
[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Page 26269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0138]


Questions and Answers Regarding Mandatory Food Recalls; Draft 
Guidance for Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry on the implementation of 
the mandatory food recall provisions of the FDA Food Safety 
Modernization Act (FSMA). The guidance is in the form of Questions and 
Answers and provides answers to common questions that might arise about 
the mandatory recall provisions and FDA's plans for their 
implementation.

DATES: Although you may comment on any guidance at any time, to ensure 
that the Agency considers your comments on this draft guidance before 
it completes a final version of the guidance, submit electronic or 
written comments on the draft guidance by July 6, 2015.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Outreach and Information Center (HFS-009), Center for Food Safety 
and Applied Nutrition (HFS-317), 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cecilia M. Wolyniak, Food and Drug 
Administration, WO32 Rm. 4352 HFC-210, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-796-8209.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's mandatory food recall authority went into effect when FSMA 
was enacted on January 4, 2011. Section 423 of the Federal Food, Drug 
and Cosmetic Act (FD&C Act), as added by section 206 of FSMA, gives FDA 
the authority to order a responsible party to recall an article of food 
where FDA determines that there is a reasonable probability that the 
article of food (other than infant formula) is adulterated under 
section 402 of the FD&C Act [21 U.S.C. 342] or misbranded under section 
403(w) of the FD&C Act [21 U.S.C. 343(w)] and that the use of or 
exposure to such article will cause serious adverse health consequences 
or death to humans or animals (SAHCODHA).
    FDA is announcing the availability of a draft guidance for industry 
entitled ``Questions and Answers Regarding Mandatory Food Recalls; 
Draft Guidance for Industry.'' The draft guidance provides answers to 
common questions that might arise about the mandatory recall provisions 
and FDA's plans for their implementation.
    This guidance is being issued consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our 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 alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This guidance does not refer to any information collection 
provisions found in FDA regulations. 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). We conclude 
that the Draft Guidance for Industry: Questions and Answers Regarding 
Mandatory Food Recalls is not subject to Paperwork Reduction Act of 
1995.

III. Comments

    Interested persons may submit either written comments regarding the 
guidance to the Division of Dockets Management (see ADDRESSES) or 
electronic comments regarding the guidance to http://www.regulations.gov. It is only necessary to send one set of 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, 
and will be posted to the docket at http://www.regulations.gov.

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. 
Use the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

    Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11009 Filed 5-6-15; 8:45 am]
 BILLING CODE 4164-01-P


