[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72084-72085]
[FR Doc No: 2023-23071]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1057 and FDA-2020-D-1136]

Food and Drug Administration; Center of Drug Evaluation and
Research Guidance Documents Related to Coronavirus Disease 2019,
Expiration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of guidances for industry entitled ``Notifying FDA of a
Permanent Discontinuance or Interruption in Manufacturing Under Section
506C of the FD&C Act,'' which posted March 2020 to communicate
recommendations for notifying the Agency about the permanent
discontinuance or interruption in manufacturing of certain drug
products; and ``COVID-19: Potency Assay Consideration for Monoclonal
Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2
Infectivity'' which posted January 2021 to communicate information on
the development of monoclonal antibodies (mAbs) and other therapeutic
proteins for use as COVID-19 therapeutics. FDA is withdrawing these two
guidance documents because new draft guidances are available that
reflect comments received on the COVID-19 guidances, and many of the
recommendations set forth in the COVID-19 guidances are applicable
outside the context of the public health emergency (PHE) and included
in the draft guidances.

DATES: The expiration date is November 7, 2023.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Office of Regulatory
Policy, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-2357.

SUPPLEMENTARY INFORMATION:

I. Background

    As part of FDA's commitment to providing timely guidance to support
response efforts to the Coronavirus Disease 2019 (COVID-19) \1\
pandemic, the Agency published on the FDA website the guidance for
industry entitled ``Notifying FDA of Permanent Discontinuance or
Interruption in Manufacturing Under Section 506C of the FD&C Act'' in
March 2020, and announced its availability in the Federal Register on
April 6, 2020 (85 FR 18247), (Notifying FDA Guidance); and in January
2021, the Agency published on the FDA website the guidance for industry
entitled ``COVID-19: Potency Assay Considerations for Monoclonal
Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2
Infectivity'' and announced its availability in the Federal Register
February 19, 2021 (86 FR 10285), (Potency Assay Guidance). The
Notifying FDA Guidance explained that during the COVID-19 pandemic FDA
had been closely monitoring the medical 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 Notifying FDA Guidance,
therefore, communicated the Agency's recommendations for providing
timely, informative notifications about changes in the production of
certain drugs and biological products to help the Agency in its efforts
to prevent or mitigate shortages of such products. The Potency Assay
Guidance communicated information to assist sponsors in the development
of mAbs and other therapeutic proteins for use as COVID-19 therapeutics
and described how potency assay methods required for release and
stability testing can be shown to assess known or potential
mechanism(s) of action of the product. The guidance also described
methods that applicants should use to ensure the potency of mAbs and
other therapeutic proteins proposed for use in as anti-infective agents
for COVID-19. FDA issued both guidances to communicate its
recommendations for the duration of the COVID-19 PHE declared by the
Secretary of Health and Human Services (HHS) on January 31, 2020,
including any renewals made by the HHS Secretary in accordance with
section 319(a)(2) of the Public Health Service Act (42 U.S.C.
247d(a)(2)). We also said in both guidances that we expected their
recommendations would continue to apply in circumstances outside the
context of the PHE and that following the end of the COVID-19 PHE, FDA
intended to revise and replace the guidances with updated guidances
that incorporated any appropriate changes based on comments received
and the Agency's experience with implementation. Furthermore, in the
Federal Register of March 13, 2023 (88 FR 15417), FDA listed the COVID-
19-related guidance documents that will no longer be in effect with the
expiration of the COVID-19 PHE declaration on May 11, 2023, guidances
that FDA revised to continue in effect for 180 days after the
expiration of the COVID-19 PHE declaration to provide a period for
stakeholder transition and then would no longer be in effect, and
guidances that FDA revised to continue in effect for 180 days after the
expiration of the PHE declaration during which time FDA planned to
further revise the guidances. The Notifying FDA Guidance and the
Potency Assay Guidance were included in the latter category and were
revised to remain in effect for 180 days post expiration of the PHE
declaration.
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    \1\ The virus has been named ``SARS-CoV-2'' and the disease it
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
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    FDA also stated in the Federal Register of March 13, 2023, that the

Agency ``continues to assess the needs and circumstances related to the
policies in our COVID-19-related guidances, and we may alter our
approach for individual guidances listed in this notice.'' (88 FR 15417
at 15418). Following the expiration of the COVID-19 PHE declaration on
May 11, 2023, FDA has reviewed the Notifying FDA Guidance and the
Potency Assay Guidance and determined that these two guidances are no
longer needed because new draft guidances are available.
    In March 2023 (88 FR 13126), the Agency issued the draft guidance
document entitled ``Potency Assay Considerations for Monoclonal
Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens,''
which provides information to assist in the development of mAbs and
other therapeutic proteins directly targeting viral proteins or host
cell proteins mediating pathogenic mechanisms of infection. The draft
guidance also provides detailed recommendations for drug developers
with the goal of helping to ensure that drug developers provide
adequate information to assess potency at each stage of a product's
life cycle. FDA believes that many of the recommendations set forth in
the 2021 Potency Assay Guidance are applicable outside the context of
the COVID-19 PHE and are applicable to mAbs and other therapeutic
protein directly targeting any viral surfaces (glycol) proteins
mediating pathogenic mechanisms of infection, not just those that
directly target SARS-CoV-2. In preparing the draft guidance, FDA
considered comments received regarding the 2021 Potency Assay Guidance
as well as the Agency's experience with SARS-CoV-2 and other viruses.
    In April 2023 (88 FR 20526), the Agency issued the draft guidance
for industry entitled ``Notification of a Permanent Discontinuance or
Interruption in Manufacturing Under Section 506C of the FD&C Act'' to
assist applicants and manufacturers in providing FDA timely,
informative notifications about changes in the production of certain
finished drugs and biological products as well as certain active
pharmaceutical ingredients (API) that may, in turn, help the Agency in
its effort to prevent and mitigate shortages. The draft guidance
discusses the notification requirements under section 506C of the
Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 356c),
including requirements added by the Coronavirus Aid, Relief, and
Economic Security Act (CARES Act) \2\ related to notifying FDA about
finished product and API manufacturing discontinuances and
interruptions. The draft guidance provides recommendations for
applicants and manufacturers to provide additional details and follow
additional procedures to ensure FDA has the specific information it
needs to help prevent or mitigate shortages. In addition, the draft
guidance explains how FDA communicates information about products in
shortage to the public. In preparing the draft guidance, FDA considered
comments received on the 2020 Notifying FDA Guidance.
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    \2\ The CARES Act (Pub. L. 116-136) was enacted on March 27,
2020. The CARES Act amendments to section 506C of the FD&C Act took
effect on September 23, 2020. See section 3112(g) of the CARES Act.
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    For the reasons discussed above, FDA is announcing the guidance
entitled ``Notifying FDA of Permanent Discontinuance or Interruption in
Manufacturing Under Section 506C of the FD&C Act'' (March 2020) and the
guidance entitled ``COVID-19: Potency Assay Consideration for
Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-
CoV-2 Infectivity'' (January 2021) will expire on November 7, 2023.

II. Expiration Date

    The expiration date for the guidance documents in this document is
November 7, 2023.

    Dated: October 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23071 Filed 10-18-23; 8:45 am]
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