[Federal Register: September 12, 2005 (Volume 70, Number 175)]
[Rules and Regulations]
[Page 53728-53729]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se05-3]
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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]
BILLING CODE 4160-01-S