[Federal Register Volume 75, Number 57 (Thursday, March 25, 2010)]
[Notices]
[Pages 14445-14446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6578]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry on Submitting a Report for Multiple 
Facilities to the Reportable Food Electronic Portal as Established by 
the Food and Drug Administration Amendments Act of 2007; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Submitting a Report for 
Multiple Facilities to the Reportable Food Electronic Portal 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), and more 
specifically, this guidance provides information to the industry on 
submitting a single reportable food report to FDA covering reportable 
food located at more than one of a company's facilities.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: 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. 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.

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:

[[Page 14446]]

I. Background

    On September 27, 2007, the President signed into law the Food and 
Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85). 
This law amends the Federal Food, Drug, and Cosmetic Act (the act) by 
creating a new section 417 (21 U.S.C. 350f), Reportable Food Registry. 
Section 417 of the act requires the Secretary of Health and Human 
Services (the Secretary) to establish within FDA a Reportable Food 
Registry. The congressionally-identified purpose of the Reportable Food 
Registry is to provide a ``reliable mechanism to track patterns of 
adulteration in food [which] would support efforts by the Food and Drug 
Administration to target limited inspection resources to protect the 
public health'' (Section 1005(a)(4) of FDAAA). The Secretary has 
delegated to the Commissioner of the Food and Drug Administration the 
responsibility for administering the act, including section 417. To 
further the development of the Reportable Food Registry, section 417 of 
the act requires FDA to establish an electronic portal by which 
instances of reportable food must be submitted to FDA by responsible 
parties and may be submitted by public health officials. After receipt 
of reports through the electronic portal, FDA is required to review and 
assess the information submitted for purposes of identifying reportable 
food, submitting entries to the Reportable Food Registry, issuing an 
alert or notification as FDA deems necessary, and exercising other 
existing food safety authorities under FDAAA to protect the public 
health. The requirements under the Reportable Food Registry became 
effective on September 8, 2009.
    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 issued a final 
guidance on September 8, 2009. This document is a related final 
guidance entitled ``Submitting a Report for Multiple Facilities to the 
Reportable Food Electronic Portal as Established by the Food and Drug 
Administration Amendments Act of 2007'' and contains a question and 
answer addressing the circumstance where reportable food is located at 
more than one of a company's facilities.
    FDA is issuing this guidance as level 1 guidance. Consistent with 
FDA's good guidance practices regulation (Sec.  10.115 (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 requirements under the 
Reportable Food Registry became effective on September 8, 2009. 
Clarifying the Reportable Food Registry requirements will facilitate 
compliance and implementation, and will lessen the burden on industry 
and FDA caused by unnecessary submission of multiple reports when one 
reportable food situation affects more than one of a company's 
facilities. 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 refers to previously approved collections of 
information found in the act. These collections of information 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 related to submitting reportable food 
reports to FDA in section 417 of the act have been approved under OMB 
Control No. 0910-0645.

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 
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: March 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6578 Filed 3-24-10; 8:45 am]
BILLING CODE 4160-01-S