[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]


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

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Draft Guidance for Industry: Questions and Answers Regarding the 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.

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

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availability of a draft guidance entitled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 The draft guidance provides information to the industry 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Further, the draft guidance addresses inquiries that the agency has 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the draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 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ADDRESSES:  Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 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Submit written requests for single copies of the draft guidance to the 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]
BILLING CODE 4160-01-S