Notice2023-28092
Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization; Guidance for Industry; Availability
Primary source
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Published
December 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 244 (Thursday, December 21, 2023)</title>
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[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88401-88402]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <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 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-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 <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 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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: December 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28092 Filed 12-20-23; 8:45 am]
BILLING CODE 4164-01-P
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