[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61008-61009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21455]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1824]


Assessing COVID-19-Related Symptoms in Outpatient Adult and 
Adolescent Subjects in Clinical Trials of Drugs and Biological Products 
for COVID-19 Prevention or Treatment; 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 ``Assessing 
COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects 
in Clinical Trials of Drugs and Biological Products for COVID-19 
Prevention or Treatment.'' Sponsors may encounter challenges in 
identifying methods to assess the numerous and heterogeneous 
Coronavirus Disease 2019 (COVID-19)-related symptoms across subjects 
when designing clinical trials of drugs to treat or prevent COVID-19 in 
adult and adolescent outpatient subjects. To assist sponsors, this 
guidance describes an example with a set of common COVID-19-related 
symptoms as well as an approach to their measurement for use in 
clinical trials. 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 September 29, 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 either 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-1824 for ``Assessing COVID-19-Related Symptoms in Outpatient 
Adult and Adolescent Subjects in Clinical Trials of Drugs and 
Biological Products for COVID-19 Prevention or Treatment.'' 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 to 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: Elektra Papadopoulos, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6445, Silver Spring, MD 20993-0002, 301-
796-0967; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903

[[Page 61009]]

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 ``Assessing COVID-19-Related Symptoms in Outpatient Adult and 
Adolescent Subjects in Clinical Trials of Drugs and Biological Products 
for COVID-19 Prevention or Treatment.'' Sponsors may encounter 
challenges in identifying methods to assess the numerous and 
heterogeneous COVID-19-related symptoms across subjects when designing 
clinical trials of drugs to treat or prevent COVID-19 in adult and 
adolescent outpatient subjects. In many instances, daily assessment of 
all COVID-19-related symptoms may not be feasible.
    To assist sponsors, the guidance describes an example with a set of 
common COVID-19-related symptoms derived from information provided by 
the Centers for Disease Control and Prevention as of August 28, 2020, 
as well as an approach to their measurement for use in clinical trials.
    The guidance also includes considerations and recommendations for 
handling data and for standardizing other COVID-19-related clinical 
trial assessments for trial subjects.
    In light of the public health emergency related to COVID-19 
declared by the Secretary of the Department of Health and Human 
Services (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 
practices. FDA will review comments, and the guidance will be updated 
accordingly.
    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 efforts to 
provide sponsors with considerations for the assessment of COVID-19-
related symptoms in outpatient adult and adolescent subjects in 
clinical trials evaluating drugs to treat or prevent 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 ``Assessing COVID-19-Related Symptoms in 
Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs 
and Biological Products for COVID-19 Prevention or Treatment.'' 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 601 have been approved under 
OMB control number 0910-0338; the collections of information in 21 CFR 
parts 50 and 56 have been approved under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or 
https://www.regulations.gov.

    Dated: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21455 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P


