[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77125-77126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Refusing a Drug or Device Inspection; Draft Guidance for Industry, 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the availability of a draft guidance entitled, ``Circumstances that 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 This draft guidance describes, for both 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finalized, this draft guidance is intended to supersede the October 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 However, until this draft guidance is finalized, the 
October 2014 FDA guidance remains in effect until it is withdrawn and 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DATES: Submit either electronic or written comments on the draft 
guidance by February 14, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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

[[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 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 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, [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) 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 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, 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: 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


