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HHS/FDA RIN: 0910-AC41 Publication ID: Spring 2007 
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 (the act), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), requires notification to FDA prior to the entry of imported food. The regulation 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. Section 307 authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. FDA and the Bureau of Customs and Border Protection (CBP) issued an interim final rule (IFR) on October 10, 2003 (68 FR 58974). The IFR originally provided a 75-day comment period to ensure that those that comment on the IFR have the benefit of our outreach and educational efforts and have the experience with the systems, timeframes, and data elements. We reopened the comment period for an additional 90 days in April through July 2004, to allow for additional comment on the industry's experience with the prior notice system, and comment on the Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes. The final rule currently is under development, and it will confirm or amend the IFR, as appropriate. This final rule is not expected to have a significant impact on a substantial number of small entities. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  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  09/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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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