COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability, 29949-29951 [2020-10635]
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29949
Federal Register / Vol. 85, No. 97 / Tuesday, May 19, 2020 / Notices
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, ACL is publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, ACL invites
comments on our burden estimates or
any other aspect of this collection of
information, including:
(1) Whether the proposed collection
of information is necessary for the
proper performance of ACL’s functions,
including whether the information will
have practical utility;
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates;
(3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) ways to minimize the burden of
the collection of information on
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
The Administration for Community
Living (ACL) is requesting approval for
a revised data collection associated with
the Evaluation of the Administration for
Community Living’s (ACL) American
Indian, Alaska Natives, and Native
Hawaiian Programs (Older Americans
Act [OAA] Title VI; short title:
Evaluation of the Title VI Programs).
OAA Title VI establishes grants to
Native Americans for nutrition services,
supportive services, and family
caregiver support services. The purpose
of Title VI is ‘‘to promote the delivery
of supportive services, including
nutrition services, to American Indians,
Alaskan Natives, and Native Hawaiians
that are comparable to services provided
under Title III’’ (42 U.S.C. 3057), which
provides nutrition, caregiver and
supportive services to the broader U.S.
population. Title VI is comprised of
three parts; Part A provides nutrition
and supportive services to American
Indians and Alaska Natives, Part B
provides nutrition and supportive
Number of
annual
respondents
services to Native Hawaiians, and Part
C provides caregiver services to any
programs that have Part A/B.
The evaluation will consist of six data
collection activities: (1) Tribal program
staff interviews; (2) tribal program staff
focus groups, (3) tribal elder focus
groups, (4) tribal elder interviews, (5)
tribal caregiver focus groups, and (6)
follow-up tribal program staff interview.
ACL is requesting to revise the
currently approved data collection
under OMB 0985–0059 by removing the
caregiver survey and adding a follow-up
tribal program staff interview. The
proposed revisions also include
removing annual performance reporting
data elements from the currently
approved IC under OMB 0985–0059 to
the OMB approved Title VI Annual
Performance Report under OMB 0985–
0007.
For review and comment on this
proposed information collection
request, please visit the ACL website
https://www.acl.gov/about-acl/publicinput.
Estimated Program Burden: ACL
estimates the burden associated with
this collection of information as follows:
Average
burden
per response
(in hours)
Number of
responses per
respondent
Annual burden
hours
Respondent type
Form name
Program director ............
Program director ............
Program director ............
Other Program Staff ......
Other Program Staff ......
12
12
12
12
12
1
1
1
1
1
1
2
1
1
2
12
24
12
12
20
Tribal elder .....................
Tribal elder .....................
Caregiver .......................
Program staff interview guide ..............................
Program staff focus group moderator guide .......
Program staff follow-up interview guide ..............
Tribal program staff interview guide ....................
Tribal program staff focus group moderator
guide.
Tribal elder focus group moderator guide ...........
Tribal elder interview guide .................................
Tribal caregiver focus group moderator guide ....
100
20
87
1
1
1
2
1
2
200
20
174
Total ........................
..............................................................................
267
........................
........................
474
Dated: May 12, 2020.
Mary Lazare,
Principal Deputy Administrator.
ACTION:
BILLING CODE 4154–01–P
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
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:57 May 18, 2020
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
SUMMARY:
[FR Doc. 2020–10671 Filed 5–18–20; 8:45 am]
AGENCY:
Notice of availability.
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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,
E:\FR\FM\19MYN1.SGM
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Federal Register / Vol. 85, No. 97 / Tuesday, May 19, 2020 / Notices
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
VerDate Sep<11>2014
17:57 May 18, 2020
Jkt 250001
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-201509-18/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
PO 00000
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Fmt 4703
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‘‘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.
E:\FR\FM\19MYN1.SGM
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Federal Register / Vol. 85, No. 97 / Tuesday, May 19, 2020 / Notices
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
VerDate Sep<11>2014
17:57 May 18, 2020
Jkt 250001
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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/
emergency-preparedness-and-response/
mcm-issues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders, 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the National Vaccine Advisory
Committee (NVAC) will hold a virtual
meeting. The meeting will be open to
the public and public comment will be
heard during the meeting.
DATES: The meeting will be held on
Tuesday, June 9, 2020. If needed,
SUMMARY:
PO 00000
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29951
additional sessions and may be added
on Wednesday, June 10, 2020. The
confirmed meeting times and agenda
will be posted on the NVAC website at
https://www.hhs.gov/nvpo/nvac/
meetings/ as soon as they
become available.
ADDRESSES: Instructions regarding
attending this meeting will be posted
online at: https://www.hhs.gov/nvpo/
nvac/meetings/ at least one
week prior to the meeting. Preregistration is required for those who
wish to attend the meeting or participate
in public comment. Please register at
https://www.hhs.gov/nvpo/nvac/
meetings/.
FOR FURTHER INFORMATION CONTACT: Ann
Aikin, Acting Designated Federal
Officer, at the Office of Infectious
Disease and HIV/AIDS Policy, U.S.
Department of Health and Human
Services, Mary E. Switzer Building,
Room L618, 330 C Street SW,
Washington, DC 20024. Email: nvac@
hhs.gov. Telephone: 202–795–7611.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of HHS was mandated to
establish the National Vaccine Program
to achieve optimal prevention of human
infectious diseases through
immunization and to achieve optimal
prevention against adverse reactions to
vaccines. The NVAC was established to
provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program.
During the June 2020 NVAC meeting,
sessions will focus on coronavirus
vaccine development, reimbursement
and changes in billing and coverage
with updates from members. Please note
that agenda items are subject to change,
as priorities dictate. Information on the
final meeting agenda will be posted
prior to the meeting on the NVAC
website: https://www.hhs.gov/nvpo/
nvac/.
Members of the public will have the
opportunity to provide comment at the
NVAC meeting during the public
comment period designated on the
agenda. Public comments made during
the meeting will be limited to three
minutes per person to ensure time is
allotted for all those wishing to speak.
Individuals are also welcome to submit
written comments. Written comments
should not exceed three pages in length.
Individuals submitting written
comments should email their comments
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
