[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Notices]
[Pages 64054-64055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22884]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6528]


Refusal of Inspection by a Foreign Food Establishment or Foreign 
Government; Guidance for Industry; 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 entitled ``Refusal of 
Inspection by a Foreign Food Establishment or Foreign Government.'' The 
guidance will provide information for foreign food establishments 
subject to our inspection, as well as foreign governments, on when we 
may consider that a foreign food establishment or a government of a 
foreign country has refused to permit an inspection by us as provided 
in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: The announcement of the guidance is published in the Federal 
Register on October 21, 2022.

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.
     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

[[Page 64055]]

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-2017-D-6528 for ``Refusal of Inspection by a Foreign Food 
Establishment or Foreign Government.'' 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.govinfo.gov/content/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 
Compliance Policy Staff/Office of Compliance, Center for Food Safety 
and Applied Nutrition (HFS-605), Food and Drug Administration, 5001 
Campus Dr., 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: Yinqing Ma, Center for Food Safety and 
Applied Nutrition (HFS-605), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2479.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Refusal of Inspection by a Foreign Food Establishment or 
Foreign Government.'' We are issuing this 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.
    In the Federal Register of December 12, 2017 (82 FR 58410), we made 
available a draft guidance for industry entitled ``Refusal of 
Inspection by a Foreign Food Establishment or Foreign Government'' and 
gave interested parties an opportunity to submit comments by February 
26, 2018, 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: provided additional information on FDA's inspection 
authority; clarified that the investigator will inform the owner, 
operator, or agent in charge of the establishment when they consider 
their action to be a refusal and will explain the consequences of the 
refusal; and clarified that the Agency will make the final decision 
regarding refusal and listing on Import Alert 99-32. In addition, we 
made editorial changes to improve clarity. The guidance announced in 
this notice finalizes the draft guidance dated December 2017.

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: October 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22884 Filed 10-20-22; 8:45 am]
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