[Federal Register Volume 89, Number 36 (Thursday, February 22, 2024)]
[Notices]
[Pages 13351-13352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-0584]


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.'' Although the public health emergency 
declared by the Department of Health and Human Services under section 
319 of the Public Health Services Act has ended, COVID-19 remains an 
ongoing public health problem with continued prevention and treatment 
efforts. FDA is issuing this guidance to provide sponsors and 
investigators with considerations for approaches on how common COVID-
19-related symptoms can be measured and analyzed in clinical trials 
evaluating drugs or biological products for the prevention or treatment 
of COVID-19 in outpatient adult and adolescent subjects. This guidance 
supersedes the guidance of the same name issued on September 29, 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on February 22, 2024.

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-2024-D-0584 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.
    <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.
    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

[[Page 13352]]

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 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: David Reasner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6373, Silver Spring, MD 20993, 301-837-
7667, or James Myers, 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 ``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.'' This guidance provides 
considerations for how common COVID-19-related symptoms can be measured 
and analyzed in clinical trials evaluating drugs or biological products 
for the prevention or treatment of COVID-19 in outpatient adult and 
adolescent subjects.
    This guidance supersedes the guidance of the same name issued on 
September 29, 2020 (85 FR 61008). The September 2020 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 on May 11, 2023, during which time FDA planned 
to further revise the guidances. The September 2020 guidance on 
assessing COVID-19-related symptoms in outpatient adult and adolescent 
subjects in clinical trials 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)) 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 public health emergency under section 319 of the PHS Act has 
expired, 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 to facilitate timely development of drugs and 
biological products for treatment and prevention of COVID-19. FDA is 
committed to supporting continued development of products to treat or 
prevent the COVID-19 virus by providing timely guidance. 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 2020 guidance. Changes from 
the 2020 guidance to this guidance include updating the reference list 
to refer sponsors to new resources that could support their drug 
development program (e.g., patient-focused drug development guidance 
series); providing considerations for determining which subset of 
symptoms, and aspects of those symptoms, to assess (e.g., mechanism of 
action of the drug); clarifying the item-level questions to make them 
more specific and adequate to support development of endpoint measures 
(e.g., recall period, response options); and adding recommendations for 
global scale measures to align with the concepts of interest. In 
addition, editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  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. 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 pertaining to investigational new drug applications 
have been approved under OMB control number 0910-0014. The collections 
of information in 21 CFR part 314 pertaining to new drug applications 
have been approved under OMB control number 0910-0001. The collections 
of information in 21 CFR part 601 pertaining to biologics license 
applications have been approved under OMB control number 0910-0338. The 
collections of information in 21 CFR parts 50 and 56 pertaining to 
protection of human subjects and institutional review boards have been 
approved under OMB control number 0910-0130. The collections of 
information in 21 CFR part 11 pertaining to electronic records and 
signatures have been approved under OMB control number 0910-0303.

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: February 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03622 Filed 2-21-24; 8:45 am]
BILLING CODE 4164-01-P