proposing rules to establish a comprehensive Heavy-Duty National Program that will reduce greenhouse gas emissions and increase fuel efficiency for on-road heavy-duty vehicles, responding to the President's directive on May 21, 2010, to take coordinated steps to produce a new generation of clean vehicles. NHTSA's proposed fuel consumption standards and EPA's proposed carbon dioxide (CO2) emissions standards would be tailored to each of three regulatory categories of heavy-duty vehicles: Combination Tractors; Heavy-Duty Pickup Trucks and Vans; and Vocational Vehicles, as well as gasoline and diesel heavy-duty engines. EPA's proposed hydrofluorocarbon emissions standards would apply to air conditioning systems in tractors, pickup trucks, and vans, and EPA's proposed nitrous oxide (N2O) and methane (CH4) emissions standards would apply to all heavy-duty engines, pickup trucks, and vans. EPA is also requesting comment on possible alternative CO2-equivalent approaches for model year 2012-14 light-duty vehicles. EPA's proposed greenhouse gas emission standards under the Clean Air Act would begin with model year 2014. NHTSA's proposed fuel consumption standards under the Energy Independence and Security Act of 2007 would be voluntary in model years 2014 and 2015, becoming mandatory with model year 2016 for most regulatory categories. Commercial trailers would not be regulated in this phase of the Heavy- Duty National Program, although there is a discussion of the possibility of future action for trailers.

Medical research misconduct need regulatory reforms.

PubMed

Bedi, Neeraj

2014-10-01

The medical research misconduct has become a global problem. Except from countries like the USA, China, and Germany the exact figures of misconduct are not available. The research misconduct include fabricating the data, falsifying data, and plagiarism. The irresponsible research practices are publishing research data more than once, conflicts of interest is not declared, selective reporting of data and including an author who has not contributed at all and many more. About 2% of scientists have been found to admit the fabricating the data and 33% researchers were involved in irresponsible research practices. There is no formal regulatory programs available to monitor the research projects. Few developed countries like the USA, Germany, and China tried to develop programs which can monitor the medical research misconduct. There is a need to develop a regulatory system at national and institutional level to regulate the research activity to ensure that good ethical and scientific standards are practiced by medical researchers.

41 CFR 60-741.24 - Drugs and alcohol.

Code of Federal Regulations, 2012 CFR

2012-07-01

... with the standards established in the regulations (if any) of the Departments of Defense and... regulations (if any) of the Departments of Defense and Transportation, and of the Nuclear Regulatory... Contracts OFFICE OF FEDERAL CONTRACT COMPLIANCE PROGRAMS, EQUAL EMPLOYMENT OPPORTUNITY, DEPARTMENT OF LABOR...

Probability of identifying different salmonella serotypes in poultry samples

USDA-ARS?s Scientific Manuscript database

Recent work has called attention to the unequal competitive abilities of different Salmonella serotypes in standard broth culture and plating media. Such serotypes include Enteritidis and Typhimurium that are specifically targeted in some regulatory and certification programs because they cause a l...

48 CFR 2030.201-5 - Waiver.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Waiver. 2030.201-5 Section 2030.201-5 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL CONTRACTING REQUIREMENTS COST ACCOUNTING STANDARDS CAS Program Requirements 2030.201-5 Waiver. Requests to waive Cost...

Application of Microprocessor-Based Equipment in Nuclear Power Plants - Technical Basis for a Qualification Methodology

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

Korsah, K.

This document (1) summarizes the most significant findings of the ''Qualification of Advanced Instrumentation and Control (I&C) Systems'' program initiated by the Nuclear Regulatory Commission (NRC); (2) documents a comparative analysis of U.S. and European qualification standards; and (3) provides recommendations for enhancing regulatory guidance for environmental qualification of microprocessor-based safety-related systems. Safety-related I&C system upgrades of present-day nuclear power plants, as well as I&C systems of Advanced Light-Water Reactors (ALWRs), are expected to make increasing use of microprocessor-based technology. The Nuclear Regulatory Commission (NRC) recognized that the use of such technology may pose environmental qualification challenges different from current,more » analog-based I&C systems. Hence, it initiated the ''Qualification of Advanced Instrumentation and Control Systems'' program. The objectives of this confirmatory research project are to (1) identify any unique environmental-stress-related failure modes posed by digital technologies and their potential impact on the safety systems and (2) develop the technical basis for regulatory guidance using these findings. Previous findings from this study have been documented in several technical reports. This final report in the series documents a comparative analysis of two environmental qualification standards--Institute of Electrical and Electronics Engineers (IEEE) Std 323-1983 and International Electrotechnical Commission (IEC) 60780 (1998)--and provides recommendations for environmental qualification of microprocessor-based systems based on this analysis as well as on the findings documented in the previous reports. The two standards were chosen for this analysis because IEEE 323 is the standard used in the U.S. for the qualification of safety-related equipment in nuclear power plants, and IEC 60780 is its European counterpart. In addition, the IEC document was published in 1998, and should reflect any new qualification concerns, from the European perspective, with regard to the use of microprocessor-based safety systems in power plants.« less

Leak-Before-Break: Further developments in regulatory policies and supporting research

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

Wilkowski, G.M.; Chao, K.-S.

1990-02-01

The fourth in a series of international Leak-Before-Break (LBB) Seminars supported in part by the US Nuclear Regulatory Commission was held at the National Central Library in Taipei, Taiwan on May 11 and 12, 1989. The seminar updated the international polices and supporting research on LBB. Attendees included representatives from regulatory agencies, electric utilities, nuclear power plant fabricators, research organizations, and academic institutions. Regulatory policy was the subject of presentations by Mr. G. Arlotto (US NRC, USA) Dr. B. Jarman (AECB, Canada), Dr.P. Milella (ENEA-DISP, Italy), Dr. C. Faidy (EDF/Septen, France ), and Dr. K. Takumi (NUPEC, Japan). A papermore » by Mr. K. Wichman and Mr. A. Lee of the US NRC Office of Nuclear Reactor Regulation is included as background material to these proceedings; it discusses the history and status of LBB applications in US nuclear power plants. In addition, several papers on the supporting research programs described regulatory policy or industry standards for flaw evaluations, e.g., the ASME Section XI code procedures. Supporting research programs were reviewed on the first and second day by several participants from Taiwan, US, Japan, Canada, Italy, and France. Each individual paper has been cataloged separately.« less

41 CFR 60-250.24 - Drugs and alcohol.

Code of Federal Regulations, 2012 CFR

2012-07-01

... standards established in the regulations (if any) of the Departments of Defense and Transportation, and of... (if any) of the Departments of Defense and Transportation, and of the Nuclear Regulatory Commission... Contracts OFFICE OF FEDERAL CONTRACT COMPLIANCE PROGRAMS, EQUAL EMPLOYMENT OPPORTUNITY, DEPARTMENT OF LABOR...

41 CFR 60-300.24 - Drugs and alcohol.

Code of Federal Regulations, 2012 CFR

2012-07-01

... standards established in the regulations (if any) of the Departments of Defense and Transportation, and of... (if any) of the Departments of Defense and Transportation, and of the Nuclear Regulatory Commission... Contracts OFFICE OF FEDERAL CONTRACT COMPLIANCE PROGRAMS, EQUAL EMPLOYMENT OPPORTUNITY, DEPARTMENT OF LABOR...

Regional forestry practices and forest management certification

Treesearch

Steverson O. Moffat; Frederick W. Cubbage; Matthew H. Pelkki

2001-01-01

Under a "mandated" management scenario, landowners in states with comprehensive forest practices laws meet more sustainable forestry standards and certification programs' guidelines than do owners in states with other regulatory approaches. This confers certification advantages to landowners in the Pacific Northwest where comprehensive forest laws...

10 CFR 26.1 - Purpose.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Purpose. 26.1 Section 26.1 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.1 Purpose. This part prescribes requirements and standards for the establishment, implementation, and maintenance of fitness-for-duty (FFD...

10 CFR 26.1 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Purpose. 26.1 Section 26.1 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.1 Purpose. This part prescribes requirements and standards for the establishment, implementation, and maintenance of fitness-for-duty (FFD...

10 CFR 26.1 - Purpose.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Purpose. 26.1 Section 26.1 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.1 Purpose. This part prescribes requirements and standards for the establishment, implementation, and maintenance of fitness-for-duty (FFD...

10 CFR 26.1 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Purpose. 26.1 Section 26.1 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.1 Purpose. This part prescribes requirements and standards for the establishment, implementation, and maintenance of fitness-for-duty (FFD...

10 CFR 26.1 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Purpose. 26.1 Section 26.1 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.1 Purpose. This part prescribes requirements and standards for the establishment, implementation, and maintenance of fitness-for-duty (FFD...

Stepping Stones To Using "Caring for Our Children": National Health and Safety Performance Standards for Out-of-Home Child Care Programs. Protecting Children from Harm.

ERIC Educational Resources Information Center

Colorado Univ. Health Sciences Center, Denver.

Developed in support of state licensing and regulatory agencies as well as state child care, health, and resource and referral agencies, and a variety of other public and private organizations, parents, and advocacy groups, this guide identifies those standards most needed for the prevention of injury, morbidity, and mortality in child care…

STANDARD EVALUATION PROCEDURES FOR SUBMITTED DEVELOPMENTAL NEUROTOXICITY DATA

EPA Science Inventory

As a NAFTA-inspired multi-governmental initiative, experts from the US EPA (Office of Research and Development, Office of Pesticide Program, or OPP) and the PMRA (Pest Management Regulatory Agency) of Health Canada formed a working group to create a document that would serve as a...

Technical approach to groundwater restoration. Final report

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

Not Available

1993-11-01

The Technical Approach to Groundwater Restoration (TAGR) provides general technical guidance to implement the groundwater restoration phase of the Uranium Mill Tailings Remedial Action (UMTRA) Project. The TAGR includes a brief overview of the surface remediation and groundwater restoration phases of the UMTRA Project and describes the regulatory requirements, the National Environmental Policy Act (NEPA) process, and regulatory compliance. A section on program strategy discusses program optimization, the role of risk assessment, the observational approach, strategies for meeting groundwater cleanup standards, and remedial action decision-making. A section on data requirements for groundwater restoration evaluates the data quality objectives (DQO) andmore » minimum data required to implement the options and comply with the standards. A section on sits implementation explores the development of a conceptual site model, approaches to site characterization, development of remedial action alternatives, selection of the groundwater restoration method, and remedial design and implementation in the context of site-specific documentation in the site observational work plan (SOWP) and the remedial action plan (RAP). Finally, the TAGR elaborates on groundwater monitoring necessary to evaluate compliance with the groundwater cleanup standards and protection of human health and the environment, and outlines licensing procedures.« less

78 FR 12252 - Energy Efficiency Program for Commercial and Industrial Equipment: Public Meeting and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-22

... parties. DOE is planning to conduct in-depth technical analyses in the following areas: (1) Engineering..., analyses, and processes it anticipates using to determine whether to amend energy conservation standards... impacts, and (10) regulatory impacts. DOE will also conduct several other analyses that support those...

Consultation: Professional Learning Framework for the Teaching Profession.

ERIC Educational Resources Information Center

Ontario College of Teachers, Toronto.

This publication describes the professional learning framework for teaching that was developed by the Ontario College of Teachers, a self-regulatory body for the teaching profession in Ontario. The Ontario College of Teachers has a mandate, in legislation, to identify and accredit professional learning programs that support standards of practice…

76 FR 53529 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

... intention to request the Office of Management and Budget (OMB) approval for to renew an information... collected allows the FAA to evaluate its certification standards, maintenance programs, and regulatory... of Management and Budget. Comments should be addressed to the attention of the Desk Officer...

India's growing participation in global clinical trials.

PubMed

Gupta, Yogendra K; Padhy, Biswa M

2011-06-01

Lower operational costs, recent regulatory reforms and several logistic advantages make India an attractive destination for conducting clinical trials. Efforts for maintaining stringent ethical standards and the launch of Pharmacovigilance Program of India are expected to maximize the potential of the country for clinical research. Copyright © 2011. Published by Elsevier Ltd.

An Overview of Exposure Assessment Models Used by the U.S. Environmental Protection Agency

EPA Science Inventory

Models are often used in addition to or in lieu of monitoring data to estimate environmental concentrations and exposures for use in risk assessments or epidemiological studies, and to support regulatory standards and voluntary programs (Jayjock et al., 2007; US EPA, 1989, 1992)....

Extending Safety Culture Development through Communication - 12366

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

Sneve, M.K.; Kiselev, M.; Shandala, N.K.

2012-07-01

The Norwegian Radiation Protection Authority has been implementing a regulatory support program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective is the enhancement of safety culture. The project outputs have included appropriate regulatory threat assessments, to determine the hazardous activities which are most in need of enhanced regulatory supervision; and development of the norms, standards and regulatory procedures, necessary to address the often abnormal conditions at nuclear legacy sites. Project outputs have been prepared and subsequently confirmed asmore » official regulatory documents of the Russian Federation. The continuing program of work focuses on practical application of the enhanced regulatory framework as applied to legacy sites, including safe management of radioactive wastes arising in the process of site remediation. One of the lessons learnt from this practical application is the importance of effective communication at all levels: - between managers and shop workers; - between different operators - e.g. waste producers and waste disposal organisations; - between operators and regulators; - between nuclear safety regulators, radiation protection regulators and other pollution and safety regulators; - between scientists, policy makers and wider stakeholders; and - between all of those mentioned above. A key message from this work is that it is not just an issue of risk communication; rather all aspects of communication can contribute to safety culture enhancement to support effective and efficient risk management, including the role of regulatory supervision. (authors)« less

Implementation of the fugitive emissions system program: The OxyChem experience

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

Deshmukh, A.

An overview is provided for the Fugitive Emissions System (FES) that has been implemented at Occidental Chemical in conjunction with the computer-based maintenance system called PassPort{reg_sign} developed by Indus Corporation. The goal of PassPort{reg_sign} FES program has been to interface with facilities data, equipment information, work standards and work orders. Along the way, several implementation hurdles had to be overcome before a monitoring and regulatory system could be standardized for the appropriate maintenance, process and environmental groups. This presentation includes step-by-step account of several case studies that developed during the implementation of the FES system.

Exercising Impacts on Fatigue, Depression, and Paresthesia in Female Patients with Multiple Sclerosis.

PubMed

Razazian, Nazanin; Yavari, Zeinab; Farnia, Vahid; Azizi, Akram; Kordavani, Laleh; Bahmani, Dena Sadeghi; Holsboer-Trachsler, Edith; Brand, Serge

2016-05-01

Multiple sclerosis (MS) is a chronic progressive autoimmune disease impacting both body and mind. Typically, patients with MS report fatigue, depression, and paresthesia. Standard treatment consists of immune modulatory medication, though there is growing evidence that exercising programs have a positive influence on fatigue and psychological symptoms such as depression. We tested the hypothesis that, in addition to the standard immune regulatory medication, either yoga or aquatic exercise can ameliorate both fatigue and depression, and we examined whether these interventions also influence paresthesia compared with a nonexercise control condition. Fifty-four women with MS (mean age: M = 33.94 yr, SD = 6.92) were randomly assigned to one of the following conditions: yoga, aquatic exercise, or nonexercise control. Their existing immune modulatory therapy remained unchanged. Participants completed questionnaires covering symptoms of fatigue, depression, and paresthesia, both at baseline and on completion of the study 8 wk later. Compared with the nonexercise control condition and over time, fatigue, depression, and paresthesia decreased significantly in the yoga and aquatic exercise groups. On study completion, the likelihood of reporting moderate to severe depression was 35-fold higher in the nonexercise control condition than in the intervention conditions (yoga and aquatic exercising values collapsed). The pattern of results suggests that for females with MS and treated with standard immune regulatory medication, exercise training programs such as yoga and aquatic exercising positively impact on core symptoms of MS, namely, fatigue, depression, and paresthesia. Exercise training programs should be considered in the future as possible complements to standard treatments.

76 FR 57105 - Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-15

...EPA and NHTSA, on behalf of the Department of Transportation, are each finalizing rules to establish a comprehensive Heavy-Duty National Program that will reduce greenhouse gas emissions and fuel consumption for on-road heavy-duty vehicles, responding to the President's directive on May 21, 2010, to take coordinated steps to produce a new generation of clean vehicles. NHTSA's final fuel consumption standards and EPA's final carbon dioxide (CO2) emissions standards are tailored to each of three regulatory categories of heavy-duty vehicles: Combination Tractors; Heavy-duty Pickup Trucks and Vans; and Vocational Vehicles. The rules include separate standards for the engines that power combination tractors and vocational vehicles. Certain rules are exclusive to the EPA program. These include EPA's final hydrofluorocarbon standards to control leakage from air conditioning systems in combination tractors, and pickup trucks and vans. These also include EPA's final nitrous oxide (N2O) and methane (CH4) emissions standards that apply to all heavy- duty engines, pickup trucks and vans. EPA's final greenhouse gas emission standards under the Clean Air Act will begin with model year 2014. NHTSA's final fuel consumption standards under the Energy Independence and Security Act of 2007 will be voluntary in model years 2014 and 2015, becoming mandatory with model year 2016 for most regulatory categories. Commercial trailers are not regulated in this phase of the Heavy-Duty National Program. The agencies estimate that the combined standards will reduce CO2 emissions by approximately 270 million metric tons and save 530 million barrels of oil over the life of vehicles sold during the 2014 through 2018 model years, providing over $7 billion in net societal benefits, and $49 billion in net societal benefits when private fuel savings are considered. EPA is also finalizing provisions allowing light-duty vehicle manufacturers to use CO2 credits to meet the light-duty vehicle N2O and CH4 standards, technical amendments to the fuel economy provisions for light-duty vehicles, and a technical amendment to the criteria pollutant emissions requirements for certain switch locomotives.

Self-assessment of public health essential services among Illinois local health department administrators.

PubMed

Polyak, Georgeen; Madamala, Kusuma; Vasireddy, Vamsi; Landrum, Laura B; Bassler, Elissa J; Stob, Nicole J

2010-01-01

This article uses data from a study commissioned by the Illinois Public Health Institute in 2007 as part of the Robert Wood Johnson Foundation Multistate Learning Collaborative Grant for exploring accreditation of health departments. Local health departments in Illinois were surveyed on their self-assessed performance in meeting a set of performance standards derived from the Illinois Practice Standards and the Operational Definition of a Functional Local Health Department. All state-certified local health departments were represented in the survey by the 81 respondents. The lowest scores were observed in the evaluate standard (evaluate programs and provide quality assurance in accordance with applicable professional and regulatory standards to ensure that programs are consistent with plans and policies, and provide feedback on inadequacies and changes needed to redirect programs and resources). The findings suggest that new approaches are needed to better integrate evaluation in local health departments beginning with training designed specifically for and informed by local health department administrators.

36 CFR 1234.20 - What rules apply if there is a conflict between NARA standards and other regulatory standards...

Code of Federal Regulations, 2010 CFR

2010-07-01

... a conflict between NARA standards and other regulatory standards that a facility must follow? 1234... Facility Standards § 1234.20 What rules apply if there is a conflict between NARA standards and other regulatory standards that a facility must follow? (a) If any provisions of this part conflict with local or...

75 FR 70679 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-18

... ``Manufactured Food Regulatory Program Standards'' has been approved by the Office of Management and Budget (OMB... Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0554...

77 FR 75173 - Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

... performing the technical analysis, management assessment, and program evaluation tasks required to address... premarket reviews that meet regulatory review standards. 2. Analysis of elements of the review process... process. This includes analysis of root causes for inefficiencies that may affect review performance and...

The OSHA Communication Standard and State Right-to-Know Laws.

ERIC Educational Resources Information Center

Roll, Michalene H.

1990-01-01

As a result of a 1988 federal appellate court mandate, schools and colleges in 24 states and 2 territories with OSHA-approved state plans must inform their employees about hazardous chemicals to which they may be exposed. School administrators should implement a responsible program meeting regulatory compliance, tort liability, and public…

Federal/State Regulatory Reform, Cost Allocation, and CATV/TELCO Distance Learning Initiatives in Connecticut.

ERIC Educational Resources Information Center

Pietras, Jesse John; Murphy, Robert J.

Distance learning in Connecticut has begun to develop in the wake of telecommunications (TELCO) infrastructure modernization. Progress in this area is reviewed and discussed. The state has not yet adopted a standardized statewide policy governing the delivery of educational telecommunications programing, and various private producers currently…

The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.

PubMed

Wallach, Joshua D; Ross, Joseph S; Naci, Huseyin

2018-06-01

The US Food and Drug Administration has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs is the regulatory flexibility, which allows for a customized approval approach that enables market authorization on the basis of less rigorous evidence, in exchange for requiring postmarket evidence generation. An increasing share of therapeutic agents approved by the Food and Drug Administration in recent years are associated with expedited programs. In this article, we provide an overview of the evidentiary standards required by the Food and Drug Administration's expedited development and review programs, summarize the findings of the recent academic literature demonstrating some of the limitations of these programs, and outline potential opportunities to address these limitations. Recent evidence suggests that therapeutic agents in the Food and Drug Administration's expedited programs are approved on the basis of fewer and smaller studies that may lack comparator groups and random allocation, and rather than focusing on clinical outcomes for study endpoints, rely instead on surrogate markers of disease. Once on the market, agents receiving expedited approvals are often quickly incorporated into clinical practice, and evidence generated in the postmarket period may not necessarily address the evidentiary limitations at the time of market entry. Furthermore, not all pathways require additional postmarket studies. Evidence suggests that drugs in expedited approval programs are associated with a greater likelihood that the Food and Drug Administration will take a safety action following market entry. There are several opportunities to improve the timeliness, information value, and validity of the pre- and postmarket studies of therapeutic agents receiving expedited approvals. When use of nonrandomized and uncontrolled studies cannot be avoided prior to market entry, randomized trials should be mandatory in the postmarket period, unless there are strong justifications for not carrying out such studies. In the premarket period, validity of the surrogate markers can be improved by more rigorously evaluating their correlation with patient-relevant clinical outcomes. Opportunities to reduce the duration, complexity, and cost of postmarket randomized trials should not compromise their validity and instead incorporate pragmatic "real-world" design elements. Despite recent enthusiasm for widely using real-world evidence, adaptive designs, and pragmatic trials in the regulatory setting, caution is warranted until large-scale empirical evaluations demonstrate their validity compared to more traditional trial designs.

30 CFR 761.16 - Submission and processing of requests for valid existing rights determinations.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) Requirements for property rights demonstration. You must provide a property rights demonstration under... matter Regulatory authority Regulatory program 2 (d) Public roads Does not matter Regulatory authority Regulatory program 2 (e) Occupied dwellings Does not matter Regulatory authority Regulatory program 2 (f...

KWOC (Key-Word-Out-of-Context) Index of US Nuclear Regulatory Commission Regulatory Guide Series

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

Jennings, S.D.

1990-04-01

To meet the objectives of the program funded by the Department of Energy (DOE)-Nuclear Energy (NE) Technology Support Programs, the Performance Assurance Project Office (PAPO) administers a Performance Assurance Information Program that collects, compiles, and distributes program-related information, reports, and publications for the benefit of the DOE-NE program participants. THE KWOC Index of US Nuclear Regulatory Commission Regulatory Guide Series'' is prepared as an aid in searching for specific topics in the US Nuclear Regulatory Commission, Regulatory Guide Series.

7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 11 2014-01-01 2014-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program Accounting and Regulatory Analysis. RUS, through Program Accounting and Regulatory Analysis, monitors and...

7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 11 2013-01-01 2013-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program Accounting and Regulatory Analysis. RUS, through Program Accounting and Regulatory Analysis, monitors and...

77 FR 33253 - Regulatory Guide 8.33, Quality Management Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-05

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0126] Regulatory Guide 8.33, Quality Management Program... Regulatory Commission (NRC or Commission) is withdrawing Regulatory Guide (RG) 8.33, ``Quality Management... Quality Management Program was deleted from the regulations as part of an overall revision in 2002 of the...

7 CFR 371.5 - Marketing and Regulatory Programs Business Services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 5 2010-01-01 2010-01-01 false Marketing and Regulatory Programs Business Services... AUTHORITY § 371.5 Marketing and Regulatory Programs Business Services. (a) General statement. Marketing and Regulatory Programs Business Services (MRPBS) plans and provides for the agency's human, financial, and...

Developing regulatory programs for the control of acid precipitation

Treesearch

Michael A. Berry; John D. Bachmann

1976-01-01

The U.S. Clean Air Act provides mechanisms by which the public welfare may be protected from "any known or anticipated adverse effects associated with the presence of (an) air pollutant in the ambient air." The history of the U.S. Environment Protection Agency's (EPA) efforts to establish and defend a secondary ambient air quality standard for sulfur...

34 CFR Appendix B to Subpart B of... - Appendix I, Standards for Audit of Governmental Organizations, Programs, Activities, and...

Code of Federal Regulations, 2011 CFR

2011-07-01

... accountants should be employed. The type of qualifications, as stated by the Comptroller General, deemed... shall be conducted * * * by independent certified public accountants or by independent licensed public accountants, licensed on or before December 31, 1970, who are certified or licensed by a regulatory authority...

RCRA, superfund and EPCRA hotline training module. Introduction to: Municipal solid waste disposal facility criteria updated July 1996

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

NONE

1996-07-01

The module provides a summary of the regulatory criteria for municipal solid waste landfills (MSWLFs) and provides the statutory authority under RCRA and the Clean Water Act (CWA) directing EPA to develop the MSWLF criteria in 40 CFR Part 258. It gives the part 258 effective date and the compliance dates for providing demonstrations to satisfy individual regulatory requirements. It identifies the types of facilities that qualify for the small landfill exemption. It explains the requirements of each subpart of part 258 as they apply to states with EPA-approved MSWLF permit programs and states without approved permit programs. It comparesmore » the MSWLF environmental performance standards described in part 258 to the corresponding requirements for hazardous waste TSDFs in part 264, which are generally more stringent.« less

Failure of the public health testing program for ballast water treatment systems.

PubMed

Cohen, Andrew N; Dobbs, Fred C

2015-02-15

Since 2004, an international testing program has certified 53 shipboard treatment systems as meeting ballast water discharge standards, including limits on certain microbes to prevent the spread of human pathogens. We determined how frequently certification tests failed a minimum requirement for a meaningful evaluation, that the concentration of microbes in the untreated (control) discharge must exceed the regulatory limit for treated discharges. In 95% of cases where the result was accepted as evidence that the treatment system reduced microbes to below the regulatory limit, the discharge met the limit even without treatment. This shows that the certification program for ballast water treatment systems is dysfunctional in protecting human health. In nearly all cases, the treatment systems would have equally well "passed" these tests even if they had never been turned on. Protocols must require minimum concentrations of targeted microbes in test waters, reflecting the upper range of concentrations in waters where ships operate. Copyright © 2014 Elsevier Ltd. All rights reserved.

78 FR 77538 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-23

... (c), Rule 1034 and Rule 1038 do not apply to orders placed in the cabinet. Cabinet transactions are... Exchange filed an immediately effective proposal that extended the pilot program until December 1, 2012.\\10... procedures were limited to options classes traded in $0.05 or $0.10 standard increments. The $1 cabinet...

78 FR 70905 - Extension of Comment Period for the Water Quality Standards Regulatory Clarifications Proposed Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-27

... Comment Period for the Water Quality Standards Regulatory Clarifications Proposed Rule AGENCY... Environmental Protection Agency (EPA) is extending the comment period for the proposed rule ``Water Quality... published the proposed rule ``Water Quality Standards Regulatory Clarifications'' in the Federal Register...

75 FR 34962 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-154-FOR; OSM 2010-0002] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Pennsylvania regulatory program (the ``Pennsylvania program'') under the Surface Mining Control...

The use of Minilabs to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience.

PubMed

Risha, Peter Gasper; Msuya, Zera; Clark, Malcolm; Johnson, Keith; Ndomondo-Sigonda, Margareth; Layloff, Thomas

2008-08-01

The Tanzania Food and Drugs Authority piloted the use of Minilab kits, a thin-layer-chromatographic based drug quality testing technique, in a two-tier quality assurance program. The program is intended to improve testing capacity with timely screening of the quality of medicines as they enter the market. After 1 week training of inspectors on Minilab screening techniques, they were stationed at key Ports-of-Entry (POE) to screen the quality of imported medicines. In addition, three non-Ports-of-Entry centres were established to screen samples collected during Post-Marketing-Surveillance. Standard operating procedures (SOPs) were developed to structure and standardize the implementation process. Over 1200 samples were tested using the Minilab outside the central quality control laboratory (QCL), almost doubling the previous testing capacity. The program contributed to increased regulatory reach and visibility of the Authority throughout the country, serving as a deterrent against entry of substandard medicines into market. The use of Minilab for quality screening was inexpensive and provided a high sample throughput. However, it suffers from the limitation that it can reliably detect only grossly substandard or wrong drug samples and therefore, it should not be used as an independent testing resource but in conjunction with a full-service quality control laboratory capable of auditing reported substandard results.

76 FR 16714 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-160-FOR; OSM 2010-0019] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... Pennsylvania regulatory program (the ``Pennsylvania program'') under the Surface Mining Control and Reclamation...

[Oral and maxillofacial surgery residency training in the United States: what can we learn].

PubMed

Ren, Y F

2017-04-09

China is currently in the process of establishing formal residency training programs in oral and maxillofacial surgery and other medical and dental specialties. Regulatory agencies, and educational and academic institutions in China are exploring mechanisms, goals and standards of residency training that meet the needs of the Chinese healthcare system. This article provides an introduction of residency training in oral and maxillofacial surgery in the United States, with emphasis on the accreditation standard by the Commission on Dental Accreditation. As there are fundamental differences in the medical and dental education systems between China and United States, the training standards in the United States may not be entirely applicable in China. A competency-based training model that focus on overall competencies in medical knowledge, clinical skills and values at the time of graduation should be taken into consideration in a Chinese residency training program in oral and maxillofacial surgery.

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study.

PubMed

Hoppe, Christian; Obermeier, Patrick; Muehlhans, Susann; Alchikh, Maren; Seeber, Lea; Tief, Franziska; Karsch, Katharina; Chen, Xi; Boettcher, Sindy; Diedrich, Sabine; Conrad, Tim; Kisler, Bron; Rath, Barbara

2016-10-01

Regulatory authorities often receive poorly structured safety reports requiring considerable effort to investigate potential adverse events post hoc. Automated question-and-answer systems may help to improve the overall quality of safety information transmitted to pharmacovigilance agencies. This paper explores the use of the VACC-Tool (ViVI Automated Case Classification Tool) 2.0, a mobile application enabling physicians to classify clinical cases according to 14 pre-defined case definitions for neuroinflammatory adverse events (NIAE) and in full compliance with data standards issued by the Clinical Data Interchange Standards Consortium. The validation of the VACC-Tool 2.0 (beta-version) was conducted in the context of a unique quality management program for children with suspected NIAE in collaboration with the Robert Koch Institute in Berlin, Germany. The VACC-Tool was used for instant case classification and for longitudinal follow-up throughout the course of hospitalization. Results were compared to International Classification of Diseases , Tenth Revision (ICD-10) codes assigned in the emergency department (ED). From 07/2013 to 10/2014, a total of 34,368 patients were seen in the ED, and 5243 patients were hospitalized; 243 of these were admitted for suspected NIAE (mean age: 8.5 years), thus participating in the quality management program. Using the VACC-Tool in the ED, 209 cases were classified successfully, 69 % of which had been missed or miscoded in the ED reports. Longitudinal follow-up with the VACC-Tool identified additional NIAE. Mobile applications are taking data standards to the point of care, enabling clinicians to ascertain potential adverse events in the ED setting and during inpatient follow-up. Compliance with Clinical Data Interchange Standards Consortium (CDISC) data standards facilitates data interoperability according to regulatory requirements.

75 FR 60375 - Utah Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944 [SATS No. UT-047-FOR; Docket ID OSM-2010-0012] Utah Regulatory Program AGENCY: Office of Surface Mining... amendment to the Utah regulatory program (hereinafter, the ``Utah program'') under the Surface Mining...

30 CFR 948.12 - State statutory, regulatory, and proposed program amendment provisions not approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) CSR 38-2-24.4, which concerns water quality standards for bond release. (b) We are not approving the... bond release where the quality of the untreated postmining water discharged is better than or equal to the premining water quality discharged from the mining site. (2) At CSR 38-2-7.4.b.1.C.5., the phrase...

77 FR 68871 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

... this Rule. Also, the provisions of Rule 1033(b) and (c), Rule 1034 and Rule 1038 do not apply to orders... effective proposal that extended the pilot program until December 1, 2012.\\10\\ The Exchange now proposes an... trading procedures were limited to options classes traded in $0.05 or $0.10 standard increments. The $1...

77 FR 68876 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

... this Rule. Also, the provisions of Rule 1033(b) and (c), Rule 1034 and Rule 1038 do not apply to orders... effective proposal that extended the pilot program until December 1, 2012.\\10\\ The Exchange now proposes an... trading procedures were limited to options classes traded in $0.05 or $0.10 standard increments. The $1...

30 CFR 948.12 - State statutory, regulatory, and proposed program amendment provisions not approved.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) CSR 38-2-24.4, which concerns water quality standards for bond release. (b) We are not approving the... bond release where the quality of the untreated postmining water discharged is better than or equal to the premining water quality discharged from the mining site. (2) At CSR 38-2-7.4.b.1.C.5., the phrase...

77 FR 8185 - Ohio Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 [SATS No. OH-252-FOR; Docket ID OSM 2011-0003] Ohio Regulatory Program AGENCY: Office of Surface Mining... amendment to the Ohio regulatory program (the ``Ohio program'') under the Surface Mining Control and...

78 FR 63911 - Montana Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926...; S2D2SSS08011000 SX066A00033 F13XS501520] Montana Regulatory Program AGENCY: Office of Surface Mining Reclamation... regulatory program (hereinafter, the ``Montana program'') under the Surface Mining Control and Reclamation...

77 FR 4461 - New Mexico Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-30

... [SATS No. NM-048-FOR; Docket ID OSM-2010-0014] New Mexico Regulatory Program AGENCY: Office of Surface... approving an amendment to the New Mexico regulatory program (the ``New Mexico program'') under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or ``the Act''). New Mexico proposed non...

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.

Challenges in Developing Competency-based Training Curriculum for Food Safety Regulators in India.

PubMed

Thippaiah, Anitha; Allagh, Komal Preet; Murthy, G V

2014-07-01

The Food Safety and Standards Act have redefined the roles and responsibilities of food regulatory workforce and calls for highly skilled human resources as it involves complex management procedures. 1) Identify the competencies needed among the food regulatory workforce in India. 2) Develop a competency-based training curriculum for food safety regulators in the country. 3) Develop training materials for use to train the food regulatory workforce. The Indian Institute of Public Health, Hyderabad, led the development of training curriculum on food safety with technical assistance from the Royal Society for Public Health, UK and the National Institute of Nutrition, India. The exercise was to facilitate the implementation of new Act by undertaking capacity building through a comprehensive training program. A competency-based training needs assessment was conducted before undertaking the development of the training materials. THE TRAINING PROGRAM FOR FOOD SAFETY OFFICERS WAS DESIGNED TO COMPRISE OF FIVE MODULES TO INCLUDE: Food science and technology, Food safety management systems, Food safety legislation, Enforcement of food safety regulations, and Administrative functions. Each module has a facilitator guide for the tutor and a handbook for the participant. Essentials of Food Hygiene-I (Basic level), II and III (Retail/ Catering/ Manufacturing) were primarily designed for training of food handlers and are part of essential reading for food safety regulators. The Food Safety and Standards Act calls for highly skilled human resources as it involves complex management procedures. Despite having developed a comprehensive competency-based training curriculum by joint efforts by the local, national, and international agencies, implementation remains a challenge in resource-limited setting.

30 CFR 735.14 - Coverage of grants.

Code of Federal Regulations, 2010 CFR

2010-07-01

... other personnel; (4) New or revised organizational structures; (5) Information and communications... approved State regulatory program; (2) Providing supporting and administrative services required by the State regulatory program; (3) Providing equipment required for the regulatory program and its support...

Measure in the ESRD QIP for PY 2020. Final rule.

PubMed

2017-08-04

This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018. It also revises and rebases the market basket index by updating the base year from 2010 to 2014, and by adding a new cost category for Installation, Maintenance, and Repair Services. The rule also finalizes revisions to the SNF Quality Reporting Program (QRP), including measure and standardized resident assessment data policies and policies related to public display. In addition, it finalizes policies for the Skilled Nursing Facility Value-Based Purchasing Program that will affect Medicare payment to SNFs beginning in FY 2019. The final rule also clarifies the regulatory requirements for team composition for surveys conducted for investigating a complaint and aligns regulatory provisions for investigation of complaints with the statutory requirements. The final rule also finalizes the performance period for the National Healthcare Safety Network (NHSN) Healthcare Personnel (HCP) Influenza Vaccination Reporting Measure included in the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) for Payment Year 2020.

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...

30 CFR 931.15 - Approval of New Mexico regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Approval of New Mexico regulatory program..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE NEW MEXICO § 931.15 Approval of New Mexico regulatory program amendments. The following is a list of the dates...

30 CFR 931.15 - Approval of New Mexico regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Approval of New Mexico regulatory program..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE NEW MEXICO § 931.15 Approval of New Mexico regulatory program amendments. The following is a list of the dates...

30 CFR 931.15 - Approval of New Mexico regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Approval of New Mexico regulatory program..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE NEW MEXICO § 931.15 Approval of New Mexico regulatory program amendments. The following is a list of the dates...

30 CFR 931.15 - Approval of New Mexico regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Approval of New Mexico regulatory program..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE NEW MEXICO § 931.15 Approval of New Mexico regulatory program amendments. The following is a list of the dates...

Power Plant Emission Reductions Using a Generation Performance Standard

EIA Publications

2001-01-01

In an earlier analysis completed in response to a request received from Representative David McIntosh, Chairman of the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs, the Energy Information Administration analyzed the impacts of power sector caps on nitrogen oxides, sulfur dioxide, and carbon dioxide emissions, assuming a policy instrument patterned after the sulfur dioxide allowance program created in the Clean Air Act Amendments of 1990. This paper compares the results of that work with the results of an analysis that assumes the use of a dynamic generation performance standard as an instrument for reducing carbon dioxide emissions.

Air Markets Program Data (AMPD)

EPA Pesticide Factsheets

The Air Markets Program Data tool allows users to search EPA data to answer scientific, general, policy, and regulatory questions about industry emissions. Air Markets Program Data (AMPD) is a web-based application that allows users easy access to both current and historical data collected as part of EPA's emissions trading programs. This site allows you to create and view reports and to download emissions data for further analysis. AMPD provides a query tool so users can create custom queries of industry source emissions data, allowance data, compliance data, and facility attributes. In addition, AMPD provides interactive maps, charts, reports, and pre-packaged datasets. AMPD does not require any additional software, plug-ins, or security controls and can be accessed using a standard web browser.

77 FR 31486 - Virginia Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-29

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 946 [VA-126-FOR; OSM-2008-0012] Virginia Regulatory Program AGENCY: Office of Surface Mining Reclamation... an amendment to the Virginia regulatory program under the Surface Mining Control and Reclamation Act...

30 CFR 710.2 - Objectives.

Code of Federal Regulations, 2012 CFR

2012-07-01

... REGULATIONS INITIAL REGULATORY PROGRAM § 710.2 Objectives. The objectives of the initial regulatory program... resulting from surface coal mining operations during the interval between enactment of the Act and adoption of a permanent State or Federal regulatory program; and (b) Coordinate the State and Federal...

30 CFR 710.2 - Objectives.

Code of Federal Regulations, 2014 CFR

2014-07-01

... REGULATIONS INITIAL REGULATORY PROGRAM § 710.2 Objectives. The objectives of the initial regulatory program... resulting from surface coal mining operations during the interval between enactment of the Act and adoption of a permanent State or Federal regulatory program; and (b) Coordinate the State and Federal...

30 CFR 710.2 - Objectives.

Code of Federal Regulations, 2010 CFR

2010-07-01

... REGULATIONS INITIAL REGULATORY PROGRAM § 710.2 Objectives. The objectives of the initial regulatory program... resulting from surface coal mining operations during the interval between enactment of the Act and adoption of a permanent State or Federal regulatory program; and (b) Coordinate the State and Federal...

30 CFR 710.2 - Objectives.

Code of Federal Regulations, 2013 CFR

2013-07-01

... REGULATIONS INITIAL REGULATORY PROGRAM § 710.2 Objectives. The objectives of the initial regulatory program... resulting from surface coal mining operations during the interval between enactment of the Act and adoption of a permanent State or Federal regulatory program; and (b) Coordinate the State and Federal...

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...

77 FR 49749 - Procedures for Assessment and Collection of Regulatory Fees; Assessment and Collection of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-17

... regulatory fees. Although the Commission has made a number of discrete changes to the regulatory fee program... Commission has made a number of discrete changes to the regulatory fee program since 1994, we have not...

76 FR 20838 - Standards of Conduct for Transmission Providers

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 358 [Docket No. RM07-1-003; Order No. 717-D] Standards of Conduct for Transmission Providers AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Order on rehearing and clarification. SUMMARY: The Federal Energy Regulatory...

Postdoctoral pharmacy industry fellowships: a descriptive analysis of programs and postgraduate positions.

PubMed

Melillo, Stephanie; Gangadharan, Amy; Johnson, Hiliary; Schleck, Patrick; Steinberg, Michael; Alexander, James G

2012-01-01

Postdoctoral pharmacy industry fellowship programs and the employment of fellowship graduates are described. A list of postgraduate industry fellowships was gathered from the 2009 ASHP Midyear Clinical Meeting. Data regarding program characteristics were collected using the Personnel Placement Service database and program-specific brochures. After data compilation, a standardized survey was sent in January 2010 via e-mail to the point of contact for all programs to confirm the accuracy of the program's characteristics. Only academically affiliated industry fellowship programs were analyzed. Retrospective data were collected regarding the first position of employment for all fellows who graduated from the program between 2005 and 2009 and the position of those same individuals at the time of survey completion. Surveys were sent to 64 postgraduate industry fellowship programs affiliated with a school of pharmacy, 56 (87.5%) of whom responded. The departmental breakdown for positions offered (n = 75) across all academically affiliated industry fellowship programs (including nonresponders) was as follows: medical affairs (38.7%, n = 29), clinical research (32.0%, n = 24), regulatory affairs (9.3%, n = 7), commercial (8.0%, n = 6), health economics and outcomes research (8.0%, n = 6), and pharmacovigilance (4.0%, n = 3). Data from fellows during years 1-5 after completion of the industry fellowship indicated that 90.5% of former fellows remained in the industry (n = 238). The postgraduate industry fellowship programs surveyed indicated that the majority of fellowship graduates continued to hold positions in industry after program completion. The majority of industry fellowships and subsequent job placements occurred in the areas of medical affairs, clinical research, and regulatory affairs.

News from the Biological Stain Commission No. 11.

PubMed

Lyon, H O; Horobin, R W

2012-01-01

The 11th issue of News from the Biological Stain Commission (BSC) provides our first impressions of the REACH and ECHA programs. We intend to give a more thorough account of what these important programs actually mean in later editions of News from the Biological Stain Commission. Under the heading of Regulatory Affairs, the Biological Stain Commission's International Affairs Committee presents information from the opening session of the meeting of the International Standards Organization ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems held on 2-4 June 2010 in Seoul, Republic of Korea.

75 FR 79949 - Revision of Delegation of Authority

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... Marketing and Regulatory Programs (MRP) to the Deputy Under Secretary for MRP to establish the order in..., Chief of Staff, Marketing and Regulatory Programs, USDA, 1400 Independence Avenue, SW., Washington, DC... Marketing and Regulatory Programs (MRP) has delegated to the Deputy Under Secretary for MRP the following...

HIPAA's Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights.

PubMed

Evans, Barbara J

2018-01-04

In 2014, the United States granted individuals a right of access to their own laboratory test results, including genomic data. Many observers feel that this right is in tension with regulatory and bioethical standards designed to protect the safety of people who undergo genomic testing. This commentary attributes this tension to growing pains within an expanding federal regulatory program for genetic and genomic testing. The Genetic Information Nondiscrimination Act of 2008 expanded the regulatory agenda to encompass civil rights and consumer safety. The individual access right, as it applies to genomic data, is best understood as a civil-rights regulation. Competing regulatory objectives-safety and civil rights-were not successfully integrated during the initial rollout of genomic civil-rights regulations after 2008. Federal law clarifies how to prioritize safety and civil rights when the two come into conflict, although with careful policy design, the two need not collide. This commentary opens a dialog about possible solutions to advance safety and civil rights together. Copyright © 2017 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

Opportunities to Apply the 3Rs in Safety Assessment Programs

PubMed Central

Sewell, Fiona; Edwards, Joanna; Prior, Helen; Robinson, Sally

2016-01-01

Abstract Before a potential new medicine can be administered to humans it is essential that its safety is adequately assessed. Safety assessment in animals forms an integral part of this process, from early drug discovery and initial candidate selection to the program of recommended regulatory tests in animals. The 3Rs (replacement, reduction, and refinement of animals in research) are integrated in the current regulatory requirements and expectations and, in the EU, provide a legal and ethical framework for in vivo research to ensure the scientific objectives are met whilst minimizing animal use and maintaining high animal welfare standards. Though the regulations are designed to uncover potential risks, they are intended to be flexible, so that the most appropriate approach can be taken for an individual product. This article outlines current and future opportunities to apply the 3Rs in safety assessment programs for pharmaceuticals, and the potential (scientific, financial, and ethical) benefits to the industry, across the drug discovery and development process. For example, improvements to, or the development of, novel, early screens (e.g., in vitro, in silico, or nonmammalian screens) designed to identify compounds with undesirable characteristics earlier in development have the potential to reduce late-stage attrition by improving the selection of compounds that require regulatory testing in animals. Opportunities also exist within the current regulatory framework to simultaneously reduce and/or refine animal use and improve scientific outcomes through improvements to technical procedures and/or adjustments to study designs. It is important that approaches to safety assessment are continuously reviewed and challenged to ensure they are science-driven and predictive of relevant effects in humans. PMID:28053076

FDA recognition of consensus standards in the premarket notification program.

PubMed

Marlowe, D E; Phillips, P J

1998-01-01

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.

Poker Flats Mine - Div. of Mining, Land, and Water

Science.gov Websites

Lands Coal Regulatory Program Large Mine Permits Mineral Property and Rights Mining Index Land Fishery Water Resources Factsheets Forms banner image of landscape Poker Flats Mine Home Mining Coal Regulatory Program Poker Flats Mine Mining Coal Regulatory Program Info Chickaloon Chuit Watershed Chuitna

78 FR 54517 - Water Quality Standards Regulatory Clarifications

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-04

... 131 Water Quality Standards Regulatory Clarifications; Proposed Rule #0;#0;Federal Register / Vol. 78... AGENCY 40 CFR Part 131 [EPA-HQ-OW-2010-0606; FRL-9839-7] RIN 2040-AF 16 Water Quality Standards... Environmental Protection Agency (EPA) is proposing changes to the federal water quality standards (WQS...

13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

Code of Federal Regulations, 2010 CFR

2010-01-01

... basis in accordance with Generally Accepted Accounting Principles (GAAP) as promulgated by the Financial Accounting Standards Board (FASB), supplemented by Regulatory Accounting Principles (RAP) as identified by... set forth in FASB Statement of Financial Accounting Standards No. 15, Accounting by Debtors and...

75 FR 39610 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

... Effectiveness of Proposed Rule Change Amending Financial Industry Regulatory Authority, Inc. Online Form NMA... Substance of the Proposed Rule Change FINRA is proposing to amend online Form NMA, the standardized... Proposed Rule Change 1. Purpose Form NMA is the standardized online membership application form applicants...

Water quality and management of private drinking water wells in Pennsylvania.

PubMed

Swistock, Bryan R; Clemens, Stephanie; Sharpe, William E; Rummel, Shawn

2013-01-01

Pennsylvania has over three million rural residents using private water wells for drinking water supplies but is one of the few states that lack statewide water well construction or management standards. The study described in this article aimed to determine the prevalence and causes of common health-based pollutants in water wells and evaluate the need for regulatory management along with voluntary educational programs. Water samples were collected throughout Pennsylvania by Master Well Owner Network volunteers trained by Penn State Extension. Approximately 40% of the 701 water wells sampled failed at least one health-based drinking water standard. The prevalence of most water quality problems was similar to past studies although both lead and nitrate-N were reduced over the last 20 years. The authors' study suggests that statewide water well construction standards along with routine water testing and educational programs to assist water well owners would result in improved drinking water quality for private well owners in Pennsylvania.

Analysis of medical screening and surveillance in 21 Occupational Safety and Health Administration standards: support for a generic medical surveillance standard.

PubMed

Silverstein, M

1994-09-01

Twenty-one Occupational Safety and Health Act (OSHA) standards were identified which contain medical service provisions intended to help in the identification and control of harmful health effects of workplace exposures. The utility and effectiveness of these provisions have not previously been evaluated. All 21 standards were reviewed and assigned numerical scores for each of 24 potential medical program elements. Several of these elements were combined to calculate Quality Control, Screening Utility, and Surveillance Utility scores for each standard. Total scores varied greatly, suggesting a lack of consistency and uniformity which was even more obvious when the actual regulatory language was examined. The mean Quality score was only 26% of potential points. Seventeen of 21 standards received less than half the total possible Quality score. When arrayed on a two by two matrix only two standards scored above 50% for both Screening and Surveillance Utility. It was concluded that the medical service provisions in OSHA standards are lacking in consistency and coherence. Two major shortcomings are the lack of quality control elements and the absence of surveillance features which would permit medical program results to be utilized for prevention activities including the identification and control of workplace hazards. A generic occupational medical surveillance standard could address these current weaknesses. Elements of such a generic standard are proposed.

78 FR 1570 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... Transformers (energy efficiency standards) Residential clothes washers (energy efficiency standards... Distribution Transformers (Reg Plan Seq No. 32). 263 Test Procedures for 1904-AC76 Residential Refrigerators... Efficiency Standards for Distribution Transformers Regulatory Plan: This entry is Seq. No. 32 in part II of...

Integration of a splicing regulatory network within the meiotic gene expression program of Saccharomyces cerevisiae

PubMed Central

Munding, Elizabeth M.; Igel, A. Haller; Shiue, Lily; Dorighi, Kristel M.; Treviño, Lisa R.; Ares, Manuel

2010-01-01

Splicing regulatory networks are essential components of eukaryotic gene expression programs, yet little is known about how they are integrated with transcriptional regulatory networks into coherent gene expression programs. Here we define the MER1 splicing regulatory network and examine its role in the gene expression program during meiosis in budding yeast. Mer1p splicing factor promotes splicing of just four pre-mRNAs. All four Mer1p-responsive genes also require Nam8p for splicing activation by Mer1p; however, other genes require Nam8p but not Mer1p, exposing an overlapping meiotic splicing network controlled by Nam8p. MER1 mRNA and three of the four Mer1p substrate pre-mRNAs are induced by the transcriptional regulator Ume6p. This unusual arrangement delays expression of Mer1p-responsive genes relative to other genes under Ume6p control. Products of Mer1p-responsive genes are required for initiating and completing recombination and for activation of Ndt80p, the activator of the transcriptional network required for subsequent steps in the program. Thus, the MER1 splicing regulatory network mediates the dependent relationship between the UME6 and NDT80 transcriptional regulatory networks in the meiotic gene expression program. This study reveals how splicing regulatory networks can be interlaced with transcriptional regulatory networks in eukaryotic gene expression programs. PMID:21123654

Air toxics regulatory issues facing urban settings.

PubMed Central

Olden, K; Guthrie, J

1996-01-01

Biomarker research does not exist in isolation. Its usefulness can only be realized when it is translated into prevention strategies to protect public health. In the context of air toxics, these prevention strategies begin with the development of regulatory standards derived from risk assessment schemes. The Clean Air Act Amendments of 1990 list 189 air toxics, including many volatile organics, metals, and pesticides. The National Institute of Environmental Health Sciences (NIEHS), through its affiliation with the National Toxicology Program, has generated toxicity and carcinogenicity data on more than 100 of these air toxics. The NIEHS extramural and intramural research portfolios support a variety of projects that develop and validate biomarkers for use in environmental health science and risk assessment. Biomarkers have a tremendous potential in the areas of regulating air toxics and protecting public health. Risk assessors need data provided by biomarkers of exposure, biomarkers of dose/pharmacokinetics, biomarkers of susceptibility or individual variability, and biomarkers of effects. The greatest benefit would be realized if biomarkers could be employed in four areas of primary and secondary prevention. The first is the use of biomarkers to enhance extrapolation of animal data to human exposure situations in establishing risk standards. The second is the use of biomarkers that assess noncancer, as well as cancer, end points. Important health end points include pulmonary dysfunction, immunotoxicity, and neurotoxicity. Third, biomarkers that serve as early waming signs to detect intermediate effects would enhance our ability to design timely and cost-effective intervention strategies. Finally, biomarkers used to evaluate the effectiveness of intervention strategies, both in clinical and regulatory settings, would enable us to ensure that programs designed to protect public health do, in fact, achieve the desired outcome. PMID:8933026

Challenges in Developing Competency-based Training Curriculum for Food Safety Regulators in India

PubMed Central

Thippaiah, Anitha; Allagh, Komal Preet; Murthy, G. V.

2014-01-01

Context: The Food Safety and Standards Act have redefined the roles and responsibilities of food regulatory workforce and calls for highly skilled human resources as it involves complex management procedures. Aims: 1) Identify the competencies needed among the food regulatory workforce in India. 2) Develop a competency-based training curriculum for food safety regulators in the country. 3) Develop training materials for use to train the food regulatory workforce. Settings and Design: The Indian Institute of Public Health, Hyderabad, led the development of training curriculum on food safety with technical assistance from the Royal Society for Public Health, UK and the National Institute of Nutrition, India. The exercise was to facilitate the implementation of new Act by undertaking capacity building through a comprehensive training program. Materials and Methods: A competency-based training needs assessment was conducted before undertaking the development of the training materials. Results: The training program for Food Safety Officers was designed to comprise of five modules to include: Food science and technology, Food safety management systems, Food safety legislation, Enforcement of food safety regulations, and Administrative functions. Each module has a facilitator guide for the tutor and a handbook for the participant. Essentials of Food Hygiene-I (Basic level), II and III (Retail/ Catering/ Manufacturing) were primarily designed for training of food handlers and are part of essential reading for food safety regulators. Conclusion: The Food Safety and Standards Act calls for highly skilled human resources as it involves complex management procedures. Despite having developed a comprehensive competency-based training curriculum by joint efforts by the local, national, and international agencies, implementation remains a challenge in resource-limited setting. PMID:25136155

Quality Assurance Program Plan for SFR Metallic Fuel Data Qualification

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

Benoit, Timothy; Hlotke, John Daniel; Yacout, Abdellatif

2017-07-05

This document contains an evaluation of the applicability of the current Quality Assurance Standards from the American Society of Mechanical Engineers Standard NQA-1 (NQA-1) criteria and identifies and describes the quality assurance process(es) by which attributes of historical, analytical, and other data associated with sodium-cooled fast reactor [SFR] metallic fuel and/or related reactor fuel designs and constituency will be evaluated. This process is being instituted to facilitate validation of data to the extent that such data may be used to support future licensing efforts associated with advanced reactor designs. The initial data to be evaluated under this program were generatedmore » during the US Integral Fast Reactor program between 1984-1994, where the data includes, but is not limited to, research and development data and associated documents, test plans and associated protocols, operations and test data, technical reports, and information associated with past United States Nuclear Regulatory Commission reviews of SFR designs.« less

Comparing biomarker measurements to a normal range: when ...

EPA Pesticide Factsheets

This commentary is the second of a series outlining one specific concept in interpreting biomarkers data. In the first, an observational method was presented for assessing the distribution of measurements before making parametric calculations. Here, the discussion revolves around the next step, the choice of using standard error of the mean or the calculated standard deviation to compare or predict measurement results. The National Exposure Research Laboratory’s (NERL’s) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA’s mission to protect human health and the environment. HEASD’s research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA’s strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

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...

Assessing the satisfaction and burden within an academic animal care and use program.

PubMed

Norton, John N; Reynolds, Randall P; Chan, Cliburn; Valdivia, Raphael H; Staats, Herman F

2017-09-01

Although animal research requires adherence to various regulations and standards, the manner in which compliance is maintained and the degree of additional constraints varies between institutions. Regulatory burden, particularly if institutionally imposed, has become a concern for institutions as increased regulatory expectations result in decreased resources available for research efforts. Faculty, research staff, and support staff engaged in animal research were surveyed to determine what institutional animal care and use committee (IACUC) processes were considered burdensome, the perceived value of some suggested modifications, and satisfaction with the IACUC administrative office and the animal resource unit. Although the results revealed overwhelming satisfaction with the IACUC administrative office and the animal resource unit, several IACUC processes were deemed burdensome, and therefore there would be value in modifying IACUC processes. When comparing the value of modifying IACUC processes, different groups within the animal care and use program (ACUP) tended to have different responses on many of the topics. This survey identified several perceived burdensome IACUC processes that would likely benefit individuals if modified. In today's environment of shrinking budgets for biomedical research, minimizing regulatory burden-particularly unnecessary, self-imposed burden-in the ACUP is particularly important to ensure that costs, time, and effort are appropriate to achieve animal welfare and quality of research endeavors.-Norton, J. N., Reynolds, R. P., Chan, C., Valdivia, R. H., Staats, H. F. Assessing the satisfaction and burden within an academic animal care and use program. © FASEB.

Reformation of Regulatory Technical Standards for Nuclear Power Generation Equipments in Japan

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

Mikio Kurihara; Masahiro Aoki; Yu Maruyama

2006-07-01

Comprehensive reformation of the regulatory system has been introduced in Japan in order to apply recent technical progress in a timely manner. 'The Technical Standards for Nuclear Power Generation Equipments', known as the Ordinance No.622) of the Ministry of International Trade and Industry, which is used for detailed design, construction and operating stage of Nuclear Power Plants, was being modified to performance specifications with the consensus codes and standards being used as prescriptive specifications, in order to facilitate prompt review of the Ordinance with response to technological innovation. The activities on modification were performed by the Nuclear and Industrial Safetymore » Agency (NISA), the regulatory body in Japan, with support of the Japan Nuclear Energy Safety Organization (JNES), a technical support organization. The revised Ordinance No.62 was issued on July 1, 2005 and is enforced from January 1 2006. During the period from the issuance to the enforcement, JNES carried out to prepare enforceable regulatory guide which complies with each provisions of the Ordinance No.62, and also made technical assessment to endorse the applicability of consensus codes and standards, in response to NISA's request. Some consensus codes and standards were re-assessed since they were already used in regulatory review of the construction plan submitted by licensee. Other consensus codes and standards were newly assessed for endorsement. In case that proper consensus code or standards were not prepared, details of regulatory requirements were described in the regulatory guide as immediate measures. At the same time, appropriate standards developing bodies were requested to prepare those consensus code or standards. Supplementary note which provides background information on the modification, applicable examples etc. was prepared for convenience to the users of the Ordinance No. 62. This paper shows the activities on modification and the results, following the NISA's presentation at ICONE-13 that introduced the framework of the performance specifications and the modification process of the Ordinance NO. 62. (authors)« less

Drug evaluation and the permissive principle: continuities and contradictions between standards and practices in antidepressant regulation.

PubMed

Abraham, John; Davis, Courtney

2009-08-01

Pharmaceuticals are not permitted on to the market unless they are granted regulatory approval. The regulatory process is, therefore, crucial in whether or not a drug is widely prescribed. Regulatory agencies have developed standards of performance that pharmaceuticals are supposed to meet before entering the market. Regulation of technologies is often discussed by reference to the precautionary principle. In contrast, this paper develops the concept of the 'permissive principle' as a way of understanding the departure of regulators' practices from standards of drug efficacy to which regulatory agencies themselves subscribe. By taking a case study of antidepressant regulation in the UK and the USA, the mechanisms of permissive regulatory practices are examined. An STS methodology of both spatial (international) and temporal comparisons of regulatory practices with regulatory standards is employed to identify the nature and extent of the permissive regulation. It is found that the permissive principle was adopted by drug regulators in the UK and the USA, but more so by the former than the latter. Evidently, permissive regulation, which favours the commercial interests of the drug manufacturer, but is contrary to the interests of patients, may penetrate to the heart of regulatory science. On the other hand, permissive regulation of specific drugs should not be regarded as an inevitable result of marketing strategies and concomitant networks deployed by powerful pharmaceutical companies, because the extent of permissive regulation may vary according to the intra-institutional normative commitments of regulators to uphold their technical standards against the commercial interests of the manufacturer. Likely sociological factors that can account for such permissive regulatory practices are 'corporate bias', secrecy and excessive regulatory trust in the pharmaceutical industry in the UK, political expediency and ideological capture in the USA, combined in both countries with some regulatory deference to the clinical autonomy of the psychiatry profession.

76 FR 33589 - Standards Improvement Project-Phase III

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-08

... rule: I. Background A. Introduction B. Regulatory History II. Legal Considerations III. Summary and... without diminishing worker protections. B. Regulatory History The Standards Improvement Project (SIP...

1996 LMITCO environmental monitoring program report for the Idaho National Engineering and Environmental Laboratory

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

NONE

1997-09-01

This report describes the calendar year 1996 environmental surveillance and compliance monitoring activities of the Lockheed Martin Idaho Technologies Company Environmental Monitoring Program performed at the Idaho National Engineering and Environmental Laboratory (INEEL). Results of sampling performed by the Radiological Environmental Surveillance, Site Environmental Surveillance, Drinking Water, Effluent Monitoring, Storm Water Monitoring, Groundwater Monitoring, and Special Request Monitoring Programs are included in this report. The primary purposes of the surveillance and monitoring activities are to evaluate environmental conditions, to provide and interpret data, to verify compliance with applicable regulations or standards, and to ensure protection of human health and themore » environment. This report compares 1996 data with program-specific regulatory guidelines and past data to evaluate trends.« less

Colombia's discharge fee program: incentives for polluters or regulators?

PubMed

Blackman, Allen

2009-01-01

Colombia's discharge fee system for water effluents is often held up as a model of a well-functioning, economic incentive pollution control program in a developing country. Yet few objective evaluations of the program have appeared. Based on a variety of primary and secondary data, this paper finds that in its first 5 years, the program was beset by a number of serious problems including limited implementation in many regions, widespread noncompliance by municipal sewerage authorities, and a confused relationship between discharge fees and emissions standards. Nevertheless, in some watersheds, pollution loads dropped significantly after the program was introduced. While proponents claim the incentives that discharge fees created for polluters to cut emissions in a cost-effective manner were responsible, this paper argues that the incentives they created for regulatory authorities to improve permitting, monitoring, and enforcement were at least as important.

OSHA's renewed mandate for regulatory flexibility review: in support of the 1984 ethylene oxide standard.

PubMed

LaMontagne, A D; Kelsey, K T

1998-08-01

The Regulatory Flexibility Act of 1980 requires that all federal agencies consider the impact of regulations on small entities. One of the provisions of the Act requires review of regulations ever 10 years to determine whether such regulations should be continued without changes, rescinded, or amended to make them more effective or less burdensome on businesses. The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 amended and expanded the Regulatory Flexibility Act. Most significantly, SBREFA entitles aggrieved small entities or their representative (e.g., trade associations) to sue OSHA for failure to fulfill Regulatory Flexibility Act requirements. In response to this new political reality, OSHA held the first public meeting of their kind in June of 1997 to gather information on the ethylene oxide and lock-out/tag-out standards for the purposes of Regulatory Flexibility review. This paper presents the development of the Regulatory Flexibility review process and details our analysis of the ethylene oxide standard using OSHA's eight Regulatory Flexibility review criteria. Great progress in ethylene oxide health and safety has been made since the promulgation of the standard in 1984, including a considerable decrease in average workshift exposures. Yet, important concerns remain, such as the lack of safer substitutes for EtO's most common uses, the widespread occurrence of accidental exposures to EtO that are not captured by personal monitoring, and the recent increase in the occurrence of catastrophic EtO explosions. Because of the considerable study that has been devoted to EtO and to the EtO standard, there is a very strong cases for either making the EtO standard more worker protective, or continuing the standard without change while improving outreach and enforcement efforts to address shortcomings. Other valuable standards for which fewer data exist may be inappropriately threatened by the Regulatory Flexibility review process. Importantly, Regulatory Flexibility review could be constructive if accompanied by appropriations to fund sound evaluation studies. Instead, it will likely divert OSHA's limited resources from the numerous urgent health hazard that await initial rule-making. As signified by the designation of "intervention effectiveness research" as one of the 21 priorities on the National Occupational Research Agenda, evaluation studies of OSHA standards and other interventions are urgently needed. The occupational health community's response to this need will play a crucial role in preserving hard-won protections, as well as in developing other urgently needed protections in the future.

TH-D-204-00: The Pursuit of Radiation Oncology Performance Excellence

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

NONE

The Malcolm Baldrige National Quality Improvement Act was signed into law in 1987 to advance U.S. business competitiveness and economic growth. Administered by the National Institute of Standards and Technology NIST, the Act created the Baldrige National Quality Program, now renamed the Baldrige Performance Excellence Program. The comprehensive analytical approaches referred to as the Baldrige Healthcare Criteria, are very well suited for the evaluation and sustainable improvement of radiation oncology management and operations. A multidisciplinary self-assessment approach is used for radiotherapy program evaluation and development in order to generate a fact based knowledge driven system for improving quality of care,more » increasing patient satisfaction, building employee engagement, and boosting organizational innovation. The methodology also provides a valuable framework for benchmarking an individual radiation oncology practice against guidelines defined by accreditation and professional organizations and regulatory agencies. Learning Objectives: To gain knowledge of the Baldrige Performance Excellence Program as it relates to Radiation Oncology. To appreciate the value of a multidisciplinary self-assessment approach in the pursuit of Radiation Oncology quality care, patient satisfaction, and workforce commitment. To acquire a set of useful measurement tools with which an individual Radiation Oncology practice can benchmark its performance against guidelines defined by accreditation and professional organizations and regulatory agencies.« less

TH-D-204-01: The Pursuit of Radiation Oncology Performance Excellence

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

Sternick, E.

The Malcolm Baldrige National Quality Improvement Act was signed into law in 1987 to advance U.S. business competitiveness and economic growth. Administered by the National Institute of Standards and Technology NIST, the Act created the Baldrige National Quality Program, now renamed the Baldrige Performance Excellence Program. The comprehensive analytical approaches referred to as the Baldrige Healthcare Criteria, are very well suited for the evaluation and sustainable improvement of radiation oncology management and operations. A multidisciplinary self-assessment approach is used for radiotherapy program evaluation and development in order to generate a fact based knowledge driven system for improving quality of care,more » increasing patient satisfaction, building employee engagement, and boosting organizational innovation. The methodology also provides a valuable framework for benchmarking an individual radiation oncology practice against guidelines defined by accreditation and professional organizations and regulatory agencies. Learning Objectives: To gain knowledge of the Baldrige Performance Excellence Program as it relates to Radiation Oncology. To appreciate the value of a multidisciplinary self-assessment approach in the pursuit of Radiation Oncology quality care, patient satisfaction, and workforce commitment. To acquire a set of useful measurement tools with which an individual Radiation Oncology practice can benchmark its performance against guidelines defined by accreditation and professional organizations and regulatory agencies.« less

76 FR 38212 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0275] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Revision 1 of Regulatory Guide (RG) 1.179, ``Standard Format [[Page 38213

Development and implementation of a quality assurance program for a hormonal contraceptive implant.

PubMed

Owen, Derek H; Jenkins, David; Cancel, Aida; Carter, Eli; Dorflinger, Laneta; Spieler, Jeff; Steiner, Markus J

2013-04-01

The importance of the distribution of safe, effective and cost-effective pharmaceutical products in resource-constrained countries is the subject of increasing attention. FHI 360 has developed a program aimed at evaluating the quality of a contraceptive implant manufactured in China, while the product is being registered in an increasing number of countries and distributed by international procurement agencies. The program consists of (1) independent product testing; (2) ongoing evaluation of the manufacturing facility through audits and inspections; and (3) post-marketing surveillance. This article focuses on the laboratory testing of the product. The various test methods were chosen from the following test method compendia, the United States Pharmacopeia (USP), British Pharmacopeia (BP), International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), or lot release tests mandated by Chinese regulatory requirements. Each manufactured lot is independently tested prior to its distribution to countries supported by this program. In addition, a more detailed annual testing program includes evaluation of the active ingredient (levonorgestrel), the final product and the packaging material. Over the first 4 years of this 5-year project, all tested lots met the established quality criteria. The quality assurance program developed for this contraceptive implant has helped ensure that a safe product was being introduced into developing country family planning programs. This program provides a template for establishing quality assurance programs for other cost-effective pharmaceutical products that have not yet received stringent regulatory approval and are being distributed in resource-poor settings. Copyright © 2013 Elsevier Inc. All rights reserved.

40 CFR 192.32 - Standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... § 192.32 Standards. (a) Standards for application during processing operations and prior to the end of... nonoperational and subject to a license by the Nuclear Regulatory Commission or an Agreement State shall limit... the Nuclear Regulatory Commission or Agreement State into individual site licenses. (ii) The Nuclear...

40 CFR 192.32 - Standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... § 192.32 Standards. (a) Standards for application during processing operations and prior to the end of... nonoperational and subject to a license by the Nuclear Regulatory Commission or an Agreement State shall limit... the Nuclear Regulatory Commission or Agreement State into individual site licenses. (ii) The Nuclear...

77 FR 7942 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... Sequence No. Title Identifier No. 315 Energy Efficiency 1904-AB57 Standards for Battery Chargers and... Renewable Energy (EE) Proposed Rule Stage 315. Energy Efficiency Standards for Battery Chargers and External... regulatory flexibility agenda is made up of six rulemakings setting energy efficiency standards for the...

Humanitarian Use Device and Humanitarian Device Exemption regulatory programs: pros and cons.

PubMed

Bernad, Daniel Maxwell

2009-03-01

The US FDA established the Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) program to encourage medical device firms to address rare diseases. Despite being in existence for over a decade, there has only been one peer-reviewed publication examining this field. The objective of this report is to investigate how the HUD/HDE program differs from the standard regulatory system, discuss its potential advantages and disadvantages, and to speculate which humanitarian devices will be brought to market within the next 5 years. A total of 40 semistructured interviews with stakeholders, representing approximately half (n = 20, 49%) of the firms that have successfully obtained HDE-approved products, were performed in order to acquire the primary data for this paper. There appear to be short-term gains and long-term drains associated with launching humanitarian devices to market. This report aims to provide sponsors with information that may allow them to make better decisions during their product development of humanitarian devices and may, hopefully, also play a role in encouraging other sponsors to take the necessary steps forward in helping to find treatments for patients with rare diseases.

The road to JCAHO disease-specific care certification: a step-by-step process log.

PubMed

Morrison, Kathy

2005-01-01

In 2002, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) implemented Disease-Specific Care (DSC) certification. This is a voluntary program in which organizations have their disease management program evaluated by this regulatory agency. Some of the DSC categories are stroke, heart failure, acute MI, diabetes, and pneumonia. The criteria for any disease management program certification are: compliance with consensus-based national standards, effective use of established clinical practice guidelines to manage and optimize care, and an organized approach to performance measurement and improvement activities. Successful accomplishment of DSC certification defines organizations as Centers of Excellence in management of that particular disease. This article will review general guidelines for DSC certification with an emphasis on Primary Stroke Center certification.

The National Shipbuilding Research Program. Analysis of Wash Water Treatment Efficiency for Copper and Zinc

DTIC Science & Technology

2000-12-15

per trillion for tributyltin (“ TBT ”). This regulatory action lead to an intensive research effort to develop a treatment method for ship’s wash water...antifoulant coating systems, including tributyltin , copper and zinc. In 1997 The Commonwealth of Virginia established an effluent discharge limit of 50 parts...waste stream that could consistently remove TBT to levels below this discharge standard. This work is currently being performed by the Center for

Dysregulation of haematopoietic stem cell regulatory programs in acute myeloid leukaemia.

PubMed

Basilico, Silvia; Göttgens, Berthold

2017-07-01

Haematopoietic stem cells (HSC) are situated at the apex of the haematopoietic differentiation hierarchy, ensuring the life-long supply of mature haematopoietic cells and forming a reservoir to replenish the haematopoietic system in case of emergency such as acute blood loss. To maintain a balanced production of all mature lineages and at the same time secure a stem cell reservoir, intricate regulatory programs have evolved to control multi-lineage differentiation and self-renewal in haematopoietic stem and progenitor cells (HSPCs). Leukaemogenic mutations commonly disrupt these regulatory programs causing a block in differentiation with simultaneous enhancement of proliferation. Here, we briefly summarize key aspects of HSPC regulatory programs, and then focus on their disruption by leukaemogenic fusion genes containing the mixed lineage leukaemia (MLL) gene. Using MLL as an example, we explore important questions of wider significance that are still under debate, including the importance of cell of origin, to what extent leukaemia oncogenes impose specific regulatory programs and the relevance of leukaemia stem cells for disease development and prognosis. Finally, we suggest that disruption of stem cell regulatory programs is likely to play an important role in many other pathologies including ageing-associated regenerative failure.

Integrative Genomic Analyses Yields Cell Cycle Regulatory Programs with Prognostic Value

PubMed Central

Cheng, Chao; Lou, Shaoke; Andrews, Erik H.; Ung, Matthew H.; Varn, Frederick S.

2016-01-01

Liposarcoma is the second most common form of sarcoma, which has been categorized into four molecular subtypes, which are associated with differential prognosis of patients. However, the transcriptional regulatory programs associated with distinct histological and molecular subtypes of liposarcoma have not been investigated. This study uses integrative analyses to systematically define the transcriptional regulatory programs associated with liposarcoma. Likewise, computational methods are used to identify regulatory programs associated with different liposarcoma subtypes as well as programs that are predictive of prognosis. Further analysis of curated gene sets was used to identify prognostic gene signatures. The integration of data from a variety sources including gene expression profiles, transcription factor (TF) binding data from ChIP-seq experiments, curated gene sets, and clinical information of patients indicated discrete regulatory programs (e.g., controlled by E2F1 and E2F4) with significantly different regulatory activity in one or multiple subtypes of liposarcoma with respect to normal adipose tissue. These programs were also shown to be prognostic, wherein liposarcoma patients with higher E2F4 or E2F1 activity associated with unfavorable prognosis. A total of 259 gene sets were significantly associated with patient survival in liposarcoma, among which >50% are involved in cell cycle and proliferation. PMID:26856934

Does the bathing water classification depend on sampling strategy? A bootstrap approach for bathing water quality assessment, according to Directive 2006/7/EC requirements.

PubMed

López, Iago; Alvarez, César; Gil, José L; Revilla, José A

2012-11-30

Data on the 95th and 90th percentiles of bacteriological quality indicators are used to classify bathing waters in Europe, according to the requirements of Directive 2006/7/EC. However, percentile values and consequently, classification of bathing waters depend both on sampling effort and sample-size, which may undermine an appropriate assessment of bathing water classification. To analyse the influence of sampling effort and sample size on water classification, a bootstrap approach was applied to 55 bacteriological quality datasets of several beaches in the Balearic Islands (Spain). Our results show that the probability of failing the regulatory standards of the Directive is high when sample size is low, due to a higher variability in percentile values. In this way, 49% of the bathing waters reaching an "Excellent" classification (95th percentile of Escherichia coli under 250 cfu/100 ml) can fail the "Excellent" regulatory standard due to sampling strategy, when 23 samples per season are considered. This percentage increases to 81% when 4 samples per season are considered. "Good" regulatory standards can also be failed in bathing waters with an "Excellent" classification as a result of these sampling strategies. The variability in percentile values may affect bathing water classification and is critical for the appropriate design and implementation of bathing water Quality Monitoring and Assessment Programs. Hence, variability of percentile values should be taken into account by authorities if an adequate management of these areas is to be achieved. Copyright © 2012 Elsevier Ltd. All rights reserved.

77 FR 15445 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-15

... Effectiveness of Proposed Rule Change To Amend Online Form NMA, the Standardized Membership Application Form... online Form NMA, the standardized membership application form applicants must file pursuant to NASD Rule...), each applicant for FINRA membership must complete and electronically file the standardized online Form...

Strategies to overcome clinical, regulatory, and financial challenges in the implementation of personalized medicine.

PubMed

Tsimberidou, Apostolia M; Ringborg, Ulrik; Schilsky, Richard L

2013-01-01

This article highlights major developments over the last decade in personalized medicine in cancer. Emerging data from clinical studies demonstrate that the use of targeted agents in patients with targetable molecular aberrations improves clinical outcomes. Despite a surge of studies, however, significant gaps in knowledge remain, especially in identifying driver molecular aberrations in patients with multiple aberrations, understanding molecular networks that control carcinogenesis and metastasis, and most importantly, discovering effective targeted agents. Implementation of personalized medicine requires continued scientific and technological breakthroughs; standardization of tumor tissue acquisition and molecular testing; changes in oncology practice and regulatory standards for drug and device access and approval; modification of reimbursement policies by health care payers; and innovative ways to collect and analyze electronic patient information that are linked to prospective clinical registries and rapid learning systems. Informatics systems that integrate clinical, laboratory, radiologic, molecular, and economic data will improve clinical care and will provide infrastructure to enable clinical research. The initiative of the EurocanPlatform aims to overcome the challenges of implementing personalized medicine in Europe by sharing patients, biologic materials, and technological resources across borders. The EurocanPlatform establishes a complete translational cancer research program covering the drug development process and strengthening collaborations among academic centers, pharmaceutical companies, regulatory authorities, health technology assessment organizations, and health care systems. The CancerLinQ rapid learning system being developed by ASCO has the potential to revolutionize how all stakeholders in the cancer community assemble and use information obtained from patients treated in real-world settings to guide clinical practice, regulatory decisions, and health care payment policy.

Components of laboratory accreditation.

PubMed

Royal, P D

1995-12-01

Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. This proposal was the result of the Inspector General Office reports that identified weaknesses in the current operation. Several accreditation programs can be evaluated and common components identified when proposing a structure for accrediting a GLP system. An understanding of these components is useful in building that structure. Internationally accepted accreditation programs provide a template for building a U.S. GLP accreditation program. This presentation will discuss the traditional structure of accreditation as presented in the Organization of Economic Cooperative Development/GLP program, ISO-9000 Accreditation and ISO/IEC Guide 25 Standard, and the Canadian Association for Environmental Analytical Laboratories, which has a biological component. Most accreditation programs are managed by a recognized third party, either privately or with government oversight. Common components often include a formal review of required credentials to evaluate organizational structure, a site visit to evaluate the facility, and a performance evaluation to assess technical competence. Laboratory performance is measured against written standards and scored. A formal report is then sent to the laboratory indicating accreditation status. Usually, there is a scheduled reevaluation built into the program. Fee structures vary considerably and will need to be examined closely when building a GLP program.

Integrated Module and Gene-Specific Regulatory Inference Implicates Upstream Signaling Networks

PubMed Central

Roy, Sushmita; Lagree, Stephen; Hou, Zhonggang; Thomson, James A.; Stewart, Ron; Gasch, Audrey P.

2013-01-01

Regulatory networks that control gene expression are important in diverse biological contexts including stress response and development. Each gene's regulatory program is determined by module-level regulation (e.g. co-regulation via the same signaling system), as well as gene-specific determinants that can fine-tune expression. We present a novel approach, Modular regulatory network learning with per gene information (MERLIN), that infers regulatory programs for individual genes while probabilistically constraining these programs to reveal module-level organization of regulatory networks. Using edge-, regulator- and module-based comparisons of simulated networks of known ground truth, we find MERLIN reconstructs regulatory programs of individual genes as well or better than existing approaches of network reconstruction, while additionally identifying modular organization of the regulatory networks. We use MERLIN to dissect global transcriptional behavior in two biological contexts: yeast stress response and human embryonic stem cell differentiation. Regulatory modules inferred by MERLIN capture co-regulatory relationships between signaling proteins and downstream transcription factors thereby revealing the upstream signaling systems controlling transcriptional responses. The inferred networks are enriched for regulators with genetic or physical interactions, supporting the inference, and identify modules of functionally related genes bound by the same transcriptional regulators. Our method combines the strengths of per-gene and per-module methods to reveal new insights into transcriptional regulation in stress and development. PMID:24146602

Progress, innovation and regulatory science in drug development: the politics of international standard-setting.

PubMed

Abraham, John; Reed, Tim

2002-06-01

This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and 'progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of 'technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the 'technical trajectories' of regulatory science.

75 FR 46877 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-04

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-156-FOR; OSM 2010-0004] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... Pennsylvania program (the ``Pennsylvania program'') under the Surface Mining Control and Reclamation Act of...

30 CFR 701.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-07-01

... regulatory program required by the Act. (b) The following regulations apply to the permanent regulatory program: (1) Subchapter C on State program application, approval, withdrawal, and grants, and Federal program implementation; (2) Subchapter D on surface coal mining and reclamation operations on Federal...

30 CFR 701.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-07-01

... regulatory program required by the Act. (b) The following regulations apply to the permanent regulatory program: (1) Subchapter C on State program application, approval, withdrawal, and grants, and Federal program implementation; (2) Subchapter D on surface coal mining and reclamation operations on Federal...

30 CFR 701.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-07-01

... regulatory program required by the Act. (b) The following regulations apply to the permanent regulatory program: (1) Subchapter C on State program application, approval, withdrawal, and grants, and Federal program implementation; (2) Subchapter D on surface coal mining and reclamation operations on Federal...

30 CFR 701.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-07-01

... regulatory program required by the Act. (b) The following regulations apply to the permanent regulatory program: (1) Subchapter C on State program application, approval, withdrawal, and grants, and Federal program implementation; (2) Subchapter D on surface coal mining and reclamation operations on Federal...

Regulatory Impact Analysis: Amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) and New Source Perofrmance Standards (NSPS) for the Portland Cement Manufacturing Industry Final Report

EPA Pesticide Factsheets

For the regulatory process, EPA is required to develop a regulatory impact analysis (RIA). This August 2010 RIA includes an economic impact analysis (EIA) and a small entity impacts analysis and documents the RIA methods and results for the 2010 rules

Mission Risk Reduction Regulatory Change Management

NASA Technical Reports Server (NTRS)

Scroggins, Sharon

2007-01-01

NASA Headquarters Environmental Management Division supports NASA's mission to pioneer the future in space exploration, scientific discovery, and aeronautics research by integrating environmental considerations into programs and projects early-on, thereby proactively reducing NASA's exposure to institutional, programmatic and operational risk. As part of this effort, NASA established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) as a resource for detecting, analyzing, and communicating environmental regulatory risks to the NASA stakeholder community. The RRAC PC focuses on detecting emerging environmental regulations and other operational change drivers that may pose risks to NASA programs and facilities, and effectively communicating the potential risks. For example, regulatory change may restrict how and where certain activities or operations may be conducted. Regulatory change can also directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Regulatory change can result in significant adverse impacts to NASA programs and facilities due to NASA's stringent performance requirements for materials and components related to human-rated space vehicles. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented a system for proactively managing regulatory change to minimize potential adverse impacts to NASA programs and facilities. This presentation highlights the process utilized by the RRACPC to communicate regulatory change and the associated potential risks within NASA, as well as the process for communicating and cooperating with other government agencies and industry partners, both domestic and international, to ensure mission success.

Protecting workers and the environment: An environmental NGO's perspective on nanotechnology

NASA Astrophysics Data System (ADS)

Balbus, John M.; Florini, Karen; Denison, Richard A.; Walsh, Scott A.

2007-01-01

Nanotechnology, the design and manipulation of materials at the atomic scale, may well revolutionize many of the ways our society manufactures products, produces energy, and treats diseases. New materials based on nanotechnology are already reaching the market in a wide variety of consumer products. Some of the observed properties of nanomaterials call into question the adequacy of current methods for determining hazard and exposure and for controlling resulting risks. Given the limitations of existing regulatory tools and policies, we believe two distinct kinds of initiatives are needed: first, a major increase in the federal investment in nanomaterial risk research; second, rapid development and implementation of voluntary standards of care pending development of adequate regulatory safeguards in the longer term. Several voluntary programs are currently at various stages of evolution, though the eventual outputs of each of these are still far from clear. Ultimately, effective regulatory safeguards are necessary to provide a level playing field for industry while adequately protecting human health and the environment. This paper reviews the existing toxicological literature on nanomaterials, outlines and analyzes the current regulatory framework, and provides our recommendations, as an environmental non-profit organization, for safe nanotechnology development.

U.S. Nuclear Regulatory Commission natural analogue research program

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

Kovach, L.A.; Ott, W.R.

1995-09-01

This article describes the natural analogue research program of the U.S. Nuclear Regulatory Commission (US NRC). It contains information on the regulatory context and organizational structure of the high-level radioactive waste research program plan. It also includes information on the conditions and processes constraining selection of natural analogues, describes initiatives of the US NRC, and describes the role of analogues in the licensing process.

75 FR 48382 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-10

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0275] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1228, ``Standard Format and Content of License Termination Plans for Nuclear Power Reactors.'' FOR FURTHER INFORMATION CONTACT: James C....

77 FR 34888 - Kentucky Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 [KY-255-FOR; OSM-2012-0004] Kentucky Regulatory Program AGENCY: Office of Surface Mining Reclamation... Program (hereinafter, the ``Kentucky program'') under the Surface Mining Control and Reclamation Act of...

76 FR 50436 - Kentucky Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 [KY-254-FOR; OSM-2011-0005] Kentucky Regulatory Program AGENCY: Office of Surface Mining Reclamation... Program (hereinafter, the ``Kentucky program'') under the Surface Mining Control and Reclamation Act of...

NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

NASA Technical Reports Server (NTRS)

Scroggins, Sharon; Duda, Kristen

2008-01-01

This viewgraph presentation gives an overview of NASA's risk analysis communication programs associated with changing environmental policies. The topics include: 1) NASA Program Transition; 2) Principal Center for Regulatory Risk Analysis and Communication (RRAC PC); and 3) Regulatory Tracking and Communication Process.

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...

17 CFR 37.1501 - Chief compliance officer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... facility's self-regulatory program that is requested by the board of directors or the regulatory oversight... compliance office review, look-back, internal or external audit finding, self-reported error, or validated...) Supervising the swap execution facility's self-regulatory program with respect to trade practice surveillance...

EBMT transplant centers with FACT-JACIE accreditation have significantly better compliance with related donor care standards

PubMed Central

Anthias, Chloe; O'Donnell, Paul V; Kiefer, Deidre M; Yared, Jean; Norkin, Maxim; Anderlini, Paolo; Savani, Bipin N; Diaz, Miguel A; Bitan, Menachem; Halter, Joerg P; Logan, Brent R; Switzer, Galen E; Pulsipher, Michael A; Confer, Dennis L; Shaw, Bronwen E

2016-01-01

Previous studies have identified healthcare practices that may place undue pressure on related donors (RDs) of hematopoietic cell products, and an increase in serious adverse events associated with morbidities in this population. As a result, specific requirements to safeguard RD health have been introduced to FACT-JACIE Standards, but the impact of accreditation on RD care has not previously been evaluated. A survey of transplant program directors of EBMT member centers was conducted by the Donor Health and Safety Working Committee of the Center for International Blood and Marrow Transplant Research (CIBMTR) to test the hypothesis that RD care in FACT-JACIE accredited centers is more closely aligned with international consensus donor care recommendations than RD care delivered in centers without accreditation. Responses were received from 39% of 304 centers. Our results show that practice in accredited centers was much closer to recommended standards as compared to non-accredited centers. Specifically, a higher percentage of accredited centers use eligibility criteria to assess RDs (93% versus 78%; P=0.02) and a lower percentage have a single physician simultaneously responsible for a RD and their recipient (14% versus 35%; P=0.008). In contrast, where regulatory standards do not exist, both accredited and non-accredited centers fell short of accepted best practice. These results raise concerns that despite improvements in care, current practice can place undue pressure on donors, and may increase the risk of donation-associated adverse events. We recommend measures to address these issues through enhancement of regulatory standards as well as national initiatives to standardize RD care. PMID:26597079

Determinants of Effective Information Transfer in International Regulatory Standards Adoption

ERIC Educational Resources Information Center

Popescu, Denisa

2010-01-01

The role of international regulatory standards within the current global environment has become of the most importance. The age of the global system and free market capitalism carried us into the unprecedented age of regulations, and standard setting. Regulations are now becoming the emerging mode of global governance. This study focuses on…

Energy-Efficiency Labels and Standards: A Guidebook forAppliances, Equipment, and Lighting - 2nd Edition

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

Wiel, Stephen; McMahon, James E.

2005-04-28

Energy-performance improvements in consumer products are an essential element in any government's portfolio of energy-efficiency and climate change mitigation programs. Governments need to develop balanced programs, both voluntary and regulatory, that remove cost-ineffective, energy-wasting products from the marketplace and stimulate the development of cost-effective, energy-efficient technology. Energy-efficiency labels and standards for appliances, equipment, and lighting products deserve to be among the first policy tools considered by a country's energy policy makers. The U.S. Agency for International Development (USAID) and several other organizations identified on the cover of this guidebook recognize the need to support policy makers in their efforts tomore » implement energy-efficiency standards and labeling programs and have developed this guidebook, together with the Collaborative Labeling and Appliance Standards Program (CLASP), as a primary reference. This second edition of the guidebook was prepared over the course of the past year, four years after the preparation of the first edition, with a significant contribution from the authors and reviewers mentioned previously. Their diligent participation helps maintain this book as the international guidance tool it has become. The lead authors would like to thank the members of the Communications Office of the Environmental Energy Technologies Division, Lawrence Berkeley National Laboratory for their support in the development, production, and distribution of the guidebook. This guidebook is designed as a manual for government officials and others around the world responsible for developing, implementing, enforcing, monitoring, and maintaining labeling and standards setting programs. It discusses the pros and cons of adopting energy-efficiency labels and standards and describes the data, facilities, and institutional and human resources needed for these programs. It provides guidance on the design, development, implementation, maintenance, and evaluation of the programs and on the design of the labels and standards themselves. In addition, it directs the reader to references and other resources likely to be useful in conducting the activities described and includes a chapter on energy policies and programs that complement appliance efficiency labels and standards. This guidebook attempts to reflect the essential framework of labeling and standards programs. It is the intent of the authors and sponsor to distribute copies of this book worldwide, at no charge, for the general public benefit. The guidebook is also available on the web at www.clasponline.org and may be downloaded to be used intact or piecemeal for whatever beneficial purposes readers may conceive.« less

Energy-efficiency labels and standards: A guidebook for appliances, equipment and lighting

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

McMahon, James E.; Wiel, Stephen

2001-02-16

Energy-performance improvements in consumer products are an essential element in any government's portfolio of energy-efficiency and climate change mitigation programs. Governments need to develop balanced programs, both voluntary and regulatory, that remove cost-ineffective, energy-wasting products from the marketplace and stimulate the development of cost-effective, energy-efficient technology. Energy-efficiency labels and standards for appliances, equipment, and lighting products deserve to be among the first policy tools considered by a country's energy policy makers. The U.S. Agency for International Development (USAID) and the United Nations Foundation (UNF) recognize the need to support policy makers in their efforts to implement energy-efficiency standards and labelingmore » programs and have developed this guidebook, together with the Collaborative Labeling and Appliance Standards Program (CLASP), as a primary reference. This guidebook was prepared over the course of the past year with significant contribution from the authors and reviewers mentioned previously. Their diligent participation has made this the international guidance tool it was intended to be. The lead authors would also like to thank the following individuals for their support in the development, production, and distribution of the guidebook: Marcy Beck, Elisa Derby, Diana Dhunke, Ted Gartner, and Julie Osborn of Lawrence Berkeley National Laboratory as well as Anthony Ma of Bevilacqua-Knight, Inc. This guidebook is designed as a manual for government officials and others around the world responsible for developing, implementing, enforcing, monitoring, and maintaining labeling and standards-setting programs. It discusses the pros and cons of adopting energy-efficiency labels and standards and describes the data, facilities, and institutional and human resources needed for these programs. It provides guidance on the design, development, implementation, maintenance, and evaluation of the programs and on the design of the labels and standards themselves. In addition, it directs the reader to references and other resources likely to be useful in conducting the activities described and includes a chapter on energy policies and programs that complement appliance efficiency labels and standards. This guidebook attempts to reflect the essential framework of labeling and standards programs. It is the intent of the authors and sponsors to distribute copies of this book worldwide at no charge for the general public benefit. The guidebook is also available on the web at www.CLASPonline.org and can be downloaded to be used intact or piecemeal for whatever beneficial purposes readers may conceive.« less

75 FR 28073 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-19

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0181] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-3039, ``Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities.'' FOR FURTHER INFORMATION CONTACT: Kevin M....

76 FR 24539 - Final Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0181] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide (RG) 3.67, ``Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities.'' FOR FURTHER INFORMATION CONTACT: Kevin M. Ramse...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2011 CFR

2011-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2014 CFR

2014-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2010 CFR

2010-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2013 CFR

2013-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

30 CFR 701.2 - Objective.

Code of Federal Regulations, 2012 CFR

2012-07-01

... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

25 CFR 547.17 - How does a tribal gaming regulatory authority apply for a variance from these standards?

Code of Federal Regulations, 2010 CFR

2010-04-01

... CLASS II GAMES § 547.17 How does a tribal gaming regulatory authority apply for a variance from these... 25 Indians 2 2010-04-01 2010-04-01 false How does a tribal gaming regulatory authority apply for a variance from these standards? 547.17 Section 547.17 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT...

Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan

PubMed Central

Somekawa, Layla; Maegawa, Hikoichiro; Tsukada, Shinsuke; Nakamura, Takatoshi

2017-01-01

Currently, there are no standardized regulatory systems for herbal medicinal products worldwide. Communication and sharing of knowledge between different regulatory systems will lead to mutual understanding and might help identify topics which deserve further discussion in the establishment of common standards. Regulatory information on traditional herbal medicinal products in Japan is updated by the establishment of Application Guidance for over-the-counter non-Kampo Crude Drug Extract Products. We would like to report on updated regulatory information on the new Application Guidance. Methods for comparison of Crude Drug Extract formulation and standard decoction and criteria for application and the key points to consider for each criterion are indicated in the guidance. Establishment of the guidance contributes to improvements in public health. We hope that the regulatory information about traditional herbal medicinal products in Japan will be of contribution to tackling the challenging task of regulating traditional herbal products worldwide. PMID:28894633

Improving oversight of the graduate medical education enterprise: one institution's strategies and tools.

PubMed

Afrin, Lawrence B; Arana, George W; Medio, Franklin J; Ybarra, Angela F N; Clarke, Harry S

2006-05-01

Accreditation organizations, financial stakeholders, legal systems, and regulatory agencies have increased the need for accountability in educational processes and curricular outcomes of graduate medical education. This demand for greater programmatic monitoring has placed pressure on institutions with graduate medical education (GME) programs to develop greater oversight of these programs. Meeting these challenges requires development of new GME management strategies and tools for institutional GME administrators to scrutinize programs, while still allowing these programs the autonomy to develop and implement educational methods to meet their unique training needs. At the Medical University of South Carolina (MUSC), senior administrators in the college of medicine felt electronic information management was a critical strategy for success and thus proceeded to carefully select an electronic residency management system (ERMS) to provide functionality for both individual programs and the GME enterprise as a whole. Initial plans in 2002 for a phased deployment had to be changed to a much more rapid deployment due to regulatory issues. Extensive communication and cooperation among MUSC's GME leaders resulted in a successful deployment in 2003. Evaluation completion rates have substantially improved, duty hours are carefully monitored, patient safety has improved through more careful oversight of residents' procedural privileges, regulators have been pleased, and central GME administrative visibility of program performance has dramatically improved. The system is now being expanded to MUSC's medical school and other health professions colleges. The authors discuss lessons learned and opportunities and challenges ahead, which include improving tracking of development of procedural competency, establishing and monitoring program performance standards, and integrating the ERMS with GME reimbursement systems.

Sandia National Laboratories, California Environmental Management System program manual.

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

Larsen, Barbara L.

2012-03-01

The Sandia National Laboratories, California (SNL/CA) Environmental Management System (EMS) Program Manual documents the elements of the site EMS Program. The SNL/CA EMS Program conforms to the International Standard on Environmental Management Systems, ISO 14001:2004and Department of Energy (DOE) Order 436.1. Sandia National Laboratories, California (SNL/CA) has maintained functional environmental programs to assist with regulatory compliance for more than 30 years. During 2005, these existing programs were rolled into a formal environmental management system (EMS) that expands beyond the traditional compliance focus to managing and improving environmental performance and stewardship practices for all site activities. An EMS is a setmore » of inter-related elements that represent a continuing cycle of planning, implementing, evaluating, and improving processes and actions undertaken to achieve environmental policy and goals. The SNL/CA EMS Program conforms to the International Standard for Environmental Management Systems, ISO 14001:2004 (ISO 2004). The site first received ISO 14001 certification in September 2006 and recertification in 2009. SNL/CA's EMS Program is applicable to the Sandia, Livermore site only. Although SNL/CA operates as one organizational division of the overall Sandia National Laboratories, the EMS Program is site-specific, with site-specific objectives and targets. SNL/CA (Division 8000) benefits from the organizational structure as it provides corporate level policies, procedures, and standards, and established processes that connect to and support elements of the SNL/CA EMS Program. Additionally, SNL/CA's EMS Program benefits from two corporate functional programs (Facilities Energy and Water Resource Management and Fleet Services programs) that maintain responsibility for energy management and fleet services for all Sandia locations. Each EMS element is further enhanced with site-specific processes and standards. Division 8000 has several groups operating at Sandia National Laboratories, New Mexico (SNL/NM). Although these groups, from an organizational perspective, are part of Division 8000, they are managed locally and fall under the environmental requirements specific to their New Mexico location. The New Mexico groups in Division 8000 follow the corporate EMS Program for New Mexico operations.« less

Strawman II. Recommendations for a regulatory program for mining waste and materials under Subtitle D of the Resource Conservation and Recovery Act. Final report

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

Not Available

1990-05-21

The package, referred to as 'Strawman II', is a working document that represents EPA's latest staff position on an effective program to regulate wastes and other materials uniquely associated with noncoal mining. Strawman II does not represent a proposed rule. The package consists of two parts: (1) the Foreward, which describes the pre-rulemaking Strawman process, a background and overview of the mining waste program as envisioned in the package, and discussions of major issues concerning the program and its scope; and (2) the Regulatory Approach, presented as '40 CFR XXX, XXY, and XXZ' to reflect how the program might appearmore » in regulatory language. Discussions and amplifications of specific points are also interspersed throughout the Regulatory Approach. EPA encourages all interested parties to convey their views on any and all aspects of the program concept.« less

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.

76 FR 72220 - Incorporation of Risk Management Concepts in Regulatory Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-22

... and support the adoption of improved designs or processes. \\1\\ A deterministic approach to regulation... longstanding goal to move toward more risk-informed, performance- based approaches in its regulatory programs... regulatory approach that would continue to ensure the safe and secure use of nuclear material. As part of...

76 FR 39922 - Office of New Reactors; Proposed Revision 4 to Standard Review Plan Section 8.1 on Electric Power...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... the proposed Revision 4 to Standard Review Plan Section 8.1 on ``Electric Power-- Introduction.'' The... NUCLEAR REGULATORY COMMISSION [NRC-2011-0119] Office of New Reactors; Proposed Revision 4 to Standard Review Plan Section 8.1 on Electric Power--Introduction, Correction AGENCY: Nuclear Regulatory...

75 FR 29588 - Office of New Reactors: Proposed NUREG-0800; Standard Review Plan Section 13.6.6, Draft Revision...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0184] Office of New Reactors: Proposed NUREG-0800; Standard Review Plan Section 13.6.6, Draft Revision 0 on Cyber Security Plan AGENCY: Nuclear Regulatory... Plants,'' on a proposed Standard Review Plan (SRP) Section 13.6.6 on ``Cyber Security Plan'' (Agencywide...

76 FR 64047 - Montana Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Montana regulatory program (hereinafter, the ``Montana program'') under the Surface Mining...

76 FR 36040 - Wyoming Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-21

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Wyoming regulatory program (hereinafter, the ``Wyoming program'') under the Surface Mining...

78 FR 16204 - Wyoming Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-14

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Wyoming regulatory program (hereinafter, the ``Wyoming program'') under the Surface Mining...

76 FR 80310 - Wyoming Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-23

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Wyoming regulatory program (hereinafter, the ``Wyoming program'') under the Surface Mining...

76 FR 67635 - Alaska Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-02

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 902... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Alaska regulatory program (hereinafter, the ``Alaska program'') under the Surface Mining...

76 FR 64045 - Montana Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Montana regulatory program (hereinafter, the ``Montana program'') under the Surface Mining...

76 FR 76111 - Montana Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Montana regulatory program (hereinafter, the ``Montana program'') under the Surface Mining...

77 FR 25874 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938... Mining Reclamation and Enforcement (OSM), Interior. ACTION: Final rule; removal of required amendment... regulatory program (the ``Pennsylvania program'') regulations under the Surface Mining Control and...

77 FR 1430 - Maryland Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-10

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 920... Mining Reclamation and Enforcement (OSM), Interior. ACTION: Proposed rule; extension of the comment... the Maryland regulatory program (the ``Maryland program'') under the Surface Mining Control and...

75 FR 20269 - Regulatory Reporting Requirements for the Indian Community Development Block Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-19

...-AC79 Regulatory Reporting Requirements for the Indian Community Development Block Grant Program AGENCY... final rule revises the reporting requirements for the Indian Community Development Block Grants (ICDBG... Indian Community Development Block Grant (ICDBG) program. The purpose of the ICDBG program is the...

78 FR 52224 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... Trader Continuing Education Program (S501) is a computer-based education program developed by many of the... Continuing Education Program, which is developed and maintained by the Securities Industry Regulatory Council... change will authorize the Exchange to administer different CE programs to differently registered...

NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

NASA Technical Reports Server (NTRS)

Duda, Kristen; Scroggins, Sharon

2008-01-01

NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross-Agency cooperation that is vital to supporting NASA's mission.

NASA's Agency-wide Strategy for Environmental Regulatory Risk Analysis and Communication

NASA Technical Reports Server (NTRS)

Duda, Kristen; Scroggins. Sharon

2008-01-01

NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage aPi'iications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross-Agency cooperation that is vital to supporting NASA's mission.

30th Annual Drug Information Association (DIA) Europe 2018 (April 17-19, 2018 - Basel, Switzerland).

PubMed

Hamaui Cuadrado, S; Guinart Vidal, M

2018-05-01

The Drug Information Association (DIA) Europe held its annual meeting from April 17-19, 2018, in Basel, Switzerland. The key topics discussed in the 3-day meeting were related to pharmacovigilance, clinical development, patient engagement, data and data standards, preclinical development and early-phase clinical research, regulatory science, translational medicine and science, and value and access. The program was principally focused on the current opportunities and future landscape of the healthcare system as a result of the increasingly innovative technologies and effective utilization of big data. In addition, the critical need for collaboration and partnership between all the stakeholders of the healthcare system was highlighted. This report covers some of the regulatory sessions presented at the meeting in which regulators, payers, industry and patients presented their perspectives for discussion. Copyright 2018 Clarivate Analytics.

10 CFR 51.55 - Environmental report-standard design certification.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Environmental report-standard design certification. 51.55 Section 51.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...

Regulatory Actions - Final Mercury and Air Toxics Standards (MATS) for Power Plants

EPA Pesticide Factsheets

The U.S. Environmental Protection Agency (EPA) has proposed Mercury and Air Toxics Standards (MATS) for power plants to limit mercury, acid gases and other toxic pollution from power plants. This page describes Federal regulatory actions.

78 FR 11617 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938... Surface Mining Reclamation and Enforcement (OSM), Interior. ACTION: Proposed rule; reopening of comment... regulatory program (the ``Pennsylvania program'') under the Surface Mining Control and Reclamation Act of...

The problem of epistemic jurisdiction in global governance: The case of sustainability standards for biofuels.

PubMed

Winickoff, David E; Mondou, Matthieu

2017-02-01

While there is ample scholarly work on regulatory science within the state, or single-sited global institutions, there is less on its operation within complex modes of global governance that are decentered, overlapping, multi-sectorial and multi-leveled. Using a co-productionist framework, this study identifies 'epistemic jurisdiction' - the power to produce or warrant technical knowledge for a given political community, topical arena or geographical territory - as a central problem for regulatory science in complex governance. We explore these dynamics in the arena of global sustainability standards for biofuels. We select three institutional fora as sites of inquiry: the European Union's Renewable Energy Directive, the Roundtable on Sustainable Biomaterials, and the International Organization for Standardization. These cases allow us to analyze how the co-production of sustainability science responds to problems of epistemic jurisdiction in the global regulatory order. First, different problems of epistemic jurisdiction beset different standard-setting bodies, and these problems shape both the content of regulatory science and the procedures designed to make it authoritative. Second, in order to produce global regulatory science, technical bodies must manage an array of conflicting imperatives - including scientific virtue, due process and the need to recruit adoptees to perpetuate the standard. At different levels of governance, standard drafters struggle to balance loyalties to country, to company or constituency and to the larger project of internationalization. Confronted with these sometimes conflicting pressures, actors across the standards system quite self-consciously maneuver to build or retain authority for their forum through a combination of scientific adjustment and political negotiation. Third, the evidentiary demands of regulatory science in global administrative spaces are deeply affected by 1) a market for standards, in which firms and states can choose the cheapest sustainability certification, and 2) the international trade regime, in which the long shadow of WTO law exerts a powerful disciplining function.

75 FR 1830 - Final Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-13

... review of applications for permits and licenses. RG 5.71, ``Cyber Security Programs for Nuclear... NUCLEAR REGULATORY COMMISSION [NRC-2010-0009] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2011 CFR

2011-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2014 CFR

2014-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2012 CFR

2012-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2013 CFR

2013-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2010 CFR

2010-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

Using baldrige performance excellence program approaches in the pursuit of radiation oncology quality care, patient satisfaction, and workforce commitment.

PubMed

Sternick, Edward S

2011-01-01

The Malcolm Baldrige National Quality Improvement Act was signed into law in 1987 to advance US business competitiveness and economic growth. Administered by the National Institute of Standards and Technology, the Act created the Baldrige National Quality Program, recently renamed the Baldrige Performance Excellence Program. The comprehensive analytical approaches referred to as the Baldrige Healthcare Criteria, are very well-suited for the evaluation and sustainable improvement of radiation oncology management and operations. A multidisciplinary self-assessment approach is used for radiotherapy program evaluation and development in order to generate a fact-based, knowledge-driven system for improving quality of care, increasing patient satisfaction, enhancing leadership effectiveness, building employee engagement, and boosting organizational innovation. This methodology also provides a valuable framework for benchmarking an individual radiation oncology practice's operations and results against guidelines defined by accreditation and professional organizations and regulatory agencies.

The American mobile satellite system

NASA Technical Reports Server (NTRS)

Garner, William B.

1990-01-01

During 1989, the American Mobile Satellite Corporation (AMSC) was authorized to construct, launch, and operate satellites to provide mobile satellite services (MSS) to the U.S. and Puerto Rico. The AMSC has undertaken three major development programs to bring a full range of MSS services to the U.S. The first program is the space segment program that will result in the construction and launch of the satellites as well as the construction and installation of the supporting ground telemetry and command system. The second segment will result in the specification, design, development, construction, and installation of the Network Control System necessary for managing communications access to the satellites, and the specification and development of ground equipment for standard circuit switched and packet switched communications services. The third program is the Phase 1 program to provide low speed data services within the U.S. prior to availability of the AMSC satellites and ground segment. Described here are the present status and plans for these three programs as well as an update on related business arrangements and regulatory matters.

75 FR 34960 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-155-FOR; OSM 2010-0003] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... ``Pennsylvania program'') under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act...

78 FR 9807 - Utah Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-12

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944... Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We are approving an amendment to the Utah regulatory program (the ``Utah program'') under the Surface Mining...

Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result?

PubMed

Parke, Tom; Marchenko, Olga; Anisimov, Vladimir; Ivanova, Anastasia; Jennison, Christopher; Perevozskaya, Inna; Song, Guochen

2017-01-01

Designing an oncology clinical program is more challenging than designing a single study. The standard approaches have been proven to be not very successful during the last decade; the failure rate of Phase 2 and Phase 3 trials in oncology remains high. Improving a development strategy by applying innovative statistical methods is one of the major objectives of a drug development process. The oncology sub-team on Adaptive Program under the Drug Information Association Adaptive Design Scientific Working Group (DIA ADSWG) evaluated hypothetical oncology programs with two competing treatments and published the work in the Therapeutic Innovation and Regulatory Science journal in January 2014. Five oncology development programs based on different Phase 2 designs, including adaptive designs and a standard two parallel arm Phase 3 design were simulated and compared in terms of the probability of clinical program success and expected net present value (eNPV). In this article, we consider eight Phase2/Phase3 development programs based on selected combinations of five Phase 2 study designs and three Phase 3 study designs. We again used the probability of program success and eNPV to compare simulated programs. For the development strategies, we considered that the eNPV showed robust improvement for each successive strategy, with the highest being for a three-arm response adaptive randomization design in Phase 2 and a group sequential design with 5 analyses in Phase 3.

Quality control for federal clean water act and safe drinking water act regulatory compliance.

PubMed

Askew, Ed

2013-01-01

QC sample results are required in order to have confidence in the results from analytical tests. Some of the AOAC water methods include specific QC procedures, frequencies, and acceptance criteria. These are considered to be the minimum controls needed to perform the method successfully. Some regulatory programs, such as those in 40 CFR Part 136.7, require additional QC or have alternative acceptance limits. Essential QC measures include method calibration, reagent standardization, assessment of each analyst's capabilities, analysis of blind check samples, determination of the method's sensitivity (method detection level or quantification limit), and daily evaluation of bias, precision, and the presence of laboratory contamination or other analytical interference. The details of these procedures, their performance frequency, and expected ranges of results are set out in this manuscript. The specific regulatory requirements of 40 CFR Part 136.7 for the Clean Water Act, the laboratory certification requirements of 40 CFR Part 141 for the Safe Drinking Water Act, and the ISO 17025 accreditation requirements under The NELAC Institute are listed.

AFO Manure Management - Minnesota: Feedlot Registration

EPA Pesticide Factsheets

Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

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.

78 FR 52587 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-23

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70228; File No. 4-663] Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and Declaring Effective a Plan..., Inc. and the Topaz Exchange, LLC August 19, 2013. On July 2, 2013, the Financial Industry Regulatory...

AFO Manure Management - Michigan: Manure Transfer Requirements

EPA Pesticide Factsheets

Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

77 FR 7972 - Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... Prison Rape (Reg Plan Seq No. 85). References in boldface appear in The Regulatory Plan in part II of... 396. National Standards to Prevent, Detect, and Respond to Prison Rape Regulatory Plan: This entry is...

RSAT 2015: Regulatory Sequence Analysis Tools

PubMed Central

Medina-Rivera, Alejandra; Defrance, Matthieu; Sand, Olivier; Herrmann, Carl; Castro-Mondragon, Jaime A.; Delerce, Jeremy; Jaeger, Sébastien; Blanchet, Christophe; Vincens, Pierre; Caron, Christophe; Staines, Daniel M.; Contreras-Moreira, Bruno; Artufel, Marie; Charbonnier-Khamvongsa, Lucie; Hernandez, Céline; Thieffry, Denis; Thomas-Chollier, Morgane; van Helden, Jacques

2015-01-01

RSAT (Regulatory Sequence Analysis Tools) is a modular software suite for the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, appropriate to genome-wide data sets like ChIP-seq, (ii) transcription factor binding motif analysis (quality assessment, comparisons and clustering), (iii) comparative genomics and (iv) analysis of regulatory variations. Nine new programs have been added to the 43 described in the 2011 NAR Web Software Issue, including a tool to extract sequences from a list of coordinates (fetch-sequences from UCSC), novel programs dedicated to the analysis of regulatory variants from GWAS or population genomics (retrieve-variation-seq and variation-scan), a program to cluster motifs and visualize the similarities as trees (matrix-clustering). To deal with the drastic increase of sequenced genomes, RSAT public sites have been reorganized into taxon-specific servers. The suite is well-documented with tutorials and published protocols. The software suite is available through Web sites, SOAP/WSDL Web services, virtual machines and stand-alone programs at http://www.rsat.eu/. PMID:25904632

AFO Manure Management - Nevada: CAFO Drainage Collection Requirements

EPA Pesticide Factsheets

Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

AFO Manure Management - Virginia: Nutrient Management Inspector Qualifications

EPA Pesticide Factsheets

Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

AFO Manure Management - California: Implementing TMDL Wasteload Allocations

EPA Pesticide Factsheets

Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

[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.

10 CFR 63.144 - Quality assurance program change.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance program change. 63.144 Section 63.144 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC... assurance program information that duplicates language in quality assurance regulatory guides and quality...

77 FR 27814 - Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-11

... NUCLEAR REGULATORY COMMISSION [Project No. 753; NRC-2012-0019] Model Safety Evaluation for Plant... Regulatory Commission (NRC) is announcing the availability of the model safety evaluation (SE) for plant... the Improved Standard Technical Specification (ISTS), NUREG-1431, ``Standard Technical Specifications...

Standardization of SOPs to Evaluations: Impacts on Regulatory Decisions using Learning and Memory as Case Studies

EPA Science Inventory

In an era of global trade and regulatory cooperation, consistent and scientifically based interpretation of developmental neurotoxicity (DNT) studies is essential, particularly for non­ standard assays and variable endpoints. Because there is flexibility in the selection of ...

76 FR 4102 - Smart Grid Interoperability Standards; Supplemental Notice of Technical Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-24

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM11-2-000] Smart Grid... Federal Energy Regulatory Commission announced that a Technical Conference on Smart Grid Interoperability... National Institute of Standards and Technology are ready for Commission consideration in a rulemaking...

76 FR 31997 - Final Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the U.S...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0118] Final Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the U.S. Department of Homeland Security on Chemical Facility Anti-Terrorism Standards AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability. FOR FURTHER...

Current Regulations and Regulatory Actions

EPA Pesticide Factsheets

This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

The "déjà vu effect:" evaluation of United States medical device legislation, regulation, and the Food and Drug Administration's contentious 510(k) program.

PubMed

Bauman, Jordan

2012-01-01

With the Medical Device Amendments of 1976, Congress granted FDA authority to regulate medical devices by implementing a risk-based regulatory framework. Several years prior to this legislation, the Cooper Committee reviewed the medical device regulatory landscape and uncovered weaknesses that could be detrimental to public health. However, only after several high-profile incidents involving unsafe medical devices did Congress respond with strong legislation. Since 1976, additional medical device legislative revisions have been enacted to address deficiencies highlighted by various groups representing Congress, FDA, and industry. A repetitive conclusion from these groups has been that the 510(k) program is incapable of serving as a premarket evaluation of safety and effectiveness under the existing statutory framework. However, these legislative revisions did not change the statutory framework despite these repeated findings. In 2009, CDRH convened separate groups to again review the 510(k) program. While more comprehensive than previous initiatives, the observed deficiencies and the proposed recommendations are remarkably similar to those identified by their predecessors. This cyclical review of the medical device regulatory landscape whereby the same observations and recommendations are repeated yet the output of such review does not yield major legislative revision of the existing statutory framework can be described as the "déjà vu effect." This will continue unless Congress enacts legislation that implements a new statutory framework with a different standard other than substantial equivalence. In the past, Congress has implemented major legislation only after a public health crisis. Hopefully this will not be the driving force in the future.

Managers’ Perceptions of the Value and Impact of HAZWOPER Worker Health and Safety Training

PubMed Central

Riley, Kevin; Slatin, Craig; Rice, Carol; Rosen, Mitchel; Weidner, B. Louise; Fleishman, Jane; Alerding, Linda; Delp, Linda

2018-01-01

Background Worker training is a core component of the OSHA Hazardous Waste Operations and Emergency Response (HAZWOPER) standard, but few studies have considered what motivates managers to provide HAZWOPER training to employees or what they value in that training. Methods In 2012, four university-based programs conducted an exploratory survey of managers who sent employees to HAZWOPER courses. Results from 109 respondents were analyzed. Results Forty-two percent of respondents cited regulations as the most important reason to provide HAZWOPER training; many indicated they would provide less training if there were no standard in place. Three-quarters (74%) reported training had improved workplace conditions. Fewer than half said they were likely to involve trained employees in aspects of the organization’s H&S program. Discussion Compliance with regulatory requirements is an important factor shaping managers’ training delivery decisions. Managers recognize positive impacts of training. These impacts could be enhanced by further leveraging employee H&S knowledge and skills. PMID:26010141

Managers' perceptions of the value and impact of HAZWOPER worker health and safety training.

PubMed

Riley, Kevin; Slatin, Craig; Rice, Carol; Rosen, Mitchel; Weidner, B Louise; Fleishman, Jane; Alerding, Linda; Delp, Linda

2015-07-01

Worker training is a core component of the OSHA Hazardous Waste Operations and Emergency Response (HAZWOPER) standard, but few studies have considered what motivates managers to provide HAZWOPER training to employees or what they value in that training. In 2012, four university-based programs conducted an exploratory survey of managers who sent employees to HAZWOPER courses. Results from 109 respondents were analyzed. Forty-two percent of respondents cited regulations as the most important reason to provide HAZWOPER training; many indicated they would provide less training if there were no standard in place. Three-quarters (74%) reported training had improved workplace conditions. Fewer than half said they were likely to involve trained employees in aspects of the organization's H&S program. Compliance with regulatory requirements is an important factor shaping managers' training delivery decisions. Managers recognize positive impacts of training. These impacts could be enhanced by further leveraging employee H&S knowledge and skills. © 2015 Wiley Periodicals, Inc.

75 FR 76758 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-09

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63430; File No. 4-618] Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and Declaring Effective a Plan for the Allocation of Regulatory Responsibilities Between BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago Board Options Exchange, Inc., Chicago...

40 CFR 97.287 - Change in regulatory status.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS CAIR SO2 Opt-in Units § 97.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2... authority and the Administrator of such change in the CAIR SO2 opt-in unit's regulatory status, within 30...

30 CFR 730.12 - Requirements for regulatory programs in States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... imposition of a Federal program for regulation of surface coal mining and reclamation operations. Regulation..., DEPARTMENT OF THE INTERIOR PERMANENT REGULATORY PROGRAMS FOR NON-FEDERAL AND NON-INDIAN LANDS GENERAL... each State in which coal exploration and surface coal mining and reclamation operations are or may be...

30 CFR 730.12 - Requirements for regulatory programs in States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... imposition of a Federal program for regulation of surface coal mining and reclamation operations. Regulation..., DEPARTMENT OF THE INTERIOR PERMANENT REGULATORY PROGRAMS FOR NON-FEDERAL AND NON-INDIAN LANDS GENERAL... each State in which coal exploration and surface coal mining and reclamation operations are or may be...

30 CFR 730.12 - Requirements for regulatory programs in States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... imposition of a Federal program for regulation of surface coal mining and reclamation operations. Regulation..., DEPARTMENT OF THE INTERIOR PERMANENT REGULATORY PROGRAMS FOR NON-FEDERAL AND NON-INDIAN LANDS GENERAL... each State in which coal exploration and surface coal mining and reclamation operations are or may be...

40 CFR 97.87 - Change in regulatory status.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Change in regulatory status. 97.87 Section 97.87 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS Individual Unit Opt-ins...

78 FR 33122 - Policy Statement on Adequacy and Compatibility of Agreement State Programs; Statement of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-03

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0081] Policy Statement on Adequacy and Compatibility of Agreement State Programs; Statement of Principles and Policy for the Agreement State Program AGENCY: Nuclear.... Nuclear Regulatory Commission (NRC) is proposing revisions to its policy statements on Agreement State...

30 CFR 906.15 - Approval of Colorado regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Approval of Colorado regulatory program amendments. 906.15 Section 906.15 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE COLORADO...

77 FR 36014 - Initial Test Program of Emergency Core Cooling Systems for Boiling-Water Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0134] Initial Test Program of Emergency Core Cooling... for public comment draft regulatory guide (DG), DG-1277, ``Initial Test Program of Emergency Core... acceptable to implement with regard to initial testing features of emergency core cooling systems (ECCSs) for...

Plant maintenance and advanced reactors issue, 2004

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

Agnihotri, Newal

2004-09-15

The focus of the September-October issue is on plant maintenance and advanced reactors. Major articles/reports in this issue include: Optimism about the future of nuclear power, by Ruth G. Shaw, Duke Power Company; Licensed in three countries, by GE Energy; Enhancing public acceptance, by Westinghouse Electric Company; Standardized MOV program, by Ted Neckowicz, Exelon; Inservice testing, by Steven Unikewicz, U.S. Nuclear Regulatory Commission; Asian network for education, Fatimah Mohd Amin, Malaysian Institute for Nuclear Technology Research; and, Cooling water intake optimization, by Jeffrey M. Jones and Bert Mayer, P.E., Framatome ANP.

77 FR 53769 - Receipts-Based, Small Business Size Standard; Confirmation of Effective Date

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-04

...-Based, Small Business Size Standard; Confirmation of Effective Date AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule; confirmation of effective date. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is confirming the effective date of August 22, 2012, for the direct final rule that appeared...

12 CFR 1263.11 - Financial condition requirement for depository institutions and CDFI credit unions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... following documents: (1) Regulatory financial reports. The regulatory financial reports filed by the... standards by a certified public accounting firm which submits a report on the applicant; (ii) The most... accepted auditing standards by a certified public accounting firm which submits a report on the...

12 CFR 1263.11 - Financial condition requirement for depository institutions and CDFI credit unions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... following documents: (1) Regulatory financial reports. The regulatory financial reports filed by the... standards by a certified public accounting firm which submits a report on the applicant; (ii) The most... accepted auditing standards by a certified public accounting firm which submits a report on the...

12 CFR 1263.11 - Financial condition requirement for depository institutions and CDFI credit unions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... following documents: (1) Regulatory financial reports. The regulatory financial reports filed by the... standards by a certified public accounting firm which submits a report on the applicant; (ii) The most... accepted auditing standards by a certified public accounting firm which submits a report on the...

12 CFR 1263.11 - Financial condition requirement for depository institutions and CDFI credit unions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... following documents: (1) Regulatory financial reports. The regulatory financial reports filed by the... standards by a certified public accounting firm which submits a report on the applicant; (ii) The most... accepted auditing standards by a certified public accounting firm which submits a report on the...

76 FR 40738 - Agency Information Collection Activities: Proposed Collection; Comment Request; Standard Flood...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-11

... Community Development and Regulatory Improvement Act of 1994 was signed into law. Section 303 (a) of this... requirement for federally regulated lending institutions to determine whether a building or mobile home... Regulatory Improvement Act of 1994. The establishment of the Standard Flood Hazard Determination form has...

Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting children's early self-regulation development: study protocol for a cluster randomized controlled trial.

PubMed

Howard, Steven J; Vasseleu, Elena; Neilsen-Hewett, Cathrine; Cliff, Ken

2018-01-24

For children with low self-regulation in the preschool years, the likelihood of poorer intellectual, health, wealth and anti-social outcomes in adulthood is overwhelming. Yet this knowledge has not yielded a framework for understanding self-regulatory change, nor generated particularly successful methods for enacting this change. Reconciling insights from cross-disciplinary theory, research and practice, this study seeks to implement a newly developed program of low-cost and routine practices and activities for supporting early self-regulatory development within preschool contexts and to evaluate its effect on children's self-regulation, executive function and school readiness; and educator perceived knowledge, attitudes and self-efficacy related to self-regulation. The Early Start to Self-Regulation study is a cluster randomized, controlled trial for evaluating benefits of the Preschool Situational Self-Regulation Toolkit (PRSIST) program, when implemented by early childhood educators, compared with routine practice. The PRSIST program combines professional learning, adult practices, child activities and connections to the home to support children's self-regulation development. Fifty preschool centers in New South Wales, Australia, will be selected to ensure a range of characteristics, namely: National Quality Standards (NQS) ratings, geographic location and socioeconomic status. After collection of baseline child and educator data, participating centers will then be randomly allocated to one of two groups, stratified by NQS rating: (1) an intervention group (25 centers) that will implement the PRSIST program; or (2) a control group (25 centers) that will continue to engage in practice as usual. Primary outcomes at the child level will be two measures of self-regulation: Head-Toes-Knees-Shoulders task and the PRSIST observational assessment. Secondary outcomes at the child level will be adult-reported measures of child self-regulation, executive function and school readiness. Outcomes at the educator level will involve a survey of their perceived knowledge, attitudes and self-efficacy for supporting children's self-regulatory development. In all cases, data collectors will be blinded to group allocation. This is the first randomized controlled trial of a new program to foster early self-regulation, using low-cost practices and activities that are aligned with early-years contexts, routines and practices. Results will provide important information about the efficacy of this approach and evaluate its underlying model of self-regulatory change. Australian New Zealand Clinical Trials Registry, ACTRN12617001568303 . Registered on 21 November 2017.

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

Korsah, K.; Wood, R.T.; Hassan, M.

This document presents the results of studies sponsored by the Nuclear Regulatory Commission (NRC) to provide the technical basis for environmental qualification of computer-based safety equipment in nuclear power plants. The studies were conducted by Oak Ridge National Laboratory (ORNL), Sandia National Laboratories (SNL), and Brookhaven National Laboratory (BNL). The studies address the following: (1) adequacy of the present test methods for qualification of digital I and C systems; (2) preferred (i.e., Regulatory Guide-endorsed) standards; (3) recommended stressors to be included in the qualification process during type testing; (4) resolution of need for accelerated aging for equipment to be locatedmore » in a benign environment; and (5) determination of an appropriate approach for addressing the impact of smoke in digital equipment qualification programs. Significant findings from the studies form the technical basis for a recommended approach to the environmental qualification of microprocessor-based safety-related equipment in nuclear power plants.« less

A hybrid health service accreditation program model incorporating mandated standards and continuous improvement: interview study of multiple stakeholders in Australian health care.

PubMed

Greenfield, David; Hinchcliff, Reece; Hogden, Anne; Mumford, Virginia; Debono, Deborah; Pawsey, Marjorie; Westbrook, Johanna; Braithwaite, Jeffrey

2016-07-01

The study aim was to investigate the understandings and concerns of stakeholders regarding the evolution of health service accreditation programs in Australia. Stakeholder representatives from programs in the primary, acute and aged care sectors participated in semi-structured interviews. Across 2011-12 there were 47 group and individual interviews involving 258 participants. Interviews lasted, on average, 1 h, and were digitally recorded and transcribed. Transcriptions were analysed using textual referencing software. Four significant issues were considered to have directed the evolution of accreditation programs: altering underlying program philosophies; shifting of program content focus and details; different surveying expectations and experiences and the influence of external contextual factors upon accreditation programs. Three accreditation program models were noted by participants: regulatory compliance; continuous quality improvement and a hybrid model, incorporating elements of these two. Respondents noted the compatibility or incommensurability of the first two models. Participation in a program was reportedly experienced as ranging on a survey continuum from "malicious compliance" to "performance audits" to "quality improvement journeys". Wider contextual factors, in particular, political and community expectations, and associated media reporting, were considered significant influences on the operation and evolution of programs. A hybrid accreditation model was noted to have evolved. The hybrid model promotes minimum standards and continuous quality improvement, through examining the structure and processes of organisations and the outcomes of care. The hybrid model appears to be directing organisational and professional attention to enhance their safety cultures. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

The role of NASA's Water Resources applications area in improving access to water quality-related information and water resources management

NASA Astrophysics Data System (ADS)

Lee, C. M.

2016-02-01

The NASA Applied Sciences Program plays a unique role in facilitating access to remote sensing-based water information derived from US federal assets towards the goal of improving science and evidence-based decision-making in water resources management. The Water Resources Application Area within NASA Applied Sciences works specifically to develop and improve water data products to support improved management of water resources, with partners who are faced with real-world constraints and conditions including cost and regulatory standards. This poster will highlight the efforts and collaborations enabled by this program that have resulted in integration of remote sensing-based information for water quality modeling and monitoring within an operational context.

The role of NASA's Water Resources applications area in improving access to water quality-related information and water resources management

NASA Astrophysics Data System (ADS)

Lee, C. M.

2016-12-01

The NASA Applied Sciences Program plays a unique role in facilitating access to remote sensing-based water information derived from US federal assets towards the goal of improving science and evidence-based decision-making in water resources management. The Water Resources Application Area within NASA Applied Sciences works specifically to develop and improve water data products to support improved management of water resources, with partners who are faced with real-world constraints and conditions including cost and regulatory standards. This poster will highlight the efforts and collaborations enabled by this program that have resulted in integration of remote sensing-based information for water quality modeling and monitoring within an operational context.

17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

Code of Federal Regulations, 2011 CFR

2011-04-01

... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

Code of Federal Regulations, 2012 CFR

2012-04-01

... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

Code of Federal Regulations, 2014 CFR

2014-04-01

... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

Code of Federal Regulations, 2010 CFR

2010-04-01

... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

Code of Federal Regulations, 2013 CFR

2013-04-01

... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

10 CFR 1.45 - Office of Nuclear Regulatory Research.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

10 CFR 1.45 - Office of Nuclear Regulatory Research.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

10 CFR 1.45 - Office of Nuclear Regulatory Research.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

10 CFR 1.45 - Office of Nuclear Regulatory Research.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

10 CFR 1.45 - Office of Nuclear Regulatory Research.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

AFO Manure Management - Oregon: Plan Review and Public Notice of Substantial Changes

EPA Pesticide Factsheets

Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

47 CFR 1.1167 - Error claims related to regulatory fees.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Challenges to determinations or an insufficient regulatory fee payment or delinquent fees should be made in writing. A challenge to a determination that a party is delinquent in paying a standard regulatory fee... 47 Telecommunication 1 2010-10-01 2010-10-01 false Error claims related to regulatory fees. 1.1167...

10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise.

PubMed

Khan, Saeed R; Kona, Ravikanth; Faustino, Patrick J; Gupta, Abhay; Taylor, Jeb S; Porter, Donna A; Khan, Mansoor

2014-05-01

The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. In addition to the substantial cost benefits, the program also provides the FDA's Center for Drug Evaluation and Research with significant scientific understanding and pharmaceutical resource. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. The database also serves as a scientific resource for mechanistic understanding and identification of test failures leading to the development of new formulations or more robust packaging. It has been recognized that SLEP is very important in maintaining both national security and public welfare by confirming that the stockpiled pharmaceutical products meet quality standards after the "expiration date" assigned by the sponsor. SLEP research is an example of regulatory science that is needed to best ensure product performance past the original shelf life. The objective of this article is to provide a brief history and background and most importantly the public health benefits of the SLEP. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Optimizing fish sampling for fish - mercury bioaccumulation factors

USGS Publications Warehouse

Scudder Eikenberry, Barbara C.; Riva-Murray, Karen; Knightes, Christopher D.; Journey, Celeste A.; Chasar, Lia C.; Brigham, Mark E.; Bradley, Paul M.

2015-01-01

Fish Bioaccumulation Factors (BAFs; ratios of mercury (Hg) in fish (Hgfish) and water (Hgwater)) are used to develop Total Maximum Daily Load and water quality criteria for Hg-impaired waters. Both applications require representative Hgfish estimates and, thus, are sensitive to sampling and data-treatment methods. Data collected by fixed protocol from 11 streams in 5 states distributed across the US were used to assess the effects of Hgfish normalization/standardization methods and fish sample numbers on BAF estimates. Fish length, followed by weight, was most correlated to adult top-predator Hgfish. Site-specific BAFs based on length-normalized and standardized Hgfish estimates demonstrated up to 50% less variability than those based on non-normalized Hgfish. Permutation analysis indicated that length-normalized and standardized Hgfish estimates based on at least 8 trout or 5 bass resulted in mean Hgfish coefficients of variation less than 20%. These results are intended to support regulatory mercury monitoring and load-reduction program improvements.

Watershed monitoring and modelling and USA regulatory compliance.

PubMed

Turner, B G; Boner, M C

2004-01-01

The aim of the Columbus program was to implement a comprehensive watershed monitoring-network including water chemistry, aquatic biology and alternative sensors to establish water environment health and methods for determining future restoration progress and early warning for protection of drinking water supplies. The program was implemented to comply with USA regulatory requirements including Total Maximum Daily Load (TMDL) rules of the Clean Water Act (CWA) and Source Water Assessment and Protection (SWAP) rules under the Safe Drinking Water Act (SDWA). The USEPA Office of Research and Development and the Water Environment Research Foundation provided quality assurance oversight. The results obtained demonstrated that significant wet weather data is necessary to establish relationships between land use, water chemistry, aquatic biology and sensor data. These measurements and relationships formed the basis for calibrating the US EPA BASINS Model, prioritizing watershed health and determination of compliance with water quality standards. Conclusions specify priorities of cost-effective drainage system controls that attenuate stormwater flows and capture flushed pollutants. A network of permanent long-term real-time monitoring using combination of continuous sensor measurements, water column sampling and aquatic biology surveys and a regional organization is prescribed to protect drinking water supplies and measure progress towards water quality targets.

ICH: an exclusive club of drug regulatory agencies and drug companies imposing its rules on the rest of the world.

PubMed

2010-08-01

Under the pretext of harmonising regulatory requirements for marketing authorisation of new drugs, the drug regulatory agencies of the world's wealthiest countries and three pharmaceutical industry trade associations, joined together since 1990 in the ICH, are promoting their own interests by imposing their criteria for evaluating drugs on the whole world. The toxicity standards advocated by ICH sometimes promote faster, cheaper drug development over patient protection. The drug quality standards advocated by ICH sometimes increase manufacturing costs without providing any public health benefit. It would be preferable if the World Health Organization were in charge of setting standards for drug development, focusing on patients' interests.

78 FR 64397 - Mississippi Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... text of the program amendment available at www.regulations.gov . A. Mississippi Surface Coal Mining... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 924...; S2D2SSS08011000SX066A00033F13XS501520] Mississippi Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement...

30 CFR 944.15 - Approval of Utah regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

30 CFR 944.15 - Approval of Utah regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

30 CFR 944.15 - Approval of Utah regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

30 CFR 944.15 - Approval of Utah regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

30 CFR 944.15 - Approval of Utah regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

Human Factors Engineering Program Review Model (NUREG-0711)Revision 3: Update Methodology and Key Revisions

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

OHara J. M.; Higgins, J.; Fleger, S.

The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodicmore » update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. NUREG-0711 is the first document to be addressed. We present the methodology used to update NUREG-0711 and summarize the main changes made. Finally, we discuss the current status of the update program and the future plans.« less

RSAT 2015: Regulatory Sequence Analysis Tools.

PubMed

Medina-Rivera, Alejandra; Defrance, Matthieu; Sand, Olivier; Herrmann, Carl; Castro-Mondragon, Jaime A; Delerce, Jeremy; Jaeger, Sébastien; Blanchet, Christophe; Vincens, Pierre; Caron, Christophe; Staines, Daniel M; Contreras-Moreira, Bruno; Artufel, Marie; Charbonnier-Khamvongsa, Lucie; Hernandez, Céline; Thieffry, Denis; Thomas-Chollier, Morgane; van Helden, Jacques

2015-07-01

RSAT (Regulatory Sequence Analysis Tools) is a modular software suite for the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, appropriate to genome-wide data sets like ChIP-seq, (ii) transcription factor binding motif analysis (quality assessment, comparisons and clustering), (iii) comparative genomics and (iv) analysis of regulatory variations. Nine new programs have been added to the 43 described in the 2011 NAR Web Software Issue, including a tool to extract sequences from a list of coordinates (fetch-sequences from UCSC), novel programs dedicated to the analysis of regulatory variants from GWAS or population genomics (retrieve-variation-seq and variation-scan), a program to cluster motifs and visualize the similarities as trees (matrix-clustering). To deal with the drastic increase of sequenced genomes, RSAT public sites have been reorganized into taxon-specific servers. The suite is well-documented with tutorials and published protocols. The software suite is available through Web sites, SOAP/WSDL Web services, virtual machines and stand-alone programs at http://www.rsat.eu/. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

75 FR 59261 - Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. RM06-16-010; RM06-16-011] Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical Conference September 17, 2010. On August 19, 2010 the Federal Energy Regulatory Commission announced that a Technical...

75 FR 61478 - Mandatory Reliability Standards for the Bulk Power System; Notice Allowing Post-Technical...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. RM06-16-010; RM06-16-011] Mandatory Reliability Standards for the Bulk Power System; Notice Allowing Post-Technical Conference Comments September 24, 2010. On September 23, 2010, the Federal Energy Regulatory Commission conducted a...

75 FR 57764 - Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-22

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. RM06-16-010; RM06-16-011] Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical Conference September 14, 2010. On August 19, 2010 the Federal Energy Regulatory Commission announced that a Technical...

Synthetic fiber production facilities: Background information for proposed standards

NASA Astrophysics Data System (ADS)

Goodwin, D. R.

1982-10-01

Standards of performance to control emissions of volatile organic compounds (VOC) from new, modified, and reconstructed synthetic fiber production facilities are being proposed under section III of the Clean Air Act. This document contains information on the background and authority, regulatory alternatives considered, and environmental and economic impacts of the regulatory alternatives.

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...

78 FR 59982 - Revisions to Radiation Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-30

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Revisions to Radiation Protection AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan section; issuance. SUMMARY: The U.S. Nuclear Regulatory... for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition'': Section 12.1...

77 FR 66650 - Proposed Revisions to Radiation Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-06

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Proposed Revisions to Radiation Protection AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section revision; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is revising the following sections...

To recognize the use of international standards for making harmonized regulation of medical devices in Asia-pacific.

PubMed

Anand, K; Saini, Ks; Chopra, Y; Binod, Sk

2010-07-01

'Medical Devices' include everything from highly sophisticated, computerized, medical equipment, right down to simple wooden tongue depressors. Regulations embody the public expectations for how buildings and facilities are expected to perform and as such represent public policy. Regulators, who develop and enforce regulations, are empowered to act in the public's interest to set this policy and are ultimately responsible to the public in this regard. Standardization contributes to the basic infrastructure that underpins society including health and environment, while promoting sustainability and good regulatory practice. The international organizations that produce International Standards are the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), and the International Telecommunication Union (ITU). With the increasing globalization of markets, International Standards (as opposed to regional or national standards) have become critical to the trading process, ensuring a level playing field for exports, and ensuring that imports meet the internationally recognized levels of performance and safety. The development of standards is done in response to sectors and stakeholders that express a clearly established need for them. An industry sector or other stakeholder group typically communicates its requirement for standards to one of the national members. To be accepted for development, a proposed work item must receive a majority support of the participating members, who verify the global relevance of the proposed item. The regulatory authority (RA) should provide a method for the recognition of international voluntary standards and for public notification of such recognition. The process of recognition may vary from country to country. Recognition may occur by periodic publication of lists of standards that a regulatory authority has found will meet the Essential Principles. In conclusion, International standards, such as, basic standards, group standards, and product standards, are a tool for harmonizing regulatory processes, to assure the safety, quality, and performance of medical devices. Standards represent the opinion of experts from all interested parties, including industry, regulators, users, and others.

40 CFR 73.86 - State regulatory autonomy.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State regulatory autonomy. 73.86 Section 73.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... regulatory autonomy. Nothing in this subpart shall preclude a State or State regulatory authority from...

Contact Us - Division of Mining, Land, and Water

Science.gov Websites

Lands Coal Regulatory Program Large Mine Permits Mineral Property and Rights Mining Index Land Coal Regulatory Program 550 W. 7th Ave., Suite 900D Anchorage, AK 99501-3577 Phone: (907) 269-8650 Fax

Regulatory Aspects Of Implementing Electrokinetic Remediation

EPA Science Inventory

A better understanding of the environmental impact of hazardous waste management practices has led to new environmental laws and a comprehensive regulatory program. This program is designed to address remediation of past waste management practices and to ensure that the hazardou...

Essays on remote monitoring as an emerging tool for centralized management of decentralized wastewater systems

NASA Astrophysics Data System (ADS)

Solomon, Clement

According to the United States Environmental Protections Agency (USEPA), nearly one in four households in the United States depends on an individual septic system (commonly referred as an onsite system or a decentralized wastewater system) to treat and disperse wastewater. More than half of these systems are over 30 years old, and surveys indicate at least 10 to 20% might not be functioning properly. The USEPA concluded in its 1997 report to Congress that adequately managed decentralized wastewater systems (DWS) are a cost-effective and long-term option for meeting public health and water quality goals, particularly in less densely populated areas. The major challenge however is the absence of a guiding national regulatory framework based on consistent performance-based standards and lack of proper management of DWS. These inconsistencies pose a significant threat to our water resources, local economies, and public health. This dissertation addresses key policy and regulatory strategies needed in response to the new realities confronting decentralized wastewater management. The two core objectives of this research are to demonstrate the centralized management of DWS paradigm and to present a scientific methodology to develop performance-based standards (a regulatory shift from prescriptive methods) using remote monitoring. The underlying remote monitoring architecture for centralized DWS management and the value of science-based policy making are presented. Traditionally, prescriptive standards using conventional grab sampling data are the norm by which most standards are set. Three case studies that support the potential of remote monitoring as a tool for standards development and system management are presented. The results revealed a vital role for remote monitoring in the development of standardized protocols, policies and procedures that are greatly lacking in this field. This centralized management and remote monitoring paradigm fits well and complements current USEPA policy (13 elements of management); meets the growing need for qualitative data (objective and numerical); has better time efficiencies as real-time events are sampled and translated into machine-readable signals in a short period of time; allows cost saving rapid response to system recovery and operation; produces labor and economic efficiencies through targeted responses; and, improves the quality and operational costs of any management program. This project was funded by the USEPA grant # C-82878001 as part of the National Onsite Demonstration Project (NODP), West Virginia University.

76 FR 79231 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... Extend the Penny Pilot Program December 15, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange... Chapter V, Section 33 (Penny Pilot Program) of the Rules of the Boston Options Exchange Group, LLC (``BOX... penny increments on BOX (``Penny Pilot Program''). II. Self-Regulatory Organization's Statement of the...

Government regulation of forestry practices on private forest land in the United States: an assessment of state government responsibilities and program performance

Treesearch

Paul V. Ellefson; Michael A. Kilgore; James E. Granskog

2006-01-01

In 2003, a comprehensive assessment of state government, forest practice regulatory programs in the United States was undertaken. Involved was an extensive review of the literature and information gathering h m program administration in all 50 states. The assessment determined that regulatory programs focus on a wide range of forestry practices applied to private...

75 FR 26121 - Regulation of Fuels and Fuel Additives: Alternative Affirmative Defense Requirements for Ultra...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

...EPA is issuing a direct final rule to amend the diesel sulfur regulations to allow refiners, importers, distributors, and retailers of highway diesel fuel the option to use an alternative affirmative defense if the Agency finds highway diesel fuel samples above the specified sulfur standard at retail facilities. This alternative defense consists of a comprehensive program of quality assurance sampling and testing that would cover all participating companies that produce and/or distribute highway diesel fuel if certain other conditions are met. The sampling and testing program would be carried out by an independent surveyor. The program would be conducted pursuant to a survey plan approved by EPA that is designed to achieve the same objectives as the current regulatory quality assurance requirement. This rule also amends the gasoline benzene regulations to allow disqualified small refiners the same opportunity to generate gasoline benzene credits as that afforded to non-small refiners.

The transition to competency-based pediatric training in the United Arab Emirates.

PubMed

Ibrahim, Halah; Al Tatari, Hossam; Holmboe, Eric S

2015-04-01

Although competency-based medical education has become the standard for physician training in the West, many developing countries have not yet adopted competency-based training. In 2009 in the United Arab Emirates, the government regulatory and operational authorities for healthcare in Abu Dhabi mandated a wide-scale reform of the emirate's postgraduate residency programs to the competency-based framework of the newly formed Accreditation Council for Graduate Medical Education-International (ACGME-I). This article briefly describes the rationale for competency-based medical education and provides an overview of the transition from traditional, time-based residency training to competency-based postgraduate medical education for the Pediatrics residency programs in Abu Dhabi. We will provide data on the initial impact of this transition on resident performance and patient outcomes in a Pediatrics residency program in an academic medical center in the United Arab Emirates.

The use of performance standards by AAALAC International to evaluate ethical review in European institutions.

PubMed

Guillen, Javier

2010-02-01

During the past several decades, society has become increasingly concerned about the welfare of animals used in research. Today, the public asks scientists to justify the use of research animals and to be accountable for their welfare. Research institutions, government bodies and other regulatory authorities have developed mechanisms to ensure that researchers follow the principles of the 3Rs and use and care for research animals in an ethical manner. Additionally, organizations such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) have developed voluntary programs that can help researchers to ensure that they are caring for research animals appropriately. The author discusses how AAALAC International uses performance standards to evaluate the ethical review processes of European institutions.

REFINE WETLAND REGULATORY PROGRAM

EPA Science Inventory

The Tribes will work toward refining a regulatory program by taking a draft wetland conservation code with permitting incorporated to TEB for review. Progress will then proceed in developing a permit tracking system that will track both Tribal and fee land sites within reservati...

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

Thomas, H. P.; Basso, T. S.; Kroposki, B.

The Department of Energy (DOE) Distributed Power Program (DPP) is conducting work to complete, validate in the field, and support the development of a national interconnection standard for distributed energy resources (DER), and to address the institutional and regulatory barriers slowing the commercial adoption of DER systems. This work includes support for the IEEE standards, including P1547 Standard for Interconnecting Distributed Resources with Electric Power Systems, P1589 Standard for Conformance Test Procedures for Equipment Interconnecting Distributed Resources with Electric Power Systems, and the P1608 Application Guide. Work is also in progress on system integration research and development (R&D) on themore » interface and control of DER with local energy systems. Additional efforts are supporting high-reliability power for industry, evaluating innovative concepts for DER applications, and exploring plug-and-play interface and control technologies for intelligent autonomous interconnection systems. This paper summarizes (1) the current status of the IEEE interconnection standards and application guides in support of DER, and (2) the R&D in progress at the National Renewable Energy Laboratory (NREL) for interconnection and system integration and application of distributed energy resources.« less

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.

Allergen source materials: state-of-the-art.

PubMed

Esch, Robert E

2009-01-01

A variety of positive outcomes can be realized from validation and risk management activities (see Table 4). They are dependent on the participation of multiple functional groups including the quality unit, regulatory and legal affairs, engineering and production operations, research and development, and sales and marketing. Quality risk management is receiving increased attention in the area of public health, pharmacovigilance, and pharmaceutical manufacturing. Recent examples of its regulatory use in our industry include the assessment of the potential risks of transmissible spongiform encephalopathies (TSE) agents through contaminated products], the risks of precipitates in allergenic extracts, and the revision of the potency limits for standardized dust mite and grass allergen vaccines. Its application to allergen source material process validation activities allowed for a practical strategy, especially in a complex manufacturing environment involving hundreds of products with multiple intended uses. In addition, the use of tools such as FMEA was useful in evaluating proposed changes made to manufacturing procedures and product specifications, new regulatory actions, and customer feedback or complaints. The success of such a quality assurance programs will ultimately be reflected in the elimination or reduction of product failures, improvement in the detection and prediction of potential product failures, and increased confidence in product quality.

Final Technical Report for GO17004 Regulatory Logic: Codes and Standards for the Hydrogen Economy

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

Nakarado, Gary L.

The objectives of this project are to: develop a robust supporting research and development program to provide critical hydrogen behavior data and a detailed understanding of hydrogen combustion and safety across a range of scenarios, needed to establish setback distances in building codes and minimize the overall data gaps in code development; support and facilitate the completion of technical specifications by the International Organization for Standardization (ISO) for gaseous hydrogen refueling (TS 20012) and standards for on-board liquid (ISO 13985) and gaseous or gaseous blend (ISO 15869) hydrogen storage by 2007; support and facilitate the effort, led by the NFPA,more » to complete the draft Hydrogen Technologies Code (NFPA 2) by 2008; with experimental data and input from Technology Validation Program element activities, support and facilitate the completion of standards for bulk hydrogen storage (e.g., NFPA 55) by 2008; facilitate the adoption of the most recently available model codes (e.g., from the International Code Council [ICC]) in key regions; complete preliminary research and development on hydrogen release scenarios to support the establishment of setback distances in building codes and provide a sound basis for model code development and adoption; support and facilitate the development of Global Technical Regulations (GTRs) by 2010 for hydrogen vehicle systems under the United Nations Economic Commission for Europe, World Forum for Harmonization of Vehicle Regulations and Working Party on Pollution and Energy Program (ECE-WP29/GRPE); and to Support and facilitate the completion by 2012 of necessary codes and standards needed for the early commercialization and market entry of hydrogen energy technologies.« less

The pluralization of the international: Resistance and alter-standardization in regenerative stem cell medicine

PubMed Central

Rosemann, Achim; Chaisinthop, Nattaka

2016-01-01

The article explores the formation of an international politics of resistance and ‘alter-standardization’ in regenerative stem cell medicine. The absence of internationally harmonized regulatory frameworks in the clinical stem cell field and the presence of lucrative business opportunities have resulted in the formation of transnational networks adopting alternative research standards and practices. These oppose, as a universal global standard, strict evidence-based medicine clinical research protocols as defined by scientists and regulatory agencies in highly developed countries. The emergence of transnational spaces of alter-standardization is closely linked to scientific advances in rapidly developing countries such as China and India, but calls for more flexible regulatory frameworks, and the legitimization of experimental for-profit applications outside of evidence-based medical care, are emerging increasingly also within more stringently regulated countries, such as the United States and countries in the European Union. We can observe, then, a trend toward the pluralization of the standards, practices, and concepts in the stem cell field. PMID:26983174

17 CFR 31.13 - Financial reports of leverage transaction merchants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... designated self-regulatory organization and conforms to minimum financial standards and related reporting requirements set by such designated self-regulatory organization in its bylaws, rules, regulations, or... true and exact copy of each financial report which it files with such designated self-regulatory...

The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration to Accelerate Diagnosis and Treatment of Traumatic Brain Injury.

PubMed

Manley, Geoffrey T; MacDonald, Christine L; Markowitz, Amy; Stephenson, Diane; Robbins, Ann; Gardner, Raquel C; Winkler, Ethan A; Bodien, Yelena; Taylor, Sabrina; Yue, John K; Kannan, Lakshmi; Kumar, Allison; McCrea, Michael; Wang, Kevin K W

2017-03-31

The Traumatic Brain Injury Endpoints Development (TED) Initiative is a 5-year, Department of Defense (DoD) funded project that is working toward the ultimate goal of developing better designed clinical trials, leading to more precise diagnosis, and effective treatments for traumatic brain injury (TBI). TED is comprised of leading academic clinician-scientists, along with innovative industry leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropists, working collaboratively with regulatory authorities, specifically the US Food and Drug Administration (FDA). The goals of the TED Initiative are to gain consensus and validation of TBI clinical outcome assessment measures and biomarkers for endorsement by global regulatory agencies for use in drug and device development processes. This manuscript summarizes the Initiative's Stage 1 progress over the first 18 months, including intensive engagement with a number of FDA divisions responsible for review and validation of biomarkers and clinical outcome assessments, progression into the prequalification phase of FDA's Medical Device Development Tool program for a candidate set of neuroimaging biomarkers, and receipt of FDA's Recognition of Research Importance Letter regarding TBI. Other signal achievements relate to the creation of the TED Metadataset, harmonizing study measures across eight major TBI studies, and the leadership role played by TED investigators in the conversion of the NINDS TBI Common Data Elements (CDEs) to Clinical Data Interchange Standards Consortium (CDISC) standards. This paper frames both the near-term expectations and the Initiative's long-term vision to accelerate approval of treatments for patients affected by TBI in urgent need of effective therapies.

78 FR 13002 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938... Mining Reclamation and Enforcement (``OSM''), Interior. ACTION: Proposed rule; public comment period and... regulatory program under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or the ``Act...

75 FR 21889 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

...--Resetting Fixed Interest Rate 3245-AG03 286 504 Program Governance Regulations 3245-AG04 287 Small Business...). It also conforms SBA rules for the section 7(a) Business Loan Program and the Certified Development... Part XVI Small Business Administration ###Semiannual Regulatory Agenda### [[Page 21890

75 FR 35508 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

... Systems and Networks,'' requires licensees to develop cyber-security plans and programs to protect critical digital assets, including digital safety systems, from malicious cyber attacks. Regulatory Guide 5.71, ``Cyber Security Programs for Nuclear Facilities,'' provides guidance to meet the requirements of...

U.S. regulatory research program for implementation of burnup credit in transport casks

DOT National Transportation Integrated Search

2001-09-10

In 1999 the U.S. Nuclear Regulatory Commission (U.S. NRC) initiated a research program to : support the development of technical bases and guidance that would facilitate the implementation of : burnup credit into licensing activities for transport an...

Research papers and publications (1981-1987): Workload research program

NASA Technical Reports Server (NTRS)

Hart, Sandra G. (Compiler)

1987-01-01

An annotated bibliography of the research reports written by participants in NASA's Workload Research Program since 1981 is presented, representing the results of theoretical and applied research conducted at Ames Research Center and at universities and industrial laboratories funded by the program. The major program elements included: 1) developing an understanding of the workload concept; 2) providing valid, reliable, and practical measures of workload; and 3) creating a computer model to predict workload. The goal is to provide workload-related design principles, measures, guidelines, and computational models. The research results are transferred to user groups by establishing close ties with manufacturers, civil and military operators of aerospace systems, and regulatory agencies; publishing scientific articles; participating in and sponsoring workshops and symposia; providing information, guidelines, and computer models; and contributing to the formulation of standards. In addition, the methods and theories developed have been applied to specific operational and design problems at the request of a number of industry and government agencies.

Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

PubMed

Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

2017-10-01

The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas.

PubMed

Allchurch, Martin Harvey; Barbano, Dirceu Brás Aparecido; Pinheiro, Marie-Hélène; Lazdin-Helds, Janis

2016-05-01

This report considers how the experience of the European regulatory system might be applied to help strengthen the regulatory systems for medicines in the Region of the Americas. The work of the European Medicines Agencies (EMA) is carried out through its scientific committees, composed of members from European Economic Area countries. A robust legal framework allows EMA to coordinate resources from Member States' competent authorities, including, for example, assisting candidate countries as they prepare to join the European Union (EU). Capacity-building programs help countries adjust their regulatory systems ahead of full participation in the European medicines regulatory network. These programs facilitate adoption of common technical requirements, identify areas where action might be needed to ensure the smooth transposition of EU pharmaceutical law into national legislation, and prepare candidate countries for participation in EMA committees and the European regulatory network. The methodology of these programs could be of potential interest to the Pan American Health Organization (PAHO), the Regional Office of the World Health Organization for the Americas. Given resolutions adopted by the World Health Assembly and the PAHO Directing Council, there is a strong indication that the countries of the Region of the Americas wish to assemble a system that uses the existing regulatory capacity of some countries to strengthen local regulatory capacities in others.

7 CFR 4284.906 - State laws, local laws, regulatory commission regulations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 15 2013-01-01 2013-01-01 false State laws, local laws, regulatory commission...-Added Producer Grant Program General § 4284.906 State laws, local laws, regulatory commission regulations. If there are conflicts between this subpart and State or local laws or regulatory commission...

7 CFR 4284.906 - State laws, local laws, regulatory commission regulations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 15 2014-01-01 2014-01-01 false State laws, local laws, regulatory commission...-Added Producer Grant Program General § 4284.906 State laws, local laws, regulatory commission regulations. If there are conflicts between this subpart and State or local laws or regulatory commission...

7 CFR 4284.906 - State laws, local laws, regulatory commission regulations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 15 2012-01-01 2012-01-01 false State laws, local laws, regulatory commission...-Added Producer Grant Program General § 4284.906 State laws, local laws, regulatory commission regulations. If there are conflicts between this subpart and State or local laws or regulatory commission...

13 CFR 108.585 - Voluntary decrease in NMVC Company's Regulatory Capital.

Code of Federal Regulations, 2010 CFR

2010-01-01

...'s Regulatory Capital. 108.585 Section 108.585 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Managing the Operations of a NMVC Company Voluntary Decrease in Regulatory Capital § 108.585 Voluntary decrease in NMVC Company's Regulatory Capital. You must...

78 FR 35056 - Effectiveness of the Reactor Oversight Process Baseline Inspection Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0125] Effectiveness of the Reactor Oversight Process... the effectiveness of the reactor oversight process (ROP) baseline inspection program with members of... Nuclear Reactor Regulations, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301...

76 FR 6587 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-159-FOR; OSM 2010-0017] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). In response to a required...

76 FR 12849 - Kentucky Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... (underground mining). The text of the Kentucky regulations can be found in the administrative record and online... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 [KY-252-FOR; OSM-2009-0011] Kentucky Regulatory Program AGENCY: Office of Surface Mining Reclamation...

77 FR 46346 - Ohio Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-03

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 [OH-254-FOR; Docket ID OSM-2012-0012] Ohio Regulatory Program AGENCY: Office of Surface Mining... under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Ohio's proposed...

76 FR 12920 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-157-FOR; OSM 2010-0011] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). In response to a required...

Nome Offshore Mining Information

Science.gov Websites

Lands Coal Regulatory Program Large Mine Permits Mineral Property and Rights Mining Index Land potential safety concerns, prevent overcrowding, and provide for efficient processing of the permits and Regulatory Program Large Mine Permitting Mineral Property Management Mining Fact Sheets Mining Forms APMA

76 FR 4919 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0046] Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is...

75 FR 6404 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0045] (formerly Docket No. 2004N-0408) Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics...

7 CFR 2.79 - Administrator, Agricultural Marketing Service.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 1 2014-01-01 2014-01-01 false Administrator, Agricultural Marketing Service. 2.79... for Marketing and Regulatory Programs § 2.79 Administrator, Agricultural Marketing Service. (a... following delegations of authority are made by the Under Secretary for Marketing and Regulatory Programs to...

7 CFR 2.79 - Administrator, Agricultural Marketing Service.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 1 2012-01-01 2012-01-01 false Administrator, Agricultural Marketing Service. 2.79... for Marketing and Regulatory Programs § 2.79 Administrator, Agricultural Marketing Service. (a... following delegations of authority are made by the Under Secretary for Marketing and Regulatory Programs to...

7 CFR 2.79 - Administrator, Agricultural Marketing Service.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 1 2010-01-01 2010-01-01 false Administrator, Agricultural Marketing Service. 2.79... for Marketing and Regulatory Programs § 2.79 Administrator, Agricultural Marketing Service. (a... following delegations of authority are made by the Under Secretary for Marketing and Regulatory Programs to...

7 CFR 2.79 - Administrator, Agricultural Marketing Service.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 1 2011-01-01 2011-01-01 false Administrator, Agricultural Marketing Service. 2.79... for Marketing and Regulatory Programs § 2.79 Administrator, Agricultural Marketing Service. (a... following delegations of authority are made by the Under Secretary for Marketing and Regulatory Programs to...

76 FR 6589 - West Virginia Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 948 [WV-116-FOR; OSM-2009-0008] West Virginia Regulatory Program AGENCY: Office of Surface Mining... Mining Reclamation and Enforcement (OSM) characterized the change as non-substantive, and did not note...

Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Arizona. Preliminary background report

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

Feurer, D.A.; Weaver, C.L.; Gallagher, K.C.

1980-01-01

This report is one of a series of preliminary reports describing the laws and regulatory programs of the United States and each of the 50 states affecting the siting and operation of energy generating facilities likely to be used in Integrated Community Energy Systems (ICES). Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES. This report describes laws and regulatory programs in Arizona. The Arizona state constitution establishes themore » Arizona Corporation Commission to regulate public service corporations. Within the area of its jurisdiction, the Commission has exclusive power and may not be interfered with by the legislature except in one narrow instance as described in the case Corporation Commission v. Pacific Greyhound Lines.« less

Quality Management Program

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

Not Available

1991-10-01

According to {section} 35.32, Quality Management Program,'' of 10 CFR Part 35, Medical Use of Byproduct Material,'' applicants or licensees, as applicable, are required to establish a quality management (QM) program. This regulatory guide provides guidance to licensees and applicants for developing policies and procedures for the QM program. This guide does not restrict or limit the licensee from using other guidance that may be equally useful in developing a QM program, e.g., information available from the Joint Commission on Accreditation of Healthcare Organizations or the American College of Radiology. Any information collection activities mentioned in this regulatory guide aremore » contained as requirements in 10 CFR Part 35, which provides the regulatory basis for this guide. This information collection requirements in 10 CFR Part 35 have been cleared under OMB Clearance No. 3150-0010.« less

Implementation of a commercial-grade dedication program - Benefits and lessons learned

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

Harrington, M.; MacFarlane, I.

1991-01-01

The recent issuance of industry guidelines, the Nuclear Management and Resources Council procurement initiative, and a US Nuclear Regulatory Commission NRC generic letter on commercial-grade item dedication (CGD) has been viewed by many utility managers and executives as only adding to the existing burden of compliance with regulatory requirements. While the incorporation of these documents into existing CGD programs has created additional costs, the resulting enhanced dedication programs have also produced benefits beyond regulatory compliance, and some lessons have been learned. This paper discusses the benefits and the lessons learned during implementation of an enhanced CGD program at New Hampshiremore » Yankee's (NHY's) Seabrook nuclear plant. Based on NHY's experience, it is believed that the benefits described in this paper can be realized by other utilities implementing CGD programs.« less

77 FR 34221 - Air Quality Designations for the 2008 Ozone National Ambient Air Quality Standards for Several...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-11

... Regulatory Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E... preamble. APA Administrative Procedure Act CAA Clean Air Act CFR Code of Federal Regulations D.C. District... Authority Rule U.S. United States U.S.C. United States Code VCS Voluntary Consensus Standards VOC Volatile...

78 FR 38739 - Standard Format and Content for Post-Shutdown Decommissioning Activities Report

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-27

...The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 1 of Regulatory Guide (RG) 1.185, ``Standard Format and Content for Post-shutdown Decommissioning Activities Report.'' This guide describes a method that the NRC staff considers acceptable for use in complying with the Commission's requirements regarding the submission of a post-shutdown decommissioning activities report (PSDAR).

77 FR 75198 - Standard Format and Content for Post-Shutdown Decommissioning Activities Report

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

...The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1272, ``Standard Format and Content for Post-shutdown Decommissioning Activities Report.'' This guide describes a method that the NRC staff considers acceptable for use in complying with the Commission's requirements regarding the submission of a post-shutdown decommissioning activities report (PSDAR).

77 FR 12086 - Final Staff Guidance, Revision 4 to Standard Review Plan; Section 8.1 on Electric Power-Introduction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-28

... incorporate Revision 4 of SRP Section 8.1 into the next revisions of the Regulatory Guide 1.206, ``Combined..., 2011 (76 FR 31381), the NRC published for public comment the proposed Revision 4 on Section 8.1 on... NUCLEAR REGULATORY COMMISSION [NRC-2011-0119] Final Staff Guidance, Revision 4 to Standard Review...

Human factors in waste management - potential and reality

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

Thompson, J.S.

There is enormous potential for human factors contributions in the realm of waste management. The reality, however, is very different from the potential. This is particularly true for low-level and low-level mixed-waste management. The hazards are less severe; therefore, health and safety requirements (including human factors) are not as rigorous as for high-level waste. High-level waste management presents its own unique challenges and opportunities. Waste management is strongly driven by regulatory compliance. When regulations are flexible and open to interpretation and the environment is driven so strongly by regulatory compliance, standard practice is to drop {open_quotes}nice to have{close_quotes} features, likemore » a human factors program, to save money for complying with other requirements. The challenge is to convince decision makers that human factors can help make operations efficient and cost-effective, as well as improving safety and complying with regulations. A human factors program should not be viewed as competing with compliance efforts; in fact, it should complement them and provide additional cost-effective means of achieving compliance with other regulations. Achieving this synergy of human factors with ongoing waste management operations requires educating program and facility managers and other technical specialists about human factors and demonstrating its value {open_quotes}through the back door{close_quotes} on existing efforts. This paper describes ongoing projects at Los Alamos National Laboratory (LANL) in support of their waste management groups. It includes lessons learned from hazard and risk analyses, safety analysis reports, job and task analyses, operating procedure development, personnel qualification/certification program development, and facility- and job-specific training program and course development.« less

Navigational and vessel inspection circular No. 5-86. Voluntary standards for US uninspected commercial fishing vessels. Final report

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

NONE

1986-08-18

The vessel standards program, which this NVIC addresses, originally consisted of a series of five NVICs; Stability (5-85), Radio and Shipboard Navigation Equipment (6-85), Fire Safety Measures (7-85), Lifesaving Equipment and Protection of the Crew (8-85), and Hull, Machinery, and Electrical Installations (9-85). Many of these NVICs contained specific operational and educational material for fishermen which could be used before the `Vessel Safety Manual` was published; therefore, some material previously contained in any one of the NVICs has been moved to the manual, although some overlap still exists. Since input from the fishing industry and other interested parties was essential,more » the authors published NVICs 5-85 thru 9-85 as proposed standards and distributed them to over 230 individuals, groups and organizations throuoghout the U.S. who have an interest in fishing vessel safety. These groups included safety consultants, marine surveyors, naval architects, insurance underwriters, fishing vessel owners` associations, boat builders, fisheries unions, personnel associated with the National Oceanic and Atmospheric Administration Sea Grant program, and the National Marine Fisheries Service. Several sent detailed comments; all expressed a favorable reaction to the standards. This report is a consolidation of NVICs 5-85 thru 9-85 taking into account the comments and recommendations received. For continuity, certain regulatory requirements (although not voluntary) have been included where appropriate.« less

End of FY10 report - used fuel disposition technical bases and lessons learned : legal and regulatory framework for high-level waste disposition in the United States.

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

Weiner, Ruth F.; Blink, James A.; Rechard, Robert Paul

This report examines the current policy, legal, and regulatory framework pertaining to used nuclear fuel and high level waste management in the United States. The goal is to identify potential changes that if made could add flexibility and possibly improve the chances of successfully implementing technical aspects of a nuclear waste policy. Experience suggests that the regulatory framework should be established prior to initiating future repository development. Concerning specifics of the regulatory framework, reasonable expectation as the standard of proof was successfully implemented and could be retained in the future; yet, the current classification system for radioactive waste, including hazardousmore » constituents, warrants reexamination. Whether or not consideration of multiple sites are considered simultaneously in the future, inclusion of mechanisms such as deliberate use of performance assessment to manage site characterization would be wise. Because of experience gained here and abroad, diversity of geologic media is not particularly necessary as a criterion in site selection guidelines for multiple sites. Stepwise development of the repository program that includes flexibility also warrants serious consideration. Furthermore, integration of the waste management system from storage, transportation, and disposition, should be examined and would be facilitated by integration of the legal and regulatory framework. Finally, in order to enhance acceptability of future repository development, the national policy should be cognizant of those policy and technical attributes that enhance initial acceptance, and those policy and technical attributes that maintain and broaden credibility.« less

76 FR 60713 - Establishment of Class E Airspace; Bumpass, VA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... controlled airspace required to support the new RNA V GPS standard instrument approach procedures developed... regulatory action'' under Executive Order 12866; (2) is not a ``significant rule'' under DOT Regulatory... Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only...

12 CFR 218.701 - Exemption from the definition of “broker” for certain institutional referrals.

Code of Federal Regulations, 2010 CFR

2010-01-01

... rules of any self-regulatory organization; (B) Predominantly engaged in banking activities other than..., in accordance with the qualification standards established by the rules of any self-regulatory... dealer's applicable self-regulatory organization as if the broker or dealer had recommended the...

75 FR 14212 - Proposed Generic Communications; Applicability of 10 CFR Part 21 Requirements to Applicants for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0122] Proposed Generic Communications; Applicability of 10 CFR Part 21 Requirements to Applicants for Standard Design Certifications AGENCY: Nuclear Regulatory Commission. ACTION: Notice of opportunity for public comment. SUMMARY: The U.S. Nuclear Regulatory Commission...

EMI Standards for Wireless Voice and Data on Board Aircraft

NASA Technical Reports Server (NTRS)

Ely, Jay J.; Nguyen, Truong X.

2002-01-01

The use of portable electronic devices (PEDs) on board aircraft continues to be an increasing source of misunderstanding between passengers and flight-crews, and consequently, an issue of controversy between wireless product manufacturers and air transport regulatory authorities. This conflict arises primarily because of the vastly different regulatory objectives between commercial product and airborne equipment standards for avoiding electromagnetic interference (EMI). This paper summarizes international regulatory limits and test processes for measuring spurious radiated emissions from commercially available PEDs, and compares them to international standards for airborne equipment. The goal is to provide insight for wireless product developers desiring to extend the freedom of their customers to use wireless products on-board aircraft, and to identify future product characteristics, test methods and technologies that may facilitate improved wireless freedom for airline passengers.

76 FR 64043 - Iowa Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 915 [Docket No. IA-016-FOR; Docket ID: OSM-2011-0014] Iowa Regulatory Program AGENCY: Office of Surface Mining.... SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing receipt of a...

78 FR 63909 - Missouri Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 925... 08011000 SX066A00033 F13XS501520] Missouri Regulatory Program AGENCY: Office of Surface Mining Reclamation... hearing on proposed amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM...

32 CFR 300.2 - DLA FOIA regulatory precedence.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 2 2014-07-01 2014-07-01 false DLA FOIA regulatory precedence. 300.2 Section 300.2 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) FREEDOM OF INFORMATION ACT PROGRAM DEFENSE LOGISTICS AGENCY FREEDOM OF INFORMATION ACT PROGRAM General...

10 CFR 4.510 - Self-evaluation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Self-evaluation. 4.510 Section 4.510 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission § 4.510 Self-evaluation. (a) The...

76 FR 74834 - Interim Staff Guidance on Aging Management Program for Steam Generators

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

... NRC staff's evaluation of the suitability of using Revision 3 of the Nuclear Energy Institute's (NEI... NUCLEAR REGULATORY COMMISSION [NRC-2011-0228] Interim Staff Guidance on Aging Management Program for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION: Interim staff guidance; issuance...

3 CFR 13579 - Executive Order 13579 of July 11, 2011. Regulation and Independent Regulatory Agencies

Code of Federal Regulations, 2012 CFR

2012-01-01

..., streamline, expand, or repeal them in accordance with what has been learned. Such retrospective analyses... agency's regulatory program more effective or less burdensome in achieving the regulatory objectives. Sec...

Federal environmental standards of potential importance to operations and activities at US Department of Energy sites. Draft

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

Fowler, K.M.; Bilyard, G.R.; Davidson, S.A.

1993-06-01

The US Department of Energy (DOE) is now engaged in a program of environmental restoration nationwide across its 45 sites. It is also bringing its facilities into compliance with environmental regulations, decontaminating and decommissioning unwanted facilities, and constructing new waste management facilities. One of the most difficult questions that DOE must face in successfully remediating its inactive waste sites, decontaminating and decommissioning its inactive facilities, and operating its waste management facilities is: ``What criteria and standards should be met?`` Acceptable standards or procedures for determining standards will assist DOE in its conduct of ongoing waste management and pending cleanup activitiesmore » by helping to ensure that those activities are conducted in compliance with applicable laws and regulations and are accepted by the regulatory community and the public. This document reports on the second of three baseline activities that are being conducted as prerequisites to either the development of quantitative standards that could be used by DOE, or consistent procedures for developing such standards. The first and third baseline activities are also briefly discussed in conjunction with the second of the three activities.« less

Nutrition Standards for Away-from-home Foods in the United States

PubMed Central

Cohen, Deborah A.; Bhatia, Rajiv

2012-01-01

Away-from-home foods are regulated with respect to the prevention of food-borne diseases and potential contaminants, but not for their contribution to dietary-related chronic diseases. Away-from-home foods have more calories, salt, sugar, and fat and provide fewer fruits and vegetables than recommended by national nutrition guidelines; thus, frequent consumption of away-from-home foods contributes to obesity, hypertension, diabetes, heart disease, and cancer. In light of this, many localities are already adopting regulations or sponsoring programs to improve the quality of away-from-home foods. We review the rationale for developing nutritional performance standards for away-from-home foods in light of limited human capacity to regulate intake or physiologically compensate for a poor diet. We offer a set of model performance standards to be considered as a new area of environmental regulation. Models for voluntary implementation of consumer standards exist in the environmental domain and may be useful templates for implementation. Implementing such standards, whether voluntarily or via regulations, will require addressing a number of practical and ideological challenges. Politically, regulatory standards contradict the belief that adults should be able to navigate dietary risks in away-from-home settings unaided. PMID:22329431

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

Risk Analysis as Regulatory Science: Toward The Establishment of Standards

PubMed Central

Murakami, Michio

2016-01-01

Understanding how to establish standards is essential for risk communication and also provides perspectives for further study. In this paper, the concept of risk analysis as regulatory science for the establishment of standards is demonstrated through examples of standards for evacuation and provisional regulation values in foods and drinking water. Moreover, academic needs for further studies related to standards are extracted. The concepts of the traditional ‘Standard I’, which has a paternalistic orientation, and ‘Standard II’, established through stakeholder consensus, are then systemized by introducing the current status of the new standards-related movement that developed after the Fukushima nuclear power plant accident, and the perspectives of the standards are discussed. Preparation of standards on the basis of stakeholder consensus through intensive risk dialogue before a potential nuclear power plant accident is suggested to be a promising approach to ensure a safe society and enhance subjective well-being. PMID:27475751

Risk Analysis as Regulatory Science: Toward The Establishment of Standards.

PubMed

Murakami, Michio

2016-09-01

Understanding how to establish standards is essential for risk communication and also provides perspectives for further study. In this paper, the concept of risk analysis as regulatory science for the establishment of standards is demonstrated through examples of standards for evacuation and provisional regulation values in foods and drinking water. Moreover, academic needs for further studies related to standards are extracted. The concepts of the traditional 'Standard I', which has a paternalistic orientation, and 'Standard II', established through stakeholder consensus, are then systemized by introducing the current status of the new standards-related movement that developed after the Fukushima nuclear power plant accident, and the perspectives of the standards are discussed. Preparation of standards on the basis of stakeholder consensus through intensive risk dialogue before a potential nuclear power plant accident is suggested to be a promising approach to ensure a safe society and enhance subjective well-being. © The Author 2016. Published by Oxford University Press.

Evidence for Deep Regulatory Similarities in Early Developmental Programs across Highly Diverged Insects

PubMed Central

Zhang, Yinan; Samee, Md. Abul Hassan; Halfon, Marc S.; Sinha, Saurabh

2014-01-01

Many genes familiar from Drosophila development, such as the so-called gap, pair-rule, and segment polarity genes, play important roles in the development of other insects and in many cases appear to be deployed in a similar fashion, despite the fact that Drosophila-like “long germband” development is highly derived and confined to a subset of insect families. Whether or not these similarities extend to the regulatory level is unknown. Identification of regulatory regions beyond the well-studied Drosophila has been challenging as even within the Diptera (flies, including mosquitoes) regulatory sequences have diverged past the point of recognition by standard alignment methods. Here, we demonstrate that methods we previously developed for computational cis-regulatory module (CRM) discovery in Drosophila can be used effectively in highly diverged (250–350 Myr) insect species including Anopheles gambiae, Tribolium castaneum, Apis mellifera, and Nasonia vitripennis. In Drosophila, we have successfully used small sets of known CRMs as “training data” to guide the search for other CRMs with related function. We show here that although species-specific CRM training data do not exist, training sets from Drosophila can facilitate CRM discovery in diverged insects. We validate in vivo over a dozen new CRMs, roughly doubling the number of known CRMs in the four non-Drosophila species. Given the growing wealth of Drosophila CRM annotation, these results suggest that extensive regulatory sequence annotation will be possible in newly sequenced insects without recourse to costly and labor-intensive genome-scale experiments. We develop a new method, Regulus, which computes a probabilistic score of similarity based on binding site composition (despite the absence of nucleotide-level sequence alignment), and demonstrate similarity between functionally related CRMs from orthologous loci. Our work represents an important step toward being able to trace the evolutionary history of gene regulatory networks and defining the mechanisms underlying insect evolution. PMID:25173756

Evidence for deep regulatory similarities in early developmental programs across highly diverged insects.

PubMed

Kazemian, Majid; Suryamohan, Kushal; Chen, Jia-Yu; Zhang, Yinan; Samee, Md Abul Hassan; Halfon, Marc S; Sinha, Saurabh

2014-09-01

Many genes familiar from Drosophila development, such as the so-called gap, pair-rule, and segment polarity genes, play important roles in the development of other insects and in many cases appear to be deployed in a similar fashion, despite the fact that Drosophila-like "long germband" development is highly derived and confined to a subset of insect families. Whether or not these similarities extend to the regulatory level is unknown. Identification of regulatory regions beyond the well-studied Drosophila has been challenging as even within the Diptera (flies, including mosquitoes) regulatory sequences have diverged past the point of recognition by standard alignment methods. Here, we demonstrate that methods we previously developed for computational cis-regulatory module (CRM) discovery in Drosophila can be used effectively in highly diverged (250-350 Myr) insect species including Anopheles gambiae, Tribolium castaneum, Apis mellifera, and Nasonia vitripennis. In Drosophila, we have successfully used small sets of known CRMs as "training data" to guide the search for other CRMs with related function. We show here that although species-specific CRM training data do not exist, training sets from Drosophila can facilitate CRM discovery in diverged insects. We validate in vivo over a dozen new CRMs, roughly doubling the number of known CRMs in the four non-Drosophila species. Given the growing wealth of Drosophila CRM annotation, these results suggest that extensive regulatory sequence annotation will be possible in newly sequenced insects without recourse to costly and labor-intensive genome-scale experiments. We develop a new method, Regulus, which computes a probabilistic score of similarity based on binding site composition (despite the absence of nucleotide-level sequence alignment), and demonstrate similarity between functionally related CRMs from orthologous loci. Our work represents an important step toward being able to trace the evolutionary history of gene regulatory networks and defining the mechanisms underlying insect evolution. © The Author(s) 2014. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.

Biomass Burning Emissions – The Importance of Reducing Uncertainties for Improved Regulatory Decision; an EPA Perspective

EPA Science Inventory

Biomass burning emissions from wildland and prescribed fires can have far reaching impacts in several of EPA’s regulatory programs under the Clean Air Act, ultimately affecting decisions on actions taken under State Implementation Plans (SIPs), and programs such as Visibility and...

77 FR 73966 - Utah Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-12

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944 [SATS No. UT-049-FOR; Docket ID OSM-2012-0015] Utah Regulatory Program AGENCY: Office of Surface Mining... Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Utah proposes to revise references to...

76 FR 10527 - Regulatory Flexibility Act: Section 610 Review of National Organic Program Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-25

...: This document announces the Agricultural Marketing Service's (AMS) plans to review the National Organic... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-11-0005; NOP-11-01] Regulatory Flexibility Act: Section 610 Review of National Organic Program...

Communicating with "Neglected" Farmers on Regulatory Programs.

ERIC Educational Resources Information Center

Animal and Plant Health Inspection Service (USDA), Washington, DC.

Workshop recommendations resulting from an Animal and Plant Health Service (APHS) Seminar on ways of reaching "neglected" farmers and enlisting their support for the APHS regulatory programs are provided. The "neglected" farmer is identified as those low-income/minority group marginal farmers who cannot be reached by ordinary means, e.g., poor…

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

10 CFR 4.541-4.548 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.541-4.548 Section 4.541-4.548 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.541-4.548 [Reserved] ...

10 CFR 4.552-4.559 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.552-4.559 Section 4.552-4.559 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.552-4.559 [Reserved] ...

10 CFR 4.504-4.509 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.504-4.509 Section 4.504-4.509 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.504-4.509 [Reserved] ...

10 CFR 4.531-4.539 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.531-4.539 Section 4.531-4.539 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.531-4.539 [Reserved] ...

10 CFR 4.561-4.569 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.561-4.569 Section 4.561-4.569 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.561-4.569 [Reserved] ...

10 CFR 4.512-4.529 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.512-4.529 Section 4.512-4.529 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.512-4.529 [Reserved] ...

10 CFR 4.571-4.999 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.571-4.999 Section 4.571-4.999 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.571-4.999 [Reserved] ...

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

75 FR 10806 - Training Program for Regulatory Project Managers; Information Available to Industry

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0108] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) Center for Drug Evaluation...

78 FR 8544 - Training Program for Regulatory Project Managers; Information Available to Industry

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2003-N-0453] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug...

30 CFR 902.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false State regulatory program approval. 902.10 Section 902.10 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE..., Technical Library, 1999 Broadway, Suite 3320, Denver, Colorado 80202-5733. [60 FR 33724, June 29, 1995, as...

MULTI-MEDIA MICROBIOLOGICAL RISK ASSESSMENT METHODOLOGY FOR MUNICIPAL WASTEWATER SLUDGES

EPA Science Inventory

In order to reduce the risk of municipal sludge to acceptable levels, the U.S. EPA has undertaken a regulatory program based on risk assessment and risk management. The key to such a program is the development of a methodology which allows the regulatory agency to quantify the re...

78 FR 5726 - Nationwide Permit Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... of Engineers Regulatory Home Page at http://www.usace.army.mil/Missions/CivilWorks/Regulatory... DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers 33 CFR Part 330 RIN 0710-AA60 Nationwide Permit Program AGENCY: U.S. Army Corps of Engineers, DoD. ACTION: Final rule. SUMMARY: The U.S...

Workplace Wellness Programs: How Regulatory Flexibility Might Undermine Success

PubMed Central

2014-01-01

The Patient Protection and Affordable Care Act revised the law related to workplace wellness programs, which have become part of the nation’s broader health strategy. Health-contingent programs are required to be reasonably designed. However, the regulatory requirements are lax and might undermine program efficacy in terms of both health gains and financial return. I propose a method for the government to support a best-practices approach by considering an accreditation or certification process. Additionally I discuss the need for program evaluation and the potential for employers to be subject to litigation if programs are not carefully implemented. PMID:25211713

PAA, WSH, and CIS Overview Self-Study #47656

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

Schroeder, Rachel Anne

This course presents an overview of the Department of Energy’s (DOE’s) regulatory requirements relevant to the Price-Anderson Amendments Act (PAAA, also referred to as nuclear safety), worker safety and health (WSH), and classified information security (CIS) that are enforceable under the DOE enforcement program; describes the DOE enforcement process; and provides an overview of Los Alamos National Laboratory’s (LANL’s) internal compliance program relative to these DOE regulatory requirements. The LANL PAAA Program is responsible for maintaining LANL’s internal compliance program, which ensures the prompt identification, screening, and reporting of noncompliances to DOE regulatory requirements pertaining to nuclear safety, WSH, andmore » CIS to build the strongest mitigation position for the Laboratory with respect to civil or other penalties.« less

Electric Power: Contemporary Issues and the Federal Role in Oversight and Regulation.

DTIC Science & Technology

1981-12-21

Regulatory Commission NRECA National Rural Electric Cooperative Asso- ciation PURPA Public Utility Regulatory Policies Act of 1978 REA Rural...energy efficiency standards for certain products and processes, and sets standards for solar energy and conservation in Federal buildings. PURPA --the...conservation, efficient use of facilities and resources, and equitable rates to electric consumers. PURPA also (1) encourages the use of cogeneration and

Directed evolution of a synthetic phylogeny of programmable Trp repressors.

PubMed

Ellefson, Jared W; Ledbetter, Michael P; Ellington, Andrew D

2018-04-01

As synthetic regulatory programs expand in sophistication, an ever increasing number of biological components with predictable phenotypes is required. Regulators are often 'part mined' from a diverse, but uncharacterized, array of genomic sequences, often leading to idiosyncratic behavior. Here, we generate an entire synthetic phylogeny from the canonical allosteric transcription factor TrpR. Iterative rounds of positive and negative compartmentalized partnered replication (CPR) led to the exponential amplification of variants that responded with high affinity and specificity to halogenated tryptophan analogs and novel operator sites. Fourteen repressor variants were evolved with unique regulatory profiles across five operators and three ligands. The logic of individual repressors can be modularly programmed by creating heterodimeric fusions, resulting in single proteins that display logic functions, such as 'NAND'. Despite the evolutionarily limited regulatory role of TrpR, vast functional spaces exist around this highly conserved protein scaffold and can be harnessed to create synthetic regulatory programs.

Potential Air Pollutant Emissions and Permitting Classifications for Two Biorefinery Process Designs in the United States

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

Eberle, Annika; Bhatt, Arpit; Zhang, Yimin

Advanced biofuel production facilities (biorefineries), such as those envisioned by the United States (U.S.) Renewable Fuel Standard and U.S. Department of Energy's research and development programs, often lack historical air pollutant emissions data, which can pose challenges for obtaining air emission permits that are required for construction and operation. To help fill this knowledge gap, we perform a thorough regulatory analysis and use engineering process designs to assess the applicability of federal air regulations and quantify air pollutant emissions for two feasibility-level biorefinery designs. We find that without additional emission-control technologies both biorefineries would likely be required to obtain majormore » source permits under the Clean Air Act's New Source Review program. The permitting classification (so-called 'major' or 'minor') has implications for the time and effort required for permitting and therefore affects the cost of capital and the fuel selling price. Consequently, we explore additional technically feasible emission-control technologies and process modifications that have the potential to reduce emissions to achieve a minor source permitting classification. Finally, our analysis of air pollutant emissions and controls can assist biorefinery developers with the air permitting process and inform regulatory agencies about potential permitting pathways for novel biorefinery designs.« less

Potential Air Pollutant Emissions and Permitting Classifications for Two Biorefinery Process Designs in the United States

DOE PAGES

Eberle, Annika; Bhatt, Arpit; Zhang, Yimin; ...

2017-04-26

Advanced biofuel production facilities (biorefineries), such as those envisioned by the United States (U.S.) Renewable Fuel Standard and U.S. Department of Energy's research and development programs, often lack historical air pollutant emissions data, which can pose challenges for obtaining air emission permits that are required for construction and operation. To help fill this knowledge gap, we perform a thorough regulatory analysis and use engineering process designs to assess the applicability of federal air regulations and quantify air pollutant emissions for two feasibility-level biorefinery designs. We find that without additional emission-control technologies both biorefineries would likely be required to obtain majormore » source permits under the Clean Air Act's New Source Review program. The permitting classification (so-called 'major' or 'minor') has implications for the time and effort required for permitting and therefore affects the cost of capital and the fuel selling price. Consequently, we explore additional technically feasible emission-control technologies and process modifications that have the potential to reduce emissions to achieve a minor source permitting classification. Finally, our analysis of air pollutant emissions and controls can assist biorefinery developers with the air permitting process and inform regulatory agencies about potential permitting pathways for novel biorefinery designs.« less

Potential Air Pollutant Emissions and Permitting Classifications for Two Biorefinery Process Designs in the United States.

PubMed

Eberle, Annika; Bhatt, Arpit; Zhang, Yimin; Heath, Garvin

2017-06-06

Advanced biofuel production facilities (biorefineries), such as those envisioned by the United States (U.S.) Renewable Fuel Standard and U.S. Department of Energy's research and development programs, often lack historical air pollutant emissions data, which can pose challenges for obtaining air emission permits that are required for construction and operation. To help fill this knowledge gap, we perform a thorough regulatory analysis and use engineering process designs to assess the applicability of federal air regulations and quantify air pollutant emissions for two feasibility-level biorefinery designs. We find that without additional emission-control technologies both biorefineries would likely be required to obtain major source permits under the Clean Air Act's New Source Review program. The permitting classification (so-called "major" or "minor") has implications for the time and effort required for permitting and therefore affects the cost of capital and the fuel selling price. Consequently, we explore additional technically feasible emission-control technologies and process modifications that have the potential to reduce emissions to achieve a minor source permitting classification. Our analysis of air pollutant emissions and controls can assist biorefinery developers with the air permitting process and inform regulatory agencies about potential permitting pathways for novel biorefinery designs.

Genetic toxicology in the 21st century: Reflections and future ...

EPA Pesticide Factsheets

A symposium at the 40th anniversary of the Environmental Mutagen Society, held from October 24–28, 2009 in St. Louis, MO, surveyed the current status and future directions of genetic toxicology. This article summarizes the presentations and provides a perspective on the future. An abbreviated history is presented, highlighting the current standard battery of genotoxicity assays and persistent challenges. Application of computational toxicology to safety testing within a regulatory setting is discussed as a means for reducing the need for animal testing and human clinical trials, and current approaches and applications of in silico genotoxicity screening approaches across the pharmaceutical industry were surveyed and are reported here. The expanded use of toxicogenomics to illuminate mechanisms and bridge genotoxicity and carcinogenicity, and new public efforts to use high-throughput screening technologies to address lack of toxicity evaluation for the backlog of thousands of industrial chemicals in the environment are detailed. The Tox21 project involves coordinated efforts of four U.S. Government regulatory/research entities to use new and innovative assays to characterize key steps in toxicity pathways, including genotoxic and nongenotoxic mechanisms for carcinogenesis. Progress to date, highlighting preliminary test results from the National Toxicology Program is summarized. Finally, an overview is presented of ToxCast™, a related research program of the

The U.S. Commercial Air Tour Industry: A Review of Aviation Safety Concerns

PubMed Central

Ballard, Sarah-Blythe

2016-01-01

The U.S. Title 14 Code of Federal Regulations defines commercial air tours as “flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing.” The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators. PMID:24597160

The U.S. commercial air tour industry: a review of aviation safety concerns.

PubMed

Ballard, Sarah-Blythe

2014-02-01

The U.S. Title 14 Code of Federal Regulations defines commercial air tours as "flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing." The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators.

75 FR 45172 - Withdrawal of Regulatory Guides 3.44 and 3.49

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-02

... Format and Content for the Safety Analysis Report for an Independent Spent Fuel Storage Installation... on the format and content of the safety analysis report that is required as part of an application to...: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 3.44, ``Standard Format and Content...

Medicaid program; health care-related taxes.

PubMed

2008-02-22

This final rule revises the collection threshold under the regulatory indirect guarantee hold harmless arrangement test to reflect the provisions of the Tax Relief and Health Care Act of 2006. When determining whether there is an indirect guarantee under the 2-prong test for portions of fiscal years beginning on or after January 1, 2008 and before October 1, 2011, the allowable amount that can be collected from a health care-related tax is reduced from 6 to 5.5 percent of net patient revenues received by the taxpayers. This final rule also clarifies the standard for determining the existence of a hold harmless arrangement under the positive correlation test, Medicaid payment test, and the guarantee test (with conforming changes to parallel provisions concerning hold harmless arrangements with respect to provider-related donations); codifies changes to permissible class of health care items or services related to managed care organizations as enacted by the Deficit Reduction Act of 2005; and, removes obsolete transition period regulatory language.

Thermal overload protection for electric motors on safety-related motor-operated valves: Generic Issue II. E. 6. 1

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

Rothberg, O.

1988-06-01

NRC regulatory positions, as stated in Regulatory Guide 1.106, Revision 1, have been identified by the Office for Analysis and Evaluation of Operational Data (AEOD) as potential contributors to valve motor burnout. AEOD is particularly concerned about the allowed policy of bypassing thermal overload devices during normal or accident conditions. Regulatory Guide 1.106 favors compromising the function of thermal overload devices in favor of completing the safety-related action of valves. The purpose of this study was to determine if the guidance contained in Regulatory Guide 1.106 is appropriate and, if not, to recommend the necessary changes. This report describes thermalmore » overload devices commonly used to protect safety-related valve operator motors. The regulatory guidelines stated in Regulatory Guide 1.106 along with the limitations of thermal overload protection are discussed. Supplements and alternatives to thermal overload protection are also described. Findings and conclusions of several AEOD reports are discussed. Information obtained from the standard review plan, standard technical specifications, technical specifications from representative plants, and several papers are cited.« less

Keeping the "continuous" in continuous quality improvement: exploring perceived outcomes of CQI program use in community pharmacy.

PubMed

Boyle, Todd A; Bishop, Andrea C; Duggan, Kellie; Reid, Carolyn; Mahaffey, Thomas; MacKinnon, Neil J; Mahaffey, Amelia

2014-01-01

Given the significant potential of continuous quality improvement (CQI) programs in enhancing overall levels of patient safety, community pharmacies in North America are under increasing pressure to have a formal and documented CQI program in place. However, while such initiatives may seem great on paper, in practice the outcomes of such programs to community pharmacy practice remain unclear. To explore the perceived outcomes identified by community pharmacies that adopted and actively used a standardized (i.e., common across pharmacies) CQI program for at least 1 year and to develop a framework for how such outcomes were achieved. A multi-site study of SafetyNET-Rx, a standardized and technologically sophisticated (e.g., online reporting of medication errors to a national database) CQI program, involving community pharmacies in Nova Scotia, Canada, was performed. During the summer and fall of 2011, 22 interviews were conducted with the CQI facilitators in 12 Nova Scotia community pharmacies; equally split between independent/banners and corporate chains. Of the CQI facilitators, 14 were pharmacists, while the remaining eight were pharmacy technicians. Thematic analysis following the procedures presented by Braun and Clarke was adopted to identify and explore the major outcomes. Results of the thematic analysis highlighted a number of perceived outcomes from the use of a standardized CQI program in community pharmacies, specifically: (1) perceived reduction in the number of medication errors that were occurring in the pharmacy, (2) increased awareness/confidence of individual actions related to dispensing, (3) increased understanding of the dispensing and related processes/workflow, (4) increased openness to talking about medication errors among pharmacy staff, and (5) quality and safety becoming more entrenched in the workflow (e.g., staff is more aware of their roles and responsibilities in patient safety and confident that the dispensing processes are safe and reliable). In achieving such outcomes, pharmacies had to balance customizing the CQI program to address a number of operational challenges, with ensuring that the core standardized components remained in place. This research identified the perceived outcomes of CQI program use by CQI facilitators. Additionally, the findings are incorporated into a framework for CQI implementation that can be used by pharmacy managers, corporate head offices, and regulatory authorities to leverage greater CQI adoption and success. Copyright © 2014 Elsevier Inc. All rights reserved.

75 FR 21899 - Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

....regulations.gov. FOR FURTHER INFORMATION CONTACT: Hada Flowers, Supervisor, Regulatory Secretariat Branch... Flexibility Analysis Required: Yes Agency Contact: Hada Flowers, Supervisor, Regulatory Secretariat, DOD/ GSA... Email: hada.flowers@gsa.gov RIN: 9000-AK92 301. FAR CASE 2006-005, HUBZONE PROGRAM REVISIONS Legal...

Updating Human Factors Engineering Guidelines for Conducting Safety Reviews of Nuclear Power Plants

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

O, J.M.; Higgins, J.; Stephen Fleger - NRC

The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodicmore » update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. This paper describes the role of HFE guidelines in the safety review process and the content of the key HFE guidelines used. Then we will present the methodology used to develop HFE guidance and update these documents, and describe the current status of the update program.« less

2004 Environmental Report

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

Althouse, P E; Bertoldo, N A; Brown, R A

2005-09-28

The Lawrence Livermore National Laboratory (LLNL) annual Environmental Report, prepared for the Department of Energy (DOE) and made available to the public, presents summary environmental data that characterizes site environmental management performance, summarizes environmental occurrences and responses reported during the calendar year, confirms compliance with environmental standards and requirements, and highlights significant programs and efforts. By explaining the results of effluent and environmental monitoring, mentioning environmental performance indicators and performance measure programs, and assessing the impact of Laboratory operations on the environment and the public, the report also demonstrates LLNL's continuing commitment to minimize any potentially adverse impact of itsmore » operations. The combination of environmental and effluent monitoring, source characterization, and dose assessment showed that radiological doses to the public caused by LLNL operations in 2004 were less than 0.26% of regulatory standards and more than 11,000 times smaller than dose from natural background. Analytical results and evaluations generally showed continuing low levels of most contaminants; remediation efforts further reduced the concentrations of contaminants of concern in groundwater and soil vapor. In addition, LLNL's extensive environmental compliance activities related to water, air, endangered species, waste, wastewater, and waste reduction controlled or reduced LLNL's effects on the environment. LLNL's environmental program clearly demonstrates a commitment to protecting the environment from operational impacts.« less

Kids Making Sense of Air Quality Around Them Through a Hands-On, STEM-Based Program

NASA Astrophysics Data System (ADS)

Dye, T.

2015-12-01

Air pollution in many parts of the world is harming millions of people, shortening lives, and taking a toll on our ecosystem. Cities in India, China, and even the United States frequently exceed air quality standards. The use of localized data is a powerful enhancement to regulatory monitoring site data. Learning about air quality at a local level is a powerful driver for change. The Kids Making Sense program unites Science, Technology, Engineering, and Mathematics (STEM) education with a complete measurement and environmental education system that teaches youth about air pollution and empowers them to drive positive change in their communities. With this program, youth learn about particle pollution, its sources, and health effects. A half-day lecture is followed by hands-on activity using handheld air sensors paired with an app on smartphones. Students make measurements around schools to discover pollution sources and cleaner areas. Next, the data they collect are crowdsourced on a website for guided discussion and data interpretation. This program meets Next Generation Science Standards, encourages project-based learning and deep understanding of applied science, and allows students to practice science like real scientists. The program has been successfully implemented in several schools in the United States and Asia, including New York City, San Francisco, Los Angeles, and Sacramento in the United States, and Taipei and Taichung in Taiwan. During this talk, we'll provide an overview of the program, discuss some of the challenges, and lay out the next steps for Kids Making Sense.

78 FR 66671 - Oklahoma Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 936...; S2D2SSS08011000SX066A00033F13XS501520] Oklahoma Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement... amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing...

78 FR 73912 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-09

... Rule Change To Extend the Pilot Program That Eliminated the Position and Exercise Limits for Options on... amend its rules to extend the pilot program that eliminated position and exercise limits for physically..., because not all self- regulatory organizations (``SROs'') have adopted similar rules eliminating position...

75 FR 71473 - Self-Regulatory Organizations; the Depository Trust Company; Notice of Filing of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-23

... the Requirement To Maintain a Balance Certificate in the Fast Automated Securities Transfer Program... custody a balance certificate. II. Self-Regulatory Organization's Statement of the Purpose of, and... Proposed Rule Change Under DTC's FAST program, DTC leaves securities in the form of balance certificates in...

75 FR 7641 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-22

... Fast Automated Securities Transfer Program February 5, 2010. Pursuant to Section 19(b)(1) of the... American Depositary Receipts (``ADRs'') that are a part of DTC's Fast Automated Securities Transfer Program (``FAST''). II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the...

What should a radiation regulator do about naturally occurring radioactive material?

PubMed

Loy, J

2015-06-01

The standard regulatory framework of authorisation, review and assessment, inspection and enforcement, and regulation making is directed principally towards ensuring the regulatory control of planned exposure situations. Some mining and industrial activities involving exposures to naturally occurring radioactive material (NORM), such as uranium mining or the treatment and conditioning of NORM residues, may fit readily within this standard framework. In other cases, such as oil and gas exploration and production, the standard regulatory framework needs to be adjusted. For example, it is not sensible to require that an oil company seek a licence from the radiation regulator before drilling a well. The paper discusses other approaches that a regulator might take to assure protection and safety in such activities involving exposures to NORM, including the use of conditional exemptions from regulatory controls. It also suggests some areas where further guidance from the International Commission on Radiological Protection on application of the system of radiological protection to NORM would assist both regulators and operators. © The International Society for Prosthetics and Orthotics Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Standards Improvement Project-Phase II. Final rule.

PubMed

2005-01-05

The Occupational Safety and Health Administration (OSHA) through this final rule is continuing to remove and revise provisions of its standards that are outdated, duplicative, unnecessary, or inconsistent, or can be clarified or simplified by being written in plain language. The Agency completed Phase I of the Standards Improvement Project in June 1998. In this Phase II of the Standards Improvement Project, OSHA is again revising or removing a number of health provisions in its standards for general industry, shipyard employment, and construction. The Agency believes that the changes streamline and make more consistent the regulatory requirements in OSHA health and safety standards. In some cases, OSHA has made substantive revisions to requirements because they are outdated, duplicative, unnecessary, or inconsistent with more recently promulgated health standards. The Agency believes these revisions will reduce regulatory requirements for employers without reducing employee protection.

The Belgian commitment to pharmaceutical quality: a model policy to improve quality assurance of medicines available through humanitarian and development programs.

PubMed

Ravinetto, Raffaella; Roosen, Tim; Dujardin, Catherine

2018-01-01

Today, a combination of globalization of pharmaceutical production, lack of regulatory harmonization, and weakness of Medicines Regulatory Authorities, creates the "perfect conditions" for poor-quality medicine to circulate in the global market and to penetrate the less-regulated countries. Medicines regulation is the responsibility of the national regulatory authorities in the recipient country, but in the poorer countries, in practice, the responsibility of supply of quality-assured medicines is often taken by Non-Governmental Organizations and other implementers. But with some notable exceptions, many donors lack a pharmaceutical procurement policy with adequate quality requirements; and many implementers lack the skills and expertise needed to orient themselves in the complex web of global pharmaceutical supply. Thus, patients served by humanitarian or development programs may remain exposed to the risk of poor-quality medicines. When public money is used to purchase medicines for medical programs to be carried out overseas, adequate policies should be in place to assure that the same quality requirements are set that would be required for medicines marketed in the "donor" country. We will describe here a policy recently adopted in Belgium, i.e. the "Commitment to Quality Assurance for Pharmaceutical Products", signed in October 2017 by the Vice Prime Minister and Minister for Development Cooperation and 19 Belgian implementing agencies. By signing the new policy, the counterparts committed to ensure quality of medicines in the programs funded by Belgium's Official Development Assistance, and to build quality-assurance capacity in the recipient countries. Implementers are requested to integrate in their financing applications a section for pharmaceutical quality assurance, with a justified budget. They are also invited to consider how costs could be rationalized and mutualized by aligning the strengths of the various implementers. This model policy has the potential to be considered for adoption by other donors, to help to reduce the current multiple standards in pharmaceutical quality, and to contribute to protect vulnerable communities from the plague of poor-quality medicines. The online version of this article (10.1186/s40545-018-0136-z) contains an additional file, which is available to authorized users.

76 FR 16017 - Withdrawal of Regulatory Guide 8.5

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-22

...) Standard N2.3-1979 ``Immediate Evacuation Signal for Use in Industrial Installations,'' published September... Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2011-6665 Filed 3-21-11...

A global regulatory science agenda for vaccines.

PubMed

Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

2013-04-18

The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable regulators, academics, and other stakeholders to converge around transformative actions for innovation in the regulatory process to support global immunization goals. Copyright © 2012 Elsevier Ltd. All rights reserved.

How Much Can Non-industry Standard Measurement Methodologies Benefit Methane Reduction Programs?

NASA Astrophysics Data System (ADS)

Risk, D. A.; O'Connell, L.; Atherton, E.

2017-12-01

In recent years, energy sector methane emissions have been recorded in large part by applying modern non-industry-standard techniques. Industry may lack the regulatory flexibility to use such techniques, or in some cases may not understand the possible associated economic advantage. As progressive jurisdictions move from estimation and towards routine measurement, the research community should provide guidance to help regulators and companies measure more effectively, and economically if possible. In this study, we outline a modelling experiment in which we explore the integration of non-industry-standard measurement techniques as part of a generalized compliance measurement program. The study was not intended to be exhaustive, or to recommend particular combinations, but instead to explore the inter-relationships between methodologies, development type, compliance practice. We first defined the role, applicable scale, detection limits, working distances, and approximate deployment cost of several measurement methodologies. We then considered a variety of development types differing mainly in footprint, density, and emissions "profile". Using a Monte Carlo approach, we evaluated the effect of these various factors on the cost and confidence of the compliance measurement program. We found that when added individually, some of the research techniques were indeed able to deliver an improvement in cost and/or confidence when used alongside industry-standard Optical Gas Imaging. When applied in combination, the ideal fraction of each measurement technique depended on development type, emission profile, and whether confidence or cost was more important. Results suggest that measurement cost and confidence could be improved if energy companies exploited a wider range of measurement techniques, and in a manner tailored to each development. In the short-term, combining clear scientific guidance with economic information could benefit immediate mitigation efforts over developing new super sensors.

Regulatory assessment with regulatory flexibility analysis : draft regulatory evaluation - Notice of Proposed Rulemaking -- Pipeline Safety : safety standards for increasing the maximum allowable operating pressure for natural gas transmission pipelines.

DOT National Transportation Integrated Search

2008-02-01

The Pipeline and Hazardous Materials Safety Administration (PHMSA) is proposing changes to the Federal pipeline safety regulations in 49 CFR Part 192, which cover the transportation of natural gas by pipeline. Specifically, PHMSA proposes allowing na...

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

Regulatory basis for the Waste Isolation Pilot Plant performance assessment

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

HOWARD,BRYAN A.; CRAWFORD,M.B.; GALSON,D.A.

2000-05-22

The Waste Isolation Pilot Plant (WIPP) is the first operational repository designed for the safe disposal of transuranic (TRU) radioactive waste from the defense programs of the US Department of Energy (DOE). The US Environmental Protection Agency (EPA) is responsible for certifications and regulation of the WIPP facility for the radioactive components of the waste. The EPA has promulgated general radioactive waste disposal standards at 40 CFR Part 191. and WIPP-specific criteria to implement and interpret the generic disposal standards at 40 CFR Part 194. In October 1996. the DOE submitted its Compliance Certification Application (CCA) to the EPA tomore » demonstrate compliance with the disposal standards at Subparts B and C of 40 CFR Part 191. This paper summarizes the development of the overall legal framework for radioactive waste disposal at the WIPP, the parallel development of the WIPP performance assessment (PA), and how the EPA disposal standards and implementing criteria formed the basis for the CCA WIPP PA. The CCA resulted in a certification in May 1998 by the EPA of the WIPP'S compliance with the EPA's disposal standard, thus enabling the WIPP to begin radioactive waste disposal.« less

Microbiological water methods: quality control measures for Federal Clean Water Act and Safe Drinking Water Act regulatory compliance.

PubMed

Root, Patsy; Hunt, Margo; Fjeld, Karla; Kundrat, Laurie

2014-01-01

Quality assurance (QA) and quality control (QC) data are required in order to have confidence in the results from analytical tests and the equipment used to produce those results. Some AOAC water methods include specific QA/QC procedures, frequencies, and acceptance criteria, but these are considered to be the minimum controls needed to perform a microbiological method successfully. Some regulatory programs, such as those at Code of Federal Regulations (CFR), Title 40, Part 136.7 for chemistry methods, require additional QA/QC measures beyond those listed in the method, which can also apply to microbiological methods. Essential QA/QC measures include sterility checks, reagent specificity and sensitivity checks, assessment of each analyst's capabilities, analysis of blind check samples, and evaluation of the presence of laboratory contamination and instrument calibration and checks. The details of these procedures, their performance frequency, and expected results are set out in this report as they apply to microbiological methods. The specific regulatory requirements of CFR Title 40 Part 136.7 for the Clean Water Act, the laboratory certification requirements of CFR Title 40 Part 141 for the Safe Drinking Water Act, and the International Organization for Standardization 17025 accreditation requirements under The NELAC Institute are also discussed.

Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

PubMed

Fisher, Adam C; Lee, Sau L; Harris, Daniel P; Buhse, Lucinda; Kozlowski, Steven; Yu, Lawrence; Kopcha, Michael; Woodcock, Janet

2016-12-30

Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public. Published by Elsevier B.V.

Ten Years of Addressing Children’s Health through Regulatory Policy at the U.S. Environmental Protection Agency

PubMed Central

Payne-Sturges, Devon; Kemp, Debra

2008-01-01

Background Executive Order (EO) 13045, Protection of Children From Environmental Health Risks and Safety Risks, directs each federal agency to ensure that its policies, programs, activities, and standards address disproportionate environmental health and safety risks to children. Objectives We reviewed regulatory actions published by U.S. Environmental Protection Agency (EPA) in the Federal Register from April 1998 through December 2006 to evaluate applicability of EO 13045 to U.S. EPA actions and consideration of children’s health issues in U.S. EPA rulemakings. Discussion Although virtually all actions discussed EO 13045, fewer than two regulations per year, on average, were subject to the EO requirement to evaluate children’s environmental health risks. Nonetheless, U.S. EPA considered children’s environmental health in all actions addressing health or safety risks that may disproportionately affect children. Conclusion The EO does not apply to a broad enough set of regulatory actions to ensure protection of children’s health and safety risks, largely because of the small number of rules that are economically significant. However, given the large number of regulations that consider children’s health issues despite not being subject to the EO, other statutory requirements and agency policies reach a larger set of regulations to ensure protection of children’s environmental health. PMID:19079726

Regulatory logic of pan-neuronal gene expression in C. elegans

PubMed Central

Stefanakis, Nikolaos; Carrera, Ines; Hobert, Oliver

2015-01-01

While neuronal cell types display an astounding degree of phenotypic diversity, most if not all neuron types share a core panel of terminal features. However, little is known about how pan-neuronal expression patterns are genetically programmed. Through an extensive analysis of the cis-regulatory control regions of a battery of pan-neuronal C.elegans genes, including genes involved in synaptic vesicle biology and neuropeptide signaling, we define a common organizational principle in the regulation of pan-neuronal genes in the form of a surprisingly complex array of seemingly redundant, parallel-acting cis-regulatory modules that direct expression to broad, overlapping domains throughout the nervous system. These parallel-acting cis-regulatory modules are responsive to a multitude of distinct trans-acting factors. Neuronal gene expression programs therefore fall into two fundamentally distinct classes. Neuron type-specific genes are generally controlled by discrete and non-redundantly acting regulatory inputs, while pan-neuronal gene expression is controlled by diverse, coincident and seemingly redundant regulatory inputs. PMID:26291158

49 CFR 193.2009 - Rules of regulatory construction.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 193.2009 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES: FEDERAL SAFETY STANDARDS General § 193.2009 Rules of regulatory...

78 FR 68505 - Enhancing Protections Afforded Customers and Customer Funds Held by Futures Commission Merchants...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-14

...The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is adopting new regulations and amending existing regulations to require enhanced customer protections, risk management programs, internal monitoring and controls, capital and liquidity standards, customer disclosures, and auditing and examination programs for futures commission merchants (``FCMs''). The regulations also address certain related issues concerning derivatives clearing organizations (``DCOs'') and chief compliance officers (``CCOs''). The final rules will afford greater assurances to market participants that: Customer segregated funds, secured amount funds, and cleared swaps funds are protected; customers are provided with appropriate notice of the risks of futures trading and of the FCMs with which they may choose to do business; FCMs are monitoring and managing risks in a robust manner; the capital and liquidity of FCMs are strengthened to safeguard their continued operations; and the auditing and examination programs of the Commission and the self- regulatory organizations (``SROs'') are monitoring the activities of FCMs in a prudent and thorough manner.

Personal Protective Equipment in Animal Research

PubMed Central

Villano, Jason S; Follo, Janet M; Chappell, Mark G; Jr, Morris T Collins

2017-01-01

The occupational health and safety program is an integral component of a comprehensive animal care and use program. It is important to mitigate the risk of exposures of animal care and research personnel to allergens and physical, chemical, radiologic, and biologic hazards during the conduct of various tasks. This need is especially true in infectious disease and biocontainment research. One aspect of the program is the provision of personal protective equipment (PPE). Commercially available PPE should be carefully evaluated based on their material composition and performance according to manufacturer data. To help institutions and end users by providing them guidance on choosing appropriate PPE, we here discuss the regulatory framework, device standards, and materials engineering for various PPE, including gloves, shoe covers, head caps, gowns, aprons, masks, hearing and eye protection devices, and respirators. Ultimately, the choice of appropriate PPE is based on the risk assessment, which should include consideration for personnel comfort, correct device fitting, and the containment level for the hazard used. PMID:28662749

78 FR 64255 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-28

... Amending Commentary .07 to Rule 904 To Extend the Pilot Program That Eliminated the Position Limits for... that eliminated the position limits for options on SPDR S&P 500 ETF (``SPY'') (``SPY Pilot Program...- regulatory organizations (``SROs'') have adopted similar rules eliminating position limits on SPY and market...

Regulatory Organizations and Their Requirements. MAS-113. Waste Isolation Division (WID). Management and Supervisor Training (MAST) Program.

ERIC Educational Resources Information Center

Westinghouse Electric Corp., Carlsbad, NM.

This learning module, which is part of a management and supervisor training program for managers and supervisors employed at the Department of Energy's Waste Isolation Division, is designed to enable trainees to identify regulatory organizations and oversight groups and monitor and provide guidance in the implementation of the requirements of…

40 CFR 96.287 - Change in regulatory status.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO2 Opt-in Units § 96.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2 unit under § 96.204, then the CAIR designated representative shall notify in writing...

77 FR 61462 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change Proposing a Pilot Program To... change to create and implement, on a pilot basis, a Lead Market Maker (``LMM'') Issuer Incentive Program...

Identification and Comparison of Academic Self Regulatory Learning Strategy Use of Students Enrolled in Traditional and Accelerated Baccalaureate Degree Nursing Programs

ERIC Educational Resources Information Center

Mullen, Patricia A.

2009-01-01

Objective: To explore and compare the use of metacognitive, cognitive, and environmental resource management self regulatory learning (SRL) strategies used by a national sample of students enrolled in traditional and accelerated baccalaureate nursing programs. Background: Learner focused reforms in nursing education require students to assume more…

Evaluating health risks from occupational exposure to pesticides and the regulatory response.

PubMed Central

Woodruff, T J; Kyle, A D; Bois, F Y

1994-01-01

In this study, we used measurements of occupational exposures to pesticides in agriculture to evaluate health risks and analyzed how the federal regulatory program is addressing these risks. Dose estimates developed by the State of California from measured occupational exposures to 41 pesticides were compared to standard indices of acute toxicity (LD50) and chronic effects (reference dose). Lifetime cancer risks were estimated using cancer potencies. Estimated absorbed daily doses for mixers, loaders, and applicators of pesticides ranged from less than 0.0001% to 48% of the estimated human LD50 values, and doses for 10 of 40 pesticides exceeded 1% of the estimated human LD50 values. Estimated lifetime absorbed daily doses ranged from 0.1% to 114,000% of the reference doses developed by the U.S. Environmental Protection Agency, and doses for 13 of 25 pesticides were above them. Lifetime cancer risks ranged from 1 per million to 1700 per million, and estimates for 12 of 13 pesticides were above 1 per million. Similar results were obtained for field workers and flaggers. For the pesticides examined, exposures pose greater risks of chronic effects than acute effects. Exposure reduction measures, including use of closed mixing systems and personal protective equipment, significantly reduced exposures. Proposed regulations rely primarily on requirements for personal protective equipment and use restrictions to protect workers. Chronic health risks are not considered in setting these requirements. Reviews of pesticides by the federal pesticide regulatory program have had little effect on occupational risks. Policy strategies that offer immediate protection for workers and that are not dependent on extensive review of individual pesticides should be pursued. Images Figure 1. PMID:7713022

Classification criteria and probability risk maps: limitations and perspectives.

PubMed

Saisana, Michaela; Dubois, Gregoire; Chaloulakou, Archontoula; Spyrellis, Nikolas

2004-03-01

Delineation of polluted zones with respect to regulatory standards, accounting at the same time for the uncertainty of the estimated concentrations, relies on classification criteria that can lead to significantly different pollution risk maps, which, in turn, can depend on the regulatory standard itself. This paper reviews four popular classification criteria related to the violation of a probability threshold or a physical threshold, using annual (1996-2000) nitrogen dioxide concentrations from 40 air monitoring stations in Milan. The relative advantages and practical limitations of each criterion are discussed, and it is shown that some of the criteria are more appropriate for the problem at hand and that the choice of the criterion can be supported by the statistical distribution of the data and/or the regulatory standard. Finally, the polluted area is estimated over the different years and concentration thresholds using the appropriate risk maps as an additional source of uncertainty.

Designing optimal cell factories: integer programming couples elementary mode analysis with regulation

PubMed Central

2012-01-01

Background Elementary mode (EM) analysis is ideally suited for metabolic engineering as it allows for an unbiased decomposition of metabolic networks in biologically meaningful pathways. Recently, constrained minimal cut sets (cMCS) have been introduced to derive optimal design strategies for strain improvement by using the full potential of EM analysis. However, this approach does not allow for the inclusion of regulatory information. Results Here we present an alternative, novel and simple method for the prediction of cMCS, which allows to account for boolean transcriptional regulation. We use binary linear programming and show that the design of a regulated, optimal metabolic network of minimal functionality can be formulated as a standard optimization problem, where EM and regulation show up as constraints. We validated our tool by optimizing ethanol production in E. coli. Our study showed that up to 70% of the predicted cMCS contained non-enzymatic, non-annotated reactions, which are difficult to engineer. These cMCS are automatically excluded by our approach utilizing simple weight functions. Finally, due to efficient preprocessing, the binary program remains computationally feasible. Conclusions We used integer programming to predict efficient deletion strategies to metabolically engineer a production organism. Our formulation utilizes the full potential of cMCS but adds additional flexibility to the design process. In particular our method allows to integrate regulatory information into the metabolic design process and explicitly favors experimentally feasible deletions. Our method remains manageable even if millions or potentially billions of EM enter the analysis. We demonstrated that our approach is able to correctly predict the most efficient designs for ethanol production in E. coli. PMID:22898474

Strategies of bringing drug product marketing applications to meet current regulatory standards.

PubMed

Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

2015-08-01

In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

RSAT 2018: regulatory sequence analysis tools 20th anniversary.

PubMed

Nguyen, Nga Thi Thuy; Contreras-Moreira, Bruno; Castro-Mondragon, Jaime A; Santana-Garcia, Walter; Ossio, Raul; Robles-Espinoza, Carla Daniela; Bahin, Mathieu; Collombet, Samuel; Vincens, Pierre; Thieffry, Denis; van Helden, Jacques; Medina-Rivera, Alejandra; Thomas-Chollier, Morgane

2018-05-02

RSAT (Regulatory Sequence Analysis Tools) is a suite of modular tools for the detection and the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, including from genome-wide datasets like ChIP-seq/ATAC-seq, (ii) motif scanning, (iii) motif analysis (quality assessment, comparisons and clustering), (iv) analysis of regulatory variations, (v) comparative genomics. Six public servers jointly support 10 000 genomes from all kingdoms. Six novel or refactored programs have been added since the 2015 NAR Web Software Issue, including updated programs to analyse regulatory variants (retrieve-variation-seq, variation-scan, convert-variations), along with tools to extract sequences from a list of coordinates (retrieve-seq-bed), to select motifs from motif collections (retrieve-matrix), and to extract orthologs based on Ensembl Compara (get-orthologs-compara). Three use cases illustrate the integration of new and refactored tools to the suite. This Anniversary update gives a 20-year perspective on the software suite. RSAT is well-documented and available through Web sites, SOAP/WSDL (Simple Object Access Protocol/Web Services Description Language) web services, virtual machines and stand-alone programs at http://www.rsat.eu/.

77 FR 55877 - Initial Test Program of Condensate and Feedwater Systems for Light-Water Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

...-492- 3668; email: [email protected] . NRC's Agencywide Documents Access and Management System... Systems for Light-Water Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance... Systems for Boiling Water Reactor Power Plants.'' This regulatory guide is being revised to: (1) Expand...

78 FR 55765 - Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-11

... Nuclear Power Plant Fire Protection (CARMEN-FIRE) AGENCY: Nuclear Regulatory Commission. ACTION: Draft..., ``Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN-FIRE).'' In... integral part of NRC-approved fire protection programs. However, compensatory measures are not expected to...

78 FR 57319 - Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-18

...-AB20 Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; kidSAFE... proposed self-regulatory guidelines submitted by the kidSAFE Seal Program (``kidSAFE''), owned and operated... part of the SUPPLEMENTARY INFORMATION section below. Write ``kidSAFE Application for Safe Harbor...

Nutrition standards for away-from-home foods in the USA.

PubMed

Cohen, D A; Bhatia, R

2012-07-01

Away-from-home foods are regulated with respect to the prevention of food-borne diseases and potential contaminants, but not for their contribution to dietary-related chronic diseases. Away-from-home foods have more calories, salt, sugar and fat, and include fewer fruits and vegetables than recommended by national nutrition guidelines. Thus, frequent consumption of away-from-home foods contributes to obesity, hypertension, diabetes, heart disease, and cancer. In light of this, many localities are already adopting regulations or sponsoring programs to improve the quality of away-from-home foods. We review the rationale for developing nutritional performance standards for away-from-home foods in light of limited human capacity to regulate intake or physiologically compensate for a poor diet. We offer a set of model performance standards to be considered as a new area of environmental regulation. Models for voluntary implementation of consumer standards exist in the environmental domain and may be useful templates for implementation. Implementing such standards, whether voluntarily or via regulations, will require addressing a number of practical and ideological challenges. Politically, regulatory standards contradict the belief that adults should be able to navigate dietary risks in away-from-home settings unaided. © 2012 The Authors. obesity reviews © 2012 International Association for the Study of Obesity.

Projected Standard on neutron skyshine. [Skyshine

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

Westfall, R.M.; Williams, D.S.

1987-07-01

Current interest in neutron skyshine arises from the application of dry fuel handling and storage techniques at reactor sites, at the proposed monitored retrievable storage facility and at other facilities being considered as part of the civilian radioactive waste management programs. The chairman of Standards Subcommittee ANS-6, Radiation Protection and Shielding, has requested that a work group be formed to characterize the neutron skyshine problem and, if necessary, prepare a draft Standard. The work group is comprised of representatives of storage cask vendors, architect engineering firms, nuclear utilities, the academic community and staff members of national laboratories and government agencies.more » The purpose of this presentation summary is to describe the activities of the work group and the scope and contents of the projected Standard, ANS-6.6.2, ''Calculation and Measurement of Direct and Scattered Neutron Radiation from Nuclear Power Operations.'' The specific source under consideration by the work group is an array of dry fuel casks located at a reactor site. However, it is recognized that the scope of the standard should be broad enough to encompass other neutron sources. The Standard will define appropriate methodology for properly characterizing the neutron dose due to skyshine. This dose characterization is necessary, for example, in demonstrating compliance with pertinent regulatory criteria.« less

A Multi-step Transcriptional and Chromatin State Cascade Underlies Motor Neuron Programming from Embryonic Stem Cells.

PubMed

Velasco, Silvia; Ibrahim, Mahmoud M; Kakumanu, Akshay; Garipler, Görkem; Aydin, Begüm; Al-Sayegh, Mohamed Ahmed; Hirsekorn, Antje; Abdul-Rahman, Farah; Satija, Rahul; Ohler, Uwe; Mahony, Shaun; Mazzoni, Esteban O

2017-02-02

Direct cell programming via overexpression of transcription factors (TFs) aims to control cell fate with the degree of precision needed for clinical applications. However, the regulatory steps involved in successful terminal cell fate programming remain obscure. We have investigated the underlying mechanisms by looking at gene expression, chromatin states, and TF binding during the uniquely efficient Ngn2, Isl1, and Lhx3 motor neuron programming pathway. Our analysis reveals a highly dynamic process in which Ngn2 and the Isl1/Lhx3 pair initially engage distinct regulatory regions. Subsequently, Isl1/Lhx3 binding shifts from one set of targets to another, controlling regulatory region activity and gene expression as cell differentiation progresses. Binding of Isl1/Lhx3 to later motor neuron enhancers depends on the Ebf and Onecut TFs, which are induced by Ngn2 during the programming process. Thus, motor neuron programming is the product of two initially independent transcriptional modules that converge with a feedforward transcriptional logic. Copyright © 2017 Elsevier Inc. All rights reserved.

Suborbital Safety Technical Committee- Summary of Proposed Standards & Guidelines

NASA Astrophysics Data System (ADS)

Quinn, Andy; Atencia Yepez, Amaya; Klicker, Michael; Howard, Diane; Verstraeten, Joram; Other Suborbital Safety TC Members

2013-09-01

There are currently no international safety standards and guidelines to assist designers, operators and authorities in the suborbital domain. There is a launch licensing regime in the United States (US) to assist the forerunners of the suborbital domain however this does not provide a safety approval for the vehicle against set standards or does not have an acceptable level of safety to achieve in terms of design or operation. In Europe a certification framework may be implemented however this (or any regulatory framework) is not in place as yet. This paper summarises the 5 tasks thus far completed by the International Association for the Advancement of Space Safety (IAASS) Suborbital Safety Technical Committee (SS TC) in terms of deriving standards and guidelines for the suborbital domain. The SS TC comprises members from the suborbital industry (US and European vehicle designers), safety experts, legal experts, medical/training experts, prospective spaceport operators and members from the US and European authorities (though these members cannot directly steer the standards and guidelines - they can merely review them for interest and comment on non-policy aspects). The SS TC has been divided into three working groups (WG): Regulatory WG, Technical WG and Operations WG. The 5 tasks that are summarised in this paper include: Regulatory WG - (Task 1) Clarify and promote regulatory framework for suborbital flights (including discussions on Space Law 'v' Air Law for suborbital domain); Technical WG - (Task 1) Defining & Alignment (globally) of Safety Criteria for Suborbital domain using industry best practices, (Task 2) Software/complex hardware certification for suborbital flights; Operations WG - (Task 1) Flight Crew and Spaceflight Participant Medical and Training Standards & Guidelines for suborbital flight, (Task 2) Spaceport Safety Management System. This paper also details the next set of standards and guidelines that will be derived by the SS TC. The paper concludes that these and future IAASS suborbital safety standards and guidelines are needed now and should beconsidered by the industry players before the first commercial flights expected late 2013/early 2014.

Publications of the space physiology and countermeasures program, regulatory physiology discipline: 1980 - 1990

NASA Technical Reports Server (NTRS)

Wallace-Robinson, Janice; Dickson, Katherine J.; Hess, Elizabeth; Powers, Janet V.

1992-01-01

A 10-year cumulative bibliography of publications resulting from research supported by the Regulatory Physiology discipline of the Space Physiology and Countermeasures Program of NASA's Life Sciences Division is provided. Primary subjects included in this bibliography are circadian rhythms, endocrinology, fluid and electrolyte regulation, hematology, immunology, metabolism and nutrition, temperature regulation, and general regulatory physiology. General physiology references are also included. Principal investigators whose research tasks resulted in publication are identified by asterisk. Publications are identified by a record number corresponding with their entry in the Life Sciences Bibliographic Database, maintained at the George Washington University.

78 FR 73911 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing of Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-09

... 3120 To Extend the Pilot Program That Eliminated the Position Limits for Options on SPDR S&P 500 ETF... extend the pilot program that eliminated the position limits for options on SPDR S&P 500 ETF (``SPY...- regulatory organizations (``SROs'') have adopted similar rules eliminating position limits on SPY and market...

Motivational Regulatory Styles of Graduate Students Enrolled in Online Prescribed and Elective Courses

ERIC Educational Resources Information Center

Wasmanski, Stephanie Lynn

2018-01-01

The purpose of this study was to explore the regulatory styles, as identified in Ryan and Deci's Self-Determination Theory, of graduate students enrolled in prescribed and elective courses, in a fully online Master of Education degree program. A sample consisting of 53 participants, enrolled in a master's degree program in education at a state…

77 FR 38116 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Proposing a Pilot Program To Create a Lead Market Maker Issuer Incentive Program for...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to create and implement, on a pilot basis, a...

[Introduction of Quality Management System Audit in Medical Device Single Audit Program].

PubMed

Wen, Jing; Xiao, Jiangyi; Wang, Aijun

2018-01-30

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.

Regulatory physiology discipline science plan

NASA Technical Reports Server (NTRS)

1991-01-01

The focus of the Regulatory Physiology discipline of the Space Physiology and Countermeasures Program is twofold. First, to determine and study how microgravity and associated factors of space flight affect the regulatory mechanisms by which humans adapt and achieve homeostasis and thereby regulate their ability to respond to internal and external signals; and, second, to study selected physiological systems that have been demonstrated to be influenced by gravity. The Regulatory Physiology discipline, as defined here, is composed of seven subdisciplines: (1) Circadian Rhythms, (2) Endocrinology, (3) Fluid and Electrolyte Regulation, (4) Hematology, (5) Immunology, (6) Metabolism and Nutrition, and (7) Temperature Regulation. The purpose of this Discipline Science Plan is to provide a conceptual strategy for NASA's Life Sciences Division research and development activities in the area of regulatory physiology. It covers the research areas critical to NASA's programmatic requirements for the Extended-Duration Orbiter, Space Station Freedom, and exploration mission science activities. These science activities include ground-based and flight; basic, applied, and operational; and animal and human research and development. This document summarizes the current status of the program, outlines available knowledge, establishes goals and objectives, identifies science priorities, and defines critical questions in regulatory physiology. It contains a general plan that will be used by both NASA Headquarters Program Offices and the field centers to review and plan basic, applied, and operational intramural and extramural research and development activities in this area.

Progress Cleaning the Air: Voluntary Partnership Program Accomplishments

EPA Pesticide Factsheets

EPA voluntary clean air partnership programs work in tandem with regulatory programs to protect public health and the environment. This page highlights accomplishments of selected partnership programs.

77 FR 20472 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-04

... ``Fitness Standards for Directors, Clearing Members and Others'' (``Fitness Standards'') to bring such standards into conformity with the proposed amendments to OCC's By-Laws. The Fitness Standards were... regulations, OCC's Fitness Standards, as described above, were constructed in part to comply with core...

77 FR 39385 - Receipts-Based, Small Business Size Standard

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

... Business Size Standard AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule. SUMMARY: The U.S.... The NRC is increasing its receipts-based, small business size standard from $6.5 million to $7 million to conform to the standard set by the Small Business Administration (SBA). This size standard...

Site Environmental Report for 2002, Volume 2

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

Pauer, Ron

2003-07-01

Each year, Ernest Orlando Lawrence Berkeley National Laboratory prepares an integrated report on its environmental programs to satisfy the requirements of United States Department of Energy Order 231.1. The ''Site Environmental Report for 2002'' summarizes Berkeley Lab's compliance with environmental standards and requirements, characterizes environmental management efforts through surveillance and monitoring activities, and highlights significant programs and efforts for calendar year 2002. Throughout this report, Ernest Orlando Lawrence Berkeley National Laboratory is referred to as ''Berkeley Lab,'' ''the Laboratory,'' ''Lawrence Berkeley National Laboratory,'' and ''LBNL.'' The report is separated into two volumes. Volume I contains a general overview of themore » Laboratory, the status of environmental programs, and summarized results from surveillance and monitoring activities. Volume II contains individual data results from the monitoring programs. This year, the ''Site Environmental Report'' was distributed on a CD in PDF format that includes Volume I, Volume II, and related documents. The report is also available on the Web at http://www.lbl.gov/ehs/esg/. The report follows the Laboratory's policy of using the International System of Units (SI), also known as the metric system of measurements. Whenever possible, results are additionally reported using the more conventional (non-SI) system of measurements because this system is referenced by some current regulatory standards and is more familiar to some readers. The tables included at the end of the Glossary are intended to help readers understand the various prefixes used with SI units of measurement and convert these units from one system to the other.« less

Site Environmental Report for 2002, Volume 1

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

Pauer, Ron

2003-07-01

Each year, Ernest Orlando Lawrence Berkeley National Laboratory prepares an integrated report on its environmental programs to satisfy the requirements of United States Department of Energy Order 231.1. The ''Site Environmental Report for 2002'' summarizes Berkeley Lab's compliance with environmental standards and requirements, characterizes environmental management efforts through surveillance and monitoring activities, and highlights significant programs and efforts for calendar year 2002. Throughout this report, Ernest Orlando Lawrence Berkeley National Laboratory is referred to as ''Berkeley Lab,'' ''the Laboratory,'' ''Lawrence Berkeley National Laboratory,'' and ''LBNL.'' The report is separated into two volumes. Volume I contains a general overview of themore » Laboratory, the status of environmental programs, and summarized results from surveillance and monitoring activities. Volume II contains individual data results from the monitoring programs. This year, the ''Site Environmental Report'' was distributed on a CD in PDF format that includes Volume I, Volume II, and related documents. The report is also available on the Web at http://www.lbl.gov/ehs/esg/. The report follows the Laboratory's policy of using the International System of Units (SI), also known as the metric system of measurements. Whenever possible, results are additionally reported using the more conventional (non-SI) system of measurements because this system is referenced by some current regulatory standards and is more familiar to some readers. The tables included at the end of the Glossary are intended to help readers understand the various prefixes used with SI units of measurement and convert these units from one system to the other.« less

(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

Using science soundly: The Yucca Mountain standard

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

Fri, R.W.

1995-09-01

Using sound science to shape government regulation is one of the most hotly argued topics in the ongoing debate about regulatory reform. Even though no one advaocates using unsound science, the belief that even the best science will sweep away regulatory controversy is equally foolish. As chair of a National Research Council (NRC) committee that studied the scientific basis for regulating high-level nuclear waste disposal, the author learned that science alone could resolve few of the key regulatory questions. Developing a standard that specifies a socially acceptable limit on the human health effects of nuclear waste releases involves many decisions.more » As the NRC committee learned in evaluating the scientific basis for the Yucca Mountain standard, a scientifically best decision rarely exists. More often, science can only offer a useful framework and starting point for policy debates. And sometimes, science`s most helpful contribution is to admit that it has nothing to say. The Yucca mountain study clearly illustrates that excessive faith in the power of science is more likely to produce messy frustration than crisp decisions. A better goal for regulatory reform is the sound use of science to clarify and contain the inevitable policy controversy.« less

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

NONE

The report is an overview of electric energy efficiency programs. It takes a concise look at what states are doing to encourage energy efficiency and how it impacts electric utilities. Energy efficiency programs began to be offered by utilities as a response to the energy crises of the 1970s. These regulatory-driven programs peaked in the early-1990s and then tapered off as deregulation took hold. Today, rising electricity prices, environmental concerns, and national security issues have renewed interest in increasing energy efficiency as an alternative to additional supply. In response, new methods for administering, managing, and delivering energy efficiency programs aremore » being implemented. Topics covered in the report include: Analysis of the benefits of energy efficiency and key methods for achieving energy efficiency; evaluation of the business drivers spurring increased energy efficiency; Discussion of the major barriers to expanding energy efficiency programs; evaluation of the economic impacts of energy efficiency; discussion of the history of electric utility energy efficiency efforts; analysis of the impact of energy efficiency on utility profits and methods for protecting profitability; Discussion of non-utility management of energy efficiency programs; evaluation of major methods to spur energy efficiency - systems benefit charges, resource planning, and resource standards; and, analysis of the alternatives for encouraging customer participation in energy efficiency programs.« less

World Trade Center Health Program; Amendments to Definitions, Appeals, and Other Requirements. Final rule.

PubMed

2016-12-15

In 2011 and 2012, the Secretary, Department of Health and Human Services (HHS), promulgated regulations designed to govern the World Trade Center (WTC) Health Program (Program), including the processes by which eligible responders and survivors may apply for enrollment in the Program, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatment decisions, as well as a process to add new conditions to the List of WTC-Related Health Conditions (List). After using the regulations for a number of years, the Administrator of the WTC Health Program identified potential improvements to certain existing provisions, including, but not limited to, appeals of enrollment, certification, and treatment decisions, as well as the procedures for the addition of health conditions for WTC Health Program coverage. He also identified the need to add new regulatory provisions, including, but not limited to, standards for the disenrollment of a WTC Health Program member and decertification of a certified WTC-related health condition. A notice of proposed rulemaking was published on August 17, 2016; this action addresses public comments received on that proposed rulemaking, as well as three interim final rules promulgated since 2011, and finalizes the proposed rule and three interim final rules.

RCRA, superfund and EPCRA hotline training module. Introduction to: Used oil (40 cfr part 266, subparts e, and part 279) updated July 1996

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

NONE

1996-07-01

The module reviews the various regulatory requirements associated with used oil management. The goal of the training module is to provide an overview of the used oil management program and to explain the different regulatory scenarios that can apply to used oil. The module begins by briefly tracing the developmental history of the regulations concerning used oil. A summary of the present used oil management program, as well as a brief summary of the former program, provides a basic comparison and introduction to both programs.

1998 Environmental Monitoring Program Report for the Idaho National Engineering and Environmental Laboratory

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

L. V. Street

This report describes the calendar year 1998 compliance monitoring and environmental surveillance activities of the Lockheed Martin Idaho Technologies Company Environmental Monitoring Program performed at the Idaho National Engineering and Environmental Laboratory. This report includes results of sampling performed by the Drinking Water, Effluent, Storm Water, Groundwater Monitoring, and Environmental Surveillance Programs. This report compares the 1998 results to program-specific regulatory guidelines and past data to evaluate trends. The primary purposes of the monitoring and surveillance activities are to evaluate environmental conditions, to provide and interpret data, to verify compliance with applicable regulations or standards, and to ensure protection ofmore » public health and the environment. Surveillance of environmental media did not identify any previously unknown environmental problems or trends, which would indicate a loss of control or unplanned releases from facility operations. The INEEL complied with permits and applicable regulations, with the exception of nitrogen samples in a disposal pond effluent stream and iron and total coliform bacteria in groundwater downgradient from one disposal pond. Data collected by the Environmental Monitoring Program demonstrate that the public health and environment were protected.« less

Unraveling the Tangled Skein: The Evolution of Transcriptional Regulatory Networks in Development.

PubMed

Rebeiz, Mark; Patel, Nipam H; Hinman, Veronica F

2015-01-01

The molecular and genetic basis for the evolution of anatomical diversity is a major question that has inspired evolutionary and developmental biologists for decades. Because morphology takes form during development, a true comprehension of how anatomical structures evolve requires an understanding of the evolutionary events that alter developmental genetic programs. Vast gene regulatory networks (GRNs) that connect transcription factors to their target regulatory sequences control gene expression in time and space and therefore determine the tissue-specific genetic programs that shape morphological structures. In recent years, many new examples have greatly advanced our understanding of the genetic alterations that modify GRNs to generate newly evolved morphologies. Here, we review several aspects of GRN evolution, including their deep preservation, their mechanisms of alteration, and how they originate to generate novel developmental programs.

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.

30 CFR 906.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Natural Resources, Division of Minerals and Geology, Centennial Building, room 215, 1313 Sherman Street..., the Colorado Department of Natural Resources was deemed the regulatory authority in Colorado for...

An environmental partnership - hawks and highwalls at the Jim Bridger mine

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

Harshbarger, R.M.

1996-12-31

Can industry and the environment coexist to the benefit of both? More specifically can coal mining and the environment have beneficial partnerships? Based on information normally available in the popular press, a partnership would seem impossible. Millions of pages and thousands of hours of air time have been used to convey a misinformed message that mining is always detrimental to the environment. The message is clear and one sided. Mining companies destroy the environment in their greed to extract mineral wealth from the ground. They leave barren, disturbed landscapes devoid of life. Mining and the environment can not coexist. Theremore » can be no partnership. Bridger Coal Company`s environmental programs, including the raptor mitigation program, demonstrate that mining companies in cooperation with regulatory agencies can utilize the latest scientific developments to protect environmental resources, maintain operational efficiency and in the process raise the industry standard.« less