[Federal Register Volume 75, Number 100 (Tuesday, May 25, 2010)]
[Notices]
[Pages 29350-29352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12456]
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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Draft Guidance for Industry: Questions and Answers Regarding the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 (Edition 2); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability and request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled
[[Page 29351]]
``Questions and Answers Regarding the Reportable Food Registry as
Established by the Food and Drug Administration Amendments Act of 2007
(Edition 2).'' The draft guidance provides information to the industry
in complying with the Reportable Food Registry requirements prescribed
by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Further, the draft guidance addresses inquiries that the agency has
received through its Reportable Food Registry help desk and/or by other
means since the implementation of the Reportable Food Registry on
September 8, 2009, and provides information on the new Safety Reporting
Portal. The agency is also seeking comments from industry on the
Reportable Food Registry requirements, and specifically on the issue of
``transfer'' as discussed in the current Edition 1, and draft Edition 2
guidance.
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 comments on
the draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by July 26, 2010.
ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to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Submit written requests for single copies of the draft guidance to the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 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
On September 27, 2007, the President signed into law the Food and
Drug Administration Amendments Act of 2007 (FDAAA). 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''
(Pubic Law 110-085, section 1005(a)(4)). The Secretary has delegated to
the Commissioner of Food and Drugs 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 the act 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, 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 (74 FR
27803). The agency reviewed and evaluated these comments and issued a
final guidance on September 9, 2009 (74 FR 46434). This draft guidance
is the second edition of that guidance entitled ``Questions and Answers
Regarding the Reportable Food Registry as Established by the Food and
Drug Administration Amendments Act of 2007 (Edition 2)'' and responds
to inquiries that the agency has received through its Reportable Food
Registry help desk and/or by other means since the implementation of
the Reportable Food Registry on September 8, 2009, and informs industry
about the new Safety Reporting Portal. The Safety Reporting Portal is a
joint FDA-National Institutes of Health (NIH) system that facilitates
the process of reporting several categories of safety information to
the FDA and the NIH. As of May 24, 2010, the Reportable Food electronic
portal will be a part of the Safety Reporting Portal.
This draft guidance is being issued 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 the topics
discussed. 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 numbers 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 number 0910-0249.
III. Request for Comments
In addition, although the industry is encouraged to submit comments
regarding any of the requirements under the Reportable Food Registry,
the agency is seeking comments specifically with regard to the meaning
of the word ``transfer'' as it appears in section 417(d)(2)(B) of the
act. The meaning of the word ``transfer'' in this context was discussed
in Edition 1 of the guidance at Question and Answer numbers 27 and 28,
and in the draft Edition 2 guidance at Question and Answer numbers E.4
and E.5.
Section 417(d)(2) of the act provides an exemption from the
requirement that a responsible party submit a reportable food report.
In order for the exemption to apply, the adulteration must have
originated with the responsible party, the responsible party must have
detected the adulteration ``prior to any transfer to another person''
of the article of food, and the responsible party must have corrected
the adulteration or destroyed the food. However, Congress did not
provide a definition for the term ``transfer'' as it is used in section
417(d)(2)(B) of the act. In Edition 1 of the guidance at Question and
Answer numbers 27 and 28, and in the draft Edition 2 guidance at
Question and Answer numbers E.4 and E.5, FDA said that a transfer to
another person occurs when the responsible person releases the food to
another person. In this document, FDA is asking for comment on whether
this interpretation of the term ``transfer'' is appropriate, and if
not,
[[Page 29352]]
what other interpretations of the term ``transfer'' as it is used in
section 417(d)(B)(2) of the act would be more appropriate.
Specifically, we are requesting comment on whether the interpretation
of the term ``transfer'' should be dependent upon possession of the
food, whether the interpretation should be dependent on ownership of
the food, or whether there are other interpretations we should
consider, such as a combination of possession and/or ownership.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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/FoodGuidances or http://www.regulations.gov.
Dated: May 19, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-12456 Filed 5-24-10; 8:45 am]
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