[Federal Register Volume 69, Number 151 (Friday, August 6, 2004)]
[Rules and Regulations]
[Pages 47765-47766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18057]


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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 (Edition 4); 
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 4).'' 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: You may submit comments, identified by Docket No. 2003D-
0545, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket No. 2003D-
0545 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No. or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.fda.gov/ohrms/dockets/default/htm, including any personal 
information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default/htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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.'' The second edition of this guidance 
was issued on January 12, 2004, and the third edition on February 17, 
2004. The guidance announced by this document entitled ``Questions and 
Answers Regarding the Interim Final Rule on Registration of Food 
Facilities (Edition 4)'' is a revision of the February 17, 2004, 
guidance and responds to additional questions about the interim final 
rule on registration. The guidance is intended to help the industry 
better understand and comply with the regulation in 21 CFR part 1, 
subpart H.
    FDA wishes to highlight one issue clarified in the fourth edition 
of the food facility registration guidance, the appropriate designation 
of a U.S. agent by a foreign food facility. Since the interim final 
rule published, several individuals have notified FDA that, although 
listed in a facility's registration as its U.S. agent, the individual 
had not agreed to serve as the facility's U.S. agent. Question 14.20 in 
the fourth edition clarifies how FDA will handle the registration of a 
facility when the agency is notified that the individual listed as the 
facility's U.S. agent disagrees with that designation.
    FDA is issuing the guidance entitled ``Questions and Answers 
Regarding the Interim Final Rule on Registration of Food Facilities 
(Edition 4)'' as a level 1 guidance. Consistent with FDA's good 
guidance practices (GGPs) regulation Sec.  10.115 (21 CFR 10.115), the 
agency will accept comments on this guidance, but it is implementing 
the guidance 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.
    As noted in previous notices announcing the availability of 
guidance for food facility registration, FDA continues to respond to 
requests for clarification of the registration interim final rule by 
providing guidance in a question-and-answer format. The agency is 
maintaining all responses to questions concerning food facility 
registration in a single document that is periodically updated as the 
agency responds to additional questions. The following four indicators 
are 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, at any time, submit written or electronic 
comments

[[Page 47766]]

to the Division of Dockets Management (see ADDRESSES) regarding this 
guidance. 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: August 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18057 Filed 8-4-04; 8:45 am]
BILLING CODE 4160-01-S