Notice2022-22884
Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry; Availability
Primary source
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Published
October 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 87 Issue 203 (Friday, October 21, 2022)</title>
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[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Notices]
[Pages 64054-64055]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on October 21, 2022.
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