[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]
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