[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Notices]
[Pages 46434-46435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21713]


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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announced the availability of a draft guidance entitled ``Questions and 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