Science.gov

Sample records for 95-4 regulatory status

  1. 47 CFR 101.533 - Regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Regulatory status. 101.533 Section 101.533 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES 24 GHz Service and Digital Electronic Message Service § 101.533 Regulatory status. (a)...

  2. 47 CFR 101.533 - Regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Regulatory status. 101.533 Section 101.533 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES 24 GHz Service and Digital Electronic Message Service § 101.533 Regulatory status. (a)...

  3. 47 CFR 101.533 - Regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Regulatory status. 101.533 Section 101.533 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES 24 GHz Service and Digital Electronic Message Service § 101.533 Regulatory status. (a)...

  4. 47 CFR 101.533 - Regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Regulatory status. 101.533 Section 101.533 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES 24 GHz Service and Digital Electronic Message Service § 101.533 Regulatory status. (a)...

  5. 47 CFR 101.533 - Regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Regulatory status. 101.533 Section 101.533 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES 24 GHz Service and Digital Electronic Message Service § 101.533 Regulatory status. (a)...

  6. 47 CFR 101.1309 - Regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Regulatory status. 101.1309 Section 101.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission...

  7. 47 CFR 101.1309 - Regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Regulatory status. 101.1309 Section 101.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission...

  8. Current status of herbal product: Regulatory overview.

    PubMed

    Sharma, Sanjay

    2015-01-01

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

  9. Current status of herbal product: Regulatory overview

    PubMed Central

    Sharma, Sanjay

    2015-01-01

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

  10. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... CAIR NOX Ozone Season Opt-in Units § 96.387 Change in regulatory status. (a) Notification. If a CAIR NOX Ozone Season opt-in unit becomes a CAIR NOX Ozone Season unit under § 96.304, then the CAIR... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change....

  11. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... CAIR NOX Ozone Season Opt-in Units § 96.387 Change in regulatory status. (a) Notification. If a CAIR NOX Ozone Season opt-in unit becomes a CAIR NOX Ozone Season unit under § 96.304, then the CAIR... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change....

  12. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting regulatory...

  13. 40 CFR 95.4 - Limitations on mandatory licenses

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Limitations on mandatory licenses 95.4 Section 95.4 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED... provide for termination, subject to adequate protections of the legitimate interests of the licensed...

  14. 40 CFR 95.4 - Limitations on mandatory licenses.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 20 2014-07-01 2013-07-01 true Limitations on mandatory licenses. 95.4 Section 95.4 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED... provide for termination, subject to adequate protections of the legitimate interests of the licensed...

  15. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...: common carrier, non-common carrier, private internal communications, and broadcast services. A licensee... carrier, non-common carrier, private internal communications, or broadcast services, or a combination... internal communications, or broadcast services status, or a combination thereof, in a single license. (2...

  16. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...: common carrier, non-common carrier, private internal communications, and broadcast services. A licensee... carrier, non-common carrier, private internal communications, or broadcast services, or a combination... internal communications, or broadcast services status, or a combination thereof, in a single license....

  17. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...: common carrier, non-common carrier, private internal communications, and broadcast services. A licensee... carrier, non-common carrier, private internal communications, or broadcast services, or a combination... internal communications, or broadcast services status, or a combination thereof, in a single license....

  18. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...: common carrier, non-common carrier, private internal communications, and broadcast services. A licensee... carrier, non-common carrier, private internal communications, or broadcast services, or a combination... internal communications, or broadcast services status, or a combination thereof, in a single license....

  19. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...: common carrier, non-common carrier, private internal communications, and broadcast services. A licensee... carrier, non-common carrier, private internal communications, or broadcast services, or a combination... internal communications, or broadcast services status, or a combination thereof, in a single license....

  20. 77 FR 65840 - Chrysanthemum White Rust Regulatory Status and Restrictions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-31

    ... Chrysanthemum White Rust Regulatory Status and Restrictions AGENCY: Animal and Plant Health Inspection Service... whether and how we should amend our process for responding to domestic chrysanthemum white rust (CWR... chrysanthemum white rust (CWR) outbreaks and the importation of plant material that is a host of CWR. CWR is...

  1. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting...

  2. 40 CFR 96.187 - 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. 96.187 Section 96.187 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION...

  3. 40 CFR 96.87 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in source becomes a NOX Budget unit under § 96.4, the NOX authorized account representative shall notify...

  4. 40 CFR 96.87 - 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 Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in source becomes a NOX Budget unit under § 96.4, the NOX authorized account representative shall notify...

  5. 40 CFR 96.187 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 21 2011-07-01 2011-07-01 false Change in regulatory status. 96.187 Section 96.187 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION...

  6. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting...

  7. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting...

  8. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting...

  9. 40 CFR 95.4 - Limitations on mandatory licenses

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) MANDATORY PATENT LICENSES § 95.4 Limitations on mandatory licenses (a) If the Administrator, or the Administrator's designee, decides to apply to the Attorney General for a mandatory patent license in accordance with § 95.3, the application shall include a proposed patent license with the following limitations: (1...

  10. Cardiorespiratory synchronism in estimation of regulatory and adaptive organism status.

    PubMed

    Pokrovskii, Vladimir M; Polischuk, Lily V

    2016-03-01

    The proposed method of quantitative estimation of regulatory and adaptive status (RAS) of human organism is based on complex responses of two major vegetative functions - breath and heart rates under organism exposure to a number of factors and diseases. It has been evidenced that during the follicular menstruation stage and during optimum readiness of female organism for childbirth RAS increases, however, stress impact can also cause RAS set off to decrease. Likewise, the possibility of quantitative organism stress resistance estimation is also presented. Under some pathological conditions (myocardial infarction, hypo-and hyperthyroidism, diabetes type 2), RAS goes down, and the degree of its restoration depends on the attained therapy effect. It is shown that RAS dynamics provides an innovative methodological approach to medication efficiency estimation based on its influence not only on the body organ or target function, but also on adaptive abilities of the organism.

  11. 77 FR 46339 - Chrysanthemum White Rust Regulatory Status and Restrictions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-03

    ..., destruction, treatment, or other sanitation measures called for in our National Management Plan. The... reevaluating our current regulatory strategy in order to improve the effectiveness and economic efficiency of...-Goldner, National Program Manager, Emergency and Domestic Programs, PPQ, APHIS, 4700 River Road Unit 160...

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

    PubMed Central

    Georgopoulos, P G

    1995-01-01

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

  13. Probabilistic risk assessment (PRA): status report and guidance for regulatory application. Draft report for comment

    SciTech Connect

    1984-02-01

    This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed.

  14. [The regulatory-adaptive status in the evaluation of human stress-resistance].

    PubMed

    Pokrovskiĭ, V M; Mingalev, A N

    2012-01-01

    There was offered a method of human stress-resistance evaluation via the dynamics of the regulatory-adaptive status. The regulatory-adaptive status was being determined via the parameters of the cardiorespiratory synchronism in the original state and at the application of the stress factor. Individuals, whose regulatory-adaptive status didn't change or decreased by not more than 5-6% at the exposition to the stress factor formed the group with a high level of stress-resistance. The individuals, whose regulatory adaptive status at the exposition to the stress factor decreased by less than 50% formed a group with a moderate level of stress-resistance. The examinees, whose regulatory-adaptive status decreased by more than 50% in a response to the stress factor were set in a group with a low stress-resistance level. The method was tested in the three stress models: 1) exam stress-on 58 students; 2) parachute jump stress-on 35 beginner parachutists; 3) stress, caused by the relocation to the zone of the catastrophe on 30 rescuers. In all the three models the method is highly informative. At the same time the levels of the stress-resistance were being evaluated by the psychological methods. It was shown, that the evaluation of the stress-resistance level via the dynamics of the regulatory-adaptive status allows to objectively characterize the ability of an individual to resist stress and should be included in the test complex for the casting of the candidates for the extreme professions.

  15. Regulatory Organizations for Physicians’ Status and Administrative Sanctions on Physicians

    PubMed Central

    MORIOKA, Yasuhiko; HIGUCHI, Norio; KUROYANAGI, Tatsuo; NUDESHIMA, Jiro

    2014-01-01

    Society bestows professional privilege on physicians. At the same time, it expects physicians to strive constantly to improve their ethics and quality in medical expertise. In every nation, some level of government is responsible for certifying or licensing physicians and imposes strict management, including revoking licenses from inappropriate physicians or providing severe sanctions for misconduct or conduct unbecoming of a physician. In reality, however, it is difficult to reduce the number of inappropriate or indiscreet physicians, and each nation faces its own challenges. We conducted a questionnaire survey of 13 national medical associations, including some major Western countries, regarding the licensing of physicians, the organizations managing their medical practice status, and the data and grounds for administrative sanctioning of physicians. We then examined the circumstances in Japan based on the survey results and pointed out the domestic issues. PMID:25784827

  16. 40 CFR 761.257 - Determining the regulatory status of sampled pipe.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Determining the regulatory status of sampled pipe. 761.257 Section 761.257 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION...

  17. 40 CFR 761.257 - Determining the regulatory status of sampled pipe.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Determining the regulatory status of sampled pipe. 761.257 Section 761.257 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS...

  18. 40 CFR 761.257 - Determining the regulatory status of sampled pipe.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Determining the regulatory status of sampled pipe. 761.257 Section 761.257 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS...

  19. 40 CFR 761.257 - Determining the regulatory status of sampled pipe.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Determining the regulatory status of sampled pipe. 761.257 Section 761.257 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS...

  20. 40 CFR 761.257 - Determining the regulatory status of sampled pipe.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Determining the regulatory status of sampled pipe. 761.257 Section 761.257 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS...

  1. The regulatory status of xylazine for use in food-producing animals in the United States.

    PubMed

    Chamberlain, P L; Brynes, S D

    1998-08-01

    Xylazine is commonly used in veterinary medicine as a tranquillizer or adjunct to surgical anaesthesia. Although its use is approved in companion animals and certain species of deer, xylazine remains unapproved for use in food-producing animals in the United States. This paper reviews existing toxicological and residue chemistry information on xylazine in food animals, particularly cattle, and discusses the regulatory status of the drug in the US, as well as the conclusions reached by the Joint FAO/WHO Expert Committee on Food Additives in its recent evaluation of xylazine.

  2. Current status of U.S. Nuclear Regulatory Commission regulatory efforts controlling the disposition of solid materials.

    PubMed

    Paperiello, Carl J

    2006-11-01

    Current efforts of the U.S. Nuclear Regulatory Commission (U.S. NRC) to develop rules for the disposition of low-activity solid materials and the outcome of U.S. NRC rulemaking activities in this area since the late 1990's are described. International efforts on the disposition of low-activity solid materials and future plans of the U.S. NRC on this subject are also described.

  3. Current status and regulatory perspective of chimeric antigen receptor-modified T cell therapeutics.

    PubMed

    Kim, Mi-Gyeong; Kim, Dongyoon; Suh, Soo-Kyung; Park, Zewon; Choi, Min Joung; Oh, Yu-Kyoung

    2016-04-01

    Chimeric antigen receptor-modified T cells (CAR-T) have emerged as a new modality for cancer immunotherapy due to their potent efficacy against terminal cancers. CAR-Ts are reported to exert higher efficacy than monoclonal antibodies and antibody-drug conjugates, and act via mechanisms distinct from T cell receptor-engineered T cells. These cells are constructed by transducing genes encoding fusion proteins of cancer antigen-recognizing single-chain Fv linked to intracellular signaling domains of T cell receptors. CAR-Ts are classified as first-, second- and third-generation, depending on the intracellular signaling domain number of T cell receptors. This review covers the current status of CAR-T research, including basic proof-of-concept investigations at the cell and animal levels. Currently ongoing clinical trials of CAR-T worldwide are additionally discussed. Owing to the lack of existing approved products, several unresolved concerns remain with regard to safety, efficacy and manufacturing of CAR-T, as well as quality control issues. In particular, the cytokine release syndrome is the major side-effect impeding the successful development of CAR-T in clinical trials. Here, we have addressed the challenges and regulatory perspectives of CAR-T therapy.

  4. Current status and regulatory aspects of pesticides considered to be persistent organic pollutants (POPs) in Taiwan.

    PubMed

    Tsai, Wen-Tien

    2010-10-01

    Organochlorine pesticides (OCPs) are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs) and even as endocrine disrupting chemicals (EDCs). The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs). The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years.

  5. Current Status and Regulatory Aspects of Pesticides Considered to be Persistent Organic Pollutants (POPs) in Taiwan

    PubMed Central

    Tsai, Wen-Tien

    2010-01-01

    Organochlorine pesticides (OCPs) are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs) and even as endocrine disrupting chemicals (EDCs). The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs). The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years. PMID:21139852

  6. Is it only the regulatory status? Broadening the debate on cisgenic plants.

    PubMed

    van Hove, Lilian; Gillund, Frøydis

    2017-01-01

    In current debates on emerging technologies for plant breeding in Europe, much attention has been given to the regulatory status of these techniques and their public acceptance. At present, both genetically modified plants with cisgenic approaches-using genes from crossable species-as well as transgenic approaches-using genes from different species-fall under GMO regulation in the EU and both are mandatorily labelled as GMOs. Researchers involved in the early development of cisgenic GM plants convey the message that the potential use and acceptance of cisgenic approaches will be seriously hindered if GMO regulations are not adjusted. Although the similar treatment and labelling of transgenic and cisgenic plants may be a legitimate concern for the marketability of a cisgenic GM plant, there are concerns around their commercialization that reach beyond the current focus on (de)regulation. In this paper, we will use the development of the cisgenic GM potato that aims to overcome 'late blight'-the most devastating potato disease worldwide-as a case to argue that it is important to recognize, reflect and respond to broader concerns than the dominant focus on the regulatory 'burden' and consumer acceptance. Based on insights we gained from discussing this case with diverse stakeholders within the agricultural sector and potato production in Norway during a series of workshops, we elaborate on additional issues such as the (technical) solution offered; different understandings of the late blight problem; the durability of the potato plant resistance; and patenting and ownership. Hence, this paper contributes to empirical knowledge on stakeholder perspectives on emerging plant breeding technologies, underscoring the importance to broaden the scope of the debate on the opportunities and challenges of agricultural biotechnologies, such as cisgenic GM plants. The paper offers policy-relevant input to ongoing efforts to broaden the scope of risk assessments of agricultural

  7. Quality of alcohol-based hand disinfectants and their regulatory status. Development and marketing authorisation.

    PubMed

    Stengele, Michael

    2008-10-01

    A 2005 survey showed that there are at least four legal product classifications for hand disinfectants in the European Union: medicinal products, biocidal products, cosmetics and medical devices. An internationally harmonized classification does not exist. The regulatory status of those products is defined at national level. In order to assure compliance with the regulations these four classifications provide different levels of official surveillance varying from product-specific marketing authorisations and production site audits to the obligation to just work in accordance with certain general guidelines. Biocidal product regulations cover eco-toxicological and toxicological aspects, but do not very much address to the customers' quality and efficacy expectations. In contrast, the medicinal product legislation is the most ambitious one claiming quality, safety, efficacy, and an independent benefit risk-assessment by an authority. In respect of ambition, the two remaining product categories--cosmetics and medical devices--rank between the both classifications mentioned above. For medical devices, it is the responsibility of the manufacturer to make sure the products meet defined essential requirements regarding quality, safety and performance and to have an appropriate quality assurance system implemented under third party control. For cosmetics there are some legal restrictions, but within these it is the sole responsibility of the manufacturer to ensure that the products are safe and fulfil their claims. This paper describes one way out of this increasingly complex situation, the definition of a single quality standard meeting the users' expectations as well as all legal requirements regardless of the specific sales country. This international quality standard for products would take priority over any individual national standard, to the benefit of users.

  8. Folate status, regulatory T cells and MTHFR C677T polymorphism study in allergic children.

    PubMed

    Socha-Banasiak, Anna; Kamer, Barbara; Gach, Agnieszka; Wysocka, Urszula; Jakubowski, Lucjusz; Głowacka, Ewa; Czkwianianc, Elżbieta

    2016-09-01

    This study aimed to investigate early-life folate serum concentrations in children with food, inhalant or mixed type allergy. The influence of folate levels on the FoxP3 expression in Treg (regulatory T) cells in the studied children, taking into account the MTHFR (5,10-methylenetetrahydrofolate reductase) genotypes was also analyzed. The study was performed in 83 allergic children (study group) and 49 healthy children (control group), aged 2-72 months. Medical history of each child was obtained and laboratory tests (serum folic acid concentrations and MTHFR C677T polymorphism) were carried out. The percentage of Treg cells was evaluated in almost a half of the examined subjects (48.5%). Significantly higher serum folate levels in the group of children with food allergy than in those with inhalant allergy was confirmed (P=0.037). In the study group the TT homozygotes were characterized by significantly lower folate concentrations than CC homozygotes (P=0.045). A negative correlation was demonstrated between the FoxP3 expression in CD4(+)CD25(high)FoxP3(+) peripheral blood lymphocytes and serum folic acid concentrations. The correlation was more pronounced in the group of allergic children and it was statistically significant (r=-0.339, P<0.05). The results of the study indicate a possibility of some effects of folate status on Treg cells, thus suggesting their potential role in the development and course of allergy in children. Copyright © 2016 Medical University of Bialystok. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

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

    PubMed

    Tohkin, Masahiro

    2017-01-01

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

  10. Technical Status Report of the Regulatory Assistance Project: October 2001-February 2003

    SciTech Connect

    Not Available

    2003-08-01

    This report details the work undertaken from October 2001 to February 2003 by the Regulatory Assistance Project under subcontract to the National Renewable Energy Laboratory. The objectives of this work were to develop regulatory policy options that would reduce the institutional and infrastructure barriers to full-value deployment of distributed power systems. Specific tasks included leading technical workshops on removing or overcoming regulatory barriers to distributed resources for state utility regulators and developing a draft model rule on emission performance standards for distributed generation.

  11. Harmonization of regulatory guidelines on efficacy of ectoparasiticides for companion animals: status and missing points.

    PubMed

    Curet Bobey, Marianne

    2015-02-28

    Ectoparasites of major clinical significance in companion animals include fleas, ticks, lice, mange, mite, mosquitoes and sandflies, as well as biting flies. Obtaining a marketing authorization (or licence) for an ectoparasiticide relies on the assessment by regulatory agencies of a comprehensive data package to confirm the quality, safety and efficacy of the product when used in the target animal species for the proposed claims. Such approval is done under a highly regulated system. However, the global regulatory framework for pet ectoparasiticides is complex, since these products may be classified either as pesticides or as pharmaceuticals depending on the country or even within a given country, based on the presentation or mode of action. Within each jurisdiction, regulatory guidelines provide standards relating to study designs, relevant parasite species, efficacy calculation and acceptable thresholds, and define the corresponding acceptable label claims. Despite some similarities, there is no formal international harmonization for development requirements. In some areas, gaps and/or inconsistencies are more marked than others. Published recommendations from scientific expert groups (e.g. W.A.A.V.P. guidelines) are therefore a useful tool for regulatory bodies, researchers, developers and animal health companies. These expert recommendations reflect the current position of the scientific community and potentially address aspects not covered satisfactorily by regulatory texts while taking into account the latest advancements in experimental methodologies. Since the changes to official regulatory texts generally occur at a slower pace than the scientific state-of-the-art, and because of the lack of a harmonized approach, both scientific and regulatory guidance documents are necessary. The main objective of this review is to explore the complexity of the international regulatory framework for pet ectoparasiticides and to highlight some areas that are

  12. Current regulatory and licensing status for byproduct sources, facilities and applications

    SciTech Connect

    Tingey, G.L.; Jensen, G.A.; Hazelton, R.F.

    1985-02-01

    Public use of nuclear byproducts, especially radioactive isotopes, will require approval by various regulatory agencies. Use of cesium-137 as an irradiation source for sterilizing medical products will require US Nuclear Regulatory Commission (NRC) approval. Two applications have been filed with NRC, and approval is expected soon. Widespread use of irradiation for food products depends on a favorable ruling by the Food and Drug Administration (FDA). A ruling is pending that would permit irradiation of fruits and vegetables up to 100 krad. NRC also controls the use of isotopes in remote power generators, but little regulatory action has been required in recent years. Recent development of radioluminescent (RL) lighting for runway lights has led to interest by commercial manufacturers. At the present time, a license has been issued to at least one manufacturer for sale of tritium-powered runway lights. 28 refs., 1 fig.

  13. Regulatory Risk Reduction for Advanced Reactor Technologies – FY2016 Status and Work Plan Summary

    SciTech Connect

    Moe, Wayne Leland

    2016-08-01

    Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy’s (DOE) Advanced Reactor Technologies (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants

  14. Annual Technical Status Report of the Regulatory Assistance Project: September 2000--September 2001

    SciTech Connect

    Not Available

    2002-10-01

    This report summarizes the work in 2001 by the Regulatory Assistance Project (RAP), under contract to the National Renewable Energy Laboratory. This work focused on identifying and removing the regulatory and institutional barriers that keep the full economic value of distributed resources from being realized. The following five reports present the work details: (1) Accommodating Distributed Resources in Wholesale Markets, NREL/SR-560-32497; (2) Distributed Resource Distribution Credit Pilot Programs - Revealing the Value to Consumers and Vendors, NREL/SR-560-32499; (3) Distributed Resources and Electric System Reliability, NREL/SR-560-32498; (4) Distribution System Cost Methodologies for Distributed Generation, NREL/SR-560-32500; (5) Distribution System Cost Methodologies for Distributed Generation Appendices, NREL/SR. Visit www.eren.doe.gov/distributedpower for more information about RAP contract activity to establish environmental output air emissions standards for small-scale electricity generation (to be published as a future NREL subcontract report).

  15. Prebiotics and the health benefits of fiber: current regulatory status, future research, and goals.

    PubMed

    Brownawell, Amy M; Caers, Wim; Gibson, Glenn R; Kendall, Cyril W C; Lewis, Kara D; Ringel, Yehuda; Slavin, Joanne L

    2012-05-01

    First defined in the mid-1990s, prebiotics, which alter the composition and activity of gastrointestinal (GI) microbiota to improve health and well-being, have generated scientific and consumer interest and regulatory debate. The Life Sciences Research Organization, Inc. (LSRO) held a workshop, Prebiotics and the Health Benefits of Fiber: Future Research and Goals, in February 2011 to assess the current state of the science and the international regulatory environment for prebiotics, identify research gaps, and create a strategy for future research. A developing body of evidence supports a role for prebiotics in reducing the risk and severity of GI infection and inflammation, including diarrhea, inflammatory bowel disease, and ulcerative colitis as well as bowel function disorders, including irritable bowel syndrome. Prebiotics also increase the bioavailability and uptake of minerals and data suggest that they reduce the risk of obesity by promoting satiety and weight loss. Additional research is needed to define the relationship between the consumption of different prebiotics and improvement of human health. New information derived from the characterization of the composition and function of different prebiotics as well as the interactions among and between gut microbiota and the human host would improve our understanding of the effects of prebiotics on health and disease and could assist in surmounting regulatory issues related to prebiotic use.

  16. The Counselling and Psychotherapy Profession in Canada: Regulatory Processes and Current Status

    ERIC Educational Resources Information Center

    Martin, Lorna; Turcotte, Michel; Matte, Laurent; Shepard, Blythe

    2013-01-01

    Like the Canadian landscape and culture, the status of professional regulation for counselling and psychotherapy is a mosaic reflecting the unique cultural, linguistic and contextual realities of Canada. Statutory regulation in Canada is constitutionally a provincial/territorial matter. In the past five years, a major movement towards professional…

  17. 75 FR 32860 - Regulatory Guidance Concerning the Preparation of Drivers' Record of Duty Status To Document...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... Preparation of Drivers' Record of Duty Status To Document Compliance With the Hours-of-Service Requirements.... FMCSA has determined that the current requirement may be satisfied through the preparation of an... the preparation of the RODS, in duplicate. However, FMCSA has opted for a more pragmatic...

  18. The Counselling and Psychotherapy Profession in Canada: Regulatory Processes and Current Status

    ERIC Educational Resources Information Center

    Martin, Lorna; Turcotte, Michel; Matte, Laurent; Shepard, Blythe

    2013-01-01

    Like the Canadian landscape and culture, the status of professional regulation for counselling and psychotherapy is a mosaic reflecting the unique cultural, linguistic and contextual realities of Canada. Statutory regulation in Canada is constitutionally a provincial/territorial matter. In the past five years, a major movement towards professional…

  19. Replacement of in vivo acute oral toxicity studies by in vitro cytotoxicity methods: opportunities, limits and regulatory status.

    PubMed

    Ukelis, Ute; Kramer, Peter-Jürgen; Olejniczak, Klaus; Mueller, Stefan O

    2008-06-01

    The development of a new medicinal product is a long and costly process in particular due to the regulatory requirements for quality, safety and efficacy. There is a common interest to increase the efficiency of drug development and to provide new, better quality medicinal products much faster to the public. One possible way to economize time and costs, as well as to consider animal protection issues, is to introduce new alternative methods into non-clinical toxicity testing. Currently, animal tests are mandatory for the evaluation of acute toxicity of chemicals and new drugs. The replacement of the in vivo tests by alternative in vitro assays would offer the opportunity to screen and assess numerous compounds at the same time, to predict acute oral toxicity and thus accelerate drug development. Moreover, the substitution of in vivo tests by in vitro methods shows a proactive pursuit of ethical and animal welfare issues. Importantly, the implementation of in vitro assays for acute oral toxicity would require the establishment of common test guidelines across the EU, USA and Japan, i.e., the regions of ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). Presently, alternative in vitro tests are being investigated internationally. Yet, in order to achieve regulatory acceptance and implementation of in vitro assays, convincing results from validation studies are required. In this review, we discuss the current regulatory status of acute oral toxicity testing and point out achievements of alternative methods. We describe the application of in vitro tests, correlating in vitro with in vivo data. The use of in vitro data to predict in vivo acute oral toxicity is analyzed using the Registry of Cytotoxicity, an official independent database. We have then analyzed opportunities and drawbacks for future implementation of in vitro test methods, with particular focus on industrial use.

  20. Fruit fly (Diptera: Tephritidae) host status determination: critical conceptual, methodological, and regulatory considerations.

    PubMed

    Aluja, Martín; Mangan, Robert L

    2008-01-01

    Although fruit fly host status determination/designation lies at the heart of strategic decisions on national and international trade of fruit and vegetables, all attempts thus far to define host plant status have been contentious and as a result long-standing disputes between commercial partners throughout the world have lingered over decades. Part of the problem is that too little effort has been devoted to understanding the underlying mechanisms involved in host plant use by fruit flies and that instead economic and political interests usually prevail. Here we review the most important evolutionary, biological, ecological, physiological, and behavioral aspects that drive host use by fruit flies, and then construct a flow diagram rooted in these fundamentals that outlines a series of steps and definitions to determine if a particular fruit or vegetable (and cultivars thereof) is a natural host, or a conditional (potential, artificial) host, or a nonhost. Along the way, we incorporate risk analysis considerations and propose that the underlying complexity determining host plant utilization by fruit flies requires a flexible systems approach capable of realistically dealing with fly/host/environment/geographic variability on a case-by-case basis.

  1. Antimicrobials in shrimp aquaculture in the United States: regulatory status and safety concerns.

    PubMed

    Park, E D; Lightner, D V; Park, D L

    1994-01-01

    The consumption of seafood, especially shrimp, increases yearly in the U.S. The U.S. is the second largest importer of shrimp in the world, consuming more than 11% of the total world production. Aquaculture is becoming an increasingly important source of the world's shrimp, currently accounting for approximately 30% of the world's supply. Unfortunately, in this era of international trade deficits, U.S. production of aquacultured shrimp is insignificant (< 0.1%) compared with world production. As shrimp aquaculture expands in the U.S., so does the use of intensive farming techniques. Shrimp aquaculture is like any other animal husbandry industry in that shrimp are subject to disease, especially under intensive farming methods. In penaeid shrimp, the primary diseases associated with mortalities are usually viral or bacterial. The majority of bacterial infections in penaeid shrimp are attributable to Vibrio species, with mortalities ranging from insignificant to 100%. However, the rapid growth of this industry has outpaced efforts by researchers, pharmaceutical companies, and federal regulatory agencies to provide approved therapeutants for shrimp disease management. Approval of drugs and their surveillance for compliance with regulations applicable to seafoods, including aquacultured goods, is the responsibility of the FDA. There are three general areas of concern regarding human health when chemotherapeutants are used in aquaculture: (1) residues of drugs in fish destined for human consumption; (2) development of drug resistance in human pathogenic bacteria; and (3) direct toxic effects to humans from handling of drugs. Currently, there are no antibacterials approved for shrimp aquaculture in the U.S. One of the major obstacles in the development and approval of new drugs for aquaculture is the cost of conducting the required studies. The high cost to pharmaceutical companies discourages investment in shrimp chemotherapeutant research, since the current U.S. market

  2. A Regulatory Role of NAD Redox Status on Flavin Cofactor Homeostasis in S. cerevisiae Mitochondria

    PubMed Central

    Giancaspero, Teresa Anna; Barile, Maria

    2013-01-01

    Flavin adenine dinucleotide (FAD) and nicotinamide adenine dinucleotide (NAD) are two redox cofactors of pivotal importance for mitochondrial functionality and cellular redox balance. Despite their relevance, the mechanism by which intramitochondrial NAD(H) and FAD levels are maintained remains quite unclear in Saccharomyces cerevisiae. We investigated here the ability of isolated mitochondria to degrade externally added FAD and NAD (in both its reduced and oxidized forms). A set of kinetic experiments demonstrated that mitochondrial FAD and NAD(H) destroying enzymes are different from each other and from the already characterized NUDIX hydrolases. We studied here, in some detail, FAD pyrophosphatase (EC 3.6.1.18), which is inhibited by NAD+ and NADH according to a noncompetitive inhibition, with Ki values that differ from each other by an order of magnitude. These findings, together with the ability of mitochondrial FAD pyrophosphatase to metabolize endogenous FAD, presumably deriving from mitochondrial holoflavoproteins destined to degradation, allow for proposing a novel possible role of mitochondrial NAD redox status in regulating FAD homeostasis and/or flavoprotein degradation in S. cerevisiae. PMID:24078860

  3. Regulatory Status of Fumigants

    EPA Pesticide Factsheets

    Information on the EPA reregistration process for four soil fumigant pesticides in May 2009: chloropicrin, dazomet, metam sodium/potassium, and methyl bromide. New safety measures were included in the reregistration eligibility decisions (REDs).

  4. Effect of cognitive status on self-regulatory driving behavior in older adults: an assessment of naturalistic driving using in-car video recordings.

    PubMed

    Festa, Elena K; Ott, Brian R; Manning, Kevin J; Davis, Jennifer D; Heindel, William C

    2013-03-01

    Previous findings that older drivers engage in strategic self-regulatory behaviors to minimize perceived safety risks are primarily based on survey reports rather than actual behavior. This study analyzed in-car video recording of naturalistic driving of 18 patients with Alzheimer disease (AD) and 20 age-matched controls in order to (1) characterize self-regulatory behaviors engaged by older drivers and (2) assess how behaviors change with cognitive impairment. Only participants who were rated "safe" on a prior standardized road test were selected for this study. Both groups drove primarily in environments that minimized the demands on driving skill and that incurred the least risk for involvement in major crashes. Patients with AD displayed further restrictions of driving behavior beyond those of healthy elderly individuals, suggesting additional regulation on the basis of cognitive status. These data provide critical empirical support for findings from previous survey studies indicating an overall reduction in driving mobility among older drivers with cognitive impairment.

  5. It Comes With the Job: Work Organizational, Job Design, and Self-Regulatory Barriers to Improving the Health Status of Train Drivers.

    PubMed

    Naweed, Anjum; Chapman, Janine; Allan, Matthew; Trigg, Joshua

    2017-03-01

    This study aimed to examine the impacts of key barriers to improving the occupational health status of Australian train drivers. From May to June, 2015, five semi-structured qualitative focus groups were conducted with 29 train drivers from South Australian, Victorian, and New South Wales-based rail organizations in Australia. Occupational health was impeded by multiple barriers regarding sleep (patterns/fatigue), diet (planning/context), mental health (occupational stress), rostering (low autonomy), sedentary time, low fitness motivation, and family/social life conflicts. Work organizational barriers included communication issues, low organizational support, and existing social norms. Job design barriers included rostering, fatigue, stimulant reliance, and family/social life imbalances. Self-regulatory barriers included dietary and exercise patterns habits and patterns. Occupational health interventions for Australian train drivers must address work organizational, job design, and self-regulatory barriers to healthier lifestyle behaviors.

  6. Copper toxicity in Chinese cabbage is not influenced by plant sulphur status, but affects sulphur metabolism-related gene expression and the suggested regulatory metabolites.

    PubMed

    Shahbaz, M; Stuiver, C E E; Posthumus, F S; Parmar, S; Hawkesford, M J; De Kok, L J

    2014-01-01

    The toxicity of high copper (Cu) concentrations in the root environment of Chinese cabbage (Brassica pekinensis) was little influenced by the sulphur nutritional status of the plant. However, Cu toxicity removed the correlation between sulphur metabolism-related gene expression and the suggested regulatory metabolites. At high tissue Cu levels, there was no relation between sulphur metabolite levels viz. total sulphur, sulphate and water-soluble non-protein thiols, and the expression and activity of sulphate transporters and expression of APS reductase under sulphate-sufficient or-deprived conditions, in the presence or absence of H2 S. This indicated that the regulatory signal transduction pathway of sulphate transporters was overruled or by-passed upon exposure to elevated Cu concentrations.

  7. Properties of CaLa4(Zr0.05Ti0.95)4O15 thin films by RF magnetron sputtering

    NASA Astrophysics Data System (ADS)

    Hsu, Cheng-Hsing; Liu, Jen-Chieh; Tseng, Ching-Fang; Hsieh, Wan-Yu; Yang, Yu-Han; Chou, Po-Heng; Chang, Chia-Hsien

    2017-01-01

    CaLa4(Zr0.05Ti0.95)4O15 thin films deposited on n-type Si(100) substrates at different substrate temperatures and radio-frequency (RF) powers were investigated. The structural and morphological characteristics analyzed by X-ray diffraction (XRD), atomic force microscopy (AFM), and scanning electron microscopy (SEM) were found to be affected by substrate temperature (150-300 °C) and RF power (200-300 W). Highly oriented CaLa4(Zr0.05Ti0.95)4O15 (110) perpendicular to the substrate surface was identified for all of the deposition conditions. The XRD showed that the deposited films exhibited a polycrystalline microstructure. As the RF power and substrate temperature increased, the quality of the CaLa4(Zr0.05Ti0.95)4O15 thin films improved, and the kinetic energies of the sputtered atoms increased, resulting in a structural improvement of the deposited CaLa4(Zr0.05Ti0.95)4O15 thin films. The optimum conditions for the growth of CaLa4(Zr0.05Ti0.95)4O15 thin films in this study were a RF power of 300 W and substrate temperature of 300 °C. A high dielectric constant of 46.2 (f = 1 MHz), dissipation factor of 0.049 (f = 1 MHz) and a low leakage current density of 7.3 × 10-7 A/cm2 in an electrical field of 100 kV/cm were obtained for the prepared films.

  8. THE ACCOUNTING PROFESSION: Status of Panel on Audit Effectiveness Recommendations to Enhance the Self-Regulatory System

    DTIC Science & Technology

    2002-05-01

    investor confidence in our capital markets. These areas include corporate governance , accounting standards and financial reporting, auditing, and...accountability if the right thing is not done. Further, the components in the regulatory and corporate governance systems must proactively assess risks...governing the accounting profession, the current financial reporting model, or various corporate governance issues. On January 17, 2002, the Chairman of the

  9. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan.

    PubMed

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-03-18

    Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region.

  10. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan

    PubMed Central

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-01-01

    Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region. PMID:26344953

  11. Effects of nutritional status and gonadal steroids on expression of appetite-regulatory genes in the hypothalamic arcuate nucleus of sheep.

    PubMed

    Archer, Z A; Findlay, P A; McMillen, S R; Rhind, S M; Adam, C L

    2004-09-01

    Sheep exhibit photoperiod-driven seasonal changes in appetite and body weight so that nutritional status increases in long days (LD) and decreases in short days (SD); additionally, they are reproductively active in SD and inactive in LD. We addressed the hypothesis that appetite-regulatory genes in the hypothalamus respond differently to changes in nutritional feedback induced by photoperiod as opposed to food restriction, and that responses would be influenced by gonadal steroid status. Castrated oestradiol-implanted male sheep were kept in SD (8 h light/day) or LD (16 h light/day) for 11 weeks, with ad libitum or restricted food (experiment 1; n=8/group). Rams were kept in SD or LD for 12 weeks with ad libitum or restricted food (experiment 2; n=6/group). Gene expression (by in situ hybridisation) in the hypothalamic arcuate nucleus for leptin receptor (OB-Rb), neuropeptide Y (NPY), pro-opiomelanocortin (POMC) and agouti-related peptide (AGRP) was unaffected by photoperiod treatment, but food restriction increased NPY and AGRP mRNAs, in experiment 1. In experiment 2, mRNAs for POMC and cocaine- and amphetamine-regulated transcript (CART) were up-regulated and AGRP down-regulated in SD, while food restriction increased OB-Rb mRNA, increased NPY and AGRP mRNAs only in LD and decreased POMC mRNA only in SD. Thus, gene expression responded differently to photoperiod and food restriction, and the melanocortin pathway was up-regulated in SD in reproductively activated rams but not in oestradiol-implanted castrates. These data support the hypothesis that hypothalamic appetite-regulatory pathways respond differently to changes in nutritional feedback induced by photoperiod as opposed to food restriction, with gonadal steroid feedback additionally influencing the responses.

  12. Current status and use of short/medium-term models for assessment of carcinogenicity of human pharmaceuticals: regulatory perspectives.

    PubMed

    van der Laan, J W

    2000-03-15

    In the summer of 1997 international governmental organizations and industry partners agreed upon a new document on 'Testing for Carcinogenicity of Pharmaceuticals'. The most important element in the new guidance was the acceptability of only one life-time carcinogenicity study in a rodent species (preferably the rat). In addition a choice could be made to test the pharmaceutical in one of the newly developed models, i.e. the newborn mouse assay or one of the various transgenic mouse assays. In the present paper the strengths and weaknesses of various models are discussed from a regulatory point of view. The aim of the new animal models would eventually be replacing animal life-span studies without compromizing human safety. Such studies should supplement the life-span studies and provide additional information not readily available from the long-term assay. At present there is insufficient information to predict or offer guidance on which of the models may be the most suitable. New models are not useful to test the carcinogenic potential of biotechnological products.

  13. Energy Regulatory Public Protection Act

    THOMAS, 113th Congress

    Rep. Gerlach, Jim [R-PA-6

    2013-04-12

    House - 04/30/2013 Referred to the Subcommittee on Regulatory Reform, Commercial And Antitrust Law. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  14. Aberrant gene expression in the Arabidopsis SULTR1;2 mutants suggests a possible regulatory role for this sulfate transporter in response to sulfur nutrient status.

    PubMed

    Zhang, Bo; Pasini, Rita; Dan, Hanbin; Joshi, Naveen; Zhao, Yihong; Leustek, Thomas; Zheng, Zhi-Liang

    2014-01-01

    Sulfur is required for the biosynthesis of cysteine, methionine and numerous other metabolites, and thus is critical for cellular metabolism and various growth and developmental processes. Plants are able to sense their physiological state with respect to sulfur availability, but the sensor remains to be identified. Here we report the isolation and characterization of two novel allelic mutants of Arabidopsis thaliana, sel1-15 and sel1-16, which show increased expression of a sulfur deficiency-activated gene β-glucosidase 28 (BGLU28). The mutants, which represent two different missense alleles of SULTR1;2, which encodes a high-affinity sulfate transporter, are defective in sulfate transport and as a result have a lower cellular sulfate level. However, when treated with a very high dose of sulfate, sel1-15 and sel1-16 accumulated similar amounts of internal sulfate and its metabolite glutathione (GSH) to wild-type, but showed higher expression of BGLU28 and other sulfur deficiency-activated genes than wild-type. Reduced sensitivity to inhibition of gene expression was also observed in the sel1 mutants when fed with the sulfate metabolites Cys and GSH. In addition, a SULTR1;2 knockout allele also exhibits reduced inhibition in response to sulfate, Cys and GSH, consistent with the phenotype of sel1-15 and sel1-16. Taken together, the genetic evidence suggests that, in addition to its known function as a high-affinity sulfate transporter, SULTR1;2 may have a regulatory role in response to sulfur nutrient status. The possibility that SULTR1;2 may function as a sensor of sulfur status or a component of a sulfur sensory mechanism is discussed.

  15. Increased percentages of regulatory T cells are associated with inflammatory and neuroendocrine responses to acute psychological stress and poorer health status in older men and women.

    PubMed

    Ronaldson, Amy; Gazali, Ahmad M; Zalli, Argita; Kaiser, Frank; Thompson, Stephen J; Henderson, Brian; Steptoe, Andrew; Carvalho, Livia

    2016-05-01

    The percentage of regulatory T cells (TRegs)-a subtype of T lymphocyte that suppresses the immune response-appears to be reduced in a number of stress-related diseases. The role of the TReg in stress-disease pathways has not yet been investigated. The aim of the study was to investigate the association between biological responsivity to acute psychosocial stress and the percentage of TRegs in healthy older adults. The secondary purpose was to measure the associations between TReg percentage and psychological and physical well-being in the participants. Salivary cortisol and plasma interleukin (IL)-6 samples were obtained from 121 healthy older men and women from the Whitehall II cohort following acute psychophysiological stress testing. Three years later at a follow-up visit, we measured TReg percentages and psychological and physical well-being were recorded using the Short Form 36 Health Survey and the Center for Epidemiologic Studies Depression Scale. Blunted cortisol responses (p = 0.004) and elevated IL-6 responses (p = 0.027) to acute psychophysiological stress were associated with greater TReg percentage independently of age, sex, BMI, smoking status, employment grade, time of testing, and baseline measures of cortisol and IL-6, respectively. Percentage of TRegs was associated cross-sectionally with lower physical (p = 0.043) and mental health status (p = 0.008), and higher levels of depressive symptoms (p = 0.002), independently of covariates. Increased levels of TRegs may act as a defence against increased inflammation and may be a pre-indication for chronically stressed individuals on the cusp of clinical illness.

  16. Regulatory Forum.

    PubMed

    Peden, W Michael

    2016-12-01

    Revision of the International Council for Harmonization (ICH) S1 guidance for rat carcinogenicity studies to be more selective of compounds requiring a 2-year rat carcinogenicity study has been proposed following extensive evaluation of rat carcinogenicity and chronic toxicity studies by industry and drug regulatory authorities. To inform the ICH S1 expert working group in their potential revision of ICH S1, a prospective evaluation study was initiated in 2013, in which sponsors would assess the pharmacologic and toxicologic findings present in the chronic toxicity studies and predict a positive or negative carcinogenicity outcome using a weight of evidence argument (a carcinogenicity assessment document [CAD]). The Scientific and Regulatory Policy Committee was asked by the Society of Toxicology Pathology (STP) executive committee to track these changes with ICH S1 and inform the STP membership of status changes. This commentary is intended to provide a brief summary of recent changes to the CAD guidance and highlight the importance of STP membership participation in the process of CAD submissions.

  17. NRC regulatory initiatives

    SciTech Connect

    Johnson, T.C.

    1989-11-01

    The US Nuclear Regulatory Commission (NRC) is addressing several low-level waste disposal issues that will be important to waste generators and to States and Compacts developing new disposal capacity. These issues include Greater-Than-Class C (GTCC) waste, mixed waste, below regulatory concern (BRC) waste, and the low-level waste data base. This paper discusses these issues and their current status.

  18. Exposure to 3,3',5-triiodothyronine affects histone and RNA polymerase II modifications, but not DNA methylation status, in the regulatory region of the Xenopus laevis thyroid hormone receptor βΑ gene.

    PubMed

    Kasai, Kentaro; Nishiyama, Norihito; Izumi, Yushi; Otsuka, Shunsuke; Ishihara, Akinori; Yamauchi, Kiyoshi

    2015-11-06

    Thyroid hormones (THs) play a critical role in amphibian metamorphosis, during which the TH receptor (TR) gene, thrb, is upregulated in a tissue-specific manner. The Xenopus laevis thrb gene has 3 TH response elements (TREs) in the 5' flanking regulatory region and 1 TRE in the exon b region, around which CpG sites are highly distributed. To clarify whether exposure to 3,3',5-triiodothyronine (T3) affects histone and RNA polymerase II (RNAPII) modifications and the level of DNA methylation in the 5' regulatory region, we conducted reverse transcription-quantitative polymerase chain reaction, bisulfite sequencing and chromatin immunoprecipitation assay using X. laevis cultured cells and premetamorphic tadpoles treated with or without 2 nM T3. Exposure to T3 increased the amount of the thrb transcript, in parallel with enhanced histone H4 acetylation and RNAPII recruitment, and probably phosphorylation of RNAPII at serine 5, in the 5' regulatory and exon b regions. However, the 5' regulatory region remained hypermethylated even with exposure to T3, and there was no significant difference in the methylation status between DNAs from T3-untreated and -treated cultured cells or tadpole tissues. Our results demonstrate that exposure to T3 induced euchromatin-associated epigenetic marks by enhancing histone acetylation and RNAPII recruitment, but not by decreasing the level of DNA methylation, in the 5' regulatory region of the X. laevis thrb gene.

  19. DNAPL Remediation: Selected Projects Approaching Regulatory Closure

    EPA Pesticide Factsheets

    This paper is a status update on the use of DNAPL source reduction remedial technologies, and provides information about recent projects where regulatory closure has been reached or projects are approaching regulatory closure, following source reduction.

  20. Effects of iron supplementation on binding activity of iron regulatory proteins and the subsequent effect on growth performance and indices of hematological and mineral status of young pigs.

    PubMed

    Rincker, M J; Clarke, S L; Eisenstein, R S; Link, J E; Hill, G M

    2005-09-01

    Two experiments were conducted to evaluate the effects of supplemental Fe on the binding activity of iron regulatory proteins (IRP) and the subsequent effect on growth performance and indices of hematological and mineral status of young pigs. In Exp. 1, male pigs (n = 10; 1.8 kg; age = 14 +/- 1 h) were allotted by BW to two treatments (five pigs per treatment). Treatments administered by i.m. injection were as follows: 1) 1 mL of sterile saline solution (Sal); and 2) 1 mL of 200 mg Fe as Fe-dextran (Fe). Pigs were bled (d 0 and 13) to determine hemoglobin (Hb), hematocrit (Hct), transferrin (Tf), and plasma Fe (PFe), and then killed (d 13) to determine spontaneous and 2-mercaptoethanol (2-ME)-inducible IRP RNA binding activity in liver and liver and whole-body mineral concentrations. Contemporary pigs (n = 5; 2.2 kg; age = 14 +/- 2 h) were killed at d 0 to establish baseline (BL1) measurements. In Exp. 2, pigs (six pigs per treatment; 6.5 kg; age = 19 +/- 3 d) were fed a basal diet (Phase 1 = d 0 to 7; Phase 2 = d 7 to 21; Phase 3 = d 21 to 35) supplemented with 0 or 150 mg/kg of Fe as ferrous sulfate and killed at d 35 (18.3 kg; age = 54 +/- 3 d). In addition, pigs (n = 5; 5.9 kg; age = 19 +/- 3 d) were killed at the start of Exp. 2 to establish baseline (BL2) measurements, and liver samples were collected and analyzed for IRP RNA binding activity. In Exp. 1, no difference (P = 0.482) was observed in ADG. On d 13, Fe-treated pigs had greater (P = 0.001) Hb, Hct, and PFe and less (P = 0.002) Tf than Sal-treated pigs. Whole-body Fe concentration was greater (P = 0.002) in Fe- vs. Sal-treated pigs. Treated pigs (Fe or Sal) had greater (P = 0.006) whole-body Cu and less (P = 0.002) whole-body Ca, Mg, Mn, P, and Zn concentrations than BL1. Liver Fe concentration was greater (P = 0.001) in Fe- vs. Sal-treated pigs, but liver Fe concentration of Sal-treated pigs was less (P = 0.001) than that of BL1 pigs. Sal-treated pigs had greater (P = 0.004) spontaneous IRP binding

  1. National Regulatory Budget Act of 2014

    THOMAS, 113th Congress

    Rep. Scalise, Steve [R-LA-1

    2014-07-24

    House - 09/26/2014 Referred to the Subcommittee on Regulatory Reform, Commercial And Antitrust Law. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  2. Regulatory Sunset and Review Act of 2013

    THOMAS, 113th Congress

    Rep. Hultgren, Randy [R-IL-14

    2013-01-18

    House - 02/28/2013 Referred to the Subcommittee on Regulatory Reform, Commercial And Antitrust Law. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  3. 45 CFR 95.4 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS) Time Limits for States To File... under title IV-A and for support enforcement services under title IV-D means any agency or organization... State Child Health Agency, its fiscal agents, a State health agency, or any other State or...

  4. 45 CFR 95.4 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS) Time Limits for States To File... amount of a particular cost item that was previously claimed under an interim rate concept and for...

  5. 45 CFR 95.4 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GENERAL ADMINISTRATION-GRANT PROGRAMS (PUBLIC ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS) Time Limits for States To File... Enforcement, Office of Human Development Services, or the Social Security Administration, depending on the...

  6. From prescription-only (Rx) to over-the-counter (OTC) status in Germany 2006-2015: pharmacological perspectives on regulatory decisions.

    PubMed

    Barrenberg, Eva; Garbe, Edeltraut

    2017-07-01

    Little is known about the extent of switches from prescription-only (Rx) to over-the-counter (OTC) status in Europe and about the pharmacological properties of the switched substances. The objectives of this study were to provide an overview of the substances that were switched from Rx to OTC status in Germany between 2006 and 2015 and to assess their pharmacological properties. Session minutes of the German Expert Advisory Committee for Prescription-Only Issues, changes to the German Ordinance on Prescription-Only Medicines and the Summary of Product Characteristics of the switched substances were analysed. Pharmacological properties were studied in relation to the EU Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use (the 'EU switch guide'). Between 2006 and 2015, seven substances (almotriptan, omeprazole, benzydamine, ibuprofen/pseudoephedrine, racecadotril, ketotifen and levonorgestrel) were switched from Rx to OTC status in Germany. In all cases, the OTC status was restricted to certain indications, doses, pack sizes, or other limitations. Notwithstanding recommendations of the EU switch guide, some of the switched substances might interact with commonly used drugs potentially resulting in serious adverse drug reactions or have contraindications or warnings regarding substantial parts of the population. The stipulations of the EU switch guide were fully met for only some switches, while this was not completely the case for others. Further development of guidance on balancing risks and benefits of OTC availability is recommended.

  7. Status of legislation and regulatory control of public health pesticides in countries endemic with or at risk of major vector-borne diseases.

    PubMed

    Matthews, Graham; Zaim, Morteza; Yadav, Rajpal Singh; Soares, Agnes; Hii, Jeffrey; Ameneshewa, Birkinesh; Mnzava, Abraham; Dash, Aditya Prasad; Ejov, Mikhail; Tan, Soo Hian; van den Berg, Henk

    2011-11-01

    Legislation and regulation of pesticides used in public health are essential for reducing risks to human health and the environment. We assessed the global situation on legislation and regulatory control of public health pesticides. A peer-reviewed and field-tested questionnaire was distributed to 142 member states of the World Health Organization (WHO); 113 states completed the questionnaire. Legislation on public health pesticides was absent in 25% of the countries. Where present, legislation often lacked comprehensiveness, for example, on basic aspects such as labeling, storage, transport, and disposal of public health pesticides. Guidelines or essential requirements for the process of pesticide registration were lacking in many countries. The capacity to enforce regulations was considered to be weak across WHO regions. Half of all countries lacked pesticide quality control laboratories, and two-thirds reported high concern over quality of products on the market. National statistics on production and trade of pesticides and poisoning incidents were lacking in many countries. Despite the shortcomings, WHO recommendations were considered to constitute a supportive or sole basis in national registration. Also, some regions showed high participation of countries in regional schemes to harmonize pesticide registration requirements. Critical deficiencies are evident in the legislative and regulatory framework for public health pesticides across regions, posing risks to human health and the environment. Recent experience in some countries with situational analysis, needs assessment, action planning, and regional collaboration has signaled a promising way forward.

  8. Status of Legislation and Regulatory Control of Public Health Pesticides in Countries Endemic with or at Risk of Major Vector-Borne Diseases

    PubMed Central

    Matthews, Graham; Zaim, Morteza; Soares, Agnes; Hii, Jeffrey; Ameneshewa, Birkinesh; Mnzava, Abraham; Dash, Aditya Prasad; Ejov, Mikhail; Tan, Soo Hian; van den Berg, Henk

    2011-01-01

    Background: Legislation and regulation of pesticides used in public health are essential for reducing risks to human health and the environment. Objective: We assessed the global situation on legislation and regulatory control of public health pesticides. Methods: A peer-reviewed and field-tested questionnaire was distributed to 142 member states of the World Health Organization (WHO); 113 states completed the questionnaire. Results: Legislation on public health pesticides was absent in 25% of the countries. Where present, legislation often lacked comprehensiveness, for example, on basic aspects such as labeling, storage, transport, and disposal of public health pesticides. Guidelines or essential requirements for the process of pesticide registration were lacking in many countries. The capacity to enforce regulations was considered to be weak across WHO regions. Half of all countries lacked pesticide quality control laboratories, and two-thirds reported high concern over quality of products on the market. National statistics on production and trade of pesticides and poisoning incidents were lacking in many countries. Despite the shortcomings, WHO recommendations were considered to constitute a supportive or sole basis in national registration. Also, some regions showed high participation of countries in regional schemes to harmonize pesticide registration requirements. Conclusions: Critical deficiencies are evident in the legislative and regulatory framework for public health pesticides across regions, posing risks to human health and the environment. Recent experience in some countries with situational analysis, needs assessment, action planning, and regional collaboration has signaled a promising way forward. PMID:21742577

  9. A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part III. Countermeasures under early stages of development along with 'standard of care' medicinal and procedures not requiring regulatory approval for use.

    PubMed

    Singh, Vijay K; Hanlon, Briana K; Santiago, Paola T; Seed, Thomas M

    2017-09-01

    Terrorist attacks, with their intent to maximize psychological and economic damage as well as inflicting sickness and death on given targeted populations, are an ever-growing worldwide concern in government and public sectors as they become more frequent, violent, and sensational. If given the chance, it is likely that terrorists will use radiological or nuclear weapons. To thwart these sinister efforts, both physical and medical countermeasures against these weapons are currently being researched and developed so that they can be utilized by the first responders, military, and medical providers alike. This is the third article of a three-part series in which we have reviewed additional radiation countermeasures that are currently under early preclinical phases of development using largely animal models and have listed and discussed clinical support measures, including agents used for radiation-induced emesis, as well as countermeasures not requiring Food and Drug Administration approval. Despite the significant progress that has been made in this area during the last several years, additional effort is needed in order to push promising new agents, currently under development, through the regulatory pipeline. This pipeline for new promising drugs appears to be unreasonably slow and cumbersome; possible reasons for this inefficiency are briefly discussed. Significant and continued effort needs to be afforded to this research and development area, as to date, there is no approved radioprotector that can be administered prior to high dose radiation exposure. This represents a very significant, unmet medical need and a significant security issue. A large number of agents with potential to interact with different biological targets are under development. In the next few years, several additional radiation countermeasures will likely receive Food and Drug Administration approval, increasing treatment options for victims exposed to unwanted ionizing irradiation.

  10. A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part I. Radiation sub-syndromes, animal models and FDA-approved countermeasures.

    PubMed

    Singh, Vijay K; Seed, Thomas M

    2017-09-01

    The increasing global risk of nuclear and radiological accidents or attacks has driven renewed research interest in developing medical countermeasures to potentially injurious exposures to acute irradiation. Clinical symptoms and signs of a developing acute radiation injury, i.e. the acute radiation syndrome, are grouped into three sub-syndromes named after the dominant organ system affected, namely the hematopoietic, gastrointestinal, and neurovascular systems. The availability of safe and effective countermeasures against the above threats currently represents a significant unmet medical need. This is the first article within a three-part series covering the nature of the radiation sub-syndromes, various animal models for radiation countermeasure development, and the agents currently approved by the United States Food and Drug Administration for countering the medical consequences of several of these prominent radiation exposure-associated syndromes. From the U.S. and global perspectives, biomedical research concerning medical countermeasure development is quite robust, largely due to increased government funding following the 9/11 incidence and subsequent rise of terrorist-associated threats. A wide spectrum of radiation countermeasures for specific types of radiation injuries is currently under investigation. However, only a few radiation countermeasures have been fully approved by regulatory agencies for human use during radiological/nuclear contingencies. Additional research effort, with additional funding, clearly will be needed in order to fill this significant, unmet medical health problem.

  11. Safety system status monitoring

    SciTech Connect

    Lewis, J.R.; Morgenstern, M.H.; Rideout, T.H.; Cowley, P.J.

    1984-03-01

    The Pacific Northwest Laboratory has studied the safety aspects of monitoring the preoperational status of safety systems in nuclear power plants. The goals of the study were to assess for the NRC the effectiveness of current monitoring systems and procedures, to develop near-term guidelines for reducing human errors associated with monitoring safety system status, and to recommend a regulatory position on this issue. A review of safety system status monitoring practices indicated that current systems and procedures do not adequately aid control room operators in monitoring safety system status. This is true even of some systems and procedures installed to meet existing regulatory guidelines (Regulatory Guide 1.47). In consequence, this report suggests acceptance criteria for meeting the functional requirements of an adequate system for monitoring safety system status. Also suggested are near-term guidelines that could reduce the likelihood of human errors in specific, high-priority status monitoring tasks. It is recommended that (1) Regulatory Guide 1.47 be revised to address these acceptance criteria, and (2) the revised Regulatory Guide 1.47 be applied to all plants, including those built since the issuance of the original Regulatory Guide.

  12. Parabens can enable hallmarks and characteristics of cancer in human breast epithelial cells: a review of the literature with reference to new exposure data and regulatory status.

    PubMed

    Darbre, Philippa D; Harvey, Philip W

    2014-09-01

    A framework for understanding the complexity of cancer development was established by Hanahan and Weinberg in their definition of the hallmarks of cancer. In this review, we consider the evidence that parabens can enable development in human breast epithelial cells of four of six of the basic hallmarks, one of two of the emerging hallmarks and one of two of the enabling characteristics. In Hallmark 1, parabens have been measured as present in 99% of human breast tissue samples, possess oestrogenic activity and can stimulate sustained proliferation of human breast cancer cells at concentrations measurable in the breast. In Hallmark 2, parabens can inhibit the suppression of breast cancer cell growth by hydroxytamoxifen, and through binding to the oestrogen-related receptor gamma may prevent its deactivation by growth inhibitors. In Hallmark 3, in the 10 nm-1 μm range, parabens give a dose-dependent evasion of apoptosis in high-risk donor breast epithelial cells. In Hallmark 4, long-term exposure (>20 weeks) to parabens leads to increased migratory and invasive activity in human breast cancer cells, properties that are linked to the metastatic process. As an emerging hallmark methylparaben has been shown in human breast epithelial cells to increase mTOR, a key regulator of energy metabolism. As an enabling characteristic parabens can cause DNA damage at high concentrations in the short term but more work is needed to investigate long-term, low-dose mixtures. The ability of parabens to enable multiple cancer hallmarks in human breast epithelial cells provides grounds for regulatory review of the implications of the presence of parabens in human breast tissue. Copyright © 2014 John Wiley & Sons, Ltd.

  13. 78 FR 1634 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... analysis is required, and the status of regulations previously reported. ADDRESSES: Director, for Internal... ``disability'' in lieu of the term ``handicap,'' changes to definitions, and other sections based on the... Date FR Cite NPRM 02/00/13 Regulatory Flexibility Analysis Required: No. Agency Contact: Robert W...

  14. 78 FR 44329 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... analysis is required, and the status of regulations previously reported. ADDRESSES: Acting Assistant... of the term ``disability'' in lieu of the term ``handicap,'' changes to definitions, and other....nasa.gov/open . Timetable: Action Date FR Cite NPRM 10/00/13 Regulatory Flexibility Analysis Required...

  15. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake.

    PubMed

    Bowen, Jane; Noakes, Manny; Clifton, Peter M

    2006-08-01

    Although dietary protein produces higher acute satiety relative to carbohydrate, the influence of protein source and body mass index (BMI) has not been clearly described. The objective of the study was to assess postprandial responses to different protein sources, compared with glucose, in males with normal and high BMI. This was a randomized, crossover study of four preloads followed by blood sampling (+15, 30, 45, 60, 90, 120, 180 min) and buffet meal. The study was conducted at an outpatient clinic. The study population included 72 men, with a BMI range 20.6-39.9 kg/m(2). Interventions consisted of liquid preloads (1.1 MJ, 450 ml) containing 50 g whey, soy, gluten, or glucose. Fasting and postprandial plasma glucose, insulin, ghrelin, glucagon-like peptide-1 (GLP-1) and cholecystokinin (n = 38), ad libitum energy intake, and appetite ratings were measured. Energy intake was 10% lower after all protein preloads, compared with the glucose treatment (P < 0.05), independent of BMI status and protein type. All protein loads prolonged the postprandial suppression of ghrelin (P < 0.01) and elevation of GLP-1 (P < 0.01) and cholecystokinin (P < 0.05). Fasting GLP-1 concentrations [overweight, 17.5 +/- 1.3; lean, 14.7 +/- 0.1 pg/ml (5.2 +/- 0.4 and 4.4 +/- 0.1 pmol/liter, respectively); P < 0.001] and postprandial responses (P = 0.038) were higher in overweight subjects. Whey, soy, and gluten similarly tend to reduce ad libitum food intake 3 h later in lean and overweight males relative to glucose. Postprandial ghrelin, GLP-1, insulin, and cholecystokinin may contribute to this higher satiety after protein consumption. GLP-1 concentrations are increased in overweight subjects, which may affect satiety responses in this group.

  16. Job Creation and Regulatory Freeze Act of 2011

    THOMAS, 112th Congress

    Rep. Griffin, Tim [R-AR-2

    2011-10-13

    11/02/2011 Referred to the Subcommittee on Regulatory Affairs, Stimulus Oversight and Government Spending . (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  17. Job Creation and Regulatory Freeze Act of 2011

    THOMAS, 112th Congress

    Rep. Griffin, Tim [R-AR-2

    2011-10-13

    House - 11/02/2011 Referred to the Subcommittee on Regulatory Affairs, Stimulus Oversight and Government Spending . (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  18. Cost-Benefit and Regulatory Transparency Enhancement Act of 2013

    THOMAS, 113th Congress

    Rep. Hunter, Duncan D. [R-CA-50

    2013-06-28

    House - 07/15/2013 Referred to the Subcommittee on Regulatory Reform, Commercial And Antitrust Law. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  19. Job Creation and Regulatory Freeze Act of 2011

    THOMAS, 112th Congress

    Rep. Griffin, Tim [R-AR-2

    2011-10-13

    11/02/2011 Referred to the Subcommittee on Regulatory Affairs, Stimulus Oversight and Government Spending . (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  20. A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part II. Countermeasures for limited indications, internalized radionuclides, emesis, late effects, and agents demonstrating efficacy in large animals with or without FDA IND status.

    PubMed

    Singh, Vijay K; Garcia, Melissa; Seed, Thomas M

    2017-09-01

    The threat of a radiological/nuclear event is a critical concern for all government agencies involved in national security and public health preparedness. Countermeasures that are safe, easily administered, and effective at diminishing or eliminating adverse health effects to individuals and the overall public health impact of radiation exposure are urgently needed. Radiation countermeasures included in this three-part series have been classified under various subheadings based specifically on their developmental stages for United States Food and Drug Administration (FDA) approval. We have included FDA-approved agents for acute radiation syndrome (ARS) in part I. This is part II in which we have reviewed FDA-approved agents for limited indications, internalized radionuclides, emesis, late effects, radiomitigators available in the strategic national stockpile (SNS), agents with FDA investigational new drug (IND) status, and those with NHP efficacy data without FDA IND. Agents discussed in part III are those agents that have been peer reviewed, published, and have demonstrated significant survival benefits in animal models of ARS. Agents investigated in in vitro models only or studied in animal models without peer-reviewed publications have not been included. The dearth of FDA-approved radiation countermeasures has prompted intensified research for a new generation of radiation countermeasures. A number of promising radiation countermeasures are currently moving forward with continued support and effort by both governmental agencies and by publicly and privately held pharmaceutical companies. There is a limited number of countermeasures which are progressing well following the Animal Rule and may get approved in the near future, thus serving to close the gap of this critically important, unmet radiobiomedical need.

  1. Regulatory Physiology

    NASA Technical Reports Server (NTRS)

    Lane, Helen W.; Whitson, Peggy A.; Putcha, Lakshmi; Baker, Ellen; Smith, Scott M.; Stewart, Karen; Gretebeck, Randall; Nimmagudda, R. R.; Schoeller, Dale A.; Davis-Street, Janis

    1999-01-01

    As noted elsewhere in this report, a central goal of the Extended Duration Orbiter Medical Project (EDOMP) was to ensure that cardiovascular and muscle function were adequate to perform an emergency egress after 16 days of spaceflight. The goals of the Regulatory Physiology component of the EDOMP were to identify and subsequently ameliorate those biochemical and nutritional factors that deplete physiological reserves or increase risk for disease, and to facilitate the development of effective muscle, exercise, and cardiovascular countermeasures. The component investigations designed to meet these goals focused on biochemical and physiological aspects of nutrition and metabolism, the risk of renal (kidney) stone formation, gastrointestinal function, and sleep in space. Investigations involved both ground-based protocols to validate proposed methods and flight studies to test those methods. Two hardware tests were also completed.

  2. Regulatory Anatomy

    PubMed Central

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of “safety” produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape. PMID:26139952

  3. Environment, safety, and health regulatory implementation plan

    SciTech Connect

    Not Available

    1993-10-21

    To identify, document, and maintain the Uranium Mill Tailings Remedial Action (UMTRA) Project`s environment, safety, and health (ES&H) regulatory requirements, the US Department of Energy (DOE) UMTRA Project Office tasked the Technical Assistance Contractor (TAC) to develop a regulatory operating envelope for the UMTRA Project. The system selected for managing the UMTRA regulatory operating envelope data bass is based on the Integrated Project Control/Regulatory Compliance System (IPC/RCS) developed by WASTREN, Inc. (WASTREN, 1993). The IPC/RCS is a tool used for identifying regulatory and institutional requirements and indexing them to hardware, personnel, and program systems on a project. The IPC/RCS will be customized for the UMTRA Project surface remedial action and groundwater restoration programs. The purpose of this plan is to establish the process for implementing and maintaining the UMTRA Project`s regulatory operating envelope, which involves identifying all applicable regulatory and institutional requirements and determining compliance status. The plan describes how the Project will identify ES&H regulatory requirements, analyze applicability to the UMTRA Project, and evaluate UMTRA Project compliance status.

  4. Toxicogenomics in regulatory ecotoxicology

    USGS Publications Warehouse

    Ankley, Gerald T.; Daston, George P.; Degitz, Sigmund J.; Denslow, Nancy D.; Hoke, Robert A.; Kennedy, Sean W.; Miracle, Ann L.; Perkins, Edward J.; Snape, Jason; Tillitt, Donald E.; Tyler, Charles R.; Versteeg, Donald

    2006-01-01

    Recently, we have witnessed an explosion of different genomic approaches that, through a combination of advanced biological, instrumental, and bioinformatic techniques, can yield a previously unparalleled amount of data concerning the molecular and biochemical status of organisms. Fueled partially by large, well-publicized efforts such as the Human Genome Project, genomic research has become a rapidly growing topical area in multiple biological disciplines. Since 1999, when the term “toxicogenomics” was coined to describe the application of genomics to toxicology (1), a rapid increase in publications on the topic has occurred (Figure 1). The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions and, as with any new technology, has evoked a wide range of opinion (2–6).

  5. Toxicogenomics in regulatory ecotoxicology

    SciTech Connect

    Ankley, Gerald; Daston, George; Degitz, Sigmund J.; Denslow, Nancy; Hoke, Robert; Kennedy, Sean; Miracle, Ann L.; Perkins, Edward; Snape, Jason; Tillitt, Donald; Tyler, Charles R.; Versteeg, Donald

    2006-07-01

    Recent years have witnessed an explosion of different genomic approaches which, through a combination of advanced biological, instrumental and bioinformatic techniques, can yield a previously unparalleled amount of data concerning the molecular and biochemical status of organisms. Fueled partially by large, well-publicized efforts such as the human genome project, genomic research has become a rapidly growing topical area in multiple biological disciplines. Since 1999 when the term toxicogenomics was coined to describe the application of genomics to toxicology, a citation analysis reveals a rapid increase in publications dealing with the topic. The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions and, as with any new technology, there is a wide range of opinion. The purpose of this feature article is to consider roles of toxicogenomics in the field of regulatory ecotoxicology, explore current limitations in the science and practice of genomics, and propose possible avenues to approach and resolve some of the major challenges. A significant amount of input to our analysis came from a workshop sponsored by the Society of Environmental Toxicology and Chemistry in Pellston, MI in September, 2005.

  6. 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.

  7. Professional and Regulatory Search

    EPA Pesticide Factsheets

    Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.

  8. Congressional Office of Regulatory Analysis Creation and Sunset and Review Act of 2011

    THOMAS, 112th Congress

    Rep. Young, Don [R-AK-At Large

    2011-01-07

    02/08/2011 Referred to the Subcommittee on Regulatory Affairs, Stimulus Oversight and Government Spending . (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  9. Congressional Office of Regulatory Analysis Creation and Sunset and Review Act of 2011

    THOMAS, 112th Congress

    Rep. Young, Don [R-AK-At Large

    2011-01-07

    02/08/2011 Referred to the Subcommittee on Regulatory Affairs, Stimulus Oversight and Government Spending . (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  10. Congressional Office of Regulatory Analysis Creation and Sunset and Review Act of 2011

    THOMAS, 112th Congress

    Rep. Young, Don [R-AK-At Large

    2011-01-07

    House - 02/08/2011 Referred to the Subcommittee on Regulatory Affairs, Stimulus Oversight and Government Spending . (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  11. Regulatory RNAs in Planarians.

    PubMed

    Pawlicka, Kamila; Perrigue, Patrick M; Barciszewski, Jan

    2016-01-01

    The full scope of regulatory RNA evolution and function in epigenetic processes is still not well understood. The development of planarian flatworms to be used as a simple model organism for research has shown a great potential to address gaps in the knowledge in this field of study. The genomes of planarians encode a wide array of regulatory RNAs that function in gene regulation. Here, we review planarians as a suitable model organism for the identification and function of regulatory RNAs.

  12. Regulatory Information By Sector

    EPA Pesticide Factsheets

    Find environmental regulatory, compliance, & enforcement information for various business, industry and government sectors, listed by NAICS code. Sectors include agriculture, automotive, petroleum manufacturing, oil & gas extraction & other manufacturing

  13. The effect of nutritional status and myogenic satellite cell age on turkey satellite cell proliferation, differentiation, and expression of myogenic transcriptional regulatory factors and heparan sulfate proteoglycans syndecan-4 and glypican-1.

    PubMed

    Harthan, Laura B; McFarland, Douglas C; Velleman, Sandra G

    2014-01-01

    Posthatch satellite cell mitotic activity is a critical component of muscle development and growth. Satellite cells are myogenic stem cells that can be induced by nutrition to follow other cellular developmental pathways, and whose mitotic activity declines with age. The objective of the current study was to determine the effect of restricting protein synthesis on the proliferation and differentiation, expression of myogenic transcriptional regulatory factors myogenic determination factor 1, myogenin, and myogenic regulatory factor 4, and expression of the heparan sulfate proteoglycans syndecan-4 and glypican-1 in satellite cells isolated from 1-d-, 7-wk-, and 16-wk-old turkey pectoralis major muscle (1 d, 7 wk, and 16 wk cells, respectively) by using variable concentrations of Met and Cys. Four Met concentrations-30 (control), 7.5, 3, or 0 mg/L with 3.2 mg/L of Cys per 1 mg/L of Met-were used for culture of satellite cells to determine the effect of nutrition and age on satellite cell behavior during proliferation and differentiation. Proliferation was reduced by lower Met and Cys concentrations in all ages at 96 h of proliferation. Differentiation was increased in the 1 d Met-restricted cells, whereas the 7 wk cells treated with 3 mg/L of Met had decreased differentiation. Reduced Met and Cys levels from the control did not significantly affect the 16 wk cells at 72 h of differentiation. However, medium with no Met or Cys suppressed differentiation at all ages. The expression of myogenic determination factor 1, myogenin, myogenic regulatory factor 4, syndecan-4, and glypican-1 was differentially affected by age and Met or Cys treatment. These data demonstrate the age-specific manner in which turkey pectoralis major muscle satellite cells respond to nutritional availability and the importance of defining optimal nutrition to maximize satellite cell proliferation and differentiation for subsequent muscle mass accretion.

  14. 76 FR 67011 - Self-Regulatory Organizations; Chicago Mercantile Exchange, Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-28

    ... Effectiveness of Proposed Rule Change To Amend Rules To Reflect the Change in Regulatory Status of Eris Exchange... with its clearing of contracts listed by the Eris Exchange, LLC (``Eris'') to reflect the pending change in regulatory status of Eris from an ``EBOT'' to a designated contract market. CME is also at...

  15. 22 CFR 95.4 - Review and construction.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... application of the policy set forth in section 2242(a), except as part of the review of a final order of removal pursuant to section 242 of the Immigration and Nationality Act (8 U.S.C. 1252), which is not...

  16. 22 CFR 95.4 - Review and construction.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... application of the policy set forth in section 2242(a), except as part of the review of a final order of removal pursuant to section 242 of the Immigration and Nationality Act (8 U.S.C. 1252), which is not...

  17. Regulatory guidance document

    SciTech Connect

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM`s evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7.

  18. SEC Regulatory Accountability Act

    THOMAS, 112th Congress

    Sen. Vitter, David [R-LA

    2012-04-26

    Senate - 04/26/2012 Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  19. Swaps Regulatory Improvement Act

    THOMAS, 113th Congress

    Sen. Hagan, Kay R. [D-NC

    2013-03-06

    Senate - 03/06/2013 Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  20. Regulatory Balance Act

    THOMAS, 112th Congress

    Rep. Fincher, Stephen Lee [R-TN-8

    2011-06-14

    House - 06/27/2011 Referred to the Subcommittee on Department Operations, Oversight, and Credit. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  1. 3 CFR - Regulatory Review

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... in general—should be revisited. I therefore direct the Director of OMB, in consultation with... delay; clarify the role of the behavioral sciences in formulating regulatory policy; and identify...

  2. Select Biosolids Regulatory Processes

    EPA Pesticide Factsheets

    Historical Regulatory Development and activities EPA has undertaken to respond to statutory obligations, respond to the National Academy of Sciences, understand pollutants that may occur in sewage sludge, and address dioxins in sewage sludge.

  3. Regulatory T cell memory

    PubMed Central

    Rosenblum, Michael D.; Way, Sing Sing; Abbas, Abul K.

    2016-01-01

    Memory for antigen is a defining feature of adaptive immunity. Antigen-specific lymphocyte populations show an increase in number and function after antigen encounter and more rapidly re-expand upon subsequent antigen exposure. Studies of immune memory have primarily focused on effector B cells and T cells with microbial specificity, using prime challenge models of infection. However, recent work has also identified persistently expanded populations of antigen-specific regulatory T cells that protect against aberrant immune responses. In this Review, we consider the parallels between memory effector T cells and memory regulatory T cells, along with the functional implications of regulatory memory in autoimmunity, antimicrobial host defence and maternal fetal tolerance. In addition, we discuss emerging evidence for regulatory T cell memory in humans and key unanswered questions in this rapidly evolving field. PMID:26688349

  4. Assessing the regulatory picture

    SciTech Connect

    Not Available

    1994-02-01

    This article addresses the safety of the nation's drinking water supply and discusses compliance of the Clean Water Act. Right now, the shape of the regulatory future is uncertain. The results of the D-DBP regulatory negotiation are imminent. Congress is ready to begin debating reauthorization of the Safe Drinking Water Act, and utilities are trying to comply with the regulations while trying not to price water out of the reach of some of their customers.

  5. [Regulatory T cells].

    PubMed

    Marinić, Igor; Gagro, Alenka; Rabatić, Sabina

    2006-12-01

    Regulatory T-cells are a subset of T cells that have beene extensively studied in modern immunology. They are important for the maintenance of peripheral tolerance, and have an important role in various clinical conditions such as allergy, autoimmune disorders, tumors, infections, and in transplant medicine. Basically, this population has a suppressive effect on the neighboring immune cells, thus contributing to the local modulation and control of immune response. There are two main populations of regulatory T cells - natural regulatory T cells, which form a distinct cellular lineage, develop in thymus and perform their modulatory action through direct intercellular contact, along with the secreted cytokines; and inducible regulatory T cells, which develop in the periphery after contact with the antigen that is presented on the antigen presenting cell, and their primary mode of action is through the interleukin 10 (IL-10) and transforming growth factor beta (TGF-alpha) cytokines. Natural regulatory T cells are activated through T cell receptor after contact with specific antigen and inhibit proliferation of other T cells in an antigen independent manner. One of the major difficulties in the research of regulatory T cells is the lack of specific molecular markers that would identify these cells. Natural regulatory T cells constitutively express surface molecule CD25, but many other surface and intracellular molecules (HLA-DR, CD122, CD45RO, CD62, CTLA-4, GITR, PD-1, Notch, FOXP3, etc.) are being investigated for further phenotypic characterization of these cells. Because regulatory T cells have an important role in establishing peripheral tolerance, their importance is manifested in a number of clinical conditions. In the IPEX syndrome (immunodysregulation, polyendocrinopathy and enteropathy, X-linked), which is caused by mutation in Foxp3 gene that influences the development and function of regulatory T cells, patients develop severe autoimmune reactions that

  6. A regulatory model for clinical laboratories: an empirical evaluation.

    PubMed

    Peddecord, K M

    1989-04-01

    Clinical laboratories in the United States are subject to various regulatory and accreditation programs, which mandate a broad range of requirements regarding personnel, quality-control systems, and analytical proficiency standards. Reported here, for a cross-section of U.S. laboratories, is the degree of compliance with these regulatory requirements, some other laboratory characteristics, and their relation to analytical proficiency. The results suggest that those laboratory characteristics that predict highest proficiency-test performance differ for each laboratory specialty. Regression models are presented that explain from 12% to 35% of the variation in analytical performance and suggest that factors outside of those specified in the regulatory model and other characteristics measured in this research are important. Indeed, the current regulatory approach may not ensure highest performance. Also discussed are the current status, limitations, and prospects for change of the clinical laboratory regulatory system.

  7. Innovative regulatory approaches to reduce sodium consumption: could a cap-and-trade system work?

    PubMed

    Forshee, Richard A

    2008-05-01

    Many regulatory and professional organizations are calling for strict new regulations to reduce sodium consumption on a population basis. New regulations on sodium may have significant public health and economic impacts. This article explores five regulatory options to reduce sodium consumption: 1) maintaining the status quo, 2) improving risk communication and information, 3) revoking generally regarded as safe status of sodium and regulating its use in food products, 4) establishing a sodium tax, and 5) establishing a market-based, cap-and-trade system for sodium that builds on similar approaches in environmental regulatory policy. Cap-and-trade may be a promising regulatory option for sodium and other ingredients.

  8. Rationales for regulatory activity

    SciTech Connect

    Perhac, R.M.

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  9. Regulatory aspects of clinical xenotransplantation.

    PubMed

    Schuurman, Henk-Jan

    2015-11-01

    Xenotransplantation attracted interest from regulatory authorities, particularly after the demonstration of pig-to-human transmission of porcine endogenous retrovirus (1996). This added to the risk of a product, resulting in a Guidance of the US Food and Drug Administration (2003). This addresses the full flow chart in product manufacturing, starting with the designated pathogen-free status of the source animal; and special aspects regarding the recipient like informed consent and monitoring for infectious pathogens. Also archiving of records from the donor and recipient, as well as storage of samples is described. The European Medicines Agency issued a Guideline on xenogeneic cell therapy products (2009). Cell-based medicinal products are subject to specific regulations and directives, which apply also to xenogeneic products: the xenotransplant guidances/guidelines are an addition to these regulations. Noteworthy, acellular products like heart valves and decellularized cornea are not considered a cell therapy product, but rather a medical device with its own regulation. WHO issued relevant documents, especially about safety, and the International Xenotransplantation Association published consensus documents, a.o., addressing preclinical efficacy requirements before entering clinical trials. This manuscript presents an overview of the regulatory framework, with special focus on cell therapy products necause these are expected to reach the market first (i.e., pancreatic islets, hepatocytes and cellularized cornea); major illustrations are from the European situation. Albeit being complex, the regulation of xenotransplant products does not form a block in product development, but rather supports the introduction of efficacious and safe products to meet the medical need. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  10. SEC Regulatory Accountability Act

    THOMAS, 113th Congress

    Rep. Garrett, Scott [R-NJ-5

    2013-03-12

    Senate - 05/20/2013 Received in the Senate and Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  11. Swaps Regulatory Improvement Act

    THOMAS, 113th Congress

    Rep. Hultgren, Randy [R-IL-14

    2013-03-06

    Senate - 10/31/2013 Received in the Senate and Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  12. Silviculture Regulatory Consistency Act

    THOMAS, 113th Congress

    Sen. Wyden, Ron [D-OR

    2013-05-16

    05/16/2013 Read twice and referred to the Committee on Environment and Public Works. (text of measure as introduced: CR S3573) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  13. Swaps Regulatory Improvement Act

    THOMAS, 113th Congress

    Rep. Hultgren, Randy [R-IL-14

    2013-03-06

    10/31/2013 Received in the Senate and Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  14. SEC Regulatory Accountability Act

    THOMAS, 113th Congress

    Rep. Garrett, Scott [R-NJ-5

    2013-03-12

    05/20/2013 Received in the Senate and Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  15. Swaps Regulatory Improvement Act

    THOMAS, 113th Congress

    Rep. Hultgren, Randy [R-IL-14

    2013-03-06

    10/31/2013 Received in the Senate and Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  16. EPAct Transportation Regulatory Activities

    SciTech Connect

    2011-11-21

    The U.S. Department of Energy's (DOE) Vehicle Technologies Program manages several transportation regulatory activities established by the Energy Policy Act of 1992 (EPAct), as amended by the Energy Conservation Reauthorization Act of 1998, EPAct 2005, and the Energy Independence and Security Act of 2007 (EISA).

  17. OAR Regulatory Reform

    EPA Pesticide Factsheets

    The U.S. EPA's Office of Air and Radiation is hosting a public teleconference to solicit input on specific air and radiation actions that should be considered for “repeal, replacement, or modification” to reduce regulatory burden consistent with EO 13777.

  18. The regulatory horizon

    NASA Technical Reports Server (NTRS)

    Cook, ED

    1987-01-01

    The author briefly discusses the FAA's position as it relates to cockpit resource management. For example, if Cockpit Resource Management (CRM) is a positive concept, why isn't everyone required to implement it? The regulatory practice of the FAA is discussed and questions and answers are presented.

  19. Toxicogenomics in Regulatory Ecotoxicology

    EPA Science Inventory

    The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions, and as with any new technology, there is a wide range of opinion. The purpose of this feature article is to consider roles of toxicogenomic...

  20. 10 CFR 75.35 - Material status reports.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Material status reports. 75.35 Section 75.35 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT Reports § 75.35 Material status reports. (a) A material status report must be submitted for...

  1. 10 CFR 75.35 - Material status reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Material status reports. 75.35 Section 75.35 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT Reports § 75.35 Material status reports. (a) A material status report must be submitted for...

  2. 10 CFR 75.35 - Material status reports.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Material status reports. 75.35 Section 75.35 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT Reports § 75.35 Material status reports. (a) A material status report must be submitted for...

  3. 10 CFR 75.35 - Material status reports.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Material status reports. 75.35 Section 75.35 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT Reports § 75.35 Material status reports. (a) A material status report must be submitted for...

  4. 10 CFR 75.35 - Material status reports.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Material status reports. 75.35 Section 75.35 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT Reports § 75.35 Material status reports. (a) A material status report must be submitted for...

  5. Toxicogenomics and the Regulatory Framework

    EPA Science Inventory

    Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expec...

  6. Toxicogenomics and the Regulatory Framework

    EPA Science Inventory

    Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expec...

  7. Steam generators regulatory practices and issues in Spain

    SciTech Connect

    Mendoza, C.; Castelao, C.; Ruiz-Colino, J.; Figueras, J.M.

    1997-02-01

    This paper presents the actual status of Spanish Steam Generator tubes, actions developed by PWR plant owners and submitted to CSN, and regulatory activities related to tube degradation mechanisms analysis; NDT tube inspection techniques; tube, tubesheet and TSPs integrity studies; tube plugging/repair criteria; preventive and corrective measures including whole SGs replacement; tube leak measurement methods and other operational aspects.

  8. Functional footprinting of regulatory DNA

    PubMed Central

    Vierstra, Jeff; Reik, Andreas; Chang, Kai-Hsin; Stehling-Sun, Sandra; Zhou, Yuan-Yue; Hinkley, Sarah J.; Paschon, David E.; Zhang, L.; Psatha, Nikoletta; Bendana, Yuri R.; O'Neill, Colleen M.; Song, Alex H.; Mich, Andrea; Liu, Pei-Qi; Lee, Gary; Bauer, Daniel E.; Holmes, Michael C.; Orkin, Stuart H.; Papayannopoulou, Thalia; Stamatoyannopoulos, George; Rebar, Edward J.; Gregory, Philip D.; Urnov, Fyodor D.; Stamatoyannopoulos, John A.

    2017-01-01

    Regulatory regions harbor multiple transcription factor recognition sites; however, the contribution of individual sites to regulatory function remains challenging to define. We describe a facile approach that exploits the error-prone nature of genome editing-induced double-strand break repair to map functional elements within regulatory DNA at nucleotide resolution. We demonstrate the approach on a human erythroid enhancer, revealing single TF recognition sites that gate the majority of downstream regulatory function. PMID:26322838

  9. Nuclear Regulatory Commission information digest

    SciTech Connect

    None,

    1990-03-01

    The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide.

  10. Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines

    PubMed Central

    Johnston, John D; Feldschreiber, Peter

    2014-01-01

    The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed. PMID:23738917

  11. Cognitive regulatory control therapies.

    PubMed

    Bowins, Brad

    2013-01-01

    Cognitive regulatory control processes play an essential but typically unappreciated role in maintaining mental health. The purpose of the current paper is to identify this role and demonstrate how cognitive-behavioral and related techniques can compensate for impairments. Impaired cognitive regulation contributes to the overly intense emotional states present in anxiety disorders, depression, and personality disorders; progression of adaptive hypomania to mania; expression of psychosis in the conscious and awake state; dominance of immature defense mechanisms in borderline and other personality disorders. A wide variety of standard (monitoring, reappraisal, response inhibition, relaxation training) and more novel (suppression therapy, willful detachment, cost-benefit analysis, normalization, mature defense mechanism training) cognitive-behavioral and related techniques can be applied to compensate for cognitive regulatory control impairments, and their success probably aligns with this capacity.

  12. Orphan drugs: the regulatory environment.

    PubMed

    Franco, Pedro

    2013-02-01

    The definition of a rare disease is not universal and depends on the legislation and policies adopted by each region or country. The main objective of this article is to describe and discuss the legal framework and the regulatory environment of orphan drugs worldwide. Some reflections and discussions on the need for specific orphan drug legislation or policies are described at length. Furthermore, some aspects of the history of each region in respect of the orphan drug legislation evolution are outlined. This article describes and compares the orphan drug legislation or policies of the following countries or regions: United Sates of America (US), European Union (EU), Japan, Australia, Singapore, Taiwan and Canada. The incentives described in the orphan drug legislations or policies, the criteria for designation of orphan status and the authorisation process of an orphan drug are also described and compared. The legislations and policies are to some extent similar but not the same. It is important to understand the main differences among all available legislative systems to improve the international collaboration in the field of orphan drugs and rare diseases.

  13. Status Epilepticus.

    PubMed

    Hocker, Sara E

    2015-10-01

    Status epilepticus, which is simultaneously a neurologic and systemic emergency, often results in significant disability and may be fatal. This article presents a pragmatic approach to the evaluation and management of status epilepticus in adults for the practicing clinician. Rapid recognition, treatment respecting a written protocol, and careful attention to potential complications may limit sequelae. Studies aimed at earlier identification of etiologies in cryptogenic status epilepticus and improving the treatment of established status epilepticus are urgently needed to limit the development of refractoriness. This article reviews the guidelines and up-to-date information on the use of both pharmacologic and nonpharmacologic therapies in status epilepticus and discusses the shifts in our understanding of the balance between the need for aggressive control of seizures and the risks of treatment. This article also presents a suggested approach to the evaluation and management of common types of status epilepticus and explores future directions.

  14. 75 FR 61531 - Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... E. Norris, Component Integrity Branch, Division of Engineering, Office of Nuclear Regulatory... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice. SUMMARY:...

  15. Current Status of On-Site Wastewater Management

    ERIC Educational Resources Information Center

    Senn, Charles L.

    1978-01-01

    Wastewater management is becoming an important environmental issue nationally. This article reports the history and current status of wastewater management. Regulatory programs are discussed with specific state examples. Needs assessment is also included. (MA)

  16. Current Status of On-Site Wastewater Management

    ERIC Educational Resources Information Center

    Senn, Charles L.

    1978-01-01

    Wastewater management is becoming an important environmental issue nationally. This article reports the history and current status of wastewater management. Regulatory programs are discussed with specific state examples. Needs assessment is also included. (MA)

  17. Regulatory issues for deep borehole plutonium disposition

    SciTech Connect

    Halsey, W.G.

    1995-03-01

    As a result of recent changes throughout the world, a substantial inventory of excess separated plutonium is expected to result from dismantlement of US nuclear weapons. The safe and secure management and eventual disposition of this plutonium, and of a similar inventory in Russia, is a high priority. A variety of options (both interim and permanent) are under consideration to manage this material. The permanent solutions can be categorized into two broad groups: direct disposal and utilization. The deep borehole disposition concept involves placing excess plutonium deep into old stable rock formations with little free water present. Issues of concern include the regulatory, statutory and policy status of such a facility, the availability of sites with desirable characteristics and the technologies required for drilling deep holes, characterizing them, emplacing excess plutonium and sealing the holes. This white paper discusses the regulatory issues. Regulatory issues concerning construction, operation and decommissioning of the surface facility do not appear to be controversial, with existing regulations providing adequate coverage. It is in the areas of siting, licensing and long term environmental protection that current regulations may be inappropriate. This is because many current regulations are by intent or by default specific to waste forms, facilities or missions significantly different from deep borehole disposition of excess weapons usable fissile material. It is expected that custom regulations can be evolved in the context of this mission.

  18. Automated Identification of Core Regulatory Genes in Human Gene Regulatory Networks.

    PubMed

    Narang, Vipin; Ramli, Muhamad Azfar; Singhal, Amit; Kumar, Pavanish; de Libero, Gennaro; Poidinger, Michael; Monterola, Christopher

    2015-01-01

    Human gene regulatory networks (GRN) can be difficult to interpret due to a tangle of edges interconnecting thousands of genes. We constructed a general human GRN from extensive transcription factor and microRNA target data obtained from public databases. In a subnetwork of this GRN that is active during estrogen stimulation of MCF-7 breast cancer cells, we benchmarked automated algorithms for identifying core regulatory genes (transcription factors and microRNAs). Among these algorithms, we identified K-core decomposition, pagerank and betweenness centrality algorithms as the most effective for discovering core regulatory genes in the network evaluated based on previously known roles of these genes in MCF-7 biology as well as in their ability to explain the up or down expression status of up to 70% of the remaining genes. Finally, we validated the use of K-core algorithm for organizing the GRN in an easier to interpret layered hierarchy where more influential regulatory genes percolate towards the inner layers. The integrated human gene and miRNA network and software used in this study are provided as supplementary materials (S1 Data) accompanying this manuscript.

  19. Automated Identification of Core Regulatory Genes in Human Gene Regulatory Networks

    PubMed Central

    Singhal, Amit; Kumar, Pavanish; de Libero, Gennaro; Poidinger, Michael; Monterola, Christopher

    2015-01-01

    Human gene regulatory networks (GRN) can be difficult to interpret due to a tangle of edges interconnecting thousands of genes. We constructed a general human GRN from extensive transcription factor and microRNA target data obtained from public databases. In a subnetwork of this GRN that is active during estrogen stimulation of MCF-7 breast cancer cells, we benchmarked automated algorithms for identifying core regulatory genes (transcription factors and microRNAs). Among these algorithms, we identified K-core decomposition, pagerank and betweenness centrality algorithms as the most effective for discovering core regulatory genes in the network evaluated based on previously known roles of these genes in MCF-7 biology as well as in their ability to explain the up or down expression status of up to 70% of the remaining genes. Finally, we validated the use of K-core algorithm for organizing the GRN in an easier to interpret layered hierarchy where more influential regulatory genes percolate towards the inner layers. The integrated human gene and miRNA network and software used in this study are provided as supplementary materials (S1 Data) accompanying this manuscript. PMID:26393364

  20. Regulatory status of caffeine in the United States.

    PubMed

    Rosenfeld, Leah S; Mihalov, Jeremy J; Carlson, Susan J; Mattia, Antonia

    2014-10-01

    This article summarizes the history of the regulation of caffeine, a key component of caffeine-containing energy drinks and other caffeine-containing energy products, in the United States. Caffeine as an ingredient in food has been regulated by the US Food and Drug Administration (FDA) since 1958, when the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act was enacted. It is listed as a substance that is generally recognized as safe by experts for its intended use in cola-type beverages at levels not to exceed 200 parts per million. Here, the history of FDA evaluations of the safe use of, as well as consumer exposure to, caffeine in food in the United States is outlined. Finally, the FDA's current concerns about caffeine and caffeine-containing energy products are reported, along with the current activities to address those concerns. Published 2014. This article is a U.S. government work and is in the public domain in the USA.

  1. 47 CFR 101.1411 - Regulatory status and eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Section 101.1411 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Multichannel Video Distribution and Data Service Rules for the 12.2-12.7... one-way video programming and data services on a non-common carrier and/or on a common carrier basis...

  2. 76 FR 3540 - Proposed Generic Communications Reporting for Decommissioning Funding Status Reports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... Funding Status Reports AGENCY: Nuclear Regulatory Commission. ACTION: Proposed generic communication... information that they should use and present to the NRC in the Decommissioning Funding Status reports to... . The Draft Regulatory Issue Summary 2010-XXX, ``10 CFR 50-75, Reporting for Decommissioning...

  3. Meeting Regulatory Needs.

    PubMed

    Weber, Michael Fred

    2017-02-01

    The world is experiencing change at an unprecedented pace, as reflected in social, cultural, economic, political, and technological advances around the globe. Regulatory agencies, like the U.S. Nuclear Regulatory Commission (NRC), must also transform in response to and in preparation for these changes. In 2014, the NRC staff commenced Project Aim 2020 to transform the agency by enhancing efficiency, agility, and responsiveness, while accomplishing NRC's safety and security mission. Following Commission review and approval in 2015, the NRC began implementing the approved strategies, including strategic workforce planning to provide confidence that NRC will have employees with the right skills and talents at the right time to accomplish the agency's mission. Based on the work conducted so far, ensuring an adequate pipeline of radiation protection professionals is a significant need that NRC shares with states and other government agencies, private industry, academia, as well as international counterparts. NRC is working to ensure that sufficient radiation protection professionals will be available to fulfill its safety and security mission and leverage the work of the National Council on Radiation Protection and Measurements, the Conference of Radiation Control Program Directors, the Health Physics Society, the Organization of Agreement States, the International Atomic Energy Agency, the Nuclear Energy Agency, and others.

  4. Clinical research: regulatory issues.

    PubMed

    Wermeling, D P

    1999-02-01

    The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.

  5. Regulatory considerations for biosimilars.

    PubMed

    Nellore, Ranjani

    2010-01-01

    Currently there is considerable interest in the legislative debate around generic biological drugs or "biosimilars" in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved "similar" biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products.

  6. Perchlorate Regulatory Determination Fact Sheets

    EPA Pesticide Factsheets

    Fact sheets have been developed for the perchlorate regulatory determination corresponding to the following stages published in the Federal Register: Final, Supplemental request for comments, and Preliminary.

  7. Drug Regulatory Affairs

    DTIC Science & Technology

    1990-04-30

    8,990; WR 142,490). o Study No. 1 (Comparative treatment of 162 patients treated with Enpiroline or Mefloquine) o Study No. 2 (Mefloquine pharmacokinetic...registration package was submitted to USAMMDA on 18 January 1990. Status of Task: Complete. 2.17 Task 88-14 Mefloquine- Enpiroline Evaluation This task...required the preparation of a scientific report on available data on mefloquine and enpiroline for future scientific and rgulatory action. The final

  8. Regulatory T cells.

    PubMed

    Thompson, Claire; Powrie, Fiona

    2004-08-01

    Regulatory T (TR) cells are a subset of T cells that function to control immune responses. Different populations of TR cells have been described, including thymically derived CD4(+)CD25+ TR cells and Tr1 cells induced in the periphery through exposure to antigen. A transcription factor, Foxp3, has been identified that is essential for CD4(+)CD25+ TR cell development and function. There is now evidence that transforming growth factor-beta might play a role in this pathway. CD4(+)CD25+ TR cells proliferate extensively in vivo in an antigen-specific manner, and can respond to both self and foreign peptides. By suppressing excessive immune responses, TR cells play a key role in the maintenance of self-tolerance, thus preventing autoimmune disease, as well as inhibiting harmful inflammatory diseases such as asthma and inflammatory bowel disease.

  9. Targeting regulatory T cells.

    PubMed

    Ménétrier-Caux, Christine; Curiel, Tyler; Faget, Julien; Manuel, Manuarii; Caux, Christophe; Zou, Weiping

    2012-03-01

    Cancers express tumor-associated antigens that should elicit immune response to antagonize the tumor growth, but spontaneous immune rejection of established cancer is rare, suggesting an immunosuppressive environment hindering host antitumor immunity. Among the specific and active tumor-mediated mechanisms, CD4(+)CD25(high) T regulatory cells (Treg) are important mediators of active immune evasion in cancer. In this review, we will discuss Treg subpopulations and the mechanisms of their suppressive functions. Treg depletion improves endogenous antitumor immunity and the efficacy of active immunotherapy in animal models for cancer, suggesting that inhibiting Treg function could also improve the limited successes of human cancer immunotherapy. We will also discuss specific strategies for devising effective cancer immunotherapy targeting Treg.

  10. Regulatory Streamlining and Improvement

    SciTech Connect

    Mark A. Carl

    2006-07-11

    The Interstate Oil and Gas Compact Commission (IOGCC) engaged in numerous projects outlined under the scope of work discussed in the United States Department of Energy (DOE) grant number DE-FC26-04NT15456 awarded to the IOGCC. Numerous projects were completed that were extremely valuable to state oil and gas agencies as a result of work performed utilizing resources provided by the grant. There are numerous areas in which state agencies still need assistance. This additional assistance will need to be addressed under future scopes of work submitted annually to DOE's Project Officer for this grant. This report discusses the progress of the projects outlined under the grant scope of work for the 2005-2006 areas of interest, which are as follows: Area of Interest No. 1--Regulatory Streamlining and Improvement: This area of interest continues to support IOGCC's regulatory streamlining efforts that include the identification and elimination of unnecessary duplications of efforts between and among state and federal programs dealing with exploration and production on public lands. Area of Interest No. 2--Technology: This area of interest seeks to improve efficiency in states through the identification of technologies that can reduce costs. Area of Interest No. 3--Training and Education: This area of interest is vital to upgrading the skills of regulators and industry alike. Within the National Energy Policy, there are many appropriate training and education opportunities. Education was strongly endorsed by the President's National Energy Policy Development group. Acting through the governors offices, states are very effective conduits for the dissemination of energy education information. While the IOGCC favors the development of a comprehensive, long-term energy education plan, states are also supportive of immediate action on important concerns, such as energy prices, availability and conservation. Area of Interest No. 4--Resource Assessment and Development: This area

  11. Regulatory Considerations for Biosimilars

    PubMed Central

    Nellore, Ranjani

    2010-01-01

    Currently there is considerable interest in the legislative debate around generic biological drugs or “biosimilars” in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved “similar” biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products. PMID:21829775

  12. 75 FR 54210 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ...-2010-032] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... Transactions August 30, 2010. On June 17, 2010, the Financial Industry Regulatory Authority, Inc....

  13. Biosimilar drugs: Current status.

    PubMed

    Kumar, Rajiv; Singh, Jagjit

    2014-07-01

    Biologic products are being developed over the past three decades. The expiry of patent protection for many biological medicines has led to the development of biosimilars in UK or follow on biologics in USA. This article reviews the literature on biosimilar drugs that covers the therapeutic status and regulatory guidelines. Appraisal of published articles from peer reviewed journals for English language publications, search from PubMed, and guidelines from European Medicines Agency, US Food Drug Administration (FDA) and India were used to identify data for review. Literature suggest that biosimilars are similar biological products, i.e., comparable but not identical to the reference product, are not generic version of innovator product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and marketing approval is also more complicated. To improve access, US Congress passed the Biologics Price Competition and Innovation act 2009 and US FDA allowed "abbreviated pathway" for their approval. U.S law has defined new standards and terms and EMA scientific guidelines have also set detailed approval standards. India being one of the most preferred manufacturing destinations of biosimilars, there is a need for stringent safety and regulatory guidelines. The New India Guidelines "Draft Guidelines on Similar Biologics were announced in June 2012, by Department of Biotechnology at Boston bio and available online.

  14. Biosimilars: policy, clinical, and regulatory considerations.

    PubMed

    Gottlieb, Scott

    2008-07-15

    The regulatory background surrounding biosimilars (biopharmaceuticals that are considered similar in composition to an innovator product, but not necessarily clinically interchangeable); equivalence, interchangeability, and unique considerations associated with biopharmaceuticals; the biopharmaceutical protein production process; scientific facts for use in the policy discussion about biosimilars; the European Union system for biosimilars; and the current status of biosimilars legislation in the United States are described. An abbreviated regulatory pathway for the approval of biosimilars, and a process for safely demonstrating the therapeutic interchangeability of these proteins, has the potential to provide meaningful cost savings. This economic advantage to patients can translate into important public health benefits. But to date, no formal regulatory process exists in the United States for bringing these drugs to market. In addition, the current tools for fully characterizing biopharmaceuticals are not--in certain cases--well developed, especially for proteins that have complex structures or are heavily glycosylated. In addition, using "similar" but not completely "identical" proteins interchangeably raises concerns about potentiating immunogenicity. The bottom line is that demonstrating therapeutic equivalence and interchangeability for biosimilars is not a straightforward matter--it cannot be based on the same criteria as for conventional small-molecule drugs. The science, while obtainable, is more complex. For example, it is assumed that showing that a biosimilar protein can be safely used interchangeably with an innovator protein would require, at the least, some limited clinical data and interchangeability studies. Notwithstanding the more complex scientific and clinical issues particular to protein products, most believe that a process for enabling the approval of safe and effective biosimilar proteins is not only possible, but an important public health

  15. Regulatory Foci and Organizational Commitment

    ERIC Educational Resources Information Center

    Markovits, Yannis; Ullrich, Johannes; van Dick, Rolf; Davis, Ann J.

    2008-01-01

    We use regulatory focus theory to derive specific predictions regarding the differential relationships between regulatory focus and commitment. We estimated a structural equation model using a sample of 520 private and public sector employees and found in line with our hypotheses that (a) promotion focus related more strongly to affective…

  16. Microbial regulatory and metabolic networks.

    PubMed

    Cho, Byung-Kwan; Charusanti, Pep; Herrgård, Markus J; Palsson, Bernhard O

    2007-08-01

    Reconstruction of transcriptional regulatory and metabolic networks is the foundation of large-scale microbial systems and synthetic biology. An enormous amount of information including the annotated genomic sequences and the genomic locations of DNA-binding regulatory proteins can be used to define metabolic and regulatory networks in cells. In particular, advances in experimental methods to map regulatory networks in microbial cells have allowed reliable data-driven reconstruction of these networks. Recent work on metabolic engineering and experimental evolution of microbes highlights the key role of global regulatory networks in controlling specific metabolic processes and the need to consider the integrated function of multiple types of networks for both scientific and engineering purposes.

  17. Drug Regulatory Affairs

    DTIC Science & Technology

    1987-07-15

    5,509 Phosphorothioic Acid (WR 2,721) 8,990 Mefloquine (WR 142,490) 9,847 Halofantrine (YR 171,669) 12,735 Enpiroline (WR 180,409) 13,487 WR 194,695...annual IND progress report for IND 12,735; WR 180,409. Clinical data from a study comprised of 162 patients treated with mefloquine or enpiroline will...complete Ketoconazole (original) 11/16/86 complete Enpiroline (original) 11/16/86 complete Pyridostigmine Status Report 5/08/87 complete Assessment Report

  18. Understanding genetic regulatory networks

    NASA Astrophysics Data System (ADS)

    Kauffman, Stuart

    2003-04-01

    Random Boolean networks (RBM) were introduced about 35 years ago as first crude models of genetic regulatory networks. RBNs are comprised of N on-off genes, connected by a randomly assigned regulatory wiring diagram where each gene has K inputs, and each gene is controlled by a randomly assigned Boolean function. This procedure samples at random from the ensemble of all possible NK Boolean networks. The central ideas are to study the typical, or generic properties of this ensemble, and see 1) whether characteristic differences appear as K and biases in Boolean functions are introducted, and 2) whether a subclass of this ensemble has properties matching real cells. Such networks behave in an ordered or a chaotic regime, with a phase transition, "the edge of chaos" between the two regimes. Networks with continuous variables exhibit the same two regimes. Substantial evidence suggests that real cells are in the ordered regime. A key concept is that of an attractor. This is a reentrant trajectory of states of the network, called a state cycle. The central biological interpretation is that cell types are attractors. A number of properties differentiate the ordered and chaotic regimes. These include the size and number of attractors, the existence in the ordered regime of a percolating "sea" of genes frozen in the on or off state, with a remainder of isolated twinkling islands of genes, a power law distribution of avalanches of gene activity changes following perturbation to a single gene in the ordered regime versus a similar power law distribution plus a spike of enormous avalanches of gene changes in the chaotic regime, and the existence of branching pathway of "differentiation" between attractors induced by perturbations in the ordered regime. Noise is serious issue, since noise disrupts attractors. But numerical evidence suggests that attractors can be made very stable to noise, and meanwhile, metaplasias may be a biological manifestation of noise. As we learn more

  19. 75 FR 40000 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change Relating to the Restated Certificate of Incorporation of Financial Industry Regulatory Authority, Inc. July 2, 2010. On May 21, 2010, Financial Industry Regulatory Authority, Inc....

  20. Internationalization of regulatory requirements.

    PubMed

    Juillet, Y

    2003-02-01

    The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

  1. Compliance status

    SciTech Connect

    Black, D.G.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the activities conducted to ensure that the Hanford Site is in compliance with federal environmental protection statutes and related Washington State and local environmental protection regulations and the status of Hanford`s compliance with these requirements. Environmental permits required under the environmental protection regulations are discussed under the applicable statute.

  2. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory... method validation data. (c) FDA will publish in the Federal Register the complete regulatory method...

  3. 77 FR 26413 - Promoting International Regulatory Cooperation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... United States of America, and in order to promote international regulatory cooperation, it is hereby... global economy, international regulatory cooperation, consistent with domestic law and prerogatives and U..., safety, labor, security, environmental, and other issues, international regulatory cooperation can...

  4. 75 FR 79929 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... From the Federal Register Online via the Government Publishing Office ] Part XXII Federal Trade Commission ###Semiannual Regulatory Agenda### ] FEDERAL TRADE COMMISSION (FTC) FEDERAL TRADE COMMISSION 16 CFR Ch. I Semiannual Regulatory Agenda AGENCY: Federal Trade Commission. ACTION: Semiannual regulatory...

  5. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory... method validation data. (c) FDA will publish in the Federal Register the complete regulatory method for...

  6. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory... method validation data. (c) FDA will publish in the Federal Register the complete regulatory method for...

  7. The Effect of Self-Regulatory and Metacognitive Strategy Instruction on Impoverished Students' Assessment Achievement in Physics

    ERIC Educational Resources Information Center

    Fouche, Jaunine

    2013-01-01

    The purpose of this nonequivalent control group design study was to evaluate the effectiveness of metacognitive and self-regulatory strategy use on the assessment achievement of 215 9th-grade, residential physics students from low socioeconomic status (low-SES) backgrounds. Students from low-SES backgrounds often lack the self-regulatory habits…

  8. The current regulatory agenda: An update

    SciTech Connect

    Pontius, F.W. ); Roberson, J.A. )

    1994-02-01

    Previous reviews have summarized the regulations promulgated for volatile organic chemicals (VOCs), fluoride, surface water treatment , total coliform bacteria, lead and copper, and Phase 2 and Phase 5 synthetic organic contaminants (SOCs) and inorganic contaminant (IOCs). Current development related to these rules and to anticipated new rules are reviewed in this article. The status and schedule of development of all current and anticipated regulations are summarized. Dates for anticipated actions are based on the US Environmental Protection Agency's published regulatory agenda and on information released by the agency through December 1993; these dates can change as priorities change within the agency. Tables listing the contaminants regulated in the various rules and summary listing of current USEPA drinking water numerical standards and best available technology for regulated contaminants were presented in the February 1993 article. Because these tables are essentially unchanged, they are not included here, and the reader is referred to that article. 62 refs., 3 tabs.

  9. Regulatory aspects of specific immunotherapy in Europe.

    PubMed

    Kaul, Susanne; Englert, Lisa; May, Sibylle; Vieths, Stefan

    2010-12-01

    The recent developments in the regulation of allergen products and their impact on specific immunotherapy (SIT) in Europe are summarized, and unmet needs are discussed. New guidance on the quality, the clinical development, and marketing authorization status of allergen products for SIT has been released. The most important documents are Guidelines from the European Medicines Agency, a revision of the European Pharmacopoeia Monograph on Allergens, regulations, and position papers of scientific societies. The increased demands on quality, safety, and efficacy will lead to allergen products being better characterized and with enhanced proof of efficacy and safety. In addition, national activities to regulate the existing broad spectrum of named patient allergen products have been started. At the same time these developments represent a challenge to manufacturers to meet all new requirements. Some problems, for example regarding patient-tailored products containing recombinant allergens remain and may require novel regulatory approaches.

  10. Transporter biology in drug approval: regulatory aspects.

    PubMed

    Maeda, Kazuya; Sugiyama, Yuichi

    2013-01-01

    Previous in vitro and clinical research have indicated that a wide variety of drug transporters as well as metabolic enzymes dominate the pharmacokinetics of drugs and that some drugs modified the expression/function of drug transporters in humans, which lead to the altered pharmacokinetics and subsequent pharmacological/toxicological effects. Thus, regulatory authorities in US and EU have recently emphasized the needs to evaluate the risk of transporter-mediated drug-drug interactions (DDIs) in the (draft) guidance for pharmaceutical industries. The revised guidance includes the key transporters governing pharmacokinetics of drugs and decision trees to determine whether NMEs are substrates or inhibitors of each key transporter and when an in vivo clinical study is needed. In the evaluation of the potency of clinical DDIs, estimation of the inhibitor concentration at the target site is essential, but difficult since its direct measurement is almost impossible. Thus, people are now discussing what kind of inhibitor concentration should be used and how much is the appropriate cutoff value of the ratio of plasma AUC in the presence of inhibitor drugs to that in its absence (AUCR) to avoid false-negative predictions and maximize prediction accuracy. This minireview briefly summarizes the current status of the criteria for risk management of transporter-mediated DDIs in the regulatory guidelines, and describes scientific achievements that may affect regulatory decisions. Target transporters include OATP1B1 (SLCO1B1) and OATP1B3 (SLCO1B3) in the liver, and OAT1 (SLC22A6), OAT3 (SLC22A8), OCT2 (SLC22A2), MATE1 (SLC47A1), and MATE2-K (SLC47A2) in the kidney, and MDR1 (ABCB1) in the intestine. Copyright © 2012 Elsevier Ltd. All rights reserved.

  11. Regulatory T cells and COPD.

    PubMed

    Dancer, Rachel; Sansom, David M

    2013-12-01

    While the innate immune system has long been implicated in the pathogenesis of COPD, a role for the acquired immune system is less well studied. The increasing recognition that COPD shares features with autoimmune disease has led to interest in a potential role for regulatory T cells, which are intimately involved in the control of autoimmunity. The suggestion that regulatory T cell numbers are increased in patients with COPD may indicate their dysfunction or resistance to suppression by target cells. Investigation of regulatory T cells may therefore be of importance in understanding the inflammation and tissue damage that occurs in patients with COPD who cease smoking.

  12. Sleep regulatory factors.

    PubMed

    Porkka-Heiskanen, T

    2014-01-01

    The state of sleep consists of different phases that proceed in successive, tightly regulated order through the night forming a physiological program, which for each individual is different but stabile from one night to another. Failure to accomplish this program results in feeling of unrefreshing sleep and tiredness in the morning. The pro- gram core is constructed by genetic factors but regulated by circadian rhythm and duration and intensity of day time brain activity. Many environmental factors modulate sleep, including stress, health status and ingestion of vigilance-affecting nutrients or medicines (e.g. caffeine). Knowledge of the factors that regulate the spontaneous sleep-wake cycle and factors that can affect this regulation forms the basis for diagnosis and treatment of the many common disorders of sleep.

  13. Medical Device Regulatory Improvement Act

    THOMAS, 112th Congress

    Sen. Klobuchar, Amy [D-MN

    2011-10-13

    Senate - 10/13/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  14. Regulatory Accountability Act of 2011

    THOMAS, 112th Congress

    Sen. Portman, Rob [R-OH

    2011-09-22

    Senate - 09/22/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  15. Regulatory Accountability Act of 2011

    THOMAS, 112th Congress

    Sen. Portman, Rob [R-OH

    2011-09-22

    09/22/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  16. Regulatory Accountability Act of 2011

    THOMAS, 112th Congress

    Sen. Portman, Rob [R-OH

    2011-09-22

    09/22/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  17. Regulatory Snapshots: integrative mining of regulatory modules from expression time series and regulatory networks.

    PubMed

    Gonçalves, Joana P; Aires, Ricardo S; Francisco, Alexandre P; Madeira, Sara C

    2012-01-01

    Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules) under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1) apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2) ignore local patterns, abundant in most interesting cases of transcriptional activity; (3) neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4) limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots). Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in functionally enriched

  18. 77 FR 7972 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... Identifier No. 396 National Standards to 1105-AB34 Prevent, Detect, and Respond to Prison Rape (Reg Plan Seq... Prevent, Detect, and Respond to Prison Rape Regulatory Plan: This entry is Seq. No. 85 in part II of this...

  19. 75 FR 79759 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Action 04/16/10 75 FR 2012 Regulatory Flexibility Analysis Required: Yes Agency Contact: Mohammed Khan Phone: 202 586-7892 Email: mohammed.khan@ee.doe.gov RIN: 1904-AA90 BILLING CODE 6450-01-S ...

  20. State/Federal Regulatory Considerations

    EPA Pesticide Factsheets

    This page contains presentations from the Brown to Green: Make the Connection to Renewable Energy workshop held in Santa Fe, New Mexico, during December 10-11, 2008, regarding State/Federal Regulatory Considerations.

  1. Taking Stock of Regulatory Variation.

    PubMed

    Maurano, Matthew T; Stamatoyannopoulos, John A

    2015-07-29

    Three recent studies measure individual variation in regulatory DNA accessibility. What do they tell us about the prospects of assessing variation in single cells and across populations? Copyright © 2015 Elsevier Inc. All rights reserved.

  2. 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.

  3. Status Epilepticus

    PubMed Central

    Manno, Edward M.

    2011-01-01

    Status epilepticus is a neurological emergency that is commonly encountered by the neurohospitalist. Successful treatment depends upon the recognition of prolonged seizure activity and the acute mobilization of available resources. Pharmacologic treatment regimens have been shown to decrease the time needed for successful control of seizures and have provided for the rapid administration of anticonvulsant medications. Treatment strategies have evolved so that clinicians can administer effective doses of medication by whatever routes of administration are immediately available. Traditional algorithms for the treatment of status epilepticus have used a stepwise approach to the administration of first-, second-, and third-order medications. More recent options have included aggressive anesthetic doses of medications while second-line medications are being titrated. PMID:23983834

  4. Regulatory facility guide for Ohio

    SciTech Connect

    Anderson, S.S.; Bock, R.E.; Francis, M.W.; Gove, R.M.; Johnson, P.E.; Kovac, F.M.; Mynatt, J.O.; Rymer, A.C.

    1994-02-28

    The Regulatory Facility Guide (RFG) has been developed for the DOE and contractor facilities located in the state of Ohio. It provides detailed compilations of international, federal, and state transportation-related regulations applicable to shipments originating at destined to Ohio facilities. This RFG was developed as an additional resource tool for use both by traffic managers who must ensure that transportation operations are in full compliance with all applicable regulatory requirements and by oversight personnel who must verify compliance activities.

  5. Electronic Commerce Removing Regulatory Impediments

    DTIC Science & Technology

    1992-05-01

    AD-A252 691 ELECTRONIC COMMERCE Removing Regulatory Impediments ~DuiG A% ELECTE I JUL1 8 1992 0 C D Daniel J. Drake John A. Ciucci ... - ""N ST AT KE...Management Institute 6400 Goldsboro Road Bethesda, Maryland 20817-5886 92 LMI Executive Summary ELECTRONIC COMMERCE : REMOVING REGULATORY IMPEDIMENTS... Electronic Commerce techniques, such as electronic mail and electronic data interchange (EDI), enable Government agencies to conduct business without the

  6. Emerging principles of regulatory evolution

    PubMed Central

    Prud'homme, Benjamin; Gompel, Nicolas; Carroll, Sean B.

    2007-01-01

    Understanding the genetic and molecular mechanisms governing the evolution of morphology is a major challenge in biology. Because most animals share a conserved repertoire of body-building and -patterning genes, morphological diversity appears to evolve primarily through changes in the deployment of these genes during development. The complex expression patterns of developmentally regulated genes are typically controlled by numerous independent cis-regulatory elements (CREs). It has been proposed that morphological evolution relies predominantly on changes in the architecture of gene regulatory networks and in particular on functional changes within CREs. Here, we discuss recent experimental studies that support this hypothesis and reveal some unanticipated features of how regulatory evolution occurs. From this growing body of evidence, we identify three key operating principles underlying regulatory evolution, that is, how regulatory evolution: (i) uses available genetic components in the form of preexisting and active transcription factors and CREs to generate novelty; (ii) minimizes the penalty to overall fitness by introducing discrete changes in gene expression; and (iii) allows interactions to arise among any transcription factor and downstream CRE. These principles endow regulatory evolution with a vast creative potential that accounts for both relatively modest morphological differences among closely related species and more profound anatomical divergences among groups at higher taxonomical levels. PMID:17494759

  7. The limits of regulatory toxicology

    SciTech Connect

    Carrington, Clark D.; Bolger, P. Michael

    2010-03-01

    The Acceptable Daily Intake (ADI) has been used by regulatory and public health organizations (e.g., the U.S. Food and Drug and Administration, and the World Health Organization) for chemicals for more than 50 years. The ADI concept was also initially employed at the U.S. Environmental Protection Agency at its inception in 1971, although with the adoption of newer terminology, it later became known as the Reference Dose (RfD). It is clear from the literature that both were first devised as instruments of regulatory policy. In the intervening years, it has become common to use language that implies that these standards are statements of scientific fact. Similarly, some of the discretionary or default values that are used to derive regulatory standards are represented as scientific assumptions when in fact they also represent regulatory policy. This confusion impedes both the best use of the available science and informed public participation in policy making. In addition, the misconception of the ADI or the RfD as statements of scientific fact may impede the consideration of alternative means to reduce exposure to chemicals that may be harmful, including regulatory measures that do not involve prescribing a regulatory concentration limit.

  8. The limits of regulatory toxicology.

    PubMed

    Carrington, Clark D; Bolger, P Michael

    2010-03-01

    The Acceptable Daily Intake (ADI) has been used by regulatory and public health organizations (e.g., the U.S. Food and Drug and Administration, and the World Health Organization) for chemicals for more than 50 years. The ADI concept was also initially employed at the U.S. Environmental Protection Agency at its inception in 1971, although with the adoption of newer terminology, it later became known as the Reference Dose (RfD). It is clear from the literature that both were first devised as instruments of regulatory policy. In the intervening years, it has become common to use language that implies that these standards are statements of scientific fact. Similarly, some of the discretionary or default values that are used to derive regulatory standards are represented as scientific assumptions when in fact they also represent regulatory policy. This confusion impedes both the best use of the available science and informed public participation in policy making. In addition, the misconception of the ADI or the RfD as statements of scientific fact may impede the consideration of alternative means to reduce exposure to chemicals that may be harmful, including regulatory measures that do not involve prescribing a regulatory concentration limit.

  9. ASSEMBLING NEURAL CREST REGULATORY CIRCUITS INTO A GENE REGULATORY NETWORK

    PubMed Central

    Betancur, Paola; Bronner-Fraser, Marianne; Sauka-Spengler, Tatjana

    2014-01-01

    The neural crest is a multipotent stem cell--like population that gives rise to a wide range of derivatives in vertebrate embryo including elements of the craniofacial skeleton and peripheral nervous system as well as melanocytes. The neural crest forms in a series of regulatory steps that include induction and specification of the prospective neural crest territory--neural plate border, specification of bona fide neural crest progenitors, and differentiation into diverse derivatives. These individual processes during neural crest ontogeny are controlled by regulatory circuits that can be assembled into a hierarchical gene regulatory network (GRN). Here we present an overview of the GRN that orchestrates the formation of cranial neural crest cells. Formulation of this network relies on information largely inferred from gene perturbation studies performed in several vertebrate model organisms. Our representation of the cranial neural crest GRN also includes information about direct regulatory interactions obtained from the cis-regulatory analyses performed to date, which increases the resolution of the architectural circuitry within the network. PMID:19575671

  10. 7 CFR 1773.40 - Regulatory assets.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 12 2011-01-01 2011-01-01 false Regulatory assets. 1773.40 Section 1773.40... § 1773.40 Regulatory assets. The CPA's workpapers must document whether all regulatory assets comply with... whether all regulatory assets have received RUS approval. ...

  11. 7 CFR 1773.40 - Regulatory assets.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 12 2010-01-01 2010-01-01 false Regulatory assets. 1773.40 Section 1773.40... § 1773.40 Regulatory assets. The CPA's workpapers must document whether all regulatory assets comply with... whether all regulatory assets have received RUS approval. ...

  12. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory... method validation data. (c) FDA will publish in the Federal Register the complete regulatory method for... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food...

  13. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory... method validation data. (c) FDA will publish in the Federal Register the complete regulatory method for... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Regulatory method. 500.88 Section 500.88 Food and...

  14. Federal Communications Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] Part XIX Federal Communications Commission Semiannual Regulatory Agenda ] FEDERAL COMMUNICATIONS COMMISSION (FCC) FEDERAL COMMUNICATIONS COMMISSION 47 CFR Ch. I Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2010 AGENCY: Federal...

  15. RHIC Status

    NASA Astrophysics Data System (ADS)

    Peggs, Steve

    1997-05-01

    The design and construction status of the Relativistic Heavy Ion Collider, RHIC, is discussed. Those novel performance features of a heavy ion collider that are distinct from hadron colliders in general are noted. These features are derived from the experimental requirements of operation with a variety of ion species over a wide energy range, including collisions between protons and ions, and between ions of unequal energies. The project is in the fifth year of a seven year construction cycle. A brief review of the recent Sextant Test is given, together with progress to date on machine construction.

  16. Tevatron status

    SciTech Connect

    Dugan, G.

    1989-03-01

    The Fermilab Tevatron is both the world's highest energy accelerator system and first large-scale superconducting synchrotron. Since Tevatron commissioning in July 1983, the accelerator has operated in 1984, 1985 and 1987 with extracted beams of 800 GeV for three runs of fixed target physics, and in 1987, and 1988, with proton-antiproton colliding beams at 900 /times/ 900 GeV. This paper will focus on the collider operation of the Tevatron: its present status and the outlook for its longer-term future evolution. 18 refs., 3 figs., 2 tabs.

  17. Anti-regulatory T cells.

    PubMed

    Andersen, Mads Hald

    2017-04-01

    Our initial understanding of immune-regulatory cells was based on the discovery of suppressor cells that assure peripheral T-cell tolerance and promote immune homeostasis. Research has particularly focused on the importance of regulatory T cells (Tregs) for immune modulation, e.g. directing host responses to tumours or inhibiting autoimmunity development. However, recent studies report the discovery of self-reactive pro-inflammatory T cells-termed anti-regulatory T cells (anti-Tregs)-that target immune-suppressive cells. Thus, regulatory cells can now be defined as both cells that suppress immune reactions as well as effector cells that counteract the effects of suppressor cells and support immune reactions. Self-reactive anti-Tregs have been described that specifically recognize human leukocyte antigen-restricted epitopes derived from proteins that are normally expressed by regulatory immune cells, including indoleamine 2,3-dioxygenase (IDO), tryptophan 2,6-dioxygenase (TDO), programmed death-ligand 1 (PD-L1), and forkhead box P3 (Foxp3). These proteins are highly expressed in professional antigen-presenting cells under various physiological conditions, such as inflammation and stress. Therefore, self-reactive T cells that recognize such targets may be activated due to the strong activation signal given by their cognate targets. The current review describes the existing knowledge regarding these self-reactive anti-Tregs, providing examples of antigen-specific anti-Tregs and discussing their possible roles in immune homeostasis and their potential future clinical applications.

  18. 75 FR 16202 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice...

  19. RHIC status

    SciTech Connect

    Peggs, S.

    1997-08-01

    The design and construction status of the Relativistic Heavy Ion Collider, RHIC, which is in the seventh year of a nine year construction cycle, is discussed. Those novel performance features of a heavy ion collider that are distinct from hadron colliders in general are noted. These features are derived from the experimental requirements of operation with a variety of ion species over a wide energy range, including collisions between protons and ions, and between ions of unequal energies. Section 1 gives a brief introduction to the major parameters and overall layout of RHIC. A review of the superconducting magnet program is given in Section 2. Activities during the recent Sextant Test are briefly reviewed in Section 3. Finally, Section 4 presents the plans for RHIC commissioning in 1999.

  20. Glycoconjugate Vaccines: The Regulatory Framework.

    PubMed

    Jones, Christopher

    2015-01-01

    Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.

  1. The rise of regulatory RNA

    PubMed Central

    Morris, K.V.; Mattick, J.S.

    2015-01-01

    Discoveries over the last decade portend a paradigm shift in molecular biology. Evidence suggests that RNA is not only functional as a messenger between DNA and protein but also in the regulation of genome organization and gene expression, which is increasingly elaborated in complex organisms. Regulatory RNAs appear to operate at many levels, but in particular to play an important role in the epigenetic processes that control differentiation and development. These discoveries suggest a central role for RNA in human evolution and ontogeny. Here we survey the emergence of the previously unsuspected world of regulatory RNAs from an historical perspective. PMID:24776770

  2. Regulatory process for decommissioning nuclear power reactors. Final report

    SciTech Connect

    1998-03-01

    This report provides regulatory guidance for utilities consistent with the changes in the decommissioning rule, 10 CFR50.82 as revised in July 1996. The purpose of this report is to explain the new rule in the context of related industry experience and to provide practical guidance to licensees contemplating or implementing a shutdown. Because the regulatory process is still rapidly evolving, this report reflects only a current status of the acceptable methods and practices derived from a review of the current regulations, guidance documents and industry experience for decommissioning a nuclear power reactor. EPRI anticipates periodic updates of this document to incorporate various utility experiences with decommissioning, and also to reflect any regulatory changes. The report provides a summary of ongoing federal agency and industry activities and the regulatory requirements that are currently applicable, or no longer applicable, to nuclear power plants at the time of permanent shutdown through the early decommissioning stage. The report describes the major components of a typical decommissioning action plan, providing industry experience and guidance for licensees considering or implementing permanent shutdown.

  3. 78 FR 17969 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... Associate General Counsel, Securities Industry and Financial Markets Association to Elizabeth M. Murphy... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of..., 2013. On February 1, 2013, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with...

  4. 75 FR 74766 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... class of its securities, another waiver will not be granted. Notwithstanding the significant...

  5. 77 FR 55517 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a.... Introduction On May 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... General Counsel, Securities Industry and Financial Markets Association, dated June 26, 2012...

  6. 75 FR 62439 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-08

    ...-2010-043] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA..., 2010 (``Wiesenberg Letter''); Letter from Manisha Kimmel, Executive Director, Financial...

  7. 75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... January 21, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities...

  8. Approach of Czech regulatory body to LBB

    SciTech Connect

    Tendera, P.

    1997-04-01

    At present there are two NPPs equipped with PWR units in Czech Republic. The Dukovany, NPP is about ten years in operation (four units 440 MW - WWBFL model 213) and Tomelin NPP is under construction (two units 1000 MW - WWER model 320). Both NPPs were built to Soviet design and according to Soviet regulations and standards but most of equipment for primary circuits was supplied by home manufacturers. The objective of the Czech LBB program is to prove the LBB status of the primary piping systems of there NPPs and the LBB concept is a part of strategy to meet western style safety standards. The reason for the Czech LBB project is a lack of some standard safety Facilities too. For both Dukovany and Tomelin NPPs a full LBB analysis should be carried out. The application of LBB to the piping system should be also a cost effective means to avoid installations of pipe whip restraints and jet shields. The Czech regulatory body issued non-mandatory requirement, {open_quotes}Leak Before Break{close_quotes} which is in compliance with national legal documents and which is based on the US NRC Regulatory Procedures and US standards (ASMF CODE, ANSI). The requirement has been published in the document {open_quotes}Safety of Nuclear Facilities{close_quotes} No 1/1991 as {open_quotes}Requirements on the Content and Format of Safety Reports and their Supplements{close_quote} and consist of two parts (1) procedure for obtaining proof of evidence {open_quotes}Leak Before Break{close_quotes} (2) leak detection systems for the pressurized reactor primary circuit. At present some changes concerning both parts of the above document will be introduced. The reasons for this modifications will be presented.

  9. Approach for Czech regulatory body to LBB

    SciTech Connect

    Tendera, P.

    1997-04-01

    At present there are two NPPs equipped with PWR units in Czech Republic. The Dukovany NPP is about ten years in operation (four units 440 MW - WWER model 213) and Temelin NPP is under construction (two units 1000 MW-WWER model 320). Both NPPs were built to Soviet design and according to Soviet regulations and standards but most of equipment for primary circuits was supplied by home manufactures. The objective for the Czech LBB programme is to prove the LBB status of the primary piping systems of these NPPs and the LBB concept is a part of strategy to meet western style safety standards. The reason for the Czech LBB project is a lack of some standard safety facilities, too. For both Dukovany and Temolin NPPs a full LBB analysis should be carried out. The application of LBB to the piping system should be also a cost effective means to avoid installations of pipe whip restraints and jet shields. The Czech regulatory body issued non-mandatory requirement {open_quotes}Leak Before Break{close_quotes} which is in compliance with national legal documents and which is based on the US NRC Regulatory Procedures and US standards (ASME, CODE, ANSI). The requirement has been published in the document {open_quotes}Safety of Nuclear Facilities{close_quotes} No. 1/1991 as {open_quotes}Requirements on the Content and Format of Safety Reports and their Supplements{close_quotes} and consists of two parts (1) procedure for obtaining proof of evidence {open_quotes}Leak Before Break{close_quotes} (2) leak detection systems for the pressurized reactor primary circuit. At present some changes concerning both parts of the above document will be introduced. The reasons for this modifications will be presented.

  10. Regulatory Accountability Act of 2013

    THOMAS, 113th Congress

    Sen. Portman, Rob [R-OH

    2013-05-23

    Senate - 03/11/2014 Committee on Homeland Security and Governmental Affairs Subcommittee on the Efficiency and Effectiveness of Federal Programs and the Federal Workforce. Hearings held. With printed Hearing: S.Hrg. 113-371. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  11. Regulatory Accountability Act of 2013

    THOMAS, 113th Congress

    Sen. Portman, Rob [R-OH

    2013-05-23

    03/11/2014 Committee on Homeland Security and Governmental Affairs Subcommittee on the Efficiency and Effectiveness of Federal Programs and the Federal Workforce. Hearings held. With printed Hearing: S.Hrg. 113-371. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  12. Regulatory Accountability Act of 2011

    THOMAS, 112th Congress

    Rep. Smith, Lamar [R-TX-21

    2011-09-22

    12/05/2011 Received in the Senate and Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  13. Regulatory Accountability Act of 2011

    THOMAS, 112th Congress

    Rep. Smith, Lamar [R-TX-21

    2011-09-22

    12/05/2011 Received in the Senate and Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  14. Regulatory Improvement Act of 2013

    THOMAS, 113th Congress

    Sen. King, Angus S. Jr. [I-ME

    2013-07-30

    03/11/2014 Committee on Homeland Security and Governmental Affairs Subcommittee on the Efficiency and Effectiveness of Federal Programs and the Federal Workforce. Hearings held. With printed Hearing: S.Hrg. 113-371. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  15. Regulatory Improvement Act of 2013

    THOMAS, 113th Congress

    Sen. King, Angus S., Jr. [I-ME

    2013-07-30

    Senate - 03/11/2014 Committee on Homeland Security and Governmental Affairs Subcommittee on the Efficiency and Effectiveness of Federal Programs and the Federal Workforce. Hearings held. With printed Hearing: S.Hrg. 113-371. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  16. Regulatory Improvement Act of 2013

    THOMAS, 113th Congress

    Sen. King, Angus S. Jr. [I-ME

    2013-07-30

    03/11/2014 Committee on Homeland Security and Governmental Affairs Subcommittee on the Efficiency and Effectiveness of Federal Programs and the Federal Workforce. Hearings held. With printed Hearing: S.Hrg. 113-371. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  17. Regulatory Accountability Act of 2011

    THOMAS, 112th Congress

    Rep. Smith, Lamar [R-TX-21

    2011-09-22

    Senate - 12/05/2011 Received in the Senate and Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  18. Regulatory Accountability Act of 2013

    THOMAS, 113th Congress

    Sen. Portman, Rob [R-OH

    2013-05-23

    03/11/2014 Committee on Homeland Security and Governmental Affairs Subcommittee on the Efficiency and Effectiveness of Federal Programs and the Federal Workforce. Hearings held. With printed Hearing: S.Hrg. 113-371. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  19. 78 FR 44279 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... From the Federal Register Online via the Government Publishing Office ] Vol. 78 Tuesday, No. 141 July 23, 2013 Part XI Department of Justice Semiannual Regulatory Agenda #0;#0;Federal Register / Vol. 78 , No. 141 / Tuesday, July 23, 2013 / Unified Agenda#0;#0; ] DEPARTMENT OF JUSTICE 8 CFR Ch. V 21...

  20. 78 FR 1574 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... 11/24/00 NPRM (Amendment) (Common Cold)...... 06/00/13 Regulatory Flexibility Analysis Required: Yes...-Counter (OTC) 0910-AF31 Drug Review--Cough/Cold (Antihistamine) Products. 271 Over-the-Counter (OTC) 0910...--Pediatric Dosing for Cough/Cold Products. 276 Electronic Distribution of 0910-AG18 Prescribing Information...

  1. 75 FR 79763 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... for the common cold. Timetable: Action Date FR Cite Reopening of Administrative Record 08/25/00 65 FR 51780 NPRM (Amendment) (Common Cold) 10/00/11 Regulatory Flexibility Analysis Required: Yes Agency... Plan Seq No. 45) 313 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products 0910-AF31...

  2. Polymorphism in regulatory gene sequences

    PubMed Central

    Mitchison, N A

    2001-01-01

    The extensive polymorphism revealed in non-coding gene-regulatory sequences, particularly in the immune system, suggests that this type of genetic variation is functionally and evolutionarily far more important than has been suspected, and provides a lead to new therapeutic strategies. PMID:11178274

  3. 75 FR 79799 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Hinchman, Senior Counsel, Office of Legal Policy, Department of Justice, Room 4252, 950 Pennsylvania Avenue... Department of Justice and the Access Board have each gathered a great deal of information regarding the... Justice ###Semiannual Regulatory Agenda### ] DEPARTMENT OF JUSTICE (DOJ) DEPARTMENT OF JUSTICE 8 CFR Ch....

  4. 78 FR 16494 - Notice of Effectiveness of Foreign Utility Company Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Foreign Utility Company Status Docket Nos...-captioned entities as Foreign Utility Companies became effective by operation of the...

  5. Report: EPA’s Management of Interim Status Permitting Needs Improvement to Ensure Continued Progress

    EPA Pesticide Factsheets

    Report #2007-P-00005, December 4, 2006. Interim status is a temporary designation, but some units have existed for as many as 25 years without formal issuance or denial of a permit, or other regulatory controls.

  6. 76 FR 18467 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-04

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 Pennsylvania Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement (OSM), Interior. ACTION: Proposed rule... amendment to the Pennsylvania regulatory program (the ``Pennsylvania program'') under the Surface Mining...

  7. Plant Evolution: Evolving Antagonistic Gene Regulatory Networks.

    PubMed

    Cooper, Endymion D

    2016-06-20

    Developing a structurally complex phenotype requires a complex regulatory network. A new study shows how gene duplication provides a potential source of antagonistic interactions, an important component of gene regulatory networks.

  8. 12 CFR 562.2 - Regulatory reports.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... § 562.2 Regulatory reports. (a) Definition and scope. This section applies to all regulatory reports, as... the OTS, to determine compliance with its rules and regulations, and to evaluate the safe and sound...

  9. Association of Regulatory Boards of Optometry

    MedlinePlus

    ... new process. Welcome to the website of the Association of Regulatory Boards of Optometry (ARBO). ARBO's web ... state legislatures. Mission Statement The mission of the Association of Regulatory Boards of Optometry is to represent ...

  10. 76 FR 62883 - Self-Regulatory Organizations; Options Clearing Corporation; Notice of Filing of Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ... Relating to Clearing Options on the CBOE Silver Volatility Index October 4, 2011. Pursuant to Section 19(b... any option contracts on the CBOE Silver ETF Volatility Index. II. Self-Regulatory Organization's... jurisdictional status of options on the CBOE Silver ETF Volatility Index, which is an index that measures...

  11. Nuclear Regulatory Commission 1989 Information Digest

    SciTech Connect

    None,

    1989-03-01

    The Nuclear Regulatory Commission 1989 Information Digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the Commission. This is the first of an annual publication for the general use of the NRC staff and is available to the public. The Digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide.

  12. 76 FR 6123 - Reducing Regulatory Burden

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... regulatory program more effective and less burdensome in achieving its regulatory objectives. DATES: Written... regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of... by objective scientific evidence. Additionally, the Executive Order directs agencies to consider...

  13. Environmental Protection Agency Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... [Environmental Protection Agency Semiannual Regulatory Agenda ] Part XIV Environmental Protection Agency Semiannual Regulatory Agenda ] ENVIRONMENTAL PROTECTION AGENCY (EPA) ENVIRONMENTAL PROTECTION AGENCY 40 CFR Ch. I EPA-HQ-OA-2007-1172 EPA-HQ-OW-2010-0169 EPA-HQ-OW-2010-0166 EPA-HQ-OAR-2010-0052 Spring 2010 Regulatory Agenda AGENCY:...

  14. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended...

  15. 40 CFR 94.6 - Regulatory structure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 94.6 Section 94... for Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this Part 94 are intended to...

  16. Reconstructing the Prostate Cancer Transcriptional Regulatory Network

    DTIC Science & Technology

    2010-07-01

    TITLE: Reconstructing the prostate cancer transcriptional regulatory network PRINCIPAL INVESTIGATOR: Keyan Salari...CONTRACT NUMBER 4. TITLE AND SUBTITLE Reconstructing the prostate cancer transcriptional regulatory network 5b. GRANT NUMBER W81XWH-09-1...of this study is to reconstruct the prostate cancer transcriptional regulatory network and to experimentally validate novel, clinically-relevant

  17. Department of Homeland Security Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Part VIII Department of Homeland Security Semiannual Regulatory Agenda ] DEPARTMENT OF HOMELAND SECURITY (DHS) DEPARTMENT OF HOMELAND SECURITY Office of the Secretary 6 CFR Chs. I and II Unified Agenda of Federal Regulatory and Deregulatory Actions AGENCY: Office of the Secretary, DHS. ACTION: Semiannual regulatory agenda. SUMMARY: This...

  18. 78 FR 11735 - Semiannual Regulatory Agenda; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... February 19, 2013 Part II Small Business Administration Semiannual Regulatory Agenda; Correction #0;#0... ADMINISTRATION 13 CFR Ch. I Semiannual Regulatory Agenda; Correction AGENCY: U.S. Small Business Administration (SBA). ACTION: Semiannual Regulatory Agenda; correction. SUMMARY: This document contains a...

  19. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended to...

  20. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 21 2013-07-01 2013-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended to...

  1. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 20 2014-07-01 2013-07-01 true Regulatory structure. 92.6 Section 92.6... Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended to control emissions from...

  2. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 21 2012-07-01 2012-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended to...

  3. On attractors in gene regulatory systems

    NASA Astrophysics Data System (ADS)

    Brokan, E.; Sadyrbaev, F. Zh.

    2017-02-01

    We describe attracting sets for differential systems appearing in mathematical models of gene regulatory systems. The relation of elements in such systems can be described by regulatory matrices containing elements -1, 0 or 1 corresponding to inhibition, no relation or activation respectively. Four types of regulatory matrices are considered. The respective examples are discussed and the attractive sets are described.

  4. Department of the Interior Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] Part X Department of the Interior Semiannual Regulatory Agenda ] DEPARTMENT OF THE INTERIOR (DOI) DEPARTMENT OF THE INTERIOR Office of the Secretary 25 CFR Ch. I 30 CFR Chs. II and VII 36 CFR Ch. I 43 CFR Subtitle A, Chs. I and II 48 CFR Ch. 14 50 CFR Chs. I...

  5. Federal Communications Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Part XVIII Federal Communications Commission Semiannual Regulatory Agenda ] FEDERAL COMMUNICATIONS COMMISSION (FCC) FEDERAL COMMUNICATIONS COMMISSION 47 CFR Ch. I Unified Agenda of Federal Regulatory and Deregulatory Actions AGENCY: Federal Communications Commission. ACTION: Semiannual regulatory agenda. SUMMARY: Twice a year, in spring and fall...

  6. 78 FR 44349 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... July 23, 2013 Part XXI Bureau of Consumer Financial Protection Semiannual Regulatory Agenda #0;#0... FINANCIAL PROTECTION 12 CFR Ch. X Semiannual Regulatory Agenda AGENCY: Bureau of Consumer Financial Protection. ACTION: Semiannual regulatory agenda. SUMMARY: The Bureau of Consumer Financial Protection (CFPB...

  7. Nutrient profiling for regulatory purposes.

    PubMed

    Rayner, Mike

    2017-08-01

    In this paper, I first provide definitions of nutrient profiling and of a nutrient profile model. I set out the purposes of nutrient profiling: both general and specific. I give two examples of nutrient profile models that have been developed for regulatory purposes by the Food Standards Agency (FSA) in the UK and the WHO for its European Region - the UK FSA/Ofcom and the WHO-Euro models - and compare the way the models are constructed and function, how they have been developed, the extent to which they have been tested and validated and their use in regulation. Finally I draw some conclusions about the future use of nutrient profiling for regulatory purposes. I argue that its full potential has yet to be realised and give some reasons why. I pose some urgent research questions with respect to nutrient profiling.

  8. Overview of Botanical Status in EU, USA, and Thailand

    PubMed Central

    Mahady, Gail B.

    2013-01-01

    The botanical status in EU, USA, and Thailand is different owing to the regulatory status, the progress of science, and the influence of culture and society. In the EU, botanicals are positioned as herbal medicinal products and food supplements, in the US they are regulated as dietary supplements but often used as traditional medicines, and in Thailand, they are regulated and used as traditional medicines. Information for some of the most popular botanicals from each country is included in this review. PMID:24228061

  9. Summation from a regulatory perspective

    PubMed Central

    Ohanian, Edward V.; Cotruvo, Joseph A.

    1986-01-01

    There is an urgent need to discuss the Office of Drinking Water's standard-setting or rulemaking process since most of the researchers whose papers are presented here directly or indirectly play a crucial role in this complex undertaking. Therefore, this paper will address the research data required to support policymaking and regulatory decisions pertaining to health effects of disinfectants and disinfection by-products. PMID:3816731

  10. Summation from a regulatory perspective

    SciTech Connect

    Ohanian, E.V.; Cotruvo, J.A.

    1986-11-01

    There is an urgent need to discuss the Office of Drinking Water's standard-setting or rule making process since most of the researchers whose papers are presented here directly or indirectly play a crucial role in this complex undertaking. Therefore, this paper will address the research data required to support policy making and regulatory decisions pertaining to health effects of disinfectants and disinfection by-products.

  11. Regulatory myeloid cells in transplantation.

    PubMed

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

    2014-02-27

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

  12. Why some groups just feel better: the regulatory fit of group power.

    PubMed

    Sassenberg, Kai; Jonas, Kai J; Shah, James Y; Brazy, Paige C

    2007-02-01

    The current research applied the regulatory fit hypothesis (E. T. Higgins, 2000) to the evaluation of groups, suggesting that individuals' group appraisal depends on how well the groups fit their regulatory needs. Specifically, it was predicted that higher power groups would fit and be more valued by those individuals with a promotion focus because these groups provide a better opportunity to sustain nurturance and achievement needs. Alternatively, lower power groups were predicted to fit and be more valued by those individuals with a prevention focus because these groups necessitate (and thus sustain) a focus on safety and security. Five studies found support for these predictions by both assessing and manipulating regulatory focus and group power and by using explicit and implicit measures of group attraction. Moreover, these regulatory fit effects occurred specifically for group power and not for general differences in group status.

  13. 76 FR 55443 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... hereby given that on August 22, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is...

  14. 75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-10

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the...

  15. 76 FR 45631 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing... replaces and supersedes the original rule filing. I. Self-Regulatory Organization's Statement of the Terms... Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the...

  16. 78 FR 36011 - Region VII Regulatory Fairness Board; Federal Regulatory Enforcement Fairness Hearing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... ADMINISTRATION Region VII Regulatory Fairness Board; Federal Regulatory Enforcement Fairness Hearing AGENCY: U.S... Business Regulatory Fairness Board. SUMMARY: The (SBA) Office of the National Ombudsman is issuing this notice to announce the location, date and time of the Regional Small Business Regulatory Fairness hearing...

  17. 75 FR 17793 - Public Federal Regulatory Enforcement Fairness Hearing; Region III Regulatory Fairness Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-07

    ... ADMINISTRATION Public Federal Regulatory Enforcement Fairness Hearing; Region III Regulatory Fairness Board.... Small Business Administration (SBA) Region III Regulatory Fairness Board and the SBA Office of the National Ombudsman will hold a National Regulatory Fairness Hearing on Tuesday, May 18, 2010, at 10 a.m...

  18. 78 FR 30384 - Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... ADMINISTRATION Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board AGENCY: U.S... Business Regulatory Fairness Board. SUMMARY: The (SBA) Office of the National Ombudsman is issuing this notice to announce the location, date and time of the Regional Small Business Regulatory Fairness hearing...

  19. 75 FR 18245 - Public Federal Regulatory Enforcement Fairness Hearing Region IX Regulatory Fairness Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... ADMINISTRATION Public Federal Regulatory Enforcement Fairness Hearing Region IX Regulatory Fairness Board.... Small Business Administration (SBA) Region IX Regulatory Fairness Board and the SBA Office of the National Ombudsman will hold a National Regulatory Fairness Hearing on Monday, April 26, 2010, at 1:30 p.m...

  20. 77 FR 12092 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...\\ notice is hereby given that February 9, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  1. 76 FR 77283 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-12

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... hereby given that on November 21, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA...\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the...

  2. 75 FR 39069 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on June 30, 2010, Financial Industry Regulatory.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  3. 76 FR 78706 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a... On October 20, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... advised that it would announce the implementation date of the proposed rule change in a Regulatory...

  4. 77 FR 58880 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...,\\2\\ notice is hereby given that on September 17, 2012, Financial Industry Regulatory Authority, Inc...\\ 15 U.S.C. 78s(b)(3)(A). \\4\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement...

  5. 75 FR 9459 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... hereby given that Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  6. 78 FR 24261 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 15, 2013, Financial Industry Regulatory...\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of...

  7. 75 FR 69503 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...\\ notice is hereby given that on October 29, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  8. 76 FR 50515 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 5, 2011, Financial Industry Regulatory...-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed...

  9. 76 FR 2739 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... is hereby given that on January 5, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is...

  10. 75 FR 28841 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on May 18, 2010, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  11. 76 FR 70195 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...,\\2\\ notice is hereby given that on October 28, 2011, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  12. 75 FR 58004 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... is hereby given that on September 7, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA... Securities Exchange, LLC, Financial Industry Regulatory Authority, Inc., The New York Stock Exchange,...

  13. 76 FR 9838 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-22

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... given that on February 4, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  14. 78 FR 10655 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...) February 8, 2013. I. Introduction On December 20, 2012, Financial Industry Regulatory Authority, Inc... Equity Securities.\\5\\ FINRA may impose a ``Foreign Regulatory Halt'' when a foreign securities...

  15. 77 FR 33537 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... is hereby given that on May 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  16. 77 FR 1524 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and... effective date of the proposed rule change in a Regulatory Notice to be published no later than 60...

  17. 76 FR 20065 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-11

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on March 30, 2011, Financial Industry Regulatory... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  18. 76 FR 72463 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ...-FINRA-2011-044] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... is hereby given that on November 8, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA...\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the...

  19. 78 FR 54359 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-03

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 20, 2103, Financial Industry Regulatory.... \\3\\ 15 U.S.C. 78s(b)(3)(A)(i). \\4\\ 17 CFR 240.19b-4(f)(1). ] I. Self-Regulatory...

  20. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving.... Introduction On August 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National... Regulatory Notice to be published no later than 90 days following this Commission approval. The...

  1. Regulatory requirements (CLIA '88, JCAHO, CAP) for decentralized testing.

    PubMed

    Ehrmeyer, S S; Laessig, R H

    1995-10-01

    All decentralized testing is regulated according to the Clinical Laboratory Improvement Amendments of 1988. Two organizations, the Joint Commission on Accreditation of Health Care Organizations and the College of American Pathologists, have received deemed status for their voluntary standards from the Health Care Financing Administration. Deemed status means that the organizations' voluntary standards meet or exceed the federal requirements. The decentralized testing sites can exercise several options in determining which organization, and hence which set of standards, will be used to regulate their testing processes. In this article, the authors outline the various regulatory requirements, provide insight into the relationship of each, and offer a framework for decentralized testing sites to follow to meet the requirements.

  2. Regulatory pathways for vaccines for developing countries.

    PubMed Central

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  3. Text-mining assisted regulatory annotation

    PubMed Central

    Aerts, Stein; Haeussler, Maximilian; van Vooren, Steven; Griffith, Obi L; Hulpiau, Paco; Jones, Steven JM; Montgomery, Stephen B; Bergman, Casey M

    2008-01-01

    Background Decoding transcriptional regulatory networks and the genomic cis-regulatory logic implemented in their control nodes is a fundamental challenge in genome biology. High-throughput computational and experimental analyses of regulatory networks and sequences rely heavily on positive control data from prior small-scale experiments, but the vast majority of previously discovered regulatory data remains locked in the biomedical literature. Results We develop text-mining strategies to identify relevant publications and extract sequence information to assist the regulatory annotation process. Using a vector space model to identify Medline abstracts from papers likely to have high cis-regulatory content, we demonstrate that document relevance ranking can assist the curation of transcriptional regulatory networks and estimate that, minimally, 30,000 papers harbor unannotated cis-regulatory data. In addition, we show that DNA sequences can be extracted from primary text with high cis-regulatory content and mapped to genome sequences as a means of identifying the location, organism and target gene information that is critical to the cis-regulatory annotation process. Conclusion Our results demonstrate that text-mining technologies can be successfully integrated with genome annotation systems, thereby increasing the availability of annotated cis-regulatory data needed to catalyze advances in the field of gene regulation. PMID:18271954

  4. Regulatory pathways for vaccines for developing countries.

    PubMed

    Milstien, Julie; Belgharbi, Lahouari

    2004-02-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world.

  5. 78 FR 44165 - Nuclear Regulatory Commission Enforcement Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Nuclear Regulatory Commission Enforcement Policy AGENCY: Nuclear Regulatory Commission. ACTION: Enforcement policy; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is...

  6. 75 FR 43207 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ..., Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE 7590-01-P ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice...

  7. 76 FR 14108 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ..., Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE 7590-01-P ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice...

  8. 76 FR 31382 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE 7590-01-P ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice...

  9. 75 FR 45166 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE 7590-01-P ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission....

  10. 75 FR 29785 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

    ... Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission....

  11. 76 FR 19817 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-08

    ... Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE 7590-01-P ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission....

  12. 75 FR 16525 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... Branch, Division of Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING... From the Federal Register Online via the Government Publishing Office NUCLEAR...

  13. 75 FR 36715 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ..., Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE 7590-01-P ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission....

  14. The core regulatory network in human cells.

    PubMed

    Kim, Man-Sun; Kim, Dongsan; Kang, Nam Sook; Kim, Jeong-Rae

    2017-03-04

    In order to discover the common characteristics of various cell types in the human body, many researches have been conducted to find the set of genes commonly expressed in various cell types and tissues. However, the functional characteristics of a cell is determined by the complex regulatory relationships among the genes rather than by expressed genes themselves. Therefore, it is more important to identify and analyze a core regulatory network where all regulatory relationship between genes are active across all cell types to uncover the common features of various cell types. Here, based on hundreds of tissue-specific gene regulatory networks constructed by recent genome-wide experimental data, we constructed the core regulatory network. Interestingly, we found that the core regulatory network is organized by simple cascade and has few complex regulations such as feedback or feed-forward loops. Moreover, we discovered that the regulatory links from genes in the core regulatory network to genes in the peripheral regulatory network are much more abundant than the reverse direction links. These results suggest that the core regulatory network locates at the top of regulatory network and plays a role as a 'hub' in terms of information flow, and the information that is common to all cells can be modified to achieve the tissue-specific characteristics through various types of feedback and feed-forward loops in the peripheral regulatory networks. We also found that the genes in the core regulatory network are evolutionary conserved, essential and non-disease, non-druggable genes compared to the peripheral genes. Overall, our study provides an insight into how all human cells share a common function and generate tissue-specific functional traits by transmitting and processing information through regulatory network.

  15. 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

  16. 10 CFR 74.13 - Material status reports.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Material status reports. 74.13 Section 74.13 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL... as specified in the instructions in NUREG/BR-0007 and NMMSS Report D-24 “Personal Computer Data Input...

  17. 10 CFR 72.76 - Material status reports.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Material status reports. 72.76 Section 72.76 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT... in NUREG/BR-0007 and NMMSS Report D-24 “Personal Computer Data Input for NRC Licensees.” Copies of...

  18. 10 CFR 5.530 - Marital or parental status.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Marital or parental status. 5.530 Section 5.530 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Discrimination on the Basis of Sex in Employment in...

  19. 10 CFR 5.530 - Marital or parental status.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Marital or parental status. 5.530 Section 5.530 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Discrimination on the Basis of Sex in Employment in...

  20. 10 CFR 5.530 - Marital or parental status.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Marital or parental status. 5.530 Section 5.530 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Discrimination on the Basis of Sex in Employment in...

  1. 10 CFR 5.530 - Marital or parental status.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Marital or parental status. 5.530 Section 5.530 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Discrimination on the Basis of Sex in Employment in...

  2. Defining Tobacco Regulatory Science Competencies.

    PubMed

    Wipfli, Heather L; Berman, Micah; Hanson, Kacey; Kelder, Steven; Solis, Amy; Villanti, Andrea C; Ribeiro, Carla M P; Meissner, Helen I; Anderson, Roger

    2017-02-01

    In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational programs. The purpose of this paper is to describe the Panel's work to develop core TRS domains and competencies. The Panel developed the list of domains and competencies using a semistructured Delphi method divided into four phases occurring between November 2013 and August 2015. The final proposed list included a total of 51 competencies across six core domains and 28 competencies across five specialized domains. There is a need for continued discussion to establish the utility of the proposed set of competencies for emerging TRS curricula and to identify the best strategies for incorporating these competencies into TRS training programs. Given the field's broad multidisciplinary nature, further experience is needed to refine the core domains that should be covered in TRS training programs versus knowledge obtained in more specialized programs. Regulatory science to inform the regulation of tobacco products is an emerging field. The paper provides an initial list of core and specialized domains and competencies to be used in developing curricula for new and emerging training programs aimed at preparing a new cohort of scientists to conduct critical TRS research. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  3. Human System Integration: Regulatory Analysis

    NASA Technical Reports Server (NTRS)

    2005-01-01

    This document was intended as an input to the Access 5 Policy Integrated Product team. Using a Human System Integration (HIS) perspective, a regulatory analyses of the FARS (specifically Part 91), the Airman s Information Manual (AIM) and the FAA Controllers Handbook (7110.65) was conducted as part of a front-end approach needed to derive HSI requirements for Unmanned Aircraft Systems (UAS) operations in the National Airspace System above FL430. The review of the above aviation reference materials yielded eighty-four functions determined to be necessary or highly desirable for flight within the Air Traffic Management System. They include categories for Flight, Communications, Navigation, Surveillance, and Hazard Avoidance.

  4. Decoding cis-regulatory systems in ascidians.

    PubMed

    Kusakabe, Takehiro

    2005-02-01

    Ascidians, or sea squirts, are lower chordates, and share basic gene repertoires and many characteristics, both developmental and physiological, with vertebrates. Therefore, decoding cis-regulatory systems in ascidians will contribute toward elucidating the genetic regulatory systems underlying the developmental and physiological processes of vertebrates. cis-Regulatory DNAs can also be used for tissue-specific genetic manipulation, a powerful tool for studying ascidian development and physiology. Because the ascidian genome is compact compared with vertebrate genomes, both intergenic regions and introns are relatively small in ascidians. Short upstream intergenic regions contain a complete set of cis-regulatory elements for spatially regulated expression of a majority of ascidian genes. These features of the ascidian genome are a great advantage in identifying cis-regulatory sequences and in analyzing their functions. Function of cis-regulatory DNAs has been analyzed for a number of tissue-specific and developmentally regulated genes of ascidians by introducing promoter-reporter fusion constructs into ascidian embryos. The availability of the whole genome sequences of the two Ciona species, Ciona intestinalis and Ciona savignyi, facilitates comparative genomics approaches to identify cis-regulatory DNAs. Recent studies demonstrate that computational methods can help identify cis-regulatory elements in the ascidian genome. This review presents a comprehensive list of ascidian genes whose cis-regulatory regions have been subjected to functional analysis, and highlights the recent advances in bioinformatics and comparative genomics approaches to cis-regulatory systems in ascidians.

  5. 10 CFR 150.17 - Submission to Commission of nuclear material status reports.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Submission to Commission of nuclear material status reports. 150.17 Section 150.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED... Authority in Agreement States § 150.17 Submission to Commission of nuclear material status reports. (a...

  6. 10 CFR 150.17 - Submission to Commission of nuclear material status reports.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Submission to Commission of nuclear material status reports. 150.17 Section 150.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED... Authority in Agreement States § 150.17 Submission to Commission of nuclear material status reports. (a...

  7. 10 CFR 150.17 - Submission to Commission of nuclear material status reports.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Submission to Commission of nuclear material status reports. 150.17 Section 150.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED... Authority in Agreement States § 150.17 Submission to Commission of nuclear material status reports. (a...

  8. 10 CFR 150.17 - Submission to Commission of nuclear material status reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Submission to Commission of nuclear material status reports. 150.17 Section 150.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED... Authority in Agreement States § 150.17 Submission to Commission of nuclear material status reports....

  9. 76 FR 65716 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket No..., the status of the above-captioned entities as Exempt Wholesale Generators became effective by...

  10. 78 FR 35622 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos. CPV... status of the above-captioned entities as Exempt Wholesale Generators Companies became effective by...

  11. 76 FR 13610 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Windstar Energy... 2011, the status of the above-captioned entities as Exempt Wholesale Generators became effective by...

  12. 76 FR 81926 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos... status of the above-captioned entities as Exempt Wholesale Generators became effective by operation of...

  13. 76 FR 2365 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status January 6, 2011..., the status of the above-captioned entities as Exempt Wholesale Generators became effective by...

  14. 78 FR 69847 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Buffalo Dunes... status of the above-captioned entities as Exempt Wholesale Generators became effective by operation of...

  15. T regulatory cells in xenotransplantation.

    PubMed

    Muller, Yannick D; Golshayan, Déla; Ehirchiou, Driss; Wekerle, Thomas; Seebach, Jörg D; Bühler, Leo H

    2009-01-01

    The role of T regulatory cells (Treg) in the induction and maintenance of allograft tolerance is being studied to a great extent. In contrast, little is known on their potential to prevent graft rejection in the field of xenotransplantation, where acute vascular rejection mediated by cellular and humoral mechanisms and thrombotic microangiopathy still prevents long-term graft survival. In this regard, the induction of donor-specific tolerance through isolation and expansion of xenoantigen-specific recipient Treg is currently becoming a focus of interest. This review will summarize the present knowledge concerning Treg and their potential use in xenotransplantation describing in particular CD4(+)CD25(+)Foxp3(+) T cells, CD8(+)CD28(-) Treg, double negative CD4(-)CD8(-) T cells, and natural killer Treg. Although only studied in vitro so far, human CD4(+)CD25(+)Foxp3(+) Treg is currently the best characterized subpopulation of regulatory cells in xenotransplantation. CD8(+)CD28(-) Treg and double negative CD4(-)CD8(-) Treg also seem to be implicated in tolerance maintenance of xenografts. Finally, one study revealing a role for natural killer CD4(+)Valpha14(+) Treg in the prolongation of xenograft survival needs further confirmation. To our opinion, CD4(+)CD25(+)Foxp3(+) Treg are a promising candidate to protect xenografts. In contrast to cadaveric allotransplantation, the donor is known prior to xenotransplantation. This advantage allows the expansion of recipient Treg in a xenoantigen specific manner before transplantation.

  16. Global Summit on Regulatory Science 2013.

    PubMed

    Howard, Paul C; Tong, Weida; Weichold, Frank; Healy, Marion; Slikker, William

    2014-12-01

    Regulatory science has been defined as the science that is used to develop regulatory decisions by government bodies. Regulatory science encompasses many scientific disciplines that oversee many studies producing a wide array of data. These may include fundamental research into the cellular interaction or response to a particular chemical or substance, hazard-assessment and dose-response studies in animal species, neurophysiological or neurobehavioral studies, best practices for the generation and analysis of genomics data, bioinformatics approaches, and mathematical modeling of risk. The Global Summit on Regulatory Science is an international conference with a mission to explore emerging and innovative technologies, and provide a platform to enhance translation of basic science into regulatory applications. The Third Global Summit on Regulatory Science which focused on nanotechnology is discussed.

  17. Sharing regulatory data as tools for strengthening health systems in the Region of the Americas.

    PubMed

    Sousa, Varley Dias; Ramalho, Pedro I; Silveira, Dâmaris

    2016-05-01

    Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs) and Regional Reference Authorities (RRAs). This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report) as tools for strengthening health systems. Based on a narrative (nonsystematic) review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data) and data- and work-sharing (inter-agency data). The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1) the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics) and 2) the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

  18. Environmental Regulatory Update Table, November 1991

    SciTech Connect

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-12-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  19. Environmental Regulatory Update Table, December 1991

    SciTech Connect

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1992-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  20. Environmental Regulatory Update Table, October 1991

    SciTech Connect

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  1. Environmental Regulatory Update Table, September 1991

    SciTech Connect

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-10-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  2. Environmental Regulatory Update Table, August 1990

    SciTech Connect

    Houlberg, L.M.; Nikbakht, A.; Salk, M.S.

    1990-09-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  3. Environmental Regulatory Update Table, September 1990

    SciTech Connect

    Houlberg, L.M.; Nikbakht, A.; Salk, M.S.

    1990-10-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  4. Environmental regulatory update table, March 1989

    SciTech Connect

    Houlberg, L.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

    1989-04-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  5. Environmental regulatory update table, July 1991

    SciTech Connect

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-08-01

    This Environmental Regulatory Update Table (July 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  6. Environmental Regulatory Update Table, January 1991

    SciTech Connect

    Hawkins, G.T.; Houlberg, L.M.; Salk, M.S.

    1991-02-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  7. Environmental Regulatory Update Table, October 1990

    SciTech Connect

    Houlberg, L.M.; Noghrei-Nikbakht, P.A.; Salk, M.S.

    1990-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  8. Environmental Regulatory Update Table, August 1991

    SciTech Connect

    Houlberg, L.M., Hawkins, G.T.; Salk, M.S.

    1991-09-01

    This Environmental Regulatory Update Table (August 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  9. Environmental Regulatory Update Table, December 1989

    SciTech Connect

    Houlbert, L.M.; Langston, M.E. ); Nikbakht, A.; Salk, M.S. )

    1990-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  10. Environmental Regulatory Update Table, April 1989

    SciTech Connect

    Houlberg, L.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

    1989-05-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  11. Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina

    PubMed Central

    Whelan, Agustina I; Lema, Martin A

    2015-01-01

    ABSTRACT. “New Breeding Techniques” (NBTs) are a group of recent innovations in plant breeding using molecular biology tools. It is becoming evident that NBTs can introduce advantageous traits for agriculture that could be commercially available very soon However, there is still a need of clarifying its regulatory status, particularly in regards to worldwide regulations on Genetically Modified Organisms (GMOs). This article reviews the meaning of the NBTs concept, performs an overall regulatory analysis of these technologies and reports the first regulation in the world that is applied to these technologies, which was issued by the Argentine Government. PMID:26552666

  12. Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina.

    PubMed

    Whelan, Agustina I; Lema, Martin A

    2015-01-01

    "New Breeding Techniques" (NBTs) are a group of recent innovations in plant breeding using molecular biology tools. It is becoming evident that NBTs can introduce advantageous traits for agriculture that could be commercially available very soon However, there is still a need of clarifying its regulatory status, particularly in regards to worldwide regulations on Genetically Modified Organisms (GMOs). This article reviews the meaning of the NBTs concept, performs an overall regulatory analysis of these technologies and reports the first regulation in the world that is applied to these technologies, which was issued by the Argentine Government.

  13. Risk, resource, and regulatory issues: Remediation of chlorinated and recalcitrant compounds

    SciTech Connect

    1998-12-31

    Sites contaminated with chlorinated solvents and other recalcitrant compounds present formidable challenges in terms of risk assessment, resource allocation, and regulatory compliance. This book presents a broad overview of these issues and case studies documenting successful risk-based site remediation strategies. Included in this volume are chapters on pathways analysis and modeling for risk assessment, human health and ecological risk assessment approaches, risk assessment in a RBCA context, resource allocation and cost considerations, regulatory issues, stakeholder involvement and technology acceptance, status and trends in technical impracticability, geostatistics and data quality objectives, and innovative site-monitoring approaches.

  14. A genomic regulatory network for development

    NASA Technical Reports Server (NTRS)

    Davidson, Eric H.; Rast, Jonathan P.; Oliveri, Paola; Ransick, Andrew; Calestani, Cristina; Yuh, Chiou-Hwa; Minokawa, Takuya; Amore, Gabriele; Hinman, Veronica; Arenas-Mena, Cesar; Otim, Ochan; Brown, C. Titus; Livi, Carolina B.; Lee, Pei Yun; Revilla, Roger; Rust, Alistair G.; Pan, Zheng jun; Schilstra, Maria J.; Clarke, Peter J C.; Arnone, Maria I.; Rowen, Lee; Cameron, R. Andrew; McClay, David R.; Hood, Leroy; Bolouri, Hamid

    2002-01-01

    Development of the body plan is controlled by large networks of regulatory genes. A gene regulatory network that controls the specification of endoderm and mesoderm in the sea urchin embryo is summarized here. The network was derived from large-scale perturbation analyses, in combination with computational methodologies, genomic data, cis-regulatory analysis, and molecular embryology. The network contains over 40 genes at present, and each node can be directly verified at the DNA sequence level by cis-regulatory analysis. Its architecture reveals specific and general aspects of development, such as how given cells generate their ordained fates in the embryo and why the process moves inexorably forward in developmental time.

  15. Regulatory Information by Topic: Emergency Management

    EPA Pesticide Factsheets

    Regulatory information about emergencies, including chemical accident prevention, risk management plans (RMPs), chemical reporting, community right to know, and oil spills and hazardous substances releases.

  16. 21 CFR 26.18 - Regulatory collaboration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory...

  17. A genomic regulatory network for development

    NASA Technical Reports Server (NTRS)

    Davidson, Eric H.; Rast, Jonathan P.; Oliveri, Paola; Ransick, Andrew; Calestani, Cristina; Yuh, Chiou-Hwa; Minokawa, Takuya; Amore, Gabriele; Hinman, Veronica; Arenas-Mena, Cesar; hide

    2002-01-01

    Development of the body plan is controlled by large networks of regulatory genes. A gene regulatory network that controls the specification of endoderm and mesoderm in the sea urchin embryo is summarized here. The network was derived from large-scale perturbation analyses, in combination with computational methodologies, genomic data, cis-regulatory analysis, and molecular embryology. The network contains over 40 genes at present, and each node can be directly verified at the DNA sequence level by cis-regulatory analysis. Its architecture reveals specific and general aspects of development, such as how given cells generate their ordained fates in the embryo and why the process moves inexorably forward in developmental time.

  18. 21 CFR 26.18 - Regulatory collaboration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory collaboration...

  19. 21 CFR 26.18 - Regulatory collaboration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory collaboration...

  20. 21 CFR 26.18 - Regulatory collaboration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory collaboration...

  1. 21 CFR 26.18 - Regulatory collaboration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory collaboration...

  2. Immunometabolism of regulatory T cells

    PubMed Central

    Newton, Ryan; Priyadharshini, Bhavana; Turka, Laurence A

    2016-01-01

    The bidirectional interaction between the immune system and whole-body metabolism has been well recognized for many years. Via effects on adipocytes and hepatocytes, immune cells can modulate whole-body metabolism (in metabolic syndromes such as type 2 diabetes and obesity) and, reciprocally, host nutrition and commensal-microbiota-derived metabolites modulate immunological homeostasis. Studies demonstrating the metabolic similarities of proliferating immune cells and cancer cells have helped give birth to the new field of immunometabolism, which focuses on how the cell-intrinsic metabolic properties of lymphocytes and macrophages can themselves dictate the fate and function of the cells and eventually shape an immune response. We focus on this aspect here, particularly as it relates to regulatory T cells. PMID:27196520

  3. Regulatory Analysis of Reactivity Transients

    SciTech Connect

    Beyer, Carl E.; Clifford, Paul M.; Geelhood, Kenneth J.; Voglewede, John C.

    2009-08-01

    This paper will describe modifications made to the FRAPCON-3 and FRAPTRAN fuel performance codes and models that impact reactivity initiated accident (RIA) analyses. The modified models include an upper bound empirical and best estimate release models for fast transients, and a revised fuel failure model that accounts for ductile and brittle failure. Because experimental data exists for discrete test conditions, the codes and models are used to interpolate and to some extent, to extrapolate these test conditions. An upper bound empirical model for release is used to establish new recommended release fractions for long-lived and short lived (radioactive) isotopes for RIA events in Regulatory Guide 1.183. A best estimate release model is used in FRAPTRAN 1.4 based on grain boundary gas concentrations from FRAPCON-3.4 to predict release for RIA events. Code and model predictions will be compared to failure and release data from RIA tests to demonstrate accuracy.

  4. Small regulatory RNAs in Archaea.

    PubMed

    Babski, Julia; Maier, Lisa-Katharina; Heyer, Ruth; Jaschinski, Katharina; Prasse, Daniela; Jäger, Dominik; Randau, Lennart; Schmitz, Ruth A; Marchfelder, Anita; Soppa, Jörg

    2014-01-01

    Small regulatory RNAs (sRNAs) are universally distributed in all three domains of life, Archaea, Bacteria, and Eukaryotes. In bacteria, sRNAs typically function by binding near the translation start site of their target mRNAs and thereby inhibit or activate translation. In eukaryotes, miRNAs and siRNAs typically bind to the 3'-untranslated region (3'-UTR) of their target mRNAs and influence translation efficiency and/or mRNA stability. In archaea, sRNAs have been identified in all species investigated using bioinformatic approaches, RNomics, and RNA-Seq. Their size can vary significantly between less than 50 to more than 500 nucleotides. Differential expression of sRNA genes has been studied using northern blot analysis, microarrays, and RNA-Seq. In addition, biological functions have been unraveled by genetic approaches, i.e., by characterization of designed mutants. As in bacteria, it was revealed that archaeal sRNAs are involved in many biological processes, including metabolic regulation, adaptation to extreme conditions, stress responses, and even in regulation of morphology and cellular behavior. Recently, the first target mRNAs were identified in archaea, including one sRNA that binds to the 5'-region of two mRNAs in Methanosarcina mazei Gö1 and a few sRNAs that bind to 3'-UTRs in Sulfolobus solfataricus, three Pyrobaculum species, and Haloferax volcanii, indicating that archaeal sRNAs appear to be able to target both the 5'-UTR or the 3'-UTRs of their respective target mRNAs. In addition, archaea contain tRNA-derived fragments (tRFs), and one tRF has been identified as a major ribosome-binding sRNA in H. volcanii, which downregulates translation in response to stress. Besides regulatory sRNAs, archaea contain further classes of sRNAs, e.g., CRISPR RNAs (crRNAs) and snoRNAs.

  5. Adipocytes as immune regulatory cells

    PubMed Central

    Vielma, Silvana A.; Klein, Richard L.; Levingston, Corinne A.; Young, M. Rita I.

    2013-01-01

    Obesity is a chronic inflammatory state and adipocytes are capable of contributing to this inflammation by their production of inflammatory mediators. The present study used fibroblast-derived adipocytes and normal spleen cells as a model to determine if adipocytes can also serve as immune regulatory cells by modulating the functions of conventional immune cells. Media conditioned by the adipocytes stimulated release of the Th1-type cytokines IL-2, IFN-γ and GM-CSF from cultures of normal spleen cells. The adipocytes also stimulated spleen cell release of inhibitory cytokines, although to varying degrees. This included IL-10, IL-13 and, to a lesser extent, IL-4. Spleen cell production of the inflammatory cytokines IL-6, TNF-α and IL-9 was stimulated by adipocytes, although production of the Th17-derived cytokine, IL-17, was not stimulated. The adipocyte-conditioned medium did not stimulate production of predominantly monocytes-derived chemokines CXCL9, CCL2, CCL3, CCL4, but stimulated production of the predominantly T-cell-derived chemokine CCL5. In all cases where cytokine/chemokine production from spleen cells was stimulated by adipocytes, it was to a far greater level than was produced by the adipocytes themselves. Studies initiated to determine the identity of the adipocyte-derived mediators showed that the spleen cell modulation could not be attributed to solely adiponectin or leptin. Studies to determine the source of some of the cytokines whose production was stimulated by adipocytes showed that expression of the inflammatory cytokine IL-6 was not increased in either CD4+ or CD8+ T-cell. When the splenic T-cells were examined for IFN-γ, the adipocyte stimulation of IFN-γ was within CD8+ T-cells, not CD4+ T-cells. These studies show that adipocytes may be able to serve as immune regulatory cells to stimulate conventional immune cells to release a spectrum of immune mediators. PMID:23587489

  6. Iron regulatory proteins in pathobiology.

    PubMed Central

    Cairo, G; Pietrangelo, A

    2000-01-01

    The capacity of readily exchanging electrons makes iron not only essential for fundamental cell functions, but also a potential catalyst for chemical reactions involving free-radical formation and subsequent oxidative stress and cell damage. Cellular iron levels are therefore carefully regulated in order to maintain an adequate substrate while also minimizing the pool of potentially toxic 'free iron'. Iron homoeostasis is controlled through several genes, an increasing number of which have been found to contain non-coding sequences [i.e. the iron-responsive elements (IREs)] which are recognized at the mRNA level by two cytoplasmic iron-regulatory proteins (IRP-1 and IRP-2). The IRPs belong to the aconitase superfamily. By means of an Fe-S-cluster-dependent switch, IRP-1 can function as an mRNA-binding protein or as an enzyme that converts citrate into isocitrate. Although structurally and functionally similar to IRP-1, IRP-2 does not seem to assemble a cluster nor to possess aconitase activity; moreover, it has a distinct pattern of tissue expression and is modulated by means of proteasome-mediated degradation. In response to fluctuations in the level of the 'labile iron pool', IRPs act as key regulators of cellular iron homoeostasis as a result of the translational control of the expression of a number of iron metabolism-related genes. Conversely, various agents and conditions may affect IRP activity, thereby modulating iron and oxygen radical levels in different pathobiological settings. As the number of mRNAs regulated through IRE-IRP interactions keeps growing, the definition of IRPs as iron-regulatory proteins may in the near future become limiting as their role expands to other essential metabolic pathways. PMID:11085915

  7. Regulatory fit messages and physical activity motivation.

    PubMed

    Pfeffer, Ines

    2013-04-01

    Targeted communication about health behaviors seems to be more effective than mass communication in which undifferentiated audiences receive identical messages. Regulatory focus is psychological variable that can be used to build two target groups: promotion-focused or prevention-focused people. It is hypothesized that targeting messages to an individual's regulatory focus creates regulatory fit and is more successful to promote a physically active lifestyle than nonfit messages. Two different print messages promoting a physically active lifestyle derived from regulatory focus theory (promotion message vs. prevention message) were randomly assigned to N = 98 participants after measuring their regulatory focus. It was examined whether regulatory fit between the regulatory focus and the assigned print message would lead to more positive evaluations in the dependent variables inclination toward the message (preference for the message), intention to perform the behavior, prospective and retrospective feelings associated with the behavior (positive and negative), and perceived value of the behavior directly after reading the message. Hierarchical linear regression analyses revealed that regulatory fit led to stronger intentions in the prevention-message condition and more prospective positive and retrospective positive feelings associated with the behavior in the promotion-message condition in contrast to the nonfit conditions. Prospective positive feelings associated with the behavior mediated the effect of regulatory fit on intention. The results partly provided support for the regulatory fit concept. Matching print messages to the regulatory focus of individuals seems to be a useful approach to enhance physical activity motivation. Future studies should include an objective measure of physical activity behavior.

  8. 75 FR 32519 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... Rule 4210. In addition, FINRA proposes to re-structure the rule to improve its organization and make it... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of.... Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is...

  9. 75 FR 53362 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers... (June 30, 2009), 74 FR 32668 (July 8, 2009). \\2\\ See letter from Dale E. Brown, CAE, Financial...

  10. 75 FR 52574 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Reinstitute Short Exempt Marking for Trade Reporting and OATS August 20, 2010...,\\2\\ notice is hereby given that on August 6, 2010, Financial Industry Regulatory Authority,...

  11. 75 FR 11605 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and.../Nasdaq Trade Reporting Facility and OTC Reporting Facility Fees March 4, 2010. Pursuant to Section 19(b... hereby given that on March 1, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed...

  12. 76 FR 27707 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-12

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Amend FINRA Rule 6121 (Trading Halts Due to Extraordinary Market Volatility) and... hereby given that on May 4, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed...

  13. 75 FR 53998 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Security Futures Risk Disclosure Statement... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 16, 2010, Financial Industry Regulatory...

  14. 77 FR 4065 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-26

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule to secondary transactions of private placements). The ABA stated that the concept of a ``non... reasons for so finding or if the self- regulatory organization consents to the extension. The Commission...

  15. 76 FR 26333 - National Federal Regulatory Enforcement Fairness Hearing Region III Regulatory Fairness Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... ADMINISTRATION National Federal Regulatory Enforcement Fairness Hearing Region III Regulatory Fairness Board... III) Small Business Regulatory Fairness Board. SUMMARY: The SBA, Office of the National Ombudsman is... Fairness Hearing. This hearing is open to the public. DATES: The hearing will be held on Tuesday, May 24...

  16. 77 FR 44298 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... rule change from interested persons. I. Self-Regulatory Organization's Statement of the Terms of... Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the... statements. A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for,...

  17. 75 FR 59300 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on September 17, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``Commission'')...

  18. 75 FR 27606 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-17

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 27, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers,...

  19. 77 FR 4599 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on January 10, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  20. 77 FR 7218 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on January 30, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  1. 76 FR 77034 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-09

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...''),\\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on December 2, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange...

  2. 75 FR 39610 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Financial Industry Regulatory Authority, Inc...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on June 24, 2010, Financial...

  3. 76 FR 68240 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

    ...-2011-062] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on October 20, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  4. 76 FR 11542 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... 24, 2011. I. Introduction On November 10, 2010, the Financial Industry Regulatory Authority, Inc... fidelity bond will be a great financial burden for small firms.\\16\\ The third commenter agrees with...

  5. 77 FR 5610 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on January 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``Commission'')...

  6. 75 FR 55842 - Self-Regulatory Organizations; Financial Industry Regulatory Authority; Order Granting Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority; Order Granting Approval of a Proposed Rule Change To Adopt FINRA Rule 11000 Series (Uniform Practice Code) in the Consolidated FINRA Rulebook September 3, 2010. I. Introduction On June 14, 2010, Financial Industry Regulatory...

  7. 76 FR 20744 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Require Public Disclosure of... which the self-regulatory organization consents, the Commission shall either approve the proposed rule...

  8. 76 FR 60567 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Reporting Rules for Certain Alternative Trading Systems September 23, 2011. Pursuant to Section 19(b)(1) of... that on September 16, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with...

  9. NPDES Permit Status Reports

    EPA Pesticide Factsheets

    These reports show the backlog status nationwide, based on EPA databases and input from EPA regions and states. The reports show a snapshot in time, keep in mind that the status of facilities and the universe of permits change.

  10. Status of Women Microbiologists

    ERIC Educational Resources Information Center

    Kashket, Eva Ruth; And Others

    1974-01-01

    Presents evidence that the status of women microbiologists is lower than that of men and that the lower status of women results, to a large degree, from inequality of opportunity throughout their careers. (Author/JR)

  11. Status of Women Microbiologists

    ERIC Educational Resources Information Center

    Kashket, Eva Ruth; And Others

    1974-01-01

    Presents evidence that the status of women microbiologists is lower than that of men and that the lower status of women results, to a large degree, from inequality of opportunity throughout their careers. (Author/JR)

  12. Factors in Performance on Brief, Impromptu Essay Examinations. College Board Report No. 95-4.

    ERIC Educational Resources Information Center

    Breland, Hunter M.; And Others

    Brief, impromptu essays written for the 1990 administration of the College Board's English Composition Test (ECT) were randomly sampled for four groups of examinees. These essays were subjected to further holistic ratings beyond those conducted for the ECT, and analytical ratings were also obtained. The holistic scores were correlated with the…

  13. CD25+CD4+ Regulatory T Cells from the Peripheral Blood of Asymptomatic HIV-infected Individuals Regulate CD4+ and CD8+ HIV-specific T Cell Immune Responses In Vitro and Are Associated with Favorable Clinical Markers of Disease Status

    PubMed Central

    Kinter, Audrey L.; Hennessey, Margaret; Bell, Alicia; Kern, Sarah; Lin, Yin; Daucher, Marybeth; Planta, Maria; McGlaughlin, Mary; Jackson, Robert; Ziegler, Steven F.; Fauci, Anthony S.

    2004-01-01

    Human immunodeficiency virus (HIV) disease is associated with loss of CD4+ T cells, chronic immune activation, and progressive immune dysfunction. HIV-specific responses, particularly those of CD4+ T cells, become impaired early after infection, before the loss of responses directed against other antigens; the basis for this diminution has not been elucidated fully. The potential role of CD25+CD4+ regulatory T cells (T reg cells), previously shown to inhibit immune responses directed against numerous pathogens, as suppressors of HIV-specific T cell responses was investigated. In the majority of healthy HIV-infected individuals, CD25+CD4+ T cells significantly suppressed cellular proliferation and cytokine production by CD4+ and CD8+ T cells in response to HIV antigens/peptides in vitro; these effects were cell contact dependent and IL-10 and TGF-β independent. Individuals with strong HIV-specific CD25+ T reg cell function in vitro had significantly lower levels of plasma viremia and higher CD4+: CD8+ T cell ratios than did those individuals in whom this activity could not be detected. These in vitro data suggest that CD25+CD4+ T reg cells may contribute to the diminution of HIV-specific T cell immune responses in vivo in the early stages of HIV disease. PMID:15280419

  14. 77 FR 8144 - Texas Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ...; TX-063-FOR; Docket No. OSM-2011- 0007] Texas Regulatory Program AGENCY: Office of Surface Mining... Surface Mining Reclamation and Enforcement (OSM), are approving three amendments to the Texas regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas at its own...

  15. 76 FR 50708 - Texas Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ...; TX-063-FOR; Docket ID: OSM-2011- 0007] Texas Regulatory Program AGENCY: Office of Surface Mining... receipt of three proposed amendments to the Texas regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas at its own initiative submitted three separate amendments to...

  16. 78 FR 11579 - Texas Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 Texas Regulatory Program AGENCY... the Texas regulatory program (Texas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas proposed revisions to its regulations regarding: definitions...

  17. 77 FR 25949 - Texas Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... Enforcement 30 CFR Part 943 [SATS No. TX-060-FOR; Docket ID: OSM-2012-0007] Texas Regulatory Program AGENCY... Mining Reclamation and Enforcement (OSM), are announcing receipt of a proposed amendment to the Texas regulatory program (Texas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the...

  18. 77 FR 58025 - Texas Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-19

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 Texas Regulatory Program AGENCY... the Texas regulatory program (Texas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas proposed revisions to its regulations regarding annual permit fees...

  19. 75 FR 81122 - Texas Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 Texas Regulatory Program AGENCY... the Texas regulatory program (Texas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas proposed revisions to its regulations regarding annual permit fees...

  20. 77 FR 4461 - New Mexico Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 931 New Mexico Regulatory Program AGENCY.... SUMMARY: We are 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...

  1. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of...

  2. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains...

  3. 5 CFR 838.102 - Regulatory structure.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Regulatory structure. 838.102 Section 838... (CONTINUED) COURT ORDERS AFFECTING RETIREMENT BENEFITS Court Orders Generally Organization and Structure of Regulations on Court Orders § 838.102 Regulatory structure. (a) This part is organized as follows: (1)...

  4. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part...

  5. Reconstructing the Prostate Cancer Transcriptional Regulatory Network

    DTIC Science & Technology

    2010-09-01

    TITLE: Reconstructing the prostate cancer transcriptional regulatory network PRINCIPAL INVESTIGATOR: Keyan Salari...2009 – 30 Sep 2010 5a. CONTRACT NUMBER W81XWH-09-1-0414 4. TITLE AND SUBTITLE Reconstructing the prostate cancer transcriptional regulatory...to novel diagnostic, prognostic, and therapeutic strategies in the future. The overall objective of this study was to reconstruct the prostate

  6. 77 FR 40793 - West Virginia Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-11

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 948 West Virginia Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement (OSM), Interior. ACTION: Interim final rule... Virginia regulatory program (the West Virginia program) under the Surface Mining Control and...

  7. 78 FR 10512 - Wyoming Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950 Wyoming Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment... regulatory program (the ``Wyoming program'') under the Surface Mining Control and Reclamation Act of...

  8. Department of Transportation Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... [Department of Transportation Semiannual Regulatory Agenda ] Part XII Department of Transportation Semiannual Regulatory Agenda ] DEPARTMENT OF TRANSPORTATION (DOT) DEPARTMENT OF TRANSPORTATION Office of the Secretary 14 CFR Chs. I-III 23 CFR Chs. I-III 33 CFR Chs. I and IV 46 CFR Chs. I-III 48 CFR Ch. 12 49 CFR Subtitle A, Chs. I-VI and Chs....

  9. 77 FR 46346 - Ohio Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-03

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 Ohio Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement (OSM), Interior. ACTION: Proposed rule; public... amendment to the Ohio regulatory program under the Surface Mining Control and Reclamation Act of 1977...

  10. Meditation and Its Regulatory Role on Sleep

    PubMed Central

    Nagendra, Ravindra P.; Maruthai, Nirmala; Kutty, Bindu M.

    2012-01-01

    Intense meditation practices help to achieve a harmony between body and mind. Meditation practices influence brain functions, induce various intrinsic neural plasticity events, modulate autonomic, metabolic, endocrine, and immune functions and thus mediate global regulatory changes in various behavioral states including sleep. This brief review focuses on the effect of meditation as a self regulatory phenomenon on sleep. PMID:22529834

  11. The Effectiveness of Regulatory Disclosure Policies

    ERIC Educational Resources Information Center

    Weil, David; Fung, Archon; Graham, Mary; Fagotto, Elena

    2006-01-01

    Regulatory transparency--mandatory disclosure of information by private or public institutions with a regulatory intent--has become an important frontier of government innovation. This paper assesses the effectiveness of such transparency systems by examining the design and impact of financial disclosure, nutritional labeling, workplace hazard…

  12. Weight of evidence: regulatory toxicology in Canada

    SciTech Connect

    Somers, E.

    1986-12-01

    The legislative application of regulatory toxicology in Canada is reviewed, together with the sources of experimental evidence used for action. Examples are given of the critical toxicological information that led to a regulatory decision. Risk numbers have only been used to a limited extent in Canada. Some possibilities for future research are offered.

  13. The Effectiveness of Regulatory Disclosure Policies

    ERIC Educational Resources Information Center

    Weil, David; Fung, Archon; Graham, Mary; Fagotto, Elena

    2006-01-01

    Regulatory transparency--mandatory disclosure of information by private or public institutions with a regulatory intent--has become an important frontier of government innovation. This paper assesses the effectiveness of such transparency systems by examining the design and impact of financial disclosure, nutritional labeling, workplace hazard…

  14. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 2 2012-01-01 2012-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains general...

  15. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 2 2014-01-01 2014-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part contains...

  16. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 2 2013-01-01 2013-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains general...

  17. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 2 2014-01-01 2014-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains general...

  18. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part contains...

  19. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 2 2013-01-01 2013-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part contains...

  20. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains general...

  1. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 2 2012-01-01 2012-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part contains...

  2. 12 CFR 1010.14 - Regulatory exemptions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 8 2012-01-01 2012-01-01 false Regulatory exemptions. 1010.14 Section 1010.14 Banks and Banking BUREAU OF CONSUMER FINANCIAL PROTECTION LAND REGISTRATION (REGULATION J) General Requirements § 1010.14 Regulatory exemptions. (a) Eligibility requirements. The following transactions are...

  3. 12 CFR 1010.14 - Regulatory exemptions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 8 2014-01-01 2014-01-01 false Regulatory exemptions. 1010.14 Section 1010.14 Banks and Banking BUREAU OF CONSUMER FINANCIAL PROTECTION LAND REGISTRATION (REGULATION J) General Requirements § 1010.14 Regulatory exemptions. (a) Eligibility requirements. The following transactions are...

  4. 12 CFR 233.7 - Regulatory enforcement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Regulatory enforcement. 233.7 Section 233.7 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING (REGULATION GG) § 233.7 Regulatory enforcement....

  5. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of the...

  6. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of the...

  7. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of the...

  8. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of the...

  9. 12 CFR 233.7 - Regulatory enforcement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Regulatory enforcement. 233.7 Section 233.7 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING (REGULATION GG) § 233.7 Regulatory enforcement....

  10. 31 CFR 132.7 - Regulatory enforcement.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Regulatory enforcement. 132.7 Section 132.7 Money and Finance: Treasury Regulations Relating to Money and Finance PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING § 132.7 Regulatory enforcement. The requirements under this part are subject...

  11. Regulatory Reform: Low Risk, High Promise.

    ERIC Educational Resources Information Center

    Tanenbaum, Morris

    The press of telecommunication technologies and their progeny have undermined the natural monopoly basis for long distance telecommunications and customer premise products, forced open regulatory doors, toppled barriers to market entry, and led to the reshaping of regulatory philosophy as regulators have seen new, wider horizons for the industry.…

  12. Regulatory genes in the ancestral chordate genomes.

    PubMed

    Satou, Yutaka; Wada, Shuichi; Sasakura, Yasunori; Satoh, Nori

    2008-12-01

    Changes or innovations in gene regulatory networks for the developmental program in the ancestral chordate genome appear to be a major component in the evolutionary process in which tadpole-type larvae, a unique characteristic of chordates, arose. These alterations may include new genetic interactions as well as the acquisition of new regulatory genes. Previous analyses of the Ciona genome revealed that many genes may have emerged after the divergence of the tunicate and vertebrate lineages. In this paper, we examined this possibility by examining a second non-vertebrate chordate genome. We conclude from this analysis that the ancient chordate included almost the same repertory of regulatory genes, but less redundancy than extant vertebrates, and that approximately 10% of vertebrate regulatory genes were innovated after the emergence of vertebrates. Thus, refined regulatory networks arose during vertebrate evolution mainly as preexisting regulatory genes multiplied rather than by generating new regulatory genes. The inferred regulatory gene sets of the ancestral chordate would be an important foundation for understanding how tadpole-type larvae, a unique characteristic of chordates, evolved.

  13. 49 CFR 355.21 - Regulatory review.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Regulatory review. 355.21 Section 355.21... AND REGULATIONS AFFECTING INTERSTATE MOTOR CARRIER OPERATIONS Requirements § 355.21 Regulatory review... review are provided in the appendix to this part. (b) Responsibility. The State agency designated as lead...

  14. Genomics in the land of regulatory science.

    PubMed

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

    2015-06-01

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

  15. 75 FR 18048 - Oklahoma Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 936 Oklahoma Regulatory Program AGENCY... the Oklahoma regulatory program (Oklahoma program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The Oklahoma Department of Mines (ODM, Oklahoma, or department) made...

  16. 77 FR 8020 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... February 13, 2012 Part XIX Small Business Administration Semiannual Regulatory Agenda #0;#0;Federal Register / Vol. 77 , No. 29 / Monday, February 13, 2012 / Unified Agenda#0;#0; ] SMALL BUSINESS ADMINISTRATION 13 CFR Ch. I Semiannual Regulatory Agenda AGENCY: U.S. Small Business Administration (SBA). ACTION...

  17. The relative merits of cord blood as a cell source for autologous T regulatory cell therapy in type 1 diabetes.

    PubMed

    Theil, A; Wilhelm, C; Guhr, E; Reinhardt, J; Bonifacio, E

    2015-01-01

    Cord blood has been used as a cell source for therapeutic purposes in children with type 1 diabetes and other disorders. Here, we explore the benefits of cord blood as an autologous source of T regulatory cells for immune cell therapy in patients. CD4(+)CD25(+) T regulatory cells were isolated from cord blood and adult peripheral blood of healthy donors and compared during and after expansion in a 14-day protocol incorporating anti-CD3/anti-CD28 beads, and IL-2 with or without rapamycin. Cord blood T regulatory cells were largely naïve (89±7 vs. 31±10% in young adults, p<0.0001), and had higher expansion yields (median 5,968-fold) than adult T regulatory cells (median 516-fold, p=0.001) and adult naïve T regulatory cells (median 820-fold, p=0.003). Rapamycin reduced expansion yields, but was not necessary to obtain pure expanded cord blood T regulatory cells as judged by FOXP3 staining (94±3%), methylation status of FOXP3 (97%), and intracellular effector cytokine staining (< 6%). Expanded adult T regulatory cells were much less pure in the absence of rapamycin (72±19% FOXP3; 76% by methylation status, <13% INF-γ, <16% IL-4, <5% IL-17 positive), but purity was achieved by inclusion of rapamycin during expansion. Despite differences in purity, all preparations of expanded T regulatory from all sources were able to strongly suppress proliferation of T effector cells in vitro. Our findings suggest that cord blood is an excellent source of T regulatory cells for expansion and autologous cell therapy that may be considered as a strategy to prevent immune-mediated destruction of beta cells in type 1 diabetes. © Georg Thieme Verlag KG Stuttgart · New York.

  18. Occupational Status and Suicide.

    ERIC Educational Resources Information Center

    Lampert, Dominique I.; And Others

    1984-01-01

    Examined relationship between occupational status and suicide in California males since 1925. Findings show an inverse relationship between occupational status and suicide for all age groups. Over time, male suicide rates have increased, particularly for employed males over 65, employed males aged 14 to 24, and males in low-status occupations.…

  19. Heuristic status polling

    SciTech Connect

    Archer, Charles J.; Blocksome, Michael A.; Heidelberger, Philip; Kumar, Sameer; Parker, Jeffrey J.; Ratterman, Joseph D.

    2011-06-07

    Methods, compute nodes, and computer program products are provided for heuristic status polling of a component in a computing system. Embodiments include receiving, by a polling module from a requesting application, a status request requesting status of a component; determining, by the polling module, whether an activity history for the component satisfies heuristic polling criteria; polling, by the polling module, the component for status if the activity history for the component satisfies the heuristic polling criteria; and not polling, by the polling module, the component for status if the activity history for the component does not satisfy the heuristic criteria.

  20. 77 FR 34379 - Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory...

  1. Regulatory Science in Professional Education.

    PubMed

    Akiyama, Hiroshi

    2017-01-01

     In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.

  2. Boolean Modelingof Genetic Regulatory Networks

    NASA Astrophysics Data System (ADS)

    Albert, Réka

    Biological systems form complex networks of interaction on several scales, ranging from the molecular to the ecosystem level. On the subcellular scale, interaction between genes and gene products (mRNAs, proteins) forms the basis of essential processes like signal transduction, cell metabolism or embryonic development. Recent experimental advances helped uncover the qualitative structure of many gene control networks, creating a surge of interest in the quantitative description of gene regulation. We give a brief description of the main frameworks and methods used in modeling gene regulatory networks, then focus on a recent model of the segment polarity genes of the fruit fly Drosophila melanogaster. The basis of this model is the known interactions between the products of the segment polarity genes, and the network topology these interactions form. The interactions between mRNAs and proteins are described as logical (Boolean) functions. The success in reproducing both wild type and mutant gene expression patterns suggests that the kinetic details of the interactions are not essential as long as the network of interactions is unperturbed. The model predicts the gene patterns for cases that were not yet studied experimentally, and implies a remarkable robustness toward changes in internal parameters, initial conditions and even some mutations.

  3. Regulatory Mechanisms of Hsp90

    PubMed Central

    Prodromou, Chrisostomos

    2017-01-01

    The ability of Hsp90 to activate a disparate clientele implicates this chaperone in diverse biological processes. To accommodate such varied roles, Hsp90 requires a variety of regulatory mechanisms that are coordinated in order to modulate its activity appropriately. Amongst these, the master-regulator heat shock factor 1 (HSF1) is critically important in upregulating Hsp90 during stress, but is also responsible, through interaction with specific transcription factors (such as STAT1 and Strap/p300) for the integration of a variety of biological signals that ultimately modulate Hsp90 expression. Additionally, transcription factors, such as STAT1, STAT3 (including STAT1-STAT3 oligomers), NF-IL6, and NF-kB, are known to influence Hsp90 expression directly. Co-chaperones offer another mechanism for Hsp90 regulation, and these can modulate the chaperone cycle appropriately for specific clientele. Co-chaperones include those that deliver specific clients to Hsp90, and others that regulate the chaperone cycle for specific Hsp90-client complexes by modulating Hsp90s ATPase activity. Finally, post-translational modification (PTM) of Hsp90 and its co-chaperones helps too further regulate the variety of different Hsp90 complexes found in cells. PMID:28289734

  4. Evolving Robust Gene Regulatory Networks

    PubMed Central

    Noman, Nasimul; Monjo, Taku; Moscato, Pablo; Iba, Hitoshi

    2015-01-01

    Design and implementation of robust network modules is essential for construction of complex biological systems through hierarchical assembly of ‘parts’ and ‘devices’. The robustness of gene regulatory networks (GRNs) is ascribed chiefly to the underlying topology. The automatic designing capability of GRN topology that can exhibit robust behavior can dramatically change the current practice in synthetic biology. A recent study shows that Darwinian evolution can gradually develop higher topological robustness. Subsequently, this work presents an evolutionary algorithm that simulates natural evolution in silico, for identifying network topologies that are robust to perturbations. We present a Monte Carlo based method for quantifying topological robustness and designed a fitness approximation approach for efficient calculation of topological robustness which is computationally very intensive. The proposed framework was verified using two classic GRN behaviors: oscillation and bistability, although the framework is generalized for evolving other types of responses. The algorithm identified robust GRN architectures which were verified using different analysis and comparison. Analysis of the results also shed light on the relationship among robustness, cooperativity and complexity. This study also shows that nature has already evolved very robust architectures for its crucial systems; hence simulation of this natural process can be very valuable for designing robust biological systems. PMID:25616055

  5. IA channels: diverse regulatory mechanisms.

    PubMed

    Carrasquillo, Yarimar; Nerbonne, Jeanne M

    2014-04-01

    In many peripheral and central neurons, A-type K(+) currents, IA, have been identified and shown to be key determinants in shaping action potential waveforms and repetitive firing properties, as well as in the regulation of synaptic transmission and synaptic plasticity. The functional properties and physiological roles of native neuronal IA, however, have been shown to be quite diverse in different types of neurons. Accumulating evidence suggests that this functional diversity is generated by multiple mechanisms, including the expression and subcellular distributions of IA channels encoded by different voltage-gated K(+) (Kv) channel pore-forming (α) subunits, interactions of Kv α subunits with cytosolic and/or transmembrane accessory subunits and regulatory proteins and post-translational modifications of channel subunits. Several recent reports further suggest that local protein translation in the dendrites of neurons and interactions between IA channels with other types of voltage-gated ion channels further expands the functional diversity of native neuronal IA channels. Here, we review the diverse molecular mechanisms that have been shown or proposed to underlie the functional diversity of native neuronal IA channels.

  6. BCIP: a gene-centered platform for identifying potential regulatory genes in breast cancer

    PubMed Central

    Wu, Jiaqi; Hu, Shuofeng; Chen, Yaowen; Li, Zongcheng; Zhang, Jian; Yuan, Hanyu; Shi, Qiang; Shao, Ningsheng; Ying, Xiaomin

    2017-01-01

    Breast cancer is a disease with high heterogeneity. Many issues on tumorigenesis and progression are still elusive. It is critical to identify genes that play important roles in the progression of tumors, especially for tumors with poor prognosis such as basal-like breast cancer and tumors in very young women. To facilitate the identification of potential regulatory or driver genes, we present the Breast Cancer Integrative Platform (BCIP, http://omics.bmi.ac.cn/bcancer/). BCIP maintains multi-omics data selected with strict quality control and processed with uniform normalization methods, including gene expression profiles from 9,005 tumor and 376 normal tissue samples, copy number variation information from 3,035 tumor samples, microRNA-target interactions, co-expressed genes, KEGG pathways, and mammary tissue-specific gene functional networks. This platform provides a user-friendly interface integrating comprehensive and flexible analysis tools on differential gene expression, copy number variation, and survival analysis. The prominent characteristic of BCIP is that users can perform analysis by customizing subgroups with single or combined clinical features, including subtypes, histological grades, pathologic stages, metastasis status, lymph node status, ER/PR/HER2 status, TP53 mutation status, menopause status, age, tumor size, therapy responses, and prognosis. BCIP will help to identify regulatory or driver genes and candidate biomarkers for further research in breast cancer. PMID:28327601

  7. A survey of physical dosimetry to date and in the near future: Part 1. Review of standards and regulatory issues.

    PubMed

    Cassata, James R

    2002-02-01

    This article summarizes the status of the relevant standards and current regulatory issues for use of physical dosimetry devices for the occupational worker in the United States. Included is a summary of relevant standards from the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the American National Standards Institute (ANSI), the United States Nuclear Regulatory Commission NUREG-Series, the National Voluntary Laboratory Accreditation Program (NVLAP), the Department of Energy Laboratory Accreditation Program (DOELAP), and the U.S. Military Specifications and Standards (MIL-STD). Proposed changes to ANSI N13.11-1993, "American National Standard for Dosimetry-Personnel Dosimetry Performance Criteria for Testing," are listed. The strategic changes that the United States Nuclear Regulatory Commission (NRC) is making in rulemaking activities related to dosimetry and standards are given. The status of Measurement Program Description (MPD) C.18, "Implementation of Electronic Dosimetry for Primary Dosimetry," from the Council on Ionizing Radiation Measurements and Standards (CIRMS) is given.

  8. Evolutionary dynamics of prokaryotic transcriptional regulatory networks.

    PubMed

    Madan Babu, M; Teichmann, Sarah A; Aravind, L

    2006-04-28

    The structure of complex transcriptional regulatory networks has been studied extensively in certain model organisms. However, the evolutionary dynamics of these networks across organisms, which would reveal important principles of adaptive regulatory changes, are poorly understood. We use the known transcriptional regulatory network of Escherichia coli to analyse the conservation patterns of this network across 175 prokaryotic genomes, and predict components of the regulatory networks for these organisms. We observe that transcription factors are typically less conserved than their target genes and evolve independently of them, with different organisms evolving distinct repertoires of transcription factors responding to specific signals. We show that prokaryotic transcriptional regulatory networks have evolved principally through widespread tinkering of transcriptional interactions at the local level by embedding orthologous genes in different types of regulatory motifs. Different transcription factors have emerged independently as dominant regulatory hubs in various organisms, suggesting that they have convergently acquired similar network structures approximating a scale-free topology. We note that organisms with similar lifestyles across a wide phylogenetic range tend to conserve equivalent interactions and network motifs. Thus, organism-specific optimal network designs appear to have evolved due to selection for specific transcription factors and transcriptional interactions, allowing responses to prevalent environmental stimuli. The methods for biological network analysis introduced here can be applied generally to study other networks, and these predictions can be used to guide specific experiments.

  9. Hierarchical decomposition of dynamically evolving regulatory networks.

    PubMed

    Ay, Ahmet; Gong, Dihong; Kahveci, Tamer

    2015-05-15

    Gene regulatory networks describe the interplay between genes and their products. These networks control almost every biological activity in the cell through interactions. The hierarchy of genes in these networks as defined by their interactions gives important insights into how these functions are governed. Accurately determining the hierarchy of genes is however a computationally difficult problem. This problem is further complicated by the fact that an intrinsic characteristic of regulatory networks is that the wiring of interactions can change over time. Determining how the hierarchy in the gene regulatory networks changes with dynamically evolving network topology remains to be an unsolved challenge. In this study, we develop a new method, named D-HIDEN (Dynamic-HIerarchical DEcomposition of Networks) to find the hierarchy of the genes in dynamically evolving gene regulatory network topologies. Unlike earlier methods, which recompute the hierarchy from scratch when the network topology changes, our method adapts the hierarchy based on the wiring of the interactions only for the nodes which have the potential to move in the hierarchy. We compare D-HIDEN to five currently available hierarchical decomposition methods on synthetic and real gene regulatory networks. Our experiments demonstrate that D-HIDEN significantly outperforms existing methods in running time, accuracy, or both. Furthermore, our method is robust against dynamic changes in hierarchy. Our experiments on human gene regulatory networks suggest that our method may be used to reconstruct hierarchy in gene regulatory networks.

  10. Modeling of hysteresis in gene regulatory networks.

    PubMed

    Hu, J; Qin, K R; Xiang, C; Lee, T H

    2012-08-01

    Hysteresis, observed in many gene regulatory networks, has a pivotal impact on biological systems, which enhances the robustness of cell functions. In this paper, a general model is proposed to describe the hysteretic gene regulatory network by combining the hysteresis component and the transient dynamics. The Bouc-Wen hysteresis model is modified to describe the hysteresis component in the mammalian gene regulatory networks. Rigorous mathematical analysis on the dynamical properties of the model is presented to ensure the bounded-input-bounded-output (BIBO) stability and demonstrates that the original Bouc-Wen model can only generate a clockwise hysteresis loop while the modified model can describe both clockwise and counter clockwise hysteresis loops. Simulation studies have shown that the hysteresis loops from our model are consistent with the experimental observations in three mammalian gene regulatory networks and two E.coli gene regulatory networks, which demonstrate the ability and accuracy of the mathematical model to emulate natural gene expression behavior with hysteresis. A comparison study has also been conducted to show that this model fits the experiment data significantly better than previous ones in the literature. The successful modeling of the hysteresis in all the five hysteretic gene regulatory networks suggests that the new model has the potential to be a unified framework for modeling hysteresis in gene regulatory networks and provide better understanding of the general mechanism that drives the hysteretic function.

  11. Regulatory analysis technical evaluation handbook. Final report

    SciTech Connect

    1997-01-01

    The purpose of this Handbook is to provide guidance to the regulatory analyst to promote preparation of quality regulatory analysis documents and to implement the policies of the Regulatory Analysis Guidelines of the US Nuclear Regulatory Commission (NUREG/BR-0058 Rev. 2). This Handbook expands upon policy concepts included in the NRC Guidelines and translates the six steps in preparing regulatory analyses into implementable methodologies for the analyst. It provides standardized methods of preparation and presentation of regulatory analyses, with the inclusion of input that will satisfy all backfit requirements and requirements of NRC`s Committee to Review Generic Requirements. Information on the objectives of the safety goal evaluation process and potential data sources for preparing a safety goal evaluation is also included. Consistent application of the methods provided here will result in more directly comparable analyses, thus aiding decision-makers in evaluating and comparing various regulatory actions. The handbook is being issued in loose-leaf format to facilitate revisions. NRC intends to periodically revise the handbook as new and improved guidance, data, and methods become available.

  12. Actual operation and regulatory activities on steam generator replacement in Japan

    SciTech Connect

    Saeki, Hitoshi

    1997-02-01

    This paper summarizes the operating reactors in Japan, and the status of the steam generators in these plants. It reviews plans for replacement of existing steam generators, and then goes into more detail on the planning and regulatory steps which must be addressed in the process of accomplishing this maintenance. The paper also reviews the typical steps involved in the process of removal and replacement of steam generators.

  13. 75 FR 45171 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research, U.S..., Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE 7590-01-P ... From the Federal Register Online via the Government Publishing Office NUCLEAR...

  14. 76 FR 40943 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory... Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE... From the Federal Register Online via the Government Publishing Office NUCLEAR...

  15. 75 FR 43208 - Withdrawal of Regulatory Guide 5.17

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    .... Carpenter, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory... locations for all types of hazardous material placards, including radioactive materials. The regulation is.... Andrea D. Valentin, Chief, Regulatory Guide Development Branch, Division of Engineering, Office of...

  16. Regulatory bioinformatics for food and drug safety.

    PubMed

    Healy, Marion J; Tong, Weida; Ostroff, Stephen; Eichler, Hans-Georg; Patak, Alex; Neuspiel, Margaret; Deluyker, Hubert; Slikker, William

    2016-10-01

    "Regulatory Bioinformatics" strives to develop and implement a standardized and transparent bioinformatic framework to support the implementation of existing and emerging technologies in regulatory decision-making. It has great potential to improve public health through the development and use of clinically important medical products and tools to manage the safety of the food supply. However, the application of regulatory bioinformatics also poses new challenges and requires new knowledge and skill sets. In the latest Global Coalition on Regulatory Science Research (GCRSR) governed conference, Global Summit on Regulatory Science (GSRS2015), regulatory bioinformatics principles were presented with respect to global trends, initiatives and case studies. The discussion revealed that datasets, analytical tools, skills and expertise are rapidly developing, in many cases via large international collaborative consortia. It also revealed that significant research is still required to realize the potential applications of regulatory bioinformatics. While there is significant excitement in the possibilities offered by precision medicine to enhance treatments of serious and/or complex diseases, there is a clear need for further development of mechanisms to securely store, curate and share data, integrate databases, and standardized quality control and data analysis procedures. A greater understanding of the biological significance of the data is also required to fully exploit vast datasets that are becoming available. The application of bioinformatics in the microbiological risk analysis paradigm is delivering clear benefits both for the investigation of food borne pathogens and for decision making on clinically important treatments. It is recognized that regulatory bioinformatics will have many beneficial applications by ensuring high quality data, validated tools and standardized processes, which will help inform the regulatory science community of the requirements

  17. 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.

  18. [The regulatory framework for complementary and alternative medicines in Europe].

    PubMed

    Knöss, Werner; Stolte, F; Reh, K

    2008-07-01

    Medicinal products from complementary and alternative medicine are in Germany a regular part of the health care system. Herbal, homeopathic, anthroposophic and traditional medicinal products are highly accepted by the population. The German Medicines Act obliged the competent authorities to consider the particular characteristics of complementary and alternative medicines. The European regulatory framework defined the status of herbal medicinal products, traditional herbal medicinal products and homeopathic medicinal products within the directive 2001/83/EC. The committee for herbal medicinal products (HMPC) was established at the European Medicines Agency in London (EMEA); for homeopathic medicinal products there is a specific working group established by the Heads of Medicines Agencies. Harmonisation of medicinal products from complementary and alternative and traditional medicine in Europe was enforced by implementation of directive 2001/83/EC in national legislations of member states. The provisions of this directive will substantially influence the development of the European market during the forthcoming years.

  19. 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

  20. Nuclear Regulatory Commission: more aggressive leadership needed

    SciTech Connect

    Staats, E.B.

    1980-01-15

    The Energy Reorganization Act of 1974 which established the Nuclear Regulatory Commission required GAO to evaluate the Commission's performance by January 18, 1980. This report responds to that requirement. GAO concluded that, although improvements have been made, the Commission's nuclear regulatory performance can be characterized best as slow, indecisive, cautious - in a word, complacent. This has largely resulted from a lack of aggressive leadership as evidenced by the Commissioners' failure to establish regulatory goals, control policymaking, and most importantly, clearly define their roles in nuclear regulation.

  1. [Division of regulatory cellular systems (Lvov)].

    PubMed

    Kusen', S I

    1995-01-01

    Two departments of the A. V. Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine were founded in 1969 in Lviv. These were: the Department of Biochemistry of Cell Differentiation headed by Professor S. I. Kusen and Department of Regulation of Cellular Synthesis of Low Molecular Weight Compounds headed by Professor G. M. Shavlovsky. The Lviv Division of the A. V. Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine with Professor S. I. Kusen as its chief, was founded in 1974 on the basis of these departments and the Laboratory of Modelling of Regulatory Cellular Systems headed by Professor M. P. Derkach. The above mentioned laboratory which was not the structural unit obtained the status of Structural Laboratory of Cellular Biophysics in 1982 and was headed by O. A. Goida, Candidate of biological sciences. From 1983 the Laboratory of Correcting Therapy of Malignant Tumors and Hemoblastoses at the Institute of Molecular Biology and Genetics, Academy of Sciences of Ukraine (Chief--S. V. Ivasivka, Candidate of medical sciences) was included in the structure of the Division. That Laboratory was soon transformed into the Department of Carbohydrate Metabolism Regulation headed by Professor I. D. Holovatsky. In 1988 this Department was renamed into the Department of Glycoprotein Biochemistry and headed by M. D. Lutsik, Doctor of biological sciences. In 1982 one more Laboratory of Biochemical Genetics was founded at the Department of Regulation of Cellular Synthesis of Low Molecular Weight Compounds, in 1988 it was transformed into the Department of Biochemical Genetics (Chief--Professor A. A. Sibirny). In 1989 the Laboratory of Anion Transport was taken from A. V. Palladin Institute of Biochemistry, Academy of Sciences of Ukraine to Lviv Division of this Institute. This laboratory was headed by Professor M. M. Veliky. One more reorganization in the Division structure took place in 1994. The Department of

  2. Status of the NRC Decommissioning Program

    SciTech Connect

    Orlando, D. A.; Camper, L.; Buckley, J.; Pogue, E.; Banovac, K.

    2003-02-24

    On July 21, 1997, the U.S. Nuclear Regulatory Commission (NRC) published the final rule on Radiological Criteria for License Termination (the License Termination Rule or LTR) as Subpart E to 10 CFR Part 20. NRC regulations require that materials licensees submit Decommissioning Plans to support the decommissioning of its facility if it is required by license condition, or if the procedures and activities necessary to carry out the decommissioning have not been approved by NRC and these procedures could increase the potential health and safety impacts to the workers or the public. NRC regulations also require that reactor licensees submit Post-shutdown Decommissioning Activities Reports and License Termination Plans to support the decommissioning of nuclear power facilities. This paper provides an update on the status of the NRC's decommissioning program that was presented during WM'02. It discusses the staff's current efforts to streamline the decommissioning process, current issues being faced in the decommissioning program, such as partial site release and restricted release of sites, as well as the status of the decommissioning of complex sites and those listed in the Site Decommissioning Management Plan. The paper discusses the status of permanently shut-down commercial power reactors and the transfer of complex decommissioning sites and sites listed on the SDMP to Agreement States. Finally the paper provides an update of the status of various tools and guidance the NRC is developing to assist licensees during decommissioning, including an effort to consolidate and risk-inform decommissioning guidance.

  3. STATUS OF THE NRC'S DECOMMISSIONING PROGRAM

    SciTech Connect

    Orlando, D. A.; Camper, L. W.; Buckley, J.

    2002-02-25

    On July 21, 1997, the U.S. Nuclear Regulatory Commission published the final rule on Radiological Criteria for License Termination (the License Termination Rule) as Subpart E to 10 CFR Part 20. NRC regulations require that materials licensees submit Decommissioning Plans to support the decommissioning of its facility if it is required by license condition, or if the procedures and activities necessary to carry out the decommissioning have not been approved by NRC and these procedures could increase the potential health and safety impacts to the workers or the public. NRC regulations also require that reactor licensees submit Post-shutdown Decommissioning Activities Reports and License Termination Plans to support the decommissioning of nuclear power facilities. This paper provides an update on the status of the NRC's decommissioning program. It discusses the status of permanently shut-down commercial power reactors, complex decommissioning sites, and sites listed in the Site Decommissioning Management Plan. The paper provides the status of various tools and guidance the NRC is developing to assist licensees during decommissioning, including a Standard Review Plan for evaluating plans and information submitted by licensees to support the decommissioning of nuclear facilities and the D and D Screen software for determining the potential doses from residual radioactivity. Finally, it discusses the status of the staff's current efforts to streamline the decommissioning process.

  4. Regulatory T cells and vasectomy.

    PubMed

    Rival, Claudia; Wheeler, Karen; Jeffrey, Sarah; Qiao, Hui; Luu, Brian; Tewalt, Eric F; Engelhard, Victor H; Tardif, Stephen; Hardy, Daniel; del Rio, Roxana; Teuscher, Cory; Tung, Kenneth

    2013-11-01

    CD4+ CD25+ regulatory T cells (Tregs) strongly influence the early and late autoimmune responses to meiotic germ cell antigens (MGCA) and the gonadal immunopathology in vasectomized mice. This is supported by the published and recently acquired information presented here. Within 24h of unilateral vasectomy (uni-vx) the ipsilateral epididymis undergoes epithelial cell apoptosis followed by necrosis, severe inflammation, and granuloma formation. Unexpectedly, vasectomy alone induced MGCA-specific tolerance. In contrast, uni-vx plus simultaneous Treg depletion resulted in MGCA-specific autoimmune response and bilateral autoimmune orchitis. Both tolerance and autoimmunity were strictly linked to the early epididymal injury. We now discovered that testicular autoimmunity in uni-vx mice did not occur when Treg depletion was delayed by one week. Remarkably, this delayed Treg depletion also prevented tolerance induction. Therefore, tolerance depends on a rapid de novo Treg response to MGCA exposed after vasectomy. Moreover, tolerance was blunted in mice genetically deficient in PD-1 ligand, suggesting the involvement of induced Treg. We conclude that pre-existing natural Treg prevents post-vasectomy autoimmunity, whereas vasectomy-induced Treg maintains post-vasectomy tolerance. We further discovered that vasectomized mice were still resistant to autoimmune orchitis induction for at least 12-16 months; thus, tolerance is long-lasting. Although significant sperm autoantibodies of low titers became detectable in uni-vx mice at 7 months, the antibody titers fluctuated over time, suggesting a dynamic "balance" between the autoimmune and tolerance states. Finally, we observed severe epididymal fibrosis and hypo-spermatogenesis at 12 months after uni-vx: findings of highly critical clinical significance.

  5. REGULATORY T CELLS AND VASECTOMY

    PubMed Central

    Rival, Claudia; Wheeler, Karen; Jeffrey, Sarah; Qiao, Hui; Luu, Brian; Tewalt, Eric F; Engelhard, Victor H; Tardif, Stephen; Hardy, Daniel; del Rio, Roxana; Teuscher, Cory; Tung, Kenneth

    2013-01-01

    CD4+CD25+ regulatory T cells (Tregs) strongly influence the early and late autoimmune responses to meiotic germ cell antigens (MGCA) and the gonadal immunopathology in vasectomized mice. This is supported by the published and recently acquired information presented here. Within 24 hours of unilateral vasectomy (uni-vx) the ipsilateral epididymis undergoes epithelial cell apoptosis followed by necrosis, severe inflammation, and granuloma formation. Unexpectedly, vasectomy alone induced MGCA-specific tolerance. In contrast, uni-vx plus simultaneous Treg depletion resulted in MGCA-specific autoimmune response and bilateral autoimmune orchitis. Both tolerance and autoimmunity were strictly linked to the early epididymal injury. We now discovered that testicular autoimmunity in uni-vx mice did not occur when Treg depletion was delayed by one week. Remarkably, this delayed Treg depletion also prevented tolerance induction. Therefore, tolerance depends on a rapid de novo Treg response to MGCA exposed after vasectomy. Moreover, tolerance was blunted in mice genetically deficient in PD-1 ligand, suggesting the involvement of induced Treg. We conclude that pre-existing natural Treg prevents post-vasectomy autoimmunity, whereas vasectomy-induced Treg maintains post-vasectomy tolerance. We further discovered that vasectomized mice were still resistant to autoimmune orchitis induction for at least 12–16 months; thus, tolerance is long-lasting. Although significant sperm autoantibodies of low titers became detectable in uni-vx mice at seven months, the antibody titers fluctuated over time, suggesting a dynamic “balance” between the autoimmune and tolerance states. Finally, we observed severe epididymal fibrosis and hypo-spermatogenesis at 12 months after uni-vx: findings of highly critical clinical significance. PMID:24080233

  6. Closing Regulatory Loopholes Act of 2011

    THOMAS, 112th Congress

    Sen. Johanns, Mike [R-NE

    2011-09-08

    Senate - 09/08/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  7. Closing Regulatory Loopholes Act of 2013

    THOMAS, 113th Congress

    Sen. Johanns, Mike [R-NE

    2013-02-13

    Senate - 02/13/2013 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  8. Regulatory Information Reporting Act of 2011

    THOMAS, 112th Congress

    Sen. Whitehouse, Sheldon [D-RI

    2011-07-07

    07/20/2011 Committee on Homeland Security and Governmental Affairs. Hearings held. Hearings printed: S.Hrg. 112-220. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  9. Hydropower Regulatory Efficiency Act of 2012

    THOMAS, 112th Congress

    Rep. McMorris Rodgers, Cathy [R-WA-5

    2012-06-05

    07/10/2012 Received in the Senate and Read twice and referred to the Committee on Energy and Natural Resources. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  10. National Regulatory Budget Act of 2014

    THOMAS, 113th Congress

    Sen. Rubio, Marco [R-FL

    2014-03-25

    03/25/2014 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  11. Closing Regulatory Loopholes Act of 2013

    THOMAS, 113th Congress

    Sen. Johanns, Mike [R-NE

    2013-02-13

    02/13/2013 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  12. Reducing Regulatory Burdens Act of 2014

    THOMAS, 113th Congress

    Rep. Gibbs, Bob [R-OH-7

    2013-03-04

    08/01/2014 Received in the Senate and Read twice and referred to the Committee on Environment and Public Works. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  13. Regulatory Capture Prevention Act of 2011

    THOMAS, 112th Congress

    Sen. Whitehouse, Sheldon [D-RI

    2011-07-07

    07/20/2011 Committee on Homeland Security and Governmental Affairs. Hearings held. Hearings printed: S.Hrg. 112-220. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  14. Cement Sector Regulatory Relief Act of 2011

    THOMAS, 112th Congress

    Rep. Sullivan, John [R-OK-1

    2011-07-28

    10/12/2011 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 192. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  15. EPA Regulatory Relief Act of 2011

    THOMAS, 112th Congress

    Rep. Griffith, H. Morgan [R-VA-9

    2011-06-21

    10/18/2011 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 201. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  16. Small Business Regulatory Sunset Act of 2014

    THOMAS, 113th Congress

    Sen. Kirk, Mark Steven [R-IL

    2014-07-31

    Senate - 07/31/2014 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  17. 10th Amendment Regulatory Reform Act

    THOMAS, 111th Congress

    Rep. Cole, Tom [R-OK-4

    2010-03-25

    House - 07/26/2010 Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  18. Consumer Protection and Regulatory Enhancement Act

    THOMAS, 111th Congress

    Rep. Bachus, Spencer [R-AL-6

    2009-07-23

    House - 06/22/2010 Referred to the Subcommittee on General Farm Commodities and Risk Management. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  19. Reducing Regulatory Burdens Act of 2014

    THOMAS, 113th Congress

    Rep. Gibbs, Bob [R-OH-7

    2013-03-04

    08/01/2014 Received in the Senate and Read twice and referred to the Committee on Environment and Public Works. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  20. Novel Device Regulatory Relief Act of 2011

    THOMAS, 112th Congress

    Sen. Brown, Scott P. [R-MA

    2011-12-05

    Senate - 12/05/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  1. Regulatory Information Reporting Act of 2011

    THOMAS, 112th Congress

    Sen. Whitehouse, Sheldon [D-RI

    2011-07-07

    Senate - 07/20/2011 Committee on Homeland Security and Governmental Affairs. Hearings held. Hearings printed: S.Hrg. 112-220. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  2. Financial Regulatory Clarity Act of 2014

    THOMAS, 113th Congress

    Sen. Wicker, Roger F. [R-MS

    2014-09-16

    Senate - 09/16/2014 Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  3. Reducing Regulatory Burdens Act of 2011

    THOMAS, 112th Congress

    Rep. Gibbs, Bob [R-OH-18

    2011-03-02

    Senate - 06/21/2011 Placed on Senate Legislative Calendar under General Orders. Calendar No. 78. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  4. Small Business Regulatory Freedom Act of 2011

    THOMAS, 112th Congress

    Sen. Snowe, Olympia J. [R-ME

    2011-03-03

    03/03/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  5. Independent Agency Regulatory Analysis Act of 2013

    THOMAS, 113th Congress

    Sen. Portman, Rob [R-OH

    2013-06-18

    06/18/2013 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  6. Independent Agency Regulatory Analysis Act of 2012

    THOMAS, 112th Congress

    Sen. Portman, Rob [R-OH

    2012-08-01

    08/01/2012 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  7. Small Business Regulatory Sunset Act of 2014

    THOMAS, 113th Congress

    Sen. Kirk, Mark Steven [R-IL

    2014-07-31

    07/31/2014 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  8. Regulatory Capture Prevention Act of 2011

    THOMAS, 112th Congress

    Sen. Whitehouse, Sheldon [D-RI

    2011-07-07

    Senate - 07/20/2011 Committee on Homeland Security and Governmental Affairs. Hearings held. Hearings printed: S.Hrg. 112-220. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  9. National Regulatory Budget Act of 2014

    THOMAS, 113th Congress

    Sen. Rubio, Marco [R-FL

    2014-03-25

    Senate - 03/25/2014 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  10. Regulatory Time-Out Act of 2011

    THOMAS, 112th Congress

    Sen. Collins, Susan M. [R-ME

    2011-09-12

    09/12/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  11. Regulatory Cost Assessment Act of 2014

    THOMAS, 113th Congress

    Sen. Lee, Mike [R-UT

    2014-12-08

    Senate - 12/08/2014 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  12. Regulatory Cost Assessment Act of 2014

    THOMAS, 113th Congress

    Sen. Lee, Mike [R-UT

    2014-12-08

    12/08/2014 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  13. Closing Regulatory Loopholes Act of 2011

    THOMAS, 112th Congress

    Sen. Johanns, Mike [R-NE

    2011-09-08

    09/08/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  14. Closing Regulatory Loopholes Act of 2013

    THOMAS, 113th Congress

    Sen. Johanns, Mike [R-NE

    2013-02-13

    02/13/2013 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  15. Regulatory Time-Out Act of 2011

    THOMAS, 112th Congress

    Sen. Collins, Susan M. [R-ME

    2011-09-12

    Senate - 09/12/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  16. Regulatory Capture Prevention Act of 2011

    THOMAS, 112th Congress

    Sen. Whitehouse, Sheldon [D-RI

    2011-07-07

    07/20/2011 Committee on Homeland Security and Governmental Affairs. Hearings held. Hearings printed: S.Hrg. 112-220. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  17. Nanotechnology Regulatory Science Act of 2011

    THOMAS, 112th Congress

    Sen. Pryor, Mark L. [D-AR

    2011-10-06

    Senate - 10/06/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  18. Small Business Regulatory Freedom Act of 2011

    THOMAS, 112th Congress

    Sen. Snowe, Olympia J. [R-ME

    2011-03-03

    Senate - 03/03/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  19. Independent Agency Regulatory Analysis Act of 2013

    THOMAS, 113th Congress

    Sen. Portman, Rob [R-OH

    2013-06-18

    06/18/2013 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  20. Independent Agency Regulatory Analysis Act of 2012

    THOMAS, 112th Congress

    Sen. Portman, Rob [R-OH

    2012-08-01

    08/01/2012 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation: