
[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72084-72085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 72085]]

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]
BILLING CODE 4164-01-P


