FDA Schedules Public Meetings on Recordkeeping Under the Bioterrorism Act
The Food and Drug Administration (FDA) has issued a notice announcing that it will hold a series of domestic public meetings to discuss its final rule on the requirements for establishing and maintaining records under the Bioterrorism Act, which was published in the December 9, 2004 Federal Register.
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During the public meetings, the FDA will explain the final rule and the draft guidance that was published along with the final rule, and also answer questions of clarification.
FDA to Hold Seven Public Meetings Between January 13th and February 1st
The FDA will hold public meetings at the following locations, dates, and times:
| Location | Date | Time |
|---|---|---|
| College Park, MD | 01/13/05 | 9 a.m. - 1 p.m. EST |
| Chicago, IL | 01/25/05 | 9 a.m. - 1 p.m. CST |
| Seattle, WA | 01/25/05 | 9 a.m. - 1 p.m. PST |
| San Francisco, CA | 01/27/05 | 9 a.m. - 1p.m. PST |
| Orlando, FL | 01/27/05 | 9 a.m. - 1p.m. EST |
| Philadelphia, PA | 02/01/05 | 1 p.m. - 5 p.m. EST |
| Boston, MA | 02/01/05 | 9 a.m. - 1 p.m. EST |
Meeting Participants Asked to Submit Registration Information in Advance
The FDA asks interested parties to submit their registration information (including name, title, firm name, address, telephone number, email address, and fax number) at least five working days before the public meeting date. For specific site locations, the FDA encourages interested parties to register online at http://www.cfsan.fda.gov/dms/fsbtac23.html or fax directly to Sharon Barcellos at (202) 479-4970. See FDA's notice for additional registration instructions and information, etc.
(See ITT's Online Archives or 12/08/04 news, 04120810, for BP summary FDA's announcement of the publication of its final rule on Bioterrorism Act recordkeeping, as well as providing a link for this meeting notice.)
FDA Contact - Marion Allen (301) 436-1584
FDA Notice (D/N 2002N-0277, FR Pub 12/09/04) available athttp://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-26930.pdf