[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Pages 27803-27804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0260]


Draft Guidance for Industry: Questions and Answers Regarding the 
Reportable Food Registry as Established by the Food and Drug 
Administration Amendments Act of 2007; Availability; Announcement of 
Further Delay in Implementation of the Food and Drug Administration 
Amendments Act of 2007

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availability of a draft guidance entitled ``Guidance for Industry: 
Questions and

[[Page 27804]]

Answers Regarding the Reportable Food Registry as Established by the 
Food and Drug Administration Amendments Act of 2007.'' The draft 
guidance, when finalized, will assist the industry in complying with 
the Reportable Food Registry requirements prescribed by the Food and 
Drug Administration Amendments Act of 2007 (FDAAA). FDA is also 
announcing a further delay in the implementation of the Reportable Food 
Registry (the Registry) of FDAAA until September 8, 2009, to consider 
any comments received on the draft guidance and through the agency's 
planned outreach initiatives, and to allow for further testing of the 
electronic portal for reportable foods.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on the 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by July 27, 2009.

ADDRESSES: Submit written comments on the draft guidance to the 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comments on the draft guidance to http://www.regulations.gov. Submit 
written requests for single copies of the draft guidance to the Office 
of Food Defense, Communication and Emergency Response, Center for Food 
Safety and Applied Nutrition (HFS-005), 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 draft guidance.

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, 301-436-2428.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Guidance for Industry: Questions and Answers Regarding the Reportable 
Food Registry as Established by the Food and Drug Administration 
Amendments Act of 2007.'' The draft guidance is intended to assist 
those parties responsible for complying with the Reportable Food 
Registry requirements prescribed by FDAAA.
    FDA is issuing this draft guidance as a level 1 draft guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent 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. Notice of Further Delay in Implementation

    On September 27, 2007, the President signed FDAAA into law (Public 
Law 110-85). Section 1005 of FDAAA amends the Federal Food, Drug, and 
Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f), 
among other things. Section 417 of the act requires the Secretary of 
Health and Human Services to establish within FDA a Reportable Food 
Registry (the Registry); the Registry is to be established not later 
than 1 year after the date of enactment (i.e., by September 27, 2008).
    To further the development of the Registry, section 417 of the act 
requires FDA to establish, also within 1 year after the date of 
enactment (i.e., by September 27, 2008), an electronic portal (the 
Reportable Food electronic portal) by which instances of reportable 
food must be submitted to FDA by responsible parties and may be 
submitted by public health officials.
    FDA made the decision that the most efficient and cost effective 
means to implement the requirements of section 417 of the act relating 
to the Registry was to utilize the business enterprise system currently 
under development within the agency: the MedWatch\Plus\ Portal. This 
would permit the agency to establish an electronic portal through which 
instances of reportable food may be submitted to the agency. However, 
FDA recognized that the MedWatch\Plus\ Portal would not be implemented 
in time to meet the September 27, 2008, deadline for establishing the 
Reportable Food electronic portal and therefore announced that it was 
delaying its implementation until spring 2009 (73 FR 30405; May 27, 
2008).
    The agency now expects the system to be operational on September 8, 
2009, and is therefore announcing that the implementation of the 
requirements of section 417 of the act will be further delayed until 
September 8, 2009.
    In the interim, FDA strongly encourages persons to continue to 
report instances of adulterated food through existing mechanisms, such 
as notifying the relevant FDA District office, until such time as the 
Registry and its associated electronic portal are fully implemented.

III. Paperwork Reduction Act of 1995

    This draft guidance document contains a collection of information 
that requires clearance by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995. FDA intends to submit the 
collection of information to OMB in the near future for emergency 
processing. At that time, the agency will publish a notice in the 
Federal Register soliciting comments on the collection of information.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in question 28 of the guidance have been approved under OMB control no. 
0910-0249.

IV. 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.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm or http://www.regulations.gov.

    Dated: June 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13614 Filed 6-10-09; 8:45 am]
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