[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18247-18249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06800]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1057]
Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing Under Section 506C of
the Federal Food, Drug, and Cosmetic Act; Guidance for Industry;
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 guidance for industry entitled ``Notifying FDA of
a Permanent Discontinuance or Interruption in Manufacturing Under
Section 506C of the FD&C Act.'' Due to the Coronavirus Disease 2019
(COVID-19) pandemic, FDA has been closely monitoring the medical
product supply chain with the expectation that it may be impacted by
the COVID-19 outbreak, potentially leading to supply disruptions or
shortages of drug and biological products in the United States. The
guidance is intended to assist applicants and manufacturers in
providing FDA timely, informative notifications about changes in the
production of certain drugs and biological products that will, in turn,
help the Agency in its efforts to prevent or mitigate shortages of such
products. Given the public health emergency presented by COVID-19, this
guidance document is being implemented without prior public comment
because FDA has determined that prior public participation is not
feasible or appropriate, but it remains subject to comment in
accordance with the Agency's good guidance practices. In addition, this
guidance is intended to remain in effect for the duration of the public
health emergency related to COVID-19 declared by the Department of
Health and Human Services (HHS). However, the recommendations and
processes described in the guidance are expected to assist the Agency
more broadly in its efforts to prevent and mitigate shortages,
including under circumstances outside of the COVID-19 public health
emergency and reflect the Agency's current thinking on this issue.
Therefore, within 60 days following the termination of the public
health emergency, FDA intends to revise and replace this guidance with
any appropriate changes following the public health emergency and in
consideration of comments received on this guidance and the Agency's
experience with implementation.
DATES: The announcement of the guidance is published in the Federal
Register on April 1, 2020. The guidance document is immediately in
effect, but it remains subject to comment in accordance with the
Agency's good guidance practices.
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-2020-D-1057 for ``Notifying FDA of a Permanent Discontinuance or
Interruption in Manufacturing Under Section 506C 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.
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
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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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Jin Ahn, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6234, Silver Spring, MD 20993-0002, 301-796-1300; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Notifying FDA of a Permanent Discontinuance or Interruption
in Manufacturing Under Section 506C of the FD&C Act.'' This guidance
discusses the requirement in section 506C of the FD&C Act (21 U.S.C.
356c) and FDA's implementing regulations for applicants and
manufacturers to notify FDA of a permanent discontinuance in the
manufacture of certain products or an interruption in the manufacture
of certain products that is likely to lead to a meaningful disruption
in supply of that product in the United States. The guidance recommends
that applicants and manufacturers provide additional details and follow
additional procedures to ensure FDA has the specific information it
needs to help prevent or mitigate shortages. The guidance also explains
how FDA communicates information about products in shortage to the
public.
Timely and detailed notifications from applicants and manufacturers
play a significant role in decreasing the incidence and duration of
supply disruptions and shortages. Early, informative notifications are
the best tool FDA has to help prevent a shortage from occurring or to
mitigate the impact of an unavoidable shortage. When FDA does not
receive timely, informative notifications, the Agency's ability to
respond appropriately is limited and a shortage may result. Therefore,
FDA is issuing this guidance to assist applicants and manufacturers in
providing early, detailed notifications that will allow FDA to evaluate
the situation and take appropriate action. Among other things, the
guidance explains: (1) Who should notify FDA, (2) when and how such
notifications should be submitted; and (3) what details to include in
notifications that will ensure FDA has information it needs to help
prevent or mitigate shortages.
In light of the public health emergency related to COVID-19
declared by the Secretary of HHS, FDA has determined that prior public
participation for this guidance is not feasible or appropriate and is
issuing this guidance without prior public comment (see section
701(h)(1)(C)(i) of the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately,
but it remains subject to comment in accordance with the Agency's good
guidance practice statute and regulation.
This guidance is intended to remain in effect for the duration of
the public health emergency related to COVID-19 declared by HHS,
including any renewals made by the Secretary in accordance with section
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
However, the recommendations and processes described in the guidance
are expected to assist the Agency more broadly in its efforts to
prevent and mitigate shortages, including under circumstances outside
of the COVID-19 public health emergency, and reflect the Agency's
current thinking on this issue. Therefore, within 60 days following the
termination of the public health emergency, FDA intends to revise and
replace this guidance with any appropriate changes based on comments
received on this guidance and the Agency's experience with
implementation.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Notifying FDA of a Permanent
Discontinuance or Interruption in Manufacturing Under Section 506C 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.
III. Paperwork Reduction Act of 1995
The guidance contains information collection provisions that 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). Under
the PRA, Federal Agencies must obtain approval from OMB for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Health and Human Services Secretary Alex M. Azar II (Secretary)
determined that, as a result of confirmed cases of 2019 Novel
Coronavirus (2019-nCoV), a public health emergency (PHE) exists and has
existed since January 27, 2020. On March 19, 2020, the Secretary
waived, pursuant to section 319(f) of the PHS Act (42 U.S.C. 247d(f))
and the PHE, the requirements of the PRA for information to be
collected by FDA pertaining to our guidance documents that relate to
the COVID-19 pandemic public health emergency response. The Secretary
has posted its determination of the waiver at: https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers. Pursuant to the
waiver, the requirements of the PRA are not
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applicable with respect to the voluntary collection of information
contained in the guidance during the immediate investigation of, and
response to, COVID-19. Furthermore, the requirements of the PRA shall
not be applicable with respect to the voluntary collection of
information contained in the guidance during the immediate post-
response review regarding the public health emergency.
As noted above, while the requested information and process
described in the guidance are critical during national emergencies,
such as the COVID-19 outbreak, the guidance recommends submission of
information that is expected to assist the Agency more broadly in its
efforts to address shortages. Accordingly, following the termination of
the PHE, FDA intends to revise and replace the guidance with any
appropriate changes based on comments received on this guidance and our
experience with implementation. Upon determining that the circumstances
necessitating the COVID-19 PRA waiver no longer exist, the Secretary
will promptly update its website to reflect the termination of the
waiver. The period of this waiver will not exceed the period of time
for the public health emergency related to COVID-19, including any
immediate post-response review. The Secretary will ensure that
compliance with the requirements of the PRA occurs in as timely a
manner as possible based on the applicable circumstances, but not to
exceed 30 calendar days after the expiration of the waiver related to
COVID-19.
This guidance also refers to previously approved collections of
information found in FDA regulations. The guidance describes, among
other things, the requirements in Sec. Sec. 310.306,
314.81(b)(3)(iii), and 600.82 (21 CFR 310.306, 314.81(b)(3)(iii), and
600.82) for applicants or manufacturers of certain drugs and biological
products to notify FDA of a permanent discontinuance in the manufacture
of certain products or an interruption in manufacture of certain
products that is likely to lead to a meaningful disruption in the
supply of such products in the United States. These notifications must
provide particular information, including the name of the product and a
description of the reason for the permanent discontinuance or
interruption in manufacturing (see Section II of the guidance). The
collections of information in Sec. Sec. 310.306, 314.81(b)(3)(iii),
and 600.82 have been approved under OMB control number 0910-0759.
IV. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or
https://www.regulations.gov.
Dated: March 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06800 Filed 3-31-20; 8:45 am]
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