Sample records for generic licensing issues

  1. 77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

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

  2. NGNP High Temperature Materials White Paper

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

    Lew Lommers; George Honma

    2012-08-01

    This white paper is one in a series of white papers that address key generic issues of the combined construction and operating license (COL) pre-application program key generic issues for the Next Generation Nuclear Plant reactor using the prismatic block fuel technology. The purpose of the pre-application program interactions with the NRC staff is to reduce the time required for COL application review by identifying and addressing key regulatory issues and, if possible, obtaining agreements for their resolution

  3. 78 FR 33120 - Final Interim Staff Guidance LR-ISG-2011-04; Updated Aging Management Criteria for Reactor Vessel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-03

    ..., ``Generic Aging Lessons Learned Report'' (GALL Report), for the aging management of Pressurized Water... communicate insights and lessons learned and to address emergent issues not covered in license renewal... ensure that PWR license renewal applicants will adequately address age-related degradation and aging...

  4. The complex legal and ethical issues related to generic medications. Viral hepatitis: a case study.

    PubMed

    Danta, M; Ghinea, N

    2017-04-01

    The economic impact of medications is significant, with many countries unable to afford the essential medicines listed by the WHO. Generic medications are one strategy to address this issue. Generic medications are similar to but not the same as originator medications. They have a significant cost advantage because they do not require the background research and development studies to support registration. Consequently, they are gaining increased market share in both the developed and developing world. Many new medications are now licensed to generic manufacturers in the developing world. As a result, it is possible for patients to bypass regulatory and cost barriers by importing medications directly from generic producers. Importation of the novel hepatitis C direct-acting antiviral therapy into Australia before it was registered in the country is an illustrative case study. This review will characterise generic medications and some of the legal and ethical issues around their utilisation, focusing on the relevant players, including pharma, government, patients and doctors.

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

    PubMed

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

    2014-01-01

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

  6. 10 CFR 171.16 - Annual fees: Materials licensees, holders of certificates of compliance, holders of sealed source...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... fee is the sum of budgeted costs for the following activities: (1) Generic and other research... material issued under parts 30 and 33 of this chapter for research and development that do not authorize... licenses for possession and use of byproduct material issued under part 30 of this chapter for research and...

  7. 10 CFR 2.1315 - Generic determination regarding license amendments to reflect transfers.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... reflect transfers. 2.1315 Section 2.1315 Energy NUCLEAR REGULATORY COMMISSION RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND ISSUANCE OF ORDERS Procedures for Hearings on License Transfer Applications § 2.1315 Generic determination regarding license amendments to reflect transfers. (a) Unless...

  8. The Environmental Protection Agency's Safety Standards for Disposal of Spent Nuclear Fuel: Potential Path Forward in Response to the Report of the Blue Ribbon Commission on America's Nuclear Future - 13388

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

    Forinash, Betsy; Schultheisz, Daniel; Peake, Tom

    2013-07-01

    Following the decision to withdraw the Yucca Mountain license application, the Department of Energy created a Blue Ribbon Commission (BRC) on America's Nuclear Future, tasked with recommending a national strategy to manage the back end of the nuclear fuel cycle. The BRC issued its final report in January 2012, with recommendations covering transportation, storage and disposal of spent nuclear fuel (SNF); potential reprocessing; and supporting institutional measures. The BRC recommendations on disposal of SNF and high-level waste (HLW) are relevant to the U.S. Environmental Protection Agency (EPA), which shares regulatory responsibility with the Nuclear Regulatory Commission (NRC): EPA issues 'generallymore » applicable' performance standards for disposal repositories, which are then implemented in licensing. For disposal, the BRC endorses developing one or more geological repositories, with siting based on an approach that is adaptive, staged and consent-based. The BRC recommends that EPA and NRC work cooperatively to issue generic disposal standards-applying equally to all sites-early in any siting process. EPA previously issued generic disposal standards that apply to all sites other than Yucca Mountain. However, the BRC concluded that the existing regulations should be revisited and revised. The BRC proposes a number of general principles to guide the development of future regulations. EPA continues to review the BRC report and to assess the implications for Agency action, including potential regulatory issues and considerations if EPA develops new or revised generic disposal standards. This review also involves preparatory activities to define potential process and public engagement approaches. (authors)« less

  9. Impact of the trade-related aspects of intellectual property rights (TRIPS) agreement on India as a supplier of generic antiretrovirals.

    PubMed

    Babovic, Sonja; Wasan, Kishor M

    2011-03-01

    This is a commentary on how the trade-related aspects of intellectual property rights (TRIPS) agreement has impacted India as a supplier of generic antiretrovirals (ARVs). We provide a systematic review of the issues related to the TRIPS agreement that affects India. This includes discussion around (a) the legal landscape underpinning India as a supplier of generic ARVs; (b) supply of second-line ARVs; and (c) the future of generic drug production in India. The proclamation into force of TRIPS-compliant intellectual property law in India is likely to affect its position as a supplier of affordable ARVs, especially drugs brought to market after 2005. Currently, mechanisms exist for the generic production of almost all ARVs in India, including second-line drugs; however, the manufacture of these drugs by generic pharmaceutical companies may require additional market incentives. Compulsory licensing may emerge as an additional mechanism by which India can provide affordable versions of patented drugs to Least Developed Countries (LDCs). Copyright © 2010 Wiley-Liss, Inc.

  10. 78 FR 37325 - License Renewal of Nuclear Power Plants; Generic Environmental Impact Statement and Standard...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... Nuclear Power Plants; Generic Environmental Impact Statement and Standard Review Plans for Environmental... for Nuclear Power Plants, Supplement 1: Operating License Renewal'' (ESRP). The ESRP serves as a guide... published a final rule, ``Revisions to Environmental Review for Renewal of Nuclear Power Plant Operating...

  11. Patent litigation in India continues to throw up new challenges.

    PubMed

    Reddy Thikkavarapu, Prashant

    2016-07-01

    For several years after the reinstitution of a pharmaceutical patent regime in India, most innovator pharmaceutical companies have faced a string of high-profile defeats during litigation in India. In the last 2 years, however, the fortunes of pharmaceutical patentees have changed dramatically. Not only have Indian courts enforced pharmaceutical patents and issued injunctions restraining Indian generic companies from infringing valid patents, but they have also refused to invoke 'public interest' arguments to delay the enforcement of patents. This string of victories for pharmaceutical patents indicates a new era for the innovator industry in India. These victories for the innovator industry demonstrate the objectivity of the Indian judiciary. Even on the issue of compulsory licensing, the Patent Office, which functions as a part of the central government, has been restrained - granting only one compulsory license for a drug owned by Bayer but declining two other similar requests. Similarly, even the Indian judiciary while enforcing patents has also remained sensitive to the flexibilities in the Patents Act, such as the 'Bolar-type' provisions and compulsory licensing provisions.

  12. 10 CFR 2.1315 - Generic determination regarding license amendments to reflect transfers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... that any amendment to the license of a utilization facility or the license of an Independent Spent Fuel... transfer. Any challenge to the administrative license amendment is limited to the question of whether the...

  13. Non-voluntary licensing of antivirals under patent: options the Australian Government should consider in light of a potential bird flu pandemic.

    PubMed

    Davies, Tim

    2006-05-01

    In the face of a potential bird flu pandemic, Australian Federal Health Minister, Tony Abbott, has recently dismissed expert advice that the government should begin, or even publicly consider, authorising generic manufacturers to produce antivirals, such as Tamiflu and Relenza, under patent via non-voluntary licensing methods. This is despite the fact that the demand for antivirals in Australia, and throughout the world, cannot be met by manufacturers under the control of limited patent owners alone. This article proposes that Australian patent law, which allows for non-voluntary licensing when it comes to important public health issues that affect Australian citizens, is relevant in meeting the demand for increased antiviral treatments during a possible bird flu pandemic, domestically and abroad. It argues that the Australian Government must go beyond what is currently being done and investigate and pursue such options.

  14. 75 FR 66398 - Notice of Availability of the Draft Supplement 45 to the Generic Environmental Impact Statement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-272, 50-311, and 50-354; NRC-2009-0390 and NRC-2009- 0391] Notice of Availability of the Draft Supplement 45 to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants, and Public Meetings for the License Renewal of Hope Creek Generating Station and Salem Nuclear Generating...

  15. 78 FR 48724 - Virgil C. Summer Nuclear Station, Units 2 and 3; South Carolina Electric and Gas; Change to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ...The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and issuing License Amendment No. 7 to Combined Licenses (COL), NPF-93 and NPF-94. The COLs were issued to South Carolina Electric and Gas (SCE&G) and South Carolina Public Service Authority (Santee Cooper) (the licensee), for construction and operation of the Virgil C. Summer Nuclear Station (VCSNS), Units 2 and 3 located in Fairfield County, South Carolina. The amendment changes requested revise the design of the bracing used to support the Turbine Building structure. This request requires changing Tier 1 information found in the Design Description portion of Updated Final Safety Analysis Report (UFSAR) section 3.3, ``Buildings.'' The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.

  16. 78 FR 45990 - Vogtle Electric Generating Station, Units 3 and 4; Southern Nuclear Operating Company; Change to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ...The U.S. Nuclear Regulatory Commission (NRC) is granting both an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment No. 8 to Combined Licenses (COL), NPF-91 and NPF-92. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, Municipal Electric Authority of Georgia, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP), Units 3 and 4, located in Burke County, Georgia. The amendment requests to revise the design of the bracing used to support the Turbine Building structure. This request requires changing Tier 1 information found in the Design Description portion of Updated Final Safety Analysis Report (UFSAR) Section 3.3, ``Buildings.'' The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.

  17. NRC safety research in support of regulation - FY 1994. Volume 9

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

    NONE

    This report, the tenth in a series of annual reports, was prepared in response to congressional inquiries concerning how nuclear regulatory research is used. It summarizes the accomplishments of the Office of Nuclear Regulatory Research during FY 1994. The goal of the Office of Nuclear Regulatory Research (RES) is to ensure the availability of sound technical bases for timely rulemaking and related decisions in support of NRC regulatory/licensing/inspection activities. RES also has responsibilities related to the resolution of generic safety issues and to the review of licensee submittals regarding individual plant examinations. It is the responsibility of RES to conductmore » the NRC`s rulemaking process, including the issuance of regulatory guides and rules that govern NRC licensed activities.« less

  18. Nuclear power plant Generic Aging Lessons Learned (GALL). Main report and appendix A

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

    Kaza, K.E.; Diercks, D.R.; Holland, J.W.

    The purpose of this generic aging lessons learned (GALL) review is to provide a systematic review of plant aging information in order to assess materials and component aging issues related to continued operation and license renewal of operating reactors. Literature on mechanical, structural, and thermal-hydraulic components and systems reviewed consisted of 97 Nuclear Plant Aging Research (NPAR) reports, 23 NRC Generic Letters, 154 Information Notices, 29 Licensee Event Reports (LERs), 4 Bulletins, and 9 Nuclear Management and Resources Council Industry Reports (NUMARC IRs) and literature on electrical components and systems reviewed consisted of 66 NPAR reports, 8 NRC Generic Letters,more » 111 Information Notices, 53 LERs, 1 Bulletin, and 1 NUMARC IR. More than 550 documents were reviewed. The results of these reviews were systematized using a standardized GALL tabular format and standardized definitions of aging-related degradation mechanisms and effects. The tables are included in volume s 1 and 2 of this report. A computerized data base has also been developed for all review tables and can be used to expedite the search for desired information on structures, components, and relevant aging effects. A survey of the GALL tables reveals that all ongoing significant component aging issues are currently being addressed by the regulatory process. However, the aging of what are termed passive components has been highlighted for continued scrutiny. This document is Volume 1, consisting of the executive summary, summary and observations, and an appendix listing the GALL literature review tables.« less

  19. Modeling HIV/AIDS Drug Price Determinants in Brazil: Is Generic Competition a Myth?

    PubMed Central

    Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

    2011-01-01

    Background Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. Methods and Findings Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. Significance In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies. PMID:21858138

  20. Modeling HIV/AIDS drug price determinants in Brazil: is generic competition a myth?

    PubMed

    Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

    2011-01-01

    Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.

  1. Could international compulsory licensing reconcile tiered pricing of pharmaceuticals with the right to health?

    PubMed

    Ooms, Gorik; Forman, Lisa; Williams, Owain D; Hill, Peter S

    2014-12-18

    The heads of the Global Fund and the GAVI Alliance have recently promoted the idea of an international tiered pricing framework for medicines, despite objections from civil society groups who fear that this would reduce the leeway for compulsory licenses and generic competition. This paper explores the extent to which an international tiered pricing framework and the present leeway for compulsory licensing can be reconciled, using the perspective of the right to health as defined in international human rights law. We explore the practical feasibility of an international tiered pricing and compulsory licensing framework governed by the World Health Organization. We use two simple benchmarks to compare the relative affordability of medicines for governments - average income and burden of disease - to illustrate how voluntary tiered pricing practice fails to make medicines affordable enough for low and middle income countries (if compared with the financial burden of the same medicines for high income countries), and when and where international compulsory licenses should be issued in order to allow governments to comply with their obligations to realize the right to health. An international tiered pricing and compulsory licensing framework based on average income and burden of disease could ease the tension between governments' human rights obligation to provide medicines and governments' trade obligation to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights.

  2. 78 FR 37324 - Preparation of Environmental Reports for Nuclear Power Plant License Renewal Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... Commission's 1996 findings on the environmental impacts of renewing the operating license of a nuclear power.... Specifically, the final rule amends Table B-1 by redefining the number and scope of the environmental impact... is publishing Revision 1 to NUREG-1437, ``Generic Environmental Impact Statement for License Renewal...

  3. 10 CFR 50.54 - Conditions of licenses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... to the licensee's facility; (iii) The use of generic organizational position titles that clearly...; (iv) The use of generic organizational charts to indicate functional relationships, authorities, and... which the licensee is committed; and (vi) Organizational revisions that ensure that persons and...

  4. Managing aging effects on dry cask storage systems for extended long-term storage and transportation of used fuel - rev. 0

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

    Chopra, O.K.; Diercks, D.; Fabian, R.

    The cancellation of the Yucca Mountain repository program in the United States raises the prospect of extended long-term storage (i.e., >120 years) and deferred transportation of used fuel at operating and decommissioned nuclear power plant sites. Under U.S. federal regulations contained in Title 10 of the Code of Federal Regulations (CFR) 72.42, the initial license term for an Independent Spent Fuel Storage Installation (ISFSI) must not exceed 40 years from the date of issuance. Licenses may be renewed by the U.S. Nuclear Regulatory Commission (NRC) at the expiration of the license term upon application by the licensee for a periodmore » not to exceed 40 years. Application for ISFSI license renewals must include the following: (1) Time-limited aging analyses (TLAAs) that demonstrate that structures, systems, and components (SSCs) important to safety will continue to perform their intended function for the requested period of extended operation; and (2) a description of the aging management program (AMP) for management of issues associated with aging that could adversely affect SSCs important to safety. In addition, the application must also include design bases information as documented in the most recent updated final safety analysis report as required by 10 CFR 72.70. Information contained in previous applications, statements, or reports filed with the Commission under the license may be incorporated by reference provided that those references are clear and specific. The NRC has recently issued the Standard Review Plan (SRP) for renewal of used-fuel dry cask storage system (DCSS) licenses and Certificates of Compliance (CoCs), NUREG-1927, under which NRC may renew a specific license or a CoC for a term not to exceed 40 years. Both the license and the CoC renewal applications must contain revised technical requirements and operating conditions (fuel storage, surveillance and maintenance, and other requirements) for the ISFSI and DCSS that address aging effects that could affect the safe storage of the used fuel. The information contained in the license and CoC renewal applications will require NRC review to verify that the aging effects on the SSCs in DCSSs/ ISFSIs are adequately managed for the period of extended operation. To date, all of the ISFSIs located across the United States with more than 1,500 dry casks loaded with used fuel have initial license terms of 20 years; three ISFSIs (Surry, H.B. Robinson and Oconee) have received their renewed licenses for 20 years, and two other ISFSIs (Calvert Cliffs and Prairie Island) have applied for license renewal for 40 years. This report examines issues related to managing aging effects on the SSCs in DCSSs/ISFSIs for extended long-term storage and transportation of used fuels, following an approach similar to that of the Generic Aging Lessons Learned (GALL) report, NUREG-1801, for the aging management and license renewal of nuclear power plants. The report contains five chapters and an appendix on quality assurance for aging management programs for used-fuel dry storage systems. Chapter I of the report provides an overview of the ISFSI license renewal process based on 10 CFR 72 and the guidance provided in NUREG-1927. Chapter II contains definitions and terms for structures and components in DCSSs, materials, environments, aging effects, and aging mechanisms. Chapter III and Chapter IV contain generic TLAAs and AMPs, respectively, that have been developed for managing aging effects on the SSCs important to safety in the dry cask storage system designs described in Chapter V. The summary descriptions and tabulations of evaluations of AMPs and TLAAs for the SSCs that are important to safety in Chapter V include DCSS designs (i.e., NUHOMS{reg_sign}, HI-STORM 100, Transnuclear (TN) metal cask, NAC International S/T storage cask, ventilated storage cask (VSC-24), and the Westinghouse MC-10 metal dry storage cask) that have been and continue to be used by utilities across the country for dry storage of used fuel to date. The goal of this report is to help establish the technical basis for extended long-term storage and transportation of used fuel.« less

  5. 77 FR 22361 - Energy Northwest, Columbia Generating Station; Final Supplement 47 to the Generic Environmental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ...) solar power; (9) wind power; (10) biomass waste; (11) hydroelectric power; (12) ocean wave and current... Nuclear Plants AGENCY: Nuclear Regulatory Commission. ACTION: Final Supplement 47 to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants; issuance. SUMMARY: Notice is hereby given...

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

    PubMed

    Kuhrt, K; Gilpatrick, J

    2013-11-01

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

  7. 10 CFR 51.23 - Temporary storage of spent fuel after cessation of reactor operation-generic determination of no...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Temporary storage of spent fuel after cessation of reactor operation-generic determination of no significant environmental impact. 51.23 Section 51.23 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED...

  8. 75 FR 80857 - Notice of Availability of NUREG-1800, Revision 2; “Standard Review Plan for Review of License...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ..., Revision 2; ``Generic Aging Lessons Learned (GALL) Report'' AGENCY: Nuclear Regulatory Commission (NRC... Nuclear Power Plants'' and NUREG-1801, Revision 2; ``Generic Aging Lessons Learned (GALL) Report... Lessons Learned (GALL) Report.'' These revised documents describe methods acceptable to the NRC staff for...

  9. 75 FR 58447 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Plant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Plant License Renewal The ACRS Subcommittee on Plant License Renewal will hold a meeting on..., ``Generic Aging Lessons Learned (GALL) Report.'' The Subcommittee will hear presentations by and hold...

  10. 10 CFR 51.95 - Postconstruction environmental impact statements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... determined by the Commission, a supplement on the operation of a nuclear power plant will not include a... the storage of spent fuel for the nuclear power plant within the scope of the generic determination in... the renewal of an operating license or combined license for a nuclear power plant under parts 52 or 54...

  11. 75 FR 6737 - FPL Energy Duane Arnold, LLC; Notice of Availability of the Draft Supplement 42 to the Generic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-10

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-331; NRC-2010-0048] FPL Energy Duane Arnold, LLC... License Renewal of Nuclear Plants, and Public Meeting for the License Renewal of Duane Arnold Energy... of operation for Duane Arnold Energy Center (DAEC). DAEC is located near Cedar Rapids, Iowa...

  12. 76 FR 24064 - Arizona Public Service Company, Palo Verde Nuclear Generating Station, Units 1, 2, and 3, Notice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-29

    ... Decision Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC, the Commission) has... notice also serves as the record of decision for Renewed Facility Operating License Nos. NPF-41, NPF-51... Decision--General.'' NUREG-1437, ``Generic Environmental Impact Statement for License Renewal of Nuclear...

  13. 78 FR 25487 - Final License Renewal Interim Staff Guidance LR-ISG-2012-01: Wall Thinning Due to Erosion Mechanisms

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-01

    ....'' This LR-ISG revises an NRC staff-recommended aging management program (AMP) in NUREG-1801, Revision 2, ``Generic Aging Lessons Learned (GALL) Report,'' and the NRC staff's aging management review procedure and... for piping and components within the scope of the Requirements for Renewal of Operating Licenses for...

  14. 77 FR 74882 - STP Nuclear Operating Company, South Texas Project; Notice of Availability of Draft Supplement 48...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos.: 50-498 and 50-499; NRC-2010-0375] STP Nuclear Operating Company, South Texas Project; Notice of Availability of Draft Supplement 48 to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants and Public Meetings for the License Renewal of South Texas Project Notice is hereby...

  15. 76 FR 29279 - Prairie Island Nuclear Generating Plant, Units 1 and 2; Notice of Availability of the Final...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ... NUCLEAR REGULATORY COMMISSION NORTHERN STATES POWER COMPANY [Docket Numbers 50-282 and 50-306; NRC-2009-0507] Prairie Island Nuclear Generating Plant, Units 1 and 2; Notice of Availability of the Final Supplement 39 to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants Regarding the License Renewal of Prairie Island...

  16. MATLAB Software Versions and Licenses for the Peregrine System |

    Science.gov Websites

    : Feature usage info: Users of MATLAB: (Total of 6 licenses issued; Total of ... licenses in use) Users of Compiler: (Total of 1 license issued; Total of ... licenses in use) Users of Distrib_Computing_Toolbox : (Total of 4 licenses issued; Total of ... licenses in use) Users of MATLAB_Distrib_Comp_Engine: (Total of

  17. 14 CFR 413.19 - Issuing a license or permit.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Issuing a license or permit. 413.19 Section 413.19 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LICENSE APPLICATION PROCEDURES § 413.19 Issuing a license or permit...

  18. LAM Pilot Study with Imatinib Mesylate (LAMP 1)

    DTIC Science & Technology

    2016-10-01

    At the time of grant submission, Novartis Gleevec was scheduled to come off patent in early 2015. This was challenged after grant submission by...Novartis patent expired in 2016 we approached Sun Pharmaceutics who declined (by silence) access to their generic imatinib. Next, communication with...shared. • Inventions, patent applications, and/or licenses Identify inventions, patent applications with date, and/or licenses that have

  19. Workshop on environmental qualification of electric equipment

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

    Lofaro, R.; Gunther, W.; Villaran, M.

    1994-05-01

    Questions concerning the Environmental Qualification (EQ) of electrical equipment used in commercial nuclear power plants have recently become the subject of significant interest to the US Nuclear Regulatory Commission (NRC). Initial questions centered on whether compliance with the EQ requirements for older plants were adequate to support plant operation beyond 40 years. After subsequent investigation, the NRC Staff concluded that questions related to the differences in EQ requirements between older and newer plants constitute a potential generic issue which should be evaluated for backfit, independent of license renewal activities. EQ testing of electric cables was performed by Sandia National Laboratoriesmore » (SNL) under contract to the NRC in support of license renewal activities. Results showed that some of the environmentally qualified cables either failed or exhibited marginal insulation resistance after a simulated plant life of 20 years during accident simulation. This indicated that the EQ process for some electric cables may be non-conservative. These results raised questions regarding the EQ process including the bases for conclusions about the qualified life of components based upon artificial aging prior to testing.« less

  20. Knowledge and abilities catalog for nuclear power plant operators: Boiling water reactors, Revision 1

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

    NONE

    1995-08-01

    The Knowledge and Abilities Catalog for Nuclear Power Plant Operators: Boiling-Water Reactors (BWRs) (NUREG-1123, Revision 1) provides the basis for the development of content-valid licensing examinations for reactor operators (ROs) and senior reactor operators (SROs). The examinations developed using the BWR Catalog along with the Operator Licensing Examiner Standards (NUREG-1021) and the Examiner`s Handbook for Developing Operator Licensing Written Examinations (NUREG/BR-0122), will cover the topics listed under Title 10, Code of Federal Regulations, Part 55 (10 CFR 55). The BWR Catalog contains approximately 7,000 knowledge and ability (K/A) statements for ROs and SROs at BWRs. The catalog is organized intomore » six major sections: Organization of the Catalog, Generic Knowledge and Ability Statements, Plant Systems grouped by Safety Functions, Emergency and Abnormal Plant Evolutions, Components, and Theory. Revision 1 to the BWR Catalog represents a modification in form and content of the original catalog. The K/As were linked to their applicable 10 CFR 55 item numbers. SRO level K/As were identified by 10 CFR 55.43 item numbers. The plant-wide generic and system generic K/As were combined in one section with approximately one hundred new K/As. Component Cooling Water and Instrument Air Systems were added to the Systems Section. Finally, High Containment Hydrogen Concentration and Plant Fire On Site evolutions added to the Emergency and Abnormal Plant Evolutions section.« less

  1. Function of university reactors in operator licensing training for nuclear utilities

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

    Wicks, F.

    1985-11-01

    The director of the Division of the US Nuclear Regulatory Commission in generic letter 84-10, dated April 26, 1984, spoke the requirement that applicants for senior reactor operator licenses for power reactors shall have performed then reactor startups. Simulator startups were not acknowledged. Startups performed on a university reactor are acceptable. The content and results of a five-day program combining instruction and experiments with the Rensselaer reactor are summarized.

  2. Protecting the patient by promoting end-user competence in health informatics systems-moves towards a generic health computer user "driving license".

    PubMed

    Rigby, Michael

    2004-03-18

    The effectiveness and quality of health informatics systems' support to healthcare delivery are largely determined by two factors-the suitability of the system installed, and the competence of the users. However, the profile of users of large-scale clinical health systems is significantly different from the profile of end-users in other enterprises such as the finance sector, insurance, travel or retail sales. Work with a mental health provider in Ireland, who was introducing a customized electronic patient record (EPR) system, identified the strong legal and ethical importance of adequately skills for the health professionals and others, who would be the system users. The experience identified the need for a clear and comprehensive generic user qualification at a basic but robust level. The European computer driving license (ECDL) has gained wide recognition as a basic generic qualification for users of computer systems. However, health systems and data have a series of characteristics that differentiate them from other data systems. The logical conclusion was the recognition of a need for an additional domain-specific qualification-an "ECDL Health Supplement". Development of this is now being progressed.

  3. Biosimilars: Considerations for Oncology Nurses
.

    PubMed

    Vizgirda, Vida; Jacobs, Ira

    2017-04-01

    Biosimilars are developed to be highly similar to and treat the same conditions as licensed biologics. As they are approved and their use becomes more widespread, oncology nurses should be aware of their development and unique considerations. This article reviews properties of biosimilars; their regulation and approval process; the ways in which their quality, safety, and efficacy are evaluated; their postmarketing safety monitoring; and their significance to oncology nurses and oncology nursing.
. A search of PubMed and regulatory agency websites was conducted for references related to the development and use of biosimilars in oncology. 
. Because biologics are large, structurally complex molecules, biosimilars cannot be considered generic equivalents to licensed biologic products. Consequently, regulatory approval for biosimilars is different from approval for small-molecule generics. Oncology nurses are in a unique position to educate themselves, other clinicians, and patients and their families about biosimilars to ensure accurate understanding, as well as optimal and safe use, of biosimilars.

  4. 77 FR 28316 - Filing a Renewed License Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-14

    ... only those environmental impacts and alternatives that are reasonably foreseeable. This means that... action timeframe. With respect to assessing the potential future environmental impacts associated with... its consideration of impacts in the generic and supplemental environmental impact statements (SEISs...

  5. Generics license 30-month-olds’ inferences about the atypical properties of novel kinds

    PubMed Central

    Graham, Susan A.; Gelman, Susan A.; Clarke, Jessica

    2016-01-01

    We examined whether the distinction between generic and nongeneric language provides toddlers with a rapid and efficient means to learn about kinds. In Experiment 1, we examined 30-month-olds’ willingness to extend atypical properties to members of an unfamiliar category when the properties were introduced in one of three ways: a) using a generic noun phrase (“Blicks drink ketchup”); b) using a nongeneric noun phrase (“These blicks drink ketchup”); and c) using an attentional phrase (“Look at this”). Hearing a generic noun phrase boosted toddlers’ extension of properties to both the model exemplars and to novel members of the same category, relative to when a property had been introduced with a nongeneric noun phrase or an attentional phrase. In Experiment 2, properties were introduced with a generic noun phrase and toddlers extended novel properties to members of the same-category, but not to an out-of-category object. Taken together, these findings demonstrate that generics highlight the stability of a feature and foster generalization of the property to novel within-category exemplars. PMID:27505699

  6. 10 CFR 51.53 - Postconstruction environmental reports.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... impact statement; supplements to the final environmental impact statement, including supplements prepared at the license renewal stage; NRC staff-prepared final generic environmental impact statements; and... reflect new information in addition to that discussed in the final environmental impact statement prepared...

  7. 78 FR 79503 - Tennessee Valley Authority, Combined License Application for Bellefonte Units 3 and 4 Exemption...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ... them to submit a departures report that describes the generic changes and plant-specific departures..., Maryland 20852. FOR FURTHER INFORMATION CONTACT: Anthony Minarik, Office of New Reactors, U.S. Nuclear... advanced [[Page 79504

  8. An introduction to intellectual property licensing for technology companies

    NASA Astrophysics Data System (ADS)

    Meier, Lawrence H.

    2001-05-01

    Intellectual property licensing is an important issue facing all technology companies. Before entering into license agreements a number of issues need to be addressed, including invention ownership, obtaining and identifying licensable subject matter, and developing a licensing strategy. There are a number of important provisions that are included in most intellectual property license agreements. These provisions include definitions, the license grant, consideration, audit rights confidentiality, warranties, indemnification, and limitation of liability. Special licensing considerations exist relative to each type of intellectual property, and when the other party is a foreign company or a university.

  9. 9 CFR 102.1 - Licenses issued by the Administrator.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... biological products under the Virus-Serum-Toxin Act shall hold an unexpired and unrevoked U.S. Veterinary Biologics Establishment License issued by the Administrator and a U.S. Veterinary Biological Product License...

  10. 9 CFR 102.1 - Licenses issued by the Administrator.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... biological products under the Virus-Serum-Toxin Act shall hold an unexpired and unrevoked U.S. Veterinary Biologics Establishment License issued by the Administrator and a U.S. Veterinary Biological Product License...

  11. Fluorescence techniques in agricultural applications

    NASA Astrophysics Data System (ADS)

    McMurtrey, James E.; Corp, Lawrence A.; Kim, Moon S.; Chappelle, Emmett W.; Daughtry, Craig S. T.; DiBenedetto, J. D.

    2001-03-01

    Intellectual property licensing is an important issue facing all technology companies. Before entering into license agreements a number of issues need to be addressed, including invention ownership, obtaining and identifying licensable subject matter, and developing a licensing strategy. There are a number of important provisions that are included in most intellectual property license agreements. These provisions include definitions, the license grant, consideration, audit rights, confidentiality, warranties, indemnification, and limitation of liability. Special licensing considerations exist relative to each type of intellectual property, and when the other party is a foreign company or a university.

  12. Compulsory licenses: a tool to improve global access to the HPV vaccine?

    PubMed

    Maybarduk, Peter; Rimmington, Sarah

    2009-01-01

    Cervical cancer disproportionately affects women in lower- and middle-income countries. But the new vaccines developed to prevent infection with some strains of the human papillomavirus (HPV) that cause cervical cancer are priced beyond the reach of most women and health agencies in these regions, due in part to the monopoly pricing power of brand-name companies that hold the patents on the vaccines. Compulsory licenses, which authorize generic competition with patented products, could expand access to HPV vaccines under certain circumstances. If high-quality biogeneric HPV vaccines can be produced at low cost and be broadly and efficiently registered, and if Merck and GSK are unwilling to grant licenses on a voluntary basis, compulsory licensing could play a pivotal role in ensuring vaccinations against HPVare available to all, around the world, regardless of ability to pay.

  13. 10 CFR 72.210 - General license issued.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE General License for Storage of Spent Fuel at Power Reactor Sites § 72.210 General license issued. A general license is... reactor sites to persons authorized to possess or operate nuclear power reactors under 10 CFR part 50 or...

  14. 10 CFR 72.210 - General license issued.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE General License for Storage of Spent Fuel at Power Reactor Sites § 72.210 General license issued. A general license is... reactor sites to persons authorized to possess or operate nuclear power reactors under 10 CFR part 50 or...

  15. 31 CFR 545.514 - Payments for services rendered by the Taliban to aircraft.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) SANCTIONS REGULATIONS Licenses, Authorizations and Statements of Licensing Policy § 545.514 Payments for services rendered by the Taliban to aircraft. (a) Specific licenses may be issued on a case-by-case basis.... (b) Specific licenses may be issued on a case-by-case basis for the exportation, reexportation, sale...

  16. 42 CFR 447.502 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) approved by the Food and Drug Administration (FDA), including an authorized generic drug. It includes a... license approval (ELA) or antibiotic drug approval (ADA). Lagged price concession means any discount or... of natural origin, or independently by means of chemical synthesis, or by a combination of extraction...

  17. 42 CFR 447.502 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) approved by the Food and Drug Administration (FDA), including an authorized generic drug. It includes a... license approval (ELA) or antibiotic drug approval (ADA). Lagged price concession means any discount or... of natural origin, or independently by means of chemical synthesis, or by a combination of extraction...

  18. 42 CFR 447.502 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) approved by the Food and Drug Administration (FDA), including an authorized generic drug. It includes a... license approval (ELA) or antibiotic drug approval (ADA). Lagged price concession means any discount or... of natural origin, or independently by means of chemical synthesis, or by a combination of extraction...

  19. 42 CFR 447.502 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) approved by the Food and Drug Administration (FDA), including an authorized generic drug. It includes a... license approval (ELA) or antibiotic drug approval (ADA). Lagged price concession means any discount or... of natural origin, or independently by means of chemical synthesis, or by a combination of extraction...

  20. Drug policy and administration affecting quality of life of the poor in Thailand.

    PubMed

    Prutipinyo, Chardsumon; Sirichotiratana, Nithat

    2011-09-01

    This study aims to analyze drug policy and administration affecting quality of life of the poor in Thailand. Review of official reports and related documents, for the past 10 years (from 2000-2010). By imposing compulsory licensing, the Thai government maintains negotiating power over the price of pharmaceutical products with the patent holders of the original drugs. This gives an opportunity for relevant government agencies to produce or import patented drugs. At present, there are many problems and obstacles. The findings show that developing countries need to strengthen their negotiating power so that the pharmaceutical manufacturers cannot take advantage through mechanisms provided for such as compulsory licensing and provisions for flexibility in Trade-Related Intellectual Property Rights (TRIPS) agreement. Furthermore, these countries must support and empower the local pharmaceutical manufacturers to produce generic drugs. Developing countries should ensure that their populations have confidence in universal coverage service and medical systems regarding the quality of generic drugs.

  1. 10 CFR 780.34 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Criteria for decision to issue a license. 780.34 Section 780.34 Energy DEPARTMENT OF ENERGY PATENT COMPENSATION BOARD REGULATIONS Application for a License Pursuant to Section 153b(2) of the Atomic Energy Act of 1954 § 780.34 Criteria for decision to issue a...

  2. 10 CFR 780.34 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Criteria for decision to issue a license. 780.34 Section 780.34 Energy DEPARTMENT OF ENERGY PATENT COMPENSATION BOARD REGULATIONS Application for a License Pursuant to Section 153b(2) of the Atomic Energy Act of 1954 § 780.34 Criteria for decision to issue a...

  3. 10 CFR 780.34 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Criteria for decision to issue a license. 780.34 Section 780.34 Energy DEPARTMENT OF ENERGY PATENT COMPENSATION BOARD REGULATIONS Application for a License Pursuant to Section 153b(2) of the Atomic Energy Act of 1954 § 780.34 Criteria for decision to issue a...

  4. 10 CFR 780.34 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Criteria for decision to issue a license. 780.34 Section 780.34 Energy DEPARTMENT OF ENERGY PATENT COMPENSATION BOARD REGULATIONS Application for a License Pursuant to Section 153b(2) of the Atomic Energy Act of 1954 § 780.34 Criteria for decision to issue a...

  5. 10 CFR 780.34 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Criteria for decision to issue a license. 780.34 Section 780.34 Energy DEPARTMENT OF ENERGY PATENT COMPENSATION BOARD REGULATIONS Application for a License Pursuant to Section 153b(2) of the Atomic Energy Act of 1954 § 780.34 Criteria for decision to issue a...

  6. 18 CFR 16.13 - Standards and factors for issuing a new license.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Standards and factors for issuing a new license. 16.13 Section 16.13 Conservation of Power and Water Resources FEDERAL... and 15 of the Federal Power Act § 16.13 Standards and factors for issuing a new license. (a) In...

  7. 77 FR 52344 - Proposed Information Collection; Annual Certification of Hunting and Sport Fishing Licenses Issued

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-29

    ... Hunting and Sport Fishing Licenses Issued AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice...-Robertson Wildlife Restoration Act (16 U.S.C. 669 et seq.) and the Dingell-Johnson Sport Fish Restoration...--Summary of Hunting and Sport Fishing Licenses Issued) to certify the number and amount of hunting and...

  8. 76 FR 34072 - Environmental Impacts Statements; Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-10

    .... 20110178, Draft EIS, NRC, FL, Generic--License Renewal of Nuclear Plants Regarding Crystal River Unit 3.... 20110182, Final EIS, WAPA, CA, Rice Solar Energy Project, Proposed 150 megawatt Solar Energy Generating..., Access, Wildlife, Fisheries, Soil and Water, Idaho Panhandle National Forest, St. Joe Ranger District...

  9. 75 FR 54145 - Environmental Impacts Statements; Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ... to Construct a Concentrated Solar Thermal Power Plant Facility, Nye County, NV, Comment Period Ends..., GENERIC--License Renewal of Nuclear Plants for Kewaunee Power Station, Supplement 40 to NUREG-1437... EIS, NRC, GA, Vogtle Electric Generating Plant Units 3 and 4, Construction and Operation, Application...

  10. 10 CFR 51.95 - Postconstruction environmental impact statements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... the storage of spent fuel for the nuclear power plant within the scope of the generic determination in... a license to store spent fuel at a nuclear power reactor after expiration of the operating or... Section 51.95 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR...

  11. 10 CFR 51.95 - Postconstruction environmental impact statements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... the storage of spent fuel for the nuclear power plant within the scope of the generic determination in... a license to store spent fuel at a nuclear power reactor after expiration of the operating or... Section 51.95 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR...

  12. A Generic Ground Framework for Image Expertise Centres and Small-Sized Production Centres

    NASA Astrophysics Data System (ADS)

    Sellé, A.

    2009-05-01

    Initiated by the Pleiadas Earth Observation Program, the CNES (French Space Agency) has developed a generic collaborative framework for its image quality centre, highly customisable for any upcoming expertise centre. This collaborative framework has been design to be used by a group of experts or scientists that want to share data and processings and manage interfaces with external entities. Its flexible and scalable architecture complies with the core requirements: defining a user data model with no impact on the software (generic access data), integrating user processings with a GUI builder and built-in APIs, and offering a scalable architecture to fit any preformance requirement and accompany growing projects. The CNES jas given licensing grants for two software companies that will be able to redistribute this framework to any customer.

  13. US domestic and international regulatory issues

    NASA Technical Reports Server (NTRS)

    Levin, Lon C.; Nash, Dennis C.

    1993-01-01

    The U.S. domestic and international regulatory and policy milestones since 1982, when NASA filed its petition with the Federal Communications Commission (FCC) to establish the U.S. domestic Mobile Satellite Service (MSS), are described. In 1985, the FCC proposed to establish MSS services and allocate spectrum for such service. In 1986, the FCC allocated L-band spectrum for MSS. In 1987, at the Mobile World Administrative Radio Conference (MOB WARC-87), despite U.S., Canadian, and Mexican efforts, the WARC did not adopt a multi-service, generic MSS allocation. In 1989, the FCC licensed the first MSS system. After two decisions by the U.S. Court of Appeals, the FCC's licensing actions remain intact. The FCC also has permitted Comsat to provide international aeronautical and land MSS via the Inmarsat system. Inmarsat, however, may not serve the domestic U.S. market. In 1991, the FCC accepted applications for MSS systems, most of which were non-geostationary proposals, for operation in the Radiodetermination Satellite Service (RDSS) bands, and the VHF and UHF bands. In 1992, the FCC proposed rules for non-geostationary MSS systems and applied a negotiated rulemaking procedure to each. Also in 1992, the U.S. position for flexibility in existing MSS bands and for additional worldwide MSS allocations was adopted in large part at the 1992 World Administrative Radio Conference (WARC-92).

  14. Innovation strategies for generic drug companies: moving into supergenerics.

    PubMed

    Ross, Malcolm S F

    2010-04-01

    Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

  15. 10 CFR 32.25 - Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Conditions of licenses issued under § 32.22: Quality... Concentrations and Items § 32.25 Conditions of licenses issued under § 32.22: Quality control, labeling, and... in the manufacture of the product to assure that each production lot meets the quality control...

  16. 10 CFR 32.25 - Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Conditions of licenses issued under § 32.22: Quality... Concentrations and Items § 32.25 Conditions of licenses issued under § 32.22: Quality control, labeling, and... in the manufacture of the product to assure that each production lot meets the quality control...

  17. 78 FR 70588 - STP Nuclear Operating Company; South Texas Project

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-26

    ... efficiency; (8) wind power; (9) solar power; (10) hydroelectric power; (11) ocean wave and current energy... generic environmental impact statement for license renewal of nuclear plants; issuance. SUMMARY: Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC) has published the final, plant-specific...

  18. Kmonodium, a Program for the Numerical Solution of the One-Dimensional Schrodinger Equation

    ERIC Educational Resources Information Center

    Angeli, Celestino; Borini, Stefano; Cimiraglia, Renzo

    2005-01-01

    A very simple strategy for the solution of the Schrodinger equation of a particle moving in one dimension subjected to a generic potential is presented. This strategy is implemented in a computer program called Kmonodium, which is free and distributed under the General Public License (GPL).

  19. 15 CFR 303.7 - Issuance of licenses and shipment permits.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (Continued) INTERNATIONAL TRADE ADMINISTRATION, DEPARTMENT OF COMMERCE MISCELLANEOUS REGULATIONS WATCHES....5 the Director shall issue a non-transferable license (Form ITA-333) to each producer. The Director shall also issue a replacement license if a producer's allocation is reduced pursuant to § 303.6. (2...

  20. 15 CFR 303.7 - Issuance of licenses and shipment permits.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... (Continued) INTERNATIONAL TRADE ADMINISTRATION, DEPARTMENT OF COMMERCE MISCELLANEOUS REGULATIONS WATCHES....5 the Director shall issue a non-transferable license (Form ITA-333) to each producer. The Director shall also issue a replacement license if a producer's allocation is reduced pursuant to § 303.6. (2...

  1. Structuring the Multimedia Deal: Legal Issues--Part 1: Licensing in the Multimedia Arena.

    ERIC Educational Resources Information Center

    Gersh, David L.; Jeffrey, Sheri

    1993-01-01

    Provides an overview of legal issues related to licensing entertainment rights for multimedia source materials, including the grant of rights clause, copyright ownership, territory and languages, term provision, specifications, approvals/controls, royalties, guilds, bankruptcies, termination of the license, and confidentiality. Common mistakes…

  2. 47 CFR 74.632 - Licensing requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... home-city users. (e) A license for a TV translator relay station will be issued only to licensees of low power TV and TV translator stations. However, a television translator relay station license may be issued to a cooperative enterprise wholly owned by licensees of television broadcast translators or...

  3. Compulsory licensing often did not produce lower prices for antiretrovirals compared to international procurement.

    PubMed

    Beall, Reed F; Kuhn, Randall; Attaran, Amir

    2015-03-01

    Compulsory licensing has been widely suggested as a legal mechanism for bypassing patents to introduce lower-cost generic antiretrovirals for HIV/AIDS in developing countries. Previous studies found that compulsory licensing can reduce procurement prices for drugs, but it is unknown how the resulting prices compare to procurements through the Global Fund to Fight AIDS, Tuberculosis, and Malaria; UNICEF; and other international channels. For this study we systematically constructed a case-study database of compulsory licensing activity for antiretrovirals and compared compulsory license prices to those in the World Health Organization's (WHO's) Global Price Reporting Mechanism and the Global Fund's Price and Quality Reporting Tool. Thirty compulsory license cases were analyzed with 673 comparable procurements from WHO and Global Fund data. Compulsory license prices exceeded the median international procurement prices in nineteen of the thirty case studies, often with a price gap of more than 25 percent. Compulsory licensing often delivered suboptimal value when compared to the alternative of international procurement, especially when used by low-income countries to manufacture medicines locally. There is an ongoing need for multilateral and charitable actors to work collectively with governments and medicine suppliers on policy options. Project HOPE—The People-to-People Health Foundation, Inc.

  4. Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

    PubMed

    Chong, Chee Ping; Hassali, Mohamed Azmi; Bahari, Mohd Baidi; Shafie, Asrul Akmal

    2011-02-01

    To evaluate the Malaysian community pharmacists' views on generic medicines. A sample of 1419 Malaysian community pharmacies with resident pharmacists. A cross-sectional nationwide survey using a self-completed mailing questionnaire. Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

  5. 49 CFR 383.23 - Commercial driver's license.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... STANDARDS; REQUIREMENTS AND PENALTIES Single License Requirement § 383.23 Commercial driver's license. (a... the single license provision of § 383.21, a driver holding a commercial driver's license issued under... be considered valid commercial drivers' licenses for purposes of behind-the-wheel training on public...

  6. 78 FR 26662 - Draft Supplement to the Generic Environmental Impact Statement for License Renewal of Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-07

    ... reasonable alternative energy sources. DATES: Submit comments by June 30, 2013. Comments received after this... for comments received on or before this date. ADDRESSES: You may access information and comment... INFORMATION CONTACT section of this document. Mail comments to: Cindy Bladey, Chief, Rules, Announcements, and...

  7. 78 FR 57538 - Proposed Waste Confidence Rule and Draft Generic Environmental Impact Statement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ....nrc.gov/public-involve/public-meetings/index.cfm no later than 10 days prior to the meetings. Dated at... storage of spent nuclear fuel beyond a reactor's licensed life for operation and prior to ultimate... the proposed Waste Confidence rule and DGEIS in order to maximize public participation at these...

  8. 78 FR 56621 - Draft Waste Confidence Generic Environmental Impact Statement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    .../public-involve/public-meetings/index.cfm no later than 10 days prior to the meetings. Dated at Rockville... licensed life for operation and prior to ultimate disposal (proposed Waste Confidence rule). The NRC staff... confirming receipt, then contact us at 301-415-1677. Fax comments to: Secretary, U.S. Nuclear Regulatory...

  9. 75 FR 80545 - Carolina Power & Light Company; H.B. Robinson Steam Electric Plant, Unit No. 2; Environmental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

    ....B. Robinson Steam Electric Plant, Unit No. 2; Environmental Assessment and Finding of No Significant...), for operation of the H. B. Robinson Steam Electric Plant, Unit 2 (HBRSEP), located in Darlington... ``Generic Environmental Impact Statement for License Renewal of Nuclear Plants: H.B. Robinson Steam Electric...

  10. 78 FR 20146 - Lost Creek ISR, LLC, Lost Creek Uranium In-Situ Recovery Project, Sweetwater County, Wyoming

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    ... ISR, LLC, Lost Creek Uranium In-Situ Recovery Project, Sweetwater County, Wyoming AGENCY: Nuclear... to Source Materials License SUA-1598 for continued uranium production operations and in-situ recovery... identified in NUREG-1910, ``Generic Environmental Impact Statement for In-Situ Leach Uranium Milling...

  11. 76 FR 71082 - Strata Energy, Inc., Ross Uranium Recovery Project; New Source Material License Application...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ...-situ recovery (ISR), also known as in-situ leach, facilities and restoration of the aquifer from which... Supplemental Environmental Impact Statement (SEIS) to the Generic Environmental Impact Statement for In-Situ... located in Crook County, Wyoming, 32 miles northeast of Gillette, Wyoming and 30 miles northwest of...

  12. 78 FR 19330 - Supplemental Environmental Impact Statement for the Ross In-Situ Uranium Recovery Project in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

    ... Ross In-Situ Uranium Recovery Project in Crook County, Wyoming AGENCY: Nuclear Regulatory Commission... Commission (NRC) for a new source materials license for the proposed Ross In-Situ Uranium Recovery (ISR... SEIS is Supplement 5 to NUREG-1910, ``Generic Environmental Impact Statement for In-Situ Leach Uranium...

  13. 10 CFR 2.627 - Partial decision on site suitability issues in combined license proceeding.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... license proceeding. 2.627 Section 2.627 Energy NUCLEAR REGULATORY COMMISSION RULES OF PRACTICE FOR... License To Construct Certain Utilization Facilities; and Advance Issuance of Limited Work Authorizations... accordance with this subpart. A limited work authorization may not be issued under 10 CFR 50.10(e) and no...

  14. 10 CFR 60.43 - License specification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false License specification. 60.43 Section 60.43 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Licenses License Issuance and Amendment § 60.43 License specification. (a) A license issued under this part shall...

  15. Application of the IBERDROLA RETRAN Licensing Methodology to the Confrentes BWR-6 110% Extended Power Uprate

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

    Fuente, Rafael de la; Iglesias, Javier; Sedano, Pablo G.

    IBERDROLA (Spanish utility) and IBERDROLA INGENIERIA (engineering branch) have been developing during the last 2 yr the 110% Extended Power Uprate Project for Cofrentes BWR-6. IBERDROLA has available an in-house design and licensing reload methodology that has been approved in advance by the Spanish Nuclear Regulatory Authority. This methodology has been applied to perform the nuclear design and the reload licensing analysis for Cofrentes cycles 12 and 13 and to develop a significant number of safety analyses of the Cofrentes Extended Power.Because the scope of the licensing process of the Cofrentes Extended Power Uprate exceeds the range of analysis includedmore » in the Cofrentes generic reload licensing process, it has been required to extend the applicability of the Cofrentes RETRAN model to the analysis of new transients. This is the case of the total loss of feedwater (TLFW) transient.The content of this paper shows the benefits of having an in-house design and licensing methodology and describes the process to extend the applicability of the Cofrentes RETRAN model to the analysis of new transients, particularly in this paper the TLFW transient.« less

  16. 10 CFR 60.42 - Conditions of license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Conditions of license. 60.42 Section 60.42 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Licenses License Issuance and Amendment § 60.42 Conditions of license. (a) A license issued pursuant to this part...

  17. 10 CFR 50.20 - Two classes of licenses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Two classes of licenses. 50.20 Section 50.20 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Classification and Description of Licenses § 50.20 Two classes of licenses. Licenses will be issued to named persons...

  18. 76 FR 24925 - Solicitation for Public Comment on Potential Alternatives To Resolve Generic Safety Issue 191...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... comment on potential alternatives for risk informing the path forward to resolve Generic Safety Issue (GSI... Notation Vote Paper (SECY-10-0113) which presented to the Commission the regulatory path forward options... the staff, in part, to explore alternative paths forward for resolving GSI-191. Discussion While GSI...

  19. AVC/H.264 patent portfolio license

    NASA Astrophysics Data System (ADS)

    Horn, Lawrence A.

    2004-11-01

    MPEG LA, LLC recently announced terms of a joint patent license for the AVC (a/k/a H.264) Standard (ISO/IEC IS 14496-10: Information technology -- Coding of audio-visual objects -- Part 10: Advanced Video Coding | ITU-T Rec. H.264: Series H: Audiovisual and Multimedia Systems: Infrastructure of audiovisual services -- Coding of moving video: Advanced video coding for generic audiovisual services). Like MPEG LA"s other licenses, the AVC Patent Portfolio License is offered for the convenience of the marketplace as an alternative enabling users to access essential intellectual property owned by many patent holders under a single license rather than negotiating licenses with each of them individually. The AVC Patent Portfolio License includes essential patents owned by Columbia Innovation Enterprises; Electronics and Telecommunications Research Institute (ETRI); France Télécom, société anonyme; Fujitsu Limited; Koninklijke Philips Electronics N.V.; Matsushita Electric Industrial Co., Ltd.; Microsoft Corporation; Mitsubishi Electric Corporation; Robert Bosch GmbH; Samsung Electronics Co., Ltd.; Sharp Kabushiki Kaisha; Sony Corporation; Toshiba Corporation; and Victor Company of Japan, Limited. MPEG LA"s objective is to provide worldwide access to as much AVC essential intellectual property as possible for the benefit of AVC users. Therefore, any party that believes it has essential patents is welcome to submit them for evaluation of their essentiality and inclusion in the License if found essential.

  20. [It is not only about cost ... when it comes to generic medication].

    PubMed

    Piguet, Valérie; D'Incau, Stéphanie; Besson, Marie; Desmeules, Jules; Cedraschi, Christine

    2016-06-22

    The aim of this qualitative study was to explore patients' representations regarding generics in patients suffering from non-specific disabling chronic musculoskeletal pain, as these patients are confronted with the issue of the prescription and/or substitution of original formulations with generics. Patients' representations suggest that they might be confident in taking a generic medication: when the generic medication is prescribed by the physician and each prescription is discussed, i.e., the patient is prescribed the generic version of a given medication and not a generic medication. Economic arguments are not sufficient to accept substitution. Negative representations require attention and need be considered.

  1. 47 CFR 87.87 - Classification of operator licenses and endorsements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Classification of operator licenses and... § 87.87 Classification of operator licenses and endorsements. (a) Commercial radio operator licenses... Telecommunication Union. (b) The following licenses are issued by the Commission. International classification, if...

  2. 76 FR 47612 - NextEra Energy Seabrook, LLC; Notice of Availability of Draft Supplement 46 to the Generic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    ... Hampshire. Possible alternatives to the proposed action (license renewal) include no action and reasonable alternative energy sources. Any interested party may submit comments on the draft supplement to the GEIS for... NUCLEAR REGULATORY COMMISSION [NRC-2010-0206; Docket No. 50-443] NextEra Energy Seabrook, LLC...

  3. 78 FR 54789 - Proposed Waste Confidence Rule and Draft Generic Environmental Impact Statement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    .../index.cfm no later than 10 days prior to the meetings. Dated at Rockville, Maryland, this 30th day of... storage of spent nuclear fuel beyond a reactor's licensed life for operation and prior to ultimate... the proposed Waste Confidence rule and DGEIS in order to maximize public participation at these...

  4. 78 FR 65903 - Proposed Waste Confidence Rule and Draft Generic Environmental Impact Statement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    .../public-involve/public-meetings/index.cfm no later than 10 days prior to each meeting. Dated at Rockville... reactor's licensed life for operation and prior to ultimate disposal (the proposed Waste Confidence rule... documents online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html . To begin the search...

  5. 75 FR 47856 - Nebraska Public Power District: Cooper Nuclear Station; Notice of Availability of the Final...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-298; NRC-2008-0617] Nebraska Public Power District: Cooper Nuclear Station; Notice of Availability of the Final Supplement 41 to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC, Commission) has...

  6. 75 FR 80547 - Carolina Power & Light Company, Shearon Harris Nuclear Power Plant, Unit No. 1; Exemption

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

    ..., Shearon Harris Nuclear Power Plant, Unit No. 1; Exemption 1.0 Background Carolina Power & Light Company... operation of the Shearon Harris Nuclear Power Plant (HNP), Unit 1. The license provides, among other things... request to generically extend the rule's compliance date for all operating nuclear power plants, but noted...

  7. The Role of the Deans and the AADS in Licensure: A Call for Leadership and a Necessity to Toil on "The Road Less Travelled."

    ERIC Educational Resources Information Center

    DePaola, Dominick P.

    1992-01-01

    In addressing dental licensing reform issues, the American Association of Dental Schools and deans of dental schools must provide both leadership and advocacy. Issues include limited geographic mobility of dentists resulting from state licensing differences, licensing of dentists through credentials, and development of a national dental licensing…

  8. 14 CFR 413.19 - Issuing a license or permit.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Issuing a license or permit. 413.19 Section 413.19 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION.... After the FAA completes its reviews and makes the decisions required by this chapter, the FAA issues a...

  9. 14 CFR 413.19 - Issuing a license or permit.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Issuing a license or permit. 413.19 Section 413.19 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION.... After the FAA completes its reviews and makes the decisions required by this chapter, the FAA issues a...

  10. 14 CFR 413.19 - Issuing a license or permit.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Issuing a license or permit. 413.19 Section 413.19 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION.... After the FAA completes its reviews and makes the decisions required by this chapter, the FAA issues a...

  11. 14 CFR 413.19 - Issuing a license or permit.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Issuing a license or permit. 413.19 Section 413.19 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION.... After the FAA completes its reviews and makes the decisions required by this chapter, the FAA issues a...

  12. The role of the PIRT process in identifying code improvements and executing code development

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

    Wilson, G.E.; Boyack, B.E.

    1997-07-01

    In September 1988, the USNRC issued a revised ECCS rule for light water reactors that allows, as an option, the use of best estimate (BE) plus uncertainty methods in safety analysis. The key feature of this licensing option relates to quantification of the uncertainty in the determination that an NPP has a {open_quotes}low{close_quotes} probability of violating the safety criteria specified in 10 CFR 50. To support the 1988 licensing revision, the USNRC and its contractors developed the CSAU evaluation methodology to demonstrate the feasibility of the BE plus uncertainty approach. The PIRT process, Step 3 in the CSAU methodology, wasmore » originally formulated to support the BE plus uncertainty licensing option as executed in the CSAU approach to safety analysis. Subsequent work has shown the PIRT process to be a much more powerful tool than conceived in its original form. Through further development and application, the PIRT process has shown itself to be a robust means to establish safety analysis computer code phenomenological requirements in their order of importance to such analyses. Used early in research directed toward these objectives, PIRT results also provide the technical basis and cost effective organization for new experimental programs needed to improve the safety analysis codes for new applications. The primary purpose of this paper is to describe the generic PIRT process, including typical and common illustrations from prior applications. The secondary objective is to provide guidance to future applications of the process to help them focus, in a graded approach, on systems, components, processes and phenomena that have been common in several prior applications.« less

  13. Evaluation of the "e-rater"® Scoring Engine for the "GRE"® Issue and Argument Prompts. Research Report. ETS RR-12-02

    ERIC Educational Resources Information Center

    Ramineni, Chaitanya; Trapani, Catherine S.; Williamson, David M.; Davey, Tim; Bridgeman, Brent

    2012-01-01

    Automated scoring models for the "e-rater"® scoring engine were built and evaluated for the "GRE"® argument and issue-writing tasks. Prompt-specific, generic, and generic with prompt-specific intercept scoring models were built and evaluation statistics such as weighted kappas, Pearson correlations, standardized difference in…

  14. 77 FR 46127 - Interim Staff Guidance on Changes to the Generic Aging Lessons Learned (GALL) Report Revision 2...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-02

    ... Aging Lessons Learned (GALL) Report Revision 2 AMP XI.M41, ``Buried and Underground Piping and Tanks... AMPs in NUREG-1801, Revision 2, ``Generic Aging Lessons Learned (GALL) Report,'' and the NRC staff's... issues LR-ISG to communicate insights and lessons learned and to address emergent issues not covered in...

  15. 76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-01

    ... design estimates. Analyses performed under the Generic Issue program (GIP) indicated the need to evaluate... Examination of External Events (IPEEE) for Severe Accident Vulnerabilities,'' (ADAMS Accession No. ML031150485) to request that each licensee identify and report to the NRC all plant- specific vulnerabilities to...

  16. 10 CFR Appendix S to Part 50 - Earthquake Engineering Criteria for Nuclear Power Plants

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... under part 50, or a design certification, combined license, design approval, or manufacturing license... license, design approval, or manufacturing license is required by §§ 50.34(a)(12), 50.34(b)(10), or 10 CFR... design for a nuclear power facility. Manufacturing license means a license, issued under subpart F of...

  17. A cross-sectional survey of pharmacists to understand their personal preference of brand and generic over-the-counter medications used to treat common health conditions.

    PubMed

    Patel, Mira; Slack, Marion; Cooley, Janet; Bhattacharjee, Sandipan

    2016-01-01

    Consumers are hesitant in choosing generic medications as they are under the assumption that they are not as safe nor effective as brand medications. However, pharmacists do have the education and training to know that this is not the case. The aim of this study was to determine pharmacists' preference of generic versus brand over-the-counter (OTC) medication for their personal use as self-treatment for various health symptoms. A prospective, cross sectional study was conducted on 553 licensed pharmacists who were presumed to have expertise in the use of generic and brand name OTC medications. In a single Southwestern state in the United States, from December 2014 to January 2015, a web-based questionnaire was sent to pharmacists to explore their preference of brand and generic medications based on various health symptoms. Thirty-one brand-generic medication pairs were used to identify which medication type pharmacists preferred when asked about nine health symptoms. Frequency counts of pharmacists' preference of a brand medication or a generic OTC medication overall and for each of the nine health symptoms were determined. Chi-squared analyses and one-way ANOVA were conducted to determine if there were any differences between the preferences of brand and generic OTC medications across each symptom. The study overall showed that pharmacists preferred generic OTC medications to brand OTC medications (62 to 5 %, respectively). Based on an 11-point rating scale, pharmacists were likely to take OTC generic medications (as their choice of self-treatment) when presented with health symptoms (mean = 7.32 ± 2.88). In addition, pharmacists chose generic OTC medications over brand medications regardless of health symptoms (p < 0.001). Pharmacists who have expertise in medications were shown to prefer using generic OTC medications rather than brand name OTC medications for self-treating a variety of health symptoms. These study findings support the theory that expertise affects preference for generic versus brand name OTC medications. This information can be used to provide consumers the evidence needed to make well-informed choices when choosing between brand and generic medications.

  18. 21 CFR 515.23 - Voluntary revocation of medicated feed mill license.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Voluntary revocation of medicated feed mill... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.23 Voluntary revocation of medicated feed mill license. A license issued under...

  19. 22 CFR 123.5 - Temporary export licenses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DEFENSE ARTICLES § 123.5 Temporary export licenses. (a) The Directorate of Defense Trade Controls may issue a license for the temporary export of unclassified defense articles (DSP-73). Such licenses are... license or other written approval must be obtained from the Directorate of Defense Trade Controls if the...

  20. 22 CFR 123.5 - Temporary export licenses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... DEFENSE ARTICLES § 123.5 Temporary export licenses. (a) The Directorate of Defense Trade Controls may issue a license for the temporary export of unclassified defense articles (DSP-73). Such licenses are... license or other written approval must be obtained from the Directorate of Defense Trade Controls if the...

  1. 10 CFR 60.41 - Standards for issuance of a license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... REPOSITORIES Licenses License Issuance and Amendment § 60.41 Standards for issuance of a license. A license to receive and possess source, special nuclear, or byproduct material at a geologic repository operations area may be issued by the Commission upon finding that: (a) Construction of the geologic repository...

  2. 77 FR 70837 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations... Commission the authority to issue and make immediately effective any amendment to an operating license or... Docket ID NRC-2012-0283. You may submit comments by the following methods: Federal rulemaking Web site...

  3. 77 FR 35069 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations... Commission the authority to issue and make immediately effective any amendment to an operating license or... ID NRC-2012-0131. You may submit comments by the following methods: Federal Rulemaking Web site: Go...

  4. 10 CFR 55.3 - License requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false License requirements. 55.3 Section 55.3 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) OPERATORS' LICENSES General Provisions § 55.3 License requirements. A person must be authorized by a license issued by the Commission to perform the function of an operator or...

  5. 10 CFR 55.3 - License requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false License requirements. 55.3 Section 55.3 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) OPERATORS' LICENSES General Provisions § 55.3 License requirements. A person must be authorized by a license issued by the Commission to perform the function of an operator or...

  6. Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

    PubMed

    Rostron, Allen

    2011-02-01

    Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

  7. The importance of being first: evidence from Canadian generic pharmaceuticals.

    PubMed

    Hollis, Aidan

    2002-12-01

    This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors. Copyright 2002 John Wiley & Sons, Ltd.

  8. 10 CFR 40.35 - Conditions of specific licenses issued pursuant to § 40.34.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Conditions of specific licenses issued pursuant to § 40.34. 40.35 Section 40.35 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL... § 40.25 and a copy of Form NRC 244 to each person to whom he transfers source material in a product or...

  9. The influence of generic substitution on the content of patient-pharmacist communication in Swedish community pharmacies.

    PubMed

    Olsson, Erika; Wallach-Kildemoes, Helle; Ahmed, Ban; Ingman, Pontus; Kaae, Susanne; Kälvemark Sporrong, Sofia

    2017-08-01

    The objective was to study the relationship between the length and content of patient-pharmacist communication in community pharmacies, and generic substitution. The study was conducted in six community pharmacies in Sweden. Non-participant observations with audio recordings and short structured interviews were conducted. Out of 32 pharmacists 29 agreed to participate (90.6%), as did 282 out of 407 patients (69.3%). Logistic regression analysis was applied to calculate odds ratio for occurrence of generic substitution. Linear regression (β-coefficients) was applied to test for differences in time spent on different categories. In encounters where generic substitution occurred more time (19.2 s) was spent on non-medical (for instance administrative or economical) issues (P = 0.01, 95% confidence interval 4.8-33.6). However, the total time of the encounter was not significantly longer. The amount of time spent on non-medical issues increased with age of patient (age 60+: β, 33 s, P < 0.001). The results indicate that more time was spent on medical issues with patients who have a higher education (high school: β, 10.8 s, P = 0.07, university: β, 10.2 s, P = 0.11) relative to those with only elementary school education. Occurrence of generic substitution was correlated with more time spent on communicating on non-medical, but not on medical, issues. No extra time was spent on medical information for the groups normally overrepresented among those with low health literacy. This study suggests that pharmacists need to further embrace their role in promoting rational use of medicines, not least when generic substitution occurs. © 2016 Royal Pharmaceutical Society.

  10. Atomic Safety and Licensing Board Panel Biennial Report, Fiscal Years 1993--1994. Volume 6

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

    NONE

    1995-08-01

    In Fiscal Year 1993, the Atomic Safety and Licensing Board Panel (``the Panel``) handled 30 proceedings. In Fiscal Year 1994, the Panel handled 36 proceedings. The cases addressed issues in the construction, operation, and maintenance of commercial nuclear power reactors and other activities requiring a license form the Nuclear Regulatory Commission. This report sets out the Panel`s caseload during the year and summarizes, highlight, and analyzes how the wide- ranging issues raised in those proceedings were addressed by the Panel`s judges and licensing boards.

  11. 9 CFR 102.2 - Licenses required.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... shall hold an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License and at least one unexpired, unsuspended, and unrevoked U.S. Veterinary Biological Product License issued...

  12. 9 CFR 102.2 - Licenses required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... shall hold an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License and at least one unexpired, unsuspended, and unrevoked U.S. Veterinary Biological Product License issued...

  13. 25 CFR 502.23 - Facility license.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false Facility license. 502.23 Section 502.23 Indians NATIONAL....23 Facility license. Facility license means a separate license issued by a tribe to each place, facility, or location on Indian lands where the tribe elects to allow class II or III gaming. [73 FR 6029...

  14. 14 CFR 420.17 - Bases for issuance of a license.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Bases for issuance of a license. 420.17 Section 420.17 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... for Obtaining a License § 420.17 Bases for issuance of a license. (a) The FAA will issue a license...

  15. 14 CFR 420.17 - Bases for issuance of a license.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Bases for issuance of a license. 420.17 Section 420.17 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... for Obtaining a License § 420.17 Bases for issuance of a license. (a) The FAA will issue a license...

  16. 14 CFR 420.17 - Bases for issuance of a license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Bases for issuance of a license. 420.17 Section 420.17 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... for Obtaining a License § 420.17 Bases for issuance of a license. (a) The FAA will issue a license...

  17. 27 CFR 478.49 - Duration of license.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Duration of license. 478....49 Duration of license. The license entitles the person to whom issued to engage in the business or activity specified on the license, within the limitations of the Act and the regulations contained in this...

  18. 75 FR 51498 - Notice of Availability of the Draft Supplement 43 to the Generic Environmental Impact Statement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-20

    ... Nuclear Plants, and Public Meetings for the License Renewal of Palo Verde Nuclear Generating Stations..., NPF-51 and NPF-74 for an additional 20 years of operation for Palo Verde Nuclear Generating Station... NRC by e-mail at PaloVerde[email protected] . All comments received by the Commission, including those made...

  19. Access to hepatitis C medicines.

    PubMed

    Edwards, Danny J; Coppens, Delphi Gm; Prasad, Tara L; Rook, Laurien A; Iyer, Jayasree K

    2015-11-01

    Hepatitis C is a global epidemic. Worldwide, 185 million people are estimated to be infected, most of whom live in low- and middle-income countries. Recent advances in the development of antiviral drugs have produced therapies that are more effective, safer and better tolerated than existing treatments for the disease. These therapies present an opportunity to curb the epidemic, provided that they are affordable, that generic production of these medicines is scaled up and that awareness and screening programmes are strengthened. Pharmaceutical companies have a central role to play. We examined the marketed products, pipelines and access to medicine strategies of 20 of the world's largest pharmaceutical companies. Six of these companies are developing medicines for hepatitis C: AbbVie, Bristol-Myers Squibb, Gilead, Johnson & Johnson, Merck & Co. and Roche. These companies employ a range of approaches to supporting hepatitis C treatment, including pricing strategies, voluntary licensing, capacity building and drug donations. We give an overview of the engagement of these companies in addressing access to hepatitis C products. We suggest actions companies can take to play a greater role in curbing this epidemic: (i) prioritizing affordability assessments; (ii) developing access strategies early in the product lifecycle; and (iii) licensing to manufacturers of generic medicines.

  20. 14 CFR 63.42 - Flight engineer certificate issued on basis of a foreign flight engineer license.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Flight engineer certificate issued on basis of a foreign flight engineer license. 63.42 Section 63.42 Aeronautics and Space FEDERAL AVIATION... PILOTS Flight Engineers § 63.42 Flight engineer certificate issued on basis of a foreign flight engineer...

  1. 14 CFR 63.42 - Flight engineer certificate issued on basis of a foreign flight engineer license.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Flight engineer certificate issued on basis of a foreign flight engineer license. 63.42 Section 63.42 Aeronautics and Space FEDERAL AVIATION... PILOTS Flight Engineers § 63.42 Flight engineer certificate issued on basis of a foreign flight engineer...

  2. 14 CFR 63.42 - Flight engineer certificate issued on basis of a foreign flight engineer license.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Flight engineer certificate issued on basis of a foreign flight engineer license. 63.42 Section 63.42 Aeronautics and Space FEDERAL AVIATION... PILOTS Flight Engineers § 63.42 Flight engineer certificate issued on basis of a foreign flight engineer...

  3. 14 CFR 63.42 - Flight engineer certificate issued on basis of a foreign flight engineer license.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Flight engineer certificate issued on basis of a foreign flight engineer license. 63.42 Section 63.42 Aeronautics and Space FEDERAL AVIATION... PILOTS Flight Engineers § 63.42 Flight engineer certificate issued on basis of a foreign flight engineer...

  4. 14 CFR 63.42 - Flight engineer certificate issued on basis of a foreign flight engineer license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Flight engineer certificate issued on basis of a foreign flight engineer license. 63.42 Section 63.42 Aeronautics and Space FEDERAL AVIATION... PILOTS Flight Engineers § 63.42 Flight engineer certificate issued on basis of a foreign flight engineer...

  5. Generic immunosuppression in solid organ transplantation: a Canadian perspective.

    PubMed

    Harrison, Jennifer J; Schiff, Jeffrey R; Coursol, Christian J; Daley, Christopher J A; Dipchand, Anne I; Heywood, Norine M; Keough-Ryan, Tammy M; Keown, Paul A; Levy, Gary A; Lien, Dale C; Wichart, Jenny R; Cantarovich, Marcelo

    2012-04-15

    The introduction of generic immunosuppressant medications may present an opportunity for cost savings in solid organ transplantation if equivalent clinical outcomes to the branded counterparts can be achieved. An interprofessional working group of the Canadian Society of Transplantation was established to develop recommendations on the use of generic immunosuppression in solid organ transplant recipients (SOTR) based on a review of the available data. Under current Health Canada licensing requirements, a demonstration of bioequivalence with the branded formulation in healthy volunteers allows for bridging of clinical data. Cyclosporine, tacrolimus, and sirolimus are designated as "critical dose drugs" and are held to stricter criteria. However, whether this provides sufficient guarantee of therapeutic equivalence in SOTR remains controversial, and failure to maintain an appropriate balance of immunosuppression may have serious consequences, including rejection, graft loss, and death. Published evidence supporting therapeutic equivalence of generic formulations in SOTR is lacking. Moreover, in the setting of multiple generic formulations the potential for uncontrolled product switching is a major concern, since generic preparations are not required to demonstrate bioequivalence with each other. Although close monitoring is recommended with any change in formulation, drug product switches are likely to occur without prescriber knowledge and may pose a significant patient safety risk. The advent of generic immunosuppression will require new practices including more frequent therapeutic drug and clinical monitoring, and increased patient education. The additional workload placed on transplant centers without additional funding will create challenges and could ultimately jeopardize patient outcomes. Until more robust clinical data are available and adequate regulatory safeguards are instituted, caution in the use of generic immunosuppressive drugs in solid organ transplantation is warranted.

  6. Is it ethical to prescribe generic immunosuppressive drugs to renal transplant patients?

    PubMed

    Allard, Julie; Fortin, Marie-Chantal

    2014-01-01

    This review was conducted to determine the ethical acceptability of prescribing generic immunosuppressive drugs to renal transplant patients. The literature search was conducted using Pubmed and Google Scholar. The use of generic immunosuppressive drugs (ISDs) in transplantation is a controversial topic. There is a consensus among transplant societies that clinical data is lacking and that caution should be exercised. The reluctance to use generic ISDs in organ transplantation is partly related to the fact that most are "critical dose drugs", and that either low dosing or overdosing could have serious adverse consequences for both patients and society (i.e., the loss of scarce organs). In this paper, we examine the various ethical issues involved such as distributive justice, physician duties, risks versus benefits, conflict of interest, informed consent, and logistical and economic issues. Our analysis was limited by the paucity of clinical data on generic ISDs and the absence of health economics studies to quantify the benefits of prescribing generic ISDs. Our study led us to conclude that it would be ethical to prescribe generic ISDs provided certain conditions were met. These include regulatory safeguards to minimize the risks of substitution; education of patients; and further clinical and health economics studies to better inform clinicians, patients and society of the risks and costs related to drug substitution.

  7. 10 CFR 780.45 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Pursuant to Section 153c of the Atomic Energy Act of 1954 § 780.45 Criteria for decision to issue a license... patent is of primary importance in the production or utilization of special nuclear material or atomic...

  8. 10 CFR 780.45 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Pursuant to Section 153c of the Atomic Energy Act of 1954 § 780.45 Criteria for decision to issue a license... patent is of primary importance in the production or utilization of special nuclear material or atomic...

  9. 10 CFR 780.45 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Pursuant to Section 153c of the Atomic Energy Act of 1954 § 780.45 Criteria for decision to issue a license... patent is of primary importance in the production or utilization of special nuclear material or atomic...

  10. 10 CFR 780.45 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Pursuant to Section 153c of the Atomic Energy Act of 1954 § 780.45 Criteria for decision to issue a license... patent is of primary importance in the production or utilization of special nuclear material or atomic...

  11. 10 CFR 780.45 - Criteria for decision to issue a license.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Pursuant to Section 153c of the Atomic Energy Act of 1954 § 780.45 Criteria for decision to issue a license... patent is of primary importance in the production or utilization of special nuclear material or atomic...

  12. 9 CFR 102.6 - Conditional licenses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... PRODUCTS § 102.6 Conditional licenses. In order to meet an emergency condition, limited market, local...) of this part, issue a conditional U.S. Veterinary Biological Product License to an establishment... available, the Administrator shall either reissue the U.S. Veterinary Biological Product License or allow it...

  13. Asserting the primacy of health over patent rights: a comparative study of the processes that led to the use of compulsory licensing in Thailand and Brazil.

    PubMed

    Rosenberg, Stephanie T

    2014-08-01

    Since the 1970s, the United States has adopted a trade policy agenda that has forced countries to trade away flexible patent provisions for access to US markets. While pharmaceutical companies have argued that the recognition of patent rights is essential for recovering investments in research and development of pharmaceuticals and incentivizing future innovation, the lack of competition has had damaging consequences for public health, as companies tend to set the prices of treatments beyond the reach of consumers and government programs. Thailand and Brazil are bound by law to provide universal access to anti-retroviral treatment (ART) to People Living with HIV/AIDS (PLWHA). This has been made possible in part due to the universal health care systems in each country and the countries' local technical and industrial capacities that provide the government with affordable generic medicines. The introduction of stronger intellectual property protection laws however, has limited possibilities for procuring generic medicines and inflated the cost of treatment. Between 2006-2008, Thailand and Brazil used compulsory licensing to authorize generic competition against the consent of the pharmaceutical companies in order to guarantee the right to health and ensure the viability of government health budgets. This paper will demonstrate how the interaction between individual / collective action and structural and institutional elements in Thailand and Brazil produced propitious conditions for each country to assert the primacy of health over patent rights. © 2014 John Wiley & Sons Ltd.

  14. Aging management guideline for commercial nuclear power plants - heat exchangers

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

    Booker, S.; Lehnert, D.; Daavettila, N.

    1994-06-01

    This Aging Management Guideline (AMG) describes recommended methods for effective detection and mitigation of age-related degradation mechanisms in commercial nuclear power plant heat exchangers important to license renewal. The intent of this AMG is to assist plant maintenance and operations personnel in maximizing the safe, useful life of these components. It also supports the documentation of effective aging management programs required under the License Renewal Rule 10 CFR 54. This AMG is presented in a manner that allows personnel responsible for performance analysis and maintenance to compare their plant-specific aging mechanisms (expected or already experienced) and aging management program activitiesmore » to the more generic results and recommendations presented herein.« less

  15. 77 FR 26321 - Reed College, Reed Research Nuclear Reactor, Renewed Facility Operating License No. R-112

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... Nuclear Reactor, Renewed Facility Operating License No. R-112 AGENCY: Nuclear Regulatory Commission... Commission (NRC or the Commission) has issued renewed Facility Operating License No. R- 112, held by Reed... License No. R-112 will expire 20 years from its date of issuance. The renewed facility operating license...

  16. 43 CFR 3141.2-2 - Exploration licenses.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... license to conduct core drilling and other exploration activities to collect geologic, environmental and... drilling for oil or gas will be allowed under an exploration license issued under this subpart. No specific...

  17. 43 CFR 3141.2-2 - Exploration licenses.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... license to conduct core drilling and other exploration activities to collect geologic, environmental and... drilling for oil or gas will be allowed under an exploration license issued under this subpart. No specific...

  18. 43 CFR 3141.2-2 - Exploration licenses.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... license to conduct core drilling and other exploration activities to collect geologic, environmental and... drilling for oil or gas will be allowed under an exploration license issued under this subpart. No specific...

  19. 43 CFR 3141.2-2 - Exploration licenses.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... license to conduct core drilling and other exploration activities to collect geologic, environmental and... drilling for oil or gas will be allowed under an exploration license issued under this subpart. No specific...

  20. 10 CFR 50.51 - Continuation of license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Issuance... license will be issued for a fixed period of time to be specified in the license but in no case to exceed... expiration date to authorize ownership and possession of the production or utilization facility, until the...

  1. 10 CFR 50.51 - Continuation of license.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Issuance... license will be issued for a fixed period of time to be specified in the license but in no case to exceed... expiration date to authorize ownership and possession of the production or utilization facility, until the...

  2. 75 FR 51917 - Perishable Agricultural Commodities Act: Increase in License Fees

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-24

    ... of the proposed license fee increase. Paperwork Reduction Act In accordance with Office of Management... 0581-AC92 Perishable Agricultural Commodities Act: Increase in License Fees AGENCY: Agricultural... regulations issued under the Perishable Agricultural Commodities Act (PACA or Act) to increase license fees...

  3. 47 CFR 80.151 - Classification of operator licenses and endorsements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Classification of operator licenses and... SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Operator Requirements § 80.151 Classification of... following licenses are issued by the Commission. International classification, if different from the license...

  4. 22 CFR 120.20 - License.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false License. 120.20 Section 120.20 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS PURPOSE AND DEFINITIONS § 120.20 License. License means a document bearing the word “license” issued by the Directorate of Defense Trade...

  5. 22 CFR 120.20 - License.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false License. 120.20 Section 120.20 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS PURPOSE AND DEFINITIONS § 120.20 License. License means a document bearing the word “license” issued by the Directorate of Defense Trade...

  6. 22 CFR 120.20 - License.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false License. 120.20 Section 120.20 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS PURPOSE AND DEFINITIONS § 120.20 License. License means a document bearing the word “license” issued by the Directorate of Defense Trade...

  7. 22 CFR 120.20 - License.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false License. 120.20 Section 120.20 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS PURPOSE AND DEFINITIONS § 120.20 License. License means a document bearing the word “license” issued by the Directorate of Defense Trade...

  8. Government use licenses in Thailand: The power of evidence, civil movement and political leadership

    PubMed Central

    2011-01-01

    This paper attempts to describe and analyse the policy processes that led to the granting and implementation of the government use licenses to enable the import and production of generic versions of medicines patented in Thailand. The decision to grant the series of government use licenses was taken despite much domestic and international controversy. The paper demonstrates that the policy processes leading to the granting of government use licenses are a successful application of the concept of "the triangle that moves the mountain". This is a well-known conceptualisation of a philosophical and strategic approach to public policy advocacy in Thailand, which propounds that the effective bridging of three powers; a.) Knowledge and evidence generated by research and analysis, b.) Civil society movements and public support, and c.) Leadership of policy makers and politicians; in a synergistic "triangle" can move "mountains", meaning the resolution of seemingly insurmountable problems. The paper provides insights into the policy context for the decision and analyses the roles of key actors, their motivations and the policy processes in the country. PMID:21910864

  9. Legal and policy foundations for global generic competition: Promoting affordable drug pricing in developing societies.

    PubMed

    Zapatero Miguel, Pablo

    2015-01-01

    The so-called 'TRIPS flexibilities' restated in 2001 by the World Trade Organization's Doha Declaration on TRIPS and Public Health offer a variety of policy avenues for promoting global price-based competition for essential medicines, and thus for improving access to affordable medicines in the developing world. In recent years, developing countries and international organisations alike have begun to explore the potentialities of global generic markets and competition generally, and also of using compulsory licensing to remedy anti-competitive practices (e.g. excessive pricing) through TRIPS-compatible antitrust enforcement. These and other 'pro-competitive' TRIPS flexibilities currently available provide the critical leverage and policy space necessary to improve access to affordable medicines in the developing world.

  10. 77 FR 2600 - Revocation of License of Small Business Investment Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-18

    ... SMALL BUSINESS ADMINISTRATION Revocation of License of Small Business Investment Company Pursuant... Limited Partnership, to function as a small business investment company under the Small Business Investment Company License No. 09790431 issued to AltoTech II, L.P. on December 04, 2000 and said license is...

  11. 47 CFR 80.13 - Station license required.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... individually or by fleet. (b) One ship station license will be granted for operation of all maritime services... be authorized, however, unless specifically requested by the applicant. (c) A ship station is licensed by rule and does not need an individual license issued by the FCC if the ship station is not...

  12. 47 CFR 80.13 - Station license required.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... individually or by fleet. (b) One ship station license will be granted for operation of all maritime services... be authorized, however, unless specifically requested by the applicant. (c) A ship station is licensed by rule and does not need an individual license issued by the FCC if the ship station is not...

  13. 47 CFR 80.13 - Station license required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... individually or by fleet. (b) One ship station license will be granted for operation of all maritime services... be authorized, however, unless specifically requested by the applicant. (c) A ship station is licensed by rule and does not need an individual license issued by the FCC if the ship station is not...

  14. 47 CFR 80.13 - Station license required.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... individually or by fleet. (b) One ship station license will be granted for operation of all maritime services... be authorized, however, unless specifically requested by the applicant. (c) A ship station is licensed by rule and does not need an individual license issued by the FCC if the ship station is not...

  15. 47 CFR 80.13 - Station license required.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... individually or by fleet. (b) One ship station license will be granted for operation of all maritime services... be authorized, however, unless specifically requested by the applicant. (c) A ship station is licensed by rule and does not need an individual license issued by the FCC if the ship station is not...

  16. 22 CFR 120.20 - License or other approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false License or other approval. 120.20 Section 120.20 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS PURPOSE AND DEFINITIONS § 120.20 License or other approval. License means a document bearing the word “license” issued by...

  17. 9 CFR 102.4 - U.S. Veterinary Biologics Establishment License.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false U.S. Veterinary Biologics... LICENSES FOR BIOLOGICAL PRODUCTS § 102.4 U.S. Veterinary Biologics Establishment License. (a) Before a U.S. Veterinary Biologics Establishment License will be issued by the Administrator for any establishment, an...

  18. 9 CFR 102.4 - U.S. Veterinary Biologics Establishment License.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false U.S. Veterinary Biologics... LICENSES FOR BIOLOGICAL PRODUCTS § 102.4 U.S. Veterinary Biologics Establishment License. (a) Before a U.S. Veterinary Biologics Establishment License will be issued by the Administrator for any establishment, an...

  19. Special issue : graduated licensing

    DOT National Transportation Integrated Search

    1999-12-04

    This special issue focuses on graduated licensing. Until recently, it was legal for five or six teenagers to pile into a car and go joyriding at 2.a.m. That has changed. In a few short years, 35 states have adopted one or more elements of graduated l...

  20. 75 FR 77920 - Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating Unit Nos. 2 and 3; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-247 and 50-286; NRC-2008-0672] Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating Unit Nos. 2 and 3; Notice of Availability of the Final Supplement 38 to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants Notice is hereby given that the U.S. Nuclear...

  1. 76 FR 19148 - PSEG Nuclear, LLC, Hope Creek Generating Station and Salem Nuclear Generating Station, Units 1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-272, 50-311, 50-354; NRC-2009-0390 and NRC-2009-0391] PSEG Nuclear, LLC, Hope Creek Generating Station and Salem Nuclear Generating Station, Units 1 and 2; Notice of Availability of the Final Supplement 45 to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants Notice is...

  2. 21 CFR 1301.17 - Special procedures for certain applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... pharmacy, the pharmacy has been issued a license from the appropriate State licensing agency, the applicant... following form: Affidavit for New Pharmacy I, , the (Title of officer, official, partner, or other position... Street), (City) ______ (State) ______ (Zip code), hereby certify that said store was issued a pharmacy...

  3. 21 CFR 1301.17 - Special procedures for certain applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... pharmacy, the pharmacy has been issued a license from the appropriate State licensing agency, the applicant... following form: Affidavit for New Pharmacy I, , the (Title of officer, official, partner, or other position... Street), (City) ______ (State) ______ (Zip code), hereby certify that said store was issued a pharmacy...

  4. 21 CFR 1301.17 - Special procedures for certain applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... pharmacy, the pharmacy has been issued a license from the appropriate State licensing agency, the applicant... following form: Affidavit for New Pharmacy I, , the (Title of officer, official, partner, or other position... Street), (City) ______ (State) ______ (Zip code), hereby certify that said store was issued a pharmacy...

  5. 21 CFR 1301.17 - Special procedures for certain applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... pharmacy, the pharmacy has been issued a license from the appropriate State licensing agency, the applicant... following form: Affidavit for New Pharmacy I, , the (Title of officer, official, partner, or other position... Street), (City) ______ (State) ______ (Zip code), hereby certify that said store was issued a pharmacy...

  6. 21 CFR 1301.17 - Special procedures for certain applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... pharmacy, the pharmacy has been issued a license from the appropriate State licensing agency, the applicant... following form: Affidavit for New Pharmacy I, , the (Title of officer, official, partner, or other position... Street), (City) ______ (State) ______ (Zip code), hereby certify that said store was issued a pharmacy...

  7. Application Of The Iberdrola Licensing Methodology To The Cofrentes BWR-6 110% Extended Power Up-rate

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

    Mata, Pedro; Fuente, Rafael de la; Iglesias, Javier

    Iberdrola (spanish utility) and Iberdrola Ingenieria (engineering branch) have been developing during the last two years the 110% Extended Power Up-rate Project (EPU 110%) for Cofrentes BWR-6. IBERDROLA has available an in-house design and licensing reload methodology that has been approved by the Spanish Nuclear Regulatory Authority. This methodology has been already used to perform the nuclear design and the reload licensing analysis for Cofrentes cycles 12 to 14. The methodology has been also applied to develop a significant number of safety analysis of the Cofrentes Extended Power Up-rate including: Reactor Heat Balance, Core and Fuel performance, Thermal Hydraulic Stability,more » ECCS LOCA Evaluation, Transient Analysis, Anticipated Transient Without Scram (ATWS) and Station Blackout (SBO) Since the scope of the licensing process of the Cofrentes Extended Power Up-rate exceeds the range of analysis included in the Cofrentes generic reload licensing process, it has been required to extend the applicability of the Cofrentes licensing methodology to the analysis of new transients. This is the case of the TLFW transient. The content of this paper shows the benefits of having an in-house design and licensing methodology, and describes the process to extend the applicability of the methodology to the analysis of new transients. The case of analysis of Total Loss of Feedwater with the Cofrentes Retran Model is included as an example of this process. (authors)« less

  8. Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

    PubMed

    Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

    2017-12-28

    Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of <0.05 were considered significant. A total of 302 community pharmacists were interviewed, slightly more than half were males (52.3%). The mean knowledge score of participants regarding generic medicines was (5.91 ± 1.27) where the highest score was 8 of 10. Knowledge score was not significantly influenced by any of the socio-demographic characteristics. Our data showed that most of included pharmacists in the study (95.4%) agreed that health authorities should implement bioequivalence policies prior to marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

  9. 27 CFR 555.45 - Original license or permit.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Original license or permit. 555.45 Section 555.45 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS... Original license or permit. (a) Licenses issued prior to May 24, 2003. Any person who intends to engage in...

  10. 76 FR 62868 - Washington State University; Notice of Issuance of Renewed Facility Operating License No. R-76

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ...; Notice of Issuance of Renewed Facility Operating License No. R-76 AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance of renewed facility operating license No. R- 76. ADDRESSES: You can access.... Nuclear Regulatory Commission (NRC, the Commission) has issued renewed Facility Operating License No. R-76...

  11. 77 FR 27096 - Notice of Intent To Grant Exclusive Copyright License

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-08

    ..., copyright-only license in the United States to software and its documentation described in NASA Case No. KSC... Exclusive Copyright License AGENCY: National Aeronautics and Space Administration. ACTION: Notice of Intent To Grant Exclusive Copyright License. SUMMARY: This notice is issued in accordance with 35 U.S.C. 209...

  12. 78 FR 70077 - Issuance of Materials License for U.S. Army Installation Management Command

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... Barracks and Pohakuloa Training Area installations in Hawaii. Materials License SUC-1593 authorizes... conditions listed in Materials License SUC-1593. This notice also serves as the record of decision for the... Schofield Barracks and Pohakuloa Training Area and issue Materials License SUC-1593. The NRC considers the...

  13. 47 CFR 74.832 - Licensing requirements and procedures.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Stations § 74.832 Licensing requirements and procedures. (a) A license authorizing operation of one or more low power auxiliary stations will be issued only to the following: (1) A licensee of an AM, FM, TV, or International broadcast station or low power TV station. Low power auxiliary stations will be licensed for used...

  14. 47 CFR 74.832 - Licensing requirements and procedures.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Stations § 74.832 Licensing requirements and procedures. (a) A license authorizing operation of one or more low power auxiliary stations will be issued only to the following: (1) A licensee of an AM, FM, TV, or International broadcast station or low power TV station. Low power auxiliary stations will be licensed for used...

  15. 47 CFR 74.832 - Licensing requirements and procedures.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Stations § 74.832 Licensing requirements and procedures. (a) A license authorizing operation of one or more low power auxiliary stations will be issued only to the following: (1) A licensee of an AM, FM, TV, or International broadcast station or low power TV station. Low power auxiliary stations will be licensed for used...

  16. 47 CFR 74.832 - Licensing requirements and procedures.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Stations § 74.832 Licensing requirements and procedures. (a) A license authorizing operation of one or more low power auxiliary stations will be issued only to the following: (1) A licensee of an AM, FM, TV, or International broadcast station or low power TV station. Low power auxiliary stations will be licensed for used...

  17. 47 CFR 74.832 - Licensing requirements and procedures.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Stations § 74.832 Licensing requirements and procedures. (a) A license authorizing operation of one or more low power auxiliary stations will be issued only to the following: (1) A licensee of an AM, FM, TV, or International broadcast station or low power TV station. Low power auxiliary stations will be licensed for used...

  18. 25 CFR 11.601 - Marriage licenses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Marriage licenses. 11.601 Section 11.601 Indians BUREAU... ORDER CODE Domestic Relations § 11.601 Marriage licenses. A marriage license shall be issued by the clerk of the court in the absence of any showing that the proposed marriage would be invalid under any...

  19. 10 CFR 2.1115 - Designation of issues for adjudicatory hearing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... at Civilian Nuclear Power Reactors § 2.1115 Designation of issues for adjudicatory hearing. (a) After... reactor already licensed to operate at the site, or any civilian nuclear power reactor for which a... the issuance of a construction permit or operating license for a civilian nuclear power reactor at...

  20. 31 CFR 515.552 - Proceeds of insurance policies.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... licenses are issued authorizing payment of the proceeds of blocked life insurance policies issued on the life of a Cuban national who died in Cuba after July 8, 1963, to certain beneficiaries licensed as...; (ii) Voter registration card; (iii) Permanent resident alien card; or (iv) National identity card...

  1. 31 CFR 515.552 - Proceeds of insurance policies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... licenses are issued authorizing payment of the proceeds of blocked life insurance policies issued on the life of a Cuban national who died in Cuba after July 8, 1963, to certain beneficiaries licensed as...; (ii) Voter registration card; (iii) Permanent resident alien card; or (iv) National identity card...

  2. 31 CFR 515.552 - Proceeds of insurance policies.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... licenses are issued authorizing payment of the proceeds of blocked life insurance policies issued on the life of a Cuban national who died in Cuba after July 8, 1963, to certain beneficiaries licensed as...; (ii) Voter registration card; (iii) Permanent resident alien card; or (iv) National identity card...

  3. 31 CFR 515.552 - Proceeds of insurance policies.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... licenses are issued authorizing payment of the proceeds of blocked life insurance policies issued on the life of a Cuban national who died in Cuba after July 8, 1963, to certain beneficiaries licensed as...; (ii) Voter registration card; (iii) Permanent resident alien card; or (iv) National identity card...

  4. 31 CFR 515.552 - Proceeds of insurance policies.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... licenses are issued authorizing payment of the proceeds of blocked life insurance policies issued on the life of a Cuban national who died in Cuba after July 8, 1963, to certain beneficiaries licensed as...; (ii) Voter registration card; (iii) Permanent resident alien card; or (iv) National identity card...

  5. Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

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

    Moe, Wayne L.

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

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

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

    Moe, Wayne Leland

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

  7. The crisis in access to essential medicines in India: key issues which call for action.

    PubMed

    Bhargava, Anurag; Kalantri, S P

    2013-01-01

    The government is planning to introduce free generic and essential medicines in public health facilities. Most people in India buy healthcare from the private sector, a compulsion that accounts for a high proportion of healthcare-related expenditure. To reduce the burden of healthcare costs, the government must improve availability and affordability of generic and essential medicines in the market. It can do so because India's large pharmaceutical industry is a major source of generic medicines worldwide. In this article, we discuss three factors that have impeded access to generic and essential medicines: (1) mistaken notions among policymakers, prescribers and patients about branded drugs and generic drugs in India; (2) high prices of medicines due to the progressive dismantling of the system of regulation of medicine prices, and (3) a drug approval and regulatory system that allows medicines (including fixed dose combinations) of doubtful efficacy, rationale, safety and public health relevance to dominate the market at the cost of access to affordable generic and essential medicines. The consequences of ill-health and wasted expenditure on drugs raise issues of public health ethics.Improving access to essential medicines in India is an urgent public health and ethical imperative. This should include improved public provisioning, a system of regulation of drug prices, and an evidence-based drug approval process.

  8. Access to hepatitis C medicines

    PubMed Central

    Coppens, Delphi GM; Prasad, Tara L; Rook, Laurien A; Iyer, Jayasree K

    2015-01-01

    Abstract Hepatitis C is a global epidemic. Worldwide, 185 million people are estimated to be infected, most of whom live in low- and middle-income countries. Recent advances in the development of antiviral drugs have produced therapies that are more effective, safer and better tolerated than existing treatments for the disease. These therapies present an opportunity to curb the epidemic, provided that they are affordable, that generic production of these medicines is scaled up and that awareness and screening programmes are strengthened. Pharmaceutical companies have a central role to play. We examined the marketed products, pipelines and access to medicine strategies of 20 of the world’s largest pharmaceutical companies. Six of these companies are developing medicines for hepatitis C: AbbVie, Bristol-Myers Squibb, Gilead, Johnson & Johnson, Merck & Co. and Roche. These companies employ a range of approaches to supporting hepatitis C treatment, including pricing strategies, voluntary licensing, capacity building and drug donations. We give an overview of the engagement of these companies in addressing access to hepatitis C products. We suggest actions companies can take to play a greater role in curbing this epidemic: (i) prioritizing affordability assessments; (ii) developing access strategies early in the product lifecycle; and (iii) licensing to manufacturers of generic medicines. PMID:26549908

  9. 77 FR 43866 - Notice of Intent To Grant Exclusive License

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... License AGENCY: National Aeronautics and Space Administration. ACTION: Notice of intent to grant exclusive license. SUMMARY: This notice is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). NASA hereby gives notice of its intent to grant an exclusive, license in the United States to practice...

  10. 10 CFR 31.10 - General license for strontium 90 in ice detection devices.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

  11. 77 FR 71404 - Notice of Intent to License Government-Owned Inventions; Intent to License on a Partially...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

    ... DEPARTMENT OF DEFENSE Department of the Army Notice of Intent to License Government-Owned Inventions; Intent to License on a Partially-Exclusive Basis AGENCY: Department of the Army, DoD. ACTION..., issued 07/ 28/2009 and entitled ``Radiation source with self-aligning optics,'' U.S. Patent 7,852,469...

  12. 21 CFR 601.22 - Products in short supply; initial manufacturing at other than licensed location.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Products in short supply; initial manufacturing at other than licensed location. 601.22 Section 601.22 Food and Drugs FOOD AND DRUG ADMINISTRATION... in short supply; initial manufacturing at other than licensed location. A biologics license issued to...

  13. 10 CFR 31.10 - General license for strontium 90 in ice detection devices.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

  14. 10 CFR 31.10 - General license for strontium 90 in ice detection devices.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

  15. 10 CFR 31.10 - General license for strontium 90 in ice detection devices.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

  16. 10 CFR 31.10 - General license for strontium 90 in ice detection devices.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

  17. 10 CFR 35.15 - Exemptions regarding Type A specific licenses of broad scope.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Exemptions regarding Type A specific licenses of broad... General Information § 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use, issued under Part 33 of this chapter, is...

  18. 10 CFR 35.15 - Exemptions regarding Type A specific licenses of broad scope.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Exemptions regarding Type A specific licenses of broad... General Information § 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use, issued under part 33 of this chapter, is...

  19. 10 CFR 35.15 - Exemptions regarding Type A specific licenses of broad scope.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Exemptions regarding Type A specific licenses of broad... General Information § 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use, issued under Part 33 of this chapter, is...

  20. 10 CFR 35.15 - Exemptions regarding Type A specific licenses of broad scope.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Exemptions regarding Type A specific licenses of broad... General Information § 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use, issued under Part 33 of this chapter, is...

  1. 10 CFR 35.15 - Exemptions regarding Type A specific licenses of broad scope.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Exemptions regarding Type A specific licenses of broad... General Information § 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use, issued under Part 33 of this chapter, is...

  2. 76 FR 35480 - Notice of Intent To Grant Exclusive License

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... Exclusive License AGENCY: National Aeronautics and Space Administration. ACTION: Notice of intent to grant exclusive license. SUMMARY: This notice is issued in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i). NASA hereby gives notice of its intent to grant an exclusive patent and copyright license in...

  3. Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.

    PubMed

    Wouters, Olivier J; Kanavos, Panos G; McKEE, Martin

    2017-09-01

    Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer-reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off-patent products. There are policy solutions to address issues in Europe and the United States, such as streamlining the generic drug approval process and requiring generic prescribing and substitution where such policies are not yet in place. The history of substitution laws in the United States provides insights into the economic, political, and cultural issues influencing the adoption of generic drug policies. Governments should apply coherent supply- and demand-side policies in generic drug markets. An immediate priority is to convince more physicians, pharmacists, and patients that generic drugs are bioequivalent to branded products. Special-interest groups continue to obstruct reform in Europe and the United States. © 2017 The Authors The Milbank Quarterly published by Wiley Periodicals, Inc. on behalf of The Millbank Memorial Fund.

  4. 21 CFR 1.281 - What information must be in a prior notice?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... issue a determination that ACS or its successor system can accommodate such transactions, the tracking... applicable, then the name of the carrier. If the carrier is a privately owned vehicle, the license plate number of the vehicle and the State or Province that issued the license plate number; (17) Planned...

  5. 21 CFR 1.281 - What information must be in a prior notice?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... issue a determination that ACS or its successor system can accommodate such transactions, the tracking... applicable, then the name of the carrier. If the carrier is a privately owned vehicle, the license plate number of the vehicle and the State or Province that issued the license plate number; (17) Planned...

  6. 21 CFR 1.281 - What information must be in a prior notice?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... issue a determination that ACS or its successor system can accommodate such transactions, the tracking... applicable, then the name of the carrier. If the carrier is a privately owned vehicle, the license plate number of the vehicle and the State or Province that issued the license plate number; (17) Planned...

  7. 21 CFR 1.281 - What information must be in a prior notice?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... issue a determination that ACS or its successor system can accommodate such transactions, the tracking... applicable, then the name of the carrier. If the carrier is a privately owned vehicle, the license plate number of the vehicle and the State or Province that issued the license plate number; (17) Planned...

  8. 47 CFR 97.505 - Element credit.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... but within the grace period for renewal) FCC-granted Technician or Technician Plus Class operator (including a Technician Class operator license granted before February 14, 1991) license grant: Element 2. (4) An expired FCC-issued Technician Class operator license document granted before March 21, 1987...

  9. Establishment of a dental license regulation authority is required in Korea: results of the Delphi technique.

    PubMed

    Choi, Jin-Woo; Kim, Kack-Kyun; Lee, Jihyun; Choi, Dong-Ju; Kim, Kyung-Nyun

    2017-01-01

    In addition to dental education, a system for the evaluation and management of dental licensing and certification is required to meet the growing societal demand for more competent dentists. In this study, the Delphi technique was used to gather opinions from a variety of professionals on the problems of and remedies for the dental license management system in Korea. Delphi surveys were conducted from April 2016 to October 2016 in South Korea. A variety of dental professionals were included and categorized into 3 groups according to their expertise as follows: the basic dentistry group, the clinical dentistry group, and the policy group. The Delphi technique was conducted in 3 rounds of e-mail surveys, each with different questions that probed with increasing depth on the dental license management system. In each successive round, the responses were categorized, scored on a Likert scale, and statistically analyzed. After categorizing the results of the first survey and ranking the results of the second survey using the Delphi technique, regulation by a licensing authority was found to be the most critical issue. This was followed by the license renewal system, continuing education, a tiered licensure system, improvement of foreign license approval, and utilization of retirees, in decreasing order of importance. The third Delphi survey showed a similar ranking, with regulation by a licensing authority being the major concern. Opinions regarding the dental license management system were provided as open-ended responses. The responses of the 3 groups showed statistically significant differences in the scores for the issue of regulation by a licensing authority. After re-grouping into the dentistry group and the policy group, the issue received a significantly higher score in the dentistry group. The quality of dental treatment should be managed to protect patients and dental professionals. For this purpose, the establishment of an independent license regulation authority along with legislative changes is required.

  10. Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health?

    PubMed

    Oliveira, Maria Auxiliadora; Bermudez, Jorge Antonio Zepeda; Chaves, Gabriela Costa; Velásquez, Germán

    2004-11-01

    The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights.

  11. Patents and profits: A disparity of manufacturing margins in the tenofovir value chain.

    PubMed

    Walwyn, David

    2013-03-01

    Registered in 2001, tenofovir disoproxil fumarate (TDF) has quickly become a mainstay of first line regimens for the treatment of HIV. Initially only available in developed countries at a cost of US$5 000 per person per year (ppy), Gilead's Access Programme (GAP) has extended the use of the product to 2.4 million patients in low and middle income countries. The programme has two components: distribution of the branded product at reduced prices and licensing partnerships with generic manufacturers. The licensing partnerships now supply 75% of the market by volume, at a treatment cost of US$57 ppy (1% of the branded cost). From Gilead's perspective, GAP must be considered a huge success. It has enabled the company to maintain high prices in developed countries whilst reducing its input costs and deflecting criticism of its failure to provide essential medicines for the poor, hence risking the possibility of compulsory licensing. Over the period 2001 to 2011, TDF in its various forms has generated for Gilead more than US$31 billion revenue at a gross margin of 80%, equivalent to a gross profit of US$25 billion. Analysis of the TDF value chain, from preparation of the active pharmaceutical ingredient (API) to sale of the formulated product, shows that manufacturing margins are highly skewed in favour of the originator, with the latter's profit being US$3.2 billion vs. US$4 million for API manufacturers and US$39 million for formulators (2011). The data argues for a more rational approach to drug pricing including possible regulation in developed countries and more sustainable margins for the generic producers.

  12. Differentiation of parenteral anticoagulants in the prevention and treatment of venous thromboembolism.

    PubMed

    Fareed, Jawed; Adiguzel, Cafer; Thethi, Indermohan

    2011-03-28

    The prevention of venous thromboembolism has been identified as a leading priority in hospital safety. Recommended parenteral anticoagulant agents with different indications for the prevention and treatment of venous thromboembolism include unfractionated heparin, low-molecular-weight heparins and fondaparinux. Prescribing decisions in venous thromboembolism management may seem complex due to the large range of clinical indications and patient types, and the range of anticoagulants available. MEDLINE and EMBASE databases were searched to identify relevant original articles. Low-molecular-weight heparins have nearly replaced unfractionated heparin as the gold standard antithrombotic agent. Low-molecular-weight heparins currently available in the US are enoxaparin, dalteparin, and tinzaparin. Each low-molecular-weight heparin is a distinct pharmacological entity with different licensed indications and available clinical evidence. Enoxaparin is the only low-molecular-weight heparin that is licensed for both venous thromboembolism prophylaxis and treatment. Enoxaparin also has the largest body of clinical evidence supporting its use across the spectrum of venous thromboembolism management and has been used as the reference standard comparator anticoagulant in trials of new anticoagulants. As well as novel oral anticoagulant agents, biosimilar and/or generic low-molecular-weight heparins are now commercially available. Despite similar anticoagulant properties, studies report differences between the branded and biosimilar and/or generic agents and further clinical studies are required to support the use of biosimilar low-molecular-weight heparins. The newer parenteral anticoagulant, fondaparinux, is now also licensed for venous thromboembolism prophylaxis in surgical patients and the treatment of acute deep-vein thrombosis; clinical experience with this anticoagulant is expanding. Parenteral anticoagulants should be prescribed in accordance with recommended dose regimens for each clinical indication, based on the available clinical evidence for each agent to assure optimal safety and efficacy.

  13. A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

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

    None

    1995-11-01

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors.more » To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.« less

  14. 76 FR 18261 - University of Wisconsin; Notice of Issuance of Renewed Facility License No. R-74

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... of Issuance of Renewed Facility License No. R-74 The U.S. Nuclear Regulatory Commission (NRC, the Commission) has issued renewed Facility License No. R-74, held by the University of Wisconsin (the licensee... to 1.4% [Delta]k/k. The renewed Facility License No. R-74 will expire at midnight 20 years from its...

  15. Children's interpretations of general quantifiers, specific quantifiers, and generics

    PubMed Central

    Gelman, Susan A.; Leslie, Sarah-Jane; Was, Alexandra M.; Koch, Christina M.

    2014-01-01

    Recently, several scholars have hypothesized that generics are a default mode of generalization, and thus that young children may at first treat quantifiers as if they were generic in meaning. To address this issue, the present experiment provides the first in-depth, controlled examination of the interpretation of generics compared to both general quantifiers ("all Xs", "some Xs") and specific quantifiers ("all of these Xs", "some of these Xs"). We provided children (3 and 5 years) and adults with explicit frequency information regarding properties of novel categories, to chart when "some", "all", and generics are deemed appropriate. The data reveal three main findings. First, even 3-year-olds distinguish generics from quantifiers. Second, when children make errors, they tend to be in the direction of treating quantifiers like generics. Third, children were more accurate when interpreting specific versus general quantifiers. We interpret these data as providing evidence for the position that generics are a default mode of generalization, especially when reasoning about kinds. PMID:25893205

  16. 14 CFR 413.1 - Scope of this part.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LICENSE APPLICATION PROCEDURES § 413.1 Scope of this part. (a) This part explains how to apply for a license or experimental permit. These procedures apply to all applications for issuing a...

  17. 77 FR 39679 - Request for Public Comments on Shipping Tolerances for Export Licenses Issued by the Bureau of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ... the applicable ``unit,'' BIS allows either no shipping tolerance on dollar value, or up to 25 percent shipping tolerance on dollar value. The Department of State, which issues licenses for commodities identified on the USML, measures shipping tolerances based on dollar value. The Department of State applies a...

  18. 10 CFR 51.108 - Public hearings on Commission findings that inspections, tests, analyses, and acceptance criteria...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... CFR 52.103(b), the Commission will not admit any contentions on environmental issues, the adequacy of the environmental impact statement for the combined license issued under subpart C of part 52, or the... finding under 10 CFR 52.103(g). [72 FR 49517, Aug. 28, 2007] materials licenses ...

  19. 10 CFR 51.108 - Public hearings on Commission findings that inspections, tests, analyses, and acceptance criteria...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... CFR 52.103(b), the Commission will not admit any contentions on environmental issues, the adequacy of the environmental impact statement for the combined license issued under subpart C of part 52, or the... finding under 10 CFR 52.103(g). [72 FR 49517, Aug. 28, 2007] materials licenses ...

  20. 10 CFR 51.108 - Public hearings on Commission findings that inspections, tests, analyses, and acceptance criteria...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... CFR 52.103(b), the Commission will not admit any contentions on environmental issues, the adequacy of the environmental impact statement for the combined license issued under subpart C of part 52, or the... finding under 10 CFR 52.103(g). [72 FR 49517, Aug. 28, 2007] materials licenses ...

  1. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... accordance with a license issued under 10 CFR part 30 and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State; (b) Sealed sources or devices non-commercially transferred from a Part 35... in accordance with a license issued under 10 CFR part 30 or the equivalent requirements of an...

  2. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State; (b) Sealed sources or devices non-commercially transferred from a Part 35... in accordance with a license issued under 10 CFR Part 30 or the equivalent requirements of an...

  3. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State; (b) Sealed sources or devices non-commercially transferred from a Part 35... in accordance with a license issued under 10 CFR Part 30 or the equivalent requirements of an...

  4. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State; (b) Sealed sources or devices non-commercially transferred from a Part 35... in accordance with a license issued under 10 CFR Part 30 or the equivalent requirements of an...

  5. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State; (b) Sealed sources or devices non-commercially transferred from a Part 35... in accordance with a license issued under 10 CFR Part 30 or the equivalent requirements of an...

  6. 47 CFR 73.6002 - Licensing requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Class A Television Broadcast Stations § 73.6002 Licensing requirements. (a) A Class A television broadcast license will only be issued to a qualified low power television licensee that: (1) Filed a Statement of Eligibility for Class A Low Power Television Station Status on or before January 28, 2000...

  7. 47 CFR 73.6002 - Licensing requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Class A Television Broadcast Stations § 73.6002 Licensing requirements. (a) A Class A television broadcast license will only be issued to a qualified low power television licensee that: (1) Filed a Statement of Eligibility for Class A Low Power Television Station Status on or before January 28, 2000...

  8. 47 CFR 73.6002 - Licensing requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Class A Television Broadcast Stations § 73.6002 Licensing requirements. (a) A Class A television broadcast license will only be issued to a qualified low power television licensee that: (1) Filed a Statement of Eligibility for Class A Low Power Television Station Status on or before January 28, 2000...

  9. 47 CFR 73.6002 - Licensing requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Class A Television Broadcast Stations § 73.6002 Licensing requirements. (a) A Class A television broadcast license will only be issued to a qualified low power television licensee that: (1) Filed a Statement of Eligibility for Class A Low Power Television Station Status on or before January 28, 2000...

  10. 47 CFR 73.6002 - Licensing requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Class A Television Broadcast Stations § 73.6002 Licensing requirements. (a) A Class A television broadcast license will only be issued to a qualified low power television licensee that: (1) Filed a Statement of Eligibility for Class A Low Power Television Station Status on or before January 28, 2000...

  11. 76 FR 75939 - Revocation of License of Small Business Investment Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... SMALL BUSINESS ADMINISTRATION Revocation of License of Small Business Investment Company Pursuant... Growth Capital, Inc. a Georgia Corporation, to function as a small business investment company under the Small Business Investment Company License No. 04045251 issued to First Growth Capital, Inc., on December...

  12. 77 FR 32167 - Surrender of License of Small Business Investment Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... SMALL BUSINESS ADMINISTRATION Surrender of License of Small Business Investment Company Pursuant... Across America, L.P. a Delaware limited partnership, to function as a small business investment company under the Small Business Investment Company License No. 04040273 issued to Capital Across America, on...

  13. 77 FR 12640 - Revocation of License of Small Business Investment Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... SMALL BUSINESS ADMINISTRATION Revocation of License of Small Business Investment Company Pursuant... Investment Partners, L.P. a Kentucky limited partnership, to function as a small business investment company under the Small Business Investment Company License No. 04/74-0283 issued to Prosperitas Investment...

  14. 77 FR 37089 - Revocation of License of Small Business Investment Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... SMALL BUSINESS ADMINISTRATION Revocation of License of Small Business Investment Company Pursuant... SBIC, LLC, a Delaware limited liability company, to function as a small business investment company under the Small Business Investment Company License No. 07070100 issued to Berthel SBIC, LLC, on May 4...

  15. 77 FR 32167 - Revocation of License of Small Business Investment Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... SMALL BUSINESS ADMINISTRATION Revocation of License of Small Business Investment Company Pursuant... Delaware limited partnership, to function as a small business investment company under the Small Business Investment Company License No. 02720594 issued to LV Equity Partners SBIC, on August 25, 1999 and said...

  16. 9 CFR 102.6 - Conditional licenses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... Preparation of products under a conditional license shall be in compliance with all applicable regulations and standards and may be restricted as follows: (a) The preparation may be limited to a predetermined time... data and information obtained since the license was issued. After considering all data and information...

  17. Generic immunosuppression in transplantation: current evidence and controversial issues.

    PubMed

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

    2015-05-01

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

  18. Aging Management Guideline for commercial nuclear power plants: Motor control centers; Final report

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

    Toman, G.; Gazdzinski, R.; O`Hearn, E.

    1994-02-01

    This Aging Management Guideline (AMG) provides recommended methods for effective detection and mitigation of age-related degradation mechanisms in Boiling Water Reactor (BWR) and Pressurized Water Reactor (PWR) commercial nuclear power plant motor control centers important to license renewal. The intent of this AMG is to assist plant maintenance and operations personnel in maximizing the safe, useful life of these components. It also supports the documentation of effective aging management programs required under the License Renewal Rule 10 CFR Part 54. This AMG is presented in a manner that allows personnel responsible for performance analysis and maintenance to compare their plant-specificmore » aging mechanisms (expected or already experienced) and aging management program activities to the more generic results and recommendations presented herein.« less

  19. 76 FR 3540 - Proposed Generic Communications Reporting for Decommissioning Funding Status Reports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ...-2010-0366] Proposed Generic Communications Reporting for Decommissioning Funding Status Reports AGENCY... and present to the NRC in the Decommissioning Funding Status reports to ensure that the NRC staff... Regulatory Issue Summary 2010-XXX, ``10 CFR 50-75, Reporting for Decommissioning Funding Status Reports'' is...

  20. Generic medicine pricing in Europe: current issues and future perspective.

    PubMed

    Simoens, Steven

    2008-01-01

    This editorial discusses a number of trends affecting the pricing of generic medicines in Europe. With respect to pricing, recent evidence has emerged that European generic medicine manufacturers face competition from Indian manufacturers; that the price level of generic medicines varies substantially between European countries; and that generic medicine manufacturers engage in competition by discount rather than price competition in France, The Netherlands and the UK. These trends suggest that there may be scope for further reducing the prices of generic medicines in several countries. In relation to reference pricing, most European countries have incorporated market incentives within reference pricing systems with a view to promoting price competition. The European experience indicates that the generic medicines industry delivers competitive prices under a reference pricing system if demand-side policies are in place that stimulate physicians, pharmacists and patients to use generic medicines. Finally, caution needs to be exercised when focusing on the drivers of generic medicine pricing as these drivers not only vary between countries, but may also vary within a country. Manufacturers of originator and generic medicines do not take a single pricing approach following patent expiry, but vary their pricing strategy from molecule to molecule.

  1. 10 CFR 40.22 - Small quantities of source material.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Small quantities of source material. 40.22 Section 40.22 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL General Licenses § 40.22 Small quantities of source material. (a) A general license is hereby issued authorizing commercial and industrial...

  2. 47 CFR 13.9 - Eligibility and application for new license or endorsement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... endorsement. 13.9 Section 13.9 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMERCIAL RADIO..., the following persons are eligible to apply for commercial radio operator licenses: (1) Any person..., no person shall be eligible to be issued a commercial radio operator license when (i) The person's...

  3. 10 CFR 72.6 - License required; types of licenses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE General... the receipt, handling, storage, and transfer of reactor-related GTCC are specific licenses. Any... hereby issued to receive title to and own spent fuel, high-level radioactive waste, or reactor-related...

  4. 10 CFR 72.6 - License required; types of licenses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE General... the receipt, handling, storage, and transfer of reactor-related GTCC are specific licenses. Any... hereby issued to receive title to and own spent fuel, high-level radioactive waste, or reactor-related...

  5. 76 FR 23639 - Revocation of License of Small Business Investment Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-27

    ... SMALL BUSINESS ADMINISTRATION Revocation of License of Small Business Investment Company Pursuant..., II, L.P., a Delaware Limited Partnership, to function as a small business investment company under the Small Business Investment Company License No. 09790400 issued to Aspen Ventures West, II, L.P., on...

  6. 77 FR 32167 - Revocation of License of Small Business Investment Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... SMALL BUSINESS ADMINISTRATION Revocation of License of Small Business Investment Company Pursuant... Delaware limited partnership, to function as a small business investment company under the Small Business Investment Company License No. 03730213 issued to Women's Growth Capital Fund I, LLLP, on June 17, 1998 and...

  7. 43 CFR 3900.40 - Multiple use development of leased or licensed lands.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... (Continued) BUREAU OF LAND MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) OIL SHALE MANAGEMENT-GENERAL Oil Shale Management-Introduction § 3900.40 Multiple use development of leased or licensed... production of deposits of oil shale does not preclude the BLM from issuing other exploration licenses or...

  8. 43 CFR 3900.40 - Multiple use development of leased or licensed lands.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... (Continued) BUREAU OF LAND MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) OIL SHALE MANAGEMENT-GENERAL Oil Shale Management-Introduction § 3900.40 Multiple use development of leased or licensed... production of deposits of oil shale does not preclude the BLM from issuing other exploration licenses or...

  9. 43 CFR 3900.40 - Multiple use development of leased or licensed lands.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... (Continued) BUREAU OF LAND MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) OIL SHALE MANAGEMENT-GENERAL Oil Shale Management-Introduction § 3900.40 Multiple use development of leased or licensed... production of deposits of oil shale does not preclude the BLM from issuing other exploration licenses or...

  10. 43 CFR 3900.40 - Multiple use development of leased or licensed lands.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... (Continued) BUREAU OF LAND MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) OIL SHALE MANAGEMENT-GENERAL Oil Shale Management-Introduction § 3900.40 Multiple use development of leased or licensed... production of deposits of oil shale does not preclude the BLM from issuing other exploration licenses or...

  11. 22 CFR 123.5 - Temporary export licenses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... AND TEMPORARY IMPORT OF DEFENSE ARTICLES § 123.5 Temporary export licenses. (a) The Directorate of Defense Trade Controls may issue a license for the temporary export of unclassified defense articles (DSP... Defense Trade Controls if the article is to remain outside the United States beyond the period for which...

  12. 15 CFR 750.7 - Issuance of licenses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... After a license application is approved, a computer generated license is issued by the Department of... technology, commodities will be approved with a quantity or dollar value limit. The “Unit” paragraph within... is related to a multi-year project, when production lead time will not permit an export or reexport...

  13. 78 FR 22576 - Application and Amendment to Facility Operating License Involving Proposed No Significant Hazards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-16

    ... Facility Operating License Involving Proposed No Significant Hazards Consideration Determination; San... Operating License No. NPF-10, issued to Southern California Edison (SCE, the licensee), for operation of the... operating conditions'' and ``normal steady state full power operation'' and restricts operation to 70...

  14. 78 FR 25484 - License Amendment for Anadarko Petroleum Corporation, Bear Creek Facility, Converse County, Wyoming

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-01

    ... NUCLEAR REGULATORY COMMISSION [Docket No.: 40-8452; NRC-2012-0095] License Amendment for Anadarko Petroleum Corporation, Bear Creek Facility, Converse County, Wyoming AGENCY: Nuclear Regulatory Commission... License SUA- 1310 issued to Anadarko Petroleum Corporation (APC or the licensee) to authorize alternate...

  15. 7 CFR 6.28 - Transfer of license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... issued for that quota year. Such sale or conveyance must be unconditional, except that it may be in... such sale does not meet the requirements of this paragraph. (b) The parties seeking transfer of license shall give written notice to the Licensing Authority of the intended sale or conveyance described in...

  16. Sharing, samples, and generics: an antitrust framework.

    PubMed

    Carrier, Michael A

    Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified version--has received the lion's share of attention. But sample denials are overdue for antitrust scrutiny. This Article fills this gap. Given the failure of Congress and the FDA to remedy the issue, antitrust can play a crucial role in ensuring generic access to samples, affirming a linchpin of the pharmaceutical regime.

  17. 10 CFR 2.623 - Notice of hearing on application for early review of site suitability issues in combined license...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Notice of hearing on application for early review of site... Applicable to Early Partial Decisions on Site Suitability Issues in Connection With an Application for a... Limited Work Authorizations Early Partial Decisions on Site Suitability-Combined License Under 10 Cfr Part...

  18. 10 CFR 2.623 - Notice of hearing on application for early review of site suitability issues in combined license...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Notice of hearing on application for early review of site... Applicable to Early Partial Decisions on Site Suitability Issues in Connection With an Application for a... Limited Work Authorizations Early Partial Decisions on Site Suitability-Combined License Under 10 Cfr Part...

  19. 10 CFR 2.623 - Notice of hearing on application for early review of site suitability issues in combined license...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Notice of hearing on application for early review of site... Applicable to Early Partial Decisions on Site Suitability Issues in Connection With an Application for a... Limited Work Authorizations Early Partial Decisions on Site Suitability-Combined License Under 10 Cfr Part...

  20. 78 FR 755 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-04

    ... and Budget (OMB) for Approval; Annual Certification of Hunting and Sport Fishing Licenses Issued... Hunting and Sport Fishing Licenses Issued, 50 CFR 80, Subpart D. Service Form Number(s): 3-154a and 3-154b...-Robertson Wildlife Restoration Act (16 U.S.C. 669 et seq.) and the Dingell-Johnson Sport Fish Restoration...

  1. 47 CFR 80.1185 - Supplemental eligibility for mobile-satellite stations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... station license for a ship earth station may be issued to: (1) The owner or operator of a ship. (2) A... operator of the ship aboard which the ship earth station is to be installed and operated. (b) A station license for a portable ship earth station may be issued to the owner or operator of portable earth station...

  2. 47 CFR 80.1185 - Supplemental eligibility for mobile-satellite stations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... station license for a ship earth station may be issued to: (1) The owner or operator of a ship. (2) A... operator of the ship aboard which the ship earth station is to be installed and operated. (b) A station license for a portable ship earth station may be issued to the owner or operator of portable earth station...

  3. 47 CFR 80.1185 - Supplemental eligibility for mobile-satellite stations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... station license for a ship earth station may be issued to: (1) The owner or operator of a ship. (2) A... operator of the ship aboard which the ship earth station is to be installed and operated. (b) A station license for a portable ship earth station may be issued to the owner or operator of portable earth station...

  4. 47 CFR 80.1185 - Supplemental eligibility for mobile-satellite stations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... station license for a ship earth station may be issued to: (1) The owner or operator of a ship. (2) A... operator of the ship aboard which the ship earth station is to be installed and operated. (b) A station license for a portable ship earth station may be issued to the owner or operator of portable earth station...

  5. 47 CFR 80.1185 - Supplemental eligibility for mobile-satellite stations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... station license for a ship earth station may be issued to: (1) The owner or operator of a ship. (2) A... operator of the ship aboard which the ship earth station is to be installed and operated. (b) A station license for a portable ship earth station may be issued to the owner or operator of portable earth station...

  6. 10 CFR 2.629 - Finality of partial decision on site suitability issues in a combined license proceeding.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...), the Director of the Office of New Reactors or the Director of the Office of Nuclear Reactor Regulation... 10 Energy 1 2014-01-01 2014-01-01 false Finality of partial decision on site suitability issues in a combined license proceeding. 2.629 Section 2.629 Energy NUCLEAR REGULATORY COMMISSION AGENCY RULES...

  7. 10 CFR 2.629 - Finality of partial decision on site suitability issues in a combined license proceeding.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...), the Director of the Office of New Reactors or the Director of the Office of Nuclear Reactor Regulation... 10 Energy 1 2013-01-01 2013-01-01 false Finality of partial decision on site suitability issues in a combined license proceeding. 2.629 Section 2.629 Energy NUCLEAR REGULATORY COMMISSION AGENCY RULES...

  8. Limitations and drawbacks of using Preliminary Environmental Reports (PERs) as an input to Environmental Licensing in Sao Paulo State: A case study on natural gas pipeline routing

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

    Kirchhoff, Denis; Montano, Marcelo; Ranieri, Victor Eduardo Lima

    2007-05-15

    This article discusses the limitations and implications to environmental management issues posed by the Environmental Licensing approach adopted in Sao Paulo State. In Brazil, Environmental Impact Assessment (EIA) is an essential precondition to the Environmental Licensing of activities and, in fact, it has been the most important and required tool for the licensing of projects. However, in 1994 the State of Sao Paulo implemented a simplified instrument called a 'Preliminary Environmental Report' in order to make the environmental licensing process faster. Since then, the Preliminary Environmental Report (PER) has had the role of indicating whether an EIA needs to bemore » elaborated upon or not. The positives and negatives regarding technical, institutional and legal aspects related to the use of Preliminary Environmental Reports (rather than EIA) are discussed using the case study of a high-pressure natural gas pipeline between the cities of Sao Carlos and Porto Ferreira in the State of Sao Paulo. The main conclusion is that the Environmental Licensing process in Sao Paulo should not use PERs as the sole input to decision making about proposed activities, since the PER approach does not guarantee that the proposed activity is environmentally suitable, does not address locational issues or comparison of alternatives, and risk assessment issues are not considered in the earliest stages of assessment.« less

  9. Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland.

    PubMed

    O'Leary, A; Usher, C; Lynch, M; Hall, M; Hemeryk, L; Spillane, S; Gallagher, P; Barry, M

    2015-12-15

    The Health (Pricing and Supply of Medical Goods) Act 2013 passed into law in July 2013 and legislated for generic substitution in Ireland. The aim of the study was to ascertain the knowledge and perceptions of stakeholders i.e. patients, pharmacists and prescribers, of generic medicines and to generic substitution with the passing of legislation. Three stakeholder specific questionnaires were developed to assess knowledge of and perceptions to generic medicines and generic substitution. Purposive samples of patients, prescribers and pharmacists were analysed. Descriptive quantitative and qualitative analyses were undertaken. A total of 762 healthcare professionals and 353 patients were recruited. The study highlighted that over 84% of patients were familiar with generic medicines and are supportive of the concept of generic substitution. Approximately 74% of prescribers and 84% of pharmacists were supportive of generic substitution in most cases. The main areas of concern highlighted by the healthcare professionals that might impact on the successful implementation of the policy, were the issue of bioequivalence with generic medicines, the computer software systems used at present in general practitioner (GP) surgeries and the availability of branded generics. The findings from this study identify a high baseline rate of acceptance to generic medicines and generic substitution among patients, prescribers and pharmacists in the Irish setting. The concerns of the main stakeholders provide a valuable insight into the potential difficulties that may arise in its implementation, and the need for on-going reassurance and proactive dissemination of the impact of the generic substitution policy. The existing positive attitude to generic medicines and generic substitution among key stakeholders in Ireland to generic substitution, combined with appropriate support and collaboration should result in the desired increase in rates of prescribing, dispensing and use of generic medicines.

  10. Licensing: pros and cons for biotech.

    PubMed

    Villiger, Ralph; Bogdan, Boris

    2009-03-01

    This article guides the reader through strategic considerations when facing the option to license a drug development project. It is crucial to understand these licensing events in their full complexity in order to achieve maximum value for the company and the shareholders, while minimizing risk. First, the nature of various license agreements and the needs of licensor and licensee are discussed. Second, the main strategic issues for the licensor are explained and a guideline, how to come to a decision whether to license and to what terms, is given. Third, the authors explain how to overcome different assumptions when negotiating a license contract.

  11. 78 FR 21826 - Tribal Background Investigations and Licensing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-12

    ... employees and submit those results to the Commission before issuing gaming licenses. 25 U.S.C. 2710(b)(2)(F... licenses to their primary management officials or key employees. 25 U.S.C. 2710(b)(2)(F)(ii)(I). On January... increase in costs or prices for consumers, individual industries, Federal, State, local government agencies...

  12. 76 FR 46329 - Notice of Issuance of Renewed Materials License No. SNM-2504; Department of Energy; Fort St...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ... Materials License No. SNM-2504; Department of Energy; Fort St. Vrain Independent Spent Fuel Storage... INFORMATION CONTACT: Christopher Staab, Project Manager, Division of Spent Fuel Storage and Transportation... issued renewed Materials License No. SNM-2504 to the Department of Energy (DOE) for the receipt...

  13. License suspensions for nondriving offenses : practices in four states that may ease the financial impact on low-income individuals, February 2010.

    DOT National Transportation Integrated Search

    2010-02-01

    States suspend drivers licenses for a variety of offenses that are not directly related to driving safety.1 For example, all states have procedures to suspend licenses for child support arrearages. In addition, a majority of states issue suspensio...

  14. 14 CFR 431.9 - Issuance of a reusable launch vehicle mission license.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Issuance of a reusable launch vehicle mission license. 431.9 Section 431.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL... VEHICLE (RLV) General § 431.9 Issuance of a reusable launch vehicle mission license. (a) The FAA issues...

  15. 14 CFR 431.9 - Issuance of a reusable launch vehicle mission license.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Issuance of a reusable launch vehicle mission license. 431.9 Section 431.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL... VEHICLE (RLV) General § 431.9 Issuance of a reusable launch vehicle mission license. (a) The FAA issues...

  16. 14 CFR 431.9 - Issuance of a reusable launch vehicle mission license.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Issuance of a reusable launch vehicle mission license. 431.9 Section 431.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL... VEHICLE (RLV) General § 431.9 Issuance of a reusable launch vehicle mission license. (a) The FAA issues...

  17. 14 CFR 431.9 - Issuance of a reusable launch vehicle mission license.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Issuance of a reusable launch vehicle mission license. 431.9 Section 431.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL... VEHICLE (RLV) General § 431.9 Issuance of a reusable launch vehicle mission license. (a) The FAA issues...

  18. 14 CFR 431.9 - Issuance of a reusable launch vehicle mission license.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Issuance of a reusable launch vehicle mission license. 431.9 Section 431.9 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL... VEHICLE (RLV) General § 431.9 Issuance of a reusable launch vehicle mission license. (a) The FAA issues...

  19. 31 CFR 515.548 - Services rendered by Cuba to United States aircraft.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Services rendered by Cuba to United... REGULATIONS Licenses, Authorizations, and Statements of Licensing Policy § 515.548 Services rendered by Cuba to United States aircraft. Specific licenses are issued for payment to Cuba of charges for services...

  20. 31 CFR 515.548 - Services rendered by Cuba to United States aircraft.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Services rendered by Cuba to United... REGULATIONS Licenses, Authorizations, and Statements of Licensing Policy § 515.548 Services rendered by Cuba to United States aircraft. Specific licenses are issued for payment to Cuba of charges for services...

  1. 31 CFR 515.548 - Services rendered by Cuba to United States aircraft.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Services rendered by Cuba to United... REGULATIONS Licenses, Authorizations, and Statements of Licensing Policy § 515.548 Services rendered by Cuba to United States aircraft. Specific licenses are issued for payment to Cuba of charges for services...

  2. Alternative Fuels Data Center

    Science.gov Websites

    Virginia Clean Special Fuel license plate may use Virginia HOV lanes, regardless of the number of occupants license plates issued before July 1, 2011, are exempt from HOV lane requirements. For express lanes serving the I-95/I-395 corridor, registered vehicles displaying Clean Special Fuel license plates are not

  3. 76 FR 44614 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses Involving No...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... Facility Operating Licenses Involving No Significant Hazards Considerations Background Pursuant to Section... authority to issue and make immediately effective any amendment to an operating license upon a determination... electronic form will be posted on the NRC Web site and on the Federal rulemaking Web site http://www...

  4. 9 CFR 102.5 - U.S. Veterinary Biological Product License.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false U.S. Veterinary Biological Product... BIOLOGICAL PRODUCTS § 102.5 U.S. Veterinary Biological Product License. (a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the...

  5. 9 CFR 102.5 - U.S. Veterinary Biological Product License.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false U.S. Veterinary Biological Product... BIOLOGICAL PRODUCTS § 102.5 U.S. Veterinary Biological Product License. (a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the...

  6. 7 CFR 6.23 - Eligibility to apply for a license.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... quantities and number of shipments required under (A) or (B) above. (2) Certain butter. A person issued a nonhistorical license for butter for the 1997 or 1998 quota year may annually apply for a historical license (Appendix 1) for the same quantity of butter for the subsequent quota year and each year thereafter...

  7. 7 CFR 6.23 - Eligibility to apply for a license.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... quantities and number of shipments required under (A) or (B) above. (2) Certain butter. A person issued a nonhistorical license for butter for the 1997 or 1998 quota year may annually apply for a historical license (Appendix 1) for the same quantity of butter for the subsequent quota year and each year thereafter...

  8. 7 CFR 6.23 - Eligibility to apply for a license.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... quantities and number of shipments required under (A) or (B) above. (2) Certain butter. A person issued a nonhistorical license for butter for the 1997 or 1998 quota year may annually apply for a historical license (Appendix 1) for the same quantity of butter for the subsequent quota year and each year thereafter...

  9. 7 CFR 6.23 - Eligibility to apply for a license.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... quantities and number of shipments required under (A) or (B) above. (2) Certain butter. A person issued a nonhistorical license for butter for the 1997 or 1998 quota year may annually apply for a historical license (Appendix 1) for the same quantity of butter for the subsequent quota year and each year thereafter...

  10. e-Learning Business Research Methods

    ERIC Educational Resources Information Center

    Cowie, Jonathan

    2004-01-01

    This paper outlines the development of a generic Business Research Methods course from a simple name in a box to a full e-Learning web based module. It highlights particular issues surrounding the nature of the discipline and the integration of a large number of cross faculty subject specific research methods courses into a single generic module.…

  11. Generic Certificates. Agricultural Economic Report Number 594.

    ERIC Educational Resources Information Center

    Glauber, Joseph W.

    The Food Security Act of 1985 authorizes the U.S. Department of Agriculture to issue generic certificates in lieu of cash payments due to program participants and merchants of agricultural products under provisions of several programs. The certificates may be used to acquire stocks held as collateral on government loans or owned by the Commodity…

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

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

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

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

  13. 9 CFR 102.1 - Licenses issued by the Administrator.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS LICENSES FOR... biological products under the Virus-Serum-Toxin Act shall hold an unexpired and unrevoked U.S. Veterinary...

  14. 9 CFR 102.1 - Licenses issued by the Administrator.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS LICENSES FOR... biological products under the Virus-Serum-Toxin Act shall hold an unexpired and unrevoked U.S. Veterinary...

  15. 10 CFR 171.5 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... self-supporting chain reaction. Operating license means having a license issued pursuant to § 50.57 of..., telecommunications and supplies)]; and (4) Indirect costs that would include, but not be limited to, NRC central...

  16. 10 CFR 171.5 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... self-supporting chain reaction. Operating license means having a license issued pursuant to § 50.57 of..., telecommunications and supplies)]; and (4) Indirect costs that would include, but not be limited to, NRC central...

  17. Copyright and Creative Commons License: Can Educators Gain Benefits in the Digital Age?

    ERIC Educational Resources Information Center

    Lamlert, Wariya

    2014-01-01

    In this society of digital environment, to keep pace with the technological change that causes the difficulties of information access together with royalty fees remunerated for making use of copyrighted materials, Creative Commons (CC) license is introduced. However, debates on the issues of copyright and CC license have widely arisen. This…

  18. 10 CFR 40.27 - General license for custody and long-term care of residual radioactive material disposal sites.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false General license for custody and long-term care of residual... residual radioactive material disposal sites. (a) A general license is issued for the custody of and long... water characterization and any necessary ground water protection activities or strategies. This...

  19. 77 FR 40092 - License Amendment To Increase the Maximum Reactor Power Level, Florida Power & Light Company, St...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... Increase the Maximum Reactor Power Level, Florida Power & Light Company, St. Lucie, Units 1 and 2 AGENCY... amendment for Renewed Facility Operating License Nos. DPR-67 and NPF-16, issued to Florida Power & Light... St. Lucie County, Florida. The proposed license amendment would increase the maximum thermal power...

  20. 76 FR 15826 - Fisheries of the Exclusive Economic Zone Off Alaska; Gulf of Alaska License Limitation Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... or non-trawl gear designations); and (4) designate the type of vessel operation permitted (i.e., LLP... catcher/processor). The endorsements for specific regulatory areas, gear designations, and vessel operational types are non-severable from the LLP license (i.e., once an LLP license is issued, the components...

  1. 78 FR 31958 - Privacy Act of 1974; Department of Homeland Security U.S. Customs and Border Protection-007...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ...; Secondary Examination Status, and License Plate number (or Vehicle Identification Number (VIN), if no plate... License Plate number of the conveyance (or VIN number when no plate exists). Under the Entry/Exist Program... Driver's License (EDL); (5) another Federal Agency that has issued a valid travel document, such as...

  2. 19 CFR 112.26 - Duration of license.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... license issued in accordance with this subpart shall remain in force and effect until the license is... this chapter. [T.D. 76-324, 41 FR 50822, Nov. 18, 1976, as amended by T.D. 84-213, 49 FR 41171, Oct. 19, 1984; 49 FR 44867, Nov. 9, 1984; T.D. 97-82, 62 FR 51770, Oct. 3, 1997] ...

  3. 19 CFR 112.26 - Duration of license.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... license issued in accordance with this subpart shall remain in force and effect until the license is... this chapter. [T.D. 76-324, 41 FR 50822, Nov. 18, 1976, as amended by T.D. 84-213, 49 FR 41171, Oct. 19, 1984; 49 FR 44867, Nov. 9, 1984; T.D. 97-82, 62 FR 51770, Oct. 3, 1997] ...

  4. 10 CFR 50.21 - Class 104 licenses; for medical therapy and research and development facilities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Class 104 licenses; for medical therapy and research and...; for medical therapy and research and development facilities. A class 104 license will be issued, to an... Administration entered into under the Cooperative Power Reactor Demonstration Program, except as otherwise...

  5. 10 CFR 2.629 - Finality of partial decision on site suitability issues in a combined license proceeding.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... a combined license proceeding. 2.629 Section 2.629 Energy NUCLEAR REGULATORY COMMISSION RULES OF... Work Authorizations Early Partial Decisions on Site Suitability-Combined License Under 10 Cfr Part 52... complete and acceptable for docketing under § 2.101(a)(3), the Director of the Office of New Reactors or...

  6. 77 FR 73008 - Notice of Intent To Grant Exclusive License

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... Schillinger Genetics, Inc. of West Des Moines, Iowa, an exclusive license to U.S. Patent No. 7,951,537, ``Development of Low Allergen Soybean Seeds Using Molecular Markers for the P34 Allele,'' issued on May 31, 2011... Agriculture. It is in the public interest to so license this invention as Schillinger Genetics, Inc. of West...

  7. Your EHR license agreement: critical issues.

    PubMed

    Shay, Daniel F

    2014-01-01

    This article discusses several key provisions and concepts in software license agreements for electronic health records. It offers insight into what physician practices can expect to find in their license agreements, as well as practical advice on beneficial provisions. The article examines contractual language relating to term and termination, technical specifications and support, and compliance with governmental programs.

  8. University Study Licenses and Clerical Education in the Diocese of Norwich, 1325-35.

    ERIC Educational Resources Information Center

    Shinners, John R., Jr.

    1988-01-01

    Assesses the strengths and weaknesses of university study licenses such as the "Licet canon" and the "Cum ex eo" which, when issued by the Vatican in the 13th century, allowed unordained parochial rectors and ordained priests to obtain higher education. Concludes that study licenses improved the education of the parochial…

  9. 10 CFR 51.107 - Public hearings in proceedings for issuance of combined licenses; limited work authorizations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... the issuance of a combined license for a nuclear power reactor under part 52 of this chapter, the... or Director, Office of Nuclear Reactor Regulation, as appropriate. (b) If a combined license... authorization should be issued as proposed by the Director of New Reactors or the Director of Nuclear Reactor...

  10. 10 CFR 51.107 - Public hearings in proceedings for issuance of combined licenses; limited work authorizations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... the issuance of a combined license for a nuclear power reactor under part 52 of this chapter, the... or Director, Office of Nuclear Reactor Regulation, as appropriate. (b) If a combined license... authorization should be issued as proposed by the Director of New Reactors or the Director of Nuclear Reactor...

  11. 10 CFR 51.107 - Public hearings in proceedings for issuance of combined licenses; limited work authorizations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... the issuance of a combined license for a nuclear power reactor under part 52 of this chapter, the... or Director, Office of Nuclear Reactor Regulation, as appropriate. (b) If a combined license... authorization should be issued as proposed by the Director of New Reactors or the Director of Nuclear Reactor...

  12. 10 CFR 140.94 - Appendix D-Form of indemnity agreement with Federal agencies.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (hereinafter referred to as the Act). Article I As used in this agreement, 1. Nuclear reactor, byproduct... irradiated or to be irradiated by, the nuclear reactor or reactors subject to the license or licenses... construction of a nuclear reactor with respect to which no operating license has been issued by the Nuclear...

  13. 10 CFR 51.107 - Public hearings in proceedings for issuance of combined licenses; limited work authorizations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... the issuance of a combined license for a nuclear power reactor under part 52 of this chapter, the... or Director, Office of Nuclear Reactor Regulation, as appropriate. (b) If a combined license... authorization should be issued as proposed by the Director of New Reactors or the Director of Nuclear Reactor...

  14. 10 CFR 51.107 - Public hearings in proceedings for issuance of combined licenses; limited work authorizations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... the issuance of a combined license for a nuclear power reactor under part 52 of this chapter, the... or Director, Office of Nuclear Reactor Regulation, as appropriate. (b) If a combined license... authorization should be issued as proposed by the Director of New Reactors or the Director of Nuclear Reactor...

  15. 47 CFR 80.25 - License term.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... maritime services will normally be issued for a term of ten years from the date of original issuance, or... of ten years from the date of original issuance, major modification, or renewal. (c) Licenses for...

  16. 75 FR 42431 - Notice of Intent To Grant Partially Exclusive License; METOCEAN Data System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ... exclusive license, with exclusive fields of use in portable acoustic scoring, acoustic sounding and..., issued February 7, 2006, entitled ``Integrated Maritime Portable Acoustic Scoring and Simulator Control...

  17. Invited Commentary on Wallace and Beange (2008): "On the Need for a Specialist Service within the Generic Hospital Setting"

    ERIC Educational Resources Information Center

    O'Hara, David

    2008-01-01

    In this article, the author comments on the paper "On the need for a specialist service within the generic hospital setting" (Wallace & Beange, 2008), which raises critical issues regarding effective models of healthcare delivery for individuals with intellectual disability (ID), particularly within a hospital setting (but not…

  18. 77 FR 14446 - Changes to the Generic Aging Lessons Learned (GALL) Report Revision 2 AMP XI.M41, “Buried and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0055] Changes to the Generic Aging Lessons Learned (GALL... Aging Lessons Learned (GALL) Report,'' and the NRC staff's aging management review procedure and... into ADAMS. II. Background The NRC issues LR-ISGs to communicate insights and lessons learned and to...

  19. The impact of the 2007 graduated driver licensing law in Massachusetts on the rate of citations and licensing in teenage drivers.

    PubMed

    DePesa, Christopher; Raybould, Toby; Hurwitz, Shelley; Lee, Jarone; Gervasini, Alice; Velmahos, George C; Masiakos, Peter T; Kaafarani, Haytham M A

    2017-06-01

    We recently demonstrated that the 2007 Massachusetts Graduated Driving Licensing (GDL) law decreased the rate of motor vehicle crashes in teenage drivers. To better understand this decrease, we sought to examine the law's impact on the issuance of driving licenses and traffic citations to teenage drivers. Citation and license data were obtained from the Massachusetts Department of Transportation. Census data were obtained from the Census Data Center. Two study periods were defined: pre-GDL (2002-2006) and post-GDL (2007-2012). Two populations were defined: the study population (aged 16-17) and the control population (aged 25-29). The rates of licenses per population were compared pre- vs. post-GDL for the study group. The numbers of total, state, and local citations per population were compared pre- vs. post-GDL for both populations. A sensitivity analysis was performed for the rates of citations using licenses issued as a denominator. While licenses per population obtained by the study group decreased over the entire period, there was no change in the rate of decrease per year pre- vs. post-GDL (2.0% vs. 1.4%; p=0.6392). In the study population, total, state, and local citations decreased post-GDL (17.8% vs. 8.1%, p<0.0001; 3.7% vs. 2.2%, p<0.0001; 14.1% vs. 5.8%, p<0.0001, respectively). In the control group, total and state citations did not change (26.7% vs. 23.9%, p=0.3606; 9.2% vs. 10.2%, p=0.3404, respectively), and local citations decreased (17.5% vs. 13.7%, p=0.0389). The rates of decrease per year for total, state, and local citations were significantly greater in the study population compared with control (p<0.0001, p=0.0002, p<0.0001, respectively). The 2007 GDL law in Massachusetts was associated with fewer traffic citations without a change in the rate of licenses issued to teenagers. These findings suggest that 2007 GDL may be improving driving habits as opposed to motivating teenagers to delay the issuing of licenses. Copyright © 2017. Published by Elsevier Ltd.

  20. Adapting the coping in deliberation (CODE) framework: a multi-method approach in the context of familial ovarian cancer risk management.

    PubMed

    Witt, Jana; Elwyn, Glyn; Wood, Fiona; Rogers, Mark T; Menon, Usha; Brain, Kate

    2014-11-01

    To test whether the coping in deliberation (CODE) framework can be adapted to a specific preference-sensitive medical decision: risk-reducing bilateral salpingo-oophorectomy (RRSO) in women at increased risk of ovarian cancer. We performed a systematic literature search to identify issues important to women during deliberations about RRSO. Three focus groups with patients (most were pre-menopausal and untested for genetic mutations) and 11 interviews with health professionals were conducted to determine which issues mattered in the UK context. Data were used to adapt the generic CODE framework. The literature search yielded 49 relevant studies, which highlighted various issues and coping options important during deliberations, including mutation status, risks of surgery, family obligations, physician recommendation, peer support and reliable information sources. Consultations with UK stakeholders confirmed most of these factors as pertinent influences on deliberations. Questions in the generic framework were adapted to reflect the issues and coping options identified. The generic CODE framework was readily adapted to a specific preference-sensitive medical decision, showing that deliberations and coping are linked during deliberations about RRSO. Adapted versions of the CODE framework may be used to develop tailored decision support methods and materials in order to improve patient-centred care. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  1. ImgLib2--generic image processing in Java.

    PubMed

    Pietzsch, Tobias; Preibisch, Stephan; Tomancák, Pavel; Saalfeld, Stephan

    2012-11-15

    ImgLib2 is an open-source Java library for n-dimensional data representation and manipulation with focus on image processing. It aims at minimizing code duplication by cleanly separating pixel-algebra, data access and data representation in memory. Algorithms can be implemented for classes of pixel types and generic access patterns by which they become independent of the specific dimensionality, pixel type and data representation. ImgLib2 illustrates that an elegant high-level programming interface can be achieved without sacrificing performance. It provides efficient implementations of common data types, storage layouts and algorithms. It is the data model underlying ImageJ2, the KNIME Image Processing toolbox and an increasing number of Fiji-Plugins. ImgLib2 is licensed under BSD. Documentation and source code are available at http://imglib2.net and in a public repository at https://github.com/imagej/imglib. Supplementary data are available at Bioinformatics Online. saalfeld@mpi-cbg.de

  2. Statistical Primer on Biosimilar Clinical Development.

    PubMed

    Isakov, Leah; Jin, Bo; Jacobs, Ira Allen

    A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the originator and the potential biosimilar are large and structurally complex proteins, biosimilars are not generic equivalents of the originator. Thus, the regulatory approach for a small-molecule generic is not appropriate for a potential biosimilar. As a result, different study designs and statistical approaches are used in the assessment of a potential biosimilar. This review covers concepts and terminology used in statistical analyses in the clinical development of biosimilars so that clinicians can understand how similarity is evaluated. This should allow the clinician to understand the statistical considerations in biosimilar clinical trials and make informed prescribing decisions when an approved biosimilar is available.

  3. Alternative Fuels Data Center

    Science.gov Websites

    state-issued PEV license plates may use HOV lanes regardless of the number of passengers and are exempt from parking fees charged by any state or county authority. PEVs displaying state PEV license plates

  4. 47 CFR 90.375 - RSU license areas, communication zones and registrations

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    .... Governmental applicants will be issued a geographic area license based on the geo-political area encompassing... Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554 or National Archives and...

  5. 47 CFR 90.375 - RSU license areas, communication zones and registrations

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    .... Governmental applicants will be issued a geographic area license based on the geo-political area encompassing... Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554 or National Archives and...

  6. 47 CFR 90.375 - RSU license areas, communication zones and registrations

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    .... Governmental applicants will be issued a geographic area license based on the geo-political area encompassing... Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554 or National Archives and...

  7. 47 CFR 90.375 - RSU license areas, communication zones and registrations

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    .... Governmental applicants will be issued a geographic area license based on the geo-political area encompassing... Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554 or National Archives and...

  8. 47 CFR 90.375 - RSU license areas, communication zones and registrations

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    .... Governmental applicants will be issued a geographic area license based on the geo-political area encompassing... Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554 or National Archives and...

  9. 77 FR 45410 - Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... as driver's license, passport, U.S. government or military ID) are required for entrance into the... government-issued photo identification number and type (such as driver's license number/ state, passport...

  10. 78 FR 46565 - Assessment of Fees for Dairy Import Licenses for the 2014 Tariff-Rate Import Quota Year

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ... Service Assessment of Fees for Dairy Import Licenses for the 2014 Tariff- Rate Import Quota Year AGENCY... charged for the 2014 tariff-rate quota (TRQ) year for each license issued to a person or firm by the... 2014 calendar year. Notice: The total cost to the Department of Agriculture of administering the...

  11. Licensed Professional Counselor Interns' Level of Self-Efficacy Relating to Graduate Program of Study and Institution Type

    ERIC Educational Resources Information Center

    Webster, Matthew A.

    2012-01-01

    In the state of Texas, Licensed Professional Counselors (LPCs) work to provide mental- health services designed to meet the needs of those who are dealing with a variety of affective, cognitive, and behavioral issues. Multiple educational pathways are available for obtaining the LPC license, with primary distinctions being among the graduate…

  12. Exploring Knowledge and Perceptions of Generic Medicines Among Drug Retailers and Community Pharmacists

    PubMed Central

    Basak, S. C.; Sathyanarayana, D.

    2012-01-01

    The study was carried out to evaluate community pharmacists’ and drug retailers’ knowledge and perceptions about generic medicines. A cross-sectional descriptive study, with a questionnaire, was conducted to survey community pharmacists and drug retailers working in 39 randomly selected private pharmacies from two towns of Tamil Nadu, India. Among 66 respondents (pharmacists and drug retailers), 39 (59.1%) were drug retailers; 52 (78.8%) were self-employed; majority in the age group 31-40 (31.8%); and mostly males (83.3%). Overall, 21 respondents (31.8%) did not know what generic medicines were. About 30% of the respondents thought that generic medicines are of inferior quality compared to branded medicines. Only 63.6% of the surveyed pharmacists and drug retailers agreed that generic medicines can be considered therapeutically equivalent with the branded ones. A higher level of education had a direct relationship having correct knowledge of generic medicines (P<0.01). The majority of the respondents (80%) did not support generic substitution, even in case of prescribed medicines are not available. Many community pharmacists and drug retailers have misconceptions regarding generic medicines. Lack of knowledge may negatively affect the community pharmacists’ support towards generic medicines in India. This issue should be addressed by academicians and other relevant bodies. PMID:23798785

  13. 47 CFR 87.45 - Time in which station is placed in operation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SPECIAL RADIO SERVICES AVIATION SERVICES Applications and Licenses § 87.45 Time in which station is placed..., excluding radionavigation land test stations. When a new license has been issued or additional operating...

  14. 77 FR 77118 - Notice of Availability of Environmental Assessment and Finding of No Significant Impact for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-31

    ... Department of Agriculture, Beltsville, MD AGENCY: Nuclear Regulatory Commission. ACTION: Notice of... license amendment to NRC License No. 19-00915-03, issued to the United States Department of Agriculture...

  15. 78 FR 9105 - Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-07

    ... a valid government-issued photo ID (such as driver's license, passport, U.S. government or military... identification number and type (such as driver's license number/ state, passport number/country, or U.S...

  16. 75 FR 71787 - Advisory Committee On Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-24

    ... notification and a valid government-issued photo ID (such as driver's license, passport, U.S. government or... driver's license number/state, passport number/country, or U.S. government ID number/agency or [[Page...

  17. 77 FR 5292 - Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-02

    ... notification and a valid government-issued photo ID (such as driver's license, passport, U.S. government or... as driver's license number/ state, passport number/country, or U.S. government ID number/agency or...

  18. 76 FR 53165 - Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-25

    ..., DC. Prior notification and a valid government-issued photo ID (such as driver's license, passport, U... as driver's license number/state, passport number/country, or U.S. government ID number/agency or...

  19. 75 FR 8176 - Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... notification and a valid government-issued photo ID (such as driver's license, passport, U. S. government or... license number/State, passport number/country, or US government ID number/agency or military ID number...

  20. Site Operators License: Guidelines for Applicants

    DOT National Transportation Integrated Search

    1995-08-08

    The U. S. Department of Transportation's Office of Commercial Space : Transportation (OCST) issues site operator licenses based on the site : operator's demonstration of the ability to ensure public safety and the : safety of property, both on and of...

  1. Education of advanced practice nurses in Canada.

    PubMed

    Martin-Misener, Ruth; Bryant-Lukosius, Denise; Harbman, Patricia; Donald, Faith; Kaasalainen, Sharon; Carter, Nancy; Kilpatrick, Kelley; DiCenso, Alba

    2010-12-01

    In Canada, education programs for the clinical nurse specialist (CNS) and nurse practitioner (NP) roles began 40 years ago. NP programs are offered in almost all provinces. Education for the CNS role has occurred through graduate nursing programs generically defined as providing preparation for advanced nursing practice. For this paper, we drew on pertinent sections of a scoping review of the literature and key informant interviews conducted for a decision support synthesis on advanced practice nursing to describe the following: (1) history of advanced practice nursing education in Canada, (2) current status of advanced practice nursing education in Canada, (3) curriculum issues, (4) interprofessional education, (5) resources for education and (6) continuing education. Although national frameworks defining advanced nursing practice and NP competencies provide some direction for education programs, Canada does not have countrywide standards of education for either the NP or CNS role. Inconsistency in the educational requirements for primary healthcare NPs continues to cause significant problems and interferes with inter-jurisdictional licensing portability. For both CNSs and NPs, there can be a mismatch between a generalized education and specialized practice. The value of interprofessional education in facilitating effective teamwork is emphasized. Recommendations for future directions for advanced practice nursing education are offered.

  2. Intellectual property rights, market competition and access to affordable antiretrovirals.

    PubMed

    Pascual, Fernando

    2014-01-01

    The number of patients receiving antiretroviral therapy (ART) has increased from around half a million in 2003 to almost 10 million in only 10 years, and will continue to increase in the coming years. Over 16 million more are eligible to start ART according to the last World Health Organization (WHO) guidelines. The demand is also switching from the less expensive antiretrovirals (ARVs) that allowed such scale-up to newer more expensive ones with fewer side effects or those that can be used by people who have developed resistance to first-line treatment. However, patents on these new drugs can delay robust generic competition and, consequently, price reduction made possible by economies of scale. Various ways to address this issue have been envisaged or implemented, including the use of the flexibilities available under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), systematic widespread voluntary licensing, of which the Medicines Patent Pool (MPP) is an example, and the application of different prices in different countries, called tiered pricing. This paper helps explain the impact of patents on market competition for ARVs and analyses various approaches available today to minimize this impact.

  3. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    PubMed Central

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

    2011-01-01

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

  4. A Chado case study: an ontology-based modular schema for representing genome-associated biological information.

    PubMed

    Mungall, Christopher J; Emmert, David B

    2007-07-01

    A few years ago, FlyBase undertook to design a new database schema to store Drosophila data. It would fully integrate genomic sequence and annotation data with bibliographic, genetic, phenotypic and molecular data from the literature representing a distillation of the first 100 years of research on this major animal model system. In developing this new integrated schema, FlyBase also made a commitment to ensure that its design was generic, extensible and available as open source, so that it could be employed as the core schema of any model organism data repository, thereby avoiding redundant software development and potentially increasing interoperability. Our question was whether we could create a relational database schema that would be successfully reused. Chado is a relational database schema now being used to manage biological knowledge for a wide variety of organisms, from human to pathogens, especially the classes of information that directly or indirectly can be associated with genome sequences or the primary RNA and protein products encoded by a genome. Biological databases that conform to this schema can interoperate with one another, and with application software from the Generic Model Organism Database (GMOD) toolkit. Chado is distinctive because its design is driven by ontologies. The use of ontologies (or controlled vocabularies) is ubiquitous across the schema, as they are used as a means of typing entities. The Chado schema is partitioned into integrated subschemas (modules), each encapsulating a different biological domain, and each described using representations in appropriate ontologies. To illustrate this methodology, we describe here the Chado modules used for describing genomic sequences. GMOD is a collaboration of several model organism database groups, including FlyBase, to develop a set of open-source software for managing model organism data. The Chado schema is freely distributed under the terms of the Artistic License (http://www.opensource.org/licenses/artistic-license.php) from GMOD (www.gmod.org).

  5. 75 FR 52580 - Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ... notification and a valid government-issued photo ID (such as driver's license, passport, U.S. government or... license number/ state, passport number/country, or U.S. government ID number/agency or military ID number...

  6. 75 FR 36619 - International Fisheries; South Pacific Tuna Fisheries; Procedures to Request Licenses and a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... Islands Forum Fisheries Agency (FFA), based in Honiara, Solomon Islands, which acts as the Treaty..., Papua New Guinea, Samoa, Solomon Islands, Tonga, Tuvalu, and Vanuatu. Treaty licenses are issued by the...

  7. 25 CFR 11.1115 - Information collection.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... collected to obtain a marriage license (§ 11.600) and a divorce decree (§ 11.606) from the Courts of Indian Offenses, and will be used by the courts to issue a marriage license or divorce decree. Response to this...

  8. 25 CFR 11.1115 - Information collection.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... collected to obtain a marriage license (§ 11.600) and a divorce decree (§ 11.606) from the Courts of Indian Offenses, and will be used by the courts to issue a marriage license or divorce decree. Response to this...

  9. 25 CFR 11.1115 - Information collection.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... collected to obtain a marriage license (§ 11.600) and a divorce decree (§ 11.606) from the Courts of Indian Offenses, and will be used by the courts to issue a marriage license or divorce decree. Response to this...

  10. 25 CFR 11.1115 - Information collection.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... collected to obtain a marriage license (§ 11.600) and a divorce decree (§ 11.606) from the Courts of Indian Offenses, and will be used by the courts to issue a marriage license or divorce decree. Response to this...

  11. 25 CFR 11.1115 - Information collection.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... collected to obtain a marriage license (§ 11.600) and a divorce decree (§ 11.606) from the Courts of Indian Offenses, and will be used by the courts to issue a marriage license or divorce decree. Response to this...

  12. 75 FR 53271 - Assessment of Fees for Dairy Import Licenses for the 2011 Tariff-Rate Import Quota Year

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... Service Assessment of Fees for Dairy Import Licenses for the 2011 Tariff- Rate Import Quota Year AGENCY... charged for the 2011 tariff-rate quota (TRQ) year for each license issued to a person or firm by the U.S... tariff-rate quotas set forth in the Harmonized Tariff Schedule (HTS) of the United States. DATES...

  13. 10 CFR Appendix B to 10 Cfr Part 2 - Model Milestones To Be Used By a Presiding Officer as a Guideline in Developing a Hearing...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... the issues, any other relevant consideration that a party brings to the attention of the presiding... CFR Part 2, Subpart L These model milestones would apply to proceedings conducted under 10 CFR Part 2, Subpart L, including those on applications for combined licenses (COLs), renewed licenses, and license...

  14. 10 CFR Appendix B to 10 Cfr Part 2 - Model Milestones To Be Used By a Presiding Officer as a Guideline in Developing a Hearing...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... the issues, any other relevant consideration that a party brings to the attention of the presiding... CFR Part 2, Subpart L These model milestones would apply to proceedings conducted under 10 CFR Part 2, Subpart L, including those on applications for combined licenses (COLs), renewed licenses, and license...

  15. 43 CFR 45.1 - What is the purpose of this part, and to what license proceedings does it apply?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... prescriptions that the Department of the Interior (DOI) may develop for inclusion in a hydropower license issued... apply to recommendations that DOI may submit to FERC under FPA section 10(a) or (j), 16 U.S.C. 803(a... a hydropower license. Where DOI and either or both of these other Departments develop conditions or...

  16. 43 CFR 45.1 - What is the purpose of this part, and to what license proceedings does it apply?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... prescriptions that the Department of the Interior (DOI) may develop for inclusion in a hydropower license issued... apply to recommendations that DOI may submit to FERC under FPA section 10(a) or (j), 16 U.S.C. 803(a... a hydropower license. Where DOI and either or both of these other Departments develop conditions or...

  17. No hair theorem in quasi-dilaton massive gravity

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

    Wu, De-Jun; Zhou, Shuang-Yong

    We investigate the static, spherically symmetric black hole solutions in the quasi-dilaton model and its generalizations, which are scalar extended dRGT massive gravity with a shift symmetry. We show that, unlike generic scalar extended massive gravity models, these theories do not admit static, spherically symmetric black hole solutions until the theory parameters in the dRGT potential are fine-tuned. When fine-tuned, the geometry of the static, spherically symmetric black hole is necessarily that of general relativity and the quasi-dilaton field is constant across the spacetime. The fine-tuning and the no hair theorem apply to black holes with flat, anti-de Sitter ormore » de Sitter asymptotics. (C) 2016 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). Funded by SCOAP(3).« less

  18. No hair theorem in quasi-dilaton massive gravity

    DOE PAGES

    Wu, De-Jun; Zhou, Shuang-Yong

    2016-04-11

    We investigate the static, spherically symmetric black hole solutions in the quasi-dilaton model and its generalizations, which are scalar extended dRGT massive gravity with a shift symmetry. We show that, unlike generic scalar extended massive gravity models, these theories do not admit static, spherically symmetric black hole solutions until the theory parameters in the dRGT potential are fine-tuned. When fine-tuned, the geometry of the static, spherically symmetric black hole is necessarily that of general relativity and the quasi-dilaton field is constant across the spacetime. The fine-tuning and the no hair theorem apply to black holes with flat, anti-de Sitter ormore » de Sitter asymptotics. (C) 2016 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). Funded by SCOAP(3).« less

  19. Understanding and perceptions of final-year Doctor of Pharmacy students about generic medicines in Karachi, Pakistan: a quantitative insight

    PubMed Central

    Jamshed, Shazia Qasim; Ibrahim, Mohamad Izham Mohamad; Hassali, Mohamad Azmi; Sharrad, Adheed Khalid; Shafie, Asrul Akmal; Babar, Zaheer-Ud-Din

    2015-01-01

    General objective To evaluate the understanding and perceptions of generic medicines among final-year Doctor of Pharmacy students in Karachi, Pakistan. Methods A 23-item survey instrument that included a question on the bioequivalence limits and Likert-type scale questions regarding the understanding and perceptions of generic medicines among the students was executed. Cronbach’s alpha was found to be 0.62. Results Responses were obtained from 236 final-year Doctor of Pharmacy students (n=85 from a publicly funded institute; n=151 from a privately funded institute). When comparing a brand-name medicine to a generic medicine, pharmacy students scored poorly on bioequivalence limits. More than 80% of the students incorrectly answered that all the products that are rated as generic equivalents are therapeutically equivalent to each other (P<0.04). Half of the students agreed that a generic medicine is bioequivalent to the brand-name medicine (P<0.001). With regard to quality, effectiveness, and safety, more than 75% of the students disagreed that generic medicines are of inferior quality and are less effective than brand-name medicines (P<0.001). More than 50% of the students disagreed that generic medicines produce more side effects than brand-name medicines (P<0.001). Conclusion The current study identified a positive perception toward generic medicines but also gaps in the understanding of generic medicines. Pharmacy students lacked a thorough understanding of the concepts of bioequivalence. Pharmacy academia should address these issues, which will help build confidence in generic medicines and increase the generic medicine use in Pakistan. PMID:26028981

  20. FCC to begin issuing licenses for use of mobile radios in the 460 to 470 MHz band.

    PubMed

    2005-11-01

    The U.S. Federal Communications Commission (FCC) has stated that after December 31, 2005, it will begin issuing licenses for use of private land mobile radios (PLMRs) in the 460 to 470 MHz frequency band. Medical telemetry systems operating in this band after December 31 will therefore be at increased risk for interference, which could compromise patient safety. Any medical facility in the vicinity of a PLMR could be affected.

  1. Ground-water development and problems in Idaho

    USGS Publications Warehouse

    Crosthwaite, E.G.

    1954-01-01

    The development of groundwater for irrigation in Idaho, as most of you know, has proceeded at phenomenal rate since the Second World War. In the period 1907 to 1944 inclusive only about 328 valid permits and licenses to appropriate ground water were issued by the state. thereafter 28 permits became valid in 1945, 83 in 1946, and 121 in 1947. Sine 1947 permits and licenses have been issued at the rate of more than 400 a year.  

  2. Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment.

    PubMed

    Hill, Andrew; Gotham, Dzintars; Fortunak, Joseph; Meldrum, Jonathan; Erbacher, Isabelle; Martin, Manuel; Shoman, Haitham; Levi, Jacob; Powderly, William G; Bower, Mark

    2016-01-27

    To calculate sustainable generic prices for 4 tyrosine kinase inhibitors (TKIs). TKIs have proven survival benefits in the treatment of several cancers, including chronic myeloid leukaemia, breast, liver, renal and lung cancer. However, current high prices are a barrier to treatment. Mass production of low-cost generic antiretrovirals has led to over 13 million people being on HIV/AIDS treatment worldwide. This analysis estimates target prices for generic TKIs, assuming similar methods of mass production. Four TKIs with patent expiry dates in the next 5 years were selected for analysis: imatinib, erlotinib, lapatinib and sorafenib. Chemistry, dosing, published data on per-kilogram pricing for commercial transactions of active pharmaceutical ingredient (API), and quotes from manufacturers were used to estimate costs of production. Analysis included costs of excipients, formulation, packaging, shipping and a 50% profit margin. Target prices were compared with current prices. Global numbers of patients eligible for treatment with each TKI were estimated. API costs per kg were $347-$746 for imatinib, $2470 for erlotinib, $4671 for lapatinib, and $3000 for sorafenib. Basing on annual dose requirements, costs of formulation/packaging and a 50% profit margin, target generic prices per person-year were $128-$216 for imatinib, $240 for erlotinib, $1450 for sorafenib, and $4020 for lapatinib. Over 1 million people would be newly eligible to start treatment with these TKIs annually. Mass generic production of several TKIs could achieve treatment prices in the range of $128-$4020 per person-year, versus current US prices of $75161-$139,138. Generic TKIs could allow significant savings and scaling-up of treatment globally, for over 1 million eligible patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  3. The politics behind the implementation of the WTO Paragraph 6 Decision in Canada to increase global drug access

    PubMed Central

    2012-01-01

    Background The reform of pharmaceutical policy can often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a legislative amendment that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only two orders of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda have been exported. Future use of the regime appears unlikely. This research aimed to examine the politics of CAMR. Methods Parliamentary Committee hearing transcripts from CAMR's legislative development (2004) and legislative review (2007) were analysed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analysed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR. Results In 2004, policy debates in Canada were dominated by two themes: intellectual property rights and the TRIPS Agreement. The right to medicines as a basic human right and CAMR's potential impact on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by experience in implementing the legislation and hence a greater representation of the interests of potential beneficiary country governments. Conclusions The Canadian Government designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access. PMID:22472291

  4. The politics behind the implementation of the WTO Paragraph 6 Decision in Canada to increase global drug access.

    PubMed

    Esmail, Laura C; Kohler, Jillian Clare

    2012-04-03

    The reform of pharmaceutical policy can often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a legislative amendment that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only two orders of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda have been exported. Future use of the regime appears unlikely. This research aimed to examine the politics of CAMR. Parliamentary Committee hearing transcripts from CAMR's legislative development (2004) and legislative review (2007) were analysed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analysed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR. In 2004, policy debates in Canada were dominated by two themes: intellectual property rights and the TRIPS Agreement. The right to medicines as a basic human right and CAMR's potential impact on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by experience in implementing the legislation and hence a greater representation of the interests of potential beneficiary country governments. The Canadian Government designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access.

  5. Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health?

    PubMed Central

    Oliveira, Maria Auxiliadora; Bermudez, Jorge Antonio Zepeda; Chaves, Gabriela Costa; Velásquez, Germán

    2004-01-01

    OBJECTIVE: The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. METHODS: Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). FINDINGS: By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. CONCLUSION: The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights. PMID:15640916

  6. 10 CFR 52.93 - Exemptions and variances.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... referencing a nuclear power reactor manufactured under a manufacturing license issued under subpart F of this... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS..., site parameters, terms and conditions, or approved design of the manufactured reactor. The Commission...

  7. Simulation system architecture design for generic communications link

    NASA Technical Reports Server (NTRS)

    Tsang, Chit-Sang; Ratliff, Jim

    1986-01-01

    This paper addresses a computer simulation system architecture design for generic digital communications systems. It addresses the issues of an overall system architecture in order to achieve a user-friendly, efficient, and yet easily implementable simulation system. The system block diagram and its individual functional components are described in detail. Software implementation is discussed with the VAX/VMS operating system used as a target environment.

  8. Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment.

    PubMed

    Nunn, Amy S; Fonseca, Elize M; Bastos, Francisco I; Gruskin, Sofia; Salomon, Joshua A

    2007-11-13

    Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil's AIDS treatment program has been cited widely as the developing world's largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART) for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs), procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005. We compared Brazil's ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil's reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir-ritonavir (lopinavir/r) have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six specific drugs: patented lopinavir/r, efavirenz, tenofovir, atazanavir, enfuvirtide, and a locally produced generic, fixed-dose combination of zidovudine and lamivudine (AZT/3TC). Because prices declined for many of the patented drugs that constitute the largest share of drug costs, nearly the entire increase in overall drug expenditures between 2001 and 2005 is attributable to increases in drug quantities. Had all drug quantities been held constant from 2001 until 2005 (or for those drugs entering treatment guidelines after 2001, held constant between the year of introduction and 2005), total costs would have increased by only an estimated US$7 million. We estimate that in the absence of price declines for patented drugs, Brazil would have spent a cumulative total of US$2 billion on drugs for HAART between 2001 and 2005, implying a savings of US$1.2 billion from price declines. Finally, in comparing Brazilian prices for locally produced generic ARVs to the lowest international prices meeting global pharmaceutical quality standards, we find that current prices for Brazil's locally produced generics are generally much higher than corresponding global prices, and note that these prices have risen in Brazil while declining globally. We estimate the excess costs of Brazil's locally produced generics totaled US$110 million from 2001 to 2005. Despite Brazil's more costly generic ARVs, the net result of ARV price changes has been a cost savings of approximately US$1 billion since 2001. HAART costs have nevertheless risen steeply as Brazil has scaled up treatment. These trends may foreshadow future AIDS treatment cost trends in other developing countries as more people start treatment, AIDS patients live longer and move from first-line to second and third-line treatment, AIDS treatment becomes more complex, generic competition emerges, and newer patented drugs become available. The specific application of the Brazilian model to other countries will depend, however, on the strength of their health systems, intellectual property regulations, epidemiological profiles, AIDS treatment guidelines, and differing capacities to produce drugs locally.

  9. Current issues and areas for improvement in the Korean Dental Hygienist National Licensing Examination: an expert Delphi survey among dental hygienists

    PubMed Central

    2017-01-01

    Purpose This study aimed to investigate current issues and areas for improvement in the Korean Dental Hygienist National Licensing Examination (KDHNLE) through an expert Delphi survey. Methods A Delphi survey was conducted from May through August 2016 in Korea. This Delphi survey included 20 persons representing the field of dental hygiene (7 groups from various dental hygiene-related organizations). The Delphi survey was administered through e-mail as 3 rounds of questionnaire surveys regarding the issues facing the KDHNLE and potential solutions to those challenges. The primary Delphi survey was an open questionnaire. In each round, subjects’ responses were categorized according to the detailed themes of their responses. The minimum value of the content validity ratio of the survey results was determined by the number of panels participating in the Delphi survey. Results Issues facing the KDHNLE were identified from the results of the Delphi survey. The following 4 items had an average importance score of 4.0 or higher and were considered as important by over 85% of the panels: the failure of the practical test to reflect actual clinical settings, the focus of the practical test on dental scaling, the gap between the items evaluated on the national examination and actual practical work, and insufficiency in strengthening the expertise of licensed dental hygienists. The following items were suggested for improvement: more rigorous rater training, adjustment of the difficulty of the licensing examination, the introduction of a specialized dental hygienist system, and more rigorous refresher training for licensed dental hygienists. Conclusion Based on the above results, the KDHNLE should be improved according to the core competencies of dental hygienists, including on-site clinical practice experience. PMID:28900069

  10. Current issues and areas for improvement in the Korean Dental Hygienist National Licensing Examination: an expert Delphi survey among dental hygienists.

    PubMed

    Hwang, Yoon-Sook; Kang, Hyun-Sook; Kim, Soo-Hwa; Moon, Hee-Jung; Lee, Sun-Mi; Jung, Jae-Yeon; Hwang, Su-Jeong; Ha, Jung-Eun

    2017-01-01

    This study aimed to investigate current issues and areas for improvement in the Korean Dental Hygienist National Licensing Examination (KDHNLE) through an expert Delphi survey. A Delphi survey was conducted from May through August 2016 in Korea. This Delphi survey included 20 persons representing the field of dental hygiene (7 groups from various dental hygiene-related organizations). The Delphi survey was administered through e-mail as 3 rounds of questionnaire surveys regarding the issues facing the KDHNLE and potential solutions to those challenges. The primary Delphi survey was an open questionnaire. In each round, subjects' responses were categorized according to the detailed themes of their responses. The minimum value of the content validity ratio of the survey results was determined by the number of panels participating in the Delphi survey. Issues facing the KDHNLE were identified from the results of the Delphi survey. The following 4 items had an average importance score of 4.0 or higher and were considered as important by over 85% of the panels: the failure of the practical test to reflect actual clinical settings, the focus of the practical test on dental scaling, the gap between the items evaluated on the national examination and actual practical work, and insufficiency in strengthening the expertise of licensed dental hygienists. The following items were suggested for improvement: more rigorous rater training, adjustment of the difficulty of the licensing examination, the introduction of a specialized dental hygienist system, and more rigorous refresher training for licensed dental hygienists. Based on the above results, the KDHNLE should be improved according to the core competencies of dental hygienists, including on-site clinical practice experience.

  11. Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.

    PubMed

    Ting, Tricia Y; Jiang, Wenlei; Lionberger, Robert; Wong, Jessica; Jones, Jace W; Kane, Maureen A; Krumholz, Allan; Temple, Robert; Polli, James E

    2015-09-01

    To test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand-name drug pharmacokinetic (PK) performance in "generic-brittle" patients with epilepsy under clinical use conditions. This randomized, double-blind, multiple-dose, steady-state, fully replicated bioequivalence study compared generic lamotrigine to brand-name Lamictal in "generic-brittle" patients with epilepsy (n = 34) who were already taking lamotrigine. Patients were repeatedly switched between masked Lamictal and generic lamotrigine. Intensive PK blood sampling at the end of each 2-week treatment period yielded two 12-h PK profiles for brand-name and generic forms for each patient. Steady-state area under the curve (AUC), peak plasma concentration (Cmax ), and minimum plasma concentration (Cmin ) data were subjected to conventional average bioequivalence (ABE) analysis, reference-scaled ABE analysis, and within-subject variability (WSV) comparisons. In addition, generic-versus-brand comparisons in individual patients were performed. Secondary clinical outcomes included seizure frequency and adverse events. Generic demonstrated bioequivalence to brand. The 90% confidence intervals of the mean for steady-state AUC, Cmax , and Cmin for generic-versus-brand were 97.2-101.6%, 98.8-104.5%, and 93.4-101.0%, respectively. The WSV of generic and brand were also similar. Individual patient PK ratios for generic-versus-brand were similar but not identical, in part because brand-versus-brand profiles were not identical, even though subjects were rechallenged with the same product. Few subjects had seizure exacerbations or tolerability issues with product switching. One subject, however, reported 267 focal motor seizures, primarily on generic, although his brand and generic PK profiles were practically identical. Some neurologists question whether bioequivalence in healthy volunteers ensures therapeutic equivalence of brand and generic antiepileptic drugs in patients with epilepsy, who may be at increased risk for problems with brand-to-generic switching. Bioequivalence results in "generic-brittle" patients with epilepsy under clinical conditions support the soundness of the FDA bioequivalence standards. Adverse events on generic were not related to the small, allowable PK differences between generic and brand. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

  12. Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation

    PubMed Central

    Johnston, Atholl

    2013-01-01

    The calcineurin inhibitors (CNIs), ciclosporin and tacrolimus, are the mainstay of immunosuppression in solid organ transplantation. Generic formulations of these drugs are now available. With increasing pressure on healthcare budgets and the consequent need to match health expectations to available resources, substitution with a generic product appears an attractive option to reduce costs. Approval of generic products differs from innovator drugs, and narrow therapeutic index drugs (NTIs; including CNIs) bring their own particular considerations. With NTIs, small variations in drug exposure could result in reduced immunosuppression or drug toxicity with potentially adverse effects on patient outcomes. NTIs are subject to stricter regulatory approval versus many other generic drugs. However, different generic formulations may still not necessarily be therapeutically equivalent in individuals, raising the possibility of significant differences in exposure between products. Although regional recommendations vary, many guidelines emphasise the need for NTI drug substitution to be initiated by the transplant physician, thus ensuring careful therapeutic monitoring and reduced negative patient impact. The need for therapeutic monitoring during generic substitution has important implications for the overall costs of generic treatment as these costs have to be factored in to the potential savings made from using generic formulations. The reduced acquisition costs of generic products may not necessarily translate into lower overall healthcare costs. This article examines the issue of equivalence and interchangeability of NTI drugs used in organ transplantation, the implications of the approval process for generic drugs on treatment efficacy and safety, and the effective management of substitutions between products. PMID:24089632

  13. Arms Sales: Congressional Review Process

    DTIC Science & Technology

    2015-12-17

    the Arms Export Control Act (AECA), Congress must be formally notified 30 calendar days before the Administration can take the final steps to...Commercially licensed arms sales also must be formally notified to Congress 30 calendar days before the export license is issued if they involve the sale...also be formally notified to Congress for review 30 days prior to the license for export being approved. In the case of proposed licences for such

  14. A vision of the pharmaceutical industry.

    PubMed

    Muñio, S

    1998-01-01

    As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing.

  15. International Conference on Curves and Surfaces (4th), Saint-Malo, France, 1-7 July 1999. Proceedings, Volume 1. Curve and Surface Design

    DTIC Science & Technology

    2000-04-01

    the Air Force grant issued by the European Aerospace Office of Research and Development. The United States has a royalty free license throughout the...UNIVERSITY PRESS Nashville fl9 ~Oc -O i U.S. Government Rights License This work relates to Department of the Air Force Grant/rContract issued by the...in engineering , medicine, and the sciences. SERIES EDITOR: Larry L. Schumaker Stevenson Professor of Mathematics Vanderbilt University PREVIOUSLY

  16. The effectiveness of written driver knowledge tests.

    DOT National Transportation Integrated Search

    1979-01-01

    Highway Safety Program Standard 5, Driver Licensing, issued by the U. S. Department of Transportation requires, in part, that the states test applicants for a renewal of their operator's license on rules of the road at least once every 4 years. The s...

  17. 14 CFR 415.21 - General.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false General. 415.21 Section 415.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH LICENSE Policy Review and Approval § 415.21 General. The FAA issues a policy...

  18. 14 CFR 415.21 - General.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false General. 415.21 Section 415.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH LICENSE Policy Review and Approval § 415.21 General. The FAA issues a policy...

  19. 14 CFR 415.21 - General.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false General. 415.21 Section 415.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH LICENSE Policy Review and Approval § 415.21 General. The FAA issues a policy...

  20. 14 CFR 415.21 - General.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false General. 415.21 Section 415.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH LICENSE Policy Review and Approval § 415.21 General. The FAA issues a policy...

  1. 14 CFR 415.21 - General.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false General. 415.21 Section 415.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH LICENSE Policy Review and Approval § 415.21 General. The FAA issues a policy...

  2. 15 CFR 970.506 - Environmental effects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Environmental effects. 970.506 Section... ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Issuance/Transfer/Terms... Environmental effects. Before issuing or transferring an exploration license, the Administrator must find that...

  3. 15 CFR 970.506 - Environmental effects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Environmental effects. 970.506 Section... ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Issuance/Transfer/Terms... Environmental effects. Before issuing or transferring an exploration license, the Administrator must find that...

  4. Testing and evaluation of graduated driver license marker : summary report.

    DOT National Transportation Integrated Search

    2008-01-01

    The objective of this project was to assist New Jersey Motor Vehicle Commission in determining the feasibility of a removable visual marker for Graduated Drivers License (GDL) drivers. The NJ Teen Driver Safety Study Commission issued a report to the...

  5. 47 CFR 5.54 - Types of authorizations available.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... experimentation for the development and advancement of new broadcast technology, equipment, systems or services... testing experimental radio license. This type of license is issued to hospitals and health care institutions that demonstrate expertise in testing and operation of experimental medical devices that use...

  6. 47 CFR 5.54 - Types of authorizations available.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... experimentation for the development and advancement of new broadcast technology, equipment, systems or services... testing experimental radio license. This type of license is issued to hospitals and health care institutions that demonstrate expertise in testing and operation of experimental medical devices that use...

  7. 10 CFR 72.212 - Conditions of general license issued under § 72.210.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... guard or watchman on patrol in lieu of video surveillance technology; (v) For the purpose of this... storage under this general license are those shown in § 170.31 of this chapter. [55 FR 29191, July 18...

  8. 47 CFR 74.1232 - Eligibility and licensing requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Translator Stations and FM Broadcast Booster Stations § 74.1232 Eligibility and licensing requirements. (a... translator station may be issued to any qualified individual, organized group of individuals, broadcast... the installation and operation of the translator are sufficiently sound to assure prompt construction...

  9. Reducing the cost of headache medication.

    PubMed

    Solomon, Glen D

    2009-06-01

    Although medication costs make up one of the smallest portions of the overall expense of headache care, it is the segment of expense that often impacts the patient most directly. The advent of triptans marked a major advance in migraine therapy, but their high cost has limited their widespread use. Four options can be considered as potential means to reduce the cost of triptans. These include compulsory licensing, exclusive contracting, over-the-counter -availability, and the introduction of generic triptans. Each method impacts the consumer, third-party payer, or pharmaceutical company in a different manner.

  10. 76 FR 40282 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; NRC Regulation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-08

    ... Commission (NRC) is proposing to issue a RIS that clarifies those discrete sources of radium-226 under... Officers. Intent The NRC is issuing this RIS to clarify which discrete sources of radium-226 under military... definition of byproduct material to include discrete sources of radium-226, discrete sources of naturally...

  11. 75 FR 76757 - Licensing Support System Advisory Review Panel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ... provide advice on the fundamental issues of design and development of an electronic information management... electronic information management system was known as the Licensing Support System (LSS). In November, 1998... experience in electronic information management systems may also participate on the Panel. The Nuclear...

  12. 77 FR 38742 - Non-Power Reactor License Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-29

    ...-0087] RIN 3150-AI96 Non-Power Reactor License Renewal AGENCY: Nuclear Regulatory Commission. ACTION... reactors. This contemplated rulemaking would also make conforming changes to address technical issues in existing non-power reactor regulations. The NRC is seeking input from the public, licensees, certificate...

  13. The short-term effectiveness of written driver knowledge tests.

    DOT National Transportation Integrated Search

    1978-01-01

    Highway Safety Program Standard 5, Driver Licensing, issued by the U. S. Department of Transportation requires the states to test applicants for a renewal of their operator's license on rules of the road at least once every four years. The cost of ad...

  14. 10 CFR 60.3 - License required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES General... byproduct material at a geologic repository operations area except as authorized by a license issued by the Commission pursuant to this part. (b) DOE shall not commence construction of a geologic repository operations...

  15. 37 CFR 1.740 - Formal requirements for application for extension of patent term; correction of informalities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... drug application (NDA) or a Product License Application (PLA) was initially submitted and the NDA or PLA number; and (C) The date on which the NDA was approved or the Product License issued; (ii) For a...

  16. Reporter Licensing.

    ERIC Educational Resources Information Center

    Henderson, Leslie C.

    This report reviews some of the efforts to license news reporters. The review summarizes court litigation concerning city and state legislation and federal efforts to screen or regulate the movements of journalists covering political news events. Highlighting the report are discussions of the United States Secret Service's role in issuing White…

  17. 7 CFR 400.207 - Representative licensing and certification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... insurance; (5) Liability insurance; or (6) Fire insurance and allied lines. The Contractor must submit... INSURANCE CORPORATION, DEPARTMENT OF AGRICULTURE GENERAL ADMINISTRATIVE REGULATIONS Agency Sales and Service... policies are issued, which license authorizes the sales of insurance in any one or more of the following...

  18. 76 FR 6456 - Intent To Grant an Exclusive License for a U.S. Government-Owned Invention

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ..., revocable license, to U.S. Patent No. 6,254,873, issued July 3, 2001, entitled ``Inactivated Dengue Virus... against Dengue virus for human use. The intended licensee is GlaxoSmithKline Bio, with its principal place...

  19. 77 FR 71454 - Notice of Atomic Safety And Licensing Board Reconstitution, Tennessee Valley Authority (Watts Bar...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

    ... accordance with the NRC E-Filing rule. See 10 CFR 2.302 et seq. Issued at Rockville, Maryland this 16th day of November 2012. E. Roy Hawkens, Chief Administrative Judge, Atomic Safety and Licensing Board Panel...

  20. 31 CFR 500.556 - Joint bank accounts.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY FOREIGN ASSETS CONTROL REGULATIONS Licenses... unblocking a portion of or all of a blocked joint bank account where a non-blocked applicant claims... survivorship provision. Specific licenses are issued unblocking an amount equivalent to that portion of the...

  1. 75 FR 5035 - Notice of Intent To Grant Exclusive License

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ... DEPARTMENT OF AGRICULTURE Agricultural Research Service Notice of Intent To Grant Exclusive License AGENCY: Agricultural Research Service, USDA. ACTION: Notice of intent. SUMMARY: Notice is hereby..., ``Direct Polymerase Chain Reaction Assay, or Bio-PCR'', issued on June 25, 2002. DATES: Comments must be...

  2. Translating research into licensed vaccines and validated and licensed diagnostic tests.

    PubMed

    Hill, R E; Foley, P L; Clough, N E; Ludemann, L R; Murtle, D C

    2013-01-01

    The USDA Center for Veterinary Biologics (CVB) has the regulatory authority to issue licenses and permits that allow the marketing of pure, safe, potent, and effective veterinary biological products. Under the standard licensing or permitting process, a manufacturer develops, characterizes, and evaluates a product prior to licensure. The CVB evaluates the submitted information, inspects the manufacturing facilities and methods of production and testing, and confirms key product test results through independent testing. This complete and comprehensive evaluation may not be possible during the emergence of a new animal disease or in response to an introduction of a significant transboundary animal disease agent. Processes are in place in the US that allow for more rapid availability of veterinary products in an emerging or emergency animal health situation. But, it can be advantageous to attain preapproval of products prior to their anticipated need. In this article, issues associated with obtaining approval for use of a biological product under emerging or emergency conditions are discussed.

  3. 76 FR 11264 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-01

    ... questionnaires and certain institution notices) for a series of import injury investigations that are required by... information requested in questionnaires and five-year sunset review institution notices issued under the... Commission's generic survey clearance to issue questionnaires will not apply to repetitive questionnaires...

  4. 40 CFR 261.147 - Liability requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... insurance policy must be issued by an insurer which, at a minimum, is licensed to transact the business of... minimum, is licensed to transact the business of insurance, or eligible to provide insurance as an excess... procedures engagement in accordance with professional auditing standards and shall describe the procedures...

  5. Evaluating Independently Licensed Counselors' Articulation of Professional Identity Using Structural Coding

    ERIC Educational Resources Information Center

    Burns, Stephanie; Cruikshanks, Daniel R.

    2017-01-01

    Inconsistent counselor professional identity contributes to issues with licensure portability, parity in hiring practices, marketplace recognition in U.S. society and third-party payments for independently licensed counselors. Counselors could benefit from enhancing the counseling profession's identity as well as individual professional identities…

  6. 43 CFR 3910.32 - Environmental analysis.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Environmental analysis. 3910.32 Section 3910.32 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND... Licenses § 3910.32 Environmental analysis. (a) Before the BLM will issue an exploration license, the BLM...

  7. 10 CFR 26.187 - Substance abuse expert.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... physician; (2) A licensed or certified social worker; (3) A licensed or certified psychologist; (4) A... and the return-to-duty process, including the initial evaluation, referrals for education and/or... providers; (7) Reporting and recordkeeping requirements of this part; and (8) Issues that SAEs confront in...

  8. 10 CFR 26.187 - Substance abuse expert.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... physician; (2) A licensed or certified social worker; (3) A licensed or certified psychologist; (4) A... and the return-to-duty process, including the initial evaluation, referrals for education and/or... providers; (7) Reporting and recordkeeping requirements of this part; and (8) Issues that SAEs confront in...

  9. 10 CFR 26.187 - Substance abuse expert.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... physician; (2) A licensed or certified social worker; (3) A licensed or certified psychologist; (4) A... and the return-to-duty process, including the initial evaluation, referrals for education and/or... providers; (7) Reporting and recordkeeping requirements of this part; and (8) Issues that SAEs confront in...

  10. 78 FR 75579 - License Renewal Application for Grand Gulf Nuclear Station, Unit 1

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-12

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

  11. Antisocial Personalities, Antidemocractic Solutions.

    ERIC Educational Resources Information Center

    Schneiderman, Howard G.

    1996-01-01

    Provides critical analysis of David T. Lykken's article "Psychopathy, Sociopathy, and Crime" (1996) and its correlation between unstable families and sociopathy and the use of parental licensing as a solution. Discusses reasons for the appeal of parental licensing as well as the issue of state control replacing social control. (GR)

  12. 31 CFR 1010.312 - Identification required.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... evidencing nationality or residence (e.g., a Provincial driver's license with indication of home address... cashing checks for nondepositors (e.g., a driver's license or credit card). A bank signature card may be relied upon only if it was issued after documents establishing the identity of the individual were...

  13. 31 CFR 1010.312 - Identification required.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... evidencing nationality or residence (e.g., a Provincial driver's license with indication of home address... cashing checks for nondepositors (e.g., a driver's license or credit card). A bank signature card may be relied upon only if it was issued after documents establishing the identity of the individual were...

  14. 31 CFR 1010.312 - Identification required.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... evidencing nationality or residence (e.g., a Provincial driver's license with indication of home address... cashing checks for nondepositors (e.g., a driver's license or credit card). A bank signature card may be relied upon only if it was issued after documents establishing the identity of the individual were...

  15. 31 CFR 1010.312 - Identification required.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... evidencing nationality or residence (e.g., a Provincial driver's license with indication of home address... cashing checks for nondepositors (e.g., a driver's license or credit card). A bank signature card may be relied upon only if it was issued after documents establishing the identity of the individual were...

  16. 10 CFR 50.57 - Issuance of operating license. 1

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... contested activity sought to be authorized. The Director of Nuclear Reactor Regulation will make findings on... Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Issuance... presiding officer will issue an order in accordance with § 2.319(p) authorizing the Director of Nuclear...

  17. 10 CFR 50.57 - Issuance of operating license. 1

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... contested activity sought to be authorized. The Director of Nuclear Reactor Regulation will make findings on... Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Issuance... presiding officer will issue an order in accordance with § 2.319(p) authorizing the Director of Nuclear...

  18. 10 CFR 50.57 - Issuance of operating license. 1

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... contested activity sought to be authorized. The Director of Nuclear Reactor Regulation will make findings on... Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Issuance... presiding officer will issue an order in accordance with § 2.319(p) authorizing the Director of Nuclear...

  19. 10 CFR 50.57 - Issuance of operating license. 1

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... contested activity sought to be authorized. The Director of Nuclear Reactor Regulation will make findings on... Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Issuance... presiding officer will issue an order in accordance with § 2.319(p) authorizing the Director of Nuclear...

  20. 10 CFR 50.57 - Issuance of operating license. 1

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... contested activity sought to be authorized. The Director of Nuclear Reactor Regulation will make findings on... Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Issuance... presiding officer will issue an order in accordance with § 2.319(p) authorizing the Director of Nuclear...

  1. On the use of Bayesian decision theory for issuing natural hazard warnings

    NASA Astrophysics Data System (ADS)

    Economou, T.; Stephenson, D. B.; Rougier, J. C.; Neal, R. A.; Mylne, K. R.

    2016-10-01

    Warnings for natural hazards improve societal resilience and are a good example of decision-making under uncertainty. A warning system is only useful if well defined and thus understood by stakeholders. However, most operational warning systems are heuristic: not formally or transparently defined. Bayesian decision theory provides a framework for issuing warnings under uncertainty but has not been fully exploited. Here, a decision theoretic framework is proposed for hazard warnings. The framework allows any number of warning levels and future states of nature, and a mathematical model for constructing the necessary loss functions for both generic and specific end-users is described. The approach is illustrated using one-day ahead warnings of daily severe precipitation over the UK, and compared to the current decision tool used by the UK Met Office. A probability model is proposed to predict precipitation, given ensemble forecast information, and loss functions are constructed for two generic stakeholders: an end-user and a forecaster. Results show that the Met Office tool issues fewer high-level warnings compared with our system for the generic end-user, suggesting the former may not be suitable for risk averse end-users. In addition, raw ensemble forecasts are shown to be unreliable and result in higher losses from warnings.

  2. On the use of Bayesian decision theory for issuing natural hazard warnings.

    PubMed

    Economou, T; Stephenson, D B; Rougier, J C; Neal, R A; Mylne, K R

    2016-10-01

    Warnings for natural hazards improve societal resilience and are a good example of decision-making under uncertainty. A warning system is only useful if well defined and thus understood by stakeholders. However, most operational warning systems are heuristic: not formally or transparently defined. Bayesian decision theory provides a framework for issuing warnings under uncertainty but has not been fully exploited. Here, a decision theoretic framework is proposed for hazard warnings. The framework allows any number of warning levels and future states of nature, and a mathematical model for constructing the necessary loss functions for both generic and specific end-users is described. The approach is illustrated using one-day ahead warnings of daily severe precipitation over the UK, and compared to the current decision tool used by the UK Met Office. A probability model is proposed to predict precipitation, given ensemble forecast information, and loss functions are constructed for two generic stakeholders: an end-user and a forecaster. Results show that the Met Office tool issues fewer high-level warnings compared with our system for the generic end-user, suggesting the former may not be suitable for risk averse end-users. In addition, raw ensemble forecasts are shown to be unreliable and result in higher losses from warnings.

  3. On the use of Bayesian decision theory for issuing natural hazard warnings

    PubMed Central

    Stephenson, D. B.; Rougier, J. C.; Neal, R. A.; Mylne, K. R.

    2016-01-01

    Warnings for natural hazards improve societal resilience and are a good example of decision-making under uncertainty. A warning system is only useful if well defined and thus understood by stakeholders. However, most operational warning systems are heuristic: not formally or transparently defined. Bayesian decision theory provides a framework for issuing warnings under uncertainty but has not been fully exploited. Here, a decision theoretic framework is proposed for hazard warnings. The framework allows any number of warning levels and future states of nature, and a mathematical model for constructing the necessary loss functions for both generic and specific end-users is described. The approach is illustrated using one-day ahead warnings of daily severe precipitation over the UK, and compared to the current decision tool used by the UK Met Office. A probability model is proposed to predict precipitation, given ensemble forecast information, and loss functions are constructed for two generic stakeholders: an end-user and a forecaster. Results show that the Met Office tool issues fewer high-level warnings compared with our system for the generic end-user, suggesting the former may not be suitable for risk averse end-users. In addition, raw ensemble forecasts are shown to be unreliable and result in higher losses from warnings. PMID:27843399

  4. Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges.

    PubMed

    Di Paolo, Antonello; Arrigoni, Elena

    2018-03-01

    Generic drugs are important components of measures introduced by healthcare regulatory authorities to reduce treatment costs. In most patients and conditions the switch from a branded drug to its generic counterpart is performed with no major complications. However, evidence from complex diseases suggests that generic substitution requires careful evaluation in some settings and that current bioequivalence criteria may not always be adequate for establishing the interchangeability of branded and generic products. Rare diseases, also called orphan diseases, are a group of heterogeneous diseases that share important characteristics: in addition to their scarcity, most are severe, chronic, highly debilitating, and often present in early childhood. Finding a treatment for a rare disease is challenging. Thanks to incentives that encourage research and development programs in rare diseases, several orphan drugs are currently available. The elevated cost of orphan drugs is a highly debated issue and a cause of limited access to treatment for many patients. As patent protection and the exclusivity period of several orphan drugs will expire soon, generic versions of orphan drugs should reach the market shortly, with great expectations about their impact on the economic burden of rare diseases. However, consistent with other complex diseases, generic substitution may require thoughtful considerations and may be even contraindicated in some rare conditions. This article provides an overview of rare disease characteristics, reviews reports of problematic generic substitution, and discusses why generic substitution of orphan drugs may be challenging and should be undertaken carefully in rare disease patients.

  5. Pharmacists' experiences and attitudes regarding generic drugs and generic substitution: two sides of the coin.

    PubMed

    Olsson, Erika; Kälvemark Sporrong, Sofia

    2012-12-01

    Generic drug substitution reduces costs for medicines, but the downsides include unintentional double medication, confusion and anxiety among patients. Information from pharmacists affects patients' experiences of substitution with generic drugs. The aim of this study was to explore experiences and attitudes to generic substitution among Swedish community pharmacists. An interview guide was developed. Semi-structured interviews with community pharmacists were conducted and transcribed verbatim. Analysis was inductive; extracts from the transcripts were compared and combined to form themes and subcategories. Pharmacists from a heterogeneous convenience sample of pharmacies were interviewed until data saturation had been achieved. Sixteen pharmacists were interviewed. Three main themes and twelve subcategories were identified, with the main themes being the role of the pharmacist, pharmacists' concerns regarding patients, and the generic drug. Pharmacists found it positive that generic substitution decreases the costs for pharmaceuticals but also emphasized that the switch can confuse and worry patients, which could result in less benefit from treatment. Respondents claimed that generic substitution has changed the focus in the pharmacist-patient meeting towards economics and regulations. According to the interviewed pharmacists generic substitution is not primarily an issue of generic versus brand-name products, but concerns above all the challenges that the switch implies for patients and pharmacists. To prevent known confusion and concerns among patients it is important that community pharmacists acquire the necessary tools and knowledge to manage this situation; pharmacists themselves as well as pharmacy owners and authorities share responsibility for this. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

  6. Affordable antiretroviral drugs for the under-served markets: how to expand equitable access against the backdrop of challenging scenarios?

    PubMed

    Dionisio, Daniele; Cao, Yunzhen; Hongzhou, Lu; Kraisintu, Krisana; Messeri, Daniela

    2006-01-01

    Threats by enforced Intellectual Property (IP) rights to equitable HIV treatment access by poor populations are impending. India and China's policy directions in the field will be crucial in ultimately affecting the affordability and accessibility of antiretroviral (ARV) therapy in the under-served markets. These directions, together with the exploitation level of IP-bound flexibilities and the evolutionary modelling in partnerships and trade agreements between research-based and generic pharmaceutical industry, will also affect the outcomes of self-sufficiency efforts now at their beginning in the developing world as far as domestic manufacturing of generic ARV drugs is concerned. This paper explores key issues, implications and interaction dynamics across these challenging scenarios while attempting to provide equitable solution glimpses into the near future. Access-oriented long-term drug policy strategies entitled to pass muster of governments, research-based as well as generic industries in both developed and developing countries are needed if equitable access to affordable ARV treatments by poor people has to be achieved despite enforced IP rights. Predictable dynamics between western multinationals and transitional country generic corporations let regard IP-bound Voluntary License flexibilities as a fitting measure into just mentioned needs especially if substantial incentives to generic corporations are concurrently secured. Efforts to equitably expand ARV drug access through exploiting IP opportunities should encompass attainment of self-sufficiency in domestic drug manufacturing whenever basic requirements are in place in the developing world as a whole. A credible industrial potential would act, indeed, as a boosting factor for drawing branded drug producers into technology transfer agreements, the terms of which would let all contractors enjoy substantial advantages. These perspectives consistently bind up with the foreseeable long-term trade and drug policy directions of India and China according to frontier crossing implications of their key IP management trends as well as their multifaceted penetration strategies of both the wealthy and under-served markets worldwide. As coherent with these perspectives, more disbursement by wealthy country governments and donors to basic infrastructure development in sub-Saharan African nations with stable governments in place is urged both as a priority for improving Africa's economy and a prerequisite for allowing domestic industrial plants to take off. Aiming at the targets just underscored, WHO's brokering role in negotiated agreements between wealthy and developing country-based firms as well as its technical guidance in setting international standards have always to be sought if equitable and appropriate end results are to be attained. Overall insights in this paper would mean that, while research-based corporations are to be praised whenever waiving, on humanitarian purposes, part of their profits, the trade and profit rules cannot basically be given up if long-term sustainable results are the goal to look for. Only negotiated agreements securing all contracting parties lasting advantages may ensure shifting of such a goal from mere vision to a really sustainable attainment.

  7. Biosimilar therapeutics-what do we need to consider?

    PubMed

    Schellekens, Huub

    2009-01-01

    Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as 'biosimilars' (European Union) or 'follow-on protein products' (United States). Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions.The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs. Current analytical methods cannot characterize these complex molecules sufficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge. Furthermore, a critical safety issue, the immunogenicity of biopharmaceuticals, has been highlighted in recent years, confirming a need for comprehensive immunogenicity testing prior to approval and extended post-marketing surveillance.Biosimilars present a new set of challenges for regulatory authorities when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is sufficient for conventional, small-molecule generic agents, a number of issues will make the approval of biosimilars more complicated. Documents recently published by the European Medicines Agency (EMEA) outlining requirements for the market approval of biosimilars provide much-needed guidance. The EMEA has approved a number of biosimilar products in a scientifically rigorous and balanced process. Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more comprehensive labelling for biosimilars to include relevant clinical data.

  8. 10 CFR 40.61 - Records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Records. 40.61 Section 40.61 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL Records, Reports, and Inspections § 40.61 Records. (a) Each person who receives source or byproduct material pursuant to a license issued pursuant to the regulations...

  9. 78 FR 63959 - Notice of Intent To Grant Exclusive License

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... Research Service, intends to grant to EPG Technologies, Inc. of Gainesville, Florida, an exclusive license to U.S. Patent No. 8,004,292, ``ELECTRICAL PENETRATION GRAPH SYSTEM,'' issued on August 23, 2011..., Office of Technology Transfer, 5601 Sunnyside Avenue, Rm. 4-1174, Beltsville, Maryland 20705-5131. FOR...

  10. 50 CFR 622.240 - Permits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., DEPARTMENT OF COMMERCE FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH ATLANTIC Golden Crab Fishery of..., respectively, must be issued to the dealer. (2) State license and facility requirements. To obtain a dealer permit, the applicant must have a valid state wholesaler's license in the state(s) where the dealer...

  11. Selling Our Collecting Souls: How License Agreements Are Controlling Collection Management.

    ERIC Educational Resources Information Center

    McGinnis, Suzan D.

    2000-01-01

    Considers the challenges that licensing for electronic products are creating for academic libraries. Discusses ownership of versus access to information; packaging of electronic journals; cost-benefit analysis; multiple versions of the same information, e.g. print and electronic; consortial agreements; negotiating; legal issues; and the question…

  12. 18 CFR 5.24 - Applications not requiring a draft NEPA document.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... requiring a draft NEPA document. 5.24 Section 5.24 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE... assessment issued pursuant to this paragraph must include draft license articles, a preliminary determination...

  13. 18 CFR 5.24 - Applications not requiring a draft NEPA document.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requiring a draft NEPA document. 5.24 Section 5.24 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE... assessment issued pursuant to this paragraph must include draft license articles, a preliminary determination...

  14. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

  15. 7 CFR 110.5 - Availability of records to facilitate medical treatment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... agencies that deal with pesticide use or any health issue related to the use of pesticides when necessary... attending licensed health care professional, or an individual acting under the direction of the attending licensed health care professional, determines that any record of the application of any restricted use...

  16. Cybercounseling and Regulations: Quagmire or Quest?

    ERIC Educational Resources Information Center

    Hughes, Rosemarie Scotti

    Regulation of on-line counseling is a complex issue. In telemedicine, some have advocated an international worldwide license. The hurdles are many, such as accommodating the variety of educational standards and legal codes, not to mention determining who will administer this license. It seems that a start might be national counselor certification…

  17. 31 CFR 500.552 - Research samples.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Research samples. 500.552 Section 500..., Authorizations and Statements of Licensing Policy § 500.552 Research samples. Specific licenses are issued for importation of commodities subject to § 500.204 for bona fide research purposes in sample quantities only. [40...

  18. 31 CFR 515.547 - Research samples.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false Research samples. 515.547 Section 515..., Authorizations, and Statements of Licensing Policy § 515.547 Research samples. Specific licenses are issued for importation of Cuban-origin commodities for bona-fide research purposes in sample quantities only. [39 FR...

  19. 31 CFR 515.547 - Research samples.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false Research samples. 515.547 Section 515..., Authorizations, and Statements of Licensing Policy § 515.547 Research samples. Specific licenses are issued for importation of Cuban-origin commodities for bona-fide research purposes in sample quantities only. [39 FR...

  20. 31 CFR 515.547 - Research samples.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Research samples. 515.547 Section 515..., Authorizations, and Statements of Licensing Policy § 515.547 Research samples. Specific licenses are issued for importation of Cuban-origin commodities for bona-fide research purposes in sample quantities only. [39 FR...

  1. 31 CFR 515.547 - Research samples.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Research samples. 515.547 Section 515..., Authorizations, and Statements of Licensing Policy § 515.547 Research samples. Specific licenses are issued for importation of Cuban-origin commodities for bona-fide research purposes in sample quantities only. [39 FR...

  2. 31 CFR 515.547 - Research samples.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Research samples. 515.547 Section 515..., Authorizations, and Statements of Licensing Policy § 515.547 Research samples. Specific licenses are issued for importation of Cuban-origin commodities for bona-fide research purposes in sample quantities only. [39 FR...

  3. 10 CFR 70.19 - General license for calibration or reference sources.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... State who holds a specific license issued by the Commission or the Atomic Energy Commission which... the Commission or the Atomic Energy Commission which authorizes him to receive, possess, use and... effect on January 1, 1975. The receipt, possession, use and transfer of this source, Model ___, Serial No...

  4. 10 CFR 39.17 - Request for written statements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Request for written statements. 39.17 Section 39.17 Energy... Licensing Requirements § 39.17 Request for written statements. Each license is issued with the condition..., submit written statements, signed under oath or affirmation, to enable the Commission to determine...

  5. 18 CFR 4.1 - Initial cost statement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... OF PROJECT COSTS Determination of Cost of Projects Constructed Under License § 4.1 Initial cost statement. (a) Notification of Commission. When a project is constructed under a license issued under the... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Initial cost statement...

  6. 18 CFR 4.1 - Initial cost statement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... OF PROJECT COSTS Determination of Cost of Projects Constructed Under License § 4.1 Initial cost statement. (a) Notification of Commission. When a project is constructed under a license issued under the... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Initial cost statement...

  7. 18 CFR 4.1 - Initial cost statement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OF PROJECT COSTS Determination of Cost of Projects Constructed Under License § 4.1 Initial cost statement. (a) Notification of Commission. When a project is constructed under a license issued under the... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Initial cost statement...

  8. 18 CFR 4.1 - Initial cost statement.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... OF PROJECT COSTS Determination of Cost of Projects Constructed Under License § 4.1 Initial cost statement. (a) Notification of Commission. When a project is constructed under a license issued under the... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Initial cost statement...

  9. 75 FR 6731 - Carolina Power & Light Company; Notice of Consideration of Issuance of Amendment to Facility...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-10

    ...; Notice of Consideration of Issuance of Amendment to Facility Operating License, Proposed No Significant Hazards Consideration Determination and Opportunity for a Hearing, and Order Imposing Procedures for... Commission) is considering issuance of an amendment to Facility Operating License No. DPR-23 issued to...

  10. 22 CFR 129.1 - Purpose.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS REGISTRATION AND LICENSING OF BROKERS § 129.1... engaged in the business of brokering activities shall register and pay a registration fee as prescribed in regulations, and that no person may engage in the business of brokering activities without a license issued in...

  11. 15 CFR 764.2 - Violations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... prohibited by or contrary to, or refrain from engaging in any conduct required by, the EAA, the EAR, or any... prohibited, or the omission of any act required, by the EAA, the EAR, or any order, license or authorization..., the EAR, or any order, license or authorization issued thereunder. (d) Conspiracy. No person may...

  12. 15 CFR 764.2 - Violations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... prohibited by or contrary to, or refrain from engaging in any conduct required by, the EAA, the EAR, or any... prohibited, or the omission of any act required, by the EAA, the EAR, or any order, license or authorization..., the EAR, or any order, license or authorization issued thereunder. (d) Conspiracy. No person may...

  13. 15 CFR 764.2 - Violations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... prohibited by or contrary to, or refrain from engaging in any conduct required by, the EAA, the EAR, or any... prohibited, or the omission of any act required, by the EAA, the EAR, or any order, license or authorization..., the EAR, or any order, license or authorization issued thereunder. (d) Conspiracy. No person may...

  14. 15 CFR 764.2 - Violations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... prohibited by or contrary to, or refrain from engaging in any conduct required by, the EAA, the EAR, or any... prohibited, or the omission of any act required, by the EAA, the EAR, or any order, license or authorization..., the EAR, or any order, license or authorization issued thereunder. (d) Conspiracy. No person may...

  15. 15 CFR 764.2 - Violations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... prohibited by or contrary to, or refrain from engaging in any conduct required by, the EAA, the EAR, or any... prohibited, or the omission of any act required, by the EAA, the EAR, or any order, license or authorization..., the EAR, or any order, license or authorization issued thereunder. (d) Conspiracy. No person may...

  16. 76 FR 60557 - Environmental Assessment and Finding of No Significant Impact for a License Amendment to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... Electric Company, LLC, Hematite Decommissioning Project, Hematite, MO AGENCY: Nuclear Regulatory Commission... (SNM) License number SNM-33, issued to Westinghouse Electric Company, LLC (WEC) to authorize... radioactively contaminated material by rail car to an offsite facility located in Idaho was also confirmed in...

  17. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

  18. 76 FR 16376 - Notice of Intent To Grant Exclusive License

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... Service Notice of Intent To Grant Exclusive License AGENCY: Agricultural Research Service, USDA. ACTION... Research Service, intends to grant to Landmark Earth Solutions, Inc., a subsidiary of Leggett & Platt, Inc... PROCESS FOR THEIR MANUFACTURE,'' issued on May 7, 2002. DATES: Comments must be received within thirty (30...

  19. 15 CFR 960.13 - Prohibitions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SERVICE LICENSING OF PRIVATE REMOTE SENSING SYSTEMS Prohibitions § 960.13 Prohibitions. It is unlawful for... subsidiary or affiliate to: (a) Operate a private remote sensing space system in such a manner as to...) Operate a private remote sensing space system without possession of a valid license issued under the Act...

  20. 47 CFR 27.14 - Construction requirements; Criteria for renewal.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... May 1, 2011. With respect to initial BRS licenses issued on or after November 6, 2009, the licensee... record for the relevant license period demonstrates that: (1) The renewal applicant has provided... showing must include: (1) A description of its current service in terms of geographic coverage and...

  1. 22 CFR 129.1 - Purpose.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS REGISTRATION AND LICENSING OF BROKERS § 129.1... engaged in the business of brokering activities shall register and pay a registration fee as prescribed in regulations, and that no person may engage in the business of brokering activities without a license issued in...

  2. 45 CFR 158.120 - Aggregate reporting.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... covered by the report. The report must aggregate data for each entity licensed within a State, aggregated... reporting. (a) General requirements. For purposes of submitting the report required in § 158.110 of this subpart, the issuer must submit a report for each State in which it is licensed to issue health insurance...

  3. 49 CFR 40.281 - Who is qualified to act as a SAP?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...); (2) You are a licensed or certified social worker; (3) You are a licensed or certified psychologist..., including the initial employee evaluation, referrals for education and/or treatment, the follow-up...; (ix) Issues that SAPs confront in carrying out their duties under the program. (2) Following your...

  4. 49 CFR 40.281 - Who is qualified to act as a SAP?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...); (2) You are a licensed or certified social worker; (3) You are a licensed or certified psychologist..., including the initial employee evaluation, referrals for education and/or treatment, the follow-up...; (ix) Issues that SAPs confront in carrying out their duties under the program. (2) Following your...

  5. 49 CFR 40.281 - Who is qualified to act as a SAP?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...); (2) You are a licensed or certified social worker; (3) You are a licensed or certified psychologist..., including the initial employee evaluation, referrals for education and/or treatment, the follow-up...; (ix) Issues that SAPs confront in carrying out their duties under the program. (2) Following your...

  6. 75 FR 8147 - Notice of Consideration of Amendment Request for Decommissioning of Analytical Bio-Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 030-05154; NRC-2010-0056] Notice of Consideration of Amendment Request for Decommissioning of Analytical Bio-Chemistry Laboratories, Inc. Sanitary Lagoon... license amendment to Byproduct Material License No. 24- 13365-01 issued to Analytical Bio-Chemistry...

  7. 15 CFR 960.13 - Prohibitions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... SERVICE LICENSING OF PRIVATE REMOTE SENSING SYSTEMS Prohibitions § 960.13 Prohibitions. It is unlawful for... subsidiary or affiliate to: (a) Operate a private remote sensing space system in such a manner as to...) Operate a private remote sensing space system without possession of a valid license issued under the Act...

  8. 15 CFR 960.13 - Prohibitions.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... SERVICE LICENSING OF PRIVATE REMOTE SENSING SYSTEMS Prohibitions § 960.13 Prohibitions. It is unlawful for... subsidiary or affiliate to: (a) Operate a private remote sensing space system in such a manner as to...) Operate a private remote sensing space system without possession of a valid license issued under the Act...

  9. 15 CFR 960.13 - Prohibitions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... SERVICE LICENSING OF PRIVATE REMOTE SENSING SYSTEMS Prohibitions § 960.13 Prohibitions. It is unlawful for... subsidiary or affiliate to: (a) Operate a private remote sensing space system in such a manner as to...) Operate a private remote sensing space system without possession of a valid license issued under the Act...

  10. 15 CFR 960.13 - Prohibitions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... SERVICE LICENSING OF PRIVATE REMOTE SENSING SYSTEMS Prohibitions § 960.13 Prohibitions. It is unlawful for... subsidiary or affiliate to: (a) Operate a private remote sensing space system in such a manner as to...) Operate a private remote sensing space system without possession of a valid license issued under the Act...

  11. 77 FR 40586 - Coastal Programs Division

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-10

    ... approval of extension of deep sea hard mineral exploration licenses and amended exploration plan. SUMMARY... FR 12245 on the request of Lockheed Martin Corp. to extend the deep seabed hard mineral exploration licenses USA-1 and USA-4 issued under the Deep Seabed Hard Mineral Resources Act (DSHMRA; 30 U.S.C. 1401...

  12. 10 CFR 51.105a - Public hearings in proceedings for issuance of manufacturing licenses.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... should be issued as proposed by the NRC's Director, Office of New Reactors or Director, Office of Nuclear Reactor Regulation, as appropriate. [73 FR 5724, Jan. 31, 2008] ... manufacturing licenses. 51.105a Section 51.105a Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL...

  13. 10 CFR 51.105a - Public hearings in proceedings for issuance of manufacturing licenses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... should be issued as proposed by the NRC's Director, Office of New Reactors or Director, Office of Nuclear Reactor Regulation, as appropriate. [73 FR 5724, Jan. 31, 2008] ... manufacturing licenses. 51.105a Section 51.105a Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL...

  14. 10 CFR 51.105a - Public hearings in proceedings for issuance of manufacturing licenses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... should be issued as proposed by the NRC's Director, Office of New Reactors or Director, Office of Nuclear Reactor Regulation, as appropriate. [73 FR 5724, Jan. 31, 2008] ... manufacturing licenses. 51.105a Section 51.105a Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL...

  15. 10 CFR 51.105a - Public hearings in proceedings for issuance of manufacturing licenses.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... should be issued as proposed by the NRC's Director, Office of New Reactors or Director, Office of Nuclear Reactor Regulation, as appropriate. [73 FR 5724, Jan. 31, 2008] ... manufacturing licenses. 51.105a Section 51.105a Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL...

  16. 10 CFR 51.105a - Public hearings in proceedings for issuance of manufacturing licenses.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... should be issued as proposed by the NRC's Director, Office of New Reactors or Director, Office of Nuclear Reactor Regulation, as appropriate. [73 FR 5724, Jan. 31, 2008] ... manufacturing licenses. 51.105a Section 51.105a Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL...

  17. An Economic Analysis of Occupational Licensure. Final Report.

    ERIC Educational Resources Information Center

    Rayack, Elton

    To examine the hypothesis that occupational licensure is primarily a restrictive device to protect those licensed from competition, analysis focused on the licensure of non-professional occupations in Rhode Island, Massachusetts, and Connecticut, covering 36 licenses issued by the three states for 12 occupations (e.g. electricians, barbers,…

  18. 75 FR 35515 - Commercial Driver's License (CDL) Standards: Granting of Exemption; Volvo Trucks North America

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006... AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of final disposition... motor vehicles (CMV) in the United States without a commercial driver's license (CDL) issued by one of...

  19. Knowledge, attitudes, and practices of community pharmacists on generic medicines in Qatar.

    PubMed

    Awaisu, Ahmed; Kheir, Nadir; Ibrahim, Mohamed Izham Mohamed; El-Hajj, Maguy; Hazi, Huda; Khudair, Nada; Barazi, Raja

    2014-04-01

    The practice of generic medicines prescribing, dispensing and substitution in developing countries has been controversial among healthcare professionals, particularly due to issues on quality, safety and efficacy. These controversies are as a result of inter-country differences in policies and laws as well as individualized knowledge and attitudes of pharmacists pertaining to generic medicines. This study primarily aims to assess the knowledge, attitudes, and practices of community pharmacists in Qatar towards generic medicines. Community pharmacy settings throughout the State of Qatar. A cross-sectional study using a pretested paper-based survey was conducted among a random sample of community pharmacists in Qatar. The data were analyzed using IBM-SPSS(®) version 20. Both descriptive and inferential statistical analyses were applied. Knowledge, attitudes, and practices of generic medicines pertaining to regulatory standards, safety, efficacy, quality, and future policies. Results A total of 160 surveys were distributed to community pharmacists of which 118 were returned (response rate, 74 %). The mean total score of generic medicines knowledge among the pharmacists was 6.8 ± 1.6 (maximum possible score was 10). Years of practice as well as place of obtaining academic degree did not influence knowledge score. Approximately 72 % of the pharmacists supported generic substitution for brand name drugs in all cases where a generic medicine is available and the majority (93 %) agreed that pharmacists should be given generic substitution right. Nearly 61 % of the pharmacists considered lack of proven bioequivalence to original brands as an important barrier for selecting generic medicines and 55 % rated "lack of policy for directing the practice of generic medicine" as an important barrier. In order to enhance the quality use of and to promote the practice of generic medicines in Qatar, an educational program should be implemented. A national generic medicine policy and guidelines are warranted in the State of Qatar.

  20. 75 FR 57537 - Sunshine Act; Notice of Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ..., 2010 9:30 a.m. Briefing on Security Issues (Closed--Ex. 1). * * * * * * The schedule for Commission..., 2010 1 p.m. Briefing on Resolution of Generic Safety Issue (GSI)--191, Assessment of Debris... 18, 2010 1:30 p.m. NRC All Employees Meeting (Public Meeting) Marriott Bethesda North Hotel, 5701...

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