[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Notifications; Draft Guidance for Industry and Food and Drug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Under Section 506J of the FD&C Act'' and the draft guidance entitled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 FDA is concurrently issuing a draft guidance to propose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 This draft guidance proposes a list of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 This draft guidance is not final nor is it for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]
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