September 2, 2005

"Questions and Answers Regarding Establishment
and Maintenance of Records" Now Available

FDA has announced the availability of a 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 (the Bioterrorism Act) 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.

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), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 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 further information, contact Denise Beavers at the address above or by calling 301-436-1721.