The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) is holding a public meeting and 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:
http://edocket.access.gpo.gov/2009/E9-6198.htm
http://prsinfo.clinicaltrials.gov/Clinical_Trials_FRN31609_POST.pdf
The public meeting will be held on Monday, April 20, 2009, from 9:00 a.m. to 5:00 p.m. The meeting agenda will be posted here (and submitted to the public docket) by Wednesday, April 15, 2009.
The public meeting will be held in Masur Auditorium, which is located on the NIH Campus, Building 10, South Side, First Floor,
To ensure sufficient seating for all participants, please register by 5:00 p.m. on Monday, April 13, 2009, at http://www.tech-res.com/public-meeting-april09/registration.asp. Registration is on a first-come, first-served basis and walk-in registrations will be accepted at the site on a space-available basis.
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.
Participants wishing to make an oral statement at the Public Meeting are requested to register at http://www.tech-res.com/public-meeting-april09/registration.asp and to submit to the meeting docket a written version of their remarks by 5:00 p.m. on Monday, April 13, 2009.
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@xxxxxxxxxxxx.
For additional drug information, please visit our DDI websites: http://www.fda.gov/cder/Offices/DDI/default.htm and http://www.fda.gov/cder/Offices/DDI/pathfinder.htm.
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