[Federal Register Volume 68, Number 241 (Tuesday, December 16, 2003)]
[Rules and Regulations]
[Pages 69957-69958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2002N-0278]


Guidance for Industry: Questions and Answers on the Interim Final 
Rule on Prior Notice of Imported Food; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability of guidance.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Prior Notice of Imported Food, 
Questions and Answers.'' The guidance responds to various questions 
raised about the section 307 of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism 
Act) and the agency's implementing regulations that require, beginning 
on December 12, 2003, prior notice to FDA before food is imported or 
offered for import into the United States.

DATES: Submit written or electronic comments on the agency guidance at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Prior Notice Help Desk, phone 1-800-216-7331 or 301-575-0156, or 
Fax 301-210-0247. See the Supplementary Information section for 
electronic access to the guidance document.
    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.

FOR FURTHER INFORMATION CONTACT: Domenic Veneziano, Office of 
Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 781-596-7785.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 10, 2003 (68 FR 58974), FDA 
issued an interim final rule to implement section 307 of the 
Bioterrorism Act. The prior notice regulations require, beginning on 
December 12, 2003, notification to FDA before food (including animal 
feed) is imported or offered for import into the United States. This 
guidance responds to questions raised about the interim final rule on 
prior notice, and it is intended to help the industry better understand 
and comply with the regulations.
    FDA is issuing the guidance entitled ``Prior Notice of Imported 
Food, Questions and Answers'' as a Level 1 guidance. Consistent with 
FDA's good guidance practices regulation (21 CFR 10.115), the agency 
will accept comment, but it is implementing the guidance document 
immediately, in accordance with Sec.  10.115(g)(2), because the agency 
has determined that prior public participation is not feasible or 
appropriate. FDA is under a strict statutory deadline in which to 
implement these regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance at any 
time. Two copies of any mailed comments are to be submitted, except 
that individuals may submit one copy. Comments are to

[[Page 69958]]

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

    Persons with access to the Internet may obtain the document at 
http://www/cfsan.fda.gov/guidance.html.

    Dated: December 11, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-31038 Filed 12-12-03; 8:45 am]
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