Notice2024-13674
Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Guidance for Industry, Revision 1; Availability
Primary source
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Published
June 21, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled, "Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection." The FDA Reauthorization Act of 2017 (FDARA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) so that, as is the case with a drug, a device is deemed to be adulterated if the owner, operator, or agent of the factory, warehouse, or establishment at which the device is manufactured, processed, packed, or held delays, denies, or limits an FDA inspection. This final guidance describes, for both drugs and now devices, the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. This guidance finalizes the draft guidance of the same title issued on December 16, 2022, and supersedes the October 2014 final guidance entitled, "Circumstances That Constitute Delaying, Limiting, or Refusing a Drug Inspection."
Full Text
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<title>Federal Register, Volume 89 Issue 120 (Friday, June 21, 2024)</title>
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[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52062-52063]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13674]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0710]
Circumstances That Constitute Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection; Guidance for Industry, Revision
1; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled, ``Circumstances That
Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device
Inspection.'' The FDA Reauthorization Act of 2017 (FDARA) amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act) so that, as is the case
with a drug, a device is deemed to be adulterated if the owner,
operator, or agent of the factory, warehouse, or establishment at which
the device is manufactured, processed, packed, or held delays, denies,
or limits an FDA inspection. This final guidance describes, for both
drugs and now devices, the types of behaviors (actions, inactions, and
circumstances) that FDA considers to constitute delaying, denying, or
limiting inspection, or refusing to permit entry or inspection. This
guidance finalizes the draft guidance of the same title issued on
December 16, 2022, and supersedes the October 2014 final guidance
entitled, ``Circumstances That Constitute Delaying, Limiting, or
Refusing a Drug Inspection.''
DATES: The announcement of the guidance is published in the Federal
Register on June 21, 2024.
ADDRESSES: You may submit comments on any guidance 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 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-
[[Page 52063]]
2013-D-0710 for ``Circumstances That Constitute Delaying, Denying,
Limiting, or Refusing a Drug or Device Inspection.'' 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, 240-402-7500.
<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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for a single hard copy of the guidance
entitled ``Circumstances That Constitute Delaying, Denying, Limiting,
or Refusing a Drug or Device Inspection'' to the Office of Policy,
Compliance and Enforcement, Office of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Drive, Element Building, Rockville, MD
20857. Send one self-addressed adhesive label to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lola Burford, Office of Regulatory
Affairs, Division of Operational Policy, Food and Drug Administration,
12420 Parklawn Drive, Element Building, Rockville, MD 20857,
<a href="/cdn-cgi/l/email-protection#abe7c4c7ca85e9ded9cdc4d9cfebcdcfca85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="2965464548076b5c5b4f465b4d694f4d480741415a074e465f">[email protected]</span></a>, 240-402-5865. SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) added section 501(j) to the
FD&C Act (21 U.S.C. 351(j)) to deem adulterated a drug that ``has been
manufactured, processed, packed, or held in any factory, warehouse, or
establishment and the owner, operator, or agent of such factory,
warehouse, or establishment delays, denies, or limits an inspection, or
refuses to permit entry or inspection.'' Section 707(b) of FDASIA
required the Food and Drug Administration to issue guidance that
defined the circumstances that would constitute delaying, denying, or
limiting inspection, or refusing to permit entry or inspection, for
purposes of section 501(j). In the Federal Register of October 22, 2014
(79 FR 63130), FDA announced the availability of a guidance for
industry entitled, ``Circumstances That Constitute Delaying, Denying,
Limiting, or Refusing a Drug Inspection'' (hereinafter, 2014 guidance).
Subsequently, on August 18, 2017, FDARA (Pub. L. 115-52) was signed
into law. Section 702 of FDARA amended the scope of section 501(j) of
the FD&C Act to provide that, as the case with drugs, devices are
deemed to be adulterated if an FDA inspection is delayed, denied,
limited, or refused by the owner, operator, or agent of the
establishment at which the device is manufactured, processed, packed,
or held. This final guidance supersedes the 2014 final guidance to
incorporate devices and to explain the circumstances that FDA would
consider to constitute delaying, denying, or limiting inspection, or
refusing to permit entry or inspection, resulting in a drug or device
manufactured in the facility being deemed adulterated.
This final guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). FDA considered the
comments received on the draft guidance and did not make substantial
changes from the draft to the final guidance. This final guidance
represents the current thinking of FDA on ``Circumstances That
Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device
Inspection'' 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.
II. Paperwork Reduction Act of 1995
This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Persons unable to download an
electronic copy of ``Circumstances That Constitute Delaying, Denying,
Limiting, or Refusing a Drug or Device Inspection'' may send an email
request to <a href="/cdn-cgi/l/email-protection#feb1acbfae9192979d87ad8a9f98988dbe989a9fd096968dd0999188"><span class="__cf_email__" data-cfemail="652a3724350a090c061c361104030316250301044b0d0d164b020a13">[email protected]</span></a> to receive an electronic copy of
the document.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13674 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P
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