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November
16, 2005
FDA has issued its final guidance for Records access authority, and this guidance document is being distributed for use by FDA staff and Industry. It is a revision of the previously issued guidance entitled "Draft Guidance for Records Access Authority provided in Title III, Subtitle A of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" dated December 9, 2004. The final guidance is available online.
Comments and suggestions regarding this document may be submitted at any time to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number 2004G-0381. For questions regarding this document contact Diane Kelley, Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-632-6860.
FDA has updated its guidance entitled "Questions and Answers Regarding Establishment and Maintenance of Records." The guidance responds to various questions raised about section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the agency's implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. Persons covered by the regulation must be in compliance by December 9, 2005, June 9, 2006, or December 11, 2006, depending on the size of the business. The updated Questions and Answers are available online.
Written or electronic comments on the agency guidance may be submitted at any time. Submit written comments on the guidance to the Division of Documents Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to Dockets Open for Comment. Written requests for single copies of the guidance may be made to Denise Beavers, Office of Regulations and Policy (HFS-24), CFSAN, FDA, 5100 Paint Branch Pkwy., College Park, MD 20740. Requests should include the guidance title and one self-addressed adhesive label to assist that office in processing your request. For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 1-888-SAFEFOOD, (Fax) 1-877-366-3322, or by e-mail:
FDA has posted a revised compliance policy guide (CPG) Sec. 110.310 entitled "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The CPG provides written guidance to FDA's and Customs and Border Protection's (CBP's) staff on enforcement of section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States. The CPG has been revised to finalize the sections pertaining to routine shipments of food that are transshipped through the United States, arriving from and exiting to the same country, and regarding the Harmonized Tariff Schedule (HTS) code that is part of the planned shipment information. The revised CPG is available online.
Written or electronic comments on the revised CPG may be submitted at any time. Submit written comments on the guidance to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. For further information, contact Laura Draski, Office of Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 866-521-2297.
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Office of Food Safety, Defense, and Outreach |
Office Number: (301) 436-2277 ยท FAX (301) 436-2605 CFSAN Web site: http://www.cfsan.fda.gov/ |
