Notice2022-27344
Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Draft Guidance for Industry, Revision 1; Availability
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Published
December 16, 2022
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled, "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection."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 This draft guidance describes, for both drugs and now devices, the types of behaviors (actions, inactions, and circumstances) that the FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. Once finalized, this draft guidance is intended to supersede the October 2014 FDA final guidance for industry entitled, "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection." However, until this draft guidance is finalized, the October 2014 FDA guidance remains in effect until it is withdrawn and will continue to reflect FDA's current thinking on this issue. FDA is particularly interested in comments on the inclusion of devices to the October 2014 guidance.
Full Text
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<title>Federal Register, Volume 87 Issue 241 (Friday, December 16, 2022)</title>
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[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77125-77126]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27344]
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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Refusing a Drug or Device Inspection; Draft Guidance for Industry,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 draft 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 draft guidance describes, for both
drugs and now devices, the types of behaviors (actions, inactions, and
circumstances) that the FDA considers to constitute delaying, denying,
or limiting inspection, or refusing to permit entry or inspection. Once
finalized, this draft guidance is intended to supersede the October
2014 FDA final guidance for industry entitled, ``Circumstances that
Constitute Delaying, Denying, Limiting, or Refusing a Drug
Inspection.'' However, until this draft guidance is finalized, the
October 2014 FDA guidance remains in effect until it is withdrawn and
will continue to reflect FDA's current thinking on this issue. FDA is
particularly interested in comments on the inclusion of devices to the
October 2014 guidance.
DATES: Submit either electronic or written comments on the draft
guidance by February 14, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
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-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
[[Page 77126]]
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 draft
guidance to the Division of Operational Policy, Office of Regulatory
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn
Drive, 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 draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Lola Burford, Office of Regulatory
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn
Dr., Rockville, MD 20857, <a href="/cdn-cgi/l/email-protection#0945666568274b7c7b6f667b6d496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="327e5d5e531c704740545d4056725456531c5a5a411c555d44">[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) of the FD&C Act. 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 draft guidance is intended to update 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.
The 2014 guidance will remain in effect and will continue to reflect
FDA's current thinking regarding circumstances that would constitute
delaying, deny, or limiting inspection, or refusing to permit entry or
inspection, for purposes of 501(j) of the FD&C Act with respect to drug
inspections, until this draft guidance is finalized.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Circumstances that Constitute Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection'' and will supersede the 2014
guidance. 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
FDA tentatively concludes that this draft 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 <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>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-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#632c3122330c0f0a001a301702050510230507024d0b0b104d040c15"><span class="__cf_email__" data-cfemail="fab5a8bbaa9596939983a98e9b9c9c89ba9c9e9bd4929289d49d958c">[email protected]</span></a> to receive an
electronic copy of the document.
Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27344 Filed 12-15-22; 8:45 am]
BILLING CODE 4164-01-P
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