[Federal Register: March 4, 2005 (Volume 70, Number 42)]
[Notices]               
[Page 10657]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr05-74]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0554]

 
Revised Compliance Policy Guide Regarding 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 draft revisions to 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 and Customs and Border 
Protection (CBP) 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 prior notice for food imported or offered for import into the 
United States. The CPG has been revised to provide additional guidance 
to FDA and CBP staff regarding specific situations covering routine 
shipments of food that are transported through the United States, 
arriving from and exiting to the same country, and regarding the 
Harmonized Tariff Schedule (HTS) code that is part of the planned 
shipment information.

DATES: The draft revisions to the CPG are found in section C, items 7 
and 8. Submit written or electronic comments concerning the draft 
revisions to the CPG by April 4, 2005. You may submit written or 
electronic comments on the other sections of the CPG at any time.

ADDRESSES: Submit written requests for single copies of the revised 
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, 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 for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Domenic Veneziano, Office of 
Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 703-621-7809.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft revision to CPG Sec. 
110.310 entitled ``Prior Notice of Imported Food Under the Public 
Health Security and Bioterrorism Preparedness and Response Act of 
2002.'' This revised guidance is issued with CBP concurrence and 
explains to FDA and CBP staff the new FDA and CBP policies on 
enforcement of section 307 of the Bioterrorism Act and its implementing 
regulations, which require prior notice to FDA of all food imported or 
offered for import into the United States (21 CFR part 1.276 through 
1.285).
    FDA is considering taking these steps while the prior notice final 
rule is under development to provide additional flexibility in filing 
prior notice when, due to the geography, the only practical 
transportation route available for the shipment is through the United 
States and when there is a prior notice violation because the prior 
notice does not include the 6-digit HTS code for the article of food.
    FDA is issuing the revisions to the CPG as level 1 draft guidance 
consistent with FDA's good guidance practices regulation Sec.  10.115 
(21 CFR 10.115). The draft revisions to the CPG represent the agency's 
current thinking on its enforcement policy concerning prior notice. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. The draft revisions to the CPG are 
found in section C, items 7 and 8.

II. 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 copies or two 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 revised CPG 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 the revised CPG 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: February 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4218 Filed 3-3-05; 8:45 am]

BILLING CODE 4160-01-S