[Federal Register: December 15, 2003 (Volume 68, Number 240)]
[Notices]
[Page 69708-69709]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de03-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0554]
Compliance Policy Guide Sec. 110.310--``Prior Notice of Imported
Food 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. 110.310 entitled
``Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides
written guidance to FDA's and Customs and Border Protection's (CBP's)
staff on enforcement of section 307 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism
Act) and the agency's implementing regulations, which require,
beginning on December 12, 2003, prior notice for all food imported or
offered for import into 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION
section
[[Page 69709]]
for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Joe McCallion, Office of Regulatory
Affairs, Food and Drug Administration, (301) 443-6553 or Ted Poplawski,
Office of Regulatory Affairs, Food and Drug Administration, (301) 443-
6553.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of CPG Sec. 110.310 entitled
``Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002.'' This guidance is
issued jointly with CBP and explains to FDA and CBP staff the FDA and
CBP policies on enforcement of section 307 of the Bioterrorism Act and
its implementing regulations, which require, beginning on December 12,
2003, prior notice to FDA of all food imported or offered for import
into the United States. (68 FR 58974 (Oct. 10, 2003) (to be codified at
21 CFR 1.276-1.285).)
FDA is issuing this document as level 1 guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The CPG Sec.
110.310 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 or appropriate. Under section 307
of the Bioterrorism Act, the prior notice requirements are effective
December 12, 2003, making it urgent that the agencies explain how they
intend to enforce those requirements.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance
document. Submit two copies of written comments, except that
individuals may submit one 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora under ``Compliance References.''
Dated: December 10, 2003.
John M. Taylor, III,
Associate Commissioner for Regulatory Affairs, Food and Drug
Administration.
Jayson P. Ahern,
Assistant Commissioner, Office of Field Operations, U.S. Customs and
Border Protection.
[FR Doc. 03-30920 Filed 12-11-03; 8:45 am]
BILLING CODE 4160-01-P