[Federal Register: June 29, 2004 (Volume 69, Number 124)]
[Notices]               
[Page 38906-38907]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn04-73]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0554]

 
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 a revised Compliance Policy Guide (CPG) Sec. 110.310 
entitled ``Prior Notice of Imported Food

[[Page 38907]]

Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002.'' The original CPG, which was published in the 
Federal Register of December 15, 2003 (68 FR 69708), 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 prior 
notice for all 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 how to address food that is imported or offered 
for import for noncommercial purposes with a noncommercial shipper. The 
revised CPG also reflects a change in the date of Stage III enforcement 
guidance for the interim final rule from May 13, 2004, to June 4, 2004.

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, 5630 Firhers 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 revised 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 (68 FR 58974, October 10, 2003 (codified at 21 CFR 1.276 
through 1.285)). FDA has revised the original CPG, which was published 
on December 15, 2003 (68 FR 69708), to include additional guidance 
regarding food imported or offered for import for noncommercial 
purposes with a noncommercial shipper. The CPG explains that a ``non-
commercial purpose'' generally exists when the food is purchased or 
otherwise acquired by an individual for nonbusiness purposes and the 
shipper is the individual (i.e., the individual delivers the food to a 
post office or common carrier for delivery to self, family member, or 
friend for nonbusiness purposes, i.e., not for sale, resale, barter, 
business use, or commercial use). With respect to these food imports, 
FDA intends to focus its efforts on education through March 2005 (or 
shortly thereafter, depending on the date of issuance of the final 
rule). Examples of foods imported or offered for import that may be 
covered by this noncommercial category include the following:
     Food in household goods, including military, civilian, 
governmental agency, and diplomatic transfers;
     Food purchased by a traveler and mailed or shipped to the 
traveler's U.S. address by the traveler;
     Gifts purchased at a commercial establishment and shipped 
by the purchaser, not the commercial establishment. The revised CPG 
also corrects the date of Stage III enforcement guidance for the 
interim final rule from May 13, 2004, to June 4, 2004, per the 
Automated Broker Interface (ABI) Administrative Message 04-1406 issued 
by CBP on June 3, 2004.
    FDA is issuing this document as level 1 guidance consistent with 
FDA's good guidance practices regulation Sec.  10.115 (21 CFR 10.115). 
The revised 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 were effective December 12, 2003, making it urgent 
that the agencies explain how they intend to enforce those 
requirements. Moreover, as a result of the revision to the CPG, FDA's 
policies are generally less burdensome for food imported or offered for 
import for noncommercial purposes with a noncommercial shipper.

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: June 24, 2004.
John M. Taylor,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-14766 Filed 6-25-04; 9:17 am]

BILLING CODE 4160-01-S