[Federal Register Volume 70, Number 175 (Monday, September 12, 2005)]
[Rules and Regulations]
[Pages 53728-53729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18039]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2005D-0356]


Guidance for Industry: Questions and Answers Regarding the Final 
Rule on Establishment and Maintenance of Records; 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 guidance for industry entitled ``Questions and 
Answers Regarding Establishment and Maintenance of Records.'' The 
guidance responds to various questions raised about the recordkeeping 
provisions of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (the Bioterrorism Act) and the agency's 
implementing regulation, which requires the establishment and 
maintenance of records by persons who manufacture, process, pack, 
transport, distribute, receive, hold, or import food in the United 
States. Such records are to allow for the identification of the 
immediate previous sources and the immediate subsequent recipients of 
food.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Questions and Answers Regarding Establishment and 
Maintenance of Records'' to Denise Beavers (see FOR FURTHER INFORMATION 
CONTACT). Send one self-addressed adhesive label to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Denise Beavers, Center for Food Safety 
and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1721.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 9, 2004 (69 FR 71562), FDA 
issued a final rule to implement section 306 of the Bioterrorism Act 
(21 U.S.C. 350c). The regulation requires the establishment and 
maintenance of records by persons who manufacture, process, pack, 
transport, distribute, receive, hold, or import food in the United 
States. Such records are to allow for the identification of the 
immediate previous sources and the immediate subsequent recipients of 
food. Persons subject to the regulation are required to be in 
compliance by December 9, 2005, June 9, 2006, or December 11, 2006, 
depending on the size of the business.
    The guidance for industry entitled ``Questions and Answers 
Regarding Establishment and Maintenance of Records'' responds to 
questions about the final rule on records. It is intended to help 
industry better understand and comply with the regulation in 21 CFR 
part 1, subpart J. FDA is issuing this guidance as a level 1 guidance. 
The guidance represents the agency's current thinking on the topic. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. 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 final rule requires that covered 
persons begin to establish and maintain records identifying the 
immediate previous sources and immediate subsequent recipients of food 
by December 9, 2005, June 9, 2006, or December 11, 2006, depending on 
the size of the business. Clarifying the provisions of the final rule 
will facilitate prompt compliance with these requirements and ensure 
complete implementation of the final rule.
    FDA continues to receive large numbers of questions regarding the 
records final rule, and is responding to these questions 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 establishment and maintenance of records 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 regarding this document. 
Submit a single copy of electronic comments or two paper copies of any

[[Page 53729]]

mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments and the guidance 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 guidance at 
http://www.cfsan.fda.gov/guidance.html.

    Dated: September 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18039 Filed 9-7-05; 3:12 pm]
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