A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

Science.gov (United States)

DiMasi, J A; Hermann, J C; Twyman, K; Kondru, R K; Stergiopoulos, S; Getz, K A; Rackoff, W

2015-11-01

We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology drugs from the top 50 pharmaceutical companies (2006 sales) that first entered clinical development from 1999 to 2007, had been taken to at least phase II development, and had a known final outcome (research abandonment or regulatory marketing approval). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Logistic regression and machine-learning methods were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors. We found that a simple four-factor model (activity, number of patients in the pivotal phase II trial, phase II duration, and a prevalence-related measure) had high sensitivity and specificity for predicting regulatory marketing approval. © 2015 American Society for Clinical Pharmacology and Therapeutics.

30 CFR 906.15 - Approval of Colorado regulatory program amendments.

Science.gov (United States)

2010-07-01

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

76 FR 78059 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

Science.gov (United States)

2011-12-15

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65927; File No. SR-OCC-2011-15] Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Management of..., future regulatory requirements for clearinghouses could impose liquidity requirements that would be...

78 FR 28267 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Science.gov (United States)

2013-05-14

... Trust Company (``DTC'') and maintain accounts to facilitate Delivery Orders (``DOs'') to approved... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... securities transactions and foster cooperation and coordination with persons engaged in the clearance and...

75 FR 1437 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

Science.gov (United States)

2010-01-11

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61274; File No. SR-CBOE-2009-089] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule... announce to members via Regulatory Circular any determination regarding the routing of market stock-option...

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

Science.gov (United States)

Mattingly, T Joseph; Simoni-Wastila, Linda

2017-10-01

Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. There is no funding to disclose. Mattingly

77 FR 27529 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Granting Accelerated Approval of...

Science.gov (United States)

2012-05-10

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66922; File No. SR-ICC-2012-05] Self-Regulatory... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... of the Comptroller of the Currency, U.K. Financial Services Authority, or any other regulatory body...

Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

Science.gov (United States)

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

2011-03-01

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

Gender-specific Regulatory Challenges to Product Approval: a panel discussion.

Science.gov (United States)

McGregor, Alyson J; Barr, Helen; Greenberg, Marna R; Safdar, Basmah; Wildgoose, Peter; Wright, David W; Hollander, Judd E

2014-12-01

On May 13, 2014, a 1-hour panel discussion session titled "Gender-specific Regulatory Challenges to Product Approval" was held during the Academic Emergency Medicine consensus conference, "Gender-specific Research in Emergency Medicine: Investigate, Understand, and Translate How Gender Affects Patient Outcomes." The session sought to bring together leaders in emergency medicine (EM) research, authors, and reviewers in EM research publications, as well as faculty, fellows, residents, and students engaged in research and clinical practice. A panel was convened involving a representative from the Office of Women's Health of the U.S. Food and Drug Administration, two pharmaceutical executives, and a clinical EM researcher. The moderated discussion also involved audience members who contributed significantly to the dialogue. Historical background leading up to the session along with the main themes of the discussion are reproduced in this article. These revolve around sex- and gender-specific research, statistical analysis of sex and gender, clinical practice, financial costs associated with pharmaceutical development, adaptive design, and specific recommendations on the regulatory process as it affects the specialty of EM. © 2014 by the Society for Academic Emergency Medicine.

77 FR 76319 - Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Minor Rule Violation...

Science.gov (United States)

2012-12-27

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68489; File No. 4-655] Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Minor Rule Violation Plan for BOX Options Exchange LLC... \\4\\ requiring that a self-regulatory organization (``SRO'') promptly file notice with the Commission...

Proposed Changes to EPA's Transuranic Waste Characterization Approval Process

International Nuclear Information System (INIS)

Joglekar, R.D.; Feltcorn, E.M.; Ortiz, A.M.

2003-01-01

This paper describes the changes to the waste characterization (WC) approval process proposed in August 2002 by the U.S. Environmental Protection Agency (EPA or the Agency or we). EPA regulates the disposal of transuranic (TRU) waste at the Waste Isolation Pilot Plant (WIPP) repository in Carlsbad, New Mexico. EPA regulations require that waste generator/storage sites seek EPA approval of WC processes used to characterize TRU waste destined for disposal at WIPP. The regulations also require that EPA verify, through site inspections, characterization of each waste stream or group of waste streams proposed for disposal at the WIPP. As part of verification, the Agency inspects equipment, procedures, and interviews personnel to determine if the processes used by a site can adequately characterize the waste in order to meet the waste acceptance criteria for WIPP. The paper discusses EPA's mandate, current regulations, inspection experience, and proposed changes. We expect that th e proposed changes will provide equivalent or improved oversight. Also, they would give EPA greater flexibility in scheduling and conducting inspections, and should clarify the regulatory process of inspections for both Department of Energy (DOE) and the public

Approaches to safety, environment and regulatory approval for the International Thermonuclear Experimental Reactor

International Nuclear Information System (INIS)

Saji, G.; Bartels, H.W.; Chuyanov, V.; Holland, D.; Kashirski, A.V.; Morozov, S.I.; Piet, S.J.; Poucet, A.; Raeder, J.; Rebut, P.H.; Topilski, L.N.

1995-01-01

International Thermonuclear Experimental Reactor (ITER) Engineering Design Activities (EDA) in safety and environment are approaching the point where conceptual safety design, topic studies and research will give way to project oriented engineering design activities. The Joint Central Team (JCT) is promoting safety design and analysis necessary for siting and regulatory approval. Scoping studies are underway at the general level, in terms of laying out the safety and environmental design framework for ITER. ITER must follow the nuclear regulations of the host country as the future construction site of ITER. That is, regulatory approval is required before construction of ITER. Thus, during the EDA, some preparations are necessary for the future application for regulatory approval. Notwithstanding the future host country's jurisdictional framework of nuclear regulations, the primary responsibility for safety and reliability of ITER rests with the legally responsible body which will operate ITER. Since scientific utilization of ITER and protection of the large investment depends on safe and reliable operation of ITER, we are highly motivated to achieve maximum levels of operability, maintainability, and safety. ITER will be the first fusion facility in which overall 'nuclear safety' provisions need to be integrated into the facility. For example, it will be the first fusion facility with significant decay heat and structural radiational damage. Since ITER is an experimental facility, it is also important that necessary experiments can be performed within some safety design limits without requiring extensive regulatory procedures. ITER will be designed with such a robust safety envelope compatible with the fusion power and the energy inventories. The basic approach to safety will be realized by 'defense-in-depth'. (orig.)

77 FR 40928 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Order Granting Approval of...

Science.gov (United States)

2012-07-11

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67357; File No. SR-C2-2012-011] Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Order Granting Approval of Proposed Rule Change To Implement a... and subsequently migrates to the DRF, the regulatory data for the portion of the day that the main...

The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

Science.gov (United States)

Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

2018-01-01

The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

77 FR 52096 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as...

Science.gov (United States)

2012-08-28

...'s rules, the financial and regulatory risk management controls and supervisory procedures required...-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

75 FR 2899 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

Science.gov (United States)

2010-01-19

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61333; File No. SR-NYSE-2009-117] Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Amending Its... regulatory program. III. Discussion and Commission's Findings After careful review, the Commission finds that...

40 CFR 123.61 - Approval process.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process for...

Regulatory Challenges for Cartilage Repair Technologies.

Science.gov (United States)

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

77 FR 52097 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as...

Science.gov (United States)

2012-08-28

... financial and regulatory risk management controls and supervisory procedures required by Rule 15c3-5 under...-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

76 FR 2737 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Science.gov (United States)

2011-01-14

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63668; File No. SR-NSCC-2010-09] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change... Facility January 6, 2011. I. Introduction On August 30, 2010, the National Securities Clearing Corporation...

40 CFR 145.31 - Approval process.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process. (a...

Unique characteristics of regulatory approval and pivotal studies of orphan anticancer drugs in Japan.

Science.gov (United States)

Nakayama, Hiroki; Tsukamoto, Katsura

2018-04-17

The approval of orphan anticancer drugs has increased, with the number exceeding that of non-orphan drugs in Japan in recent years. Although orphan anticancer drugs may have unique characteristics due to their rarity, these have not been fully characterized. We investigated anticancer drugs approved in Japan between April 2004 and November 2017 to reveal the characteristics of regulatory approval and pivotal studies on orphan anticancer drugs compared to non-orphan drugs. The median regulatory review time and number of patients in pivotal studies on orphan anticancer drugs (281.0 days [interquartile range, 263.3-336.0]; 222.5 patients [66.0-454.3]) were significantly lower than those on non-orphan drugs (353.0 days [277.0-535.5]; 521.0 patients [303.5-814.5], respectively) (P < 0.001). Phase II, non-randomized and non-controlled designs were more frequently used in pivotal studies on orphan anticancer drugs (45.9%, 41.9% and 43.2%) than non-orphan drugs (17.2%, 14.1% and 14.1%, respectively). Response rate was more commonly used as a primary endpoint in pivotal studies on orphan anticancer drugs (48.6%) than non-orphan drugs (17.2%). Indications limited by molecular features, second or later treatment line, and accelerated approval in the United States were associated with the use of response rate in orphan anticancer drug studies. In conclusion, we demonstrated that orphan anticancer drugs in Japan have unique characteristics compared to non-orphan drugs: shorter regulatory review and pivotal studies frequently using phase II, non-randomized, or non-controlled designs and response rate as a primary endpoint, with fewer patients.

The US Food and Drug Administration's tentative approval process and the global fight against HIV.

Science.gov (United States)

Chahal, Harinder Singh; Murray, Jeffrey S; Shimer, Martin; Capella, Peter; Presto, Ryan; Valdez, Mary Lou; Lurie, Peter G

2017-12-01

In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. In this paper, we describe the

A drug's life: the pathway to drug approval.

Science.gov (United States)

Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

2013-10-01

In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

77 FR 66196 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

Science.gov (United States)

2012-11-02

... Accounting Principles (``GAAP''). Canadian clearing members that use Form 1 report the same, and in some... Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Financial... financial reporting by Canadian clearing members to reflect the Investment Industry Regulatory Organization...

75 FR 2915 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

Science.gov (United States)

2010-01-19

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61317; File No. SR-ISE-2009-103] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Market Data Fees January 8, 2010. I. Introduction On November 25, 2009, the International...

77 FR 4852 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

Science.gov (United States)

2012-01-31

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66234; File No. SR-ISE-2011-82] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Legging Orders January 25, 2012. I. Introduction On November 29, 2011, the International Securities...

76 FR 64980 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

Science.gov (United States)

2011-10-19

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65548; File No. SR-ISE-2011-39] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Complex Orders October 13, 2011. I. Introduction On July 1, 2011, the International Securities Exchange...

77 FR 15432 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Science.gov (United States)

2012-03-15

... corporate governance structure of OCC by: (i) Increasing the number of public directors on OCC's Board of... directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds... Directors, OCC stated that the changes would enhance the corporate governance structure at OCC. As such, the...

Changing innovation into a registered product: From concept to regulatory approval.

Science.gov (United States)

Rhodes, Linda

2018-05-01

Innovation in animal health pharmaceuticals is important to address unmet and underserved medical needs, and often comes from products initially developed for human medicine. The purpose of the review is to help readers understand how breakthroughs from human biotechnology may be developed for use in veterinary medicine, while understanding the key drivers to success, the difficulties of regulatory approval, and the realistic risks and rewards of developing applications for animals. The types of human drugs which may be useful for veterinary applications are reviewed, including examples. The regulatory path is discussed, with a review of the various oversight agencies, and the categories of data required to be submitted, including safety, efficacy, manufacturing, environmental impact and human food safety. In conclusion, the cost, development time, and barriers to innovation in veterinary medical pharmaceuticals are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

Analysis of the Education Program Approval Process: A Program Evaluation.

Science.gov (United States)

Fountaine, Charles A.; And Others

A study of the education program approval process involving the Veterans Administration (VA) and the State Approving Agencies (SAAs) had the following objectives: to describe the present education program approval process; to determine time and costs associated with the education program approval process; to describe the approval process at…

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

Science.gov (United States)

Benda, Norbert; Brandt, Andreas

2018-01-01

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

77 FR 4605 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Granting Approval of Proposed Rule...

Science.gov (United States)

2012-01-30

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66231; File No. SR-EDGA-2011-40] Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Granting Approval of Proposed Rule Change Amending EDGA Rule 11.9 January 24, 2012. On December 2, 2011, EDGA Exchange, Inc. (``Exchange'' or ``EDGA'') filed...

75 FR 30095 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Amending Its...

Science.gov (United States)

2010-05-28

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62157; File No. SR-NYSEArca-2010-28] Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Amending Its Schedule of Fees May 24, 2010. On April 12, 2010, NYSE Arca, Inc. (``NYSE Arca'') filed with the Securities and Exchange...

78 FR 62814 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Science.gov (United States)

2013-10-22

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Assume... Authority and Supervision September 30, 2013. On July 31, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or...) Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...

77 FR 65237 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2012-10-25

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...Tree Trust October 19, 2012. I. Introduction On August 15, 2012, The NASDAQ Stock Market LLC (``Nasdaq... temporary defensive strategies that are inconsistent with its investment strategies, the Fund's ability to...

48 CFR 1819.7203 - Mentor approval process.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Mentor approval process... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

77 FR 48570 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Science.gov (United States)

2012-08-14

... Underlying Securities) of the NASDAQ Options Market rules.\\11\\ Additionally, the Target Component's and the...\\ Additionally, the Target Component's and the Benchmark Component's trading volume (in all markets in which the...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change Relating to the...

76 FR 55148 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Adopt...

Science.gov (United States)

2011-09-06

...-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Adopt Rules for the...-4 thereunder,\\2\\ a proposed rule change to adopt rules for the qualification, listing, and delisting... the Proposal The Exchange proposes rules to adopt a program for the qualification, listing, and...

76 FR 4968 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Science.gov (United States)

2011-01-27

...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Relating to Listing and Trading Shares of the AdvisorShares Active Bear ETF January 19, 2011. I. Introduction On... of the security or investment in the portfolio. \\14\\ Under accounting procedures followed by the Fund...

78 FR 75437 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

Science.gov (United States)

2013-12-11

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71004; File No. SR-Phlx-2013-101] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Regarding the Short Term Options Program December 6, 2013. I. Introduction On October 3, 2013, NASDAQ OMX PHLX LLC...

77 FR 67851 - Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Proposed Rule Change To...

Science.gov (United States)

2012-11-14

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68177; File No. SR-BOX-2012-003] Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Proposed Rule Change To Amend the Price Improvement Period November 7, 2012. I. Introduction On July 25, 2012, BOX Options Exchange LLC (``Exchange...

76 FR 8793 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

Science.gov (United States)

2011-02-15

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63875; File No. SR-Phlx-2010-183] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Expanding Its Short Term Option Program February 9, 2011. I. Introduction On December 15, 2010, NASDAQ OMX PHLX LLC...

75 FR 69491 - Self-Regulatory Organizations; Order Approving Proposed Rule Change by New York Stock Exchange...

Science.gov (United States)

2010-11-12

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63266; File No. SR-NYSE-2010-67] Self-Regulatory Organizations; Order Approving Proposed Rule Change by New York Stock Exchange LLC Changing the NYBX Order Execution Sequence November 5, 2010. I. Introduction On September 9, 2010, the New York...

75 FR 9988 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Granting Approval of Proposed Rule...

Science.gov (United States)

2010-03-04

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61590; File No. SR-Phlx-2009-113] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Granting Approval of Proposed Rule Change Relating to Index Option Position Limits February 25, 2010. On December 29, 2009, NASDAQ OMX PHLX, Inc. (``Phlx'' or...

76 FR 2182 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

Science.gov (United States)

2011-01-12

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63654; File No. SR-Phlx-2010-158] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Establishing a $5 Strike Price Program January 6, 2011. I. Introduction On November 12, 2010, NASDAQ OMX PHLX LLC...

78 FR 15394 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

Science.gov (United States)

2013-03-11

...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Adopting... paragraph (d) it contains a provision establishing how the transition period from NYSE Rule 477 will work... to announce the effective date of the new rules at least 30 days in advance in an Information...

76 FR 45308 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2011-07-28

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change To... change should provide NOM Participants assistance in effectively managing their quotations. \\6\\ 15 U.S.C...,\\2\\ a proposed rule change to adopt a new risk monitor mechanism. The proposed rule change was...

78 FR 62834 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2013-10-22

... Fund of First Trust Exchange-Traded Fund VII October 9, 2013. I. Introduction On August 16, 2013, The... for the provision of custody, transfer agency, and accounting agent services with the same or with...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...

76 FR 21085 - Self-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To...

Science.gov (United States)

2011-04-14

...-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To Amend The NASDAQ OMX Group, Inc. By- Laws April 8, 2011. I. Introduction On February 8, 2011, The NASDAQ Stock Market... vote cast either ``for'' or ``against'' that director's election. In its filing, NASDAQ noted that...

77 FR 47472 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

Science.gov (United States)

2012-08-08

... proposed rule change to make certain amendments that, in part, clarified the operation of the new Market... equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change, as Modified by...

77 FR 35455 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2012-06-13

...-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed Rule Change Amending NYSE Rule 107B To Add a Class of Supplemental Liquidity Providers That Are Registered as Market... proposed rule change to amend NYSE Rule 107B to add a class of Supplemental Liquidity Providers (``SLP...

75 FR 12590 - Self-Regulatory Organizations; The Chicago Stock Exchange, Inc.; Order Approving a Proposed Rule...

Science.gov (United States)

2010-03-16

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61680; File No. SR-CHX-2009-18] Self-Regulatory Organizations; The Chicago Stock Exchange, Inc.; Order Approving a Proposed Rule Change To Amend Its Co-Location Fees March 10, 2010. I. Introduction On December 22, 2009, the Chicago Stock Exchange, Inc. (``CHX'' or...

77 FR 38879 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Science.gov (United States)

2012-06-29

... marketable non-displayed interest, the Market Maker would be required to re-enter a quotation for purposes of...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Adding New... Securities Exchange Act of 1934 (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to add new...

76 FR 67238 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS...

Science.gov (United States)

2011-10-31

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65619, File No. SR-BATS-2011-032] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS Exchange, Inc. To Adopt Rules Applicable to Auctions Conducted by the Exchange for Exchange-Listed Securities October 25, 2011. I. Introduction On August 22, 2011,...

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

Science.gov (United States)

2010-01-11

...)(iv). Finally, because DMMs no longer act as agent for orders on the Display Book under the rules of... the Policy would not be in violation the Order Display rule \\8\\ and/or the Firm Quote rule \\9\\ under...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule Change Rescinding...

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

Science.gov (United States)

2010-01-11

...(a)(iv). Finally, because DMMs no longer act as agent for orders on the Display Book under the rules... fails to follow the Policy would not be in violation the Order Display rule \\8\\ and/or the Firm Quote...-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Rescinding NYSE Information...

75 FR 80553 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Relating to...

Science.gov (United States)

2010-12-22

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63558; File No. SR-NYSEAmex-2010-100] Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Relating to Complex Orders December 16, 2010. I. Introduction On October 20, 2010, NYSE Amex LLC (``NYSE Amex'' or the ``Exchange...

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

Science.gov (United States)

2011-12-19

... incorporated NYSE Rule 2A (Jurisdiction) as part of the process of developing a consolidated rulebook..., among other things, rulemaking, examinations, disciplinary actions, and listing applications. NYSE Rule... executives, employees and approved persons in connection with their conduct of the business of member...

75 FR 65541 - Self-Regulatory Organizations; Order Approving Proposed Rule Change by NASDAQ OMX PHLX, Inc. To...

Science.gov (United States)

2010-10-25

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63132; File No. SR-Phlx-2010-118] Self-Regulatory Organizations; Order Approving Proposed Rule Change by NASDAQ OMX PHLX, Inc. To Expand the $.50 Strike Price Program October 19, 2010. On August 25, 2010, NASDAQ OMX PHLX, Inc. (``Phlx'' or ``Exchange...

75 FR 38584 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change To...

Science.gov (United States)

2010-07-02

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62395; File No. SR-Phlx-2010-18] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change To Codify Prices for Co-Location Services June 28, 2010. I. Introduction On January 29, 2010, NASDAQ OMX PHLX (``Phlx'' or...

75 FR 38585 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To...

Science.gov (United States)

2010-07-02

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62396; File No. SR-BX-2010-012] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To Codify Prices for Co-Location Services June 28, 2010. I. Introduction On January 29, 2010, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange...

Credit Risk Management - Loan Approval Process

Directory of Open Access Journals (Sweden)

Lulzim Rashiti

2016-03-01

Full Text Available The aim of this study is on understanding the international regulations issued by Basel I, Basel II and Basel III to best supervise and manage credit risk management policies. Part of paper will focus on the description and impacts of the regulations and the pivotal importance they play in providing a sound banking system. Credit risk represents another important element that will be analysed considering that it lays the foundation during the loan consideration and approval process. The paper will also explain in detail procedures and responsibilities shared along the process of loan acceptance by a banker. To sum up, the overall process from application to loan approval or denial will be explained pointing out the implications that are faced along the way

Biosimilars approval process.

Science.gov (United States)

Zuñiga, Leyre; Calvo, Begoña

2010-04-01

For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. Copyright 2009 Elsevier Inc. All rights reserved.

Challenges in orphan drug development and regulatory policy in China.

Science.gov (United States)

Cheng, Alice; Xie, Zhi

2017-01-18

While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements have begun to support rare disease patients and facilitate drug discovery through research. Recently, the Chinese FDA set new regulatory guidelines for drugs being developed in China, including an expedited review process for life-saving treatments. In this review, we discuss the effects of these new policy changes on and suggest potential solutions to innovate orphan drug development in China.

A Document Imaging Technique for Implementing Electronic Loan Approval Process

Directory of Open Access Journals (Sweden)

J. Manikandan

2015-04-01

Full Text Available The image processing is one of the leading technologies of computer applications. Image processing is a type of signal processing, the input for image processor is an image or video frame and the output will be an image or subset of image [1]. Computer graphics and computer vision process uses an image processing techniques. Image processing systems are used in various environments like medical fields, computer-aided design (CAD, research fields, crime investigation fields and military fields. In this paper, we proposed a document image processing technique, for establishing electronic loan approval process (E-LAP [2]. Loan approval process has been tedious process, the E-LAP system attempts to reduce the complexity of loan approval process. Customers have to login to fill the loan application form online with all details and submit the form. The loan department then processes the submitted form and then sends an acknowledgement mail via the E-LAP to the requested customer with the details about list of documents required for the loan approval process [3]. The approaching customer can upload the scanned copies of all required documents. All this interaction between customer and bank take place using an E-LAP system.

76 FR 21932 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

Science.gov (United States)

2011-04-19

... statement therein, as follows: I. Introduction On February 4, 2011, the Financial Industry Regulatory...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a... Financial Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of the Code of Arbitration...

42 CFR 410.142 - CMS process for approving national accreditation organizations.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false CMS process for approving national accreditation... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving national accreditation organizations. (a) General rule. CMS may approve and recognize a nonprofit or not...

44 CFR 78.9 - Planning grant approval process.

Science.gov (United States)

2010-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve applications for Planning Grants. Funds will be provided only for the flood portion of any mitigation plan, and...

FERC approves process for Lake Erie link: Project meets significant regulatory milestone

International Nuclear Information System (INIS)

Anon

2002-01-01

The Federal Electric Regulatory Commission (FERC) of the United States has issued an order to TransEnergie US Ltd., and Hydro One Inc., authorizing the sale of transmission rights for the proposed Lake Erie link. This project will consists of bi-directional high voltage direct current facilities connecting the transmission grids of Ontario, Canada and the United States. The sale is authorized to proceed via a non-discriminatory 'open season' process. The project will consist of buried underwater cables under Lake Erie connecting the transmission systems near Simcoe, Ontario with those in the US at either, or both, of Springfield, Pennsylvania, and Ashtabula, Ohio. The project will provide an increase in transmission capability of up to 975 MW between the electric control areas of the Ontario Independent Electricity Market Operator, the East Central Area Reliability Coordination Agreement in Ohio and the Pennsylvania-New Jersey-Maryland Interconnection. The Lake Erie Link will be financially supported by those consumers who see value in the associated transmission rights, rather than through the regulated rates paid by transmission customers in general. The article provides an overview of the background of the Lake Erie Link, the cable system, the converter station, and the potential economic benefits

A review of NRC regulatory processes and functions

International Nuclear Information System (INIS)

1981-05-01

A reexamination by the ACRS of the Regulatory Process has been made. Objectives were to provide in a single source, ACRS' understanding of the Regulatory Process and to point out perceived weaknesses and to make appropriate recommendations for change

The Ethics and Politics of Ethics Approval

Science.gov (United States)

Battin, Tim; Riley, Dan; Avery, Alan

2014-01-01

The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

14 CFR 21.305 - Approval of materials, parts, processes, and appliances.

Science.gov (United States)

2010-01-01

..., and appliances. 21.305 Section 21.305 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION..., Parts, Processes, and Appliances § 21.305 Approval of materials, parts, processes, and appliances. Whenever a material, part, process, or appliance is required to be approved under this chapter, it may be...

Petitioning process for irradiated foods and animal feeds in North America

International Nuclear Information System (INIS)

Marcotte, M.; Kunstadt, P.

1993-01-01

The lack of sufficient regulatory approvals continues to delay the commercial application of food irradiation in several countries. Often, the regulatory approval process itself appears too challenging and approvals are not even requested. The objective of this paper is to review petition requirements so that researchers and companies in other countries will be able to prepare petitions requesting approval for the import and sale of irradiated foods into North America. (author)

25 CFR 1200.15 - What is the approval process for management plans?

Science.gov (United States)

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove each...

HyApproval - Handbook for the approval of hydrogen refuelling stations - First preliminary achievements

Energy Technology Data Exchange (ETDEWEB)

Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.

2007-05-15

The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)

The emergence of diagnostic imaging technologies in breast cancer: discovery, regulatory approval, reimbursement, and adoption in clinical guidelines.

Science.gov (United States)

Gold, Laura S; Klein, Gregory; Carr, Lauren; Kessler, Larry; Sullivan, Sean D

2012-01-25

In this article, we trace the chronology of developments in breast imaging technologies that are used for diagnosis and staging of breast cancer, including mammography, ultrasonography, magnetic resonance imaging, computed tomography, and positron emission tomography. We explore factors that affected clinical acceptance and utilization of these technologies from discovery to clinical use, including milestones in peer-reviewed publication, US Food and Drug Administration approval, reimbursement by payers, and adoption into clinical guidelines. The factors driving utilization of new imaging technologies are mainly driven by regulatory approval and reimbursement by payers rather than evidence that they provide benefits to patients. Comparative effectiveness research can serve as a useful tool to investigate whether these imaging modalities provide information that improves patient outcomes in real-world settings.

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

Science.gov (United States)

Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

2018-05-02

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

A planning support system to optimize approval of private housing development projects

Science.gov (United States)

Hussnain, M. Q.; Wakil, K.; Waheed, A.; Tahir, A.

2016-06-01

Out of 182 million population of Pakistan, 38% reside in urban areas having an average growth rate of 1.6%, raising the urban housing demand significantly. Poor state response to fulfil the housing needs has resulted in a mushroom growth of private housing schemes (PHS) over the years. Consequently, only in five major cities of Punjab, there are 383 legal and 150 illegal private housing development projects against 120 public sector housing schemes. A major factor behind the cancerous growth of unapproved PHS is the prolonged and delayed approval process in concerned approval authorities requiring 13 months on average. Currently, manual and paper-based approaches are used for vetting and for granting the permission which is highly subjective and non-transparent. This study aims to design a flexible planning support system (PSS) to optimize the vetting process of PHS projects under any development authority in Pakistan by reducing time and cost required for site and documents investigations. Relying on the review of regulatory documents and interviews with professional planners and land developers, this study describes the structure of a PSS developed using open- source geo-spatial tools such as OpenGeo Suite, PHP, and PostgreSQL. It highlights the development of a Knowledge Module (based on regulatory documents) containing equations related to scheme type, size (area), location, access road, components of layout plan, planning standards and other related approval checks. Furthermore, it presents the architecture of the database module and system data requirements categorized as base datasets (built-in part of PSS) and input datasets (related to the housing project under approval). It is practically demonstrated that developing a customized PSS to optimize PHS approval process in Pakistan is achievable with geospatial technology. With the provision of such a system, the approval process for private housing schemes not only becomes quicker and user-friendly but also

Activities relating to PSA in the regulatory process

International Nuclear Information System (INIS)

Campbell, J.F.; Grint, G.C.

1994-01-01

In addition to the IAEA activities concerning the use of PSA in the regulatory process there are two other international initiatives in this area by the European Commission and the OECD's Committee for Nuclear Regulatory Authorities (CRNA). The paper gives a brief outline of these activities as well as introducing an update on the regulatory use of PSA in the UK. 3 refs, 3 tabs

Novel excipients - Regulatory challenges and perspectives - The EU insight.

Science.gov (United States)

Kozarewicz, Piotr; Loftsson, Thorsteinn

2018-05-21

Novel excipients are indispensable in development of modern, advanced drug delivery systems and biotechnology-derived drugs. Although numerous novel excipients are developed for pharmaceutical use, they are not frequently seen in medicinal products due to the strict regulatory requirements and perception that their use makes new product evaluation more complex with risk of delays in the approval process. Regulators regard novel excipients as new substances and whenever new excipient is used in a formulation it must be subjected to full evaluation, similarly to the one required for new active substance. Consequently, the amount of information required in support of the regulatory approval (i.e. marketing authorization) is much more complex and comprehensive than for established excipients. This short review provides an insight into the use of novel excipients in medicinal products approved in the European Union. In addition, barriers and challenges in development of novel excipients are being discussed as well as means to overcome those barriers. Copyright © 2018 Elsevier B.V. All rights reserved.

Food irradiation—US regulatory considerations

Science.gov (United States)

Morehouse, Kim M.

2002-03-01

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

Food irradiation--US regulatory considerations

International Nuclear Information System (INIS)

Morehouse, Kim M.

2002-01-01

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

44 CFR 78.10 - Project grant approval process.

Science.gov (United States)

2010-10-01

..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.10 Project grant approval process. The State POC will solicit applications from...

13 CFR 108.380 - Final approval as a NMVC Company.

Science.gov (United States)

2010-01-01

... VENTURE CAPITAL (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.380 Final approval as a... amount of Regulatory Capital set forth in its application, pursuant to § 108.310(a)(1); and (B) The... at least 30 percent of its Regulatory Capital if the Conditionally Approved NMVC Company— (i) Already...

Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

Science.gov (United States)

DiMasi, Joseph A

2013-06-01

Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean

Integration of new technology into clinical practice after FDA approval.

Science.gov (United States)

Govil, Ashul; Hao, Steven C

2016-10-01

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

Global Regulatory Differences for Gene- and Cell-Based Therapies

DEFF Research Database (Denmark)

Coppens, Delphi G M; De Bruin, Marie L; Leufkens, Hubert G M

2017-01-01

Gene- and cell-based therapies (GCTs) offer potential new treatment options for unmet medical needs. However, the use of conventional regulatory requirements for medicinal products to approve GCTs may impede patient access and therapeutic innovation. Furthermore, requirements differ between...... jurisdictions, complicating the global regulatory landscape. We provide a comparative overview of regulatory requirements for GCT approval in five jurisdictions and hypothesize on the consequences of the observed global differences on patient access and therapeutic innovation....

Requirements, guidance and logic in planning environmental investigations: Approval versus implementation

International Nuclear Information System (INIS)

Brice, D.A.; Meredith, D.V.; Harris, M.Q.

1993-01-01

In today's litigious society, it is important for both private parties and government to plan and conduct environmental investigations in a scientifically sound manner, documenting the purpose, methods, and results in a consistent fashion throughout the exercise. Planning documents are prepared during the initial phases of environmental investigations. Project objectives, including data quality requirements, specific work to be conducted to fulfill data needs, and operating procedures are specified. Regulatory agency approval of these documents is often required prior to plan implementation. These approvals are necessary and appropriate to fulfilling the agency's mandated role. Many guidance documents prepared by regulatory agencies suggest the content and format of various scoping documents. These guidances help standardize thought processes and considerations in planning, and provide a template to ensure that both the plan and the proposed work will fulfill regulatory requirements. This work describes the preparation and use of guidance documents for planning environmental studies. The goals and some of the pitfalls of such documents are discussed. Guidance should include the following elements: the purpose of the guidance and a description of where it applies; the type of items to be addressed in planning; identification of requirements are applicable to all projects for which the guidance is intended; identification of requirements only applicable in certain situations; a description of items to facilitate planning; a suggested format for fulfilling requirements; example applications of the guidance. Disagreements arise between planners and reviewers/approvers when elements of guidance are used as leverage to require work not directly related to project objectives. Guidance may be inappropriately used as a milestone by which site-specific plans are judged. Regulatory agency review and approval may be regarded as a primary objective of the plan

Auditing the process of ethics approval for Master's degrees at a ...

African Journals Online (AJOL)

Objective. This study audited the process of ethics approval for Master's research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa. Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master's proposal for the year 2010 was reviewed.

System engineering in the Nuclear Regulatory Commission licensing process: Program architecture process and structure

International Nuclear Information System (INIS)

Romine, D.T.

1989-01-01

In October 1987, the U.S. Nuclear Regulatory Commission (NRC) established the Center for Nuclear Waste Regulatory Analyses at Southwest Research Institute in San Antonio, Texas. The overall mission of the center is to provide a sustained level of high-quality research and technical assistance in support of NRC regulatory responsibilities under the Nuclear Waste Policy Act (NWPA). A key part of that mission is to assist the NRC in the development of the program architecture - the systems approach to regulatory analysis for the NRC high-level waste repository licensing process - and the development and implementation of the computer-based Program Architecture Support System (PASS). This paper describes the concept of program architecture, summarizes the process and basic structure of the PASS relational data base, and describes the applications of the system

The approval process for biosimilar erythropoiesis-stimulating agents.

Science.gov (United States)

Wish, Jay B

2014-09-05

A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well. Copyright �

The relationship between time perspective and self-regulatory processes, abilities and outcomes: a protocol for a meta-analytical review.

Science.gov (United States)

Baird, Harriet M; Webb, Thomas L; Martin, Jilly; Sirois, Fuschia M

2017-07-05

Both theoretical and empirical evidence suggests that time perspective is likely to influence self-regulatory processes and outcomes. Despite the theoretical and practical significance of such relations, the relationship between time perspective and self-regulatory processes and outcomes across different measures, samples and life domains, including health, has yet to be explored. The proposed review will develop a taxonomy for classifying measures according to the self-regulatory process, ability or outcome that they are likely to reflect. Electronic scientific databases will be searched, along with relevant conference abstract booklets and citation lists. Additionally, a call for unpublished data will be submitted to relevant bodies. To be eligible for inclusion, studies must include a measure of time perspective and a measure of at least one self-regulatory process, ability and/ or outcome. Eligibility will not be restricted by publication date, language, type of sample or setting. The bivariate correlations will be extracted (or calculated) and submitted to a random-effects meta-analysis. The sample-weighted average effect size, heterogeneity, risk of bias and publication bias will be calculated, and the effects of categorical and continuous moderator variables on the effect sizes will be determined. The proposed meta-analysis will synthesise previously conducted research; thus, ethical approval is not required. The findings will be submitted for publication in an international peer-reviewed journal and reported as part of the first author’s PhD thesis. The findings will also be disseminated to the research community and, where appropriate, to other interested parties through presentations at relevant academic and non-academic conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Setting up a randomized clinical trial in the UK: approvals and process.

Science.gov (United States)

Greene, Louise Eleanor; Bearn, David R

2013-06-01

Randomized clinical trials are considered the 'gold standard' in primary research for healthcare interventions. However, they can be expensive and time-consuming to set up and require many approvals to be in place before they can begin. This paper outlines how to determine what approvals are required for a trial, the background of each approval and the process for obtaining them.

Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

Science.gov (United States)

Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

acceptance of 3R testing approaches, including a process for collection of real-life data (safe harbour). Pathways for regulatory acceptance of 3R testing approaches are depicted and a new procedure for submission and evaluation of a proposal for regulatory acceptance of 3R testing approaches is described.

Regulatory approval and a first-in-human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants.

Science.gov (United States)

Ma, Julian K-C; Drossard, Jürgen; Lewis, David; Altmann, Friedrich; Boyle, Julia; Christou, Paul; Cole, Tom; Dale, Philip; van Dolleweerd, Craig J; Isitt, Valerie; Katinger, Dietmar; Lobedan, Martin; Mertens, Hubert; Paul, Mathew J; Rademacher, Thomas; Sack, Markus; Hundleby, Penelope A C; Stiegler, Gabriela; Stoger, Eva; Twyman, Richard M; Vcelar, Brigitta; Fischer, Rainer

2015-10-01

Although plant biotechnology has been widely investigated for the production of clinical-grade monoclonal antibodies, no antibody products derived from transgenic plants have yet been approved by pharmaceutical regulators for clinical testing. In the Pharma-Planta project, the HIV-neutralizing human monoclonal antibody 2G12 was expressed in transgenic tobacco (Nicotiana tabacum). The scientific, technical and regulatory demands of good manufacturing practice (GMP) were addressed by comprehensive molecular characterization of the transgene locus, confirmation of genetic and phenotypic stability over several generations of transgenic plants, and by establishing standard operating procedures for the creation of a master seed bank, plant cultivation, harvest, initial processing, downstream processing and purification. The project developed specifications for the plant-derived antibody (P2G12) as an active pharmaceutical ingredient (API) based on (i) the guidelines for the manufacture of monoclonal antibodies in cell culture systems; (ii) the draft European Medicines Agency Points to Consider document on quality requirements for APIs produced in transgenic plants; and (iii) de novo guidelines developed with European national regulators. From the resulting process, a GMP manufacturing authorization was issued by the competent authority in Germany for transgenic plant-derived monoclonal antibodies for use in a phase I clinical evaluation. Following preclinical evaluation and ethical approval, a clinical trial application was accepted by the UK national pharmaceutical regulator. A first-in-human, double-blind, placebo-controlled, randomized, dose-escalation phase I safety study of a single vaginal administration of P2G12 was carried out in healthy female subjects. The successful completion of the clinical trial marks a significant milestone in the commercial development of plant-derived pharmaceutical proteins. © 2015 Society for Experimental Biology, Association of

Navigating the Process of Ethical Approval: A methodological note

Directory of Open Access Journals (Sweden)

Eileen Carey, RNID, BSc. (hons, MSc.

2010-12-01

Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.

Biosimilars: a regulatory perspective from America.

Science.gov (United States)

Kay, Jonathan

2011-05-12

Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an abbreviated pathway that permits a biosimilar to be evaluated by comparing it with only a single reference biological product. This paper reviews the processes for approval of biosimilars in the US and the European Union and highlights recent changes in federal regulations governing the approval of biosimilars in the US.

78 FR 54626 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal...

Science.gov (United States)

2013-09-05

...-01] Announcing Approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal... Commerce's approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal Identity... Information Processing Standards (FIPS). Homeland Security Presidential Directive (HSPD) 12, entitled ``Policy...

7 CFR 1735.90 - Preliminary approvals.

Science.gov (United States)

2010-01-01

... AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Requirements for... franchises, licenses, and permits; (4) All required regulatory body approvals; (5) All required corporate...

77 FR 13294 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure...

Science.gov (United States)

2012-03-06

...-02] Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure... approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure Hash Standard (SHS... Federal Information Processing Standard (FIPS) Publication 180-4, Secure Hash Standard (SHS). FIPS 180-4...

Decree 328/003. Is approve the organizational structure reformulation project of the regulatory unit of Unit 006 Energy and water services of subsection 02 Presidency of the Republic

International Nuclear Information System (INIS)

2003-01-01

This decree approve the organizational structure project of The regulatory energy and water services ( URSEA). This unit is responsible for monitoring the activities related to electricity, gas, drinking water, sanitation and oil, fuel and other hydrocarbon derivatives

APPROVAL OF WASTE TREATMENT AND IMMOBILIZATION PLANT CONTRACTOR-INITIATED AUTHORIZATION BASIS AMENDMENT REQUESTS (ABAR)

International Nuclear Information System (INIS)

JONES GL

2008-01-01

The objective is to describe the process used by the Office of River Protection (ORP) for evaluating and implementing Contractor-initiated changes to the Waste Treatment and Immobilization Plant (WTP) Authorization Basis (AB). The WTP Project's history has provided a unique challenge for establishing and maintaining an ORP-approved AB during design and construction. Until operations begin, the project cannot implement the classic Unreviewed Safety Question (USQ) process to determine when ORP approval of Contractor-initiated changes is required. A 'quasiUSQ' process has been implemented that defines when AB changes could occur. The three types of AB changes are (1) Limited Scope Changes, (2) Authorization Basis Deviations, and (3) Authorization Basis Amendment Request (ABAR). DOE RL/REG 97-13, 'Office of River Protection Position on Contractor-Initiated Changes to the Authorization Basis', describes the process the WTP Contractor must follow to make changes to the AB, with and without ORP approval. The process uses a 'safety evaluation' process that is similar to the USQ process but at a more qualitative level. The maturation of the WTP Contractor's facility design and activities, and other changing conditions, resulted in a process that allows the Contractor to make changes to the AB without ORP approval; however, those changes that may significantly affect nuclear safety do require ORP approval. This process balances the WTP regulatory principle of efficiency with assurance that adequate safety will not be compromised. The process has reduced the number of ABARs requiring ORP approval and reduced the potential for delays in design and procurement activities

Supporting Biotechnology Regulatory Policy Processes in Southeast ...

International Development Research Centre (IDRC) Digital Library (Canada)

Supporting Biotechnology Regulatory Policy Processes in Southeast Asia. Biotechnology innovations or bio-innovations can provide solutions to problems associated with food security, poverty and environmental degradation. Innovations such as genetically engineered (GE) crops can increase food production and ...

State regulatory issues in acid rain compliance

International Nuclear Information System (INIS)

Solomon, B.D.; Brick, S.

1992-01-01

This article discusses the results of a US EPA workshop for state regulators and commission staff on acid rain compliance concerns. The topics of the article include the results of market-based emissions control, how emissions trading is expected to reduce emissions, public utility commissions approval of compliance plans, the purposes of the workshop, market information, accounting issues, regulatory process and utility planning, multi-state compliance planning, and relationship to other compliance issues

15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.

Science.gov (United States)

2010-01-01

... approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations... REGULATIONS OF THE FOREIGN-TRADE ZONES BOARD Manufacturing and Processing Activity-Reviews § 400.32 Procedure for review of request for approval of manufacturing or processing. (a) Request as part of application...

Safeguards inventory and process monitoring regulatory comparison

Energy Technology Data Exchange (ETDEWEB)

Cavaluzzi, Jack M. [Texas A & M Univ., College Station, TX (United States); Gibbs, Philip W. [Brookhaven National Lab. (BNL), Upton, NY (United States)

2013-06-27

Detecting the theft or diversion of the relatively small amount of fissile material needed to make a nuclear weapon given the normal operating capacity of many of today’s running nuclear production facilities is a difficult task. As throughput increases, the ability of the Material Control and Accountability (MC&A) Program to detect the material loss decreases because the statistical measurement uncertainty also increases. The challenge faced is the ability of current accounting, measurement, and material control programs to detect small yet significant losses under some regulatory approaches can decrease to the point where it is extremely low if not practically non-existent at normal operating capacities. Adding concern to this topic is that there are variations among regulatory bodies as far as what is considered a Significant Quantity (SQ). Some research suggests that thresholds should be lower than those found in any current regulation which if adopted would make meeting detection goals even more difficult. This paper reviews and compares the current regulatory requirements for the MA elements related to physical inventory, uncertainty of the Inventory Difference (ID), and Process Monitoring (PM) in the United States Department of Energy (DOE) and Nuclear Regulatory Commission (NRC), Rosatom of the Russian Federation and the Chinese Atomic Energy Agency (CAEA) of China. The comparison looks at how the regulatory requirements for the implementation of various MA elements perform across a range of operating capacities in example facilities.

Trends in global approvals of biotech crops (1992-2014).

Science.gov (United States)

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

78 FR 43145 - Announcing Approval of Federal Information Processing Standard 186-4, Digital Signature Standard

Science.gov (United States)

2013-07-19

...-01] Announcing Approval of Federal Information Processing Standard 186-4, Digital Signature Standard.... SUMMARY: This notice announces the Secretary of Commerce's approval of Federal Information Processing... changes are effective on July 19, 2013. FOR FURTHER INFORMATION CONTACT: Elaine Barker (301) 975-2911...

44 CFR 78.6 - Flood Mitigation Plan approval process.

Science.gov (United States)

2010-10-01

... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Flood Mitigation Plan..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all Flood...

Trial endpoints for drug approval in oncology: Chemoprevention.

Science.gov (United States)

Beitz, J

2001-04-01

As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.

Review of NRC Regulatory processes and functions

International Nuclear Information System (INIS)

1980-01-01

The Advisory Committee on Reactor Safeguards (ACRS) has spent much time over many years observing and examining the NRC licensing process. The Committee is, consequently, in a position to comment on the situation, and it believes this review will be helpful to those examining the regulatory process by discussing how it works, where it is weak, and the opportunities for improvement. The Committee's review may also help put current proposals and discussions in perspective

18 CFR 1304.4 - Application review and approval process.

Science.gov (United States)

2010-04-01

... hearing is requested by the USACE pursuant to the TVA/Corps joint processing Memorandum of Understanding... the application as appropriate. (b) If a hearing is held for any of the reasons described in paragraph... contained in the hearing notice. (c) Hearings concerning approval of applications are conducted (in...

Regulatory Aspects of Sabin Type 2 Withdrawal From Trivalent Oral Poliovirus Vaccine: Process and Lessons Learned.

Science.gov (United States)

Decina, Daniela; Fournier-Caruana, Jacqueline; Takane, Marina; Ostad Ali Dehaghi, Razieh; Sutter, Roland

2017-07-01

Withdrawal of type 2 oral poliovirus vaccine (OPV) in OPV-using countries required regulatory approval for use of inactivated poliovirus vaccine and bivalent OPV in routine immunization. Worldwide, a variety of mechanisms were used by member states, with some differences in approach observed between inactivated poliovirus vaccine and bivalent OPV. These included acceptance for use of World Health Organization (WHO) prequalified vaccines, registration and licensure pathways, participation in WHO-convened joint reviews of licensing dossiers, as well as pragmatic application of alternatively available mechanisms, when appropriate. Simple but effective tools were used to monitor progress and to record, authenticate, and share information. Essential to achievement of regulatory targets was ongoing communication with key stakeholders, including switch-country national regulatory authorities, vaccine manufacturers, partner organizations, and relevant units within WHO. Understanding of the regulatory environment gained through the OPV switch can be helpful in supporting further stages of the polio end game and other time-sensitive vaccine introduction programs. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Regulatory practices of radiation safety of SNF transportation in Russia

International Nuclear Information System (INIS)

Kuryndina, Lidia; Kuryndin, Anton; Stroganov, Anatoly

2008-01-01

This paper overviews current regulatory practices for the assurance of nuclear and radiation safety during railway transportation of SNF on the territory of Russian Federation from NPPs to longterm-storage of reprocessing sites. The legal and regulatory requirements (mostly compliant with IAEA ST-1), licensing procedure for NM transportation are discussed. The current procedure does not require a regulatory approval for each particular shipment if the SNF fully comply with the Rosatom's branch standard and is transported in approved casks. It has been demonstrated that SNF packages compliant with the branch standard, which is knowingly provide sufficient safety margin, will conform to the federal level regulations. The regulatory approval is required if a particular shipment does not comply with the branch standard. In this case, the shipment can be approved only after regulatory review of Applicant's documents to demonstrate that the shipment still conformant to the higher level (federal) regulations. The regulatory review frequently needs a full calculation test of the radiation safety assurance. This test can take a lot of time. That's why the special calculation tools were created in SEC NRS. These tools aimed for precision calculation of the radiation safety parameters by SNF transportation use preliminary calculated Green's functions. Such approach allows quickly simulate any source distribution and optimize spent fuel assemblies placement in cask due to the transport equation property of linearity relatively the source. The short description of calculation tools are presented. Also, the paper discusses foreseen implications related to transportation of mixed-oxide SNF. (author)

The regulatory framework in the UK

International Nuclear Information System (INIS)

O'Sullivan, R.

1984-01-01

The subject is covered in sections, headed: basic regulatory requirements covering the transport of radioactive material in the UK; responsibility for safety (competent authority; provision of regulations; implementation of regulations (international and national); design of transport flask; safety case; testing; assessment; approval certificate; compliance assurance; administration); advice and information on the regulatory safety standards. (U.K.)

Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics

Directory of Open Access Journals (Sweden)

Ryan D. Rykhus

2017-12-01

Full Text Available Over the past two decades, the biopharmaceutical industry has seen unprecedented expansion and innovation in concert with significant technological advancements. While the industry has experienced marked growth, the regulatory system in the United States still operates at a capacity much lower than the influx of new drug and biologic candidates. As a result, it has become standard for months or even years of waiting for commercial approval by the U.S. Food and Drug Administration. These regulatory delays have generated a system that stifles growth and innovation due to the exorbitant costs associated with awaiting approval from the nation’s sole regulatory agency. The recent re-emergence of diseases that impact pediatric demographics represents one particularly acute reason for developing a regulatory system that facilitates a more efficient commercial review process. Herein, we present a range of initiatives that could represent early steps toward alleviating the delays in approving life-saving therapeutics.

Trends in global approvals of biotech crops (1992–2014)

Science.gov (United States)

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

ABSTRACT With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992–2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits. PMID:26039675

47 CFR 69.119 - Basic service element expedited approval process.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 3 2010-10-01 2010-10-01 false Basic service element expedited approval process. 69.119 Section 69.119 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES (CONTINUED) ACCESS CHARGES Computation of Charges § 69.119 Basic service element...

Modeling Dynamic Regulatory Processes in Stroke

Science.gov (United States)

McDermott, Jason E.; Jarman, Kenneth; Taylor, Ronald; Lancaster, Mary; Shankaran, Harish; Vartanian, Keri B.; Stevens, Susan L.; Stenzel-Poore, Mary P.; Sanfilippo, Antonio

2012-01-01

The ability to examine the behavior of biological systems in silico has the potential to greatly accelerate the pace of discovery in diseases, such as stroke, where in vivo analysis is time intensive and costly. In this paper we describe an approach for in silico examination of responses of the blood transcriptome to neuroprotective agents and subsequent stroke through the development of dynamic models of the regulatory processes observed in the experimental gene expression data. First, we identified functional gene clusters from these data. Next, we derived ordinary differential equations (ODEs) from the data relating these functional clusters to each other in terms of their regulatory influence on one another. Dynamic models were developed by coupling these ODEs into a model that simulates the expression of regulated functional clusters. By changing the magnitude of gene expression in the initial input state it was possible to assess the behavior of the networks through time under varying conditions since the dynamic model only requires an initial starting state, and does not require measurement of regulatory influences at each time point in order to make accurate predictions. We discuss the implications of our models on neuroprotection in stroke, explore the limitations of the approach, and report that an optimized dynamic model can provide accurate predictions of overall system behavior under several different neuroprotective paradigms. PMID:23071432

Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics.

Science.gov (United States)

Hernandez, J Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M; Molinski, Steven V

2017-01-01

The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.

Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics

Directory of Open Access Journals (Sweden)

J. Javier Hernandez

2017-11-01

Full Text Available The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.

The United States nuclear regulatory commission license renewal process

International Nuclear Information System (INIS)

Holian, B.E.

2009-01-01

The United States (U.S.) Nuclear Regulatory Commission (NRC) license renewal process establishes the technical and administrative requirements for the renewal of operating power plant licenses. Reactor ope-rating licenses were originally issued for 40 years and are allowed to be renewed. The review process for license renewal applications (L.R.A.) provides continued assurance that the level of safety provided by an applicant's current licensing basis is maintained for the period of extended operation. The license renewal review focuses on passive, long-lived structures and components of the plant that are subject to the effects of aging. The applicant must demonstrate that programs are in place to manage those aging effects. The review also verifies that analyses based on the current operating term have been evaluated and shown to be valid for the period of extended operation. The NRC has renewed the licenses for 52 reactors at 30 plant sites. Each applicant requested, and was granted, an extension of 20 years. Applications to renew the licenses of 20 additional reactors at 13 plant sites are under review. As license renewal is voluntary, the decision to seek license renewal and the timing of the application is made by the licensee. However, the NRC expects that, over time, essentially all U.S. operating reactors will request license renewal. In 2009, the U.S. has 4 plants that enter their 41. year of ope-ration. The U.S. Nuclear Industry has expressed interest in 'life beyond 60', that is, requesting approval of a second renewal period. U.S. regulations allow for subsequent license renewals. The NRC is working with the U.S. Department of Energy (DOE) on research related to light water reactor sustainability. (author)

Review process for license renewal applications

International Nuclear Information System (INIS)

Craig, John W.; Kuo, P.T.

1991-01-01

In preparation for license renewal reviews, the Nuclear Regulatory Commission has recently published for public review and comment a proposed rule for license renewal and a draft Standard Review Plan as well as a draft Regulatory Guide relating to the implementation of the proposed rule. In support of future license renewal applications, the nuclear industry has also submitted 11 industry reports for NRC review and approval. This paper briefly describe how these parallel regulatory and industry activities will be factored into the NRC review process for license renewal. (author)

What's the Regulatory Value of a Target Product Profile?

Science.gov (United States)

Breder, Christopher D; Du, Wenny; Tyndall, Adria

2017-07-01

Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog. Published by Elsevier Ltd.

Directory of certificates of compliance for radioactive materials packages: Summary report of NRC approved packages

International Nuclear Information System (INIS)

1987-11-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1). This directory makes available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volume 1

Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations.

Science.gov (United States)

Rosemann, Achim; Bortz, Gabriela; Vasen, Federico; Sleeboom-Faulkner, Margaret

2016-10-01

In this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU.

Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

Science.gov (United States)

Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

2014-01-01

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

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

Science.gov (United States)

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

2012-11-01

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

9 CFR 317.4 - Labeling approval.

Science.gov (United States)

2010-01-01

... undue economic hardship; and (iv) An unfair competitive advantage would not result from the granting of... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and...

76 FR 28102 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2011-05-13

... Analysis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555... qualitative, traditional or probabilistic), data, and criteria for considering risk are appropriate for making... 10 CFR part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants.'' Other types of...

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

Science.gov (United States)

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

2017-01-01

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

Some Numbers behind Canada's Decision to Adopt an Orphan Drug Policy: US Orphan Drug Approvals in Canada, 1997-2012.

Science.gov (United States)

Herder, Matthew; Krahn, Timothy Mark

2016-05-01

We examined whether access to US-approved orphan drugs in Canada has changed between 1997 (when Canada chose not to adopt an orphan drug policy) and 2012 (when Canada reversed its policy decision). Specifically, we looked at two dimensions of access to US-approved orphan drugs in Canada: (1) regulatory access; and (2) temporal access. Whereas only 63% of US-approved orphan drugs were granted regulatory approval in 1997, we found that regulatory access to US-approved orphan drugs in Canada increased to 74% between 1997 and 2012. However, temporal access to orphan drugs is slower in Canada: in a head-on comparison of 40 matched drugs, only two were submitted and four were approved first in Canada; moreover, the mean review time in Canada (423 days) was longer than that in the US (mean = 341 days), a statistically significant difference (t[39] = 2.04, p = 0.048). These results raise questions about what motivated Canada's apparent shift in orphan drug policy. Copyright © 2016 Longwoods Publishing.

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

International Nuclear Information System (INIS)

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

Creating a comprehensive, efficient, and sustainable nuclear regulatory structure. A Process Report from the U.S. Department of Energy's Material Protection, Control and Accounting Program

International Nuclear Information System (INIS)

Davis, Gregory E.; Brownell, Lorilee; Wright, Troy L.; Tuttle, John D.; Cunningham, Mitchel E.; O'Brien, Patricia E.

2006-01-01

This paper describes the strategies and process used by the U.S. Department of Energy's (DOE) nuclear Material Protection, Control and Accounting (MPC and A) Regulatory Development Project (RDP) to restructure its support for MPC and A regulations in the Russian Federation. The RDP adopted a project management approach to defining, implementing, and managing an effective nuclear regulatory structure. This approach included defining and developing the regulatory documents necessary to provide the Russian Federation with a comprehensive regulatory structure that supports an effective and sustainable MPC and A Program in Russia. This effort began in February 2005, included a series of three multi-agency meetings in April, June, and July, and culminated in August 2005 in a mutually agreed-upon plan to define and populate the nuclear regulatory system in the Russian Federation for non-military, weapons-usable material. This nuclear regulatory system will address all non-military Category I and II nuclear material at the Russian Federal Atomic Energy Agency (Rosatom), the Russian Agency for Industry (Rosprom), and the Federal Agency for Marine and River Transport (FAMRT) facilities; nuclear material in transport and storage; and nuclear material under the oversight of the Federal Environmental, Industrial and Nuclear Supervisory Service of Russia (Rostechnadzor). The Russian and U.S. MPC and A management teams approved the plan, and the DOE National Nuclear Security Administration's (NNSA) NA-255, Office of Infrastructure and Sustainability (ONIS), is providing funding. The Regulatory Development Project is managed by the Pacific Northwest National Laboratory (PNNL) for the U.S. Department of Energy's (DOE) NNSA

Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process.

Science.gov (United States)

Chambers, James D; Thorat, Teja; Wilkinson, Colby L; Neumann, Peter J

2017-08-01

We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes. We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains. Project HOPE—The People-to-People Health Foundation, Inc.

78 FR 32077 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

Science.gov (United States)

2013-05-29

... Fuel Storage Casks: MAGNASTOR[supreg] System AGENCY: Nuclear Regulatory Commission. ACTION: Direct... All-purpose Storage (MAGNASTOR[supreg]) System listing within the ``List of Approved Spent Fuel... CoC No. 1031, MAGNASTOR[supreg] System listing within the ``List of Approved Spent Fuel Storage Casks...

USAR managing and updating process

International Nuclear Information System (INIS)

Prah, M.; Spiler, J.

1996-01-01

In this paper basis and background of the FSAR (Final Safety Analysis Report) document and its conversion process to the USAR (Updated Safety Analysis Report) document are described. In addition, there are internal and external reviews as approval process presented. The following is included in our new approach to manage USAR changes: initiating the USAR change, technical reviewing, preparing a safety evaluation, KSC (Krsko Safety Committee) and KOC (Krsko Operating Committee) review, ESD Director approval, and the Regulatory Body review or approval. The intensive technological modification activities started in the year 1992 when the NEK Engineering Services Division was established. These activities are one of the most important reason for a very intensive USAR items change. The other reason for its conversation to an electronic format is a possibility for easier and faster searching, updating and changing process and introducing a new systematic USAR managing approach as mentioned above. (author)

The nuclear regulatory process in Canada experience and possible future direction

International Nuclear Information System (INIS)

Sainsbury, J.D.

1987-01-01

The underlying principle in the Canadian licensing process is that the licensee (owner/operatopr) bears the responsibility for safety while the regulatory authority sets safety objectives and audits their achievement. As a consequence, Canadian Regulatory Requirements emphasize numerical safety goals, and minimize specific design or operational rules. This paper traces the evolution of this approach, and indicates direction for the future. (author)

The process of regulatory authorization. A report by the CRPPH expert group on the regulatory application of Authorization (EGRA)

International Nuclear Information System (INIS)

2006-01-01

Governments and regulatory authorities are responsible for the definition of regulatory controls or conditions, if any, that should be applied to radioactive sources or radiation exposure situations in order to protect the public, workers and the environment. Although countries use different policy and structural approaches to fulfill this responsibility, the recommendations of the International Commission on Radiological Protection (ICRP) are generally used as at least part of the basis for protection. Previously, the ICRP recommended the use of variable approaches to protection. New ICRP recommendations are proposing a single, conceptually simple and self-coherent approach to defining appropriate protection under all circumstances. While the ICRP has been reviewing the broad principles of protection, the NEA Committee on Radiation Protection and Public Health (CRPPH) has been focusing its efforts on how radiological protection could be better implemented by governments and/or regulatory authorities. To this end, the CRPPH has developed a concept that it calls ''the process of regulatory authorization''. It is described in detail in this report, and is intended to help regulatory authorities apply more transparently, coherently and simply the broad recommendations of the ICRP to the real-life business of radiological protection regulation and application. In developing this concept, the CRPPH recognizes the importance of an appropriate level of stakeholder involvement in the process. (author)

Value Assessment in the Regulatory Context.

Science.gov (United States)

Miller, Kathleen L; Woodcock, Janet

2017-02-01

Value assessments are made on new drugs before they even enter the market. Regulators at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration make a clinical benefit-risk assessment to determine whether to approve a new drug. Benefits of a drug are typically quantified directly, as an assessment of efficacy. CDER defines risk as the intersection of the severity of possible harm and the probability of that harm. For a novel drug to be approved, its benefits and risks must be well understood, and the trade-off between the two must be acceptable. To assist with these benefit-risk value assessments, CDER has two ongoing initiatives: the Patient-Focused Drug Development Initiative that aims to substantially increase the role of patient voice in the regulatory process, and a transparency initiative that focuses on creating a structured framework for benefit-risk assessment. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

National legislative and regulatory activities

International Nuclear Information System (INIS)

2015-01-01

This section treats of the following National legislative and regulatory activities: 1 - Australia: General legislation - Bill to amend the Australian Radiation Protection and Nuclear Safety Act 1998; 2 - France: General legislation - Law No. 2015-992 of 17 August 2015 on the energy transition for green growth; ASN Report on the state of nuclear safety and radiation protection in France in 2014; 3 - Germany: Radioactive waste management - First Ordinance to amend the 2005 Gorleben Development Freeze Ordinance (2015); 4 - Greece: Radioactive waste management - Joint Ministerial Decision establishing the national policy on the management of spent fuel and radioactive waste; 5 - Lithuania: Nuclear safety and radiological protection - Revised requirements for modifications, Plan for enhancement of nuclear safety, New requirements for the commissioning of nuclear power plants, Revised requirements regulating the provision of information on abnormal events; Radioactive waste management - Revised requirements for acceptance criteria for near surface repository; Nuclear security - Revised requirements for physical protection; 6 - Romania: Licensing and regulatory infrastructure - Government Decision No. 600/2014 for approval of National Nuclear Safety and Security; International co-operation - Government Decision No. 525/2014 for approval of the Co-operation Agreement on the radioactive waste management between the French National Radioactive Waste Management Agency (ANDRA) and Nuclear Agency and Radioactive Waste (ANDR) Strategy; Memorandum of Understanding for Co-operation and Exchange of Information in Nuclear Regulatory Matters between the National Commission for Nuclear Activities Control (CNCAN) of Romania and the President of National Atomic Energy Agency (PAA) of Poland; Government Decision No. 540/2015 for approval of the Agreement between the Government of Romania and the Government of the People's Republic of China regarding co-operation in the peaceful

Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC approved packages

International Nuclear Information System (INIS)

1988-12-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Directory of certificates of compliance for radioactive materials packages, Report of NRC approved packages

International Nuclear Information System (INIS)

1990-10-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Materials Packages effective October 1, 1990. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

78 FR 16601 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

Science.gov (United States)

2013-03-18

... Storage Casks: MAGNASTOR[supreg] System AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule... (MAGNASTOR[supreg]) System listing within the ``List of Approved Spent Fuel Storage Casks'' to include... for the MAGNASTOR[supreg] System cask design within the list of approved spent fuel storage casks that...

Accelerated approval of oncology products: the food and drug administration experience.

Science.gov (United States)

Johnson, John R; Ning, Yang-Min; Farrell, Ann; Justice, Robert; Keegan, Patricia; Pazdur, Richard

2011-04-20

We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.

Regulatory issues resolved through design certification on the System 80+trademark standard plant design

International Nuclear Information System (INIS)

Ritterbusch, S.E.; Brinkman, C.B.

1996-01-01

The US Nuclear Regulatory Commission (NRC) has completed its review of the System 80+trademark Standard Plant Design, approving advanced design features and closing severe accident licensing issues. Final Design Approval was granted in July 1994. The NRC review was extensive, requiring written responses to over 4,950 questions and formal printing of over 50,000 Safety Analysis Report pages. New safety issues never before addressed in a regulatory atmosphere had to be resolved with detailed analysis and evaluation of design features. the System 80+ review demonstrated that regulatory issues can be firmly resolved only through presentation of a detailed design and completion of a comprehensive regulatory review

Development approach on usage of radiation and inspection of QA according to the change of approval procedure of safety regulatory guides

International Nuclear Information System (INIS)

Oh, B. J.; Ahn, H. Z.; Kim, S. W.; Yoo, S. O.; Kang, S. C.; Yang, S. H.; Han, S. J.; Kim, H. S.; Kim, H. J.

2002-01-01

In accordance with 2001 amendment of the Atomic Energy Act(AEA), KINS also amended its internal 'Regulation on Implementation of Entrusted AEA-related Work'. Up to now the nuclear safety-specialized institute has used its internally developed guidelines in the safety regulation. From now on, however, the institute will enhance the objectivity and transparency by having the instruments approved by the Ministry of Science ad Technology. In this paper, we introduced the major points and directions to be considered to the development of the safety regulatory guides on Inspection for the quality assurance of the nuclear reactor facilities and the use of radioisotopes, and review and inspection for dosimeter reading

GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations.

Science.gov (United States)

Van Eenennaam, Alison L

2013-09-25

In 2012, genetically engineered (GE) crops were grown by 17.3 million farmers on over 170 million hectares. Over 70% of harvested GE biomass is fed to food producing animals, making them the major consumers of GE crops for the past 15 plus years. Prior to commercialization, GE crops go through an extensive regulatory evaluation. Over one hundred regulatory submissions have shown compositional equivalence, and comparable levels of safety, between GE crops and their conventional counterparts. One component of regulatory compliance is whole GE food/feed animal feeding studies. Both regulatory studies and independent peer-reviewed studies have shown that GE crops can be safely used in animal feed, and rDNA fragments have never been detected in products (e.g. milk, meat, eggs) derived from animals that consumed GE feed. Despite the fact that the scientific weight of evidence from these hundreds of studies have not revealed unique risks associated with GE feed, some groups are calling for more animal feeding studies, including long-term rodent studies and studies in target livestock species for the approval of GE crops. It is an opportune time to review the results of such studies as have been done to date to evaluate the value of the additional information obtained. Requiring long-term and target animal feeding studies would sharply increase regulatory compliance costs and prolong the regulatory process associated with the commercialization of GE crops. Such costs may impede the development of feed crops with enhanced nutritional characteristics and durability, particularly in the local varieties in small and poor developing countries. More generally it is time for regulatory evaluations to more explicitly consider both the reasonable and unique risks and benefits associated with the use of both GE plants and animals in agricultural systems, and weigh them against those associated with existing systems, and those of regulatory inaction. This would represent a shift away

TU-AB-204-01: Device Approval Process

International Nuclear Information System (INIS)

Delfino, J.

2016-01-01

), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose

TU-AB-204-01: Device Approval Process

Energy Technology Data Exchange (ETDEWEB)

Delfino, J. [Food & Drug Administration (United States)

2016-06-15

), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.

Regulatory requirements related to maintenance and compliance monitoring

International Nuclear Information System (INIS)

Ling, A.K.H.

1997-01-01

The maintenance related regulatory requirements are identified in the regulatory documents and licence conditions. Licensee complies with these requirements by operating the nuclear power plant within the safe operating envelope as given in the operating policies and principles and do maintenance according to approved procedures and/or work plans. Safety systems are regularly tested. AECB project officers review and check to ensure that the licensee operates the nuclear power plant in accordance with the regulatory requirements and licence conditions. (author). 6 tabs

Bioattractors: dynamical systems theory and the evolution of regulatory processes

Science.gov (United States)

Jaeger, Johannes; Monk, Nick

2014-01-01

In this paper, we illustrate how dynamical systems theory can provide a unifying conceptual framework for evolution of biological regulatory systems. Our argument is that the genotype–phenotype map can be characterized by the phase portrait of the underlying regulatory process. The features of this portrait – such as attractors with associated basins and their bifurcations – define the regulatory and evolutionary potential of a system. We show how the geometric analysis of phase space connects Waddington's epigenetic landscape to recent computational approaches for the study of robustness and evolvability in network evolution. We discuss how the geometry of phase space determines the probability of possible phenotypic transitions. Finally, we demonstrate how the active, self-organizing role of the environment in phenotypic evolution can be understood in terms of dynamical systems concepts. This approach yields mechanistic explanations that go beyond insights based on the simulation of evolving regulatory networks alone. Its predictions can now be tested by studying specific, experimentally tractable regulatory systems using the tools of modern systems biology. A systematic exploration of such systems will enable us to understand better the nature and origin of the phenotypic variability, which provides the substrate for evolution by natural selection. PMID:24882812

2016 in review: FDA approvals of new molecular entities.

Science.gov (United States)

Griesenauer, Rebekah H; Kinch, Michael S

2017-11-01

An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms. Copyright © 2017 Elsevier Ltd. All rights reserved.

Treatment of differing professional opinions in the regulatory review process

International Nuclear Information System (INIS)

Shapar, H.K.

1978-01-01

The Nuclear Regulatory Commission is an independent body whose purpose is to assure that civilian nuclear activities are consistent with the public health and safety and environmental protection. To this effect, Congress has vested it with the necessary control powers. The question here is how to reconcile diverging opinions expressed within NRC by executives and technicians during the enquiry pocedure for licensing of nuclear installations. The diversity of professional viewpoints should be viewed as a positive factor strengthening the regulatory process and should therefore be maintained. However, decisions must be made; therefore some viewpoints will not prevail but that should not be construed as a signal that the internal discussion process is condemned. NRC staff are entitled to express their views and not subjected to professional and administrative sanctions for doing so. (NEA) [fr

Nuclear Regulatory Commission's antitrust review process: an analysis of the impacts

International Nuclear Information System (INIS)

1981-06-01

The Nuclear Regulatory Commission's (NRC) antitrust process is reviewed and its impacts to small systems and applicant systems are studied. This process takes the form of a description of the NRC's antitrust review process as implemented, a generic categorization of potential impacts and individual case-by-case studies of four different utilities

Croatian energy regulatory council - independent Croatian regulatory body

International Nuclear Information System (INIS)

Klepo, M.

2002-01-01

By means of approving five energy laws, the Republic of Croatia established an appropriate legislative framework for energy sector regulation. A series of sub-law acts is presently being elaborated as well as some additional documents in order to bring about transparent and non-discriminatory provisions for the establishment of electric energy, gas, oil/oil derivatives and thermal energy markets, i.e. for the introduction and management of market activities and public services. A considerable share of these activities relates to the definition of transparent regulatory mechanisms that would guarantee the implementation of regulation rules based on the law, and be carried out by the independent regulatory body - Croatian Energy Regulatory Council. The Council's rights and obligations include firm executive functions, which present obligations to every energy entity. A dissatisfied party may set in motion a settlement of dispute, if it maintains that the decisions are not based on the law or reveal a flaw in the procedure. Therefore, it is the Council's priority to always make careful and law-abiding decisions. This paper gives insight into the regulatory framework elements based on the laws including the Council's organisational structure and non-profit entities that will prepare act proposals for the Council and perform other professional activities. (author)

75 FR 15470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Science.gov (United States)

2010-03-29

...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is proposing... (Disclosure of Price and Concessions in Selling Agreements) and the deletion of NASD Rule 2770 (Disclosure of Price in Selling Agreements). FINRA Rule 5160 was approved by the Commission on January 25, 2010 \\5\\ and...

17 CFR 1.52 - Self-regulatory organization adoption and surveillance of minimum financial requirements.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Self-regulatory organization... Miscellaneous § 1.52 Self-regulatory organization adoption and surveillance of minimum financial requirements. (a) Each self-regulatory organization must adopt, and submit for Commission approval, rules...

Stakeholder involvement activities in Slovakia. NRA's Commitment to Transparent Regulatory Process. Stakeholder Involvement in the French Regulatory Process - From Public Information to Public Participation. Stakeholder involvement in nuclear decision making in the Russian Federation

International Nuclear Information System (INIS)

Ziakova, Marta Chairperson; Nuclear Regulatory Authority of the Slovak Republic; Nuclear Regulation Authority - NRA; Ferapontov, Alexey

2017-01-01

Session 2 focused on the regulatory perspectives related to stakeholder involvement in the regulatory decision-making process. Presentations provided the audience with information regarding the international and national legal framework implemented in the Slovak Republic, in France, in Japan and in Russia. Examples of stakeholder involvement, as well as some tools used for this purpose, were presented and discussed. The value of consistency and complementarity between international and national requirements was highlighted. Presentations and discussion confirmed the very close tie between the way the stakeholder involvement process is conducted and the public confidence and perception of reliability the regulatory body may gain, or lose. The four presentations confirmed that stakeholder involvement is a key challenge for maintaining regulatory body credibility, independence and legitimacy. All countries confirmed their commitment to trying to make their stakeholder involvement processes as open, visible, transparent and comprehensive as possible. Involvement represents a long and permanent process which requires investment of time, human resources and money, as well as the ability to reach out, to listen, to share, and to take input into account, while keeping in view the goal of delivering decisions that are as rational and objective as possible. Involving stakeholders is more than informing or communicating. The earlier the stakeholders are involved in the decision-making process, the greater the chance of success. If losing credibility is easy, all regulatory bodies agreed on the long process needed to recover it

Implementation of safety goals in NRC's regulatory process

International Nuclear Information System (INIS)

Murley, T.E.

1985-01-01

In May 1983 the Nuclear Regulatory Commission issued a policy statement on Safety Goals For Nuclear Power Plant Operation. The Commission at the same time judged that a two-year evaluation period was necessary to judge the effectiveness of the goals and design objectives, and directed the staff to develop information and understanding as to how to further define and use the design objectives and the cost-benefit guidelines. In carrying out the Commission's mandate, the staff framed three major questions to be addressed during the safety goal evaluation period. These three questions are: 1) to what extent is it practical to use safety goals in the regulatory process. 2) Should the quantitative design objectives be modified or supplemented. If so, how. 3) How should the safety goals be implemented at the end of the evaluation period. The staff's conclusions are discussed

Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved packages

International Nuclear Information System (INIS)

1983-01-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

The role of the US regulatory process in public acceptance of nuclear power

International Nuclear Information System (INIS)

Rowden, M.A.

1977-01-01

This paper focuses, on NRC's regulatory responsibilities in relation to public acceptance of nuclear power. Since public attitudes in the United States may influence reaction to nuclear power in other nations, it is fair to say that the credibility of our regulatory program has international significance. Stated simply, unless the public is convinced that the regulatory process is effective in assuring safety, safeguarding nuclear facilities and materials, and protecting the environment, the use of nuclear power could be curtailed or even brought to a halt. Not only must the regulatory process be effective, it must at the same time be recognized by the public as being effective. Opinion polls in the United States have shown consistently that a majority of Americans believe it is important to develop nuclear power to help meet our future energy needs. The direction of public concern has shifted from year to year. Most recently, public apprehension has been expressed about the potential hazards of long-term storage of the high-level wastes from spent fuel reprocessing, and about the risks that nuclear materials and facilities may be subject to theft or diversion or sabotage. Uppermost in the public mind is the question whether the regulatory process can cope with these potential threats to public health and safety. The licensing process of the NRC is conducted in full public view. Issues of a generic nature are aired in rulemaking hearings, while each proposal to construct and operate a nuclear power plant or a facility such as fuel reprocessing plant is the subject of public hearings, which are held near the site of the proposed plant. During the last two years, we have noted that some persons who object to nuclear power plants have indicated that they believe that decisions to permit construction of such plants should be made at the State government level, rather than by a Federal agency. As a result, there now are movements to enact State laws and to set up State

The regulatory process for the decommissioning of nuclear facilities

International Nuclear Information System (INIS)

1990-01-01

The objective of this publication is to provide general guidance to Member States for regulating the decommissioning of nuclear facilities within the established nuclear regulatory framework. The Guide should also be useful to those responsible for, or interested in, the decommissioning of nuclear facilities. The Guide describes in general terms the process to be used in regulating decommissioning and the considerations to be applied in the development of decommissioning regulations and guides. It also delineates the responsibilities of the regulatory body and the licensee in decommissioning. The provisions of this Guide are intended to apply to all facilities within the nuclear fuel cycle and larger industrial installations using long lived radionuclides. For smaller installations, however, less extensive planning and less complex regulatory control systems should be acceptable. The Guide deals primarily with decommissioning after planned shutdown. Most provisions, however, are also applicable to decommissioning after an abnormal event, once cleanup operations have been terminated. The decommissioning planning in this case must take account of the abnormal event. 28 refs, 1 fig

77 FR 63311 - Acacia Natural Gas Corporation; Notice of Petition for Rate Approval

Science.gov (United States)

2012-10-16

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR13-1-000] Acacia Natural Gas Corporation; Notice of Petition for Rate Approval Take notice that on October 9, 2012, Acacia Natural Gas Corporation (Acacia) filed a Petition for Rate Approval pursuant to 284.123(b)(2) of the...

The role of women in nuclear - attracting public participation in regulatory decision-making process

Science.gov (United States)

Mohamad Jais, Azlina; Hassan, Najwa

2018-01-01

Public participation is vital in demonstrating transparency and enhancing effectiveness of a nuclear regulatory process. As such, it is necessary for nuclear practitioners to involve the public in key nuclear delivery milestones. This paper specifically discusses challenges faced in attracting public participation throughout the nuclear regulatory decision-making process, and highlights the roles of women in nuclear (WiN) in initiating the said public discourse.

76 FR 41154 - Review and Approval of Projects

Science.gov (United States)

2011-07-13

..., production fluids, tophole water, and unconventional natural gas development. In order to encourage the reuse... techniques. The ``gallon one'' regulatory threshold currently applicable under the regulations to gas well... rulemaking; provide for administrative approval of interbasin transfers of flowback and production fluids...

REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

International Nuclear Information System (INIS)

Markman, D.W.

1999-01-01

Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control

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

Science.gov (United States)

2013-09-18

...-AB20 Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; kidSAFE... proposed self-regulatory guidelines submitted by the kidSAFE Seal Program (``kidSAFE''), owned and operated... enabling industry groups or others to submit to the Commission for approval self-regulatory guidelines that...

The current status of the debate on socio-economic regulatory assessments: positions and policies in Canada, the USA, the EU and developing countries

NARCIS (Netherlands)

Falck-Zepeda, J.; Wesseler, J.H.H.; Smyth, S.

2013-01-01

Article 26.1 of the Cartagena Protocol on Biosafety has the option of considering socio-economic issues in biosafety regulatory approval processes related to genetically engineered organisms. National laws and regulations in some countries have already defined positions and may have enacted policies

Food and Drug Administration Drug Approval Process: A History and Overview.

Science.gov (United States)

Williams, Christopher Ty

2016-03-01

In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively. Copyright © 2016 Elsevier Inc. All rights reserved.

17 CFR 202.11 - Public Company Accounting Oversight Board budget approval process.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Public Company Accounting Oversight Board budget approval process. 202.11 Section 202.11 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES § 202.11 Public Company Accounting Oversight...

Bioremediation, regulatory agencies and public acceptance of this technology

International Nuclear Information System (INIS)

Westlake, D. W. S.

1997-01-01

The technology of bioremediation, i.e. the utilization of microorganisms to degrade environmental pollutants, the dangers and consequences inherent in the large-scale use of microbial organisms in such processes, and the role of regulatory agencies in the utilization and exploitation of bioremediation technologies, were discussed. Factors influencing public acceptance of bioremediation as a satisfactory tool for cleaning up the environment vis-a-vis other existing and potential rehabilitation techniques were also reviewed. The ambiguity of regulatory agencies in the matter of bioremediation was noted. For example, there are many regulatory hurdles relative to the testing, use and approval of transgenic microorganisms for use in bioremediation. On the other hand, the use and release of engineered plants is considered merely another form of hybrid and their endorsement is proceeding rapidly. With regard to public acceptance, the author considered bioremediation technology as too recent, with not enough successful applications to attract public attention. Although the evidence suggests that bioremediation is environmentally safe, the efficacy, reliability and predictability of the various technologies have yet to be demonstrated. 25 refs

Directory of certificates of compliance for radioactive materials packages: Summary report of NRC approved quality assurance programs for radioactive material packages

International Nuclear Information System (INIS)

1987-11-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1987. This directory makes available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Overcoming regulatory and economic challenges facing pharmacogenomics.

Science.gov (United States)

Cohen, Joshua P

2012-09-15

The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

Slovak Nuclear Regulatory Body Position in the Transport of Radioactive Waste

International Nuclear Information System (INIS)

Homola, J.

2003-01-01

This paper describes safety requirements for transport of radioactive waste in Slovakia and the role of regulatory body in the transport licensing and assessment processes. Importance of radioactive waste shipments have been increased since 1999 by starting of NPP A-1 decommissioning and operation of near surface disposal facility. Also some information from history of shipment as well as future activities are given. Legal basis for radioactive waste transport is resulting from IAEA recommendations in this area. Different types of transport equipment were approved by regulatory body for both liquid and solid waste and transportation permits were issued to their shipment. Regulatory body attention during evaluation of transport safety is focused mainly on ability of individual packages to withstand different transport conditions and on safety analyses performed for transport equipment for liquid waste with high frequency of shipments. During past three years no event was occurred in connection with radioactive waste transport in Slovakia

Glycoconjugate Vaccines: The Regulatory Framework.

Science.gov (United States)

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.

U.S. Nuclear Regulatory Commission Process for Risk-Informing the Nuclear Waste Arena

International Nuclear Information System (INIS)

Leslie, B. W.

2003-01-01

The U.S. Nuclear Regulatory Commission (NRC) is increasing the use of risk insights and information in its regulation of nuclear materials and waste. The objective of this risk-informed regulatory effort is to improve the effectiveness and efficiency of the agency, while maintaining or increasing its focus on safety. The agency's Office of Nuclear Material Safety and Safeguards (NMSS) proposed a five-step process to carry out a framework for increasing the use of risk information and insights in its regulation of nuclear materials and waste. The office is carrying out the five-step process to risk-inform the nuclear materials and waste arenas. NMSS's actions included forming a Risk Task Group and the use of case studies to test and complete screening criteria for identifying candidate regulatory applications amenable for risk-informing. Other actions included involving stakeholders through enhanced public participation, developing safety goals for materials and waste regulatory applications, and establishing a risk training program for staff. Through the case studies, NRC staff found the draft screening criteria to be effective in deciding regulatory areas that may be amenable to an increased use of risk insights. NRC staff also found that risk information may have the potential to reduce regulatory burden and improve staff's efficiency in making decisions, while maintaining safety. Finally, staff found that it would be possible to develop safety goals for the nuclear materials and waste arenas

CNCAN Knowledge Management Process and Tools in Support of Sustainable Development of Regulatory Competences

International Nuclear Information System (INIS)

Tronea, M.; Ciurea, C.; Oprisescu, M.; Liutiev, C.; Ghinea, P.

2016-01-01

Full text: The paper presents the knowledge management process and the knowledge management portal developed by CNCAN, in the framework of the Regional Excellence Project on Regulatory Capacity Building in Nuclear and Radiological Safety, Emergency Preparedness and Response in Romania. The activities of this project started in 2014. The general process for knowledge management is presented, together with its sub-processes: identification of the necessary knowledge; identification of the risk of knowledge loss; acquisition and/or creation of knowledge; knowledge retention (capture, collect, store and organize knowledge); knowledge utilization; review of the effectiveness of the knowledge management process; identification of opportunities for improving the knowledge management process. The paper also presents a set of indicators of the effectiveness of the knowledge management process and the artifacts, espoused values and basic assumptions supporting an effective knowledge management process. The necessary knowledge has been identified using the IAEA recommendations on managing regulatory body competence and the SARCoN methodology. The knowledge management process has been developed based on the IAEA publications on knowledge management in the nuclear industry and in regulatory bodies. The implementation of the process and the development of the portal are ongoing, with more than 20% of the staff using the portal. (author

78 FR 11639 - Houston Pipe Line Company LP; Notice of Petition for Rate Approval

Science.gov (United States)

2013-02-19

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR13-31-000] Houston Pipe Line Company LP; Notice of Petition for Rate Approval Take notice that on February 1, 2013, Houston Pipe Line Company LP (HPL) filed for approval of rates for transportation service pursuant to section...

77 FR 11677 - Medicaid Program; Review and Approval Process for Section 1115 Demonstrations

Science.gov (United States)

2012-02-27

... for Medicare & Medicaid Services 42 CFR Part 431 Department of the Treasury 31 CFR Part 33 Department of Health and Human Services 45 CFR Part 155 Medicaid Program; Review and Approval Process for... Regulations#0;#0; [[Page 11678

Practice of Regulatory Science (Development of Medical Devices).

Science.gov (United States)

Niimi, Shingo

2017-01-01

Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

Deliberation by the French Energy Regulatory Commission of 13 July 2017 relating to the report on the implementation of GRTgaz's investment programme for 2016 and approving its amended investment programme for 2017. Deliberation by the French Energy Regulatory Commission of 13 July 2017 concerning the report on the implementation of TIGF's investment programme for 2016 and approving its amended investment programme for 2017

International Nuclear Information System (INIS)

Carenco, Jean-Francois; Chauvet, Christine; Edwige, Catherine; Gassin, Helene; Lastelle, Jean-Laurent

2017-01-01

Pursuant to the provisions of 2 of Article L.134-3 and of II of Article L.431-6 of the French Energy code, gas transmission system operators (TSOs) must transmit their annual investment programmes to the French Energy Regulatory Commission (CRE) for approval. Within this framework, CRE 'ensures that the investments required for the proper development of the networks, and for transparent and non-discriminatory access to them are made'. With regard to the investment programme for the year 2016: - in the deliberation of 17 December 2015, CRE approved GRTgaz's and TIGF's investment programmes for 2016; - in the deliberation of 15 December 2016, CRE approved the update of GRTgaz's and TIGF's 2016 investment programmes, and requested the operators to present, for mid-2017, the definitive report on the implementation of their 2016 investment programme. With regard to the investment programme for the year 2017: - in the deliberation of 15 December 2016, CRE approved GRTgaz's and TIGF's 2017 investment programmes, and requested the operators to present, for mid-2017, a report on the implementation mid-year of the investment programme for the year 2017. On 31 May 2017, GRTgaz's and TIGF's forwarded their amended investment programme for 2017 and were interviewed by CRE's Board on 6 July 2017. GRTgaz's and TIGF's presented the differences observed between the investment levels approved and the actual investments made for 2016 on the one hand, and the updated forecasts for 2017 on the other hand

Quality assurance within regulatory bodies

International Nuclear Information System (INIS)

1999-06-01

The IAEA directed extensive efforts during the years 1991 to 1995 to the integral revision of all NUSS quality assurance publications, which were approved and issued as Safety Series No.50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations (1996). When these quality assurance publications were developed, their prime focus was on requirements against which work performed by the licensees could be measured and assessed by the regulatory bodies. In this way, they only helped to facilitate the functions of regulators. No requirements or recommendations were provided on how the regulators should ensure the effective implementation of their own activities. The present publication is a first attempt to collect, integrate and offer available experience to directly support performance of regulatory activities. It presents a comprehensive compilation on the application of quality assurance principles and methods by regulatory bodies to their activities. The aim is consistent good performance of regulatory activities through a systematic approach

18 CFR 300.10 - Application for confirmation and approval.

Science.gov (United States)

2010-04-01

... REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS FOR FEDERAL POWER MARKETING ADMINISTRATIONS CONFIRMATION AND APPROVAL OF THE RATES OF FEDERAL POWER MARKETING ADMINISTRATIONS Filing Requirements § 300.10... with applicable laws and that it is the lowest possible rate consistent with sound business principles...

The European Medicines Agency's approval of new medicines for type 2 diabetes.

Science.gov (United States)

Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A

2018-05-08

Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.

The revised version of the German Radiation Protection Regulatory Guide for Medical Applications (Richtlinie Strahlenschutz in der Medizin)

International Nuclear Information System (INIS)

Kemmer, W.

1995-01-01

The revised version of the regulatory guide, effective since 1 June 1993, is intended to enhance and effect in practice a harmonisation of approval and acceptance procedures and standardized testing processes for acceptance and approval, as well as to facilitate governmental supervisory functions relating to the application of radioactive substances and ionizing radiation in the medical field. The guide can furthermore serve as a useful source of reference and information for doctors or medical personnel being trained in applying the Radiation Protection Ordinance, or for acquisition of the required expert knowledge in medical radiological protection. (orig./HP) [de

Competent authority approval of package designs in the United Kingdom

International Nuclear Information System (INIS)

Morgan-Warren, E.J.

1999-01-01

Type B packages and all packages containing fissile material, as well as special form radioactive materials, special arrangements and certain shipments, are required to be approved by the competent authority. In the United Kingdom competent authority approval is carried out on behalf of the Secretary of State by the Radioactive Materials Transport Division (RMTD) of the Department of the Environment, Transport and the Regions (DETR). Competent authority approval of a package design is given only after a detailed assessment of the design by the specialist staff of RMTD. There are three facets to the assessment procedure, namely engineering, criticality and radiation protection, and quality assurance. The engineering assessor ensures that the designer has demonstrated the integrity of the containment and shielding systems under the regulatory conditions. The criticality assessor examines criticality safety and radiation protection measures, and together with the engineering assessor, decides whether this is maintained under regulatory conditions. The quality assurance assessor verifies that the applicant has established the necessary controls to ensure that the design requirements are met. The applicant is responsible for making the case for approval, but the assessment is facilitated if the competent authority is involved with the designer at an early stage in development and during the construction of any test prototype. When a regulatory test programme is required, it is designed and carried out by the applicant, but agreed and witnessed by representatives of RMTD. Following the test programme, the applicant submits a formal application, supported by a design safety report (DSR). The DSR provides a full analysis of the design and the test results, including the behaviour of the package under normal and accident conditions of transport, the manufacturing and maintenance procedures, quality assurance and the emergency provisions for the operation of the package

Peptidomics and processing of regulatory peptides in the fruit fly Drosophila

Directory of Open Access Journals (Sweden)

Dennis Pauls

2014-06-01

Full Text Available More than a decade has passed since the release of the Drosophila melanogaster genome and the first predictions of fruit fly regulatory peptides (neuropeptides and peptide hormones. Since then, mass spectrometry-based methods have fuelled the chemical characterisation of regulatory peptides, from 7 Drosophila peptides in the pre-genomic area to more than 60 today. We review the development of fruit fly peptidomics, and present a comprehensive list of the regulatory peptides that have been chemically characterised until today. We also summarise the knowledge on peptide processing in Drosophila, which has strongly profited from a combination of MS-based techniques and the genetic tools available for the fruit fly. This combination has a very high potential to study the functional biology of peptide signalling on all levels, especially with the ongoing developments in quantitative MS in Drosophila.

A flexible regulatory framework

International Nuclear Information System (INIS)

Silvennoinen, T.

2000-01-01

Regulatory reform of the Finnish electricity market meant opening up potentially competitive parts of the electricity sector to competition and eliminating all unnecessary forms of regulation covering generation, wholesale supply, retail supply, and foreign trade in electricity. New types of control and regulatory mechanisms and institutions were set up for those parts of the electricity industry that were excluded from competition, such as network operations. Network activities now have to be licensed, whereas no licence is needed for generation or supply. A new sector-specific regulatory authority was established in 1995 to coincide with the implementation of the Electricity Market Act, known as the Electricity Market Authority. This is responsible for regulating network activities and retail supply to captive customers. The core function of the authority, which employs some 14 people, is to promote the smooth operation of the Finnish electricity market and to oversee the implementation of the Electricity Market Act and its provisions. Its most important duties are linked to overseeing the process by which network companies price their electricity. As price regulation no longer exists, all the companies in the electricity sector set their tariffs independently, even network companies. The job of controlling the pricing of network services is handed by the Electricity Market Authority, following the principles of competition control. Pricing control takes place ex post - after a pricing system has been adopted by a company and concentrates on individual cases and companies. There is no ex ante system of setting or approving prices and tariffs by the regulator. The tariffs and pricing of network services can be evaluated, however, by both the Electricity Market Authority and the Finnish Competition Authority, which have overlapping powers as regards the pricing of network activities. The Finnish regulatory framework can be described as a system of light

77 FR 56241 - Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000

Science.gov (United States)

2012-09-12

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0131] Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000 By letter dated December 10, 2010, Westinghouse Electric... final design approval (FDA) for the Advanced Passive 1000 (AP1000) design upon the completion of...

75 FR 15413 - Approval for Processing Authority, Foreign-Trade Zone 196, ATC Logistics & Electronics (Personal...

Science.gov (United States)

2010-03-29

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1671] Approval for Processing Authority, Foreign-Trade Zone 196, ATC Logistics & Electronics (Personal Navigation Devices), Fort Worth... & Electronics, an operator of Foreign-Trade Zone 196, has requested processing authority within FTZ 196 in Fort...

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

Science.gov (United States)

2012-02-28

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

48 CFR 2052.215-77 - Travel approvals and reimbursement.

Science.gov (United States)

2010-10-01

... reimbursement. 2052.215-77 Section 2052.215-77 Federal Acquisition Regulations System NUCLEAR REGULATORY....215-77 Travel approvals and reimbursement. As prescribed at 2015.209-70(d), the contracting officer shall insert the following clause in cost reimbursement solicitations and contracts which require travel...

Regulatory Oversight Program, July 1, 1993 - March 3, 1997. Volume 1

International Nuclear Information System (INIS)

1997-09-01

On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation

Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 1

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-09-01

On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation.

Avelumab: First Global Approval.

Science.gov (United States)

Kim, Esther S

2017-05-01

Avelumab (Bavencio ® ) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.

75 FR 56946 - Medicaid Program; Review and Approval Process for Section 1115 Demonstrations

Science.gov (United States)

2010-09-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 431 [CMS-2325-P] RIN 0938-AQ46 Medicaid Program; Review and Approval Process for Section 1115 Demonstrations AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This...

75 FR 51437 - Notice of Request for Extension of a Currently Approved Information Collection (Advanced Meat...

Science.gov (United States)

2010-08-20

... Request for Extension of a Currently Approved Information Collection (Advanced Meat Recovery) AGENCY: Food... information collection regarding the regulatory requirements associated with the production of meat from Advanced Meat Recovery systems because the OMB approval will expire on January 31, 2011. DATES: Comments on...

10 CFR 76.119 - Security facility approval and safeguarding of National Security Information and Restricted Data.

Science.gov (United States)

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Security facility approval and safeguarding of National Security Information and Restricted Data. 76.119 Section 76.119 Energy NUCLEAR REGULATORY COMMISSION... approval and safeguarding of National Security Information and Restricted Data. The requirements for...

Safety system upgrades to a research reactor: A regulatory perspective

International Nuclear Information System (INIS)

Lamarre, G.B.; Martin, W.G.

2003-01-01

The NRU (National Research Universal) reactor, located at the Chalk River Laboratories of Atomic Energy of Canada Limited (AECL), first achieved criticality November 3, 1957. AECL continues to operate NRU for research to support safety and reliability studies for CANDU reactors and as a major supplier of medical radioisotopes. Following a detailed systematic review and assessment of NRU's design and the condition of its primary systems, AECL formally notified the Canadian Nuclear Safety Commission's (CNSC) predecessor - the Atomic Energy Control Board - in 1992 of its intention to upgrade NRU's safety systems. AECL proposed seven major upgrades to provide improvements in shutdown capability, heat removal, confinement, and reactor monitoring, particularly during and after a seismic event. From a CNSC perspective, these upgrades were necessary to meet modern safety standards. From the start of the upgrades project, the CNSC provided regulatory oversight aimed at ensuring that AECL maintained a structured approach to the upgrades. The elements of the approach include, but are not limited to, the determination of project milestones and target dates; the formalization of the design process and project quality assurance requirements; the requirements for updated documentation, including safety reports, safety notes and commissioning reports; and the approval and authorization process. This paper details, from a regulatory perspective, the structured approach used in approving the design, construction, commissioning and subsequent operation of safety system upgrades for an existing and operating research reactor, including the many challenges faced when attempting to balance the requirements of the upgrades project with AECL's need to keep NRU operating to meet its important research and production objectives. (author)

Pharmacovigilance of biologicals : dynamics in post-approval safety learning

NARCIS (Netherlands)

Vermeer, N.S.

2015-01-01

Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict

75 FR 1734 - Children’s Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; i-SAFE...

Science.gov (United States)

2010-01-13

... Proposed Self-Regulatory Guidelines; i-SAFE, Inc. Application for Safe Harbor AGENCY: Federal Trade... for public comment concerning proposed self-regulatory guidelines submitted by i-SAFE, Inc. under the... approval self-regulatory guidelines that would implement the Rule's protections.\\3\\ \\1\\ 64 FR 59888 (1999...

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

Science.gov (United States)

Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

2016-01-01

Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

Managing the high level waste nuclear regulatory commission licensing process

International Nuclear Information System (INIS)

Baskin, K.P.

1992-01-01

This paper reports that the process for obtaining Nuclear Regulatory Commission permits for the high level waste storage facility is basically the same process commercial nuclear power plants followed to obtain construction permits and operating licenses for their facilities. Therefore, the experience from licensing commercial reactors can be applied to the high level waste facility. Proper management of the licensing process will be the key to the successful project. The management of the licensing process was categorized into four areas as follows: responsibility, organization, communication and documentation. Drawing on experience from nuclear power plant licensing and basic management principles, the management requirement for successfully accomplishing the project goals are discussed

78 FR 45112 - Approval and Promulgation of Air Quality Implementation Plans; Missouri; Reasonably Available...

Science.gov (United States)

2013-07-26

... description of the VOC rule that is proposed for approval in this action is provided below. 10 CSR 10-5.455... to approve a revision to Missouri's VOC rule 10 CSR 10-5.455 into Missouri's SIP, as EPA believes... regulatory action'' subject to review by the Office of Management and Budget under Executive Order 12866 (58...

Recent Advances in Drug Development and Regulatory Science in China.

Science.gov (United States)

Chen, Jie; Zhao, Naiqing

2018-01-01

As the second largest pharmaceutical market with a great potential for future growth, China has drawn much attention from the global pharmaceutical community. With an increasing government investment in biomedical research, the domestic biopharmaceutical (biotechnological) companies in China are turning their attention to the development of innovative medicines and targeting the global market. To introduce innovative products to Chinese patients sooner, to improve the efficiency of its review and approval processes, and to harmonize its regulatory science with international standards, the China Food and Drug Administration (CFDA) has initiated a series of major changes to its policies and regulations. This paper presents a snapshot of China's pharmaceutical market, and research and development status, and introduces technical guidelines pertaining to clinical trials and new drug applications. The recent wave of ground-breaking reforms in CFDA's regulatory science is discussed. Examples of clinical trials and new drug applications are provided throughout the discussion.

40 CFR 80.585 - What is the process for approval of a test method for determining the sulfur content of diesel or...

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false What is the process for approval of a... voluntary consensus-based standards bodies. For such a method to be approved, the following information must... approved: Any test method approved by a voluntary consensus-based standards body, such as the American...

Electronic Approval of Invoices (AEF)

CERN Document Server

2004-01-01

With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...

Directory of certificates of compliance for radioactive materials packages. Volume 1. Summary report of NRC approved packages

International Nuclear Information System (INIS)

1977-12-01

Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the U.S. Nuclear Regulatory Commission. This volume contains a summary report of NRC-approved packages for radioactive material packages effective Nov. 30, 1977

Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust.

Science.gov (United States)

Cazap, Eduardo; Jacobs, Ira; McBride, Ali; Popovian, Robert; Sikora, Karol

2018-05-16

Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics. Biosimilar approval pathways in many major regulatory regions worldwide are, to a broad degree, scientifically aligned. However, owing to regional differences in health care priorities, policies, and resources, some important regulatory inconsistencies are evident. Acceptance of biosimilars by health care systems, health care professionals, and patients will be a key factor in the uptake of these therapies, and such regulatory variations could contribute to confusion and diminished confidence regarding the quality, efficacy, and reliability of these agents. Furthermore, the need for manufacturers to account for regulatory inconsistencies introduces inefficiencies and delays into biosimilar development programs. These issues should be addressed if biosimilars are to attain their maximal global potential. This review summarizes the evolution of the global biosimilar landscape and provides examples of inconsistencies between regulatory requirements in different regions. In addition, we review ongoing efforts to improve regulatory alignment and highlight the importance of education as a crucial factor in generating trust in, and acceptance of, biosimilars on a worldwide scale. Biosimilars of monoclonal antibody anticancer therapies are beginning to emerge, and more are likely to become available for clinical use in the near future. The extent to which biosimilars

Approving cancer treatments based on endpoints other than overall survival: an analysis of historical data using the PACE Continuous Innovation Indicators™ (CII).

Science.gov (United States)

Brooks, Neon; Campone, Mario; Paddock, Silvia; Shortenhaus, Scott; Grainger, David; Zummo, Jacqueline; Thomas, Samuel; Li, Rose

2017-01-01

There is an active debate about the role that endpoints other than overall survival (OS) should play in the drug approval process. Yet the term 'surrogate endpoint' implies that OS is the only critical metric for regulatory approval of cancer treatments. We systematically analyzed the relationship between U.S. Food and Drug Administration (FDA) approval and publication of OS evidence to understand better the risks and benefits of delaying approval until OS evidence is available. Using the PACE Continuous Innovation Indicators (CII) platform, we analyzed the effects of cancer type, treatment goal, and year of approval on the lag time between FDA approval and publication of first significant OS finding for 53 treatments approved between 1952 and 2016 for 10 cancer types (n = 71 approved indications). Greater than 59% of treatments were approved before significant OS data for the approved indication were published. Of the drugs in the sample, 31% had lags between approval and first published OS evidence of 4 years or longer. The average number of years between approval and first OS evidence varied by cancer type and did not reliably predict the eventual amount of OS evidence accumulated. Striking the right balance between early access and minimizing risk is a central challenge for regulators worldwide. We illustrate that endpoints other than OS have long helped to provide timely access to new medicines, including many current standards of care. We found that many critical drugs are approved many years before OS data are published, and that OS may not be the most appropriate endpoint in some treatment contexts. Our examination of approved treatments without significant OS data suggests contexts where OS may not be the most relevant endpoint and highlights the importance of using a wide variety of fit-for-purpose evidence types in the approval process.

Information processing in the transcriptional regulatory network of yeast: Functional robustness

Directory of Open Access Journals (Sweden)

Dehmer Matthias

2009-03-01

Full Text Available Abstract Background Gene networks are considered to represent various aspects of molecular biological systems meaningfully because they naturally provide a systems perspective of molecular interactions. In this respect, the functional understanding of the transcriptional regulatory network is considered as key to elucidate the functional organization of an organism. Results In this paper we study the functional robustness of the transcriptional regulatory network of S. cerevisiae. We model the information processing in the network as a first order Markov chain and study the influence of single gene perturbations on the global, asymptotic communication among genes. Modification in the communication is measured by an information theoretic measure allowing to predict genes that are 'fragile' with respect to single gene knockouts. Our results demonstrate that the predicted set of fragile genes contains a statistically significant enrichment of so called essential genes that are experimentally found to be necessary to ensure vital yeast. Further, a structural analysis of the transcriptional regulatory network reveals that there are significant differences between fragile genes, hub genes and genes with a high betweenness centrality value. Conclusion Our study does not only demonstrate that a combination of graph theoretical, information theoretical and statistical methods leads to meaningful biological results but also that such methods allow to study information processing in gene networks instead of just their structural properties.

Reflections on the Ethics-Approval Process

Science.gov (United States)

Murray, Lee; Pushor, Debbie; Renihan, Pat

2012-01-01

It is sometimes a difficult journey receiving ethics approval for research involving vulnerable populations, research involving our own children, or innovative research methodologies such as autoethnography. This autoethnographical account is a story about one student who wanted to write a PhD dissertation in a very different way and also the…

Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive material packages

International Nuclear Information System (INIS)

1988-12-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

What is the Process Approvals for Survey Research in the Department of Defense (DoD)

Science.gov (United States)

2017-04-26

persons as individuals / representatives of agencies that elicit attitudes, opinions, behavior , and related demographic, social, and economic data to...processes are reported to be confusing. The survey approval process between services is inconsistent and time consuming . Barriers, real or perceived...The working group formed as part of the Behavioral Health Research Interest Group

Regulatory control of radiation sources in Slovakia

International Nuclear Information System (INIS)

Auxtova, L.

2001-01-01

In Slovakia, there are two regulatory authorities. Regulatory control of the utilization of nuclear energy, based on the Slovak National Council's law No. 130/1998 on the peaceful uses of nuclear energy, is exercised by the Nuclear Regulatory Authority of the Slovak Republic. The second regulatory authority - the Ministry of Health - is empowered by law No. 72/1994 on the protection of human health to license radiation sources and is responsible for radiation protection supervision (there are nearly 3000 establishments with sealed sources, radiation generators and unsealed sources in Slovakia). Pursuant to a new radiation protection regulation based on international standards, radiation sources are to be categorized in six classes according to the associated exposure and contamination hazards. A national strategy for improving the safety of radiation sources over their life-cycle and for the management of disused and orphan sources is being prepared for governmental approval. (author)

77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

Science.gov (United States)

2012-05-02

... exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval...] Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza AGENCY: Food and Drug... regulatory review period for Victoza and is publishing this notice of that determination as required by law...

Bringing the frame into focus: the influence of regulatory fit on processing fluency and persuasion.

Science.gov (United States)

Lee, Angela Y; Aaker, Jennifer L

2004-02-01

This research demonstrates that people's goals associated with regulatory focus moderate the effect of message framing on persuasion. The results of 6 experiments show that appeals presented in gain frames are more persuasive when the message is promotion focused, whereas loss-framed appeals are more persuasive when the message is prevention focused. These regulatory focus effects suggesting heightened vigilance against negative outcomes and heightened eagerness toward positive outcomes are replicated when perceived risk is manipulated. Enhanced processing fluency leading to more favorable evaluations in conditions of compatibility appears to underlie these effects. The findings underscore the regulatory fit principle that accounts for the persuasiveness of message framing effects and highlight how processing fluency may contribute to the "feeling right" experience when the strategy of goal pursuit matches one's goal.

Directory of certificates of compliance for radioactive materials packages. Volume 1. Summary report of NRC approved packages. Revision 6

International Nuclear Information System (INIS)

1983-09-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective September 14, 1983

Streamlining the Capstone Process: A Time-Saving Approval System for Graduate Theses/Projects

Science.gov (United States)

Grooms, James; Kline, Douglas; Cummings, Jeffrey

2016-01-01

Capstones have become an integral part of many information systems programs, both at the undergraduate and graduate level. One of the challenges can be tracking the process from the start of the capstone to completion. This paper describes the analysis, design and implementation of a web application for the approval workflow of a master's program…

Toward the Development of a Canadian Less Lethal Weapon Approval Process: A Study of Contemporary Process Models

Science.gov (United States)

2011-10-01

they must be ISO / IEC 17025 compliant. A list of laboratories accredited to also certify terminal apparatus is available on the Industry Canada...accredited by Standards Council of Canada or Certified to ISO / IEC 17025 . The emphasis in the approval process is on the independence of testing or the...of Canada. Industry Canada takes a similar approach depending on ISO / IEC 17025 certified labs for most testing. In summary, technical/testing

Impact of a Fragmented Regulatory Environment on Sustainable Urban Development Design Management

Directory of Open Access Journals (Sweden)

Kerry Anne London

2009-12-01

Full Text Available The building project development approval process is increasingly complex and fraught with conflict due to the rise of the sustainable urban development movement and inclusive decision making. Coupled with this, government decision-making decentralization has resulted in a fragmented and over-regulated compliance system. Problems arising from the process include wasted resources, excessive time delays, increased holding and litigation costs, inadequate planning coordination, high levels of advocacy costs and a divisive politicized approval process. In Australia, despite attempts by government and industry associations, numerous problems are still unresolved. Design managers increasingly assume a liaison role during the approval phase. There is a long tradition of planning theory literature which provides context for understanding the knowledge-power-participation relationship for this paper. This study investigated the policy, process and practice conflicts during the approval stage in achieving sustainable urban developments. Three regional local government areas within one state jurisdiction and observations from detailed structured focus group interviews involving 23 stakeholders, proposers and assessors were analysed to explore this conflictual environment. As a result of regulatory fragmentation and excessive consultation, various persuasion tactics have been developed by all stakeholders of which `reciprocity' and `authority' were identified as the most common. Two challenges for design managers were thus identified: first, the emergence of the role of a by default central informal arbitrator across conflicting planning instruments; and, second, as a navigator through a set of persuasion tactics. An inclusive knowledge-based design management framework for sustainable urban development is proposed considering Habermas' communicative planning theory, Foucaltian governance and discursive powers thesis and Cialdini's persuasion theory, as

Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC Approved Packages

International Nuclear Information System (INIS)

1993-10-01

This directory contains a Report of NRC Approved Packages (Volume 1). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

Science.gov (United States)

Kudrin, Alex; Knezevic, Ivana; Joung, Jeewon; Kang, Hye-Na

2015-01-01

The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia. The following topics were discussed by the working groups: clinical criteria for biosimilarity, extrapolation approach and the overall regulatory decision making process. In order to determine typical pitfalls in the design of a SBP clinical programme and evaluate the gap of knowledge, amongst different industry and regulatory stakeholders on the appraisal of the data arising from SBP clinical studies, we have presented two fictional but realistic clinical case studies. The first case consists of the fictional development programme for an infliximab SBP candidate. The second case describes clinical studies proposed for a fictional rituximab SBP candidate. In the first scenario a highly similar quality profile has been taken forward into clinical studies whereas there was an important residual difference in functional attributes for the rituximab SBP candidate. These case studies were presented at the WHO implementation workshop for the WHO guidelines on evaluation of similar biotherapeutic products held in Seoul, Republic of Korea, in May 2014. The goal was to illustrate the interpretation of the clinical data arising from studies with SBP candidates and elicit knowledge gaps in clinical assessment. This paper reflects the outcome of the exercise and discussions held in Seoul and offers an analysis of the case studies as a learning opportunity on clinical development and evaluation of SBPs. Copyright © 2014 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications.

Science.gov (United States)

Liberti, Lawrence; Stolk, Pieter; McAuslane, James Neil; Schellens, Jan; Breckenridge, Alasdair M; Leufkens, Hubert

2015-06-01

Guidance and exploratory evidence indicate that the type of endpoints and the magnitude of their outcome can define a therapy's clinical activity; however, little empirical evidence relates specific endpoint properties with regulatory outcomes. We explored the relationship of 3 endpoint properties to regulatory outcomes by assessing 50 oncology marketing authorization applications (MAAs; reviewed from 2009 to 2013). Overall, 16 (32%) had a negative outcome. The most commonly used hard endpoints were overall survival (OS) and the duration of response or stable disease. OS was a component of 91% approved and 63% failed MAAs. The most commonly used surrogate endpoints were progression-free survival (PFS), response rate, and health-related quality of life assessments. There was no difference (p = .3801) between the approved and failed MAA cohorts in the proportion of hard endpoints used. A mean of slightly more than four surrogate endpoints were used per approved MAA compared with slightly more than two for failed MAAs. Longer OS and PFS duration outcomes were generally associated with approvals, often when not statistically significant. The approved cohort was associated with a preponderance of statistically significant (p < .05) improvements in primary endpoints (p < .0001 difference between the approved and failed groups). Three key endpoint properties (type of endpoint [hard/surrogate], magnitude of an endpoint outcome, and its statistical significance) are consistent with the European Medicines Agency guidance and, notwithstanding the contribution of unique disease-specific circumstances, are associated with a predictable positive outcome for oncology MAAs. Regulatory decisions made by the European Medicines Agency determine which new medicines will be available to European prescribers and for which therapeutic indications. Regulatory success or failure can be influenced by many factors. This study assessed three key properties of endpoints used in

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Directory of Open Access Journals (Sweden)

Emel Mashaki Ceyhan

2018-01-01

Full Text Available Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP in order to facilitate the TITCK progress toward agency goals.Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA, Health Canada, Singapore's Health Science Authority (HSA, and the Saudi Arabia Food and Drug Administration (SFDA.Results: The TITCK performs a full review for all new active substance (NAS applications. Submission of a Certificate of Pharmaceutical product (CPP with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized.Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP process by sharing GMP inspection outcomes and certificates issued by

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore.

Science.gov (United States)

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Science.gov (United States)

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other

Right to experimental treatment: FDA new drug approval, constitutional rights, and the public's health.

Science.gov (United States)

Leonard, Elizabeth Weeks

2009-01-01

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

ELECTRONIC COMPLIANCE AND APPROVAL PROJECT (ECAP)

Energy Technology Data Exchange (ETDEWEB)

Hope Morgan; Richard A. Varela; Deborah LaHood; Susan Cisco; Mary Ann Benavides; Donna Burks

2002-11-01

The Texas Railroad Commission (RRC), working in partnership with the United States Department of Energy and the oil and gas industry it regulates, is implementing a strategy for improving efficiency in regulations and significantly reducing administrative operating costs through the Electronic Compliance and Approval Process (ECAP). The project will streamline regulatory compliance and reporting by providing the ability to electronically submit, process, and query oil and gas applications and reports through the Internet-based ECAP system. Implementation of an ECAP drilling permit pilot project began September 1999 after funding resources were secured--a $700,000 grant from the U.S. Department of Energy and an appropriation of $1.4 million from the Texas Legislature. The pilot project involves creating the ability to file, review, and approve a well's drilling permit application through a completely electronic process. The pilot project solution will ultimately provide the infrastructure, technology, and electronic modules to enable the filing of all compliance permits and performance reports through the internet from a desktop computer. The pilot project was conducted in three phases. The first phase, implemented May 2000, provided the infrastructure that allows the electronic filing and approval of simple drilling permit applications, associated fees, and attachments. The official ''roll-out'' of ECAP and the first electronically filed drilling permit application occurred on May 11, 2000 in Dallas in conjunction with an Internet Workshop sponsored by the Petroleum Technology Transfer Council. After the completion of Phase I, the ECAP team conducted an extensive review of progress to date and analyzed requirements and opportunities for future steps. The technical team identified core infrastructure modifications that would facilitate and better support future development and expansion of the ECAP system and work began on database structure

Price, performance, and the FDA approval process: the example of home HIV testing.

Science.gov (United States)

Paltiel, A David; Pollack, Harold A

2010-01-01

The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.

Licensing process of the digital application: Nuclear measurement analysis and control power range neutron monitor (NUMAC-PRNM) system for their implementation in the Laguna Verde NPP unit 2

International Nuclear Information System (INIS)

Ledesma-Carrion, R.; Hernandez-Cortes, A.

1998-01-01

This paper describe the licensing process performed by the Mexican Regulatory Commission (CNSNS) for the NUclear Measurement Analysis and Control-Power Range Neutron Monitor (NUMAC-PRNM) system, which sends trip signals to the Reactor Protection System (RPS), and has been implemented in the Laguna Verde Nuclear Power Plant Unit (LVNPP-U2) before its first fuel loading. The review and approval process was performed with the advise role of the United States of America Nuclear Regulatory Commission (USNRC): the regulatory frame applied includes the Code of Federal Regulation, some Regulatory Guides and some Industrial Standards. The evaluation covered topics related with the software, hardware and firmware specifications, design, tests, training, maintenance and operational experience. After the revision of these topics, the NUMAC-PRNM was approved through the CNSNS Safety Evaluation Report (SER) and then installed in the LVNPP-U2. This paper include a description of the regulatory requirements to this digital application, the safety concerns involved, the compliance to these requirements by the utility and the results of the CNSNS evaluation, mentioning the experience acquired during the process and the method used to perform the evaluation. Additionally, the interface between the designer-vendor, the utility and the regulatory body during the licensing process is commented. Finally, the conclusion is presented, taking into account the operational experience of the NUMAC applications implemented in the LVNPP. It also gives the future regulatory tasks related to the assessment of digital performance equipment and upgrades. (author)

A critical assessment of regulatory triggers for products of biotechnology: Product vs. process

Science.gov (United States)

McHughen, Alan

2016-01-01

ABSTRACT Regulatory policies governing the safety of genetic engineering (rDNA) and the resulting products (GMOs) have been contentious and divisive, especially in agricultural applications of the technologies. These tensions led to vastly different approaches to safety regulation in different jurisdictions, even though the intent of regulations—to assure public and environmental safety—are common worldwide, and even though the international scientific communities agree on the basic principles of risk assessment and risk management. So great are the political divisions that jurisdictions cannot even agree on the appropriate triggers for regulatory capture, whether product or process. This paper reviews the historical policy and scientific implications of agricultural biotechnology regulatory approaches taken by the European Union, USA and Canada, using their respective statutes and regulations, and then critically assesses the scientific underpinnings of each. PMID:27813691

Enhancing regulatory effectiveness by improving the process for identifying and resolving generic issues

International Nuclear Information System (INIS)

Vander Molen, Harold J.

2001-01-01

The Generic Issues Program first began formally in response to a Commission directive in October of 1976. In 1983, it became one of the first programs to make successful use of probabilistic risk information to aid in regulatory decision-making. In the 16 years since the program became quantitative, 836 issues have been processed. Of these, 106 reactor safety issues were prioritized as requiring further evaluation to determine the final resolution. Approximately a dozen generic issues remain unresolved. Although there is far less reactor licensing activity than in the 1970s, new issues continue to be identified from research and operational experience. These issues often involve complex and controversial questions of safety and regulation, and an efficient and effective means of addressing these issues is essential for regulatory effectiveness. Issues that involve a significant safety question require swift, effective, enforceable, and cost-effective regulatory actions. Issues that are of little safety significance must be quickly shown to be so and dismissed in an expeditious manner so as to avoid unnecessary expenditure of limited resources and to reduce regulatory uncertainty. Additionally, in the time since the generic issue program began, probabilistic risk assessment techniques have advanced significantly while agency resources have continued to diminish. Accordingly, the paper discusses the steps that have been taken to enhance the effectiveness and efficiency of the generic issue resolution process. Additionally, four resolved issues are discussed, along with key elements of a proposed new procedure for resolving potential generic issues

Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved quality assurance programs for radioactive material packages

International Nuclear Information System (INIS)

1983-01-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Directory of Certificates of Compliance for Radioactive Materials Packages. Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages. Volume 3. Revision 5

International Nuclear Information System (INIS)

1985-10-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1985. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory. Shipments of radioactive material utilizing these packages must be in accordance with the provisions of 49 CFR Section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with a Nuclear Regulatory Commission approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR Section 71.12 does not authorize the receipt, possession, use or transfer of byproduct, source or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, or 70

78 FR 62322 - Hydropower Regulatory Efficiency Act of 2013; Notice of Rescheduled Two-Year Licensing Process...

Science.gov (United States)

2013-10-16

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD13-9-000] Hydropower... recommendations on the feasibility of a two-year process for the issuance of a license for hydropower development... Hydropower Regulatory Efficiency Act of 2013. The workshop will be held in the Commission Meeting Room at 888...

The PREEV project of the Latin American Forum.Regulatory practices on aging and life extension

International Nuclear Information System (INIS)

Figueras, J. M.

2011-01-01

The American Forum Plenary approved in 2008 the PREEV project, Regulatory Practices in Aging and Life Extension, whose main objective is to improve the regulatory action with regard to the management programs of life and long-term operation of nuclear power plants in the countries of the region Latin American.

Regulatory pathways for vaccines for developing countries.

Science.gov (United States)

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

Regulatory compliance guide for DOT-7A type A packaging design

International Nuclear Information System (INIS)

Kelly, D.L.

1996-01-01

The purpose of this guide is to provide instruction for assuring that the regulatory design requirements for a DOT-7A Type A packaging are met. This guide also supports the testing and evaluation activities that are performed on new packaging designs by a DOE-approved test facility through the DOE's DOT-7A Test Program. This Guide was updated to incorporate regulatory changes implemented by HM-169A (49 CFR, 'Transportation')

A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.

Science.gov (United States)

Hourd, Paul; Medcalf, Nicholas; Segal, Joel; Williams, David J

2015-01-01

Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.

Organization and practices on regulatory review in the licensing process of nuclear power plants in Spain

International Nuclear Information System (INIS)

Trueba, P.

1979-01-01

The actual organisation, practices and experience of the JEN Nuclear Safety Department on the regulatory review in the licensing process of nuclear power plants in Spain, are presented. Topics to be covered are: The structure, organisation, staff and principal functional areas of the NSD, the academic qualifications and work experience of the NSD personnel, recruiting and training, the conduct of the regulatory review during the licensing process and working procedures, the manpower and coverage of the different technical areas, the principal problems and conclusions. (author)

Organization of nuclear regulatory activities

International Nuclear Information System (INIS)

Blidaru, Valentin

2008-01-01

facilities; - Accident analyses; - Criticality calculations; - Licensing process for TRIGA research reactor; - Application of RESP code for CANDU type power reactors. The main tasks, objectives and methodologies applied by the Regulatory Authority are presented. The main nuclear facilities to which specific regulatory approaches are applied are: - Cernavoda Nuclear Power Plant Unit 1; - Cernavoda NPP Unit 2; - TRIGA Research reactor; - WWR-S research reactor (in conservation); - Specific installations related to the nuclear safety area of licensing, namely; - devices as C-2, C-5, C-6, by the TRIGA research reactor; - criticality aspects relating to transportation and storage of the fresh and spent fuels; - CANDU6 fuel plant; - dry storage facilities for spent fuel. The second half of the paper deals with specific aspects concerning the TRIGA research reactors. There are described the regulatory approaches and the licensing process, it is given a presentation of the configuration of the reactor, the operation of replacing the HEU fuel by LEU fuel, operation and applications of the reactor and finally specific aspects of the licensing process. These aspects concern the following issues: - reactivity accidents; - core interaction; - fuel temperature; prompt negative temperature coefficient. The regulatory approach for further licensing process deals with the following aspects: - nuclear safety documentation assessment for the reactor and each experimental device; - the operational licence to be issued for the whole nuclear unit; - technical nuclear safety documentation to be revised by the licensee and additional safety assessment to be performed for the reactor itself and also for the experimental devices in order to establish the concordance with the design changes (conversion to LEU from HEU fuel, 6 control rods in the reactor control system); - technical limits and conditions to be well established according to the tests conclusions or independent calculations and safety

Mexico's Regulatory Engagement in Bulk Electric Power System Planning: An Overview of U.S. Practices and Tools

Energy Technology Data Exchange (ETDEWEB)

O' Neill, Barbara; Hurlbut, David; Pena, Ivonne; Gagne, Douglas; Cook, Jeff; Bracho, Ricardo

2016-06-01

Mexico's transition to a modern wholesale power market will place new demands on how regulators evaluate and approve transmission expansion projects. Transmission projects in a modern wholesale market fulfill one of several needs, and utilities, regional transmission organizations, and regulatory authorities in the United States have encountered comparable challenges in their market transitions to ensure projects meeting each type of need can be built. The purpose of this report is to open a window to view that experience. The report examines key practices of different U.S. jurisdictions that have moved from transmission planning to transmission approval, and it focuses on the role of the regulator in supporting a planning process that equitably meets identified needs.

Exploring the impact of permitting and local regulatory processes on residential solar prices in the United States

International Nuclear Information System (INIS)

Burkhardt, Jesse; Wiser, Ryan; Darghouth, Naïm; Dong, C.G.; Huneycutt, Joshua

2015-01-01

This article statistically isolates the impacts of city-level permitting and other local regulatory processes on residential PV prices in the United States. We combine data from two “scoring” mechanisms that independently capture local regulatory process efficiency with the largest dataset of installed PV prices in the United States. We find that variations in local permitting procedures can lead to differences in average residential PV prices of approximately $0.18/W between the jurisdictions with the least-favorable and most-favorable permitting procedures. Between jurisdictions with scores across the middle 90% of the range (i.e., 5th percentile to 95th percentile), the difference is $0.14/W, equivalent to a $700 (2.2%) difference in system costs for a typical 5-kW residential PV installation. When considering variations not only in permitting practices, but also in other local regulatory procedures, price differences grow to $0.64–$0.93/W between the least-favorable and most-favorable jurisdictions. Between jurisdictions with scores across the middle 90% of the range, the difference is equivalent to a price impact of at least $2500 (8%) for a typical 5-kW residential PV installation. These results highlight the magnitude of cost reduction that might be expected from streamlining local regulatory regimes. - Highlights: • We show local regulatory processes meaningfully affect U.S. residential PV prices. • We use regression analysis and two mechanisms for “scoring” regulatory efficiency. • Local permitting procedure variations can produce PV price differences of $0.18/W. • Broader regulatory variations can produce PV price differences of $0.64–$0.93/W. • The results suggest the cost-reduction potential of streamlining local regulations

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

Science.gov (United States)

2012-06-05

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

Evaluation of transport safety analysis processes of radioactive material performed by a regulatory body

International Nuclear Information System (INIS)

Mattar, Patricia Morais

2017-01-01

Radioactive substances have many beneficial applications, ranging from power generation to uses in medicine, industry and agriculture. As a rule, they are produced in different places from where they are used, needing to be transported. In order for transport to take place safely and efficiently, national and international standards must be complied with. This research aims to assess the safety analysis processes for the transport of radioactive material carried out by the regulatory body in Brazil, from the point of view of their compliance with the International Atomic Energy Agency (IAEA) standards. The self-assessment methodology named SARIS, developed by the AIEA, was used. The following steps were carried out: evaluation of the Diagnosis and Processes Mapping; responses to the SARIS Question Set and complementary questions; SWOT analysis; interviews with stakeholders and evaluation of a TranSAS mission conducted by the IAEA in 2002. Considering only SARIS questions, processes are 100% adherent. The deepening of the research, however, led to the development of twenty-two improvement proposals and the identification of nine good practices. The results showed that the safety analysis processes of the transport of radioactive material are being carried out in a structured, safe and reliable way but also that there is much opportunity for improvement. The formulation of an action plan, based on the presented proposals, can bring to the regulatory body many benefits. This would be an important step towards convening an external evaluation, providing greater reliability and transparency to the regulatory body´s processes. (author)

49 CFR 107.709 - Processing of an application for approval, including an application for renewal or modification.

Science.gov (United States)

2010-10-01

... TRANSPORTATION HAZARDOUS MATERIALS AND OIL TRANSPORTATION HAZARDOUS MATERIALS PROGRAM PROCEDURES Approvals... before the disposition of an application. (b) At any time during the processing of an application, the...

75 FR 2897 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Science.gov (United States)

2010-01-19

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule... hereby given that on December 23, 2009, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). NASD Rule 2450...

Self-Regulatory Processes Mediate the Intention-Behavior Relation for Adherence and Exercise Behaviors

NARCIS (Netherlands)

Bruin, de M.; Sheeran, P.; Kok, G.; Hiemstra, A.; Prins, J.M.; Hospers, H.J.; Breukelen, G.J.P.

2012-01-01

Objectives: Understanding the gap between people's intentions and actual health behavior is an important issue in health psychology. Our aim in this study was to investigate whether self-regulatory processes (monitoring goal progress and responding to discrepancies) mediate the intention-behavior

Factors related to drug approvals: predictors of outcome?

Science.gov (United States)

Liberti, Lawrence; Breckenridge, Alasdair; Hoekman, Jarno; McAuslane, Neil; Stolk, Pieter; Leufkens, Hubert

2017-06-01

There is growing interest in characterising factors associated with positive regulatory outcomes for drug marketing authorisations. We assessed empirical studies published over the past 15 years seeking to identify predictive factors. Factors were classified to one of four 'factor clusters': evidentiary support; product or indication characteristics; company experience or strategy; social and regulatory factors. We observed a heterogeneous mix of technical factors (e.g., study designs, clinical evidence of efficacy) and less studied social factors (e.g., company-regulator interactions). We confirmed factors known to be of relevance to drug approval decisions (imperative) and a cohort of less understood (compensatory) social factors. Having robust supportive clinical evidence, addressing rare or serious illness, following scientific advice and prior company experience were associated with positive outcomes, which illustrated the multifactorial nature of regulatory decision making and factors need to be considered holistically while having varying, context-dependent importance. Copyright © 2017 Elsevier Ltd. All rights reserved.

Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule

Directory of Open Access Journals (Sweden)

Chia-Wei eTsai

2015-12-01

Full Text Available On December 14, 2012, the FDA approved raxibacumab, the first product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or Animal Rule. Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues.

Regulatory policies for using oil dispersants in the Barents Sea

Directory of Open Access Journals (Sweden)

Natalia Belkina

2015-04-01

Full Text Available Use of dispersants requires assessment of which environmental values are at stake. In the Barents Sea this issue is of high concern as large oil spills can cause transboundary pollution, affecting the interests of two neighbouring countries. The Joint Contingency Plan in the Barents Sea does not set any specific requirements for use of dispersants and lets Norway and Russia follow their national procedures. The Plan emphasizes that in case of transboundary pollution the decision to use dispersants shall only be undertaken upon common agreement. The paper presents a comparison of the national regulatory approaches of Norway and Russia to using dispersants. The research is based on the analysis of legislative documents and interviews with oil companies, oil spill responders and relevant national authorities. The research reveals that in both countries use of dispersants requires preliminary authorization of the national agencies. In Norway the pre-approval procedure and the algorithm of dispersants involvement in response to a real accident are clearly documented and are regularly tested. This has made the process of approval for using dispersants more efficient. In Russia the lack of practical experience in using dispersants and well-established approval procedures can result in a long and unclear permitting process for each oil spill case. This could seriously hinder the use of dispersants to combat transboundary pollution in the Barents Sea, even if it is considered to be beneficial. We conclude that the development of a harmonized approach for dispersants use in the Barents Sea should be thoroughly assessed.

Investigating relationship between self- and co-regulatory learning processes in a workplace e-learning system

NARCIS (Netherlands)

Rahimi, E.; Tampinongkol, S.; Sedighi, M.; Van den Berg, J.; Veen, W.

2014-01-01

While supporting regulatory learning processes in work environments is increasingly becoming important, there is not a clear picture of the interaction between self- and coregulatory processes performed by learners in workplace e-learning systems. In this paper, by following a design-based research

30 CFR 948.15 - Approval of West Virginia regulatory program amendments.

Science.gov (United States)

2010-07-01

..., 2008 CSR 38-2-2.39 (deletion of cumulative impact definition).CSR 38-2-3.22.e (approval of material... Legislative Rules at title 38, Series 2. June 29, 1990 October 4, 1991 CSR 38-2 §§ 2, 3, 5, 6, 9, 11 through 14, 17, 20, 22. July 12, 1991 November 19, 1991 CSR 38-2-20.5, .6, .7. July 30, 1993 August 16, 1995...

Digital mammography. Why hasn't it been approved for U.S. hospitals?

Science.gov (United States)

2000-01-01

Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.

Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice.

Science.gov (United States)

Cohen, A D; Wu, J J; Puig, L; Chimenti, S; Vender, R; Rajagopalan, M; Romiti, R; de la Cruz, C; Skov, L; Zachariae, C; Young, H S; Foley, P; van der Walt, J M; Naldi, L; Prens, E P; Blauvelt, A

2017-12-01

The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of 'big data' should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies. © 2017 British Association of Dermatologists.

Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety.

Science.gov (United States)

Shimazawa, Rumiko; Ikeda, Masayuki

2016-03-01

Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.

Nuclear energy's future: lifting the regulatory cloud

International Nuclear Information System (INIS)

Walske, C.

1983-01-01

Nuclear energy provides 13% of US and 10% of world electricity, with an exemplary safety record and less insult to the environment than any other power source. Walske argues that nuclear power is 15% cheaper than coal despite the high capital and regulatory costs, but regulatory delays in the construction and licensing periods have increased 70% to 10 to 14 years, more than twice the lead time in France and Japan. The long lead time exaggerates the difficulty in forecasting demand, and allows interruptions for fundamental design changes after construction has begun. Walske outlines new legislation for site pre-approval, plant standardization, combined construction and operating licenses, and hybrid procedures for public hearings that would make regulation less uncertain

A Process Perspective on Regulation: A Grounded Theory Study into Regulatory Practice in Newly Liberalized Network-Based Markets

NARCIS (Netherlands)

Ubacht, J.

The transition from a former monopolistic towards a more competitive market in
newly liberalized network-based markets raises regulatory issues. National Regulatory Authorities (NRA) face the challenge to deal with these issues in order to guide the transition process. Although this transition

Methodological challenges for the evaluation of clinical effectiveness in the context of accelerated regulatory approval: an overview.

Science.gov (United States)

Woolacott, Nerys; Corbett, Mark; Jones-Diette, Julie; Hodgson, Robert

2017-10-01

Regulatory authorities are approving innovative therapies with limited evidence. Although this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology assessment, where assessment of cost-effectiveness requires reliable estimates of effectiveness relative to existing clinical practice. Some key issues associated with a limited evidence base include using data, from nonrandomized studies, from small single-arm trials, or from single-center trials; and using surrogate end points. We examined these methodological challenges through a pragmatic review of the available literature. Methods to adjust nonrandomized studies for confounding are imperfect. The relative treatment effect generated from single-arm trials is uncertain and may be optimistic. Single-center trial results may not be generalizable. Surrogate end points, on average, overestimate treatment effects. Current methods for analyzing such data are limited, and effectiveness claims based on these suboptimal forms of evidence are likely to be subject to significant uncertainty. Assessments of cost-effectiveness, based on the modeling of such data, are likely to be subject to considerable uncertainty. This uncertainty must not be underestimated by decision makers: methods for its quantification are required and schemes to protect payers from the cost of uncertainty should be implemented. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Electronic Approval of Invoices (AEF)

CERN Multimedia

2003-01-01

With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95

75 FR 75678 - Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA

Science.gov (United States)

2010-12-06

..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review... or systemic therapy. Subsequent to this approval, the Patent and Trademark Office received a patent...

Technology Overview Using Case Studies of Alternative Landfill Technologies and Associated Regulatory Topics

National Research Council Canada - National Science Library

2003-01-01

... alternative landfill cover projects. The purpose of the case studies is to present examples of the flexibility used in the regulatory framework for approving alternative landfill cover designs, current research information about the use...

First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan　- Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent.

Science.gov (United States)

Konishi, Akihide; Ho, Mami; Shirai, Yuko; Shirato, Haruki

2018-05-25

A prospective randomized clinical trial showed that the BioFreedom stent (Biosensors International), which is a polymer-free and carrier-free drug-coated stent, was significantly superior to a bare-metal stent (BMS) in patients at high bleeding risk who were receiving a 1-month course of dual antiplatelet therapy (DAPT). However, the stent thrombosis rate (2.01% for BioFreedom vs. 2.20% for BMS) was 4-6-fold higher than that of approved drug-eluting stents based on real-world data in Japan. Furthermore, the frequency of stent thrombosis at more than 1 month with the BioFreedom stent was slightly higher than that at less than 1 month. This result suggested that it would not be acceptable to stop DAPT universally at 1 month. Thus, the target patients for the BioFreedom stent are unspecified patients at high bleeding risk needing to continue DAPT for as long as necessary in Japan. Therefore, based on the pre- and post-marketing balance of medical devices regulations, regulatory approval was given for unspecified patients conditionally upon real-world data collection of 2,000 patients with a Use-Results Survey, instead of conducting additional pre-marketing clinical trial(s). The Use-Results Survey System is part of a strategy to expedite patients' access to innovative medical devices and to accelerate the development of medical devices.

Regulatory Approval Decisions in the Presence of Market Externalities: The Case of Genetically Modified Wheat

OpenAIRE

Furtan, William Hartley; Gray, Richard S.; Holzman, J.J.

2005-01-01

This study examines the optimal approval strategy for genetically modified (GM) wheat varieties in Canada and the United States. Without an affordable segregation system, the introduction of GM wheat will create a market for "lemons" that will result in the loss of important export markets. Using a differentiated product trade model for spring wheat, with endogenous technology pricing, a payoff matrix is generated for the possible approval outcomes. Results show that the existence of the mark...

Application for approval to construct the Waste Receiving And Processing facility

International Nuclear Information System (INIS)

1993-02-01

The following Application For Approval Of Construction is being submitted by the US Department of Energy, Richland Field Office pursuant to 40 CFR 61.07, ''Application for Approval of Construction or Modification,'' for the Waste Receiving and Processing (WRAP) Module 1 facility (also referred to as WRAP 1). The WRAP 1 facility will be a new source of radioactive emissions to the atmosphere. The WRAP 1 facility will be housed in the new 2336-W Building, which will be located in the 200 West Area south of 23rd Street and west of Dayton Avenue. The 200 West Area is located within the boundary of the Hanford Site. The mission of the WRAP 1 facility is to examine, assay, characterize, treat, and repackage solid radioactive and mixed waste to enable permanent disposal of the waste in accordance with all applicable regulations. The solid wastes to be handled in the WRAP 1 facility include low-level waste (LLW), Transuranic (TRU) waste, TRU mixed waste, and low-level mixed waste (LLMW). The WRAP 1 facility will only accept contact handled (CH) waste containers. CH waste is a waste category whose external surface dose rate does not exceed 200 mrem/h. These containers have a surface dose rate of less than 200 mrem/h

75 FR 27340 - Enterprise Alabama Intrastate, LLC; Notice of Petition for Rate Approval

Science.gov (United States)

2010-05-14

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR10-21-000] Enterprise..., Enterprise Alabama Intrastate, LLC (Enterprise Alabama) filed a petition for rate approval pursuant to section 284.123(b)(2) of the Commission's regulations. Enterprise Alabama states it is filing to justify...

Safety regulation for the design approval of special form radioactive sources

International Nuclear Information System (INIS)

Cho, Woon-Kap

2009-01-01

Several kinds of special form radioactive sources for industrial, medical applications are being produced in Korea. Special form radioactive sources should meet strict safety requirements specified in the domestic safety regulations and the design of the sources should be certified by the regulatory authority, the Ministry of Education, Science and Technology (MEST). Several safety tests such as impact, percussion, heating, and leak tests are performed on the sources according to the domestic regulations and the international safety standards such as ANSI N542-1977 and ISO 2919-1999(E). As a regulatory expert body, Korea Institute of Nuclear Safety (KINS) assesses various types of application documents, such as safety analysis report, quality assurance program, and other documents evidencing fulfillment of requirements for design approval of the special form radioactive sources, submitted by a legal person who intends to produce special form radioactive sources and then reports the assessment result to MEST. A design approval certificate is issued to the applicant by MEST on the basis of a technical evaluation report presented by KINS.

MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

Energy Technology Data Exchange (ETDEWEB)

Kroger, L. [University of California Davis (United States)

2015-06-15

The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

International Nuclear Information System (INIS)

Kroger, L.

2015-01-01

The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

Regulatory review of NPP Krsko Periodic Safety Review

International Nuclear Information System (INIS)

Lovincic, D.; Muehleisen, A.; Persic, A.

2004-01-01

At the request of the Slovenian Nuclear Safety Administration (SNSA), Krsko NPP prepared a Periodic Safety Review (PSR) program in January 2001. This is the first PSR of NPP Krsko, the only nuclear power plant in Slovenia. The program was reviewed by the IAEA mission in May 2001 and approved by SNSA in July 2001. The program is made in accordance with the IAEA Safety Guide 'Periodic Safety Review of Operational Nuclear Power Plants' No. 50-SG-012 and with European practice. It contains a systematic review of operation of the NPP Krsko, including the review of the changes as a result of the modernization of the facility. The main tasks of PSR are review of plant status for each safety factor, development of aging and life cycle management program, review of seismic design and PSHA analysis and update of regulatory compliance program. The prioritization process of findings and action plan are also important tasks of PSR. The basic safety factors of the PSR review are: Operational Experience, Safety Assessment and Analyses, Equipment Qualification and Ageing Management, Safety Culture, Emergency Planing, Environmental Impact and Radioactive Waste, Compliance with license requirements and Prioritization. It had been agreed that SNSA will have reviewed all PSR reports generated during the PSR process. At the end of 2003 the PSR Summary Report with selected recommendations for action plan was completed and delivered to SNSA for review. The paper presents regulatory review of NPP Krsko PSR with emphasis on the evaluation of the PSR issues ranking process. (author)

Ethical and regulatory problems of molecular imaging

International Nuclear Information System (INIS)

Jeong, Jae Min

2004-01-01

As a molecular imaging is the most up-to-date technology in nuclear medicine, it has complicate ethical and regulatory problems. For animal experiment, we have to follow institutional animal care committee. For clinical experiment, we have to get approval of Institutional Review Board according to Helsinki declaration. In addition, approval from Korea Food and Drug Administration (KFDA) is essential for manufacturing and commercialization. However, too much regulation would suppress development of new technology, which would result in the loss of national competitive power. In addition, most new radioactive ligands for molecular imaging are administered to human at sub-pharmacological and sub-toxicological level. In conclusion, a balanced regulation is essential for the safety of clinical application and development of new technology

Innovative farmers and regulatory gatekeepers: Genetically modified crops regulation and adoption in developing countries.

Science.gov (United States)

Sinebo, Woldeyesus; Maredia, Karim

2016-01-02

The regulation of genetically modified (GM) crops is a topical issue in agriculture and environment over the past 2 decades. The objective of this paper is to recount regulatory and adoption practices in some developing countries that have successfully adopted GM crops so that aspiring countries may draw useful lessons and best practices for their biosafatey regulatory regimes. The first 11 mega-GM crops growing countries each with an area of more than one million hectares in 2014 were examined. Only five out of the 11 countries had smooth and orderly adoption of these crops as per the regulatory requirement of each country. In the remaining 6 countries (all developing countries), GM crops were either introduced across borders without official authorization, released prior to regulatory approval or unapproved seeds were sold along with the approved ones in violation to the existing regulations. Rapid expansion of transgenic crops over the past 2 decades in the developing world was a result of an intense desire by farmers to adopt these crops irrespective of regulatory roadblocks. Lack of workable biosafety regulatory system and political will to support GM crops encouraged unauthorized access to GM crop varieties. In certain cases, unregulated access in turn appeared to result in the adoption of substandard or spurious technology which undermined performance and productivity. An optimal interaction among the national agricultural innovation systems, biosafety regulatory bodies, biotech companies and high level policy makers is vital in making a workable regulated progress in the adoption of GM crops. Factoring forgone opportunities to farmers to benefit from GM crops arising from overregulation into biosafety risk analysis and decision making is suggested. Building functional biosafety regulatory systems that balances the needs of farmers to access and utilize the GM technology with the regulatory imperatives to ensure adequate safety to the environment and human

77 FR 26290 - Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA

Science.gov (United States)

2012-05-03

..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... chronic gout in adult patients refractory to conventional therapy. Subsequent to this approval, the Patent...

Incorporating consideration of health impacts into land use development approval processes: Development of a Health Background Study Framework.

Science.gov (United States)

Moloughney, Brent W; Bursey, Gayle E; Neumann, Jana; Leeming, Daniel H; Gutmann, Christine E; Sivanand, Bhavna; Mowat, David L

2014-09-12

This project involved development of a Health Background Study (HBS) Framework to support consideration of health impacts within municipalities' approval process for land use development. Peel Public Health and Toronto Public Health led the project with the participation of planners, urban designers, engineers, public health staff and development industry representatives. Historical growth in the Region of Peel and suburban Toronto has resulted in extensive low-density development, creating car-dependent communities with disconnected streets and segregated land uses. The inclusion of an HBS in developers' applications to municipalities is one approach by which health-related expectations for the built environment can be established within the approval process. Development of the HBS Framework used the six core elements of the built environment with the strongest evidence for impact on health and was informed by analysis of the provincial and local policy contexts, practices of other municipalities and stakeholder interviews. The Framework's contents were refined according to feedback from multidisciplinary stakeholder workshops. The HBS Framework identifies minimum standards for built environment core elements that developers need to address in their applications. The Framework was created to be simple and instructive with applicability to a range of development locations and scales, and to various stages of the development approval process. Peel Public Health is leading several initiatives to support the use of the HBS as a part of the development application process. The HBS Framework is a tool that public health and planning can use to support the consideration of health impacts within municipalities' land use development processes.

75 FR 19645 - Enterprise Texas Pipeline LLC; Notice of Petition for Rate Approval

Science.gov (United States)

2010-04-15

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR10-14-000] Enterprise..., 2010, Enterprise Texas Pipeline LLC (Enterprise Texas) filed a petition for rate approval pursuant to section 284.123(b)(2) of the Commission's regulations. Enterprise Texas proposes rates of $0.6090 per...

75 FR 64771 - Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for BATS Y-Exchange, Inc.

Science.gov (United States)

2010-10-20

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63113; File No. 4-616] Self-Regulatory... provisions of Rule 19d-1(c)(1) of the Act \\4\\ requiring that a self-regulatory organization promptly file... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs...

77 FR 4203 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System, Revision 2

Science.gov (United States)

2012-01-27

... Storage Casks: MAGNASTOR[supreg] System, Revision 2 AGENCY: Nuclear Regulatory Commission. ACTION: Direct... storage regulations by revising the NAC International, Inc. (NAC) MAGNASTOR[supreg] System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 2 to Certificate of...

75 FR 33736 - List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision 1

Science.gov (United States)

2010-06-15

... Fuel Storage Casks: MAGNASTOR System, Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION... storage cask regulations by revising the NAC International, Inc. (NAC), MAGNASTOR System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 1 to Certificate of...

Miracle drug: Brazil approves never-tested cancer medicine.

Science.gov (United States)

Kuchenbecker, Ricardo S; Mota, Daniel M

2017-07-01

Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.

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

Science.gov (United States)

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

1998-01-01

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

Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.

Science.gov (United States)

Halioua-Haubold, Celine-Lea; Peyer, James G; Smith, James A; Arshad, Zeeshaan; Scholz, Matthew; Brindley, David A; MacLaren, Robert E

2017-12-01

Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs fall in the United States, the European Union, and Japan, and a comprehensive overview of the regulatory guidance applicable to the developer of GTP. Understanding the regulatory requirements for seeking GTP market approval in these major jurisdictions is crucial for an effective and expedient path to market. The novel challenges facing GTP developers is highlighted by a case study of alipogene tiparvovec (Glybera).

Supporting the self-regulatory resource: does conscious self-regulation incidentally prime nonconscious support processes?

Science.gov (United States)

Dorris, Derek C

2009-11-01

Ego-depletion (depletion of self-regulatory strength) can impair conscious efforts at self-regulation. Research into nonconscious self-regulation has demonstrated that preconscious automaticity and implementation intentions can automatically carry out regulatory tasks during times of ego-depletion. However, preconscious automaticity can only emerge during well-practiced tasks while implementation intentions can only support tasks that have been explicitly planned. Thus, when it comes to supporting the conscious self-regulation of nonroutine and unplanned behaviour during times of ego-depletion these processes should be ineffective. However, it is argued here that because the conscious self-regulation of nonroutine and unplanned behaviour can incidentally prime the underlying mental representations those primed representations can be postconsciously re-activated to support that behaviour during times of ego-depletion. Postconscious self-regulation might, therefore, support a type of self-regulatory behaviour that has, thus far, not been associated with any form of support.

1988-year of high integrity container evaluation, controversy and regulatory action

International Nuclear Information System (INIS)

Jones, D.

1989-01-01

During 1988, the Nuclear Regulatory Commission(NRC) completed review of and prepared technical evaluation reports on several topical reports describing containers designed to meet the 10CFR61 requirements for high integrity containers (HICs). An all metal Ferralium container and a stainless steel/polyethylene lined container were approved by the NRC. However, the NRC did not approve any containers designed from polyethylene material. The NRC staff concluded that polyethylene containers do not meet the structural stability requirements of Part 61, and unless they are combined with some engineered structure or overpack, they are not adequate for disposal of low-level radioactive wastes that require disposal in a structurally stable form. In conflict with these NRC findings, the State of South Carolina Department of Health and Environmental Control (SCDHEC) has given interim approval for continued use of polyethylene containers at the Barnwell disposal site with some restrictions on how the containers are buried depending on the classification of the waste. This paper reviews the applicable federal regulations, presents a chronology of events describing how the controversy over high integrity containers evolved from 1980 to 1989, summarizes the technical issues involved and suggests an approach that waste generators should follow during this situation of regulatory uncertainty

77 FR 59679 - Central Vermont Public Service Corporation (Millstone Power Station, Unit 3); Order Approving...

Science.gov (United States)

2012-09-28

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0044; Docket No. 50-423] Central Vermont Public Service Corporation (Millstone Power Station, Unit 3); Order Approving Application Regarding Corporate Restructuring and Conforming Amendment I Dominion Nuclear Connecticut, Inc. (DNC), Central Vermont Public Service...

Creating a Comprehensive, Efficient, and Sustainable Nuclear Regulatory Structure: A Process Report from the U.S. Department of Energy's Material Protection, Control and Accounting Program

International Nuclear Information System (INIS)

Wright, Troy L.; O'Brien, Patricia E.; Hazel, Michael J.; Tuttle, John D.; Cunningham, Mitchel E.; Schlegel, Steven C.

2010-01-01

With the congressionally mandated January 1, 2013 deadline for the U.S. Department of Energy's (DOE) Nuclear Material Protection, Control and Accounting (MPC and A) program to complete its transition of MPC and A responsibility to the Russian Federation, National Nuclear Security Administration (NNSA) management directed its MPC and A program managers and team leaders to demonstrate that work in ongoing programs would lead to successful and timely achievement of these milestones. In the spirit of planning for successful project completion, the NNSA review of the Russian regulatory development process confirmed the critical importance of an effective regulatory system to a sustainable nuclear protection regime and called for an analysis of the existing Russian regulatory structure and the identification of a plan to ensure a complete MPC and A regulatory foundation. This paper describes the systematic process used by DOE's MPC and A Regulatory Development Project (RDP) to develop an effective and sustainable MPC and A regulatory structure in the Russian Federation. This nuclear regulatory system will address all non-military Category I and II nuclear materials at State Corporation for Atomic Energy 'Rosatom,' the Federal Service for Ecological, Technological, and Nuclear Oversight (Rostechnadzor), the Federal Agency for Marine and River Transport (FAMRT, within the Ministry of Transportation), and the Ministry of Industry and Trade (Minpromtorg). The approach to ensuring a complete and comprehensive nuclear regulatory structure includes five sequential steps. The approach was adopted from DOE's project management guidelines and was adapted to the regulatory development task by the RDP. The five steps in the Regulatory Development Process are: (1) Define MPC and A Structural Elements; (2) Analyze the existing regulatory documents using the identified Structural Elements; (3) Validate the analysis with Russian colleagues and define the list of documents to be

75 FR 60157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Science.gov (United States)

2010-09-29

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...

Auditing the process of ethics approval for Master’s degrees at a South African university

Directory of Open Access Journals (Sweden)

Damian Clarke

2014-04-01

Full Text Available Introduction. This study audited the process of ethics approval for Master’s research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa.Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master’s proposal for the year 2010 was reviewed. Results. A total of 53 proposals for Master’s degrees were available for review. All the proposals were for low-risk studies, and all were subjected to expedited review. It took an average of 15 weeks (range 3 - 32 for the institutional ethics review board (the Biomedical Research Ethics Committee (BREC to respond to each of the 53 proposals. Twenty-three studies (43.4% received provisional approval on the first response, 2 proposals (3.8% were rejected, and 28 proposals (52.8% were sent back with major queries. For the 28 proposals that required major revisions, 11 responses had been submitted by the time the data were collected. The average length of time to receive a response from the applicants to BREC queries was 4 weeks.Conclusion. This study suggests that there is a potential cumulative delay of over 4 months before data collection for low-risk clinical audits can be commenced. Any system designed to improve this situation must ensure that high standards of vigilance are maintained, but must be flexible enough to allow for a faster review and approval process.

Neuroimaging of developmental psychopathologies: the importance of self-regulatory and neuroplastic processes in adolescence.

Science.gov (United States)

Spessot, Alexandra L; Plessen, Kerstin J; Peterson, Bradley S

2004-06-01

Normal brain maturational and developmental processes, together with plastic reorganization of the brain in response to experiential demands, contribute to the acquisition of improved capacities for self-regulation and impulse control during adolescence. The frontal lobe is a main focus for these developmental and plastic processes during the transition from adolescence into adulthood. Tourette syndrome (TS), defined as the chronic presence of motor and vocal tics, has been increasingly conceptualized as a disorder of impaired self-regulatory control. This disordered control is thought to give rise to semicompulsory urges to perform the movements that constitute simple tics, complex tics, or compulsions. Neuroimaging studies suggest that the expression of the genetic diathesis to TS is influenced by genetic and nongenetic factors affecting activity-dependent reorganization of neuroregulatory systems, thereby influencing the phenotype, illness severity, and adult outcome of tic disorders. Similar developmental processes during adolescence likely determine the phenotype and natural history of a broad range of other complex neuropsychiatric disorders of childhood onset, and they likely contribute to the acquisition of improved self-regulatory capacities that characterize normal adolescent development.

76 FR 20759 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Science.gov (United States)

2011-04-13

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

75 FR 71164 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Science.gov (United States)

2010-11-22

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved packages. Volume 1, Revision 18

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date.

Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved packages. Volume 1, Revision 18

International Nuclear Information System (INIS)

1995-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date

MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223

Energy Technology Data Exchange (ETDEWEB)

Phillips, L. [Stanford University (United States)

2015-06-15

The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223

International Nuclear Information System (INIS)

Phillips, L.

2015-01-01

The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

A complex process - transforming scientific research into regulatory rules for environmental protection

International Nuclear Information System (INIS)

Yan, J.J.; Goss, D.; Huffman, A.

2002-01-01

The protection of isolated wetlands from consumptive use withdrawals has been a policy in the South Florida Water Management District (SFWMD) for over 15 years. A guideline for protecting isolated wetlands was established in the mid-1980's for the consumptive water use permitting program administered by the SFWMD. The guideline specifies groundwater drawdown criteria associated with well field pumpage. In 1994, the SFWMD convened a panel of wetland scientists to review the existing groundwater drawdown criteria. The panel concluded there was insufficient information to determine if the criteria were either too restrictive or insufficient in protecting wetlands. The panel recommended that the SFWMD conduct research to answer related questions. Since that time, staff at the SFWMD have developed a research plan, selected 38 isolated wetland monitoring sites in seven study areas, collected over four years of data, and developed an integrated surface water and groundwater simulation model. However, the staff at the SFWMD has had difficulties in transforming the research results into regulatory rules. The nature of an isolated wetland is quite complicated. Its setting changes significantly from time to time depending on the variation of rainfall, hydro-geological conditions, and human activities. A regulatory rule requires simple and more easily measurable criteria. The regulatory staff need simple tools to evaluate many permit applications within a limited time frame. The tools used in the research process are often complicated and time consuming. This paper describes the wetland research, and the difficulties of transforming research results into regulatory rules. (author)

76 FR 60106 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Science.gov (United States)

2011-09-28

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... 14, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

Managing risk in developing transplant immunosuppressive agents: the new regulatory environment.

Science.gov (United States)

Gabardi, S; Halloran, P F; Friedewald, J

2011-09-01

Recent adverse experience with a number of medications after their approval, including rofecoxib, erythropoietin and rosiglitazone, has led to an increased focus on safety in drug development in the postmarketing setting. The result was implementation of new measures to address perceived deficits in the system for drug approval and postmarketing safety. The resulting legislation introduced risk evaluation and mitigation strategies (REMS) and postmarketing requirements (PMRs). Although these initiatives have the potential to improve patient outcomes, many healthcare practitioners are not yet familiar with REMS or PMRs or may have misconceptions regarding their goals and limitations. REMS is a program to manage known or potential serious risks associated with pharmaceutical products and is designed to ensure that the benefits of using a particular product outweigh the risks. Although the concepts underlying REMS and PMRs are not novel, the FDA now has legal authority to enforce such measures as part of the drug approval process. This article outlines the objectives and limitations of REMS and PMRs, with a focus on how these regulatory measures may impact the clinical specialty of transplantation. The article also briefly describes efforts to address aspects of drug safety less amenable to management through REMS and PMRs. © 2011 The Authors Journal compilation © 2011 The American Society of Transplantation and the American Society of Transplant Surgeons.

Protection of third parties by collateral clauses of plan approvals or licenses

International Nuclear Information System (INIS)

Badura, P.

1989-01-01

This contribution discusses the regulatory functions of collateral clauses of plan approvals or licences, the legal protection of the constitutional and other rights of third parties in connection with the licensing of installations or similar projects, infringements of such rights and means of defence, and protection of neighbours under public law against noise. (RST) [de

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

Science.gov (United States)

2012-02-10

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... thereunder,\\2\\ notice is hereby given that on January 30, 2012, Financial Industry Regulatory Authority, Inc.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

Regulatory systems for the control of land remediation processes

Energy Technology Data Exchange (ETDEWEB)

Lowe, J.; Vijgen, J.; Summersgill, M.

2003-07-01

One of the recurring themes in looking at land remediation over the last decade has been identifying and overcoming barriers to the use of innovative, sustainable technologies, whilst still ensuring that there are no adverse environmental impacts from their use. In parallel with this, the regeneration of brownfield sites has increasingly needed effective and economic solutions that leave the site without the stigma of being associated with contamination and waste disposal. Regulatory controls are often identified as one of the main barriers to both of these objectives. Previously, the focus of attention in the study of regulatory controls relating to land contamination has largely been on regimes that trigger the need for clean-up. These may be pollution control legislation or land-use planning controls. However, the focus of this paper will be on the controls on the selection and implementation of the remediation technologies and processes themselves. It will look in particular at the European-wide controls on waste management, pollution prevention and environmental impact assessment. The UK work is being carried out by a working group involving: landowners; developers; public sector regeneration agencies; house-builders; industry; insurers; technology providers; professional advisers; local government authorities; and national government regulators and policy-makers. This multi-stakeholder approach has facilitated the identification of practical, legal, financial and administrative issues to assist in developing new solutions. (orig.)

Access to the decision-making process: opportunities for public involvement in the facility decommissioning process of the United States Nuclear Regulatory Commission

International Nuclear Information System (INIS)

Cameron, F.X.

1996-01-01

This paper discusses recent initiatives taken by the United States Nuclear Regulatory Commission NRC) to effectively involve the public in decommissioning decisions. Initiatives discussed include the Commission's rulemaking to establish the radiological criteria for decommissioning, as well as public involvement methods that have been used on a site-by-site basis. As un example of public involvement, the NRC is currently in the process of developing generic rules on the radiological criteria for the decontamination and decommissioning of NRC-licensed sites. Not only was this proposed rule developed through an extensive and novel approach for public involvement, but it also establishes the basic provisions that will govern public involvement in future NRC decisions on the decommissioning of individual sites. The aim is to provide the public with timely information about all phases of the NRC staff to express concerns and make recommendations. Th NRC recognizes the value and the necessity of effective public involvement in its regulatory activities and has initiated a number of changes to its regulatory program to accomplish this. From the NRC's perspective, it is much easier and less costly to incorporate these mechanisms for public involvement into the regulatory program early in the process, rather than try to add them after considerable public controversy on an action has already been generated. The historical antecedents for initiatives mentioned, as well as 'lessons learned' from prior experience are also discussed. (author)

The Danish Regulatory Reform of Telecommunications

DEFF Research Database (Denmark)

Skouby, Knud Erik

1998-01-01

An overview of the liberalisation process and regulatory reform of telecommunications in Denmark......An overview of the liberalisation process and regulatory reform of telecommunications in Denmark...

Regulatory considerations for computational requirements for nuclear criticality safety

International Nuclear Information System (INIS)

Bidinger, G.H.

1995-01-01

As part of its safety mission, the U.S. Nuclear Regulatory Commission (NRC) approves the use of computational methods as part of the demonstration of nuclear criticality safety. While each NRC office has different criteria for accepting computational methods for nuclear criticality safety results, the Office of Nuclear Materials Safety and Safeguards (NMSS) approves the use of specific computational methods and methodologies for nuclear criticality safety analyses by specific companies (licensees or consultants). By contrast, the Office of Nuclear Reactor Regulation approves codes for general use. Historically, computational methods progressed from empirical methods to one-dimensional diffusion and discrete ordinates transport calculations and then to three-dimensional Monte Carlo transport calculations. With the advent of faster computational ability, three-dimensional diffusion and discrete ordinates transport calculations are gaining favor. With the proper user controls, NMSS has accepted any and all of these methods for demonstrations of nuclear criticality safety

U.S. licensing process and ABWR certification

International Nuclear Information System (INIS)

Quirk, J.F.; Williams, W.A.

1996-01-01

Part 50 of Title 10 of the Code of Federal Regulation (CFR) establishes a two-step licensing process by which the U.S. Nuclear Regulatory Committee (NRC) authorizes nuclear reactor plant construction through issuance of a construction permit and authorizes operation by issuance of an operating license. At each stage, the NRC Staff conducts technical reviews and there is potential for public hearings. In 1989, the NRC issued a new, simplified licensing process: Part 52. The purpose of the Part 52 licensing process is to provide a regulatory framework that brings about earlier resolution of licensing issues. Because issues are not resolved early in the Part 50 licensing process, approval of an operating license is not assured until after a significant investment has been made in the plant. Part 52 increases the stability and certainty of the licensing process by providing for the early resolution of safety and environmental issues. The Part 52 licensing process features (1) early site permits, (2) design certification, and (3) combined construction permit and operating licenses. As part of the U.S. Advanced Light Water Reactor (ALWR) Program to revitalize the nuclear option through the integration of government/utility/industry efforts, GE undertook the role of applying for certification for its latest product line, the Advanced Boiling Water Reactor (ABWR), under the U.S. ABWR certification program. The ABWR design is an essentially complete plant. Initial application for design certification was in 1987 under Part 50. GE reapplied in late 1991 under the newly promulgated Part 52. Following seven years of intensive interactions with the NRC and ACRS, GE was awarded the first Final Design Approval (FDA) under Part 52. The Commission initiated rulemaking by publishing the proposed ABWR Certification Rule in the Federal Register in early 1995. Certification is anticipated mid-1996. (J.P.N.)

Regulatory control and challenges in Medical facilities using ionising radiation sources

International Nuclear Information System (INIS)

Agarwal, S.P.

2008-01-01

Medical facilities utilising ionising radiation sources for diagnostic and treatment of cancer are regulated under the provisions of Atomic Energy (Radiation Protection) Rules, 2004 promulgated under the Atomic Energy Act 1962. The Competent Authority for the enforcement of the rules is Chairman, Atomic Energy Regulatory Board (AERB). Practice specific codes are issued by AERB for medical facilities such as Radiotherapy, Nuclear Medicine and Radiology. Regulatory process for control of medical facilities covers the entire life cycle of the radiation sources in three stages viz pre-Iicensing, during useful life and decommissioning and disposal. Pre-Iicensing requirements include use of type approved sources and equipment, approval of design layout of the facility and installation, exclusive (safe and secure) source storage facility when the equipment is not in use, radiation (area/individual) monitoring devices, qualified, trained and certified manpower, emergency response plans and commitment from the licensee for the safe disposal of disused/decayed sources. Compliance to these requirements makes the applicant eligible to obtain license from AERB for the operation of the medical facility. During the use of radiation sources, specific prior approval of the Competent Authority is required in respect of every source replacement, sale, transfer, transport, import and export. Further, all licensees are required to send the periodic safety Status reports to AERB as well as reporting of any off normal events. AERB conducts inspection of the facilities to ensure compliance with the safety requirements during operation of the facility. Violation of safety norms by licensee attracts enforcement action which includes suspension, modification or withdrawal of licensee for operation of the facility. Upon completion of the useful life of the source, the licensee decommissions the facility and returns the source to the original supplier. For returning the source, prior

75 FR 39932 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2010-07-13

...; Comment Request; Recognition Application for Sustainable Water Leadership Program (Renewal) AGENCY... Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval... to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention...

Drug-device combination products: regulatory landscape and market growth.

Science.gov (United States)

Bayarri, L

2015-08-01

Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

Premarket Approvals (PMA)

Data.gov (United States)

U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

Radiation processing in the United States

International Nuclear Information System (INIS)

Brynjolfsson, A.

1986-01-01

In animal feeding studies, including the huge animal feeding studies on radiation sterilized poultry products irradiated with sterilizing dose of 58 kGy revealed no harmful effects. This finding is corroborated by the very extensive analysis of the radiolytic products, which indicated that the radiolytic products could not in the quantity found in the food be expected to produce any toxic effect. It thus appears to be proven with reasonable certainty that no harm will result from the proposed use of the process. Accordingly, FDA is moving forward with approvals while allowing the required time for hearings and objection. On July 5, 1983 FDA permitted gamma irradiation for control of microbial contamination in dried spices and dehydrated vegetable seasoning at doses up to 10 kGy; on June 19, 1984 the approval was expanded to cover insect infection; and additional seasonings and irradiation of dry or dehydrated enzyme preparations were approved on February 12 and June 4, respectively, 1985. In addition, in July 1985, FDA cleared irradiation of pork products with doses of 0.3 to 1 kGy for eliminating trichinosis. Approvals of other agencies, including Food and Drug Administration, Department of Agriculture, the Nuclear Regulatory Commission, Occupational Safety and Health Administration, Department of Transportation, Environmental Protection Agency, and States and local communities, are usually of a technological nature and can then be obtained if the process is technologically feasible. (Namekawa, K.)

76 FR 37867 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving...

Science.gov (United States)

2011-06-28

..., as Modified by Amendment No. 1, to Reduce the Minimum Size of the Nominating and Governance Committee... proposed rule change to reduce the minimum size of the Nominating and Governance Committee (``NGC'') from... the original proposed rule change, it had not yet obtained formal approval from its Board of Directors...

Drug lag and key regulatory barriers in the emerging markets

Directory of Open Access Journals (Sweden)

Harriet Wileman

2010-01-01

This work concludes that the overall relative drug lag in the emerging markets has decreased over time and that there are seven key regulatory barriers which need to be targeted in order to make further improvements; ′Western Approval′, local clinical development (LCD, Certificate of Pharmaceutical Product (CPP, Good Manufacturing Practice (GMP, pricing approval, document authentication and harmonisation.

75 FR 41855 - Enogex L.L.C.; Notice of Petition for Rate Approval

Science.gov (United States)

2010-07-19

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR10-52-000] Enogex L.L.C.; Notice of Petition for Rate Approval July 13, 2010. Take notice that on July 1, 2010, Enogex L.L.C. (Enogex) filed pursuant to section 284.123(b)(2) of the Commission's regulations, filed a petition...

Top-level regulatory criteria for the standard MHTGR

Energy Technology Data Exchange (ETDEWEB)

NONE

1986-10-15

The Licensing Plan for the Standard MHTGR (Ref. 1) describes a program to support a U.S. Nuclear Regulatory Commission (NRC) design review and approval. The Plan calls for the submittal of Top-Level Regulatory Criteria to the NRC for concurrence with their completeness and acceptability for the MHTGR program. The Top-Level Regulatory Criteria are defined as the standards for judging licensability that directly specify acceptable limits for protection of the public health and safety and the environment. The criteria proposed herein are for normal plant operation and a broad spectrum of anticipated events, including accidents. The approach taken is to define a set of criteria which are general as opposed to being design specific. Specifically, it is recommended that criteria be met which: 1. Are less prescriptive than current regulation, thereby encouraging maximum flexibility in design approaches. 2. Are measurable. 3. Are not more strict than the criteria for current power plants.

Directory of certificates of compliance for radioactive materials packages. Volume 1, Revision 17: Report of NRC approved packages

International Nuclear Information System (INIS)

1994-10-01

This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

76 FR 12380 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Science.gov (United States)

2011-03-07

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1..., the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...

Data Management in a Regulatory Context

Directory of Open Access Journals (Sweden)

Niels Grønning

2017-07-01

Full Text Available With the implementation of Article 57(2 in 2012 the European Medicines Agency (EMA embarked on a digitalization journey that foreseeably would ensure greater product oversight and interoperability across the community. This initiative has subsequently led to additional focus from the agency with respect to the utilization and harmonization of data as part of the regulatory process. Driven by both internal and external factors, the EMA have through the European Union telematics strategy laid the foundation for the regulatory-driven services that may be expected from the community the coming years. Supported by standardization initiatives (e.g., ISO Identification of Medicinal Products, the EMA is gradually building an information management-driven approach to data utilization and exploitation within drug evaluation and approval. Primarily driven by the increasing demand for signal detection, the EMA is additionally hoping to leverage the establishment of defined information models and supporting controlled terms to safeguard future activities within the community. Collectively, the overall community may seek to gain from the overall digitalization roadmap proposed by the EMA and interesting opportunities may be sought as part of the transition. Already now pharmaceutical companies are gradually adapting to this new paradigm and actively seeking to explore how they may leverage the future EMA operating model to serve internal business requirements. If successful, the collective efforts from industry and regulators may lead to an unprecedented product oversight and offer regulators the opportunity to proactively drive corrective actions and, therefore, improve patient safety.

76 FR 70331 - List of Approved Spent Fuel Storage Casks: MAGNASTOR ® System, Revision 2

Science.gov (United States)

2011-11-14

... Fuel Storage Casks: MAGNASTOR [supreg] System, Revision 2 AGENCY: Nuclear Regulatory Commission. ACTION... its spent fuel storage regulations by revising the NAC International, Inc. (NAC) MAGNASTOR [supreg] System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 2 to...

76 FR 2277 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD System Revision 1

Science.gov (United States)

2011-01-13

... Fuel Storage Casks: NUHOMS[supreg] HD System Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION... System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 1 to... the NUHOMS[supreg] HD Horizontal Modular Storage System for Irradiated Nuclear Fuel. [[Page 2279...

Safety Evaluation Report related to the final design approval of the GESSAR II BWR/6 Nuclear Island design, Docket No. 50-447

International Nuclear Information System (INIS)

1983-04-01

The Safety Evaluation Report for the application filed by General Electric Company for the Final Design Approval for the General Electric Standard Safety Analysis Report (GESSAR II FSAR) has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. This report summarizes the results of the staff's safety review of the GESSAR II BWR/6 Nuclear Island Design. Subject to favorable resolution of items discussed in the Safety Evaluation Report, the staff concludes that the facilities referencing GESSAR II, subject to approval of the balance-of-plant design, can conform with the provisions of the Act and the regulations of the Nuclear Regulatory Commission

Poet Marion Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

Poet Portland Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Poet Alexandria Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

Poet Laddonia Approval

Science.gov (United States)

This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f

Regulatory aspects of low doses control in Albania

International Nuclear Information System (INIS)

Dollani, K.; Kushe, R.

1997-01-01

In the present paper are described the status of regulatory aspects of low doses control as well as the existing procedures for their implementation in Albania. According to new Radiological Protection Act, approved by Parliament in 1995, the establishment of the infrastructures in radiation protection area is in course, accompanied by the installation and functioning of new equipment for low dose control. Based in many years experience it is concluded that personal doses of the workers added by practices in Albania are 1/10 of dose Emits. Some particular cases of overexposured workers were investigated. Last times the elements of the optimisation procedures (QA and QC) are outlined in the frame of improving regulatory aspects of low doses control. (author)

78 FR 2315 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-01-10

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 15402 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 11947 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-02-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

78 FR 17281 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2013-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 16317 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-03-20

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 21143 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-04-09

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 34455 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-06-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55891 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 55892 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-11

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

77 FR 59239 - Projects Approved for Consumptive Uses of Water

Science.gov (United States)

2012-09-26

... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

75 FR 26827 - Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGA Exchange, Inc.

Science.gov (United States)

2010-05-12

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62037; File No. 4-595] Self-Regulatory... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs... would not be subject to the provisions of Rule 19d-1(c)(1) under the Act\\4\\ requiring that a self...

75 FR 26822 - Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGX Exchange, Inc.

Science.gov (United States)

2010-05-12

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62036; File No. 4-594] Self-Regulatory... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs... would not be subject to the provisions of Rule 19d-1(c)(1) under the Act \\4\\ requiring that a self...

Applying for ethical approval for research: the main issues.

Science.gov (United States)

Gelling, Leslie

2016-01-13

The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

Quantitative safety goals for the regulatory process

International Nuclear Information System (INIS)

Joksimovic, V.; O'Donnell, L.F.

1981-01-01

The paper offers a brief summary of the current regulatory background in the USA, emphasizing nuclear, related to the establishment of quantitative safety goals as a way to respond to the key issue of 'how safe is safe enough'. General Atomic has taken a leading role in advocating the use of probabilistic risk assessment techniques in the regulatory process. This has led to understanding of the importance of quantitative safety goals. The approach developed by GA is discussed in the paper. It is centred around definition of quantitative safety regions. The regions were termed: design basis, safety margin or design capability and safety research. The design basis region is bounded by the frequency of 10 -4 /reactor-year and consequences of no identifiable public injury. 10 -4 /reactor-year is associated with the total projected lifetime of a commercial US nuclear power programme. Events which have a 50% chance of happening are included in the design basis region. In the safety margin region, which extends below the design basis region, protection is provided against some events whose probability of not happening during the expected course of the US nuclear power programme is within the range of 50 to 90%. Setting the lower mean frequency to this region of 10 -5 /reactor-year is equivalent to offering 90% assurance that an accident of given severity will not happen. Rare events with a mean frequency below 10 -5 can be predicted to occur. However, accidents predicted to have a probability of less than 10 -6 are 99% certain not to happen at all, and are thus not anticipated to affect public health and safety. The area between 10 -5 and 10 -6 defines the frequency portion of the safety research region. Safety goals associated with individual risk to a maximum-exposed member of public, general societal risk and property risk are proposed in the paper

The development of AECB regulatory documents

International Nuclear Information System (INIS)

Joyce, M.

1981-01-01

This document describes the Atomic Energy Control Board's (AECB) approach to the development and preparation of regulatory documents. The principal factors that have shaped the AECB'a regulatory approach are identified as background to the evolution of regulatory documents as are a number of current influences that affect the present and future development of these documents. Also described are the process by which regulatory documents are prepared and published and the points of contact between this process and the Canadian Standards Association program for nuclear standards. (author)

Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture

Directory of Open Access Journals (Sweden)

Bate R

2012-07-01

Full Text Available Roger Bate,1 Lorraine Mooney,2 Kimberly Hess,3 Julissa Milligan,1 Amir Attaran41American Enterprise Institute, Washington DC, USA; 2Africa Fighting Malaria, London, UK; 3Africa Fighting Malaria, Washington DC, USA; 4Faculty of Law and Medicine, University of Ottawa, Ottawa, CanadaBackground: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA or the World Health Organization (WHO prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab® protocol to identify whether they were substandard, degraded, or counterfeit.Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50% than Indian cities (26.57%, but they also experienced a higher failure rate (14.21% than Indian cities (7.83%. The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high

Improvements to the DOE low-level waste regulatory structure and process under recommendation 94-2 - progress to date

International Nuclear Information System (INIS)

Regnier, E.

1995-01-01

Among the concerns expressed by the Defense Nuclear Facility Safety Board (DNFSB) in its Recommendation 94-2 was the lack of a clearly defined and effective internal Department of Energy (DOE) regulatory oversight and enforcement process for ensuring that low-level radioactive waste management health, safety, and environmental requirements are met. Therefore, part of the response to the DNFSB concern is a task to clarify and strengthen the low-level waste management regulatory structure. This task is being conducted in two steps. First, consistent with the requirements of the current DOE waste management order and within the framework of the current organizational structure, interim clarification of a review process and the associated organizational responsibilities has been issued. Second, in coordination with the revision of the waste management order and consistent with the organizational responsibilities resulting from the strategic alignment of DOE, a rigorous, more independent regulatory oversight structure will be developed

Improvements to the DOE low-level waste regulatory structure and process under recommendation 94-2 - progress to date

Energy Technology Data Exchange (ETDEWEB)

Regnier, E.

1995-12-31

Among the concerns expressed by the Defense Nuclear Facility Safety Board (DNFSB) in its Recommendation 94-2 was the lack of a clearly defined and effective internal Department of Energy (DOE) regulatory oversight and enforcement process for ensuring that low-level radioactive waste management health, safety, and environmental requirements are met. Therefore, part of the response to the DNFSB concern is a task to clarify and strengthen the low-level waste management regulatory structure. This task is being conducted in two steps. First, consistent with the requirements of the current DOE waste management order and within the framework of the current organizational structure, interim clarification of a review process and the associated organizational responsibilities has been issued. Second, in coordination with the revision of the waste management order and consistent with the organizational responsibilities resulting from the strategic alignment of DOE, a rigorous, more independent regulatory oversight structure will be developed.

Benefits of standard format and content for approval of packaging for radioactive material

International Nuclear Information System (INIS)

Pstrak, D.; Osgood, N.

2004-01-01

The U.S. Nuclear Regulatory Commission (NRC) uses Regulatory Guide 7.9, ''Standard Format and Content of Part 71 Applications for Approval of Packaging for Radioactive Material'' to provide recommendations on the preparation of applications for approval of Type B and fissile material packages. The purpose of this Regulatory Guide is to assist the applicant in preparing an application that demonstrates the adequacy of a package in meeting the 10 CFR Part 71 packaging requirements. NRC recently revised Regulatory Guide 7.9 to reflect current changes to the regulations in Part 71 as a result of a recent rulemaking that included changes to the structural, containment, and criticality requirements for packages. Overall, the NRC issues Regulatory Guides to describe methods that are acceptable to the NRC staff for implementing specific parts of the NRC's regulations, to explain techniques used by the NRC staff in evaluating specific problems, and to provide guidance to applicants. It is important to note the specific purpose of this Regulatory Guide. As the name indicates, this Guide sets forth a standard format for application submission that is acceptable to the NRC staff that, when used by the applicant, will accomplish several objectives. First, use of the guide provides a consistent and repeatable approach that indicates the information to be provided by the applicant. Second, the organization of the information in the application will assist the reviewer(s) in locating information. Ultimately, accomplishing these objectives will help to ensure the completeness of the information in the application as well as decrease the review time. From an international perspective, use of a standard format approach could enhance the efficiency with which Competent Authorities certify and validate packages for use in the packaging and transportation of radioactive material worldwide. This streamlined approach of preparing package applications could ultimately lead to uniform

The European Regulatory Environment of RNA-Based Vaccines.

Science.gov (United States)

Hinz, Thomas; Kallen, Kajo; Britten, Cedrik M; Flamion, Bruno; Granzer, Ulrich; Hoos, Axel; Huber, Christoph; Khleif, Samir; Kreiter, Sebastian; Rammensee, Hans-Georg; Sahin, Ugur; Singh-Jasuja, Harpreet; Türeci, Özlem; Kalinke, Ulrich

2017-01-01

A variety of different mRNA-based drugs are currently in development. This became possible, since major breakthroughs in RNA research during the last decades allowed impressive improvements of translation, stability and delivery of mRNA. This article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. mRNA-encoded vaccines are developed both for preventive or therapeutic purposes. Most mRNA-based vaccines are directly administered to patients. Alternatively, primary autologous cells from cancer patients are modified ex vivo by the use of mRNA and then are adoptively transferred to patients. In the EU no regulatory guidelines presently exist that specifically address mRNA-based vaccines. The existing regulatory framework, however, clearly defines that mRNA-based vaccines in most cases have to be centrally approved. Interestingly, depending on whether RNA-based vaccines are directed against tumors or infectious disease, they are formally considered gene therapy products or not, respectively. Besides an overview on the current clinical use of mRNA vaccines in various therapeutic areas a detailed discussion of the current regulatory situation is provided and regulatory perspectives are discussed.

A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy.

Science.gov (United States)

Abraham, John; Davis, Courtney

2005-09-01

By going beyond individual case studies and solely quantitative surveys, this paper systematically examines why there were over twice as many new prescription drugs withdrawn from the market on grounds of safety in the UK as there were in the US between 1971 and 1992. Drawing on interviews with regulators, industry scientists and others involved, and on regulatory data never before accessed outside governments and companies, five key hypotheses which might explain this difference in drug safety withdrawals are analysed. These are: (1) simply because the UK approved more new drugs than the US; (2) because of an industrial corporate strategy to seek approval of 'less safe' drugs in the UK earlier; (3) because British regulators were more vigilant at spotting post-marketing safety problems than their US counterparts; (4) because the slowness of the US in approving new drugs enabled regulators there to learn from, and avoid, safety problems that had already emerged in the UK or European market; and (5) because more stringent regulation in the US meant that they approved fewer unsafe drugs on to the market in the first place. It is concluded that the main explanation for fewer drug safety withdrawals in the US is that the regulatory agency there applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market. Contrary to the claims frequently made by the pharmaceutical industry and regulatory agencies on both sides of the Atlantic, these results imply that it is likely that acceleration of regulatory review times in the US and the UK since the early 1990s is compromising drug safety.

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages

International Nuclear Information System (INIS)

1979-10-01

This directory contains a Summary Report of NRC Approved Packages for radioactive material packages effective September 14, 1979. Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages

Energy Technology Data Exchange (ETDEWEB)

None

1979-10-01

This directory contains a Summary Report of NRC Approved Packages for radioactive material packages effective September 14, 1979. Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory.

78 FR 78693 - List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS® Cask System

Science.gov (United States)

2013-12-27

... Storage Casks: Transnuclear, Inc. Standardized NUHOMS[supreg] Cask System AGENCY: Nuclear Regulatory... storage regulations by revising the Transnuclear, Inc. Standardized NUHOMS[supreg] Cask System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 11 to Certificate of...

77 FR 24585 - List of Approved Spent Fuel Storage Casks: HI-STORM 100, Revision 8

Science.gov (United States)

2012-04-25

... Storage Casks: HI-STORM 100, Revision 8 AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule... revising the Holtec International HI-STORM 100 System listing within the ``List of Approved Spent Fuel...) 72.214, by revising the Holtec International HI-STORM 100 System listing within the ``List of...

75 FR 24786 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD System Revision 1

Science.gov (United States)

2010-05-06

... Fuel Storage Casks: NUHOMS[supreg] HD System Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION... storage regulations by revising the Transnuclear, Inc. (TN) NUHOMS[supreg] HD System listing within the... System cask design within the list of approved spent fuel storage casks that power reactor licensees can...

78 FR 22020 - Agency Information Collection Activities: Requests for Comments; Clearance of New Approval of...

Science.gov (United States)

2013-04-12

... about our intention to request the Office of Management and Budget (OMB) approval for a new information... will define what a propeller critical part is, require the identification of propeller critical parts... information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget...

76 FR 46322 - Agency Information Collection Activities Under OMB Review; Renewal of a Currently Approved...

Science.gov (United States)

2011-08-02

... has forwarded the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval: Recreation Visitor Use Surveys. The ICR describes the nature of the... Department of the Interior at the Office of Management and Budget, Office of Information and Regulatory...

Poet Fostoria Approval

Science.gov (United States)

This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

Utilizing Lean Six Sigma Methodology to Improve the Authored Works Command Approval Process at Naval Medical Center San Diego.

Science.gov (United States)

Valdez, Michelle M; Liwanag, Maureen; Mount, Charles; Rodriguez, Rechell; Avalos-Reyes, Elisea; Smith, Andrew; Collette, David; Starsiak, Michael; Green, Richard

2018-03-14

Inefficiencies in the command approval process for publications and/or presentations negatively impact DoD Graduate Medical Education (GME) residency programs' ability to meet ACGME scholarly activity requirements. A preliminary review of the authored works approval process at Naval Medical Center San Diego (NMCSD) disclosed significant inefficiency, variation in process, and a low level of customer satisfaction. In order to facilitate and encourage scholarly activity at NMCSD, and meet ACGME requirements, the Executive Steering Council (ESC) chartered an interprofessional team to lead a Lean Six Sigma (LSS) Rapid Improvement Event (RIE) project. Two major outcome metrics were identified: (1) the number of authored works submissions containing all required signatures and (2) customer satisfaction with the authored works process. Primary metric baseline data were gathered utilizing a Clinical Investigations database tracking publications and presentations. Secondary metric baseline data were collected via a customer satisfaction survey to GME faculty and residents. The project team analyzed pre-survey data and utilized LSS tools and methodology including a "gemba" (environment) walk, cause and effect diagram, critical to quality tree, voice of the customer, "muda" (waste) chart, and a pre- and post-event value stream map. The team selected an electronic submission system as the intervention most likely to positively impact the RIE project outcome measures. The number of authored works compliant with all required signatures improved from 52% to 100%. Customer satisfaction rated as "completely or mostly satisfied" improved from 24% to 97%. For both outcomes, signature compliance and customer satisfaction, statistical significance was achieved with a p methodology and tools to improve signature compliance and increase customer satisfaction with the authored works approval process, leading to 100% signature compliance, a comprehensive longitudinal repository of all

76 FR 13442 - Joint Industry Plan; Order Approving Amendment No. 25 to the Joint Self-Regulatory Organization...

Science.gov (United States)

2011-03-11

..., Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on... Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange LLC...-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of Quotation and...

78 FR 66788 - Joint Industry Plan; Order Approving Amendment No. 30 to the Joint Self-Regulatory Organization...

Science.gov (United States)

2013-11-06

..., Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on... Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange LLC...-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of Quotation and...

Revised guideline for the approval procedure of package designs in Germany

International Nuclear Information System (INIS)

Nitsche, F.; Roedel, R.

2004-01-01

The IAEA Regulations for the Safe Transport of Radioactive Material, TS-R-1 are applied in Germany through the implementation of the Dangerous Goods Transport Regulations for class 7 of the International Modal Organisations (ADR, RID, IMDG-Code, ICAO-TI). Based on this the approval procedures for packages designs applied in Germany are in compliance with the provisions of TS-R-1. The Guideline R 003 issued by the Ministry of Transport, Building and Housing (BMVBW) in 1991 is the basis for the package design approval procedures in Germany. This Guideline has been reviewed and revised to reflect latest developments in the regulations as well as in the regulatory practice. In particular it has been extended to the approval procedures of Type C packages, packages subject to transitional arrangements, special form and low dispersible radioactive material and provides more detailed information to the applicant about the requested documentation. Publication of this revised guideline has been delayed but it is expected to take place in October 2004. The paper gives an overview about the main parts and provisions of this revised Guideline R 003 with the focus on package design approval procedures

Poet Leipsic Approval

Science.gov (United States)

This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs

Directory of Certificates of Compliance for Radioactive Materials Packages. Summary report of NRC approved packages. Volume 1, Revision 8

International Nuclear Information System (INIS)

1985-10-01

This directory contains a Summary Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure them that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages. Volume 1. Revision 9

International Nuclear Information System (INIS)

1986-10-01

This directory contains a Summary Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and Corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Sections 71.12, it is the responsibility of the licensees to insure them that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved packages. Volume 1, Revision 7

International Nuclear Information System (INIS)

1984-11-01

This directory contains a Summary Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

76 FR 51075 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Granting Approval to...

Science.gov (United States)

2011-08-17

... Organizations; International Securities Exchange, LLC; Order Granting Approval to a Proposed Rule Change Relating to Appointments to Competitive Market Makers August 11, 2011. I. Introduction On June 10, 2011, the International Securities Exchange, LLC (the ``Exchange'' or the ``ISE'') filed with the Securities...

Evolving Regulatory Processes Used by Students and Experts in the Acquiring of Improvisational Skills: A Qualitative Study

Science.gov (United States)

de Bruin, Leon R.

2018-01-01

The way an improviser practices is a vital and significant aspect to a musician's means and capacities of expression. Expert music performers utilize extensive self-regulatory processes involving planning, strategic development, and systemized approaches to learning and reflective practice. Scholars posit that these processes are constructivist…

77 FR 61033 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Science.gov (United States)

2012-10-05

...) NSCC's automated ACATS-Fund/SERV interface, for eligible mutual fund assets; (iii) NSCC's ACATS-IPS... customer account asset data. \\4\\ ACATS complements Financial Industry Regulatory Authority (``FINRA'') Rule... positions and available securities are allocated by book entry. This allocation of securities is...

Analyzing the decision making process of certifying digital control systems of nuclear power plants

International Nuclear Information System (INIS)

Yih, Swu; Fan, Chin-Feng

2012-01-01

Highlights: ► We have performed basic research in analyzing certification process and developed a regulatory decision making model for nuclear digital control system certification. The model views certification as an evidence–confidence conversion process. ► We have applied this model to analyze previous nuclear digital I and C certification experiences and obtained valuable insights. ► Furthermore, a prototype of a computer-aided licensing support system based on the model has been developed to enhance regulatory review efficiency. - Abstract: Safety-critical computing systems need regulators’ approval before operation. Such a permit issue process is called “certification”. Digital instrumentation and Control (I and C) certification in the nuclear domain has always been problematic and lengthy. Thus, the certification efficiency has always been a crucial concern to the applicant whose business depends on the regulatory decision. However, to our knowledge, there is little basic research on this topic. This study presents a Regulatory Decision-Making Model aiming at analyzing the characteristics and efficiency influence factors in a generic certification process. This model is developed from a dynamic operational perspective by viewing the certification process as an evidence–confidence conversion process. The proposed model is then applied to previous nuclear digital I and C certification experiences to successfully explain why some cases were successful and some were troublesome. Lessons learned from these cases provide invaluable insights regarding to the regulatory review activity. Furthermore, to utilize the insights obtained from the model, a prototype of a computer-aided licensing support system has been developed to speed up review evidence preparation and manipulation; thus, regulatory review efficiency can be further improved.

Trends in approval times for genetically engineered crops in the United States and the European Unio

NARCIS (Netherlands)

Smart, Richard D.; Blum, Matthias; Wesseler, J.H.H.

2017-01-01

Genetically engineered (GE) crops are subject to regulatory oversight to Ensure their safety for humans and the environment. Their approval in the European Union (EU) starts with an application in a given Member State followed by a scientific risk assessment, and ends with a political

76 FR 44583 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2011-07-26

... designated method are manufactured in an ISO 9001-registered facility. Also, an applicant must submit a minor... of Management and Budget (OMB) for review and approval. This is a request to renew an existing... and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725...

75 FR 5786 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Science.gov (United States)

2010-02-04

... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Steel Plants: Electric Arc... [email protected] , or by mail to: EPA Docket Center (EPA/DC), Environmental Protection Agency...., Washington, DC 20460, and (2) OMB at: Office of Information and Regulatory Affairs, Office of Management and...

Safety review and approval process for the TFTR

International Nuclear Information System (INIS)

Levine, J.D.; Howe, H.J.; Howe, K.E.

1983-01-01

The design, construction, and operation of the Tokamak Fusion Test Reactor (TFTR) has undergone an extensive safety and enviromental analysis involving Princeton Plasma Physics Laboratory (PPPL), the U.S. Department of Energy (DOE), the Ebasco/Grumman Industrial Subcontractor Team, and other organizations. This analysis, which is continuing during the TFTR operational phase, has been facilitated by the preparation, review and approval of several documents, including an Environmental Statement (Draft and Final), a Preliminary Safety Analysis Report (PSAR), a Final Safety Analysis Report (FSAR), Operations Safety Requirements (OSRs) and Safety Requirements (SRs), and various Operating and Maintenance Manuals. Through TFTR Safety Group participation in formal system design evaluations, change control boards, and reviews of project procurement and installation documentation, the TFTR Management Configuration Control System assures that all aspects of the project, including proposed design, installation and operational changes, receive prompt and thorough safety analyses. These efforts will continue as the TFTR Program moves into the neutral beam and D-T operational phases. The safety review and approval experience that has been acquired on the TFTR Project should serve as a foundation for similar efforts on future fusion devices

Development Perspective of Regulatory Audit Code System for SFR Nuclear Safety Evaluation

Energy Technology Data Exchange (ETDEWEB)

Bae, Moo Hoon; Lee, Gil Soo; Shin, An Dong; Suh, Nam Duk [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2012-05-15

A sodium-cooled fast reactor (SFR) in Korea is based on the KALIMER-600 concept developed by KAERI. Based on 'Long-term R and D Plan for Future Reactor Systems' which was approved by the Korea Atomic Energy Commission in 2008, the KAERI designer is scheduled to apply the design certification of the prototype SFR in 2017. In order to establish regulatory infrastructure for the licensing of a prototype SFR, KINS has develop the regulatory requirements for the demonstration SFR since 2010, and are scheduled to develop the regulatory audit code systems in regard to core, fuel, and system, etc. since 2012. In this study, the domestic code systems used for core design and safety evaluation of PWRs and the nuclear physics and code system for SFRs were briefly reviewed, and the development perspective of regulatory audit code system for SFR nuclear safety evaluation were derived

Respirator studies for the Nuclear Regulatory Commission. Protection factors for supplied-air respirators. Progress report, October 1, 1976--September 30, 1977

International Nuclear Information System (INIS)

Hack, A.; Bradley, O.D.; Trujillo, A.

1977-12-01

This report describes the work performed during FY 1977 for the Nuclear Regulatory Commission. The Protection Factors (efficiency) provided by 25 NIOSH approved supplied-air respirators were determined while the devices were worn by a panel of anthropometrically selected test subjects. The major recommendation was that demand-type respirators should neither be used nor approved

77 FR 26016 - Determination of Regulatory Review Period for Purposes of Patent Extension; Alair Bronchial...

Science.gov (United States)

2012-05-02

... approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period... asthma is not well controlled [[Page 26017

A global regulatory science agenda for vaccines.

Science.gov (United States)

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

23 CFR 420.209 - What are the conditions for approval?

Science.gov (United States)

2010-04-01

... Management § 420.209 What are the conditions for approval? (a) As a condition for approval of FHWA planning... management process that identifies and results in implementation of RD&T activities expected to address high priority transportation issues. The management process must include: (1) An interactive process for...

Establishment of the nuclear regulatory framework for the process of decommissioning of nuclear installations in Mexico

International Nuclear Information System (INIS)

Salmeron V, J. A.; Camargo C, R.; Nunez C, A.

2015-09-01

Today has not managed any process of decommissioning of nuclear installations in the country; however because of the importance of the subject and the actions to be taken to long term, the Comision Nacional de Seguridad Nuclear y Salvaguardias (CNSNS) in Mexico, accordance with its objectives is developing a National Nuclear Regulatory Framework and defined requirements to ensure the implementation of appropriate safety standards when such activities are performed. In this regard, the national nuclear regulatory framework for nuclear installations and the particular case of nuclear power reactors is presented, as well as a proposed licensing process for the nuclear power plant of Laguna Verde based on international regulations and origin country regulations of the existing reactors in nuclear facilities in accordance with the license conditions of operation to allow to define and incorporate such regulation. (Author)

Directory of certificates of compliance for radioactive materials packages; Summary Report of NRC Approved Packages

International Nuclear Information System (INIS)

1980-12-01

This directory contains a Summary Report of NRC approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the U.S. Nuclear Regulatory Commission. To assist in identifying packaging, and index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material using these packagings must be in accordance with the provisions of 49 CFR 173.393a and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure them--that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

76 FR 2243 - List of Approved Spent Fuel Storage Casks: NUHOMS ® HD System Revision 1

Science.gov (United States)

2011-01-13

... Storage Casks: NUHOMS [supreg] HD System Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION: Direct... fuel storage regulations by revising the Transnuclear, Inc. (TN) NUHOMS [supreg] HD System listing... NUHOMS [supreg] HD System cask design listed in Sec. 72.214 (List of approved spent fuel storage casks...

75 FR 82119 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

Science.gov (United States)

2010-12-29

..., the Board's basic fair practice rule, to apply the rules to municipal advisors. The proposed rule... Independent Public Finance Advisors, dated December 9, 2010. This order approves the proposed rule change. II... of which may have a substantial impact on the finances of those municipal entities. In other cases...

77 FR 75243 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

Science.gov (United States)

2012-12-19

... modeling and risk management procedures (``Risk Management Proposal'') \\9\\ is approved by the Commission... risk modeling enhancements with respect to longer-tenor options, including OTC S&P 500 Index Options... http://www.sec.gov/rules/petitions/2012/petn4-644.pdf . This Order does not address the relief...

Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages

International Nuclear Information System (INIS)

1993-10-01

This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

76 FR 5417 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

Science.gov (United States)

2011-01-31

... consisting of amendments to Rule A-3, on membership on the Board, in order to establish a Nominating... Independent Public Finance Advisors to discuss the proposed rule change among other matters. See Memorandum... to the creation of the Nominating Committee of the MSRB. On September 30, 2010, the SEC approved MSRB...

76 FR 19173 - Self-Regulatory Organizations; the Options Clearing Corporation; Order Granting Approval of...

Science.gov (United States)

2011-04-06

... to list and trade options on the CBOE Gold ETF Volatility Index.\\6\\ The March 2011 Supplement amends... on the CBOE Gold ETF Volatility Index and similarly structured equity-based volatility indexes that...) (order approving CBOE's proposed rules to list and trade CBOE Gold ETF Volatility Index options). \\7\\ For...

78 FR 24257 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Science.gov (United States)

2013-04-24

... positions are in-the- money or out-of-the-money. Volume, like open interest, is a measure of a Clearing... demands on OCC's services and facilities that are not captured by the current methodology. IV. Conclusion... Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change To Implement a Revised...

Development of regulatory policy for SMART-P

Energy Technology Data Exchange (ETDEWEB)

Lee, S. H.; Lee, Y. H.; Moo, Philip; Koh, B. J.; Son, M. K.; Han, G. H.; Kim, D. H. [Korea Association for Nuclear Technology, Daejeon (Korea, Republic of)

2004-06-15

KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors in near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

Development of regulatory policy for SMART-P

Energy Technology Data Exchange (ETDEWEB)

Lee, S. H.; Moon, S. H.; Lee, Y. H.; Son, M. K.; Han, K. H.; Kim, D. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

2003-06-15

KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors m near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

76 FR 33121 - List of Approved Spent Fuel Storage Casks: HI-STORM Flood/Wind Addition

Science.gov (United States)

2011-06-08

... Storage Casks: HI-STORM Flood/Wind Addition AGENCY: Nuclear Regulatory Commission. ACTION: Direct final... regulations to add the Holtec HI-STORM Flood/Wind cask system to the ``List of Approved Spent Fuel Storage... Title 10 of the Code of Federal Regulations Section 72.214 to add the Holtec HI- STORM Flood/Wind cask...

77 FR 28375 - Eagle Rock Desoto Pipeline, L.P.; Notice of Petition for Rate Approval

Science.gov (United States)

2012-05-14

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR12-25-000] Eagle Rock Desoto Pipeline, L.P.; Notice of Petition for Rate Approval Take notice that on May 1, 2012, Eagle Rock Desoto Pipeline, L.P. (Desoto) filed a Rate Election pursuant to 284.123(b)(1) of the Commissions...

76 FR 30832 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Permits for...

Science.gov (United States)

2011-05-27

... not a ``significant regulatory action'' subject to review by the Office of Management and Budget under... 0 2. In Sec. 52.2520, the table in paragraph (c) is amended by revising the entries for [45 CSR.../subject effective EPA approval date explanation/citation 45 CSR] date at 40 CFR 52.2565 * * * * * * * [45...

76 FR 38601 - Notice of Request for Extension of Approval of an Information Collection; Self-Certification...

Science.gov (United States)

2011-07-01

... approval of an information collection. Abstract: The Marketing and Regulatory Programs (MRP) agencies of.... agricultural products and protect the health of domestic animal and plant resources. The MRP agencies are the... human resource management, for the three MRP agencies are provided by the MRP Business Services unit of...

The role of learning environment on high school chemistry students' motivation and self-regulatory processes

Science.gov (United States)

Judd, Jeffrey S.

Changes to the global workforce and technological advancements require graduating high school students to be more autonomous, self-directed, and critical in their thinking. To reflect societal changes, current educational reform has focused on developing more problem-based, collaborative, and student-centered classrooms to promote effective self-regulatory learning strategies, with the goal of helping students adapt to future learning situations and become life-long learners. This study identifies key features that may characterize these "powerful learning environments", which I term "high self-regulating learning environments" for ease of discussion, and examine the environment's role on students' motivation and self-regulatory processes. Using direct observation, surveys, and formal and informal interviews, I identified perceptions, motivations, and self-regulatory strategies of 67 students in my high school chemistry classes as they completed academic tasks in both high and low self-regulating learning environments. With social cognitive theory as a theoretical framework, I then examined how students' beliefs and processes changed after they moved from low to a high self-regulating learning environment. Analyses revealed that key features such as task meaning, utility, complexity, and control appeared to play a role in promoting positive changes in students' motivation and self-regulation. As embedded cases, I also included four students identified as high self-regulating, and four students identified as low self-regulating to examine whether the key features of high and low self-regulating learning environments played a similar role in both groups. Analysis of findings indicates that key features did play a significant role in promoting positive changes in both groups, with high self-regulating students' motivation and self-regulatory strategies generally remaining higher than the low self-regulating students; this was the case in both environments. Findings

75 FR 25010 - Self-Regulatory Organizations; Stock Clearing Corporation of Philadelphia; Notice of Filing and...

Science.gov (United States)

2010-05-06

...-025, The NASDAQ Stock Market LLC (``NASDAQ Exchange'') sought and received Commission approval to... requirements apply to elections of directors and were not amended. Each share of common stock has one vote,\\8...-Regulatory Organizations; Stock Clearing Corporation of Philadelphia; Notice of Filing and Immediate...

76 FR 15322 - Determination of Regulatory Review Period for Purposes of Patent Extension; VPRIV

Science.gov (United States)

2011-03-21

..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... therapy for pediatric and adult patients with type 1 Gaucher Disease. Subsequent to this approval, the...,138,262) from Shire Human Genetic Therapies, Inc., and the Patent and Trademark Office requested FDA's...

Poet North Manchester Approval

Science.gov (United States)

This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

78 FR 41846 - Approval and Promulgation of Implementation Plans; New York State Ozone Implementation Plan Revision

Science.gov (United States)

2013-07-12

... Pavement and Asphalt Based Surface Coating,'' (see 77 FR 13974). It is important to note that EPA is... approved regulations'' in 40 CFR 52.1670 for the Part 241, ``Asphalt Pavement and Asphalt Based Surface..., this action: Is not a ``significant regulatory action'' subject to review by the Office of Management...

75 FR 80556 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Science.gov (United States)

2010-12-22

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on December 13, 2010, Financial Industry... application by their terms. For more information about the rulebook consolidation process, see Information...

Regulatory uncertainty and the associated business risk for emerging technologies

International Nuclear Information System (INIS)

Hoerr, Robert A.

2011-01-01

An oversight system specifically concerned with nanomaterials should be flexible enough to take into account the unique aspects of individual novel materials and the settings in which they might be used, while recognizing that heretofore unrecognized safety issues may require future modifications. This article considers a question not explicitly considered by the project team: what is the risk that uncertainty over how regulatory oversight will be applied to nanomaterials will delay or block the development of this emerging technology, thereby depriving human health of potential and substantial benefits? An ambiguous regulatory environment could delay the availability of valuable new technology and therapeutics for human health by reducing access to investment capital. Venture capitalists list regulatory uncertainty as a major reason not to invest at all in certain areas. Uncertainty is far more difficult to evaluate than risk, which lends itself to quantitative models and can be factored into projections of return on possible investments. Loss of time has a large impact on investment return. An examination of regulatory case histories suggests that an increase in regulatory resting requirement, where the path is well-defined, is far less costly than a delay of a year or more in achieving product approval and market launch.

Regulatory uncertainty and the associated business risk for emerging technologies

Science.gov (United States)

Hoerr, Robert A.

2011-04-01

An oversight system specifically concerned with nanomaterials should be flexible enough to take into account the unique aspects of individual novel materials and the settings in which they might be used, while recognizing that heretofore unrecognized safety issues may require future modifications. This article considers a question not explicitly considered by the project team: what is the risk that uncertainty over how regulatory oversight will be applied to nanomaterials will delay or block the development of this emerging technology, thereby depriving human health of potential and substantial benefits? An ambiguous regulatory environment could delay the availability of valuable new technology and therapeutics for human health by reducing access to investment capital. Venture capitalists list regulatory uncertainty as a major reason not to invest at all in certain areas. Uncertainty is far more difficult to evaluate than risk, which lends itself to quantitative models and can be factored into projections of return on possible investments. Loss of time has a large impact on investment return. An examination of regulatory case histories suggests that an increase in regulatory resting requirement, where the path is well-defined, is far less costly than a delay of a year or more in achieving product approval and market launch.

An analysis of viable financial negotiations processes and related internal controls for procurement in Pakistan

OpenAIRE

Rafique, Abdul B.; Malik, Muhammad W.; Salman, Muhammad

2016-01-01

MBA Professional Report Approved for public release; distribution is unlimited In Pakistan, the process of public procurement procedure standardization started in 2002 with the establishment of the Pakistan Public Procurement Regulatory Authority (PPRA), based on the 1994 United Nations Commission on International Trade Law (UNCITRAL) Model Law. PPRA rules allow four types of procurement procedures but limit the ability to conduct financial negotiations. PPRA rules are aimed at implemen...

Performance-Based (Risk-Informed) Regulation: A Regulatory Perspective

International Nuclear Information System (INIS)

Kadambi, N. Prasad

2005-01-01

Performance-based regulation (PBR) has been mandated at the national level in the United States and at the agency level, where appropriate, at the U.S. Nuclear Regulatory Commission (USNRC). Guidance has been developed that implements the USNRC's definitions of PBR and other such conceptual regulatory improvements. This paper describes why PBR is important, what constitutes PBR in the context of direction provided at the USNRC, and how PBR can be implemented using a five-step process. The process steps articulate questions to be posed by the analyst regarding various aspects of a regulatory issue so that a suitably performance-based resolution can be developed. A regulatory alternative thus developed can be included among other options to be considered as part of the regulatory decision-making process

Manufacturing human mesenchymal stem cells at clinical scale: process and regulatory challenges.

Science.gov (United States)

Jossen, Valentin; van den Bos, Christian; Eibl, Regine; Eibl, Dieter

2018-05-01

Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. As economic considerations have shown, allogeneic therapy seems to be the most cost-effective method. Standardized procedures based on instrumented single-use bioreactors have been shown to provide billion of cells with consistent product quality and to be superior to traditional expansions in planar cultivation systems. Furthermore, under consideration of the complex nature and requirements of allogeneic hMSC-therapeutics, a new equipment for downstream processing (DSP) was successfully evaluated. This mini-review summarizes both the current state of the hMSC production process and the challenges which have to be taken into account when efficiently producing hMSCs for the clinical scale. Special emphasis is placed on the upstream processing (USP) and DSP operations which cover expansion, harvesting, detachment, separation, washing and concentration steps, and the regulatory demands.

Regulatory impacts on the Canadian uranium industry

International Nuclear Information System (INIS)

Frost, S.E.

2001-01-01

The development of environmental and safety regulation in Canada is described and the impacts of these developments on various phases of the uranium industry are examined. In the past 25 years, seven new uranium mining projects, major expansions to four projects, and five uranium refining/conversion projects have undergone environmental assessment in Canada. As regulations and the processes for applying them have developed, the size, complexity and cost of obtaining operating approvals for uranium projects have increased exponentially. Uranium projects are subject to a level of scrutiny that goes far beyond what can be justified by their potential for environmental damage, based primarily on a perceived degree of public concern, rather than any objective measure of environmental risk. The author believes that it is time to re-examine our priorities, to establish some balance between the risks of a project and the assessment effort required. Otherwise, we shall soon find ourselves in the position where smaller projects will never be developed because they cannot cover the regulatory costs. (author)

Regulatory inspection of nuclear facilities and enforcement by the regulatory body. Safety guide

International Nuclear Information System (INIS)

2002-01-01

The purpose of this Safety Guide is to provide recommendations for regulatory bodies on the inspection of nuclear facilities, regulatory enforcement and related matters. The objective is to provide the regulatory body with a high level of confidence that operators have the processes in place to ensure compliance and that they do comply with legal requirements, including meeting the safety objectives and requirements of the regulatory body. However, in the event of non-compliance, the regulatory body should take appropriate enforcement action. This Safety Guide covers regulatory inspection and enforcement in relation to nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power plants; other reactors such as research reactors and critical assemblies; spent fuel reprocessing plants; and facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Section 2 sets out the objectives of regulatory inspection and enforcement. Section 3 covers the management of regulatory inspections. Section 4 covers the performance of regulatory inspections, including internal guidance, planning and preparation, methods of inspection and reports of inspections. Section 5 deals with regulatory enforcement actions. Section 6 covers the assessment of regulatory inspections and enforcement activities. The Appendix provides further details on inspection areas for nuclear facilities

77 FR 3828 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

Science.gov (United States)

2012-01-25

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66193; File No. SR-ODD-2012-01] Self-Regulatory... to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Relative... disclosure document (``ODD'') to reflect certain changes to disclosure regarding relative performance options...

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

Directory of Open Access Journals (Sweden)

Carla Pires

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

75 FR 53727 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving Proposed Rule Change, as...

Science.gov (United States)

2010-09-01

... underwritings; (ii) supervision of market making commitments; (iii) final approval of advertisements as these... designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable...

77 FR 3531 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

Science.gov (United States)

2012-01-24

... Organizations; The Depository Trust Company; Order Approving Proposed Rule Change To Enhance Risk Management.... Description The rule change will enhance the risk management controls associated with DTC's Receiver... Participant's net debit cap is placed on a pending (recycling) queue until another transaction creates...

77 FR 50191 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To...

Science.gov (United States)

2012-08-20

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change To Establish ``Benchmark Orders'' Under NASDAQ Rule 4751(f) August 14, 2012. I. Introduction On May 1, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange...

75 FR 29793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Science.gov (United States)

2010-05-27

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on May 4, 2010, Financial.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

77 FR 26768 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA

Science.gov (United States)

2012-05-07

... postmenopausal women with osteoporosis at high risk for fracture. Subsequent to this approval, the Patent and..., FDA-2010-E-0660, and FDA-2010-E-0659] Determination of Regulatory Review Period for Purposes of Patent... the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which...

78 FR 17108 - Approval and Promulgation of Implementation Plans; State of Washington; Revised Format for...

Science.gov (United States)

2013-03-20

...), EPA revised the procedures for IBR'ing Federally-approved SIPs, as a result of consultations between... Violations--Notices 9/8/93 2/22/95, 60 FR 9778 132 Criminal Penalty 11/13/94 10/24/95, 60 FR 54439 133 Civil............ Regulatory Actions & Civil 9/21/95 2/26/97, 62 FR 8624......... Penalties. 400-240......... Criminal...

A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer.

Science.gov (United States)

Raju, G K; Gurumurthi, K; Domike, R; Kazandjian, D; Blumenthal, G; Pazdur, R; Woodcock, J

2016-12-01

Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analyses. There is much interest in quantifying regulatory approaches to benefit and risk. In this work the use of a quantitative benefit-risk analysis was applied to regulatory decision-making about new drugs to treat advanced non-small cell lung cancer (NSCLC). Benefits and risks associated with 20 US Food and Drug Administration (FDA) decisions associated with a set of candidate treatments submitted between 2003 and 2015 were analyzed. For benefit analysis, the median overall survival (OS) was used where available. When not available, OS was estimated based on overall response rate (ORR) or progression-free survival (PFS). Risks were analyzed based on magnitude (or severity) of harm and likelihood of occurrence. Additionally, a sensitivity analysis was explored to demonstrate analysis of systematic uncertainty. FDA approval decision outcomes considered were found to be consistent with the benefit-risk logic. © 2016 American Society for Clinical Pharmacology and Therapeutics.

Poet Lake Crystal Approval

Science.gov (United States)

This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS

77 FR 74043 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

Science.gov (United States)

2012-12-12

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68368; File No. SR-ODD-2012-02] Self-Regulatory... to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Adjustments for... (``November 2012 Supplement'') to amend the options disclosure document (``ODD'') to reflect certain changes...

Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages

International Nuclear Information System (INIS)

1990-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages

International Nuclear Information System (INIS)

1989-10-01

The purpose of this directory is to make available a convenient source of information on packaging which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Risk-based Regulatory Evaluation Program methodology

International Nuclear Information System (INIS)

DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.

1987-01-01

The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions

76 FR 3684 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

Science.gov (United States)

2011-01-20

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63711; File No. SR-ODD-2011-01] Self-Regulatory... to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Credit Default Options in, and Making Certain Technical Amendments to, the June 2007 Supplement to the Options Disclosure...

77 FR 32704 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

Science.gov (United States)

2012-06-01

... securities owned or under management by the institutional customer. The MSRB stated that FINRA Rule 2111....19b-4. \\3\\ The implementation date for Financial Industry Regulatory Authority (``FINRA'') Rule 2111... General Counsel, Securities Industry and Financial Markets Association, dated May 4, 2012 (``SIFMA Letter...

77 FR 40683 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-07-10

.... I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change... senior-level) Floor Official approval, both ``buying and selling members'' must agree to the publication... ``or member organizations'' after ``buying and selling members.'' Rule 2 defines a ``member'' as a...

Regulatory Considerations for the Long Term Cooling Safe Shutdown Requirements of the Passive Residual Heat Removal Systems in Advanced Reactors

International Nuclear Information System (INIS)

Sim, S. K.; Bae, S. H.; Kim, Y. S.; Hwang, Min Jeong; Bang, Young Seok; Hwang, Taesuk

2016-01-01

USNRC approved safe shutdown at 215.6 .deg. C for a safe and long term cooling state for the redundant passive RHRSs by SECY-94-084. USNRC issued COLA(Combined Construction and Operating License) for the Levy County NP Unit-1/2 for the AP1000 passive RHRSs in 2014. Korea Hydro and Nuclear Power(KHNP) is developing APR+ and adopted Passive Auxiliary Feedwater System(PAFS) as a new passive RHRS design. Korea Institute of Nuclear Safety(KINS) has been developing regulatory guides for the advanced safety design features of the advanced ALWRs which has plan to construct in near future in Korea[5]. Safety and regulatory issues as well as the safe shut down requirements of the passive RHRS are discussed and considerations in developing regulatory guides for the passive RHRS are presented herein. Passive RHRSs have been introduced as new safety design features for the advanced reactors under development in Korea. These passive RHRSs have potential advantages over existing active RHRS, however, their functions are limited due to inherent ability of passive heat removal processes. It is high time to evaluate the performance of the passive PRHRs and develop regulatory guides for the safety as well as the performance analyses of the passive RHRS

Transportation of Large Wind Components: A Permitting and Regulatory Review

Energy Technology Data Exchange (ETDEWEB)

Levine, Aaron [National Renewable Energy Lab. (NREL), Golden, CO (United States); Cook, Jeff [National Renewable Energy Lab. (NREL), Golden, CO (United States)

2016-09-01

This report summarizes permitting and regulatory issues associated with transporting wind turbine blades, towers, and nacelles as well as large transformers (wind components). These wind components are commonly categorized as oversized and overweight (OSOW) and require specific permit approvals from state and local jurisdictions. The report was developed based on a Quadrennial Energy Review (QER) recommendation on logistical requirements for the transportation of 'oversized or high-consequence energy materials, equipment, and components.'

Pathway-based analysis of genome-wide siRNA screens reveals the regulatory landscape of APP processing.

Directory of Open Access Journals (Sweden)

Luiz Miguel Camargo

Full Text Available The progressive aggregation of Amyloid-β (Aβ in the brain is a major trait of Alzheimer's Disease (AD. Aβ is produced as a result of proteolytic processing of the β-amyloid precursor protein (APP. Processing of APP is mediated by multiple enzymes, resulting in the production of distinct peptide products: the non-amyloidogenic peptide sAPPα and the amyloidogenic peptides sAPPβ, Aβ40, and Aβ42. Using a pathway-based approach, we analyzed a large-scale siRNA screen that measured the production of different APP proteolytic products. Our analysis identified many of the biological processes/pathways that are known to regulate APP processing and have been implicated in AD pathogenesis, as well as revealing novel regulatory mechanisms. Furthermore, we also demonstrate that some of these processes differentially regulate APP processing, with some mechanisms favouring production of certain peptide species over others. For example, synaptic transmission having a bias towards regulating Aβ40 production over Aβ42 as well as processes involved in insulin and pancreatic biology having a bias for sAPPβ production over sAPPα. In addition, some of the pathways identified as regulators of APP processing contain genes (CLU, BIN1, CR1, PICALM, TREM2, SORL1, MEF2C, DSG2, EPH1A recently implicated with AD through genome wide association studies (GWAS and associated meta-analysis. In addition, we provide supporting evidence and a deeper mechanistic understanding of the role of diabetes in AD. The identification of these processes/pathways, their differential impact on APP processing, and their relationships to each other, provide a comprehensive systems biology view of the "regulatory landscape" of APP.

Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan.

Science.gov (United States)

Wang, Hui-Po; Wang, Chun-Li

2018-04-01

The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication. Copyright © 2018. Published by Elsevier B.V.

Self-regulatory processes and exercise adherence in older adults: executive function and self-efficacy effects.

Science.gov (United States)

McAuley, Edward; Mullen, Sean P; Szabo, Amanda N; White, Siobhan M; Wójcicki, Thomas R; Mailey, Emily L; Gothe, Neha P; Olson, Erin A; Voss, Michelle; Erickson, Kirk; Prakash, Ruchika; Kramer, Arthur F

2011-09-01

Self-efficacy and the use of self-regulatory strategies are consistently associated with physical activity behavior. Similarly, behavioral inhibition and cognitive resource allocation-indices of executive control function-have also been associated with this health behavior. The purpose of this study was to examine the hypothesis that self-efficacy mediates the relationship between self-regulatory processes, such as executive function, and sustained exercise behavior. Older adults (N=177, mean age=66.44 years) completed measures of executive function, self-reported use of self-regulatory strategies, and self-efficacy prior to and during the first month of a 12-month exercise intervention. Percentage of exercise classes attended over the following 11 months was used to represent adherence. Data were collected from 2007 to 2010 and analyzed in 2010-2011. Structural equation models were tested examining the effect of executive function and strategy use on adherence via efficacy. As hypothesized, results showed significant direct effects of two elements of executive function and of strategy use on self-efficacy and of efficacy on adherence. In addition, there were significant indirect effects of strategy use and executive function on adherence via self-efficacy. Higher levels of executive function and use of self-regulatory strategies at the start of an exercise program enhance beliefs in exercise capabilities, which in turn leads to greater adherence. Copyright © 2011 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

CORN, LP Goldfield Approval

Science.gov (United States)

This November 19, 2015 letter from EPA approves the petition from CORN, LP, Goldfield facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS pro

Regulatory guidance document

International Nuclear Information System (INIS)

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

Directory of Certificates of Compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive materials packages. Volume 3, Revision 15

International Nuclear Information System (INIS)

1995-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date

78 FR 63263 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Science.gov (United States)

2013-10-23

... internet service providers.\\5\\ \\5\\ Securities Exchange Act Release No. 53980 (June 14, 2006), 71 FR 36155... other things, promote the prompt and accurate clearance and settlement of securities transactions. \\8... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70704; File No. SR-OCC-2013-10] Self-Regulatory...

Interpretation of ALARA in the Canadian regulatory framework

Energy Technology Data Exchange (ETDEWEB)

Utting, R. [Atomic Energy Control Board, Ottawa, Ontario (Canada)

1995-03-01

The Atomic Energy Control Board (AECB) is responsible for the regulation of all aspects of atomic energy in Canada. This includes the complete nuclear fuel cycle from uranium mining to long-term disposal of nuclear fuel, as well as the medical and industrial utilization of radioisotopes. Clearly, the regulatory approach will differ from practice to practice but, as far as possible, the AECB has attempted to minimize the degree of prescription of regulatory requirements. The traditional modus operandi of the AECB has been to have broad general principles enshrined in regulations with the requirement that licensees submit specific operating policies and procedures to the AECB for approval. In the large nuclear facilities with their sophisticated technical infrastructures, this policy has been largely successful although in a changing legal and political milieu the AECB is finding that a greater degree of proactive regulation is becoming necessary. With the smaller users, the AECB has for a long time found it necessary to have a greater degree of prescription in its regulatory function. Forthcoming General Amendments to the Atomic Energy Control Regulations will, amongst other things, formally incorporate the concept of ALARA into the Canadian regulatory framework. Within the broad range of practices licensed by the AECB it is not practical to provide detailed guidance on optimization that will be relevant and appropriate to all licensees, however the following general principles are proposed.

Regulatory agencies and regulatory risk

OpenAIRE

Knieps, Günter; Weiß, Hans-Jörg

2008-01-01

The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

Final Regulatory Determination for Special Wastes From Mineral Processing (Mining Waste Exclusion) - Federal Register Notice, June 13, 1991

Science.gov (United States)

This action presents the Agency's final regulatory determination required by section 3001(b)(3)(C) of the Resource Conservation and Recovery Act (RCRA) for 20 special wastes from the processing of ores and minerals.

Learning by Preparing to Teach: Fostering Self-Regulatory Processes and Achievement during Complex Mathematics Problem Solving

Science.gov (United States)

Muis, Krista R.; Psaradellis, Cynthia; Chevrier, Marianne; Di Leo, Ivana; Lajoie, Susanne P.

2016-01-01

We developed an intervention based on the learning by teaching paradigm to foster self-regulatory processes and better learning outcomes during complex mathematics problem solving in a technology-rich learning environment. Seventy-eight elementary students were randomly assigned to 1 of 2 conditions: learning by preparing to teach, or learning for…

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

Science.gov (United States)

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

2016-05-01

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

75 FR 22673 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of a...

Science.gov (United States)

2010-04-29

... remove any potential cloud on the jurisdictional status of options or security futures on ETFS Palladium... that are affected by this approval order are essentially the same as the options and security futures... securities transactions and derivative transactions.\\6\\ By amending its By-Laws to help clarify that options...

Electronic Voucher Approval - Financial Management

Data.gov (United States)

US Agency for International Development — This process provides a workflow and eSignature capability which allows the CFO to router vouchers for review and electronic signature approval to COTRs in AIDW. It...

77 FR 57630 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change Amending...

Science.gov (United States)

2012-09-18

... change was published for comment in the Federal Register on July 30, 2012.\\3\\ The Commission received no comment letters regarding the proposed rule change. This order approves the proposed rule change. \\1\\ 15 U...

Directory of certificates of compliance for radioactive materials packages. Summary report of NRC approved quality assurance programs for radioactive material packages. Volume 3, Revision 4

International Nuclear Information System (INIS)

1984-11-01

This directory contains a Summary Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

76 FR 38231 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Order Approving Proposed Rule...

Science.gov (United States)

2011-06-29

... No. 1, To Reduce the Minimum Size of the Nominating and Governance Committee June 22, 2011. I... size of the Nominating and Governance Committee (``NGC'') from seven to five. On May 18, 2011, the..., it had not yet obtained formal approval from its Board of Directors for the specific Bylaw changes...

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

International Nuclear Information System (INIS)

2016-01-01

), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.

Environmental approvals in New Brunswick : economic considerations

Energy Technology Data Exchange (ETDEWEB)

Marrack, C.; Maitland, R. [Suez Renewable Energy North America, Houston, TX (United States)

2008-07-01

This presentation provided a timeline of economic considerations related to New Brunswick's regulatory approval process for wind power developments. The economics of wind power projects require careful consideration during the initial planning phases, as it is not yet known if projects are viable. Spending in the early stages of a project should therefore be limited to items that focus on components of the environmental impact assessment (EIA) process that include establishing a relationship with First Nations groups in the area, and conducting seasonal bird studies. Economic considerations change when project viability is confirmed, and developers can then progress to conducting traditional knowledge studies and further seasonal bird studies. Baseline information studies should be reviewed, and biophysical surveys should involve the identification of any wetlands, sensitive areas, and rare plants. Archaeology studies are also required by the provincial government, as well as bat studies to determine if the site has a resident population of bats. Public and stakeholder consultations and open houses should then be held with an adequate time-frame for the submission of questions and concerns and the development of mitigation strategies. Project viability should be confirmed before power purchase agreements (PPAs) are signed. After PPAs are signed, the largest economic consideration is the schedule-related risk associated with legal and financial problems. It was concluded that noise impact, visual impact, and socioeconomic assessments and studies can be conducted after the PPA is secured. tabs., figs.

Radioactive air emissions notice of construction and application for approval to construct the Hanford Waste Vitrification Plant

International Nuclear Information System (INIS)

1992-10-01

The Hanford Site is owned by the US Government and operated by the US Department of Energy, Richland Field Office. The Hanford Site manages and produces dangerous waste and mixed waste. (containing both radioactive and dangerous components). The US Department of Energy, Richland Field Office, currently stores mixed waste, resulting from various processing operations, in underground storage tanks. The Hanford Waste Vitrification Plant will be constructed and operated to process the high-activity fraction of mixed waste stored in these underground tanks. The Hanford Waste Vitrification Plant will solidify pretreated tank waste into a glass product that will be packaged for disposal in a national repository. Emissions from the Hanford Waste Vitrification Plant will be regulated by both the federal and state Clean Air Acts. The proposed Hanford Waste Vitrification Plant represents a new source of radioactive air emissions. Construction of the plant will require approval from both federal and state agencies. The Notice of Construction and Application for Approval to Construct the Hanford Waste Vitrification Plant contains information required under Title 40 of the Code of Federal Regulations, Chapter 61; and Chapter 246-247 of the Washington Administrative Code for a proposed new source of radioactive air emissions. The document contents are based on information contained in the Hanford Waste Vitrification Plant Reference Conceptual Design Report, the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report, Revision 0, and subsequent design changes made before August 1, 1992. The contents of this document may be modified to include more specific information generated during subsequent detailed design phases. Modifications will be submitted for regulatory review and approval, as appropriate

Completion report for the UMTRA Project Vitro Processing Site. Revision 1

International Nuclear Information System (INIS)

1995-03-01

This completion report provides evidence that the final Salt Lake City, Utah, processing site property conditions are in accordance with the approved design and that all US Environmental Protection Agency (EPA) standards have been satisfied. Included as appendixes to support the stated conclusions are the record drawings; a summary of grid test results; contract specifications and construction drawings, the EPA standards (40 CFR Part 192); the audit, inspection, and surveillance summary; the permit information; and project photographs. The principal objective of the remedial action at Salt Lake City is to remove the tailings from the Vitro processing site, render the site free of contamination to EPA standards, and restore the site to the final design grade elevations. The final remedial action plan (RAP), which is approved by the US Department of Energy (DOE) and concurred upon by the US Nuclear Regulatory Commission (NRC) and the state of Utah, contains the conceptual design used to develop the final approved design. During remedial action construction operations, conditions were encountered that required design features that differed from the conceptual design. These conditions and the associated design changes are noted in the record drawings. All remedial action activities were completed in conformance with the specifications and drawings; the record drawings, in the state of Utah's opinion, reflect an accurate depiction of the existing property conditions at the processing site. 25 refs., 3 figs., 22 tabs

The reform of the Moldovan nuclear and radiological regulatory infrastructure

International Nuclear Information System (INIS)