[Federal Register Volume 85, Number 97 (Tuesday, May 19, 2020)]
[Notices]
[Pages 29949-29951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10635]


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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.

DATES: The announcement of the guidance is published in the Federal 
Register on May 19, 2020. 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,

[[Page 29950]]

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.
     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.
    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 was renewed on April 21, 
2020. In addition, on March 13, 2020, the President declared a national 
emergency in response to COVID-19.
    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 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 FD&C 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 practice statute and regulation.
    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.

[[Page 29951]]

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 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

    The guidance contains information collection provisions that 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). Under 
the PRA, Federal Agencies must obtain approval from OMB for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes Agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party.
    This guidance refers to previously approved FDA collections of 
information. These 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 
FDA and Sponsors and 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 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10635 Filed 5-18-20; 8:45 am]
BILLING CODE 4164-01-P


