[Federal Register: November 22, 2005 (Volume 70, Number 224)]
[Rules and Regulations]
[Page 70488-70489]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no05-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1 and 11
[Docket No. 2005D-0356]
Guidance for Industry: Questions and Answers Regarding the Final
Rule on Establishment and Maintenance of Records (Edition 2);
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 entitled ``Questions and Answers Regarding
Establishment and Maintenance of Records (Edition 2).'' The guidance
responds to various questions raised about section 306 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. Persons covered by the regulation must
be in compliance by December 9, 2005, June 9, 2006, or December 11,
2006, depending on the size of the business.
DATES: Submit written or electronic comments on the agency guidance at
any time.
ADDRESSES: You may submit comments, identified by Docket No. 2005D-
0356, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
<bullet> FAX: 301-827-6870.
<bullet> Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For detailed
instructions on submitting comments
[[Page 70489]]
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(s), 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: Denise Beavers, 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, 301-436-1721.
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.
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.
On September 12, 2005, FDA issued the first edition of a guidance
entitled ``Questions and Answers Regarding Establishment and
Maintenance of Records.'' This guidance entitled ``Questions and
Answers Regarding Establishment and Maintenance of Records (Edition
2)'' responds to questions about the final rule on records. It is
intended to help the 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), 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 complete the rule's implementation.
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 this 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 the guidance
at any time. Submit a single copy of electronic comments or two paper
copies of any 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: November 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23062 Filed 11-21-05; 8:45 am]
BILLING CODE 4160-01-S