Department of Health and Human Services December 27, 2011 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70150). In the notice, FDA requested comments on the draft guidance that addresses the approaches FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the investigational device exemption (IDE) requirements. The Agency is taking this action to allow interested persons additional time to submit comments.
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the FDA guidance for industry on ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' This guidance document provides recommendations on postmarketing serious adverse event reporting for nonprescription (over-the-counter) human drugs marketed without an approved application. It provides recommendations on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports.
Prospective Grant of Exclusive License: Use of Methanocarba Analogues of Purine and Pyrimidine Nucleosides and Nucleotides to Treat or Prevent Cardiac Diseases in Humans
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive evaluation option license, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 176,373, filed January 14, 2000 and currently abandoned [HHS Ref. No. E-176-1999/0-US-01]; PCT Application PCT/US01/00981, filed January 12, 2001 and currently expired [HHS Ref. No. E-176-1999/0-PCT-02]; U.S. Patent Application No. 10/169,975, filed July 12, 2002 and issued as U.S. Patent No. 7,087,589 on August 8, 2006 [HHS Ref. No. E-176-1999/0- US-06]; U.S. Patent Application No. 11/500,860, filed August 8, 2006 and issued as U.S. Patent No. 7,790,735 on September 14, 2006 [HHS Ref. No. E-176-1999/0-US-07]; Australian Patent Application No. 2001230913, filed January 12, 2001 and issued as Australian Patent No. 2001230913 on October 13, 2005 [HHS Ref. No. E-176-1999/0-AU-03]; Canadian Patent Application No. 2,397,366, filed January 12, 2001 and issued as Canadian Patent No. 2,397,366 on March 15, 2011 [HHS Ref. No. E-176- 1999/0-CA-04]; European Patent Application No. 01903043.6, filed January 12, 2001 and issued as European Patent No. 1252160 on August 6, 2006 and currently abandoned [HHS Ref. No. E-176-1999/0-EP-05]; and UK Patent Application No. 01903043.6, filed January 12, 2001 and issued as UK Patent No. 1252160 on August 16, 2006 [HHS Ref. No. E-176-1999/0-GB- 08], entitled ``Methanocarba Cycloalkyl Nucleoside Analogues'' to Cornovus Pharmaceuticals, Inc., a company incorporated under the laws of the State of Delaware having its headquarters in Farmington, Connecticut. The United States of America is the assignee of the rights of the above inventions. The prospective exclusive evaluation option license territory may be ``worldwide'', and the field of use may be limited to ``The use of (1'S,2R,3S,4'R,5'S)-4- (6-amino-2-chloro-9H-purin-9-yl)-1-[phosphoryloxymethyl] bicycle[3.1.0]hexane-2,3-diol) (MRS2339) to treat and/or prevent cardiac diseases in humans.'' Upon the expiration or termination of the exclusive evaluation option license, Cornovus Pharmaceuticals, Inc. will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the evaluation license.
Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for members with expertise in epidemiology, pediatric development, and analytical chemistry or food science to serve on the Food Advisory Committee, Center for Food Safety and Applied Nutrition, Office of Regulations, Policy, and Social Sciences. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
Request for Nominations for Voting Members on Public Advisory Panels or Committees
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, and the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through December 31, 2012. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
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