[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Notices]
[Pages 82382-82383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1370]


COVID-19: Developing Drugs and Biological Products for Treatment 
or Prevention; 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 ``COVID-19: 
Developing Drugs and Biological Products for Treatment or Prevention.'' 
The purpose of this guidance is to assist sponsors in the clinical 
development of drugs and biological products for the treatment or 
prevention of COVID-19. This guidance describes FDA's current 
recommendations for phase 2 and phase 3 trials with a focus on trial 
population, trial design, efficacy endpoints, safety considerations, 
and statistical considerations. This guidance supersedes the guidance 
of the same name initially issued on May 19, 2020, and reissued on 
February 22, 2021.

DATES: The announcement of the guidance is published in the Federal 
Register on November 24, 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-1370 for ``COVID-19: Developing Drugs and Biological 
Products for Treatment or Prevention.'' 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.

[[Page 82383]]

    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 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 the 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: 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; or Anne Taylor, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``COVID-19: Developing Drugs and Biological Products for 
Treatment or Prevention.'' This guidance provides FDA's current 
recommendations for phase 2 and phase 3 trials with a focus on trial 
population, trial design, efficacy endpoints, safety considerations, 
and statistical considerations. The development of drugs for the 
treatment of Long COVID-19, preventative vaccines, and convalescent 
plasma are not within the scope of this guidance as these development 
programs raise different and additional considerations.
    This guidance supersedes the guidance ``COVID-19: Developing Drugs 
and Biological Products for Treatment or Prevention,'' which was 
initially issued on May 19, 2020 (85 FR 29949), and subsequently 
revised and reissued on February 22, 2021. This guidance was published 
to support public health efforts following a declaration, under section 
319 of the Public Health Service Act (PHS Act) (42 U.S.C. 247d), by the 
Secretary of Health and Human Services of a public health emergency 
related to COVID-19. 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 drugs and 
biological products for treatment or prevention of COVID-19 is included 
in this list.
    FDA is issuing this guidance for immediate implementation in 
accordance with our good guidance practices regulation (Sec.  
10.115(g)(3) (21 CFR 10.115(g)(3))) 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 Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 371(h)(1)(C)(i))). Specifically, we are not seeking prior 
comment because although the COVID-19-related public health emergency 
declared under section 319 of the PHS Act has expired, SARS-CoV-2 
continues to circulate, COVID-19 remains a serious health risk for some 
individuals, and there is a need to ensure that sponsors are aware of 
FDA's recommendations on the development of drugs and biological 
products for treatment and prevention of COVID-19. This guidance 
document is being implemented immediately, but it remains subject to 
comment in accordance with the Agency's good guidance practices.
    FDA considered comments received on the guidance and the Agency's 
experience with COVID-19 drug development when making revisions. 
Changes in this final guidance include the following: revisions to 
remove reference to the COVID-19 public health emergency and updates to 
the recommendations on trial population, trial design, efficacy 
endpoints, safety considerations, and statistical considerations to 
reflect the current scientific knowledge and state of the COVID-19 
pandemic. In addition, editorial changes were made to improve clarity.
    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 ``COVID-19: Developing Drugs and Biological 
Products for Treatment or Prevention.'' 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 parts 312 and 320 have been approved under OMB control number 
0910-0014. The collections of information in 21 CFR part 314 have been 
approved under OMB control number 0910-0001. The collections of 
information in 21 CFR parts 50 and 56 have been approved under OMB 
control number 0910-0130. The collections of information in 21 CFR part 
601 have been approved under OMB control number 0910-0338. The 
collections of information in FDA's final guidance for clinical trial 
sponsors entitled ``Establishment and Operation of Clinical Trial Data 
Monitoring Committees'' have been approved under OMB control number 
0910-0581. The collections of information in 42 CFR part 11 have been 
approved under OMB control number 0925-0586.

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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: November 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25952 Filed 11-22-23; 8:45 am]
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