[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]
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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.
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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]
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