[Federal Register Volume 69, Number 85 (Monday, May 3, 2004)]
[Rules and Regulations]
[Pages 24070-24071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2004D-0065]


Guidance for Industry: Questions and Answers Regarding the 
Interim Final Rule on Prior Notice of Imported Food (Edition 2); 
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 revised guidance entitled ``Questions and Answers 
Regarding the Interim Final Rule on Prior Notice of Imported Food 
(Edition 2).'' The guidance responds to various questions raised about 
section 307 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (the Bioterrorism Act) and the agency's 
implementing regulation, which require the submission to FDA of prior 
notice of food, including animal feed, that 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 Office of Regulatory Affairs, Office of Regional Operations, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or to 
the Prior Notice Help Desk at 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, Office of Regional Operations, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 866-521-2297.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 10, 2003 (68 FR 58974), FDA 
issued an interim final rule (IFR) to implement section 307 of the 
Bioterrorism Act. The prior notice regulation requires the submission 
to FDA beginning on December 12, 2003, of prior notice of food, 
including animal feed, that is imported or offered for import into the 
United States. On December 16, 2003, FDA issued the first edition of a 
guidance entitled ``Prior Notice of Imported Food Questions and Answers 
(Edition 1).'' This guidance entitled ``Questions and Answers Regarding 
the Interim Final Rule on Prior Notice of Imported Food (Edition 2)'' 
is a revision of the guidance published on December 16, 2003, and 
responds to additional questions about the prior notice IFR. It is 
intended to help the industry better understand and comply with the 
regulation in 21 CFR part 1, subpart I. FDA is issuing this guidance 
entitled ``Questions and Answers Regarding the Interim Final Rule on 
Prior Notice of Imported Food (Edition 2)'' as a level 1 guidance. 
Consistent with FDA's good guidance practices regulation (Sec.  
10.115(g)(2) (21 CFR 10.115)(g)(2)), the agency will accept comments, 
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. As noted, the 
Bioterrorism Act requires prior notice submission to FDA starting on 
December 12, 2003. Clarifying the provisions of the IFR will facilitate 
timely and accurate prior notice submissions and thus, assist in the 
implementation of the IFR. FDA continues to receive a large number of 
questions regarding the prior notice IFR, and is responding to these 
inquires under Sec.  10.115 as promptly as possible, using a question-
and-answer format. The agency believes that it is reasonable to 
maintain all responses to questions concerning prior notice of imported 
food in a single document that is periodically updated as the agency 
receives and responds to additional

[[Page 24071]]

questions. The following four indicators will be employed to help users 
of the guidance identify revisions: (1) The guidance will be identified 
as a revision of a previously issued document, (2) the revision date of 
the guidance will appear on its cover, (3) the edition number of the 
guidance will be included in its title, and (4) questions and answers 
that have been revised or added to the original guidance will be 
identified as such in the body of the guidance.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed 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

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

    Dated: April 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10023 Filed 4-29-04; 11:01 am]
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