[Federal Register: November 9, 2004 (Volume 69, Number 216)]
[Notices]               
[Page 64961-64962]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no04-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0562]

 
Revised 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 revised 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'' 
(registration CPG). The revised 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 requires, 
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 revised CPG 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 revised CPG 
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 revised 
CPG may be sent. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the revised CPG.
    Submit written comments on the revised CPG 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.


FOR FURTHER INFORMATION CONTACT:
    Food for human consumption: Judith Gushee, Center for Food Safety 
and Applied Nutrition (HFS-605), Food and Drug Administration, 301-436-
2417.
    Food for animal consumption: Isabel Pocurull, Center for Veterinary 
Medicine (HFV-226), Food and Drug Administration, 301-827-0175.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of 
revised CPG Sec. 110.300 entitled ``Registration of Food Facilities 
Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002'' (registration CPG). This revised CPG 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); (codified at 21 CFR part 1, subpart H, 1.225 through 
1.243)). 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 must be registered with FDA.

I. Background

    On December 19, 2003, FDA issued CPG Sec. 110.300 (the December 
CPG). The December CPG states that for domestic firms, FDA would 
initially plan to focus the agency's efforts on educating and otherwise 
informing the industry on how to comply with the registration of food 
facilities interim final rule, and that thereafter FDA would enforce 
the registration provision as appropriate in each situation. We set out 
in the Regulatory Action Guidance section our enforcement approach.
    For foreign facilities, the December CPG referred to the policies 
set out in CPG Sec. 110.310 entitled ``Prior Notice of Imported Food 
Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002'' (the prior notice CPG).

II. Revised CPG Sec. 110.300

    FDA is making only one substantive change in the registration CPG. 
Specifically, the revised CPG provides that, on November 8, 2004, FDA 
is fully implementing the agency's enforcement policy for domestic food 
facilities, which was set out in the Regulatory Action Guidance section 
of the December CPG. For foreign facilities, the registration CPG 
continues to state that generally, the registration requirement for the 
facilities of foreign manufacturers and shippers will be enforced in 
accordance with the policies set out in the prior notice CPG. Elsewhere 
in this issue of the Federal Register, FDA is publishing a notice of 
availability for the revision to the prior notice CPG, which is being 
issued under Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)) as level 1 
guidance that is effective November 8, 2004.
    FDA is also issuing the revised registration CPG as level 1 
guidance consistent with FDA's good guidance practices regulation 
(Sec.  10.115). Revised CPG Sec. 110.300 is being implemented 
immediately without prior public comment, under Sec.  10.115(g)(2), 
because FDA has determined that prior public participation is not 
feasible or appropriate. Revision of FDA's prior notice enforcement 
policy directly affects the agency's enforcement of the registration 
requirement for foreign manufacturers and shippers. Given this 
relationship, it is appropriate that FDA coordinate announcement and 
implementation of the agency's revised enforcement policy for food 
facilities registration with the agency's comparable actions for the 
prior notice of imported food requirement.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the revised CPG. 
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.

[[Page 64962]]

IV. Electronic Access

    An electronic version of this guidance is available on the Internet 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora under ``Compliance References.''


    Dated: November 2, 2004.
Steve M. Niedelman,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-24873 Filed 11-4-04; 8:57 am]

BILLING CODE 4160-01-S