[Federal Register Volume 68, Number 244 (Friday, December 19, 2003)]
[Notices]
[Pages 70817-70818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0562]


Compliance Policy Guide Sec.110.300--``Registration of Food 
Facilities Under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002;'' 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 compliance policy guide (CPG) Sec. 110.300 entitled 
``Registration of Food Facilities Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides 
written guidance to FDA's staff on enforcement of section 305 of the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (the Bioterrorism Act) and the agency's implementing 
regulation, which require, beginning on December 12, 2003, registration 
with FDA for all domestic and foreign facilities that manufacture/
process, pack, or hold food for human or animal consumption in the 
United States.

DATES: This guidance is final upon the date of publication. However, 
you may submit written or electronic comments at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Compliance Policy (HFC-230), Office of Enforcement, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your request or include a fax number to which the guidance 
may be sent.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: 
     Food for human consumption: Judith Gushee, Division of 
Enforcement, Office of Compliance, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 301-436-2417.
    Food for animal consumption: Isabel Pocurull, Division of Animal 
Feeds, Office of Surveillance and Compliance, Center for Veterinary 
Medicine, Food and Drug Administration, 301-827-0175.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of CPG Sec.110.300 entitled 
``Registration of Food Facilities Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002.'' This guidance 
outlines for FDA staff the agency's policy on enforcement of section 
305 of the Bioterrorism Act and its implementing regulation (68 FR 
58894, October 10, 2003; to be codified at 21 CFR part 1, subpart H). 
The Bioterrorism Act and subpart H require that, beginning on December 
12, 2003, all domestic and foreign facilities that manufacture, 
process, pack, or hold food for human or animal consumption in the 
United States be registered with FDA.
    FDA is issuing this document as level 1 guidance consistent with 
FDA's good guidance practices regulation Sec.  10.115 (21 CFR 10.115). 
The CPG Sec. 110.300 is being implemented immediately without prior 
public comment, under Sec.  10.115(g)(2), because the agency has 
determined that prior public participation is not feasible. As noted, 
under section 305 of the Bioterrorism Act, the requirement that food 
facilities be registered is effective December 12, 2003, making it 
urgent that the agency explain how it intends to enforce this 
requirement.

[[Page 70818]]

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance 
document. 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. The guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    An electronic version of this guidance is available on the Internet 
at http://www.fda.gov/ora under ``Compliance References.''

    Dated: December 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-31376 Filed 12-17-03; 9:09 am]
BILLING CODE 4160-01-S