[Federal Register: September 9, 2009 (Volume 74, Number 173)]
[Notices]
[Page 46434-46435]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se09-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0260]
Guidance for Industry: Questions and Answers Regarding the
Reportable Food Registry as Established by the Food and Drug
Administration Amendments Act of 2007; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled ``Questions and Answers
Regarding the Reportable Food Registry as Established by the Food and
Drug Administration Amendments Act of 2007.'' The document provides
guidance to the industry in complying with the Reportable Food Registry
requirements prescribed by the Food and Drug Administration Amendments
Act of 2007 (FDAAA).
DATES: Submit written or electronic comments on the guidance at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
to the Office of Food Defense, Communication and Emergency Response
(HFS-005), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments on the
guidance to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Faye Feldstein, Center for Food
Safety and Applied Nutrition (HFS-005), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 1-888-SAFEFOOD.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2009 (74 FR 27803), FDA
announced the availability of a draft guidance entitled ``Questions and
Answers Regarding the Reportable Food Registry as Established by the
Food and Drug Administration Amendments Act of 2007'' and gave
interested parties an opportunity to submit comments by July 27, 2009.
The agency reviewed and evaluated these comments and has modified the
guidance where appropriate.
The guidance contains questions and answers intended to assist
those parties responsible for complying with the Reportable Food
Registry requirements prescribed by the Food and Drug Administration
Amendments Act of 2007 (Public Law 110-085), including: (1) How, when,
and where to submit reports to FDA; (2) who is required to submit
reports to FDA; (3) what is required to be submitted to FDA; and (4)
what may be required when providing notifications to other persons in
the supply chain of an article of food.
[[Page 46435]]
FDA is issuing this guidance as level 1 guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The guidance
represents the agency's current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternate approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance were approved under OMB
Control Nos. 0910-0643 and 0910-0645. This guidance also refers to
previously approved collections of information found in FDA
regulations. The collection of information in 21 CFR 7.46 has been
approved under OMB Control No. 0910-0249.
III. 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
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 may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/default.htm or http://www.regulations.gov.
Dated: September 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21713 Filed 9-8-09; 8:45 am]
BILLING CODE 4160-01-S