[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26050-26052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10061]


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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.'' 
This guidance describes FDA's current recommendations regarding phase 2 
or phase 3 trials for drugs or biological products under development 
for the treatment or prevention of COVID-19. Given the public health 
emergency presented by COVID-19, this guidance document is being 
implemented without prior public comment because FDA has determined 
that prior public participation is not feasible or appropriate, but it 
remains subject to comment in accordance with the Agency's good 
guidance practices. This final guidance revises and replaces the final 
guidance of the same name issued

[[Page 26051]]

on May 11, 2020. Revisions were made to address the evolving landscape 
of COVID-19 drug development, including the emergence of SARS-CoV-2 
variants and the availability of COVID-19 vaccines. The revision to 
this guidance was posted to the FDA website on February 22, 2021.

DATES: The announcement of the guidance is published in the Federal 
Register on May 12, 2021. The guidance document is immediately in 
effect, but it remains subject to comment in accordance with the 
Agency's good guidance practices.

ADDRESSES: You may submit electronic or written comments on Agency 
guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     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.
     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:
     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.
     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.
     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 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, 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: Eithu Lwin, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-0728; or 
Stephen Ripley, 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 guidance for industry 
entitled ``COVID-19: Developing Drugs and Biological Products for 
Treatment or Prevention.'' There is currently an outbreak of 
respiratory disease caused by a novel coronavirus. The virus has been 
named SARS-CoV-2, and the disease it causes has been named Coronavirus 
Disease 2019 (COVID-19). On January 31, 2020, the Department of Health 
and Human Services (HHS) issued a declaration of a public health 
emergency related to COVID-19 and mobilized the Operating Divisions of 
HHS. The public health emergency declaration has been subsequently 
renewed. In addition, on March 13, 2020, the President declared a 
national emergency in response to COVID-19. The revision to this 
guidance was posted to the FDA website on February 22, 2021.
    This guidance describes FDA's current recommendations regarding 
phase 2 or phase 3 trials for drugs under development to treat or 
prevent COVID-19. This guidance focuses on the patient population, 
trial design, efficacy endpoints, safety considerations, and 
statistical considerations for such trials. Drugs should have undergone 
sufficient development before their evaluation in phase 2 or phase 3.
    This guidance focuses on the development of drugs with direct 
antiviral activity or immunomodulatory activity. However, the 
recommendations in this guidance may be applicable to development plans 
for drugs for COVID-19 with other mechanisms of action. The mechanism 
of action of the drug may impact key study design

[[Page 26052]]

elements (e.g., population, endpoints, safety assessments, duration of 
followup, etc.).
    Preventative vaccines are not within the scope of this guidance. 
Nor does this guidance provide general recommendations on early drug 
development in COVID-19, such as use of animal models.
    In light of the public health emergency related to COVID-19 
declared by the Secretary of HHS, FDA has determined that prior public 
participation for this guidance is not feasible or appropriate and is 
issuing this guidance without prior public comment (see section 
701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
371(h)(1)(C)(i)) and 21 CFR 10.115(g)(2)). This guidance document is 
being implemented immediately, but it remains subject to comment in 
accordance with the Agency's good guidance practices.
    This guidance is intended to remain in effect for the duration of 
the public health emergency related to COVID-19 declared by HHS, 
including any renewals made by the Secretary in accordance with section 
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). 
However, the recommendations and processes described in the guidance 
are expected to assist the Agency more broadly in its continued efforts 
to assist sponsors in the clinical development of drugs for the 
treatment of COVID-19 beyond the termination of the COVID-19 public 
health emergency and reflect the Agency's current thinking on this 
issue. Therefore, within 60 days following the termination of the 
public health emergency, FDA intends to revise and replace this 
guidance with any appropriate changes based on comments received on 
this guidance and the Agency's experience with implementation.
    This final guidance revises and replaces the final guidance with 
the same title issued on May 19, 2020 (85 FR 29949). The revision 
addresses the potential impact of the emergence of SARS-CoV-2 variants 
and the availability of COVID-19 vaccines. Additional updates 
reflecting the evolving landscape of COVID-19 drug development were 
made to the recommendations on patient population, trial design, 
efficacy endpoints, safety considerations, and statistical 
considerations. In addition, FDA considered comments received on the 
previous guidance, and 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. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. 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 312 
and 320 have been approved under OMB control number 0910-0014; the 
collections of information in 21 CFR part 58 regarding good laboratory 
practice for nonclinical laboratory studies have been approved under 
OMB control number 0910-0119; 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 320 have been approved 
under OMB control number 0910-0291; 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 draft guidance for industry 
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants 
of Prescription Drug User Fee Act Products'' have been approved under 
OMB control number 0910-0429; 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; and the collections of 
information in FDA's final guidance for industry entitled ``Oversight 
of Clinical Investigations--A Risk-Based Approach to Monitoring'' have 
been approved under OMB control number 0910-0733.

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, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or 
https://www.regulations.gov.

    Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10061 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P