[Federal Register: February 17, 2004 (Volume 69, Number 31)]
[Rules and Regulations]
[Page 7347]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe04-1]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
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[[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.
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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
(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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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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