FDA Schedules Second Set of Public Meetings on Recordkeeping Under the Bioterrorism Act
The Food and Drug Administration (FDA) has issued a notice announcing that it will hold a second series of domestic public meetings to discuss its December 9, 2004 final rule that requires the establishment and maintenance of records by certain persons (unless excepted) who manufacture, import, process, pack, transport, distribute, receive, or hold food in the U.S.
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(The FDA states that its December 9, 2004 final rule implements section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which requires certain persons who manufacture, process, pack, transport, distribute, receive, hold or import food to establish and maintain certain records for not longer than two years.)
During the public meetings, the FDA states it will explain the final rule and the draft guidance that was published along with the final rule, and answer questions for clarification.
FDA to Hold Five Public Meetings Between June 7th and June 15th
The FDA will hold public meetings at the following locations, dates, and times:
| Location | Date | Time |
|---|---|---|
| Kansas City, MO | 06/07/05 | 9 a.m. - 1 p.m. CST |
| Los Angeles, CA | 06/08/05 | 9 a.m. - 1 p.m. PST |
| College Park, MD | 06/09/05 | 9 a.m. - 1 p.m. EST |
| Bloomington, MN | 06/14/05 | 9 a.m. - 1 p.m. CST |
| Atlanta, GA | 06/15/05 | 9 a.m. - 1 p.m. EST |
Those Interested in Attending Should 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/fsbtac26.html or fax their registration directly to Isabelle Howes at (202) 479-6801. See FDA's notice for additional registration instructions and information, etc.
(See ITT's Online Archives or 01/11/05 news, 05011130, for BP summary of FDA's notice announcing the first set of public meetings on recordkeeping under the Bioterrorism Act.
See ITT's Online Archives, 05011495, for BP summary of the FDA's December 9, 2004 final rule. See ITT's Online Archives or 03/01/05 news, 05030115, for BP summary of the FDA's corrections to the final rule.)
FDA contact - Marion Allen (301) 436-1584
FDA notice (D/N 2002N-0277 (formerly 02N-0277), FR Pub 05/13/05) available at http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-9536.pdf