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Small Entity Compliance Guide on Prior Notice of Imported Food; Availability

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for the final rule on prior notice of imported food. The final rule issued under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and it was published in the Federal Register of November 7, 2008. The SECG is entitled “What You Need to Know About Prior Notice of Imported Food Shipments—A Small Entity Compliance Guide,” and it is intended to help all entities, especially small businesses, better understand the prior notice regulation.


Submit written or electronic comments on the SECG at any time.


Submit written requests for single copies of the SECG to the CFSAN Outreach and Information Center, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 1-877-366-3322, or email your request to

Submit written comments concerning the SECG to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the SECG to See the SUPPLEMENTARY INFORMATION section for electronic access to this SECG.

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Laura Draski, Office of Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 866-521-2297.

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I. Background

In the Federal Register of November 7, 2008 (73 FR 66294), FDA issued the prior notice final rule implementing section 307 of the Bioterrorism Act. The prior notice final rule requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States.

FDA examined the economic implication of this final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that it would have a significant economic impact on a substantial number of small entities.

In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121), FDA is making available this SECG that explains the requirements of this regulation.

FDA is issuing this SECG as a level 2 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). This SECG restates, in simplified format and language, FDA's current requirements for prior notice of imported food. As guidance, this document is not binding on either FDA or the public. FDA notes, however, that the regulation that serves as the basis for this guidance document establishes requirements for all covered activities. For this reason, FDA strongly recommends that affected parties consult the regulations at 21 CFR part 1, subpart I, in addition to reading this SECG.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this SECG. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Start Printed Page 18737Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain this SECG at​guidance.html.

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Dated: April 20, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E9-9358 Filed 4-23-09; 8:45 am]