[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80310-80312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0053]


Notifying the Food and Drug Administration of a Permanent 
Discontinuance or Interruption in Manufacturing of a Device Under 
Section 506J of the Federal Food, Drug, and Cosmetic Act; Final 
Guidance for Industry and Food and Drug Administration Staff; and 
Select Updates for the 506J Guidance: 506J Device List and Additional 
Notifications; Draft Guidance for Industry and Food and Drug 
Administration Staff; 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 the final guidance entitled ``Notifying FDA of a 
Permanent Discontinuance or Interruption in Manufacturing of a Device 
Under Section 506J of the FD&C Act'' and the draft guidance entitled 
``Select Updates for the 506J Guidance: 506J Device List and Additional 
Notifications.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act) 
requires manufacturers to notify FDA of a permanent discontinuance or 
an interruption in the manufacture of certain devices that is likely to 
lead to a meaningful disruption in supply of that device in the United 
States during or in advance of a public health emergency (PHE). This 
final guidance is intended to assist manufacturers in providing timely, 
informative notifications about changes in the production of certain 
medical device products that will help prevent or mitigate shortages of 
such devices. FDA is concurrently issuing a draft guidance to propose 
select updates to the final guidance ``Notifying FDA of a Permanent 
Discontinuance or Interruption in Manufacturing of a Device Under 
Section 506J of the FD&C Act.'' This draft guidance proposes a list of 
device product codes for which a manufacturer of such devices is 
required to notify FDA in accordance with the FD&C Act (hereafter 
referred to as the ``506J Device List'') and clarifies that 
manufacturers may submit voluntary notifications regarding supply chain 
issues at any time, unrelated to the declaration or potential 
declaration of a PHE. This draft guidance is not final nor is it for 
implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 15, 2024 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-2022-D-0053 for ``Notifying FDA of a Permanent Discontinuance or 
Interruption in Manufacturing of a Device Under Section 506J of the 
FD&C Act'' or ``Select Updates for the 506J Guidance: 506J Device List 
and Additional Notifications.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov

[[Page 80311]]

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)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the final guidance document entitled 
``Notifying FDA of a Permanent Discontinuance or Interruption in 
Manufacturing of a Device Under Section 506J of the FD&C Act'' or draft 
guidance document entitled ``Select Updates for the 506J Guidance: 506J 
Device List and Additional Notifications'' to the Office of Policy, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002; or to Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Tammy Beckham, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5550, Silver Spring, MD 20993-0002, 301-796-9081; 
or Anne Taylor, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 27, 2020, the Coronavirus Aid, Relief, and Economic 
Security Act (CARES Act) was signed into law. Section 3121 of the CARES 
Act amends the FD&C Act by adding section 506J to the statute. Section 
506J of the FD&C Act (21 U.S.C. 356j) provides FDA with new authorities 
intended to help prevent or mitigate device shortages ``during, or in 
advance of, a public health emergency'' declared under section 319 of 
the Public Health Service Act (PHS Act) (42 U.S.C. 247d). Additionally, 
on December 29, 2022, the Prepare for and Respond to Existing Viruses, 
Emerging New Threats, and Pandemics Act (``PREVENT Pandemics Act'') was 
signed into law as part of the Consolidated Appropriations Act, 2023, 
Pub. L. 117-328 (hereafter referred to as the ``FY 2023 Omnibus''). 
Section 2514(c) of the FY 2023 Omnibus directed FDA to issue or revise 
guidance regarding requirements under section 506J and include a list 
of each device product code for which a manufacturer of such device is 
required to notify FDA in accordance with section 506J. Section 2514 
the FY 2023 Omnibus amended section 506J to add section 506J(h), 
``Additional Notifications'' and directed FDA to issue guidance ``to 
facilitate voluntary notifications.''
    FDA is issuing this final guidance, ``Notifying FDA of a Permanent 
Discontinuance or Interruption in Manufacturing of a Device Under 
Section 506J of the FD&C Act'' (hereafter referred to as the ``506J 
Guidance'') to assist stakeholders in the Agency's implementation of 
section 506J. This guidance serves as the baseline for information 
about notifications under section 506J during or in advance of any PHE. 
FDA provides additional clarification on who is required to notify FDA, 
when such notifications are required, what information FDA expects 
manufacturers to include in such notifications, and how to submit 
notifications. Additionally, FDA describes how FDA determines that a 
device is in shortage and additional actions FDA may take to help 
prevent or mitigate a potential device shortage.
    In the draft guidance ``Select Updates for the 506J Guidance: 506J 
Device List and Additional Notifications,'' FDA proposes updates to the 
506J Guidance. Specifically, FDA has developed a list of devices, by 
FDA product code, for which a manufacturer of such devices is required 
to notify FDA in accordance with section 506J (hereafter referred to as 
the ``506J Device List''). The 506J Device List is based on the 
requirements under section 506J(a). In section 2514 of the FY 2023 
Omnibus, Congress directed FDA to issue guidance on the requirements 
under section 506J and to include ``a list of each device product code 
for which a manufacturer of such device is required to notify the 
Secretary in accordance with section 506J.'' Thus, manufacturers of a 
device on the 506J Device List must notify FDA in accordance with 506J 
for each such device. For more information, manufacturers should see 
the 506J Device List web page, available at https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/506j-device-list. Additionally, consistent with section 506J(h), FDA is proposing 
to clarify for stakeholders that manufacturers may submit, and FDA may 
receive, voluntary notifications regarding supply chain issues at any 
time, unrelated to the declaration or potential declaration of a PHE. 
The Agency invites comments on both the 506J Device List and the 
clarification for stakeholders on voluntary notifications.
    A notice of availability of the draft guidance, ``Notifying FDA of 
a Permanent Discontinuance or Interruption in Manufacturing of a Device 
Under Section 506J of the FD&C Act,'' appeared in the Federal Register 
of January 11, 2022 (87 FR 1417). FDA considered comments received and 
revised the guidance as appropriate in response to the comments, 
including providing additional clarifications such as when manufactures 
should notify FDA of changes in status and when manufacturers should 
provide 506J notification updates, and what information is required by 
section 506J

[[Page 80312]]

and what additional information is helpful to FDA. Additionally, FDA 
provided additional transparency regarding how FDA uses information 
from 506J notifications.
    These guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, 
``Select Updates for the 506J Guidance: 506J Device List and Additional 
Notifications,'' when finalized, will represent the current thinking of 
FDA on ``Notifying FDA of a Permanent Discontinuance or Interruption in 
Manufacturing of a Device Under Section 506J of the FD&C Act.'' These 
guidances do 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. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Notifying FDA of a Permanent Discontinuance or Interruption in 
Manufacturing of a Device Under Section 506J of the FD&C Act'' or 
``Select Updates for the 506J Guidance: 506J Device List and Additional 
Notifications'' may send an email request to [email protected] 
to receive an electronic copy of the document. Please use the document 
number GUI00021003 and complete title to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

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           Guidance                     Topic           OMB control No.
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``Notifying FDA of a Permanent  Shortages Data                 0910-0491
 Discontinuance or               Collection.
 Interruption in Manufacturing
 of a Device Under Section
 506J of the FD&C Act''.
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    Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25458 Filed 11-16-23; 8:45 am]
BILLING CODE 4164-01-P