[Federal Register Volume 69, Number 31 (Tuesday, February 17, 2004)]
[Rules and Regulations]
[Page 7347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3421]



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  Federal Register / Vol. 69, No. 31 / Tuesday, February 17, 2004 / 
Rules and Regulations  

[[Page 7347]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2003D-0545]


Guidance for Industry: Questions and Answers Regarding the 
Interim Final Rule on Registration of Food Facilities (Edition 3); 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability of guidance.

-----------------------------------------------------------------------

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 Registration of Food Facilities 
(Edition 3).'' The guidance responds to various questions raised about 
section 305 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (the Bioterrorism Act) and the agency's 
implementing regulation, which require facilities that manufacture/
process, pack, or hold food for consumption in the United States to 
register with FDA by December 12, 2003.

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 registration help desk, 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: Melissa S. Scales, Office of 
Regulations and Policy (HFS-24), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 301-436-1720.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 10, 2003 (68 FR 58894), FDA 
issued an interim final rule to implement section 305 of the 
Bioterrorism Act. The registration regulation requires facilities that 
manufacture/process, pack, or hold food (including animal feed) for 
consumption in the United States to register with FDA by December 12, 
2003.
    On December 4, 2003, FDA issued the first edition of a guidance 
entitled ``Questions and Answers Regarding the Interim Final Rule on 
Registration of Food Facilities.'' Subsequently, in the Federal 
Register of January 12, 2004 (69 FR 1675), FDA announced the 
availability of a revision of that guidance entitled ``Questions and 
Answers Regarding the Interim Final Rule on Registration of Food 
Facilities (Edition 2)''. This guidance entitled ``Questions and 
Answers Regarding the Interim Final Rule on Registration of Food 
Facilities (Edition 3)'' is a revision of the guidance announced on 
January 9, 2004, and responds to additional questions about the interim 
final rule on registration. It is intended to help the industry better 
understand and comply with the regulation in 21 CFR part 1, subpart H.
    FDA is issuing this guidance entitled ``Questions and Answers 
Regarding the Interim Final Rule on Registration of Food Facilities 
(Edition 3)'' as a level 1 guidance. Consistent with FDA's good 
guidance practices regulation Sec. 10.115(g)(2) (21 CFR 10.115), 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 that covered 
facilities be registered with FDA by December 12, 2003. Clarifying the 
provisions of the interim final rule will facilitate prompt 
registration by covered facilities and thus, complete implementation of 
the interim final rule.
    FDA continues to receive a large number of questions regarding the 
registration interim final rule, 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 food facilities registration in a 
single document that is periodically updated as the agency receives and 
responds to additional 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 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 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 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., Mondaythrough 
Friday.

III. Electronic Access

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

    Dated: February 11, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3421 Filed 2-12-04; 11:07 am]
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