[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