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HHS/FDA RIN: 0910-AC41 Publication ID: Spring 2005 
Title: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 
Abstract: This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism. Section 801(m) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. Section 801(m) requires notification to FDA prior to the entry of imported food. The required prior notice would provide the identity of the article of food; the manufacturer; the shipper; the grower, if known at the time of notification; the originating country; the shipping country; and the anticipated port of entry. The regulation identifies the parties responsible for providing the notice and explains the information that the prior notice is required to contain, the method of submission of the notice, and the minimum and maximum period of advance notice required. Section 307 also states that if FDA does not receive prior notice or receives inadequate prior notice, the imported food shall be refused admission and held at the port of entry until proper notice is provided. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 1.276 et seq   
Legal Authority: PL 107-188, sec 307   
Legal Deadline:
Action Source Description Date
Final  Statutory    12/12/2003 

Overall Description of Deadline: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 307, directs the Secretary, through FDA, to issue final regulations establishing prior notice requirements for all imported food by December 12, 2003. If FDA fails to issue final regulations by this date, the statute is self-executing on this date, and requires FDA to receive prior notice of not less than eight hours, nor more than five days until final regulations are issued.

Action Date FR Cite
NPRM  02/03/2003  68 FR 5428   
Interim Final Rule  10/10/2003  68 FR 58974   
Interim Final Rule Comment Period Reopened  04/14/2004  69 FR 19763   
Interim Final Rule Comment Period Reopened End  07/13/2004    
Final Rule  06/00/2005    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Gerie Voss
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFS-32, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426

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