[Federal Register: January 12, 2004 (Volume 69, Number 7)]
[Rules and Regulations]
[Page 1675]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja04-18]
 
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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; 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 Registration of Food Facilities.''
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 SUPPLEMENTARY INFORMATION) 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.'' This guidance, (``Questions and
Answers Regarding the Interim Final Rule on Registration of Food
Facilities (Edition 2)'') is a revision of the December 4, 2003,
document 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 the guidance entitled ``Questions and Answers
Regarding the Interim Final Rule on Registration of Food Facilities
(Edition 2)'' as a Level 1 guidance. Consistent with FDA's good
guidance practices (GGPs) 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
covered facilities to 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 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) new questions and answers 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., 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: January 7, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-598 Filed 1-8-04; 10:33 am]
 
BILLING CODE 4160-01-S
 

Guidance for Industry: Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 2) January 12, 2004