[Federal Register Volume 68, Number 240 (Monday, December 15, 2003)]
[Notices]
[Pages 69708-69709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30920]


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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://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://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