
[Federal Register: April 24, 2009 (Volume 74, Number 78)]
[Notices]               
[Page 18736-18737]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap09-79]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0187]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

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

ADDRESSES: 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 industry@fda.gov.
    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 http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to this SECG.

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

SUPPLEMENTARY INFORMATION:

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

[[Page 18737]]

Management 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 http://
www.cfsan.fda.gov/guidance.html.

    Dated: April 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9358 Filed 4-23-09; 8:45 am]

BILLING CODE 4160-01-S
