Compliance Policy Guide: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

[Federal Register: December 19, 2003 (Volume 68, Number 244)]
[Notices]
[Page 70817-70818]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de03-79]
 
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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

Compliance Policy Guide: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002