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The National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) held a public meeting and is requesting input from interested parties on issues that the agency will consider as it develops regulations to expand the clinical trial registry and results data bank commonly known as ClinicalTrials.gov in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) [Public Law 110-85]. Comments on these issues from all interested parties will inform the development of draft regulations, which will be made available for public comment via a Notice of Proposed Rulemaking (NPRM) that will be issued in the Federal Register at a later date. See the March 23, 2009 Federal Register Notice for full details (pdf).
The public meeting was held on Monday, April 20, 2009, in Masur Auditorium (Building 10) on the NIH Campus. The meeting transcript, final meeting agenda, list of speakers for public statements, presentations by Dr. Deborah A. Zarin (NLM) and Ms. Terry Toigo (FDA), and public submissions are available at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=NIH-2009-0002. A videocast and podcast of the public meeting is available at http://videocast.nih.gov/Summary.asp?File=15038.
Submit electronic comments to Docket No. NIH-2009-0002 at http://www.regulations.gov. To ensure consideration, written comments should be submitted to the docket by Monday, June 22, 2009.
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