[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52062-52063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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guidance finalizes the draft guidance of the same title issued on 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:
     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 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-

[[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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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, 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, 
[email protected], 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents or https://www.regulations.gov. 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 [email protected] 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