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Proposed RuleSignificant03-24432003-02-03

Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA) is proposing a regulation that would require domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. The proposed regulation would implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to register with FDA by December 12, 2003, even in the absence of final regulations. Registration is one of several tools that will enable FDA to act quickly in responding to a threatened or actual terrorist attack on the U.S. food supply by giving FDA information about all facilities that manufacture, process, pack, or hold food for consumption in the United States. In the event of an outbreak of food-borne illness, such information will help FDA and other authorities determine the source and cause of the event. In addition, the registration information will enable FDA to notify quickly the facilities that might be impacted by the outbreak.

Action & Dates

Action
Notice of proposed rulemaking.
Dates
Submit written or electronic comments by April 4, 2003. Written comments on the information collection provisions should be submitted by March 5, 2003.

CFR References

Topics

CosmeticsDrugsExportsFood labelingImportsLabelingReporting and recordkeeping requirements

Public Comment

Comments Close
2003-04-04

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 1 [Docket No. 02N-0276] RIN 0910-AC40 AGENCY: Food and Drug Administration, HHS. ACTION: Notice of proposed rulemaking. SUMMARY: The Food and Drug Administration (FDA) is proposing a regulation that would require domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. The proposed regulation would implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to register with FDA by December 12, 2003, even in the absence of final regulations. Registration is one of several tools that will enable FDA to act quickly in responding to a threatened or actual terrorist attack on the U.S. food supply by giving FDA information about all facilities that manufacture, process, pack, or hold food for consumption in the United States. In the event of an outbreak of food-borne illness, such information will help FDA and other authorities determine the source and cause of the event. In addition, the registration information will enable FDA to notify quickly the facilities that might be impacted by the outbreak. DATES: Submit written or electronic comments by April 4, 2003. Written comments on the information collection provisions should be submitted by March 5, 2003. ADDRESSES: Submit written comm

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Full Document

Citation: 68 FR 5378