[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Notices]
[Pages 1417-1419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00321]


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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Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Notifying FDA of a 
Permanent Discontinuance or Interruption in Manufacturing of a Device 
Under Section 506J of the FD&C Act.'' The Federal Food, Drug, and 
Cosmetic Act (FD&C Act) requires manufacturers to notify FDA of a 
permanent discontinuance in the manufacture of certain devices 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. This 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 during or in advance of a public health 
emergency. FDA is issuing this guidance to implement amendments to the 
FD&C Act by the Coronavirus Aid, Relief, and Economic Security Act 
(CARES Act), as it relates to device shortages and potential device 
shortages during or in advance of a public health emergency. This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by March 14, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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: 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

[[Page 1418]]

comments, that information will be posted on https://www.regulations.gov.
    <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-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.'' 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.
    <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 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 draft guidance document entitled 
``Notifying FDA of a Permanent Discontinuance or Interruption in 
Manufacturing of a Device Under Section 506J of the FD&C Act'' to the 
Office of Policy, Guidance and Policy Development, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the 
Center for Biologics Evaluation and Research, Office of Communication, 
Outreach, and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 
3128, Silver Spring, MD 20903. Send one self-addressed adhesive label 
to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Brittany Caldwell, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5556, Silver Spring, MD 20993-0002, 301-
796-5900 or Stephen Ripley, 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 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 the 
Secretary of Health and Human Services with new authorities intended to 
help prevent or mitigate medical device shortages ``during, or in 
advance of, a public health emergency declared by the Secretary under 
section 319 of the Public Health Service Act.''
    FDA is issuing this guidance to clarify and make recommendations 
regarding who should notify FDA, what information to include in the 
notification, and how to notify FDA, during or in advance of a public 
health emergency, regardless of the type of public health emergency. 
During a specific public health emergency, FDA may issue additional 
supplemental information to this guidance, through FDA's website or a 
supplemental guidance, to assist manufacturers in determining whether a 
notification under section 506J of the FD&C Act (hereafter referred to 
as a ``506J notification'') is required during a public health 
emergency.
    FDA is issuing this draft guidance to assist stakeholders in the 
Agency's implementation of section 506J(a) of the FD&C Act outside of 
the COVID-19 Public Health Emergency. This draft guidance is not 
intended to supersede the COVID-19 Public Health Emergency Guidance, 
``Notifying CDRH of a Permanent Discontinuance or Interruption in 
Manufacturing of a Device under 506J of the FD&C Act during the COVID-
19 Public Health Emergency'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc, which will be withdrawn at the end of the COVID-19 
Public Health Emergency. Should this guidance be finalized before the 
COVID-19 public health emergency declaration expires or is withdrawn, 
the COVID-19 Public Health Emergency Guidance will be applicable for 
506J related issues with respect to COVID-19.
    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 ``Notifying 
FDA of a Permanent Discontinuance or Interruption in Manufacturing of a 
Device Under Section 506J of the FD&C Act''. 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. 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

[[Page 1419]]

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/biologics-guidances. 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'' may send an email request to <a href="/cdn-cgi/l/email-protection#0d4e495f45204a7864696c636e684d6b696c2365657e236a627b"><span class="__cf_email__" data-cfemail="97d4d3c5dfbad0e2fef3f6f9f4f2d7f1f3f6b9ffffe4b9f0f8e1">[email protected]</span></a> to 
receive an electronic copy of the document. Please use the document 
number 21003 and complete title to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 
section 506J of the FD&C Act have been approved by OMB as listed in the 
following table:

------------------------------------------------------------------------
                                                            OMB Control
21 CFR part; guidance; or FDA form          Topic               No.
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506J..............................  Shortages Data             0910-0491
                                     Collection.
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IV. Other Issues for Consideration

    The Agency invites comments on the ``Notifying FDA of a Permanent 
Discontinuance or Interruption in Manufacturing of a Device Under 
Section 506J of the FD&C Act'' draft guidance, in general, and on the 
following questions, in particular:
    <bullet> Section 506J of the FD&C Act requires notifications 
``during, or in advance of'' a public health emergency. Does the draft 
guidance provide sufficient clarity regarding what FDA considers to be 
``in advance of a public health emergency''? Is there additional 
information that you believe would be helpful? If so, what?
    <bullet> Are there other situations or circumstances that could 
lead to a situation that could be considered to be ``in advance of a 
public health emergency''?
    <bullet> FDA has proposed providing supplemental information during 
specific public health emergencies, which is intended to contain 
information specific to that public health emergency to assist 
manufacturers in providing notifications. Is there specific information 
that you believe should be conveyed in such supplements?
    <bullet> Are there circumstances where it is unclear whether you 
should notify FDA? How could FDA provide clarity?
    <bullet> Should FDA notify stakeholders when an event is considered 
to be ``in advance of a public health emergency'', and if so, how 
should FDA best do so?
    <bullet> FDA recommends that manufacturers provide updates to 
notifications every two weeks unless otherwise indicated based on the 
nature of the situation, including the expected timeline for recovery, 
even if the status remains unchanged. Please provide feedback on this 
proposed frequency.
    <bullet> How can FDA best disseminate supplemental information 
during or in advance of a public health emergency to manufacturers and 
other stakeholders?
    <bullet> How can FDA keep all stakeholders, including healthcare 
providers and patients, better informed regarding shortages during or 
in advance of a public health emergency?
    <bullet> In the draft guidance document, Appendix A displays an 
example of supplemental information for an epidemic or pandemic that 
FDA believes would be helpful to assess the overall state of the market 
and help inform potential mitigations. What additional information 
might be helpful for other public health emergencies?

    Dated: January 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00321 Filed 1-10-22; 8:45 am]
BILLING CODE 4164-01-P


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