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HHS/FDA

RIN: 0910-AC41

Publication ID: Fall 2008

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: Completed 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 8 hours, nor more than 5 days, until final regulations are issued.

Timetable:

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 Action	11/07/2008	73 FR 66294
Final Action Effective	05/06/2009

Regulatory Flexibility Analysis Required: No	Government Levels Affected: Federal
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Gerie Voss Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration HFS-32, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993 Phone:877 287-1373 Email: ctpregulations@fda.hhs.gov