Notice2022-00321
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or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 11, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act."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 This draft guidance is not final nor is it in effect at this time.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 7 (Tuesday, January 11, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Notices]
[Pages 1417-1419]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00321]
-----------------------------------------------------------------------
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Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry and Food and Drug Administration Staff;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.
-----------------------------------------------------------------------
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc</a>, 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, https://www.fda.gov/
regulatory-information/search-fda-guidance-documents or https://
<a href="http://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>. 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#0f4c4b5d4722487a666b6e616c6a4f696b6e2167677c21686079"><span class="__cf_email__" data-cfemail="bdfef9eff590fac8d4d9dcd3ded8fddbd9dc93d5d5ce93dad2cb">[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.
------------------------------------------------------------------------
506J.............................. Shortages Data 0910-0491
Collection.
------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 11, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.