[Federal Register: September 26, 2006 (Volume 71, Number 186)]
[Rules and Regulations]
[Page 56006-56007]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se06-6]
=======================================================================
-----------------------------------------------------------------------
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 4);
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability of guidance.
-----------------------------------------------------------------------
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 4).'' The guidance
responds to various questions raised about 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 who
employ 500 or more full-time equivalent employees (FTEs) had to be in
compliance by December 9, 2005, and those who employ 11 to 499 FTEs had
to be in compliance by June 9, 2006. Persons who employ 10 or fewer
FTEs have until December 11, 2006, to be in compliance. ``Person''
includes an individual, partnership, corporation, and association.
DATES: Submit written or electronic comments on the agency guidance at
any time.
ADDRESSES: You may submit comments, identified by 2005D-0356, by any of
the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
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.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
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
additional information on submitting comments, see the ``Comments''
heading of the SUPPLEMENTARY INFORMATION section of this document.
[[Page 56007]]
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: Center for Food Safety and Applied
Nutrition at 1-888-SAFEFOOD, Fax: 1-877-366-3322, or by e-mail:
industry@fda.gov.
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 who employ 500 or more FTEs had to be in compliance by
December 9, 2005, and those who employ 11-499 FTEs had to be in
compliance by June 9, 2006. Persons who employ 10 or fewer FTEs have
until December 11, 2006 to be in compliance. ``Person'' includes an
individual, partnership, corporation, and association.
On September 12, 2005, FDA issued the first edition of a guidance
entitled ``Questions and Answers Regarding Establishment and
Maintenance of Records.'' On November 22, 2005, FDA issued a second
edition of that guidance and on June 6, 2006, FDA issued a third
edition of that guidance. This document is the fourth edition of that
guidance entitled ``Questions and Answers Regarding Establishment and
Maintenance of Records (Edition 4)'' and responds to questions
regarding persons covered by the regulation, and persons excluded by
the regulation, including additional guidance on the farm exclusion. In
addition, we are amending the response to question 4.2 to clarify that
while post-harvesting activities related to hay are subject to the
rule, certain activities that are part of harvesting remain within the
farm exemption. This guidance 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, persons who
employ 500 or more FTEs had to begin to establish and maintain records
identifying the immediate previous sources and immediate subsequent
recipients of food by December 9, 2005, and those who employ 11-499
FTEs had to be in compliance by June 9, 2006. Persons who employ 10 or
fewer FTEs have until December 11, 2006, to be in compliance.
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/~dms/recguid3.html.
Dated: September 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8241 Filed 9-21-06; 1:22 pm]
BILLING CODE 4160-01-S