[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88401-88402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1136]


Development of Monoclonal Antibody Products Targeting SARS-CoV-2 
for Emergency Use Authorization; 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 final guidance for industry entitled 
``Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for 
Emergency Use Authorization.'' This guidance provides recommendations 
to sponsors on the development of monoclonal antibody products 
targeting SARS-CoV-2 intended for the prevention or treatment of COVID-
19, including addressing the impact of emerging variants. The 
recommendations focus on the data and information that may be used to 
support a request for emergency use authorization (EUA) under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance 
supersedes the guidance entitled ``Development of Monoclonal Antibody 
Products Targeting SARS-CoV-2, Including Addressing the Impact of 
Emerging Variants, During the COVID-19 Public Health Emergency'' issued 
on February 22, 2021.

DATES: The announcement of the guidance is published in the Federal 
Register on December 21, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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 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-2020-D-1136 for ``Development of Monoclonal Antibody Products 
Targeting SARS-CoV-2 for Emergency Use Authorization.'' 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 Sec.  
10.115(g)(5) (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,

[[Page 88402]]

4th Floor, 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: Maria Clary, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4638, Silver Spring, MD 20993-0002, 240-
402-8615.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Development of Monoclonal Antibody Products Targeting SARS-
CoV-2 for Emergency Use Authorization.'' This guidance provides 
recommendations to sponsors on the development of monoclonal antibody 
products targeting SARS-CoV-2 intended for the prevention or treatment 
of COVID-19. The recommendations focus on the data and information that 
may be used to support a request for EUA under section 564 of the FD&C 
Act (21 U.S.C. 360bbb-3). Specifically, the guidance discusses the 
manufacturing, pharmacology/toxicology, virologic, and clinical 
considerations to support EUA.
    This guidance supersedes the guidance for industry entitled 
``Development of Monoclonal Antibody Products Targeting SARS-CoV-2, 
Including Addressing the Impact of Emerging Variants, During the COVID-
19 Public Health Emergency,'' which was published in February 2021. FDA 
issued the guidance to communicate its policy for the duration of the 
COVID-19 public health emergency (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)). In the Federal 
Register of March 13, 2023 (88 FR 15417), FDA listed certain guidance 
documents that FDA was revising to continue in effect for 180 days 
after the expiration of the COVID-19 PHE declaration, during which time 
FDA planned to further revise the guidances. The February 2021 guidance 
on development of monoclonal antibody products targeting SARS-CoV-2 is 
included in this list.
    Although circumstances have improved, SARS-CoV-2 remains in broad 
circulation throughout the United States. The virus has and continues 
to evolve over time, and in certain instances, mutations in the virus 
have greatly reduced the activity of monoclonal antibody therapies 
available for the prevention or treatment of COVID-19, resulting in 
vulnerable populations having limited preventative and therapeutic 
options. FDA retains the ability to issue an EUA under section 564 of 
the FD&C Act for products to treat or prevent COVID-19, so the 
recommendations in this guidance are still pertinent (88 FR 16644). 
This guidance is intended to remain in effect only for the duration of 
the declaration by the Secretary of HHS under section 564 of the FD&C 
Act effective March 27, 2020, that circumstances exist justifying the 
authorization of emergency use of drugs and biological products during 
the COVID-19 pandemic (85 FR 18250). In revising this guidance, FDA 
considered comments received on the 2021 guidance as well as the 
Agency's experience issuing COVID-19-related EUAs. In addition, 
editorial changes were made to improve clarity.
    Given the need to ensure that sponsors are aware of our current 
recommendations to facilitate timely development of monoclonal antibody 
products targeting SARS-CoV-2, FDA is issuing this guidance for 
immediate implementation without initially seeking prior comment 
because the Agency has determined that prior public participation is 
not feasible or appropriate (see Sec.  10.115(g)(2) and section 
701(h)(1)(C)(i) of the FD&C Act (21 U.S.C. 371(h)(1)(C)(i))). This 
guidance document is being implemented immediately, but it remains 
subject to comment in accordance with the Agency's good guidance 
practices (see Sec.  10.115(g)(3)).
    The guidance represents the current thinking of FDA on 
``Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for 
Emergency Use Authorization.'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information 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). The collections of information 
in 21 CFR part 314 pertaining to new drug applications have been 
approved under 0910-0001. The collections of information pertaining to 
EUA of medical products have been approved under OMB control number 
0910-0595.

III. 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/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28092 Filed 12-20-23; 8:45 am]
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