30 CFR 701.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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...

7 CFR 1710.105 - State regulatory approvals.

Code of Federal Regulations, 2012 CFR

2012-01-01

... (3) Loans for the purpose of assisting borrowers to implement demand side management and energy conservation programs and on and off grid renewable energy systems. (b) At minimum, in the case of all loans in... to obtain approval of a project or its financing from a state regulatory authority, RUS may require...

7 CFR 1710.105 - State regulatory approvals.

Code of Federal Regulations, 2013 CFR

2013-01-01

... (3) Loans for the purpose of assisting borrowers to implement demand side management and energy conservation programs and on and off grid renewable energy systems. (b) At minimum, in the case of all loans in... to obtain approval of a project or its financing from a state regulatory authority, RUS may require...

7 CFR 1710.105 - State regulatory approvals.

Code of Federal Regulations, 2011 CFR

2011-01-01

... (3) Loans for the purpose of assisting borrowers to implement demand side management and energy conservation programs and on and off grid renewable energy systems. (b) At minimum, in the case of all loans in... to obtain approval of a project or its financing from a state regulatory authority, RUS may require...

7 CFR 1710.105 - State regulatory approvals.

Code of Federal Regulations, 2014 CFR

2014-01-01

... (3) Loans for the purpose of assisting borrowers to implement demand side management and energy conservation programs and on and off grid renewable energy systems. (b) At minimum, in the case of all loans in... to obtain approval of a project or its financing from a state regulatory authority, RUS may require...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-06

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-11

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

76 FR 20063 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-11

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64181; File No. SR-OCC-2010-19] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving a Proposed Rule Change Relating to Stock Loan Programs April 5, 2011. I. Introduction On December 16, 2010, The Options Clearing Corporation (``OCC...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-12

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

30 CFR 917.16 - Required regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... to clarify that the total volume of flow from the proposed permit area, during every season of the... parties to be notified of the cabinet's decision to approve or deny the application for an operator change and to require that the regulatory authority be notified when the approved change is consummated. (i...

7 CFR 1735.90 - Preliminary approvals.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

30 CFR 916.12 - State regulatory program and proposed program amendment provisions not approved.

Code of Federal Regulations, 2010 CFR

2010-07-01

... approved. (a) The following provisions of the Kansas Administrative Regulations (K.A.R.) as submitted on April 23, 1986, and January 26, 1988, are disapproved: Paragraphs (c) and (d) of K.A.R. 47-9-1 insofar...

30 CFR 916.12 - State regulatory program and proposed program amendment provisions not approved.

Code of Federal Regulations, 2014 CFR

2014-07-01

... approved. (a) The following provisions of the Kansas Administrative Regulations (K.A.R.) as submitted on April 23, 1986, and January 26, 1988, are disapproved: Paragraphs (c) and (d) of K.A.R. 47-9-1 insofar...

77 FR 23294 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving a Proposed Rule Change To...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-18

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66808; File No. SR-BATS-2012-013] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving a Proposed Rule Change To Amend BATS Exchange, Inc. Rule 2.12 To Make Permanent the Pilot Program That Permits BATS Exchange, Inc. To Receive Inbound...

77 FR 23300 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Order Approving a Proposed Rule Change To...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-18

...-Regulatory Organizations; BATS Y-Exchange, Inc.; Order Approving a Proposed Rule Change To Amend BATS Y-Exchange, Inc. Rule 2.12 to Make Permanent the Pilot Program That Permits BATS Y-Exchange, Inc. To Receive Inbound Routes of Equities Orders Through BATS Trading, Inc., BATS Y-Exchange's Routing Broker-Dealer...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-25

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

40 CFR 272.1851 - Oklahoma State-administered program: Final authorization.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) SOLID WASTES (CONTINUED) APPROVED STATE HAZARDOUS WASTE MANAGEMENT PROGRAMS Oklahoma § 272.1851...)(1)(i) of this section are incorporated by reference as part of the hazardous waste management... Approved Oklahoma Statutory and Regulatory Requirements Applicable to the Hazardous Waste Management...

30 CFR 795.8 - Application approval and notice.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Application approval and notice. 795.8 Section 795.8 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR SMALL OPERATOR ASSISTANCE PERMANENT REGULATORY PROGRAM-SMALL OPERATOR ASSISTANCE PROGRAM § 795.8...

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

PubMed

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

2018-06-01

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

75 FR 47651 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62605; File No. SR-NASDAQ-2010-068] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change to Establish a Revenue Sharing Program With Correlix, Inc. July 30, 2010. On June 8, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed wit...

30 CFR 906.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Natural Resources, Division of Minerals and Geology, Centennial Building, room 215, 1313 Sherman Street..., the Colorado Department of Natural Resources was deemed the regulatory authority in Colorado for...

48 CFR 2022.103-4 - Approvals.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Approvals. 2022.103-4 Section 2022.103-4 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION SOCIOECONOMIC PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Basic Labor Policies 2022.103-4 Approvals...

30 CFR 935.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

...: (a) Ohio Department of Natural Resources, Division of Reclamation, Building H-2, 1855 Fountain Square..., the Department of Natural Resources shall be deemed the regulatory authority in Ohio for all surface...

75 FR 39593 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

... stocks on which option series may be listed at $1 strike price intervals. To be eligible for inclusion in..., 2003) (SR-Phlx-2002-55) (approval of pilot program). The Strike Program was then extended several times... option series with $1 strike price intervals for any class selected for the program, except as...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-14

... By-Laws To Facilitate the Use of the Stock Loan/Hedge Program by Canadian Clearing Members May 8...-Laws to define a Canadian Clearing Member approved to participate in the Stock Loan/Hedge Program as a... rule change is to add provisions to the By-Laws governing the OCC's Stock Loan/Hedge Program to...

10 CFR 26.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Information collection requirements: OMB approval. 26.8 Section 26.8 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.8 Information collection requirements: OMB approval. (a) The NRC has submitted the information...

10 CFR 26.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Information collection requirements: OMB approval. 26.8 Section 26.8 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.8 Information collection requirements: OMB approval. (a) The NRC has submitted the information...

10 CFR 26.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Information collection requirements: OMB approval. 26.8 Section 26.8 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.8 Information collection requirements: OMB approval. (a) The NRC has submitted the information...

10 CFR 26.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 26.8 Section 26.8 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.8 Information collection requirements: OMB approval. (a) The NRC has submitted the information...

10 CFR 26.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 26.8 Section 26.8 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative Provisions § 26.8 Information collection requirements: OMB approval. (a) The NRC has submitted the information...

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-11

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

77 FR 65037 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

... Organizations; C2 Options Exchange, Incorporated; Order Approving a Proposed Rule Change To Adopt a Designated... thereunder,\\2\\ a proposed rule change to adopt a Designated Primary Market-Maker (``DPM'') program. The... the Notice, C2 has proposed to adopt a DPM program. The associated proposed rules are based on the...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

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

30 CFR 938.12 - State statutory, regulatory, and proposed program amendment provisions not approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

... provisions of the proposed program amendment that Pennsylvania submitted on July 29, 1998: (1) Section 5.1(b) (52 P.S. 1406.5a(b)) of BMSLCA is not approved to the extent noted in 30 CFR 938.13(a)(1). (2)-(4... BMSLCA is not approved to the extent noted in 30 CFR 938.13(a)(5). (13) Section 5.5(b) (52 P.S. 1406.5e(b...

30 CFR 938.12 - State statutory, regulatory, and proposed program amendment provisions not approved.

Code of Federal Regulations, 2013 CFR

2013-07-01

... provisions of the proposed program amendment that Pennsylvania submitted on July 29, 1998: (1) Section 5.1(b) (52 P.S. 1406.5a(b)) of BMSLCA is not approved to the extent noted in 30 CFR 938.13(a)(1). (2)-(4... BMSLCA is not approved to the extent noted in 30 CFR 938.13(a)(5). (13) Section 5.5(b) (52 P.S. 1406.5e(b...

30 CFR 938.12 - State statutory, regulatory, and proposed program amendment provisions not approved.

Code of Federal Regulations, 2012 CFR

2012-07-01

... provisions of the proposed program amendment that Pennsylvania submitted on July 29, 1998: (1) Section 5.1(b) (52 P.S. 1406.5a(b)) of BMSLCA is not approved to the extent noted in 30 CFR 938.13(a)(1). (2)-(4... BMSLCA is not approved to the extent noted in 30 CFR 938.13(a)(5). (13) Section 5.5(b) (52 P.S. 1406.5e(b...

30 CFR 938.12 - State statutory, regulatory, and proposed program amendment provisions not approved.

Code of Federal Regulations, 2014 CFR

2014-07-01

... provisions of the proposed program amendment that Pennsylvania submitted on July 29, 1998: (1) Section 5.1(b) (52 P.S. 1406.5a(b)) of BMSLCA is not approved to the extent noted in 30 CFR 938.13(a)(1). (2)-(4... BMSLCA is not approved to the extent noted in 30 CFR 938.13(a)(5). (13) Section 5.5(b) (52 P.S. 1406.5e(b...

75 FR 347 - Information Collection; Notice of Submission to OMB for Its Review and Approval of the Voluntary...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

.... The list of program types that appear in the survey (for example, Critical Peak Pricing, Spinning... Management and Budget, Office of Information and Regulatory Affairs, Attention: Federal Energy Regulatory...

77 FR 41680 - Indiana Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-16

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 914... Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving amendments to the Indiana...

76 FR 9642 - Alabama Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-22

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 901... Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving an amendment to the Alabama...

78 FR 11579 - Texas Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943... Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving an amendment to the Texas...

77 FR 8144 - Texas Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943... AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving three...

76 FR 30008 - Alabama Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 901... Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving an amendment to the Alabama...

75 FR 81122 - Texas Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-27

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943... Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving an amendment to the Texas...

77 FR 58025 - Texas Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-19

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943... Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving an amendment to the Texas...

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

PubMed Central

Beaver, Julia A.; Tzou, Abraham; Blumenthal, Gideon M.; McKee, Amy E.; Kim, Geoffrey; Pazdur, Richard; Philip, Reena

2016-01-01

As technologies evolve, and diagnostics move from detection of single biomarkers toward complex signatures, an increase in the clinical use and regulatory submission of complex signatures is anticipated. However, to date, no complex signatures have been approved as companion diagnostics. In this article, we will describe the potential benefit of complex signatures and their unique regulatory challenges including analytical performance validation, complex signature simulation, and clinical performance evaluation. We also will review the potential regulatory pathways for clearance, approval, or acceptance of complex signatures by the U.S. Food and Drug Administration (FDA). These regulatory pathways include regulations applicable to in vitro diagnostic devices, including companion diagnostic devices, the potential for labeling as a complementary diagnostic, and the biomarker qualification program. PMID:27993967

5 CFR 470.311 - Final project approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.311 Final project approval. (a) The Office of Personnel Management will consider all timely...) The Office of Personnel Management shall provide a copy of the final version of the project plan to...

Economics of new oncology drug development.

PubMed

DiMasi, Joseph A; Grabowski, Henry G

2007-01-10

Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.

NASA firefighters breathing system program report

NASA Technical Reports Server (NTRS)

Wood, W. B.

1977-01-01

Because of the rising incidence of respiratory injury to firefighters, local governments expressed the need for improved breathing apparatus. A review of the NASA firefighters breathing system program, including concept definition, design, development, regulatory agency approval, in-house testing, and program conclusion is presented.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

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

77 FR 24737 - Notice of Proposed Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

... its maintenance of state programs and procedures for substituting Federal enforcement of state programs and withdrawing approval of state programs, has been forwarded to the Office of Management and...: Submit comments to the Office of Information and Regulatory Affairs, Office of Management and Budget...

78 FR 48541 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-08

... Management Information System testing information, and to communicate with entities subject to the program... Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be... Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th...

77 FR 68193 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-15

... Available Under the Short Term Option Series Program (``STOS Program''), To Allow for the Exchange To Delist... Program Under Limited Circumstances November 8, 2012. I. Introduction On September 6, 2012, NYSE Arca, Inc...'') to make certain modifications to the Exchange's Short Term Option Series Program (``STOS Program...

30 CFR 917.12 - State regulatory program and proposed program amendment provisions not approved.

Code of Federal Regulations, 2013 CFR

2013-07-01

... depression left by backfilling and grading, that is not a sedimentation pond or coal mine waste impoundment... completely incised or created by a depression left by backfilling and grading but not meeting MSHA...

30 CFR 917.12 - State regulatory program and proposed program amendment provisions not approved.

Code of Federal Regulations, 2014 CFR

2014-07-01

... depression left by backfilling and grading, that is not a sedimentation pond or coal mine waste impoundment... completely incised or created by a depression left by backfilling and grading but not meeting MSHA...

30 CFR 917.12 - State regulatory program and proposed program amendment provisions not approved.

Code of Federal Regulations, 2012 CFR

2012-07-01

... depression left by backfilling and grading, that is not a sedimentation pond or coal mine waste impoundment... completely incised or created by a depression left by backfilling and grading but not meeting MSHA...

The Benefits and Limitations of Hydraulic Modeling for Ordinary High Water Mark Delineation

DTIC Science & Technology

2016-02-01

ER D C/ CR RE L TR -1 6- 1 Wetland Regulatory Assistance Program (WRAP) The Benefits and Limitations of Hydraulic Modeling for Ordinary...client/default. Wetland Regulatory Assistance Program (WRAP) ERDC/CRREL TR-16-1 February 2016 The Benefits and Limitations of Hydraulic Modeling...Approved for public release; distribution is unlimited. Prepared for Headquarters, U.S. Army Corps of Engineers Washington, DC 20314-1000 Under Wetlands

77 FR 68194 - Self-Regulatory Organizations; NYSE MKT LLC; Order Granting Approval of Proposed Rule Change, as...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-15

... Available Under the Short Term Option Series Program (``STOS Program''), To Allow for the Exchange To Delist... Program Under Limited Circumstances November 8, 2012. I. Introduction On September 6, 2012, NYSE MKT LLC... make certain modifications to the Exchange's Short Term Option Series Program (``STOS Program''). The...

75 FR 68632 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-08

... Participating Organization, must be filed with and approved by the Commission before they become effective. 23... Arca'') (together, the ``Participating Organizations'' or the ``Parties'') filed with the Securities... self-regulatory organization (``SRO'') registered as either a national securities exchange or national...

78 FR 10512 - Wyoming Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-14

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment with certain... ``Wyoming program'') under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or ``the Act...

78 FR 39046 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-28

... Permit BX Options To Accept Inbound Options Orders From NASDAQ OMX PHLX LLC and NASDAQ Options Market... permanent approval of the Exchange's pilot program that permits the BX Options System to accept inbound orders routed by Nasdaq Options Services LLC (``NOS'') from the NASDAQ OMX PHLX LLC (``PHLX'') and The...

78 FR 35656 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval to Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-13

... the Program are Retail Orders as defined in Rule 4780(a)(2). NASDAQ states that the current ``any... Program, it did so with the understanding that the Program would service ``only'' retail order flow. To... flow represented by these brokers the opportunity to receive the benefits of the Program. Additionally...

30 CFR 795.4 - Information collection.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Information collection. 795.4 Section 795.4... OPERATOR ASSISTANCE PERMANENT REGULATORY PROGRAM-SMALL OPERATOR ASSISTANCE PROGRAM § 795.4 Information collection. The collections of information contained in part 795 have been approved by the Office of...

30 CFR 795.4 - Information collection.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Information collection. 795.4 Section 795.4... OPERATOR ASSISTANCE PERMANENT REGULATORY PROGRAM-SMALL OPERATOR ASSISTANCE PROGRAM § 795.4 Information collection. The collections of information contained in part 795 have been approved by the Office of...

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

Code of Federal Regulations, 2010 CFR

2010-07-01

...) except the words “other responsible party” at (e) are not approved, .5, -13, -14.5, .8, .11, .12, .14... (f); 22-3-13a, in 13a(g) the words “upon request” are not approved, in 13a(j)(2) the phrase “or the... 17, 2004 CSR 38-2-7.4.b.1.I. March 25, 2004 February 8, 2005 CSR 38-2-3.12.a.1; 7.6 (except the word...

40 CFR 282.102 - Puerto Rico State-Administered Program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... part 281, subpart E. If the Commonwealth obtains approval for the revised requirements pursuant to... RCRA, 42 U.S.C. 6991 et seq. (A) Puerto Rico Statutory Requirements Applicable to the Underground Storage Tank Program, 1997. (B) Puerto Rico Regulatory Requirements Applicable to the Underground Storage...

30 CFR 938.12 - State statutory, regulatory, and proposed program amendment provisions not approved.

Code of Federal Regulations, 2010 CFR

2010-07-01

... extent that it would allow the replaced water supply to be of a lesser quantity and quality than the premining water supply or does not provide for temporary replacement of water supplies. We are not approving Subsection (a)(1)(v) to the extent it would pass on operating and maintenance costs of a replacement water...

30 CFR 931.10 - State regulatory program approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Department, 2040 South Pacheco Street, Santa Fe, NM 87505. (b) Albuquerque Field Office, Office of Surface Mining Reclamation and Enforcement, 505 Marquette NW., suite 1200, Albuquerque, NM 87102. [47 FR 47380...

30 CFR 931.10 - State regulatory program approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Department, 2040 South Pacheco Street, Santa Fe, NM 87505. (b) Albuquerque Field Office, Office of Surface Mining Reclamation and Enforcement, 505 Marquette NW., suite 1200, Albuquerque, NM 87102. [47 FR 47380...

30 CFR 931.10 - State regulatory program approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Department, 2040 South Pacheco Street, Santa Fe, NM 87505. (b) Albuquerque Field Office, Office of Surface Mining Reclamation and Enforcement, 505 Marquette NW., suite 1200, Albuquerque, NM 87102. [47 FR 47380...

30 CFR 931.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Department, 2040 South Pacheco Street, Santa Fe, NM 87505. (b) Albuquerque Field Office, Office of Surface Mining Reclamation and Enforcement, 505 Marquette NW., suite 1200, Albuquerque, NM 87102. [47 FR 47380...

30 CFR 931.10 - State regulatory program approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Department, 2040 South Pacheco Street, Santa Fe, NM 87505. (b) Albuquerque Field Office, Office of Surface Mining Reclamation and Enforcement, 505 Marquette NW., suite 1200, Albuquerque, NM 87102. [47 FR 47380...

76 FR 72482 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-23

... Short Term Option Series Program November 17, 2011. I. Introduction On September 28, 2011, NASDAQ OMX...,\\2\\ a proposed rule change to expand the Short Term Option Program (``Program'') to allow the Exchange to: (1) Select up to 30 option classes on which Short Term Option Series (``STO Series'') may be...

30 CFR 917.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., Lexington, Kentucky 40503-2922. (b) Department for Surface Mining Reclamation and Enforcement, Number 2, Hudson Hollow Complex, Frankfort, Kentucky 40601. [48 FR 251, Jan. 4, 1983, as amended at 59 FR 17929...

30 CFR 901.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Commission, 1811 Second Avenue, 2nd Floor, P.O. Box 2390, Jasper, AL 35502. (b) Office of Surface Mining Reclamation and Enforcement, Birmingham Field Office, Barber Business Park, 135 Gemini Circle, Homewood, AL...

30 CFR 901.10 - State regulatory program approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Commission, 1811 Second Avenue, 2nd Floor, P.O. Box 2390, Jasper, AL 35502. (b) Office of Surface Mining Reclamation and Enforcement, Birmingham Field Office, Barber Business Park, 135 Gemini Circle, Homewood, AL...

30 CFR 901.10 - State regulatory program approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Commission, 1811 Second Avenue, 2nd Floor, P.O. Box 2390, Jasper, AL 35502. (b) Office of Surface Mining Reclamation and Enforcement, Birmingham Field Office, Barber Business Park, 135 Gemini Circle, Homewood, AL...

30 CFR 901.10 - State regulatory program approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Commission, 1811 Second Avenue, 2nd Floor, P.O. Box 2390, Jasper, AL 35502. (b) Office of Surface Mining Reclamation and Enforcement, Birmingham Field Office, Barber Business Park, 135 Gemini Circle, Homewood, AL...

30 CFR 901.10 - State regulatory program approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Commission, 1811 Second Avenue, 2nd Floor, P.O. Box 2390, Jasper, AL 35502. (b) Office of Surface Mining Reclamation and Enforcement, Birmingham Field Office, Barber Business Park, 135 Gemini Circle, Homewood, AL...

30 CFR 710.10 - Information collection.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Information collection. 710.10 Section 710.10... PROGRAM REGULATIONS INITIAL REGULATORY PROGRAM § 710.10 Information collection. The collections of information contained in §§ 710.4, 710.11, and 710.12 have been approved by the Office of Management and...

30 CFR 710.10 - Information collection.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Information collection. 710.10 Section 710.10... PROGRAM REGULATIONS INITIAL REGULATORY PROGRAM § 710.10 Information collection. The collections of information contained in §§ 710.4, 710.11, and 710.12 have been approved by the Office of Management and...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-15

... Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415- 6219..., 11555 Rockville Pike, Rockville, Maryland. NRC's Agencywide Documents Access and Management System... M. McCausland, Office of Federal and State Materials and Environmental Management Programs, U.S...

76 FR 5415 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-31

... Rule Change Regarding Rule 4.20--Anti-Money Laundering Compliance Program January 25, 2011. I... Rule 4.20, Anti-Money Laundering Compliance Program, to require all Trading Permit Holders or TPH... or TPH organization's existence to ensure anti-money laundering compliance is in place and...

30 CFR 917.15 - Approval of Kentucky regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... amendments. 917.15 Section 917.15 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE KENTUCKY... Production After Mining;” “Estimated Crop Yields on Prime Farmland Soils in Western Kentucky Coalfields...

30 CFR 917.15 - Approval of Kentucky regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

... amendments. 917.15 Section 917.15 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE KENTUCKY... Production After Mining;” “Estimated Crop Yields on Prime Farmland Soils in Western Kentucky Coalfields...

30 CFR 917.15 - Approval of Kentucky regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

... amendments. 917.15 Section 917.15 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE KENTUCKY... Production After Mining;” “Estimated Crop Yields on Prime Farmland Soils in Western Kentucky Coalfields...

30 CFR 917.15 - Approval of Kentucky regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

... amendments. 917.15 Section 917.15 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE KENTUCKY... Production After Mining;” “Estimated Crop Yields on Prime Farmland Soils in Western Kentucky Coalfields...

30 CFR 917.15 - Approval of Kentucky regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

... amendments. 917.15 Section 917.15 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE KENTUCKY... Production After Mining;” “Estimated Crop Yields on Prime Farmland Soils in Western Kentucky Coalfields...

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

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

NONE

1996-07-01

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

30 CFR 938.15 - Approval of Pennsylvania regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Subsidence and Land 2001 Conservation Act: Repeal of Section 4 (52 P.S. 1406.4); 5(b)(partial approval); 5.1...)); 5.2(a)(1), (2), and (3) (52 P.S. 1406.5b(a)(1), (2), and (3)); 5.2(b)(1) (52 P.S. 1406.5b(b)(1)); 5... approval); 5.4(a)(1), (2) and (4) (52 P.S. 1406.5d(a)(1), (2) and (4)); 5.4(b) (52 P.S. 1406.5d(b)); 5.5(a...

30 CFR 938.15 - Approval of Pennsylvania regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Subsidence and Land 2001 Conservation Act: Repeal of Section 4 (52 P.S. 1406.4); 5(b)(partial approval); 5.1...)); 5.2(a)(1), (2), and (3) (52 P.S. 1406.5b(a)(1), (2), and (3)); 5.2(b)(1) (52 P.S. 1406.5b(b)(1)); 5... approval); 5.4(a)(1), (2) and (4) (52 P.S. 1406.5d(a)(1), (2) and (4)); 5.4(b) (52 P.S. 1406.5d(b)); 5.5(a...

30 CFR 938.15 - Approval of Pennsylvania regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Subsidence and Land 2001 Conservation Act: Repeal of Section 4 (52 P.S. 1406.4); 5(b)(partial approval); 5.1...)); 5.2(a)(1), (2), and (3) (52 P.S. 1406.5b(a)(1), (2), and (3)); 5.2(b)(1) (52 P.S. 1406.5b(b)(1)); 5... approval); 5.4(a)(1), (2) and (4) (52 P.S. 1406.5d(a)(1), (2) and (4)); 5.4(b) (52 P.S. 1406.5d(b)); 5.5(a...

30 CFR 938.15 - Approval of Pennsylvania regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Subsidence and Land 2001 Conservation Act: Repeal of Section 4 (52 P.S. 1406.4); 5(b)(partial approval); 5.1...)); 5.2(a)(1), (2), and (3) (52 P.S. 1406.5b(a)(1), (2), and (3)); 5.2(b)(1) (52 P.S. 1406.5b(b)(1)); 5... approval); 5.4(a)(1), (2) and (4) (52 P.S. 1406.5d(a)(1), (2) and (4)); 5.4(b) (52 P.S. 1406.5d(b)); 5.5(a...

The New Drug Conditional Approval Process in China: Challenges and Opportunities.

PubMed

Yao, Xuefang; Ding, Jinxi; Liu, Yingfang; Li, Penghui

2017-05-01

Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration. We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google. Currently, there is a large backlog of New Drug Applications in China, mainly because of the prolonged review time at the China Food and Drug Administration, resulting in a lag in drug approvals. In 2015, the Chinese government implemented the drug review and registration system reform and tackled this issue through various approaches, such as setting up a drug review fee system, adjusting the drug registration classification, and establishing innovative review pathways, including the conditional approval process. In Europe and the United States, programs comparable to the conditional approval program in China have been well developed. The conditional approval program recently established in China is an expedited new drug approval process that is expected to affect new drug development at home and abroad and profoundly influence the public health and the pharmaceutical industry in China. Like any program in its initial stage, the conditional approval program is facing several challenges, including setting up a robust system, formatting new drug clinical research requirements, and improving the regulatory agency's function for drug review and approval. The program is expected to evolve and improve as part of the government mandate of the drug registration system reform. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

PubMed Central

Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

2015-01-01

Aims Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). Methods We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA’s 210 day regulatory deadline. Results Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276–406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Conclusions Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. PMID:25808713

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

PubMed

Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

2015-10-01

Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. © 2015 The British Pharmacological Society.

76 FR 72472 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Granting Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-23

... Short Term Options Series Program November 17, 2011. I. Introduction On September 23, 2011, the...\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to expand the Short Term Options Series Program... Exchange may select up to 25 option classes to participate in the STOS Program \\5\\ and list up to 30 Short...

76 FR 72473 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-23

... Expanding the Short Term Option Series Program November 17, 2011. I. Introduction On September 28, 2011, The...,\\2\\ a proposed rule change to expand the Short Term Option Program (``Program'') to allow the NASDAQ Options Market (``NOM'' or ``Exchange'') to: (1) Select up to 30 option classes on which Short Term Option...

76 FR 37162 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... (February 7, 2011). \\3\\ Letter from Gene Thomas (Retired), (April 24, 2011); letter from Andrew S. Margolin... CFTC's regulations. OCC By-Laws, Article I, Definitions. OCC's current internal cross-margining program...-CME program. Article VI, Section 25(b) of OCC's By-Laws currently requires clearing members to obtain...

77 FR 54629 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Granting Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-05

.... Introduction On May 21, 2012, the International Securities Exchange, LLC (``ISE'' or ``Exchange'') filed with... its Short Term Option Series Program (``STOS Program'') to permit, during the expiration week of an... open for trading Short Term Option Series at $0.50 strike price intervals for option classes that trade...

75 FR 78330 - Self-Regulatory Organizations; National Stock Exchange, Inc.; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-15

... approved permanently, this pilot program will expire on December 10, 2010. The instant rule filing proposes... program should be extended. Accordingly, pursuant to the instant rule filing, the expiration date of the... filed with the Commission, and all written communications relating to the proposed rule change between...

30 CFR 944.10 - State regulatory program approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Division of Oil, Gas and Mining agreeing to the conditions in section 944.11, are available at: (a) Division of Oil, Gas and Mining, Department of Natural Resources, 3 Triad Center, suite 350, 355 West North... INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944.10 State...

30 CFR 944.10 - State regulatory program approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Division of Oil, Gas and Mining agreeing to the conditions in section 944.11, are available at: (a) Division of Oil, Gas and Mining, Department of Natural Resources, 3 Triad Center, suite 350, 355 West North... INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944.10 State...

30 CFR 944.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Division of Oil, Gas and Mining agreeing to the conditions in section 944.11, are available at: (a) Division of Oil, Gas and Mining, Department of Natural Resources, 3 Triad Center, suite 350, 355 West North... INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944.10 State...

30 CFR 944.10 - State regulatory program approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Division of Oil, Gas and Mining agreeing to the conditions in section 944.11, are available at: (a) Division of Oil, Gas and Mining, Department of Natural Resources, 3 Triad Center, suite 350, 355 West North... INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944.10 State...

30 CFR 944.10 - State regulatory program approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Division of Oil, Gas and Mining agreeing to the conditions in section 944.11, are available at: (a) Division of Oil, Gas and Mining, Department of Natural Resources, 3 Triad Center, suite 350, 355 West North... INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944.10 State...

75 FR 17196 - Self-Regulatory Organizations; The Depository Trust Company; Order Granting Approval of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-05

... Part of the Fast Automated Transfer Program March 30, 2010. I. Introduction On January 19, 2010, The... made unsponsored ADRs eligible for DTC's Fast Automated Securities Transfer Program (``FAST'').\\4\\ \\3... associated with safekeeping, transfer, shipping and insurance costs. \\4\\ FAST was designed to eliminate some...

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

PubMed

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

2016-05-01

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

77 FR 54635 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-05

... Strike Price Intervals in the Short Term Options Program August 29, 2012. I. Introduction On July 2, 2012...-4 thereunder,\\2\\ a proposed rule change to indicate that the interval between strike prices on short term options series (``STOs'') listed in accordance with its Short Term Option Series Program (``STO...

77 FR 71652 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Order Granting Approval to Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-03

... flow of eight retail brokers revealed that nearly 100% of their customer market orders were routed to... pilot program to attract additional retail order flow to the Exchange, while also providing the potential for price improvement to such order flow. The Program would be limited to trades occurring at...

Progress and challenges of protecting North American ash trees from the emerald ash borer using biological control

Treesearch

Jian Duan; Leah Bauer; Roy van Driesche; Juli Gould

2018-01-01

After emerald ash borer (EAB), Agrilus planipennis Fairmaire, was discovered in the United States, a classical biological control program was initiated against this destructive pest of ash trees (Fraxinus spp.). This biocontrol program began in 2007 after federal regulatory agencies and the state of Michigan approved release of...

77 FR 40109 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... Rule Change To Extend the Penny Pilot Program June 28, 2012. Pursuant to Section 19(b)(1) \\1\\ of the... December 31, 2012, the Penny Pilot Program (``Penny Pilot'') in options classes in certain issues (``Pilot... applicable to BATS Options' participation in the Penny Pilot, were approved on January 26, 2010. See...

77 FR 77176 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-31

... Change To Extend the Penny Pilot Program December 21, 2012. Pursuant to Section 19(b)(1) \\1\\ of the... Options'') to extend through June 30, 2013, the Penny Pilot Program (``Penny Pilot'') in options classes... Options, including rules applicable to BATS Options' participation in the Penny Pilot, were approved on...

78 FR 37862 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

... Change To Extend the Penny Pilot Program June 18, 2013. Pursuant to Section 19(b)(1) of the Securities... December 31, 2013, the Penny Pilot Program (``Penny Pilot'') in options classes in certain issues (``Pilot... applicable to BATS Options' participation in the Penny Pilot, were approved on January 26, 2010. See...

78 FR 77177 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

... Change To Extend the Penny Pilot Program December 16, 2013. Pursuant to Section 19(b)(1) of the... through June 30, 2014, the Penny Pilot Program (``Penny Pilot'') in options classes in certain issues... rules applicable to BATS Options' participation in the Penny Pilot, were approved on January 26, 2010...

30 CFR 917.12 - State regulatory program and proposed program amendment provisions not approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., effective June 20, 2001. (c) The amendment submitted by letter dated April 12, 2002, proposing a new section... depression left by backfilling and grading, that is not a sedimentation pond or coal mine waste impoundment... completely incised or created by a depression left by backfilling and grading but not meeting MSHA...

30 CFR 917.12 - State regulatory program and proposed program amendment provisions not approved.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., effective June 20, 2001. (c) The amendment submitted by letter dated April 12, 2002, proposing a new section... depression left by backfilling and grading, that is not a sedimentation pond or coal mine waste impoundment... completely incised or created by a depression left by backfilling and grading but not meeting MSHA...

78 FR 74012 - Approval and Promulgation of Implementation Plans; State of Oregon; Revised Format for Materials...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-10

...-regulatory and quasi-regulatory portions of the Oregon SIP. DATES: This action is effective January 9, 2014.... EPA-approved source-specific permits. 5. EPA-approved nonregulatory and quasi-regulatory provisions...

Accelerating drug development and approval.

PubMed

Cole, Patrick

2010-01-01

Regulatory agencies are the gateway between the pharma/biotech industry and patients and can serve as stimulators of new drug development. This article highlights several means of doing so implemented thus far, many with already impressive histories, such as orphan drug legislation, and others of a more experimental nature, such as the FDA's priority review voucher program. These initiatives represent different approaches to finding treatments for rare and widespread but neglected diseases, as well as speeding the development process for pharmaceutical and biological agents more generally. Commercial incentives, streamlined regulatory processing, exploratory trial designs, research assistance and cash infusions are all means of promoting drug development being explored in the United States, Europe and beyond. In some cases, such as fast track designation and priority review vouchers, regulatory agencies have turned their own processes into incentives, offering advantageous alternative routes to product approval, like a faster lane on the highway for vehicles carrying multiple passengers. In 2009, regulatory agencies and the governments they represent also had to confront two tremendous challenges: the global recession and the H1N1 influenza virus pandemic. These tests have been met with increased funding in the former case and coordinated efforts to develop, approve and stockpile H1N1 vaccines in the latter.

5 CFR 470.315 - Project modification and extension.

Code of Federal Regulations, 2011 CFR

2011-01-01

....315 Section 470.315 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to... plan without the approval of the Office of Personnel Management. OPM will inform the agency of...

30 CFR 913.10 - State regulatory program approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Illinois Department of Natural Resources, Office of Mines and Minerals, Land Reclamation Division, One Natural Resources Way, Springfield, Illinois 62701-1787. (b) Illinois Department of Natural Resources... Office, Minton-Capehart Federal Building, 575 North Pennsylvania Street, Room 301, Indianapolis, IN 46204...

13 CFR 108.550 - Prior approval of secured third-party debt of NMVC companies.

Code of Federal Regulations, 2010 CFR

2010-01-01

... ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Managing the Operations of a NMVC Company Borrowing... total outstanding borrowings (not including Leverage) to exceed 50 percent of your Leverageable Capital. Voluntary Decrease in Regulatory Capital ...

76 FR 12857 - Montana Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment... the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or ``the Act''). Montana proposed...

Development of Physical Protection Regulations for Rosatom State Corporation Sites under the U.S.-Russian MPC&A Program

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

Izmaylov, Alexander; Babkin, Vladimir; Shemigon, Nikolai N.

2012-07-14

This paper describes issues related to upgrading the physical protection regulatory basis for Rosatom State Corporation sites. It is underlined that most of the regulatory and methodological documents for this subject area have been developed under the U.S.-Russian MPC&A Program. According to the joint management plan developed and agreed upon by the parties in 2005, nearly 50 physical protection documents were identified to be developed, approved and implemented at Rosatom sites by 2012. It is also noted that, on the whole, the plans have been fulfilled.

Reconciling Estimates of the Value to Firms of Reduced Regulatory Delay in the Marketing of Their New Drugs.

PubMed

Wilmoth, Daniel R

2015-12-01

The prescription drug user fee program provides additional resources to the U.S. Food and Drug Administration at the expense of regulated firms. Those resources accelerate the review of new drugs. Faster approvals allow firms to realize profits sooner, and the program is supported politically by industry. However, published estimates of the value to firms of reduced regulatory delay vary dramatically. It is shown here that this variation is driven largely by differences in methods that correspond to differences in implicit assumptions about the effects of reduced delay. Theoretical modeling is used to derive an equation describing the relationship between estimates generated using different methods. The method likely to yield the most accurate results is identified. A reconciliation of published estimates yields a value to a firm for a one-year reduction in regulatory delay at the time of approval of about $60 million for a typical drug. Published 2015. This article is a U.S. Government work and is in the public domain in the U.S.A. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

5 CFR 470.303 - Eligible parties.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.303... demonstration projects under 5 U.S.C. 4701(a)(1) and 4701(b) may conduct demonstration projects after approval...

10 CFR 171.21 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false [Reserved] 171.21 Section 171.21 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ANNUAL FEES FOR REACTOR LICENSES AND FUEL CYCLE LICENSES AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS AND...

78 FR 50475 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

... Amending Commentary .10 to Rule 903 To Modify the Short-Term Option Series Program To Increase the Number... option series (``Short-Term Option Series'' or ``STOS'') Program to increase the number of classes that... respective rules. \\3\\ A Short-Term Option Series is a series of an option class that is approved for listing...

77 FR 68177 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-15

... Commission has recently approved certain products to trade at $0.50 and $1 strike price intervals on CBOE... Series (``STOS'') Program that normally trade in $1 Strike Price Intervals shall be $0.50 or greater; and for classes in the STOS Program that do not normally trade in $1 Strike Price Intervals, the strike...

76 FR 5627 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-01

... Listing of Options Series with $1 Strike Prices January 25, 2011. I. Introduction On November 24, 2010... Strike Price Program. The proposed rule change was published for comment in the Federal Register on... proposed to amend Rule 6.4 Commentary .04 to modify the operation of the $1 Strike Price Program. Currently...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-26

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

78 FR 69168 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

... approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70848; File No. SR-NSCC-2013-10] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To...

75 FR 25004 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-06

... informational advantages that could place an affiliated member of an exchange at a competitive advantage vis... Member'').\\14\\ For purposes of the proposed 17d-2 Plan, Ballista would meet the definition of the term...

75 FR 55833 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-14

... Securities Exchange Act Release No. 62657 (August 5, 2010), 75 FR 49005 (August 12, 2010). I. Introduction... members' advertising, and the arbitration of disputes under the Plan.\\12\\ On May 30, 1980, the Commission...

77 FR 68172 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-15

... recently approved certain products to trade at $0.50 and $1 strike price intervals on CBOE within exactly... Short Term Option Series (``STOS'') Program that normally trade in $1 Strike Price Intervals shall be [[Page 68173

Demand Response Compensation Methodologies: Case Studies for Mexico

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

Gagne, Douglas A; Settle, Donald E; Aznar, Alexandra Y

This report examines various compensation methodologies for demand response programs in Mexico. This report presents three case studies, including New England, California, and Hawaii. Demand response (DR) can refer to a variety of approaches to changing the amount and timing of customers' electricity use, allowing the electricity supplier to more easily balance electricity supply and demand. The level of compensation for a DR program will depend greatly upon both the regulatory context of the electricity supplier, as well as the economic circumstances of the DR providers. For a regulated utility, a proposed compensation level may need to pass regulatory approval.more » To determine the value of DR resources, a regulatory body typically seeks to determine the costs that the utility would avoid if demand-side resources 'produce' energy.« less

75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-01

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

76 FR 25397 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change To Amend the By- Laws of FINRA Regulation, Inc. With Regard to District Committees April 28, 2011. I. Introduction On February 25, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the...

FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence.

PubMed

Sasinowski, Frank J; Varond, Alexander J

2016-08-01

This article examines the strength of scientific and clinical evidence for FDA's nineteen non-AIDS, non-cancer Subpart H approval determinations over the Accelerated Approval program's twenty-four year existence. The authors researched the bases for FDA's determinations when an unvalidated surrogate or intermediate clinical endpoint is "reasonably likely to predict clinical benefit." The four key factors set forth in FDA's "Guidance for Industry, Expedited Programs for Serious Conditions - Drugs and Biologics" were applied to past Subpart H approvals. For the nineteen precedents, the authors found wide variances between the quantum and quality of evidence on each of the four factors, indicating that a lack of evidence on any single factor was not disqualifying in and of itself. The results of this study, therefore, show that FDA exercises extraordinarily more regulatory flexibility than either FDA's foundational statutes or even FDA' s most recent 2014 Expedited Programs Guidance explicitly express. Given recent legislative exhortations and the increasing promise of personalized medicine and translational sciences, the authors conclude that Subpart H should be further explored and utilized. The authors provide a detailed analysis of the orecedents established in the nineteen approvals.

77 FR 74722 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68401; File No. SR-CME-2012-42] Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule Change Regarding the Valuation of...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-15

... directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66560; File No. SR-OCC-2012-01] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Public...

77 FR 40394 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-09

... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67333; File No. SR-OCC-2012-07] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Adjustment...

78 FR 59401 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-26

...\\ directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70464; File No. SR-ICEEU-2013-11] Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change Related To Enhanced...

76 FR 43360 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

.... The text of the proposed rule change is set forth below. Proposed new language is italicized; proposed... methodology approved by FINRA as announced in a Regulatory Notice (``approved margin methodology''). The... an Approved Margin Methodology. Members shall require as a minimum for computing customer or broker...

75 FR 28080 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-19

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62079; File No. 4-598] Program for Allocation... Order gives effect to the Plan filed with the Commission in File No. 4-598. The Parties shall notify all..., pursuant to Section 17(d) of the Act, that the Plan in File No. 4-598, between FINRA and EDGX, filed...

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

Code of Federal Regulations, 2010 CFR

2010-07-01

..., 1990 CSMC 80-1-1-5, definitions of “affected area,” “self-bond”; 80-1-8-20; 80-1-9-16; 80-1-14-23(d)(2..., and C, concerning verification of ownership or control application information; NMAC, sections 19.8.11...

76 FR 12852 - Louisiana Regulatory Program/Abandoned Mine Land Reclamation Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 918... Reclamation Plan AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are...

75 FR 6422 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Incorporated NYSE Rule 411(a)(ii)(5) as Part of the Process of Developing the Consolidated FINRA Rulebook February 2, 2010. On December 4, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

7 CFR 1710.105 - State regulatory approvals.

Code of Federal Regulations, 2010 CFR

2010-01-01

... and Basic Policies § 1710.105 State regulatory approvals. (a) In States where a borrower is required... loans are approved by RUS: (1) Loans requiring an Environmental Impact Statement; (2) Loans to finance...

76 FR 80992 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... 7034 Regarding Low Latency Network Connections December 20, 2011. I. Introduction On October 31, 2011...- Location Services'' to establish a program for offering low latency network connections and to establish the initial fees for such connections. The Exchange also proposed administrative modifications to...

77 FR 30032 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... Professionals'' May 15, 2012. I. Introduction On March 20, 2012, the Fixed Income Clearing Corporation (``FICC... Members and NYPC Clearing Members for certain ``market professionals.'' \\6\\ \\5\\ See Securities Exchange... professional'' cross-margining program aims to closely replicate the Options Clearing Corporation (``OCC...

42 CFR 421.110 - Requirements for approval of an agreement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SERVICES (CONTINUED) MEDICARE PROGRAM MEDICARE CONTRACTING Intermediaries § 421.110 Requirements for... regulatory authorities of the State or States in which it, or any subcontractor performing some or all of its... only providers located in a single State; (5) Has acted in good faith to achieve effective cooperation...

30 CFR 926.15 - Approval of Montana regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

....301(13), (34), (39), (46), (47), (64), (71), (73), (76), (79), (95), (103), (110), (111), (133); 17.24...(143); 17.24.302; 17.24.303(1)(w), (x), and (y); 17.24.305(2)(b)(i); 17.24.308(1)(b)(vii); 17.24.312(1...

30 CFR 926.15 - Approval of Montana regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

....301(13), (34), (39), (46), (47), (64), (71), (73), (76), (79), (95), (103), (110), (111), (133); 17.24...(143); 17.24.302; 17.24.303(1)(w), (x), and (y); 17.24.305(2)(b)(i); 17.24.308(1)(b)(vii); 17.24.312(1...

30 CFR 926.15 - Approval of Montana regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

....301(13), (34), (39), (46), (47), (64), (71), (73), (76), (79), (95), (103), (110), (111), (133); 17.24...(143); 17.24.302; 17.24.303(1)(w), (x), and (y); 17.24.305(2)(b)(i); 17.24.308(1)(b)(vii); 17.24.312(1...

30 CFR 926.15 - Approval of Montana regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

....301(13), (34), (39), (46), (47), (64), (71), (73), (76), (79), (95), (103), (110), (111), (133); 17.24...(143); 17.24.302; 17.24.303(1)(w), (x), and (y); 17.24.305(2)(b)(i); 17.24.308(1)(b)(vii); 17.24.312(1...

30 CFR 924.15 - Approval of Mississippi regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

...). September 28, 2001 December 3, 2002 Sections 105; 1103; 1105; 1106; 1107(a), (b), (f), and (h); 2103(b)(14.../description May 6, 1997 January 9, 1998 MSCMRL 53-9-3; 5; 7; 9; 11; 13; 15; 17; 19; 21; 23; 25; 26; 27; 28; 29...

75 FR 41254 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-15

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62476; File No. SR-FINRA-2010-012] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule Change To Amend FINRA Rule 8312 (FINRA BrokerCheck Disclosure) July 8, 2010. I. Introduction On March 30, 2010, the Financial Industry Regulatory...

Petitioning process for irradiated foods and animal feeds in North America

NASA Astrophysics Data System (ADS)

Marcotte, Michelle; Kunstadt, Peter

1993-07-01

The lack of sufficient regulatory approvals continues to delay the commercial application of food irradiation in several countries. Often, the regulatory approval process itself appears too challenging and approvals are not even requested. We believe that petitions can be successful and want to encourage interested parties to submit good quality approval petitions to the regulatory authorities. The objective of this paper is to review petition requirements so that researchers and companies in other countries will be able to prepare petitions requesting approval for the import and sale of irradiated foods into North America.

Effectiveness of the Civil Aviation Security Program.

DTIC Science & Technology

1982-10-26

12 IX. CIVIL AVIATION SECURITY ACTIONS . . . . . . 14 X . MPIANCE M EN4FOW . ........ 20 X . U . . . . . ... . . . . .. . . . 21 EXHIBITS 1...Screening Results 10. Weapon Detection Devices 11. X -Ray Baggage Inspection Systems 12. Basic Policies 13. Regulatory Impact 14. FAA Sponsored Explosive...WERE APPROVED FOR MORE THAN 200 AIRPORTS. D . TESTING WAS BEGUN ON A NEW C MPUTER PROGRAM FOR HE X -RAY ABSORPTION SYSTEM DEVELOPED TO DTECT BMBS IN

77 FR 55519 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-10

...\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to adopt existing NASD Interpretive Material... Policy The proposed rule change would replace several existing provisions in the Front Running Policy...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change...

78 FR 58580 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-24

... proposed rule change, FINRA would no longer require a customer to elect one of the two existing panel...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change...,\\2\\ a proposed rule change amending the Code of Arbitration Procedure for Customer Disputes...

75 FR 43588 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-26

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.

PubMed

Khozin, Sean; Abernethy, Amy P; Nussbaum, Nathan C; Zhi, Jizu; Curtis, Melissa D; Tucker, Melisa; Lee, Shannon E; Light, David E; Gossai, Anala; Sorg, Rachael A; Torres, Aracelis Z; Patel, Payal; Blumenthal, Gideon Michael; Pazdur, Richard

2018-03-01

Evidence from cancer clinical trials can be difficult to generalize to real-world patient populations, but can be complemented by real-world evidence to optimize personalization of care. Further, real-world usage patterns of programmed cell death protein 1 (PD-1) inhibitors following approval can inform future studies of subpopulations underrepresented in clinical trials. We performed a multicenter analysis using electronic health record data collected during routine care of patients treated in community cancer care clinics in the Flatiron Health network. Real-world metastatic non-small cell lung cancer (NSCLC) patients who received nivolumab or pembrolizumab in the metastatic setting ( n  = 1,344) were selected from a starting random sample of 55,969 NSCLC patients with two or more documented visits from January 1, 2011, through March 31, 2016. The primary study outcome measurement was demographic and treatment characteristics of the cohort. Median age at PD-1 inhibitor initiation was 69 years (interquartile range 61-75). Patients were 56% male, 88% smokers, 65% nonsquamous histology, and 64% diagnosed at stage IV. Of 1,344 patients, 112 (8%) were tested for programmed death-ligand 1 expression. Overall, 50% received nivolumab or pembrolizumab in the second line, with a substantial proportion of third and later line use that began to decline in Q4 2015. During the year following U.S. regulatory approval of PD-1 inhibitors for treatment of NSCLC, real-world patients receiving nivolumab or pembrolizumab were older at treatment initiation and more had smoking history relative to clinical trial cohorts. Studies of outcomes in underrepresented subgroups are needed to inform real-world treatment decisions. Evidence gathered in conventional clinical trials used to assess safety and efficacy of new therapies is not necessarily generalizable to real-world patients receiving these drugs following regulatory approval. Real-world evidence derived from electronic health record data can yield complementary evidence to enable optimal clinical decisions. Examined here is a cohort of programmed cell death protein 1 inhibitor-treated metastatic non-small cell lung cancer patients in the first year following regulatory approval of these therapies in this indication. The analysis revealed how the real-world cohort differed from the clinical trial cohorts, which will inform which patients are underrepresented and warrant additional studies. © AlphaMed Press 2018.

78 FR 52219 - State of Georgia Relinquishment of Sealed Source and Device Evaluation and Approval Authority

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0196] State of Georgia Relinquishment of Sealed Source and... evaluate and approve sealed source and device (SS&D) applications in the State of Georgia and approved the... regulatory authority for evaluating and approving sealed source and device applications on August 20, 2013...

75 FR 48525 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-10

...OSM is announcing its partial approval of a program amendment submitted by the Commonwealth of Pennsylvania for the purpose of addressing the need for financial guarantees to cover the costs of treatment of post-mining pollutional discharges and land reclamation for those surface coal mining sites that were originally bonded under the Commonwealth's now defunct alternative bonding system (ABS). OSM is requiring that Pennsylvania ensure that its program provides suitable, enforceable funding mechanisms sufficient to guarantee coverage of land reclamation at all original ABS sites.

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

PubMed

Sridhara, Rajeshwari; Johnson, John R; Justice, Robert; Keegan, Patricia; Chakravarty, Aloka; Pazdur, Richard

2010-02-24

The Office of Oncology Drug Products (OODP) in the Center for Drug Evaluation and Research at the US Food and Drug Administration began reviewing marketing applications for oncological and hematologic indications in July 2005. We conducted an overview of products that were reviewed by the OODP for marketing approval and the regulatory actions taken during July 2005 to December 2007. We identified all applications that were reviewed by the OODP from July 1, 2005, through December 31, 2007, and reviewed the actions that OODP took. We also sought the basis for the actions taken, including the clinical trial design, endpoints used, patient accrual in the trial(s) supporting approval, and the type of regulatory approval. During the study period, the OODP reviewed marketing applications for 60 new indications and took regulatory action on 58 indications. Regulatory action was based on a risk-benefit evaluation of the data submitted with each application. Products that demonstrated efficacy and had an acceptable risk-benefit ratio were granted either regular or accelerated marketing approval for use in the specific indication that was studied. Regular approval was based on endpoints that demonstrated that the drug provided clinical benefit as evidenced by a longer or better life or a favorable effect on an established surrogate for a longer or better life. Accelerated approval was based on a less well-established surrogate endpoint that was reasonably likely to predict a longer or better life. Of the 53 new indications that were approved during the study period, 39 received regular approval, nine received accelerated approval, and five were converted from accelerated to regular approval. Five applications were not approved, and two applications were withdrawn before any regulatory action was taken. Eighteen of the 53 indications that were approved were for new molecular entities. During the study period, regulatory action was taken on 58 of the 60 marketing applications. Fifty-three applications were approved. A variety of clinical trial endpoints were used in the approval trials.

78 FR 21449 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-10

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... ``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to amend FINRA's Customer and Industry... arbitrator'' in the Codes. Specifically, the proposed rule change would (a) exclude persons associated with a...

49 CFR 173.471 - Requirements for U.S. Nuclear Regulatory Commission approved packages.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 2 2011-10-01 2011-10-01 false Requirements for U.S. Nuclear Regulatory...) Materials § 173.471 Requirements for U.S. Nuclear Regulatory Commission approved packages. In addition to the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) and other requirements of...

49 CFR 173.471 - Requirements for U.S. Nuclear Regulatory Commission approved packages.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 2 2014-10-01 2014-10-01 false Requirements for U.S. Nuclear Regulatory...) Materials § 173.471 Requirements for U.S. Nuclear Regulatory Commission approved packages. In addition to the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) and other requirements of...

49 CFR 173.471 - Requirements for U.S. Nuclear Regulatory Commission approved packages.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Requirements for U.S. Nuclear Regulatory...) Materials § 173.471 Requirements for U.S. Nuclear Regulatory Commission approved packages. In addition to the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) and other requirements of...

49 CFR 173.471 - Requirements for U.S. Nuclear Regulatory Commission approved packages.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 2 2013-10-01 2013-10-01 false Requirements for U.S. Nuclear Regulatory...) Materials § 173.471 Requirements for U.S. Nuclear Regulatory Commission approved packages. In addition to the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) and other requirements of...

30 CFR 901.15 - Approval of Alabama regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

...); 10D-.28(3); 12A-.01 through .08; and other items. May 22, 1985 July 19, 1985 ASMC Rules 880-X-2E...; 11D-.10; 11E. July 16, 1990 February 28, 1991 ASMC Rules 880-X-2A-.07(1)(c); 2E-.01 through .11. July...

30 CFR 901.15 - Approval of Alabama regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

...); 10D-.28(3); 12A-.01 through .08; and other items. May 22, 1985 July 19, 1985 ASMC Rules 880-X-2E...; 11D-.10; 11E. July 16, 1990 February 28, 1991 ASMC Rules 880-X-2A-.07(1)(c); 2E-.01 through .11. July...

30 CFR 901.15 - Approval of Alabama regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

...); 10D-.28(3); 12A-.01 through .08; and other items. May 22, 1985 July 19, 1985 ASMC Rules 880-X-2E...; 11D-.10; 11E. July 16, 1990 February 28, 1991 ASMC Rules 880-X-2A-.07(1)(c); 2E-.01 through .11. July...

30 CFR 901.15 - Approval of Alabama regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

...); 10D-.28(3); 12A-.01 through .08; and other items. May 22, 1985 July 19, 1985 ASMC Rules 880-X-2E...; 11D-.10; 11E. July 16, 1990 February 28, 1991 ASMC Rules 880-X-2A-.07(1)(c); 2E-.01 through .11. July...

30 CFR 901.15 - Approval of Alabama regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

...); 10D-.28(3); 12A-.01 through .08; and other items. May 22, 1985 July 19, 1985 ASMC Rules 880-X-2E...; 11D-.10; 11E. July 16, 1990 February 28, 1991 ASMC Rules 880-X-2A-.07(1)(c); 2E-.01 through .11. July...

77 FR 58600 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

... approving expansion of STO Program)[sic]. \\9\\ These include, without limitation, options, equities, futures... hedging strategies across various investment platforms (e.g. equity and ETF, index, derivatives, futures... Web site, strike prices for options on futures may be at an interval of $.05, $.10, and $.25 per...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-18

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

30 CFR 950.15 - Approval of Wyoming regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

...), (ba), 3(b)(i); Ch II, §§ 3(a)(vi)(E), (M), (b)(xvi)(D), (xx), (v)(C); Ch IV, §§ 3(d)(vii), (e)(i)(H..., 2009 Chapter 11, Section 2(a)(vii)(A). [62 FR 9958, Mar. 5, 1997, as amended at 64 FR 53208, Oct. 1...

78 FR 21657 - Self-Regulatory Organizations; International Securities Exchange LLC; Order Approving, on an...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-11

... securities suddenly declining by significant amounts in a very short time period before suddenly reversing to... circuit breaker pilot program, which was implemented through a series of rule filings by the equity exchanges and by FINRA.\\9\\ The single-stock circuit breaker was designed to reduce extraordinary market...

77 FR 52082 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

... for, and used by, firms clearing market maker business; however, use of the Program diminished as market making operations were acquired by larger wire houses. While OCC occasionally receives an inquiry...). For the Commission by the Division of Trading and Markets, pursuant to delegated authority.\\9\\ \\9\\ 17...

75 FR 5831 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-04

... series.\\8\\ The annual report will also contain information and analysis of FLEX Options trading patterns... will also contain information and analysis of FLEX Options trading patterns, and index price volatility... To Establish a Pilot Program To Modify FLEX Option Exercise Settlement Values and Minimum Value Sizes...

10 CFR 13.7 - Complaint.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Complaint. 13.7 Section 13.7 Energy NUCLEAR REGULATORY COMMISSION PROGRAM FRAUD CIVIL REMEDIES § 13.7 Complaint. (a) On or after the date the Department of Justice approves the issuance of a complaint in accordance with 31 U.S.C. 3803(b)(1), the reviewing official may...

75 FR 62592 - Applications and Amendments to Facility Operating Licenses Involving Proposed No Significant...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

... Operating Licenses include: (1) The proposed Cyber Security Plan for CCNPP, Ginna, and NMPNS, (2) an... provisions of the Nuclear Regulatory Commission-approved Cyber Security Plan for CCNPP, Ginna, and NMPNS as... Communication Systems and Networks,'' establish the requirements for a cyber security program. This regulation...

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

ERIC Educational Resources Information Center

Roll, Michalene H.

1990-01-01

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

78 FR 21675 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving, on an Accelerated...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-11

... by significant amounts in a very short time period before suddenly reversing to prices consistent... circuit breaker pilot program, which was implemented through a series of rule filings by the equity exchanges and by FINRA.\\6\\ The single-stock circuit breaker was designed to reduce extraordinary market...

76 FR 79729 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

... plc as signatories. II. Self-Regulatory Organization's Statement of the Terms of Substance of the... approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66001; File No. SR-ICC-2011-03] Self-Regulatory...

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

PubMed

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

2018-05-16

Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics. Biosimilar approval pathways in many major regulatory regions worldwide are, to a broad degree, scientifically aligned. However, owing to regional differences in health care priorities, policies, and resources, some important regulatory inconsistencies are evident. Acceptance of biosimilars by health care systems, health care professionals, and patients will be a key factor in the uptake of these therapies, and such regulatory variations could contribute to confusion and diminished confidence regarding the quality, efficacy, and reliability of these agents. Furthermore, the need for manufacturers to account for regulatory inconsistencies introduces inefficiencies and delays into biosimilar development programs. These issues should be addressed if biosimilars are to attain their maximal global potential. This review summarizes the evolution of the global biosimilar landscape and provides examples of inconsistencies between regulatory requirements in different regions. In addition, we review ongoing efforts to improve regulatory alignment and highlight the importance of education as a crucial factor in generating trust in, and acceptance of, biosimilars on a worldwide scale. Biosimilars of monoclonal antibody anticancer therapies are beginning to emerge, and more are likely to become available for clinical use in the near future. The extent to which biosimilars can contribute to cancer care will depend on their level of acceptance by health care systems, health care professionals, and patients. A better understanding of the regulatory basis for the approval of biosimilars may enhance confidence and trust in these agents. In order to have informed discussions about treatment choices with their patients, oncologists should familiarize themselves with the biosimilar paradigm. © AlphaMed Press 2018.

10 CFR 20.1009 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 20.1009 Section 20.1009 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION General Provisions § 20.1009 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission...

10 CFR 20.1009 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 20.1009 Section 20.1009 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION General Provisions § 20.1009 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission...

10 CFR 20.1009 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Information collection requirements: OMB approval. 20.1009 Section 20.1009 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION General Provisions § 20.1009 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission...

10 CFR 20.1009 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Information collection requirements: OMB approval. 20.1009 Section 20.1009 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION General Provisions § 20.1009 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission...

10 CFR 20.1009 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Information collection requirements: OMB approval. 20.1009 Section 20.1009 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION General Provisions § 20.1009 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission...

10 CFR 55.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Information collection requirements: OMB approval. 55.8 Section 55.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) OPERATORS' LICENSES General Provisions § 55.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has...

10 CFR 9.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Information collection requirements: OMB approval. 9.8 Section 9.8 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS § 9.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information collection...

10 CFR 9.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Information collection requirements: OMB approval. 9.8 Section 9.8 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS § 9.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information collection...

10 CFR 9.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Information collection requirements: OMB approval. 9.8 Section 9.8 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS § 9.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information collection...

10 CFR 55.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 55.8 Section 55.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) OPERATORS' LICENSES General Provisions § 55.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has...

10 CFR 9.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 9.8 Section 9.8 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS § 9.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information collection...

10 CFR 9.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 9.8 Section 9.8 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS § 9.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information collection...

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

PubMed

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

2017-01-01

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

10 CFR 40.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 40.8 Section 40.8 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL General Provisions § 40.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has...

10 CFR 100.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 100.8 Section 100.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) REACTOR SITE CRITERIA § 100.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information...

10 CFR 100.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 100.8 Section 100.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) REACTOR SITE CRITERIA § 100.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information...

10 CFR 100.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Information collection requirements: OMB approval. 100.8 Section 100.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) REACTOR SITE CRITERIA § 100.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information...

A novel Web-based graduate medical education management system including ACGME compliance algorithms.

PubMed

Gauger, Paul G; Davis, Janice W; Orr, Peter J

2002-09-01

Administration of graduate medical education programs has become more difficult as compliance with ACGME work guidelines has assumed increased importance. These guidelines have caused many changes in the resident work environment, including the emergence of complicated cross-cover arrangements. Many participating residents (each with his or her own individual scheduling requirements) usually generate these schedules. Accordingly, schedules are often not submitted in a timely fashion and they may not be in compliance with the ACGME guidelines for maximum on-call assignments and mandatory days off. Our objective was the establishment of a Web-based system that guides residents in creating on-call schedules that follow ACGME guidelines while still allowing maximum flexibility -- thus allowing each resident to maintain an internal locus of control. A versatile and scalable system with password-protected user (resident) and administrator interfaces was created. An entire academic year is included, and past months and years are automatically archived. The residents log on within the first 15 days of the preceding month and choose their positions in a schedule template. They then make adjustments while receiving immediate summary feedback on compliance with ACGME guidelines. The schedule is electronically submitted to the educational administrator for final approval. If a cross-cover system is required, the program automatically generates an optimal schedule using both of the approved participating service schedules. The residents then have an additional five-day period to make adjustments in the cross-cover schedule while still receiving compliance feedback. The administrator again provides final approval electronically. The communication interface automatically pages or e-mails the residents when schedules are updated or approved. Since the information exists in a relational database, simple reporting tools are included to extract the information necessary to generate records for institutional GME management. Implementation of this program has been met with great enthusiasm from the institutional stakeholders. Specifically, residents have embraced the ability to directly control their schedules and have gained appreciation for the regulatory matrix in which they function. Institutional administrators have praised the improvement in compliance and the ease of documentation. We anticipate that the system will also meet with approval from reviewing regulatory bodies, as it generates and stores accurate information about the resident work environment. This program is robust and versatile enough to be modified for any GME training program in the country.

78 FR 689 - Notice of Request for Revision to and Extension of Approval of an Information Collection; APHIS...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-04

... exposes students to careers in APHIS, it also gives APHIS' employees the opportunity to meet and invest in...: Send your comment to Docket No. APHIS-2012-0100, Regulatory Analysis and Development, PPD, APHIS... Program is designed to help students learn about careers in animal science, veterinary medicine, plant...

76 FR 80998 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... Latency Network Connections December 20, 2011. I. Introduction On October 31, 2011, NASDAQ OMX BX, Inc... establish a program for offering low latency network connections and to establish the initial fees for such connections. The Exchange also proposed administrative modifications to Exchange Rule 7034. The proposed rule...

78 FR 79524 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval to Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71176; File No. SR-NYSEArca-2013-107] Self... Retail Liquidity Program on a Pilot Basis for a Period of One Year From the Date of Implementation and... On October 22, 2013, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'') filed with the Securities and...

30 CFR 936.15 - Approval of Oklahoma regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

... “surface coal mining operations”, 701.5: definitions of “coal preparation” and “coal preparation plant....11(b)(4), and part 702, concerning an exemption for operations when the extraction of coal is incidental to the extraction of other minerals. June 21, 1990 January 9, 1991 DOM/RR 772.12(b)(12); 773.5(a...

30 CFR 936.15 - Approval of Oklahoma regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... “surface coal mining operations”, 701.5: definitions of “coal preparation” and “coal preparation plant....11(b)(4), and part 702, concerning an exemption for operations when the extraction of coal is incidental to the extraction of other minerals. June 21, 1990 January 9, 1991 DOM/RR 772.12(b)(12); 773.5(a...

Freedom and Constraint in Teacher Education: Reflections on Experiences over Time

ERIC Educational Resources Information Center

McGraw, Amanda

2018-01-01

Teacher education programs in Australia increasingly comply with new and narrowing accountabilities so that they can be approved by diverse regulatory authorities and accredited. This is an auto-biographical narrative study which draws upon the memories of a teacher educator who contrasts her experience of learning to teach in the early 1980s with…

76 FR 4959 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... Class on NYSE Under a Pilot Program January 19, 2011. I. Introduction On November 23, 2010, New York... the Exchange's BLP proposal. For additional information, see Notice, supra note 3. (1) Quoting... technology to support electronic trading.\\10\\ \\10\\ A member organization's off-Floor technology must be fully...

76 FR 5646 - Self-Regulatory Organizations; NYSE Amex LLC; Order Granting Approval of Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-01

... strike prices and non-parallel strikes in different expiration months of the same issue. The Commission... Listing of Options Series With $1 Strike Prices January 25, 2011. I. Introduction On November 24, 2010... Strike Price Program. The proposed rule change was published for comment in the Federal Register on...

Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

PubMed Central

Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.

2015-01-01

Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691

Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

PubMed

Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

2015-10-01

The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

76 FR 28257 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-16

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change To Modify Chapter... Commission received no comment letters regarding the proposal. This order approves the proposed rule change... for imbalance and indicative data dissemination; (4) clarify when an Order Imbalance Indicator is...

78 FR 15383 - Approval of Direct Transfer of Licenses and Issuance of License Amendment To Effectuate Such...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-11

... NUCLEAR REGULATORY COMMISSION [Docket Nos. 70-7003 and 70-7004; NRC-2010-0355] Approval of Direct... Operating, LLC AGENCY: Nuclear Regulatory Commission. ACTION: Notice of approval of direct transfer of control and issuance of license amendments to effectuate such transfers. SUMMARY: The U.S. Nuclear...

Developing regulatory strategy for microbicides.

PubMed

Nardi, Ronald; Arterburn, Linda; Carlton, Lisa

2014-01-01

Ever since the discovery that a virus was responsible for AIDS, prevention of HIV infection has been a drug/vaccine development target in therapeutic research. Microbicide products are a viable, globally applicable option; however, to date, no product has been approved anywhere in the world. Development of such a product will need to account for the changing disease landscape and will need to leverage available regulatory pathways to gain approvals in the developed world and emerging markets. In countries where the regulatory pathway is not clear which is the case in several emerging markets, sponsors will need to employ a flexible approach to gather and meet local regulatory requirements and ultimately gain product approvals.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-29

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63599; File No. SR-MSRB-2010-16] Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of Amendments to Rule G-5, on Disciplinary Actions by Appropriate Regulatory Agencies, Remedial Notices by Registered Securities Associations; and Rule G-17, on Conduct...

75 FR 43584 - Self-Regulatory Organizations; EDGX Exchange, Inc; Order Approving a Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-26

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62515; File No. SR-EDGX-2010-02] Self-Regulatory Organizations; EDGX Exchange, Inc; Order Approving a Proposed Rule Change Relating to Direct Edge... DE Holdings, and DE Holdings will be the sole stockholder of DEI. The self-regulatory functions of...

75 FR 43582 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-26

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62514; File No. SR-EDGA-2010-02] Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change Relating to Direct Edge... Holdings will be the sole stockholder of DEI. The self-regulatory functions of the Exchange will remain...

78 FR 37848 - ASME Code Cases Not Approved for Use

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-06

... of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule... technology approved by the Commission under Section 218(a) for use at the site of any civilian nuclear power... NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 RIN 3150-AI75 [NRC-2009-0538] List of Approved Spent...

75 FR 33678 - List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision 1

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-15

... of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule... technology approved by the Commission under Section 218(a) for use at the site of any civilian nuclear power... NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2010-0140] RIN 3150-AI86 List of Approved Spent...

76 FR 16462 - Self-Regulatory Organizations; NASDAQ OMX BX LLC; Order Approving a Proposed Rule Change Relating...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64090; File No. SR-BX-2011-007] Self-Regulatory Organizations; NASDAQ OMX BX LLC; Order Approving a Proposed Rule Change Relating to Permanent Approval of the BX and NES Inbound Routing Relationship March 17, 2011. I. Introduction On January 28, 2011, NASDAQ...

Biosimilars: The US Regulatory Framework.

PubMed

Christl, Leah A; Woodcock, Janet; Kozlowski, Steven

2017-01-14

With the passage of the Biologics Price Competition and Innovation Act of 2009, the US Food and Drug Administration established an abbreviated pathway for developing and licensing biosimilar and interchangeable biological products. The regulatory framework and the technical requirements of the US biosimilars program involve a stepwise approach that relies heavily on analytical methods to demonstrate through a "totality of the evidence" that a proposed product is biosimilar to its reference product. By integrating analytical, pharmacological, and clinical data, each of which has limitations, a high level of confidence can be reached regarding clinical performance. Although questions and concerns about the biosimilars pathway remain and may slow uptake, a robust scientific program has been put in place. With three biosimilars already licensed and numerous development programs under way, clinicians can expect to see many new biosimilars come onto the US market in the coming decade. [Note added in proof: Since the writing of this article, a fourth biosimilar has been approved.].

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-12

... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62036; File No. 4-594] Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGX Exchange, Inc. May 5, 2010. On March 19, 2010...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-12

... Commission adopted amendments to paragraph (c) of Rule 19d-1 to allow self-regulatory organizations (``SROs... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62037; File No. 4-595] Self-Regulatory Organizations; Order Approving Minor Rule Violation Plan for EDGA Exchange, Inc. May 5, 2010. On March 19, 2010...

Innovation under Regulatory Uncertainty: Evidence from Medical Technology

PubMed Central

Stern, Ariel Dora

2016-01-01

This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34 percent (7.2 months) longer than follow-on entrants in regulatory approval. Back-of-the- envelope calculations suggest that the cost of a delay of this length is upwards of 7 percent of the total cost of bringing a new high-risk device to market. Considering potential explanations, I find that approval times are largely unrelated to technological novelty, but are meaningfully reduced by the publication of objective regulatory guidelines. Finally, I consider how the regulatory process affects small firms’ market entry patterns and find that small firms are less likely to be pioneers in new device markets, a fact consistent with relatively higher costs of doing so for more financially constrained firms. PMID:28652646

A practical guide about biosimilar data for health care providers treating inflammatory diseases.

PubMed

Markenson, Joseph; Alvarez, Daniel F; Jacobs, Ira; Kirchhoff, Carol

2017-01-01

To make informed decisions about the safety, efficacy, and clinical utility of a biosimilar, health care providers should understand the types and be able to analyze data generated from a biosimilar development program. This article reviews the biosimilar guidelines, the biosimilar development process to provide education and context about biosimilarity, and uses examples from infliximab biosimilars to review the terminology and potential types of analyses that may be used to compare potential biosimilars to the originator biologic. A biosimilar is a biologic product that is highly similar to an approved (originator) biologic, notwithstanding minor differences in clinically inactive components, and with no clinically meaningful differences in terms of the safety, purity, and potency of the product. Due to their complex nature and production in living systems, it is not possible to exactly duplicate the approved originator biologic. To ensure biosimilars provide consistent, safe, and effective treatment comparable to the originator biologic, extensive analyses of the potential biosimilar are conducted, including side-by-side analytical, nonclinical, and clinical comparisons. A key goal is to determine whether there are sufficient relevant similarities in chemical composition, biologic activity, and pharmacokinetic aspects between the potential biosimilar and the originator. Regulatory approvals and marketing authorizations for biosimilars are made on a case-by-case and agency-by-agency basis after evaluating the totality of the evidence generated from the entire development program. Understanding how regulatory agencies review data for approval can help health care providers make appropriate decisions when biosimilars become available for use in the treatment of inflammatory diseases, and therefore they should review the literature to gain further information about specific biosimilars.

[Three types of brand name loyalty strategies set up by drug manufacturers].

PubMed

PréMont, Marie-Claude; Gagnon, Marc-André

2014-11-01

The recent restructuring of the pharmaceutical industry has led to three new types of promotional strategies to build patient loyalty to brand name drugs: loyalty through rebates, patient support, and compassion programs. Loyalty through rebates seeks to keep patients on a brand name drug and prevent their switch to the generic equivalent. Loyalty through patient support provides aftersales services to help and support patients (by phone or home visits) in order to improve adherence to their treatments. Finally, compassion programs offer patients access to drugs still awaiting regulatory approval or reimbursement by insurers. When and if the approval process is successful, the manufacturer puts an end to the compassion program and benefits from a significant cohort of patients already taking a very expensive drug for which reimbursement is assured. The impact of these programs on public policies and patients' rights raises numerous concerns, among which the direct access to patients and their health information by drug manufacturers and upward pressure on costs for drug insurance plans.

Prospective Activities outlined for Regulatory Approval in Ghana Overview

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

Abrefah, R.G.; Odoi, H.C.; Mo, S.C.

The Ghana Research Reactor-1 (GHARR-1) is one of Chinese’s Miniature Neutron Source Reactor (MNSR) which was purchased under a tripartite agreement between Ghana, China and the IAEA. The reactor was installed in 1994 and has since been in operation without any incident. It has been used chiefly for Neutron Activation Analysis (NAA) and Training of students in the field of Nuclear Engineering. The GHARR-1 has been earmarked for the Conversion of Core from HEU to LEU which is in accordance with the GTRI program and other related and/or associated programs. Over the past few years the National Nuclear Research Institutemore » (NNRI), the Operating Organization of the Research Reactor for the Ghana Atomic Energy Commission (GAEC), has undertaken various tasks in order to implement the replacement of the reactor core. After completion, of the neutronic calculations, results showed that that an LEU fuel of 12.5% enrichment was desirable. However, recent developments have shown that an LEU fuel with 13% enrichment will be fabricated by the manufacturers, which is captured in a fuel specification document sent to NNRI by the CIAE. It is therefore imperative that all neutronic and thermal hydraulic calculation be done again to help acquire regulatory approval. Furthermore, the radiation exposure to personnel involved in the conversion must be estimated to help convince our regulators. This paper outlines the processes and activities that will enable us meet regulatory requirements.« less

Gene therapy for cancer: regulatory considerations for approval.

PubMed

Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K

2015-12-01

The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA.

Meeting Regulatory Needs.

PubMed

Weber, Michael Fred

2017-02-01

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

Gene therapy for cancer: regulatory considerations for approval

PubMed Central

Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K

2015-01-01

The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA. PMID:26584531

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

PubMed

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

2005-08-01

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

Reconstructing the Prostate Cancer Transcriptional Regulatory Network

DTIC Science & Technology

2010-07-01

the Medical Scientist Training Program. The funders had no role in study design , data collection and analysis , decision to publish, or preparation of...reverse analysis , building a cell line subtype classifier to classify 86 breast tumors (from the original Stanford/Norway study defining the five tumor...Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public

30 CFR 920.15 - Approval of Maryland regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., .25; and other items. January 30, 1985 September 10, 1985 COMAR 08.13.09.02, .25. January 13, 1984...(D). March 30, 1989 January 11, 1991 COMAR 08.13.09.01, .02, .13, .17, .28, .31 through .34, .42, .43...). September 28, 1990, November 21, 1990 April 26, 1991 COMAR 08.13.09.06, B, .43K(7), N(7). March 27, 1989 May...

30 CFR 918.15 - Approval of Louisiana regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., 1990 May 8, 1991 Chapters 1, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 35, 37, 39, 41, 43, 45, 47, 51... interpreting LSMR 2523; LSMR 53125. May 3, 1994 September 20, 1994 LSMR 53123.B.4.a. November 2, 1994 January 24, 1995 LSMR 5423.B.4.a; Policy Statement PS-5. December 4, 1997 March 11, 1998 LSMR section 105...

30 CFR 943.15 - Approval of Texas regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

... through .625. August 24, 1988 December 11, 1989 TCMR 806.309(j)(1)(A) through (H), (2)(A) through (D), (4)(A), (B), (C), (5)(A), (B), (6)(A) through (E), (7), (8). June 24, 1991 February 19, 1992 TCMR 806.309(j)(1)(H), (I), 806.309(j)(2), (3), (7), (8), (9). December 23, 1991 April 17, 1992 TCMR 816.394...

30 CFR 943.15 - Approval of Texas regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

... through .625. August 24, 1988 December 11, 1989 TCMR 806.309(j)(1)(A) through (H), (2)(A) through (D), (4)(A), (B), (C), (5)(A), (B), (6)(A) through (E), (7), (8). June 24, 1991 February 19, 1992 TCMR 806.309(j)(1)(H), (I), 806.309(j)(2), (3), (7), (8), (9). December 23, 1991 April 17, 1992 TCMR 816.394...

30 CFR 943.15 - Approval of Texas regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

... through .625. August 24, 1988 December 11, 1989 TCMR 806.309(j)(1)(A) through (H), (2)(A) through (D), (4)(A), (B), (C), (5)(A), (B), (6)(A) through (E), (7), (8). June 24, 1991 February 19, 1992 TCMR 806.309(j)(1)(H), (I), 806.309(j)(2), (3), (7), (8), (9). December 23, 1991 April 17, 1992 TCMR 816.394...

30 CFR 943.15 - Approval of Texas regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

... through .625. August 24, 1988 December 11, 1989 TCMR 806.309(j)(1)(A) through (H), (2)(A) through (D), (4)(A), (B), (C), (5)(A), (B), (6)(A) through (E), (7), (8). June 24, 1991 February 19, 1992 TCMR 806.309(j)(1)(H), (I), 806.309(j)(2), (3), (7), (8), (9). December 23, 1991 April 17, 1992 TCMR 816.394...

30 CFR 915.15 - Approval of Iowa regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Bill. August 12, 1986 December 11, 1986 IAC 4.522(15)c, g. April 28, 1987 October 7, 1987 I.C. 83.7. June 9, 1988. December 9, 1988 I.C. 83.26. December 26, 1990 November 6, 1991 IAC 27-40.1 through .7, .11, .12, .13, .21, .22, .23, .30 through .39, .41, .51, .61 through .68, .71 through .74, .81, .82...

30 CFR 915.15 - Approval of Iowa regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Bill. August 12, 1986 December 11, 1986 IAC 4.522(15)c, g. April 28, 1987 October 7, 1987 I.C. 83.7. June 9, 1988. December 9, 1988 I.C. 83.26. December 26, 1990 November 6, 1991 IAC 27-40.1 through .7, .11, .12, .13, .21, .22, .23, .30 through .39, .41, .51, .61 through .68, .71 through .74, .81, .82...

30 CFR 915.15 - Approval of Iowa regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Bill. August 12, 1986 December 11, 1986 IAC 4.522(15)c, g. April 28, 1987 October 7, 1987 I.C. 83.7. June 9, 1988. December 9, 1988 I.C. 83.26. December 26, 1990 November 6, 1991 IAC 27-40.1 through .7, .11, .12, .13, .21, .22, .23, .30 through .39, .41, .51, .61 through .68, .71 through .74, .81, .82...

30 CFR 915.15 - Approval of Iowa regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Bill. August 12, 1986 December 11, 1986 IAC 4.522(15)c, g. April 28, 1987 October 7, 1987 I.C. 83.7. June 9, 1988. December 9, 1988 I.C. 83.26. December 26, 1990 November 6, 1991 IAC 27-40.1 through .7, .11, .12, .13, .21, .22, .23, .30 through .39, .41, .51, .61 through .68, .71 through .74, .81, .82...

30 CFR 915.15 - Approval of Iowa regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Bill. August 12, 1986 December 11, 1986 IAC 4.522(15)c, g. April 28, 1987 October 7, 1987 I.C. 83.7. June 9, 1988. December 9, 1988 I.C. 83.26. December 26, 1990 November 6, 1991 IAC 27-40.1 through .7, .11, .12, .13, .21, .22, .23, .30 through .39, .41, .51, .61 through .68, .71 through .74, .81, .82...

30 CFR 902.15 - Approval of Alaska regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

...), .185(a)(3), (4), (5), .207(c)(5)(C), .213(g), (h), .323(a) through (d), .325(b), (c), (d)(1), (2), (3...), .349(2)(A), .353(a)(1), (2), (3), .371(d)(1) through (4), .373(b), (c), (d), .375(b), (e) through (h...), .491(a), (1), (6), (7), (8), (c)(4) through (8), (e), (f), .901(e), .907(c) through (h), (j). December...

30 CFR 902.15 - Approval of Alaska regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

...), .185(a)(3), (4), (5), .207(c)(5)(C), .213(g), (h), .323(a) through (d), .325(b), (c), (d)(1), (2), (3...), .349(2)(A), .353(a)(1), (2), (3), .371(d)(1) through (4), .373(b), (c), (d), .375(b), (e) through (h...), .491(a), (1), (6), (7), (8), (c)(4) through (8), (e), (f), .901(e), .907(c) through (h), (j). December...

10 CFR 51.17 - Information collection requirements; OMB approval.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Information collection requirements; OMB approval. 51.17 Section 51.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...

10 CFR 51.17 - Information collection requirements; OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements; OMB approval. 51.17 Section 51.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...

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

PubMed Central

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

2010-01-01

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

Is a separate monotherapy indication warranted for antiepileptic drugs?

PubMed

Mintzer, Scott; French, Jacqueline A; Perucca, Emilio; Cramer, Joyce A; Messenheimer, John A; Blum, David E; Rogawski, Michael A; Baulac, Michel

2015-12-01

Antiepileptic drugs (AEDs) are the only neurotherapeutics for which regulatory approval is consistently separated into monotherapy or adjunctive-therapy indications. Because head-to-head comparisons of AEDs (used in the European Union to approve drugs for monotherapy) have not shown substantial differences in efficacy between drugs, FDA approval for use of an AED as monotherapy has typically been based on trials with novel designs that have been criticised for reasons of ethics and clinical relevance. Many new-generation AEDs have not been approved for monotherapy, causing drug labelling and real-world use to be increasingly inconsistent, with negative consequences for patients. The regulatory requirement for separate monotherapy and adjunctive-therapy indications in epilepsy is unnecessarily restrictive. We recommend that regulatory agencies approve AEDs for the treatment of specific seizure types or epilepsy syndromes, irrespective of concomitant drug use. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

PubMed

Herder, Matthew; Krahn, Timothy Mark

2016-05-01

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

47 CFR 54.403 - Lifeline support amount.

Code of Federal Regulations, 2013 CFR

2013-10-01

... qualifying low-income consumer and that it has received any non-federal regulatory approvals necessary to... any non-federal regulatory approvals necessary to implement the required rate reduction. (b... Common Line charges or equivalent federal charges must apply federal Lifeline support to waive the...

47 CFR 54.403 - Lifeline support amount.

Code of Federal Regulations, 2012 CFR

2012-10-01

... qualifying low-income consumer and that it has received any non-federal regulatory approvals necessary to... any non-federal regulatory approvals necessary to implement the required rate reduction. (b... Common Line charges or equivalent federal charges must apply federal Lifeline support to waive the...

Regulatory Challenges for Cartilage Repair Technologies.

PubMed

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

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

Regulatory Challenges for Cartilage Repair Technologies

PubMed Central

Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)–approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product’s attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible. PMID:26069647

Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?

PubMed

Alqahtani, Saad; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Eguale, Tewodros

2015-07-01

The US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA. This study includes regulatory information on drug applications, approvals, indications, and orphan designations of all priority review drugs approved by the FDA and the EMA in the period 1999-2011. Descriptive statistics, t-tests, and chi-squared and Wilcoxon tests were performed. Overall, 100 FDA priority review new molecular entities and new therapeutic biologics were approved by both agencies; 87.0% of the products were first approved by the FDA. The average FDA review time (9.2 ± 8.4 months) was significantly lower than the EMA average review time (14.6 ± 4.0 months) (p < 0.0001). The FDA and the EMA granted orphan designation to 43.0% and 33.0%, respectively, of the applications. There were differences in the administration route (1.0% of all products), dosage (8.0%), strength (23%), posology (51.0%), indications (30.0%), restrictions of use (52.0%), limitations of use (19.0%), and outcomes limitations (28.0%) approved by both regulatory agencies. Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the EMA. Harmonization of the US and European regulatory frameworks may facilitate timely approval of pharmaceutical products. Copyright © 2015 John Wiley & Sons, Ltd.

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

PubMed Central

Downing, Nicholas S.; Shah, Nilay D.; Aminawung, Jenerius A.; Pease, Alison M.; Zeitoun, Jean-David; Krumholz, Harlan M.

2017-01-01

Importance Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. Objectives To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Design and Setting Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Exposures Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near–regulatory deadline approval, and regulatory review time. Main Outcomes and Measures A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. Results From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near–regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02). Conclusions and Relevance Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle. PMID:28492899

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

PubMed

Downing, Nicholas S; Shah, Nilay D; Aminawung, Jenerius A; Pease, Alison M; Zeitoun, Jean-David; Krumholz, Harlan M; Ross, Joseph S

2017-05-09

Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approval, and regulatory review time. A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near-regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02). Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near-regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.

76 FR 34815 - Wyoming Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-14

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

Regulatory Considerations for the Approval of Drugs Against Histomoniasis (Blackhead Disease) in Turkeys, Chickens, and Game Birds in the United States.

PubMed

Regmi, Prajwal R; Shaw, Ashley L; Hungerford, Laura L; Messenheimer, Janis R; Zhou, Tong; Pillai, Padmakumar; Omer, Amy; Gilbert, Jeffrey M

2016-12-01

Histomoniasis, commonly referred to as blackhead disease, is a serious threat to the turkey and game bird industries worldwide, and it is having an increasingly negative impact on the chicken industry as well. The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM), charged with the approval and regulation of new animal drugs in the United States, understands the rising need for the availability of therapeutic options against histomoniasis. CVM has actively engaged in discussions with the poultry industry, academic institutions, and animal health companies regarding the current status of histomoniasis in the United States and varied success of past and current management, prophylactic, and therapeutic interventions that have been used against the disease. As effective options against the disease are severely limited, CVM encourages the poultry industry, academic institutions, and animal health companies to work together to research and develop viable management, prophylactic, and therapeutic strategies, such as litter management, deworming programs, vaccines or other biologics, novel technologies, and animal drugs. CVM also recognizes the potential challenges that the poultry industry, academic institutions, and animal health companies may encounter while working towards the approval of safe and effective drug products for the treatment and control of histomoniasis. With that recognition, CVM encourages interested parties to begin discussions with CVM early in order to align research of the drug product against histomoniasis with the drug approval requirements, such that it leads to the approval of a new animal drug in an efficient and expedient manner. This article provides information about the FDA's regulatory process for the approval of new animal drugs in the United States, with especial emphasis on drug products for the treatment and control of histomoniasis in turkeys, chickens, and game birds.

76 FR 70207 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of Proposed Rule Change Regarding Professional Qualifications and Information Concerning Associated Persons November 3... information concerning associated persons. The proposed rule change was published for comment in the Federal...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

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

10 CFR 32.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 32.8 Section 32.8 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER...) The Nuclear Regulatory Commission has submitted the information collection requirements contained in...

10 CFR 32.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 32.8 Section 32.8 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER...) The Nuclear Regulatory Commission has submitted the information collection requirements contained in...

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.

PubMed

Hwang, Thomas J; Franklin, Jessica M; Chen, Christopher T; Lauffenburger, Julie C; Gyawali, Bishal; Kesselheim, Aaron S; Darrow, Jonathan J

2018-04-24

Purpose The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non-breakthrough-designated cancer drugs approved by the US Food and Drug Administration (FDA). Methods We studied all new cancer drugs approved by the FDA between January 2012 and December 2017. Regulatory and therapeutic characteristics (time to FDA approval, pivotal trial efficacy end point, novelty of mechanism of action) were compared between breakthrough-designated and non-breakthrough-designated cancer drugs. Random-effects meta-regression was used to assess the association between breakthrough therapy designation and hazard ratios for progression-free survival (PFS), response rates (RRs) for solid tumors, serious adverse events, and deaths not attributed to disease progression. Results Between 2012 and 2017, the FDA approved 58 new cancer drugs, 25 (43%) of which received breakthrough therapy designation. The median time to first FDA approval was 5.2 years for breakthrough-designated drugs versus 7.1 years for non-breakthrough-designated drugs (difference, 1.9 years; P = .01). There were no statistically significant differences between breakthrough-designated and non-breakthrough-designated drugs in median PFS gains (8.6 v 4.0 months; P = .11), hazard ratios for PFS (0.43 v 0.51; P = .28), or RRs for solid tumors (37% v 39%; P = .74). Breakthrough therapy-designated drugs were not more likely to act via a novel mechanism of action (36% v 39%; P = 1.00). Rates of deaths (6% v 4%; P = .99) and serious adverse events (38% v 36%; P = 0.93) were also similar in breakthrough-designated and non-breakthrough-designated drugs. Conclusion Breakthrough-designated cancer drugs were associated with faster times to approval, but there was no evidence that these drugs provide improvements in safety or novelty; nor was there a statistically significant efficacy advantage when compared with non-breakthrough-designated drugs.

30 CFR 913.15 - Approval of Illinois regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... March 16, 1984 September 28, 1984 62 IAC 1785.17(a). September 27, 1984 January 11, 1985 62 IAC 1816.190... September 3, 1993 62 IAC 1701, Appendix A; 1702.11(a)(2), (f)(1), (2), .17(c)(1), (2), (3); 1705.21; 1761.11.... August 17, 1993 February 2, 1994 225 ILCS 720 §§ 2.11 (a), (b), (c), (g); 6.01(b). September 9, 1994...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-02

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

18 CFR 131.20 - Application for approval of transfer of license.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY APPROVED FORMS, FEDERAL POWER ACT AND PUBLIC UTILITY... quadruplicate, together with one additional copy for each interested State commission) Before the Federal Energy... the Federal Energy Regulatory Commission of the transfer of the aforesaid license from the transferor...

77 FR 26061 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of Proposed Rule Change Consisting of Establishment of a Subscription to Historical Information and Documents Submitted to... historical information and documents submitted to the MSRB's Short-Term Obligation Rate Transparency System...

26 CFR 1.1092(c)-4 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Exchange Act Release No. 34-36841 (Feb. 21, 1996); or (ii) Self-Regulatory Organizations; Order Approving... 27, 1996); or (iii) Self-Regulatory Organizations; Order Approving Proposed Rule Change and Notice of... equity option— (1) That is described in any of the following Securities Exchange Act Releases— (i) Self...

78 FR 54349 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-03

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70263; File No. SR-NSCC-2013-09] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change.... On July 2, 2013, the National Securities Clearing Corporation filed with the Securities and Exchange...

75 FR 55836 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-14

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62849; File No. SR-NSCC-2010-07] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To... September 3, 2010. I. Introduction On July 1, 2010, National Securities Clearing Corporation (``NSCC...

77 FR 21123 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-09

... unsettled positions in classes of securities such as illiquid municipal or corporate bonds, whose volatility... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66731; File No. SR-NSCC-2012-02] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To...

75 FR 13174 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-18

...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving Proposed Rule Change To Establish Strike Price Intervals and Trading Hours for Options on Index-Linked Securities March 12, 2010. I. Introduction On January 27, 2010, the Chicago Board Options Exchange, Incorporated (``CBOE...

75 FR 29699 - Approval and Promulgation of Air Quality Implementation Plans: Florida; Approval of Section 110(a...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

... Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental...: Lynorae Benjamin, Chief, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics... Bradley, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management...

Avelumab: First Global Approval.

PubMed

Kim, Esther S

2017-05-01

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

Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.

PubMed

Nagai, Sumimasa; Ozawa, Keiya

2016-07-01

Differences in regulatory actions between Japan, the European Union (EU) and the United States (US) regarding the approval date and primary endpoints of pivotal trials have never been analysed comprehensively. This study aimed to examine such differences in haematological malignancy indications not only in applications for new molecular entity agents but also in supplemental applications for additional indications. A total of 101 haematological malignancy indications were examined for 58 drugs. Only 30 indications were approved by the regulatory agencies of all three regions with 25, 9 and 67 indications being first approved in Japan, the EU and the US, respectively. Regarding the 18 indications approved only in the US, 13 were approved based on results of single-arm trials. The approval of all nine indications approved first in the EU was based on results of comparative trials. The primary endpoints were different between the EU and the US in 4 of 49 indications approved by both regulatory agencies, all of which were approved earlier in the US than in the EU. This analysis shows that the US Food and Drug Administration has taken the most active attitude to acceptance of surrogate endpoints in single-arm trials. Therefore, not only shorter review time but also this attitude may lead to earlier approval in US. © 2016 John Wiley & Sons Ltd.

Drugs' development in acute heart failure: what went wrong?

PubMed

Teneggi, Vincenzo; Sivakumar, Nithy; Chen, Deborah; Matter, Alex

2018-05-08

Acute heart failure (AHF) is a major burden disease, with a complex physiopathology, unsatisfactory diagnosis, treatment and a very poor prognosis. In the last two decades, a number of drugs have progressed from preclinical to early and late clinical development, but only a few of them have been approved and added to a stagnant pharmacological armamentarium. We have reviewed the data published on drugs developed for AHF since early 2000s, trying to recognise factors that have worked for a successful approval or for the stoppage of the program, in an attempt to delineate future trajectories for AHF drug development. Our review has identified limitations at both preclinical and clinical levels. At the preclinical level, the major shortcoming is represented by animal models looking at short-term endpoints which do not recapitulate the complexity of the human disease. At the clinical level, the main weakness is given by the disconnect between short-term endpoints assessed in the early stage of drug development, and medium-long-term endpoints requested in Phase 3 for regulatory approval. This is further amplified by the lack of validation and standardisation of short- and long-term endpoints; absence of predictive biomarkers; conduct of studies on heterogeneous populations; and use of different eligibility criteria, time of assessments, drug schedules and background therapies. Key goals remain a better understanding of AHF and the construction of a successful drug development program. A reasonable way to move forward resides in a strong collaboration between main stakeholders of therapeutic innovation: scientific community, industry and regulatory agencies.

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR), Office of Regulatory Affairs for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Protocol Coordinator II: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials Provides deployment of clinical support services for clinical research Streamlines protocol development timeline Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture Provides quality assurance and quality control oversight Performs regulatory review of clinical protocols, informed consent and other clinical documents Tracks and facilitates a portfolio of protocols through each process step (IRB, RAC, DSMB, Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting protocol documents and consent forms Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees For protocols that are performed with other research centers: contacts coordinators at other centers to obtain review committee approvals at these centers, maintains records of these approvals at the outside centers in the protocol files, and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols Converts protocols from Word format to PDF with bookmarks Maintains the PDF version of the most current approved version of each active clinical protocol on a central server    This position has the option to be located in Frederick or Rockville, Maryland.

77 FR 5286 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-02

...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule Change To Adopt Rules Governing S&P 500 Option Variance Basket Trades January 27, 2012. I. Introduction On October 26, 2011, Chicago Board Options Exchange, Incorporated (``Exchange'' or ``CBOE'') filed...

77 FR 22027 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule Change Relating to Stock- Option Orders April 6, 2012. I. Introduction On February 7, 2012, the Chicago Board Options Exchange, Incorporated (``CBOE'' or ``Exchange''), filed with the Securities and Exchange...

10 CFR 170.8 - Information collection requirements: OMB approval

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Information collection requirements: OMB approval 170.8 Section 170.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General...

10 CFR 170.8 - Information collection requirements: OMB approval

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Information collection requirements: OMB approval 170.8 Section 170.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General...

10 CFR 170.8 - Information collection requirements: OMB approval

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Information collection requirements: OMB approval 170.8 Section 170.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General...

10 CFR 170.8 - Information collection requirements: OMB approval

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: OMB approval 170.8 Section 170.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General...

10 CFR 170.8 - Information collection requirements: OMB approval

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Information collection requirements: OMB approval 170.8 Section 170.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General...

75 FR 29597 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To List and Trade CBOE Gold ETF Volatility Index Options May 19, 2010. I. Introduction On March 18, 2010, the Chicago Board Options Exchange, Incorporated (``CBOE...

77 FR 65433 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Approving a Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-26

...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Approving a Proposed Rule Change To Amend the Real-Time Transaction Reporting System Information System and Subscription Service October 22...'') information system. The proposed rule change was published for comment in the Federal Register on September 12...

76 FR 40758 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-11

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64805; File No. SR-ISE-2011-30] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Complex Orders July 5, 2011. I. Introduction On May 23, 2011, the International Securities Exchange, LLC...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-19

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-19

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

77 FR 9274 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-16

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66375; File No. SR-CBOE-2011-117] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving Proposed Rule Change Relating to Its Automated Improvement Mechanism February 10, 2012. On December 14, 2011, the Chicago Board...

75 FR 70055 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-16

... SECURITIES AND EXCHANGE COMMISION [Release No. 34-63293; File No. SR-OCC-2010-16] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Weekly Options And Monthly Options November 9, 2010. I. Introduction On September 15, 2010, The Options Clearing...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-15

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65927; File No. SR-OCC-2011-15] Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Management of... such as settlement banks and other clearing organizations. See generally Article VIII, Sections 1 and 5...

78 FR 6356 - Notice of Consideration of Approval of Application Regarding Proposed Indirect Transfer of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-30

... NUCLEAR REGULATORY COMMISSION [Docket No. 070-3098; NRC-2011-0081] Notice of Consideration of Approval of Application Regarding Proposed Indirect Transfer of Control of the Construction Authorization for the Mixed Oxide Fuel Fabrication Facility in Aiken, SC; Correction AGENCY: Nuclear Regulatory...

78 FR 21460 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-10

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69302; File No. SR-NSCC-2012-10] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To... customers, a more accurate reflection of risks in the calculation of Clearing Fund margin, however, could...

75 FR 15757 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-30

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61716; File No. SR-CBOE-2010-008] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule Change Relating to Co- location Service Fees March 16, 2010. Correction In notice document 2010-6184...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-19

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

Regulatory approval of new medical devices: cross sectional study.

PubMed

Marcus, Hani J; Payne, Christopher J; Hughes-Hallett, Archie; Marcus, Adam P; Yang, Guang-Zhong; Darzi, Ara; Nandi, Dipankar

2016-05-20

 To investigate the regulatory approval of new medical devices.  Cross sectional study of new medical devices reported in the biomedical literature.  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval.  Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article."  Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device.  5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published.  We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

PubMed

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

2011-09-01

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

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

PubMed Central

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

2017-01-01

The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike. PMID:29184849

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

PubMed

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

2017-01-01

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

75 FR 7532 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-19

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... is hereby given that on February 4, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA...) (SEC Approves Consolidated FINRA Rules Governing Financial Responsibility). FINRA announced in...

78 FR 4914 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Approving Proposed Rule Change To Amend...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-23

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68574; File No. SR-Phlx-2012-130] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Approving Proposed Rule Change To Amend Performance Evaluations With Respect to Quote Submissions of Streaming Quote Traders and Remote Streaming Quote Traders...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-27

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

77 FR 59030 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-25

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67888; File No. SR-BATS-2012-030] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Granting Approval of Proposed Rule Change To Amend BATS Rule 14.11, Entitled ``Other Securities'' September 19, 2012. I. Introduction On July 20, 2012, BATS...

75 FR 8769 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change, as...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-25

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61545; File No. SR-BATS-2009-032] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Amend BATS Fee Schedule To Impose Fees for Physical Ports Used To Connect to BATS...

76 FR 67783 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Amend...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-02

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65646, File No. SR-BATS-2011-033] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Amend and Restate the Second Amended and Restated Certificate of Incorporation of BATS Global Markets, Inc. October 27, 2011. I...

76 FR 11533 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Granting Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63955; File No. SR-ISE-2010-73] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Granting Approval of a Proposed Rule Change To Modify Qualified Contingent Cross Order Rules February 24, 2011. I. Introduction On July 14, 2010, the...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

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

76 FR 11776 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-03

... Activities; Submission to OMB for Review and Approval; Comment Request; Regulatory Pilot Projects (Renewal... Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. FOR... information about the electronic docket, go to http://www.regulations.gov . Title: Regulatory Pilot Projects...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-12

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-28

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-14

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-19

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61333; File No. SR-NYSE-2009-117] Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Amending Its Listing Fees for Structured Products January 12, 2010. I. Introduction On November 19, 2009, New York...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-30

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

75 FR 59303 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62956; File No. SR-OCC-2010-09] Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of Proposed Rule Change Relating to... clearing organization'' registered as such with the CFTC, OCC also filed this proposed rule change for...

76 FR 52729 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65149; File No. SR-Phlx-2011-89] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Relating to Alpha Index Options August 17, 2011. I. Introduction On June 23, 2011, NASDAQ OMX PHLX LLC (the...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-04

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

76 FR 79262 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change To... Select Markets December 15, 2011. I. Introduction On August 30, 2011, The NASDAQ Stock Market LLC... Global and Global Select Markets. The proposed rule change was published in the Federal Register on...

7 CFR 1717.304 - State regulatory authority rate jurisdiction.

Code of Federal Regulations, 2010 CFR

2010-01-01

... GUARANTEED ELECTRIC LOANS Federal Pre-emption in Rate Making in Connection With Power Supply Borrowers § 1717... terms of the RUS wholesale power contract or other RUS documents may be subject to the approval of a state regulatory authority, the power supply borrower shall seek such required approval in a timely...

7 CFR 1717.304 - State regulatory authority rate jurisdiction.

Code of Federal Regulations, 2011 CFR

2011-01-01

... GUARANTEED ELECTRIC LOANS Federal Pre-emption in Rate Making in Connection With Power Supply Borrowers § 1717... terms of the RUS wholesale power contract or other RUS documents may be subject to the approval of a state regulatory authority, the power supply borrower shall seek such required approval in a timely...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-14

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

76 FR 77038 - Self-Regulatory Organizations; Stock Clearing Corporation of Philadelphia; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-09

.... Second, NASDAQ OMX is proposing to amend the compositional requirements of the Nominating & Governance... approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule... are in the custody or control of such clearing agency or for which it is responsible, and to comply...

76 FR 77048 - Self-Regulatory Organizations; Boston Stock Exchange Clearing Corporation; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-09

.... Second, NASDAQ OMX is proposing to amend the compositional requirements of the Nominating & Governance... approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule... are in the custody or control of such clearing agency or for which it is responsible, and to comply...

78 FR 21996 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Accelerated Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-12

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69341; File No. SR-NASDAQ-2013-048] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Accelerated Approval of a Proposed Rule... in a Limit State or Straddle State, and unlike normal circumstances, may not be a true reflection of...

76 FR 4400 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63731; File No. SR-BX-2010-083] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change Relating to the Price Improvement... (``BOX'') to permit an Options Participant initiating a Price Improvement Period (``PIP'') to designate a...

76 FR 14437 - Economic Simplified Boiling Water Reactor Standard Design: GE Hitachi Nuclear Energy; Issuance of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-16

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0055] Economic Simplified Boiling Water Reactor Standard Design: GE Hitachi Nuclear Energy; Issuance of Final Design Approval The U.S. Nuclear Regulatory Commission has issued a final design approval (FDA) to GE Hitachi Nuclear Energy (GEH) for the economic...

77 FR 56894 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-14

...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Amending NYSE... 611--Compliant Tool for Floor Brokers September 10, 2012. I. Introduction On July 13, 2012, New York... provide Floor Brokers with a new functionality through which to effect manual cross transactions of block...

30 CFR 946.15 - Approval of Virginia regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

...,” “coal preparation plant”. November 8, 1985 November 25, 1986 VR 480-03-19: 700 through 850; techniques... VR 480-03-19: 784.20(f)(2); 817.121(c)(2). January 16, 1987 August 17, 1987 VR 480-03-19.801.13(a)(2), .17(a). June 15, 1987, July 2, 1987 December 31, 1987 VA Code §§ 45.1-270.3:1, .4, .5:1, .6B; VR 480...

30 CFR 946.15 - Approval of Virginia regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

...,” “coal preparation plant”. November 8, 1985 November 25, 1986 VR 480-03-19: 700 through 850; techniques... VR 480-03-19: 784.20(f)(2); 817.121(c)(2). January 16, 1987 August 17, 1987 VR 480-03-19.801.13(a)(2), .17(a). June 15, 1987, July 2, 1987 December 31, 1987 VA Code §§ 45.1-270.3:1, .4, .5:1, .6B; VR 480...

30 CFR 950.15 - Approval of Wyoming regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

...), (ba), 3(b)(i); Ch II, §§ 3(a)(vi)(E), (M), (b)(xvi)(D), (xx), (v)(C); Ch IV, §§ 3(d)(vii), (e)(i)(H...(am);Chap. 1, Section 2(ao); Chap. 1, Section 2(ap); Chap. 1, Section 2(as); Chap. 1, Section 2(az... relocated rules. [62 FR 9958, Mar. 5, 1997, as amended at 64 FR 53208, Oct. 1, 1999; 67 FR 67547, Nov. 6...

30 CFR 943.15 - Approval of Texas regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

...), (f), .195(a); 785.200(a), (b), (c), (f) through (i); 786.216(p); 788.230(a)(4), (5), (6); 788.232(c...), (4), (b); .129, (a), (b), (1), (3); 780.141(g), (h); .142(b)(11), (c), (d), .146 (a) through (e...; 12.77; 12.111(1)(H); 12.112(b)(4); 12.113(a); 12.118(a) and (c); 12.151(a)(2); 12.158(a) and (c); 12...

30 CFR 926.15 - Approval of Montana regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (intro); 17.24.733(3), recodified (3)-(5); 17.24.762(1); 17.24.815(2)(c)-(e), (f)(i), (h); 17.24.821(1...)(i)-(iii); 17.24.903(1)(a), (c), (d); 17.24.911(1)-(3), (4)-(6) recodified, (7)(intro), (8)-(10); 17...)-(m), (3); 17.24.1003(1 recodified), (2)-(4); 17.24.1005(3)(c intro); 17.24.1006(1), (3)(intro); 17.24...

[Regulatory Framework for Approval of PET Drug in Korea: A Survey Report].

PubMed

Kurihara, Chieko; Inoue, Tomio

2015-11-01

To identify regulatory framework for approval of PET drugs in Korea. Interview and literature survey. In Korea Good Manufacturing Practice (GMP) regulation specific to radiopharmaceuticals, including PET (Positron Emission Tomography) drugs, under the Pharmaceutical Affairs Act was issued in August 2014, to be enforced on July 1, 2015, and its guidance was issued in December 2014. The new facilities to be established after July 1 of 2015 have to be compatible with this new regulation and already established facilities have two years grace period until June 30 of 2017. During this period, the regulatory authority will inspect all of the production sites which hold or submit approvals of radiopharmaceuticals. As of September 2015 in Korea, there are 7 commercial companies and 15 hospitals and institutes, which have approvals of PET drugs mainly FDG, and these companies and/or hospitals can supply PET drugs outside institutions. In this article we introduce the Korean regulations of development and approval of radiopharmaceuticals. The Korean regulatory authorization policy for radiopharmaceuticals are to some extent similar to the policy which the U.S. regulators set as the new regulations of PET drug. It is expected that the situations of production sites in Korea are to be improved through actual discussions among regulators and PET community through the process of actual inspection.

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

PubMed Central

Rykhus, Ryan D.; Shepard, Zachary V.; Young, Alix; Frisby, Hadley; Calder, Kailee A.; Coon, Collin M.; Falk, Justin A.; McAndrews, Sydney R.; Turner, Aspen; Chang, Christina; Michelsohn, Johanna; Petch, Raegan; Dieker, Sarah M.; Markworth, Benjamin H.; Alamo-Perez, Kevin; Hosack, Aaron J.; Berg, Jacob M.; Schmidt, Christian; Storsberg, Joachim; Brown, Mark A.

Over the past two decades, the biopharmaceutical industry has seen unprecedented expansion and innovation in concert with significant technological advancements. While the industry has experienced marked growth, the regulatory system in the United States still operates at a capacity much lower than the influx of new drug and biologic candidates. As a result, it has become standard for months or even years of waiting for commercial approval by the U.S. Food and Drug Administration. These regulatory delays have generated a system that stifles growth and innovation due to the exorbitant costs associated with awaiting approval from the nation’s sole regulatory agency. The recent re-emergence of diseases that impact pediatric demographics represents one particularly acute reason for developing a regulatory system that facilitates a more efficient commercial review process. Herein, we present a range of initiatives that could represent early steps toward alleviating the delays in approving life-saving therapeutics. PMID:29271878

46 CFR 11.302 - Course approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 1 2013-10-01 2013-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

46 CFR 11.302 - Course approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 1 2011-10-01 2011-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

46 CFR 11.302 - Course approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 1 2010-10-01 2010-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

46 CFR 11.302 - Course approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 1 2012-10-01 2012-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

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

PubMed

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

2017-07-01

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

Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

PubMed

Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

2015-01-01

Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

77 FR 38877 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-29

...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change, as Modified by...\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to allow certain cross trades effected on the...-substantive changes to its rules. The proposed rule change was published for comment in the Federal Register...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

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

76 FR 38712 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving a Proposed Rule Change To...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64754; File No. SR-BATS-2011-015] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving a Proposed Rule Change To Amend BATS Rule 11.9, Entitled ``Orders and Modifiers'' and BATS Rule 11.13, Entitled ``Order Execution'' June 27, 2011. I...

78 FR 47449 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70076; File No. SR-OCC-2013-09] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change, as Modified by Amendment No. 1, To Separate the Powers and Duties Currently Combined in the Office of OCC's Chairman Into Two Offices, Chairman and President, an...

75 FR 62443 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-08

...-Regulatory Organizations; NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Adopt a..., Section 1 (Definitions) of the rules of the Nasdaq Options Market (``NOM'') to adopt a definition of... business days. This is similar to the process of other options exchanges that have adopted a Professional...

77 FR 42533 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-19

...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Amending Its Rules... Ownership Structure of the Exchange July 13, 2012. I. Introduction On May 14, 2012, NYSE Arca, Inc. (``NYSE... Holdings from the ownership structure of the Exchange (the ``Merger''). The proposed rule changes were...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-11

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

77 FR 22374 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... I. Gross, Director, Edward Pekarek, Assistant Director, and Genavieve Shingle, Student Intern... finds good cause, pursuant to Section 19(b)(2) of the Act \\11\\ for approving the proposed rule change... that good cause exists to approve the proposal, as modified by Amendment No. 1, on an accelerated basis...

77 FR 4844 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-31

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66235; File No. SR-CBOE-2011-114] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule Change Relating to Complex Order Processing in Hybrid 3.0 Classes January 25, 2012. I. Introduction On November 29, 2011, the Chicago Board Options...

75 FR 48391 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-10

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62639; File No. SR-Phlx-2010-89] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change Relating to Pricing... proposed rule change to establish pricing for 10Gb direct circuit connections and codify pricing for 10Gb...

75 FR 48390 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-10

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62638; File No. SR-BX-2010-043] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change Relating to Pricing for Direct... establish pricing for 10Gb direct circuit connections and codify pricing for 1Gb direct circuit connections...

77 FR 43618 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-25

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67468; File No. SR-NASDAQ-2012-062] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Modify Its Corporate Governance Rules July 19, 2012. I. Introduction On May 17, 2012, The NASDAQ Stock Market LLC...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-02

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-02

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

78 FR 31993 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving Proposed Rule Change Relating...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-28

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69607; File No. SR-BX-2013-029] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving Proposed Rule Change Relating to Board of Director Qualifications May 20, 2013. On March 27, 2013, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'') filed with the...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-22

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-16

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

75 FR 20018 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving a Proposed Rule Change, As...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-16

... mechanisms for two different prices.\\42\\ NASDAQ OMX then cites two of its own proposed rule changes and...-Regulatory Organizations; BATS Exchange, Inc.; Order Approving a Proposed Rule Change, As Amended, To Offer...\\ thereunder, a proposed rule change to offer certain new Exchange data products to Exchange Members \\3\\ and...

77 FR 61649 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67970; File No. SR-ICC-2012-12] Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To Amend Schedule 502 of the ICE Clear..., 2012. I. Introduction On August 9, 2012, ICE Clear Credit LLC (``ICC'') filed with the Securities and...

75 FR 9987 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-04

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61593; File No. SR-DTC-2009-17] Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change To Allow The Depository Trust Company To Provide Settlement Services to European Central Counterparty Limited for U.S. Securities Traded on European Trading Venues...

78 FR 29186 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-17

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69562; File No. SR-DTC-2013-01] Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change To Modify Its Practice Regarding the Collection of Participants' Required Participants Fund Deposits May 13, 2013. I. Introduction On March 20, 2013, The Depository...

78 FR 36616 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-18

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69741; File No. SR-DTC-2013-03] Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change in Connection With the Implementation of The Foreign Account Tax Compliance Act (FATCA) June 12, 2013. On April 22, 2013, The Depository Trust Company (``DTC'') filed...

75 FR 21688 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Accelerated Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Accelerated Approval of Proposed Rule... 20, 2010. I. Introduction On March 11, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or ``Exchange.... Strike prices for ETF options are permitted in $1 or greater intervals where the strike price is $200 or...

77 FR 8927 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-15

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66366; File No. SR-CHX-2011-34] Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Order Approving a Proposed Rule Change Regarding Suspension of a Participant's Trading Privileges on the Exchange February 9, 2012. I. Introduction On December 16, 2011, the Chicago Stock Exchange, Inc. ...

77 FR 30562 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-23

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67013; File No. SR-OCC-2012-04] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Stock Loan Buy-In and Sell-Out Rules May 17, 2012. I. Introduction On March 22, 2012, The Options Clearing Corporation (``OCC'') filed with the...

78 FR 40538 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-05

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69890; File No. SR-NSCC-2013-05] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To Require That All Locked-In Trade Data Submitted to It for Trade Recording Be Submitted in Real-time June 28, 2013. I. Introduction On April 30, 2013,...

77 FR 26590 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-04

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66880; File No. SR-ISE-2012-16] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Procedures for Executing the Stock Leg(s) of Stock-Option Orders April 30, 2012. I. Introduction On February 29, 2012, the International...

75 FR 60158 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing of a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... Process in Providing Trustee Access to the Security Position Report Service September 24, 2010. Pursuant...'') service with an automated approval process. II. Self-Regulatory Organization's Statement of the Purpose of... approve a Trustee's access to the SPR service for a security is done manually, and the process is...

78 FR 40255 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Order Granting Approval to Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-03

...-Regulatory Organizations; BATS Y-Exchange, Inc.; Order Granting Approval to Proposed Rule Change Amending and Restating the Amended and Restated By-Laws of BATS Y-Exchange, Inc. June 27, 2013. I. Introduction On April 29, 2013, BATS Y-Exchange, Inc. (the ``Exchange'' or ``BYX'') filed with the Securities and Exchange...

77 FR 49034 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-15

... to react to the execution (an effect known as ``market impact'' or ``information leakage''). As a...' shares will avoid the deleterious effect of market impact discussed above and result in overall faster...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Amend Rule...

78 FR 21982 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Granting Accelerated Approval of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-12

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69343; File No. SR-BX-2013-026] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Granting Accelerated Approval of a Proposed Rule Change To Adopt... not be a true reflection of the value of the series being quoted. In response to these concerns, the...

78 FR 22001 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Accelerated Approval of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-12

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69344; File No. SR-Phlx-2013-29] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Accelerated Approval of a Proposed Rule Change... not be a true reflection of the value of the series being quoted. In response to these concerns, the...

78 FR 42988 - Self-Regulatory Organizations; New York Stock Exchange LLC; NYSE MKT LLC; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-18

...-2012-58] Self-Regulatory Organizations; New York Stock Exchange LLC; NYSE MKT LLC; Order Approving... Related Supplementary Material July 12, 2013. I. Introduction On October 26, 2012, the New York Stock... cover the position only pursuant to a new order, which must be time-recorded upstairs and upon receipt...

Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development.

PubMed

Sverdlov, Oleksandr; van Dam, Joris; Hannesdottir, Kristin; Thornton-Wells, Tricia

2018-07-01

Digital therapeutics represent a new treatment modality in which digital systems such as smartphone apps are used as regulatory-approved, prescribed therapeutic interventions to treat medical conditions. In this article we provide a critical overview of the rationale for investing in such novel modalities, including the unmet medical needs addressed by digital therapeutics and the potential for reducing current costs of medical care. We also discuss emerging pathways to regulatory approval and how innovative business models are enabling further growth in the development of digital therapeutics. We conclude by providing some recent examples of digital therapeutics that have gained regulatory approval and highlight opportunities for the near future. © 2018 American Society for Clinical Pharmacology and Therapeutics.

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

PubMed

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

2010-06-01

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

A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.

PubMed

Zeukeng, Minette-Joëlle; Seoane-Vazquez, Enrique; Bonnabry, Pascal

2018-06-01

This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016. The list of new drugs and therapeutic biologics approved by the FDA, the EMA, and SMC in the period 2007 to 2016 was collected from websites of those agencies. The study included regulatory information, approval date, and indication for each drug. Descriptive statistical t tests and x 2 -tests were performed for the analysis. From 2007 to 2016, 134 new drugs were approved by all three regulatory agencies. Overall, 66.4% of the drugs were first approved by the FDA, 30.6% by the EMA, and 3.0% by SMC. The difference in approval dates between SMC and the EMA, SMC and the FDA, and the FDA and the EMA were statistically significant. The indications approved by the FDA, the EMA, and SMC for the same drugs were similar in content for 23.1% drugs and different in 76.9% of the drugs. Significant differences in indications existed between the FDA and SMC and the FDA and the EMA, but not between the EMA and SMC. There were differences in the characteristics of new drugs approved by the EMA, the FDA, and SMC in the period 2007-2016. Overall, two thirds of the new drugs were first approved by the FDA. Differences in indications were found in three out of four new drugs approved by the three regulatory agencies. Despite international drug regulation harmonization efforts, significant differences in the characteristics of new drugs approved by different agencies persist.

77 FR 43620 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-25

... self-regulatory organization consents, the Commission shall either approve the proposed rule change...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to the Handling of Stop and Stop Limit...

30 CFR 925.15 - Approval of Missouri regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., 1980, March 12, 1981 July 23, 1982 10 CSR 40-2.080; 40-3.050; 40-3.100(4)(B); 40-6.010(6), .070, .090(3... January 17, 1983 10 CSR 40-8.030(6)(B)1, (C), (7)(A), (D), (8)(A)1, (E), (9)(A)2, (B), (10)(A), (13)(B), .050(8), .060. April 13, 1983 May 8, 1984 RSMo 444: .805, .830, .950, .955, .960, .965, .970; 10 CSR 40...

30 CFR 904.15 - Approval of Arkansas regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

....11(d)(2)(v); 808.14(c); 815.15(a); 816.41(d), .42(a)(7), .43, .44(b)(3), .46, .49, .52(a)(4), .53...), .43(e), .51-S(b), .52(a)(1), (2), .54, .65(f), .95(a), (b), .101(b)(1), .102(a), (g), .103, .104(a...; 761.12(b)(2), (e)(1), (2), (3); .15; 762.5; 764.13, .15(a)(1); 771.23(c)(4); 776.12, (a)(3)(vi), .14(a...

30 CFR 904.15 - Approval of Arkansas regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

....11(d)(2)(v); 808.14(c); 815.15(a); 816.41(d), .42(a)(7), .43, .44(b)(3), .46, .49, .52(a)(4), .53...), .43(e), .51-S(b), .52(a)(1), (2), .54, .65(f), .95(a), (b), .101(b)(1), .102(a), (g), .103, .104(a...; 761.12(b)(2), (e)(1), (2), (3); .15; 762.5; 764.13, .15(a)(1); 771.23(c)(4); 776.12, (a)(3)(vi), .14(a...

30 CFR 904.15 - Approval of Arkansas regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

....11(d)(2)(v); 808.14(c); 815.15(a); 816.41(d), .42(a)(7), .43, .44(b)(3), .46, .49, .52(a)(4), .53...), .43(e), .51-S(b), .52(a)(1), (2), .54, .65(f), .95(a), (b), .101(b)(1), .102(a), (g), .103, .104(a...; 761.12(b)(2), (e)(1), (2), (3); .15; 762.5; 764.13, .15(a)(1); 771.23(c)(4); 776.12, (a)(3)(vi), .14(a...

30 CFR 904.15 - Approval of Arkansas regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

....11(d)(2)(v); 808.14(c); 815.15(a); 816.41(d), .42(a)(7), .43, .44(b)(3), .46, .49, .52(a)(4), .53...), .43(e), .51-S(b), .52(a)(1), (2), .54, .65(f), .95(a), (b), .101(b)(1), .102(a), (g), .103, .104(a...; 761.12(b)(2), (e)(1), (2), (3); .15; 762.5; 764.13, .15(a)(1); 771.23(c)(4); 776.12, (a)(3)(vi), .14(a...

30 CFR 914.15 - Approval of Indiana regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., -118; 12-5-6, -34, -35, -36, -38, -40; 12-5-73, -100, -100.5, -101, -103. February 7, 1985 May 13, 1985... 310 IAC 12-0.5-78.7, -91.5, -109; 12-3-30, -32, -33, -34, -41, -47, -49, -55, -55.1, -68, -70, -71... reclamation fees had been paid. December 9, 1982 March 4, 1983 310 IAC 12-2-7, -9; 12-3-1, -12(c)(2), -21(b)(4...

30 CFR 914.15 - Approval of Indiana regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., -118; 12-5-6, -34, -35, -36, -38, -40; 12-5-73, -100, -100.5, -101, -103. February 7, 1985 May 13, 1985... 310 IAC 12-0.5-78.7, -91.5, -109; 12-3-30, -32, -33, -34, -41, -47, -49, -55, -55.1, -68, -70, -71... reclamation fees had been paid. December 9, 1982 March 4, 1983 310 IAC 12-2-7, -9; 12-3-1, -12(c)(2), -21(b)(4...

30 CFR 914.15 - Approval of Indiana regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., -118; 12-5-6, -34, -35, -36, -38, -40; 12-5-73, -100, -100.5, -101, -103. February 7, 1985 May 13, 1985... 310 IAC 12-0.5-78.7, -91.5, -109; 12-3-30, -32, -33, -34, -41, -47, -49, -55, -55.1, -68, -70, -71... reclamation fees had been paid. December 9, 1982 March 4, 1983 310 IAC 12-2-7, -9; 12-3-1, -12(c)(2), -21(b)(4...

30 CFR 914.15 - Approval of Indiana regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., -118; 12-5-6, -34, -35, -36, -38, -40; 12-5-73, -100, -100.5, -101, -103. February 7, 1985 May 13, 1985... 310 IAC 12-0.5-78.7, -91.5, -109; 12-3-30, -32, -33, -34, -41, -47, -49, -55, -55.1, -68, -70, -71... reclamation fees had been paid. December 9, 1982 March 4, 1983 310 IAC 12-2-7, -9; 12-3-1, -12(c)(2), -21(b)(4...

30 CFR 914.15 - Approval of Indiana regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., -118; 12-5-6, -34, -35, -36, -38, -40; 12-5-73, -100, -100.5, -101, -103. February 7, 1985 May 13, 1985... 310 IAC 12-0.5-78.7, -91.5, -109; 12-3-30, -32, -33, -34, -41, -47, -49, -55, -55.1, -68, -70, -71... reclamation fees had been paid. December 9, 1982 March 4, 1983 310 IAC 12-2-7, -9; 12-3-1, -12(c)(2), -21(b)(4...

Testing Methods for Challenging the National Wetland Plant List: Using Tsuga canadensis (L.) Carr. (Eastern Hemlock) as a Case Study

DTIC Science & Technology

2017-07-01

ESRI (Nature Conservancy and Environmental Systems Research Institute). 1994. Field Methods . In Field Methods for Vegetation Mapping: United States...ER D C/ CR RE L TR -1 7- 9 Wetlands Regulatory Assistance Program (WRAP) Testing Methods for Challenging the National Wetland Plant List...Robert W. Lichvar and Jennifer J. Goulet July 2017 Approved for public release; distribution is unlimited. The U.S. Army Engineer Research

30 CFR 904.15 - Approval of Arkansas regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

...), (g), (h), .38; 784.27; 800.11(b)(2); 815.15(c)(2), (3), (4), .17(a), (b); 816.49(b)(7), (c)(2), .84(b..., 1983 March 16, 1984 ASCMRC 771.25 (a)(2); 776(c)(1), (2), (4), (5)(i), (ii); 842(c). May 21, 1985...; 761.12(b)(2), (e)(1), (2), (3); .15; 762.5; 764.13, .15(a)(1); 771.23(c)(4); 776.12, (a)(3)(vi), .14(a...

30 CFR 938.15 - Approval of Pennsylvania regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

...), .30(a), (1), .31(a)(7), .32, .61, .129, .134(a), (e), .135(c)(1), (f)(2), (h), .136(a), (c), .137(18...)(4), .492(c)(4); 89.34(a)(1), (2)(ii), .59(a)(1), (2), (3), .71(d), .82, .101(a), (d), .172(b); 90...; PA SMCRA §§ 3.1, 4(a), (b), 18(c)(i), 18.8. May 27, 1992 October 28, 1992 25 PA Code 86.83, .94. June...

75 FR 13629 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-22

... contained in Rule 5250(b)(2) that a company must issue a press release announcing the receipt of an audit... Rules. Nasdaq noted in its Notice, however, that if a company fails to include the audit opinion in its...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change To...

77 FR 23532 - Self-Regulatory Organizations; NYSE Amex LLC; Order Granting Approval of a Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-19

...-Regulatory Organizations; NYSE Amex LLC; Order Granting Approval of a Proposed Rule Change Amending NYSE Amex... Securities Exchange Act of 1934 (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to amend....'' The proposed rule change was published for comment in the Federal Register on March 5, 2012.\\3\\ The...

77 FR 22032 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of a Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

...-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of a Proposed Rule Change... proposed rule change to amend NYSE Rule 476A to update its ``List of Exchange Rule Violations and Fines Applicable Thereto Pursuant to Rule 476A.'' The proposed rule change was published for comment in the Federal...

75 FR 43217 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change, as...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-23

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62524; File No. SR-BATS-2010-008] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Amend BATS Rules 2.5 and 17.2 To Establish a Registration Requirement for Principals July 16, 2010. I. Introduction On April 9,...

75 FR 65044 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval to a Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

... market value of publicly held shares for common stock on the Capital Market range from $5 million to $15...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval to a Proposed Rule Change To Modify the Eligibility Criteria for the Second Compliance Period for a Bid Price Deficiency on the Nasdaq...

77 FR 15826 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-16

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66576; File No. SR-NYSE-2012-01] Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule Change To Establish an NYBX Immediate-or- Cancel Order March 12, 2012. I. Introduction On January 11, 2012, the New York Stock Exchange LLC (``NYSE'' or ``Exchange'') file...

75 FR 3950 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-25

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61368; File No. SR-ISE-2009-87] Self-Regulatory... Exchange Act Release No. 61024 (November 18, 2009), 74 FR 61395 (November 24, 2009). II. Description of the...(b)(2) of the Act,\\7\\ that the proposed rule change (SR-ISE-2009-87) be, and hereby is, approved. \\7...

75 FR 6072 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61446; File No. SR-NASDAQ-2009-077] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change To Modify the Procedures Followed When a Listed Company Falls Below Certain Listing Requirements January 29, 2010. I. Introduction On August 17, 2009, The NASDAQ...

76 FR 71396 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Order Approving Proposed Rule Change, as...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-17

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65729, File No. SR-BYX-2011-022] Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Order Approving Proposed Rule Change, as Modified by Partial Amendment No. 1, To Amend and Restate the Amended and Restated Bylaws of BATS Global Markets, Inc. November 10, 2011. I. Introduction On September 7...

76 FR 71411 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change, as...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-17

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65728, File No. SR-BATS-2011-035] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change, as Modified by Partial Amendment No. 1, To Amend and Restate the Amended and Restated Bylaws of BATS Global Markets, Inc. November 10, 2011. I. Introduction On September 7,...

77 FR 26066 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change to...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

...-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change to Provide for a T+1 Settlement of the Initial Payment Related to the CDS Contracts Cleared by ICE Clear Europe Limited April 26, 2012. I. Introduction On March 6, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the...

75 FR 49543 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-13

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62663; File No. SR-NASDAQ-2010-077] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change Relating to Pricing for Direct Circuit Connections August 9, 2010. On June 21, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed with the...

77 FR 27254 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change To...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-09

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66911; File No. SR-ICEEU-2012-05] Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change To Amend the ICE Clear Europe Limited CDS Procedures, Finance Procedures, and Rules With Respect to the Calculation and Payment of Interest on Mark-To-Market Margin on...

76 FR 9065 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change To List...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

...-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change To List and Trade Shares of...,\\2\\ a proposed rule change to list and trade shares (``Shares'') of the SPDR Nuveen S&P High Yield... shares (``Shares'') under NYSE Arca Equities Rule 5.2(j)(3), Commentary .02, which governs the listing...

76 FR 71394 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-17

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65721; File No. SR-DTC-2011-07] Self-Regulatory Organizations; The Depository Trust Company; Order Approving a Proposed Rule Change as Modified by Amendment Nos. 1 and 2 Relating To a New Daily Report Subscription for Security Position Reports November 10, 2011. I. Introduction On August 24, 201...

Assessment of Quality Assurance Measures for Radioactive Material Transport Packages not Requiring Competent Authority Design Approval - 13282

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

Komann, Steffen; Groeke, Carsten; Droste, Bernhard

The majority of transports of radioactive materials are carried out in packages which don't need a package design approval by a competent authority. Low-active radioactive materials are transported in such packages e.g. in the medical and pharmaceutical industry and in the nuclear industry as well. Decommissioning of NPP's leads to a strong demand for packages to transport low and middle active radioactive waste. According to IAEA regulations the 'non-competent authority approved package types' are the Excepted Packages and the Industrial Packages of Type IP-1, IP-2 and IP-3 and packages of Type A. For these types of packages an assessment bymore » the competent authority is required for the quality assurance measures for the design, manufacture, testing, documentation, use, maintenance and inspection (IAEA SSR 6, Chap. 306). In general a compliance audit of the manufacturer of the packaging is required during this assessment procedure. Their regulatory level in the IAEA regulations is not comparable with the 'regulatory density' for packages requiring competent authority package design approval. Practices in different countries lead to different approaches within the assessment of the quality assurance measures in the management system as well as in the quality assurance program of a special package design. To use the package or packaging in a safe manner and in compliance with the regulations a management system for each phase of the life of the package or packaging is necessary. The relevant IAEA-SSR6 chap. 801 requires documentary verification by the consignor concerning package compliance with the requirements. (authors)« less

78 FR 12405 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-22

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the... Approval of Change in Ownership, Control, or Business Operations) to provide for a refund of the...

77 FR 20869 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Amending the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... Equities Definition of Approved Person To Exclude Foreign Affiliates, Eliminating the Application Process... Equities definition of approved person to exclude foreign affiliates, eliminate the application process for... amend the NYSE Amex Equities definition of ``approved person'' to exclude foreign affiliates, eliminate...

How do patent rights affect regulatory approvals and data exclusivity rights for pharmaceuticals in the EU?

PubMed

Bogaert, Peter; Van Keymeulen, Eveline

2012-09-01

This article sheds light on the relationship, or rather, absence of a relationship, between patent rights and regulatory approval procedures in the EU. The principle of 'patent linkage' has long been recognized and applied by regulatory authorities in the USA. The European Commission, however, opposes the idea of linking patent rights to marketing authorizations and pricing and reimbursement decisions. This position is grounded in Article 126 of Directive 2001/83 and is expected not to change anytime soon, given the clear reaffirmation thereof in the recent Sector Inquiry Report and Transparency Directive Proposal. Therefore, the European Medicines Agency or national authorities are not permitted to refuse approval and, likely, pricing and reimbursement of a generic when the innovative reference product is still protected by a patent. The authors, however, advocate that there are strong legal arguments for patent holders to challenge regulatory decisions that did not respect their patent rights before the competent national courts.

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

PubMed

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

2013-10-01

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

76 FR 5630 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Approving a Proposed Rule Change, as...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-01

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63777; File No. SR-Phlx-2010-157] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Approving a Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, Relating to Complex Orders January 26, 2011. I. Introduction On November 29, 2010, NASDAQ OMX PHLX LLC (``Phlx'' or the ``Exchange'...

76 FR 32004 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

...-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change To Expand the Number of Components in the PHLX Gold/Silver Sector\\SM\\ Known as XAU\\SM\\, on Which Options Are Listed and... Act of 1934 (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to expand the number of...

77 FR 75239 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change, as...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68430; File No. SR-NYSEArca-2012-111] Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change, as Modified by Amendment No. 1, To List and Trade Units of the Sprott Physical Platinum and Palladium Trust Pursuant to NYSE Arca Equities Rule 8.201 December 13, 2012. I...

75 FR 25889 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-10

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62019; File No. SR-NYSEArca-2010-16] Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Amending Rule 6.37A and Rule 6.64 April 30, 2010. On March 11, 2010, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'') filed with the Securities and Exchange...

76 FR 78057 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-15

...\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to introduce the Minimum Life Order as new order... proposes, by amending its rules to add Rule 3301(f)(11), to introduce the Minimum Life Order as a new order...-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change, as Modified...

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

PubMed Central

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

2015-01-01

Background. Guidance and exploratory evidence indicate that the type of endpoints and the magnitude of their outcome can define a therapy’s clinical activity; however, little empirical evidence relates specific endpoint properties with regulatory outcomes. Materials and Methods. We explored the relationship of 3 endpoint properties to regulatory outcomes by assessing 50 oncology marketing authorization applications (MAAs; reviewed from 2009 to 2013). Results. Overall, 16 (32%) had a negative outcome. The most commonly used hard endpoints were overall survival (OS) and the duration of response or stable disease. OS was a component of 91% approved and 63% failed MAAs. The most commonly used surrogate endpoints were progression-free survival (PFS), response rate, and health-related quality of life assessments. There was no difference (p = .3801) between the approved and failed MAA cohorts in the proportion of hard endpoints used. A mean of slightly more than four surrogate endpoints were used per approved MAA compared with slightly more than two for failed MAAs. Longer OS and PFS duration outcomes were generally associated with approvals, often when not statistically significant. The approved cohort was associated with a preponderance of statistically significant (p < .05) improvements in primary endpoints (p < .0001 difference between the approved and failed groups). Conclusion. Three key endpoint properties (type of endpoint [hard/surrogate], magnitude of an endpoint outcome, and its statistical significance) are consistent with the European Medicines Agency guidance and, notwithstanding the contribution of unique disease-specific circumstances, are associated with a predictable positive outcome for oncology MAAs. Implications for Practice: Regulatory decisions made by the European Medicines Agency determine which new medicines will be available to European prescribers and for which therapeutic indications. Regulatory success or failure can be influenced by many factors. This study assessed three key properties of endpoints used in preauthorization trials (type of endpoint [hard/surrogate], magnitude of endpoint outcome, and its statistical significance) and whether they are associated with a positive regulatory outcome. Clinicians can use these properties, which are described in the publicly available European public assessment reports, to help guide their understanding of the clinical effect of new oncologic therapies. PMID:25948678

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

PubMed

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

2015-06-01

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

Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products.

PubMed

Desai, Kashappa Goud; Obayashi, Hirokazu; Colandene, James D; Nesta, Douglas P

2018-03-28

Japan represents the third largest pharmaceutical market in the world. Developing a new biopharmaceutical drug product for the Japanese market is a top business priority for global pharmaceutical companies while aligning with ethical drivers to treat more patients in need. Understanding Japan-specific key regulatory requirements is essential to achieve successful approvals. Understanding the full context of Japan-specific regulatory requirements/expectations is challenging to global pharmaceutical companies due to differences in language and culture. This article summarizes key Japan-specific regulatory aspects/requirements/expectations applicable to new drug development, approval, and postapproval phases. Formulation excipients should meet Japan compendial requirements with respect to the type of excipient, excipient grade, and excipient concentration. Preclinical safety assessments needed to support clinical phases I, II, and III development are summarized. Japanese regulatory authorities have taken appropriate steps to consider foreign clinical data, thereby enabling accelerated drug development and approval in Japan. Other important topics summarized in this article include: Japan new drug application-specific bracketing strategies for critical and noncritical aspects of the manufacturing process, regulatory requirements related to stability studies, release specifications and testing methods, standard processes involved in pre and postapproval inspections, management of postapproval changes, and Japan regulatory authority's consultation services available to global pharmaceutical companies. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Considerations for Domestic Law Enforcement Implementation of a UAS Program in the Proposed FAA Regulatory Environment of Integration into the National Airspace System

DTIC Science & Technology

2015-12-01

institutional review board (IRB)-approved sequence was established for Delphi panel participants. The collection of data from the Delphi panel...The following year, the Office of the Inspector General Audit Division within the U.S. Department of Justice (DOJ) released an interim report on the...iacp_uaguidelines.pdf 11 Department of Justice, Office of the Inspector General, Audit Division, Interim Report on the Department of Justice’s Use and Support of

30 CFR 916.15 - Approval of Kansas regulatory program amendments.

Code of Federal Regulations, 2012 CFR

2012-07-01

... MLCRA 49-403, 49-405c, 49-406, 49-420; § 10 of House Bill 2182; K.A.R. 47-2-21, 47-8-10, 47-8-11. March 16, 1984 June 8, 1984 MLCRA 49-406; K.A.R. 47-1-10. December 21, 1984 April 11, 1985 K.A.R. 47-15-13. April 4, 1985 November 15, 1985 K.S.A 1984 Supp. 49-406(g); K.A.R. 47-1-11; 47-2-75; 47-3-42, (a)(23...

30 CFR 916.15 - Approval of Kansas regulatory program amendments.

Code of Federal Regulations, 2011 CFR

2011-07-01

... MLCRA 49-403, 49-405c, 49-406, 49-420; § 10 of House Bill 2182; K.A.R. 47-2-21, 47-8-10, 47-8-11. March 16, 1984 June 8, 1984 MLCRA 49-406; K.A.R. 47-1-10. December 21, 1984 April 11, 1985 K.A.R. 47-15-13. April 4, 1985 November 15, 1985 K.S.A 1984 Supp. 49-406(g); K.A.R. 47-1-11; 47-2-75; 47-3-42, (a)(23...

30 CFR 916.15 - Approval of Kansas regulatory program amendments.

Code of Federal Regulations, 2010 CFR

2010-07-01

... MLCRA 49-403, 49-405c, 49-406, 49-420; § 10 of House Bill 2182; K.A.R. 47-2-21, 47-8-10, 47-8-11. March 16, 1984 June 8, 1984 MLCRA 49-406; K.A.R. 47-1-10. December 21, 1984 April 11, 1985 K.A.R. 47-15-13. April 4, 1985 November 15, 1985 K.S.A 1984 Supp. 49-406(g); K.A.R. 47-1-11; 47-2-75; 47-3-42, (a)(23...

30 CFR 916.15 - Approval of Kansas regulatory program amendments.

Code of Federal Regulations, 2014 CFR

2014-07-01

... MLCRA 49-403, 49-405c, 49-406, 49-420; § 10 of House Bill 2182; K.A.R. 47-2-21, 47-8-10, 47-8-11. March 16, 1984 June 8, 1984 MLCRA 49-406; K.A.R. 47-1-10. December 21, 1984 April 11, 1985 K.A.R. 47-15-13. April 4, 1985 November 15, 1985 K.S.A 1984 Supp. 49-406(g); K.A.R. 47-1-11; 47-2-75; 47-3-42, (a)(23...

30 CFR 916.15 - Approval of Kansas regulatory program amendments.

Code of Federal Regulations, 2013 CFR

2013-07-01

... MLCRA 49-403, 49-405c, 49-406, 49-420; § 10 of House Bill 2182; K.A.R. 47-2-21, 47-8-10, 47-8-11. March 16, 1984 June 8, 1984 MLCRA 49-406; K.A.R. 47-1-10. December 21, 1984 April 11, 1985 K.A.R. 47-15-13. April 4, 1985 November 15, 1985 K.S.A 1984 Supp. 49-406(g); K.A.R. 47-1-11; 47-2-75; 47-3-42, (a)(23...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 1 2011-04-01 2011-04-01 false Self-regulatory organization... Miscellaneous § 1.52 Self-regulatory organization adoption and surveillance of minimum financial requirements. (a) Each self-regulatory organization must adopt, and submit for Commission approval, rules...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

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

Code of Federal Regulations, 2012 CFR

2012-04-01

... 17 Commodity and Securities Exchanges 1 2012-04-01 2012-04-01 false Self-regulatory organization... Miscellaneous § 1.52 Self-regulatory organization adoption and surveillance of minimum financial requirements. (a) Each self-regulatory organization must adopt, and submit for Commission approval, rules...

77 FR 32703 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... organization consents, the Commission shall either approve the proposed rule change, disapprove the proposed...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass...

10 CFR 52.11 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... A, B, C, D, and N of part 52. ... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 52.11 Section 52.11 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR...

10 CFR 52.11 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2012 CFR

2012-01-01

... A, B, C, D, and N of part 52. ... 10 Energy 2 2012-01-01 2012-01-01 false Information collection requirements: OMB approval. 52.11 Section 52.11 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR...

78 FR 41311 - Approval of Air Quality Implementation Plans; Indiana; Approval of “Infrastructure” SIP With...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-10

... Elements Required Under Sections 110(a)(1) and (2) for the 2006 24-Hour Fine Particle (PM 2.5 ) National... Indiana Nonregulatory and Quasi-Regulatory Provisions Title Indiana date EPA approval Explanation...

78 FR 76829 - Approval of Application Submitted by Eastern Shoshone Tribe and Northern Arapaho Tribe for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

... regulatory authority under the Clean Air Act. DATES: EPA's decision approving the Tribes' TAS application was... Decision Document, Attachment 1 (Legal Analysis of the Wind River Indian Reservation Boundary), Attachment... decision to approve the application does not approve, Tribal authority to implement any Clean Air Act...

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

PubMed

Shimazawa, Rumiko; Ikeda, Masayuki

2016-03-01

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

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR) Protocol Support Office (PSO) for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator III: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials. Provides deployment of clinical support services for clinical research. Streamlines the protocol development timeline. Provides data and documents collection and compilation for regulatory filing with the U.S. Food and Drug Administration (FDA) and other regulatory authorities.. Provides technical review and report preparation. Provides administrative coordination and general logistical support for regulatory activities. Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture. Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent and other clinical documents. Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services). Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms. Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies. Collaborates with investigators to resolve any protocol/data issues. Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA. Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events. Attends and prepares minutes for the Branch Protocol Review Committees. Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers. Maintains a schedule of all review committee submission deadline dates and meeting dates. Assists clinical investigators in understanding and complying with the entire review process. Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols. Converts protocols from Word format to .pdf with bookmarks. Maintains the .pdf version of the most current approved version of each active clinical protocol on a central server. This position is located in Rockville, Maryland.

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

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

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

1980-01-01

The state agency with principal authority to regulate electric public utilities is the Power Review Board (Board). However, the Board in fact, exercised little regulatory authority over heat and power utilities because all electrical power in Nebraska is currently supplied by public authorities and is not subject to regulation by the Board. Gas and water utilities are also subject to general supervision by municipalities. The Board is compised of five members - an attorney, an engineer, one accountant, two lay - persons appointed by the governor and confirmed by the legislature. All members are appointed to overlapping four-year terms, andmore » none may serve more than two consecutive terms. Decisions by the Board require the approval of a majority of its members. The Public Service Commission of Nebraska is a constitutionally created body. Its powers and duties include the regulation of rates, service, and general control of common carriers as the legislature may provide by law. Other state agencies also possess limited regulatory jurisdiction which may be relevant to an energy facility. Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES.« less

Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy.

PubMed

Roberts, Jeffrey N; Gruber, Marion F

2015-02-18

Despite supportive public health policies (e.g., ACIP recommendations), the potential for providing clinical benefit through maternal immunization has yet to be fully realized. For vaccines already licensed and approved for use in adults, specific FDA approval for use during pregnancy to prevent disease in the mother and/or infant may have a significant impact on uptake and usage in pregnant women. In addition, for either a licensed vaccine or a novel vaccine, FDA approval for use during pregnancy would result in labeling that would serve as a resource for practitioners and would facilitate the safe and effective use of the vaccine during pregnancy. In the U.S., while many vaccines are approved for use in adults and most are not contraindicated for use in pregnant women, no vaccine is licensed for use specifically during pregnancy. Among the perceived obstacles hindering the clinical development of vaccines for use in pregnancy, regulatory issues are frequently cited. One aim of this article is to address the perceived regulatory obstacles. General concepts and regulatory considerations for clinical safety and effectiveness evaluations for vaccines indicated for use during pregnancy will be discussed. This discussion is not intended to establish data requirements or to articulate agency policy or guidance regarding specific vaccine products. Published by Elsevier Ltd.

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

PubMed

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

2018-05-02

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

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

PubMed

Abraham, John; Davis, Courtney

2005-09-01

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

77 FR 20870 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... Definition of Approved Person To Exclude Foreign Affiliates, Eliminating the Application Process for Approved... to exclude foreign affiliates, eliminate the application process for approved persons, and make... Rules 304, 308, and 311. The Exchange also proposed to eliminate use of the Forms AP-1 and AD-G. The...

10 CFR 60.8 - Information collection requirements: Approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: Approval. 60.8 Section 60.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES General Provisions § 60.8 Information collection requirements: Approval. (a) The...

10 CFR 15.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 15.8 Section 15.8 Energy NUCLEAR REGULATORY COMMISSION DEBT COLLECTION PROCEDURES Application and Coverage § 15.8 Information collection requirements: OMB approval. This part contains no information collection...

10 CFR 75.9 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 75.9 Section 75.9 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT General Provisions § 75.9 Information collection requirements: OMB approval...

10 CFR 75.9 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 75.9 Section 75.9 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT General Provisions § 75.9 Information collection requirements: OMB approval...

The risks of risk aversion in drug regulation.

PubMed

Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Brasseur, Daniel; Breckenridge, Alasdair; Leufkens, Hubert; Raine, June; Salmonson, Tomas; Schneider, Christian K; Rasi, Guido

2013-12-01

Drugs are approved by regulatory agencies on the basis of their assessment of whether the available evidence indicates that the benefits of the drug outweigh its risks. In recent years, regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, which reflects the challenge in determining an appropriate balance between benefit and risk with the limited data that is typically available before drug approval. The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, we discuss the consequences of regulatory risk-aversion for public health and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.

10 CFR 19.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Section 19.8 Energy NUCLEAR REGULATORY COMMISSION NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTION... collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0044. (b) The approved...

10 CFR 76.8 - Information collection requirements: OMB approval not required.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: OMB approval not required. 76.8 Section 76.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS General Provisions § 76.8 Information collection requirements: OMB approval not required...

10 CFR 76.8 - Information collection requirements: OMB approval not required.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Information collection requirements: OMB approval not required. 76.8 Section 76.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS General Provisions § 76.8 Information collection requirements: OMB approval not required...

10 CFR 76.8 - Information collection requirements: OMB approval not required.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Information collection requirements: OMB approval not required. 76.8 Section 76.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS General Provisions § 76.8 Information collection requirements: OMB approval not required...

10 CFR 76.8 - Information collection requirements: OMB approval not required.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Information collection requirements: OMB approval not required. 76.8 Section 76.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS General Provisions § 76.8 Information collection requirements: OMB approval not required...

10 CFR 76.8 - Information collection requirements: OMB approval not required.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Information collection requirements: OMB approval not required. 76.8 Section 76.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS General Provisions § 76.8 Information collection requirements: OMB approval not required...

10 CFR 61.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Information collection requirements: OMB approval. 61.8 Section 61.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE General Provisions § 61.8 Information collection requirements: OMB approval. (a) The Nuclear...

10 CFR 61.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Information collection requirements: OMB approval. 61.8 Section 61.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE General Provisions § 61.8 Information collection requirements: OMB approval. (a) The Nuclear...

10 CFR 61.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Information collection requirements: OMB approval. 61.8 Section 61.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE General Provisions § 61.8 Information collection requirements: OMB approval. (a) The Nuclear...

10 CFR 61.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 61.8 Section 61.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE General Provisions § 61.8 Information collection requirements: OMB approval. (a) The Nuclear...

10 CFR 61.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 61.8 Section 61.8 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE General Provisions § 61.8 Information collection requirements: OMB approval. (a) The Nuclear...

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

PubMed

Benda, Norbert; Brandt, Andreas

2018-01-01

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

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

PubMed

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

2017-07-01

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

Canadian regulatory perspectives on genome engineered crops

PubMed Central

Smyth, Stuart J.

2017-01-01

ABSTRACT New breeding techniques in plant agriculture exploded upon the scene about two years ago, in 2014. While these innovative plant breeding techniques, soon to be led by CRISPR/Cas9, initially appear to hold tremendous promise for plant breeding, if not a revolution for the industry, the question of how the products of these technologies will be regulated is rapidly becoming a key aspect of the technology's future potential. Regulation of innovative technologies and products has always lagged that of the science, but in the past decade, regulatory systems in many jurisdictions have become gridlocked as they try to regulate genetically modified (GM) crops. This regulatory incapability to efficiently assess and approve innovative new agricultural products is particularly important for new plant breeding techniques as if these techniques are classified as genetically modified breeding techniques, then their acceptance and future will diminish considerably as they will be rejected by the European Union. Conversely, if the techniques are accepted as conventional plant breeding, then the future is blindingly bright. This article examines the international debate about the regulation of new plant breeding techniques and then assesses how the Canadian regulatory system has approached the regulation of these technologies through two more public product approvals, GM apples and GM potatoes, then discusses other crop variety approval and those in the regulatory pipeline. PMID:27858499

10 CFR 72.234 - Conditions of approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Conditions of approval. 72.234 Section 72.234 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT... Spent Fuel Storage Casks § 72.234 Conditions of approval. (a) The certificate holder and applicant for a...

77 FR 12637 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... Equities Definition of Approved Person To Exclude Foreign Affiliates, Eliminating the Application Process..., eliminate the application process for approved persons, and make related technical and conforming changes..., eliminate the application process for approved persons, and make related technical and conforming changes...

10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

Tritherapy (Spinalon)-Elicited Spinal Locomotor Network Activation: Phase I-IIa Clinical Trial in Spinal Cord-Injured Patients

DTIC Science & Technology

2013-10-01

regulatory and administrative approvals from the US Department of Defense, the Human Research Protection Offices, and the local ethic board. The...submission of the corresponding documents to Health Canada and McGill University Health Center (MUHC) for Canadian regulatory approval (IND/CTA) and Ethics ...the investigator, Dr. Mohan Radhakrishna, submitted amended protocol and ICF to the Institutional (MUHC) Ethics Review Board. • Task 1i (June 11