[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)]
[Notices]
[Pages 55551-55552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24247]


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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: Guidance 
for Industry and Food and Drug Administration Staff; Availability

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 final guidance for industry and FDA staff entitled 
``Questions and Answers Regarding Mandatory Food Recalls: Guidance for 
Industry and FDA Staff.'' The guidance provides information 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: The announcement of the guidance is published in the Federal 
Register on November 6, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.

[[Page 55552]]

     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-0138 for ``Questions and Answers Regarding Mandatory Food 
Recalls: Guidance for Industry and FDA Staff.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Strategic Planning and Operational Policy, Office of 
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., 
Element Building, Rm. 4141, Rockville, MD 20857. 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: Seth Brown, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element 
Building, Rm. 4141, Rockville, MD 20857, 240-402-4891.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Questions and Answers Regarding Mandatory Food Recalls: 
Guidance for Industry and FDA Staff.'' We are issuing the guidance 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The guidance represents the current thinking of FDA on this topic. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.
    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) (21 U.S.C. 350l), 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). The 
guidance provides answers to common questions that might arise about 
the mandatory recall provisions and FDA's plans for their 
implementation.
    In the Federal Register of May 7, 2015 (80 FR 26269), we made 
available a draft guidance for industry entitled ``Questions and 
Answers Regarding Mandatory Food Recalls; Draft Guidance for Industry'' 
and gave interested parties an opportunity to submit comments by July 
6, 2015, for us to consider before beginning work on the final version 
of the guidance. We received several comments on the draft guidance and 
have modified the final guidance where appropriate. Changes to the 
guidance include: Adding clarity regarding the process FDA will follow 
for a mandatory food recall; providing detail regarding the evidence or 
circumstances FDA may consider when deciding to move forward with a 
mandatory food recall; adding a question that lists examples of 
situations when FDA would deem a food product to represent a SAHCODHA 
risk; and making editorial changes to improve clarity.
    We are removing two questions from the guidance. We are removing 
the question about when the mandatory recall provisions go into effect, 
as this provision has been in effect since 2011. We are also removing 
the question about user fees, as we have not yet issued guidance 
associated with these fees and we have previously stated that we do not 
intend to issue invoices for mandatory recall order fees until that 
guidance has been finalized.
    The guidance announced in this notice finalizes the draft guidance 
dated May 2015.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: November 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24247 Filed 11-5-18; 8:45 am]
 BILLING CODE 4164-01-P