Department of Health and Human Services March 23, 2009 – Federal Register Recent Federal Regulation Documents

With this notice, the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) announces a public meeting and requests 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) [Pub. L. 110-85]. FDAAA requires a public meeting to be held to provide an opportunity for input from interested parties with regard to regulations that are to be issued within three years of enactment of the law. The NIH seeks input from all interested parties about issues to be considered in the proposed rulemaking. Comments on these issues will inform the development of draft regulations, which will be made available for public comment via a separate Notice of Proposed Rulemaking (NPRM) that will be issued in the Federal Register at a later date. Section III of this document lists specific topics and questions on which input is sought.