Institutional Review Board Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency; Guidance for Institutional Review Boards and Clinical Investigators; Availability, 35311-35313 [2020-12429]
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Federal Register / Vol. 85, No. 111 / Tuesday, June 9, 2020 / Notices
electing accelerated relocation, the
eligible space station operators
voluntarily commit to adhere to the
requirements, policies, and procedures
established by the Commission in the
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Each of the eligible operators filed an
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Federal Communications Commission.
Amy Brett,
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Telecommunications Bureau.
[FR Doc. 2020–12471 Filed 6–8–20; 8:45 am]
BILLING CODE 6712–01–P
FEDERAL COMMUNICATIONS
COMMISSION
[CC Docket No. 92–237; DA 20–563]
Next Meetings of the North American
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ACTION: Notice.
AGENCY:
In this document, the
Commission released a public notice
announcing the next meetings of the
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DATES: Tuesday, July 14, 2020. The
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and Jordan Reth, Deputy DFO, at
jordan.reth@fcc.gov or 202–418–1418.
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SUMMARY:
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[FR Doc. 2020–12376 Filed 6–8–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1414]
Institutional Review Board Review of
Individual Patient Expanded Access
Requests for Investigational Drugs and
Biological Products During the COVID–
19 Public Health Emergency; Guidance
for Institutional Review Boards and
Clinical Investigators; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Institutional Review Board (IRB)
Review of Individual Patient Expanded
Access Requests for Investigational
Drugs and Biological Products During
the COVID–19 Public Health
Emergency.’’ To facilitate patient access
to investigational drugs for treating
COVID–19, FDA is issuing this guidance
to provide recommendations regarding
the key factors and procedures IRBs
should consider when reviewing
requests—including when such reviews
are conducted by a single-member of an
IRB—for individual patient expanded
access. Given the public health
emergency presented by COVID–19, this
guidance 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 June 9, 2020. The guidance
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:
SUMMARY:
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
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Federal Register / Vol. 85, No. 111 / Tuesday, June 9, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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–1414 for ‘‘Institutional Review
Board (IRB) Review of Individual
Patient Expanded Access Requests for
Investigational Drugs and Biological
Products During the COVID–19 Public
Health Emergency.’’ 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
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Jkt 250001
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:
Juanita Marner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340,
Silver Spring, MD 20993–0002, 301–
796–8078.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Institutional Review Board (IRB)
Review of Individual Patient Expanded
Access Requests for Investigational
Drugs and Biological Products During
the COVID–19 Public Health
Emergency.’’ There is currently an
outbreak of respiratory disease caused
by a novel coronavirus. The virus has
been named SARS–CoV–2, and the
PO 00000
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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.
FDA is issuing this guidance to
provide recommendations regarding the
key factors and procedures IRBs,
including for reviews conducted by a
single-member, should consider when
reviewing individual patient expanded
access submissions for patient access to
investigational drugs for treating
COVID–19.
Under FDA regulations, three
categories of expanded access are
available: Expanded access for
individual (also known as single)
patients, including for emergency use;
expanded access for intermediate-size
patient populations; and ‘‘treatment’’
expanded access for larger populations.
This guidance applies to individual
patient expanded access requests, as
outlined in 21 CFR 312.310. The
recommendations in this guidance are
intended to assist IRBs in conducting
efficient reviews of individual patient
expanded access requests.
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 practices
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.
247d(a)(2)). However, the
recommendations described in the
guidance are expected to assist the
Agency more broadly in its continued
efforts to facilitate access to drugs
through expanded access 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
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Federal Register / Vol. 85, No. 111 / Tuesday, June 9, 2020 / Notices
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 ‘‘Institutional
Review Board (IRB) Review of
Individual Patient Expanded Access
Requests for Investigational Drugs and
Biological Products During the COVID–
19 Public Health Emergency.’’ 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
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
21 CFR part 312 have been approved
under OMB control number 0910–0014;
the collections of information relating to
the protection of human subjects and
IRBs have been approved under OMB
control number 0910–0130; and the
collections of information in FDA’s
guidance for industry on ‘‘Individual
Patient Expanded Access Applications:
Form FDA 3926’’ have been approved
under OMB control number 0910–0814.
III. Electronic Access
jbell on DSKJLSW7X2PROD with NOTICES
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: June 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–12429 Filed 6–8–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Tick-Borne Disease
Working Group
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As required by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Tick-Borne Disease Working
Group (TBDWG) will hold a virtual
meeting. The meeting will be open to
the public. For this meeting, the
TBDWG will review the draft 2020
report to the HHS Secretary and
Congress and review and approve
graphics and images for the report. The
2020 report will address ongoing tickborne disease research, including
research related to causes, prevention,
treatment, surveillance, diagnosis,
diagnostics, and interventions for
individuals with tick-borne diseases;
advances made pursuant to such
research; federal activities related to
tick-borne diseases; and gaps in tickborne disease research.
DATES: The meeting will be held online
via webcast on July 8, 2020, from 9:00
a.m. to 5:30 p.m. ET (times are tentative
and subject to change). The confirmed
times and agenda items for the meeting
will be posted on the TBDWG webpage
at https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
2020-7-8/ when this
information becomes available.
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the TBDWG; Office of Infectious
Disease and HIV/AIDS Policy, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services, Mary E. Switzer Building, 330
C Street SW, Suite L600, Washington,
DC 20024. Email: tickbornedisease@
hhs.gov; Phone: 202–795–7608.
SUPPLEMENTARY INFORMATION: Please
register for the virtual meeting at
https://kauffmaninc.adobeconnect.com/
tbdwg_july2020/event/event_info.html.
After registering, you will receive an
email confirmation with a personalized
link to access the webcast on July 8.
The public will have an opportunity
to present their views to the TBDWG
orally during the meeting’s public
comment session or by submitting a
written public comment. Comments
should be pertinent to the meeting
discussion. Persons who wish to
provide verbal or written public
SUMMARY:
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35313
comment should review instructions at
https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
2020-7-8/ and respond by
midnight June 24, 2020, ET. Verbal
comments will be limited to three
minutes each to accommodate as many
speakers as possible during the 30
minute session. Written public
comments will be accessible to the
public on the TBDWG web page prior to
the meeting.
Background and Authority: The TickBorne Disease Working Group was
established on August 10, 2017, in
accordance with Section 2062 of the
21st Century Cures Act, and the Federal
Advisory Committee Act, 5 U.S.C. App.,
as amended, to provide expertise and
review federal efforts related to all tickborne diseases, to help ensure
interagency coordination and minimize
overlap, and to examine research
priorities. The TBDWG is required to
submit a report to the HHS Secretary
and Congress on their findings and any
recommendations for the federal
response to tick-borne disease every two
years.
Dated: May 20, 2020.
James J. Berger,
Designated Federal Officer, Tick-Borne
Disease Working Group, Office of Infectious
Disease and HIV/AIDS Policy.
[FR Doc. 2020–12432 Filed 6–8–20; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–4040–0018]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 9, 2020.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: Ed
Calimag, ed.calimag@hhs.gov or (202)
690–7569. When submitting comments
or requesting information, please
include the document identifier 4040–
0018–30D and project title for reference.
SUMMARY:
E:\FR\FM\09JNN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 111 (Tuesday, June 9, 2020)]
[Notices]
[Pages 35311-35313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12429]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1414]
Institutional Review Board Review of Individual Patient Expanded
Access Requests for Investigational Drugs and Biological Products
During the COVID-19 Public Health Emergency; Guidance for Institutional
Review Boards and Clinical Investigators; 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
``Institutional Review Board (IRB) Review of Individual Patient
Expanded Access Requests for Investigational Drugs and Biological
Products During the COVID-19 Public Health Emergency.'' To facilitate
patient access to investigational drugs for treating COVID-19, FDA is
issuing this guidance to provide recommendations regarding the key
factors and procedures IRBs should consider when reviewing requests--
including when such reviews are conducted by a single-member of an
IRB--for individual patient expanded access. Given the public health
emergency presented by COVID-19, this guidance 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 June 9, 2020. The guidance 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, 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
[[Page 35312]]
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-1414 for ``Institutional Review Board (IRB) Review of
Individual Patient Expanded Access Requests for Investigational Drugs
and Biological Products During the COVID-19 Public Health Emergency.''
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: Juanita Marner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-8078.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Institutional Review Board (IRB) Review of Individual
Patient Expanded Access Requests for Investigational Drugs and
Biological Products During the COVID-19 Public Health Emergency.''
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.
FDA is issuing this guidance to provide recommendations regarding
the key factors and procedures IRBs, including for reviews conducted by
a single-member, should consider when reviewing individual patient
expanded access submissions for patient access to investigational drugs
for treating COVID-19.
Under FDA regulations, three categories of expanded access are
available: Expanded access for individual (also known as single)
patients, including for emergency use; expanded access for
intermediate-size patient populations; and ``treatment'' expanded
access for larger populations. This guidance applies to individual
patient expanded access requests, as outlined in 21 CFR 312.310. The
recommendations in this guidance are intended to assist IRBs in
conducting efficient reviews of individual patient expanded access
requests.
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 practices 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. 247d(a)(2)).
However, the recommendations described in the guidance are expected to
assist the Agency more broadly in its continued efforts to facilitate
access to drugs through expanded access 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
[[Page 35313]]
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 ``Institutional Review Board (IRB) Review of
Individual Patient Expanded Access Requests for Investigational Drugs
and Biological Products During the COVID-19 Public Health Emergency.''
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
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information relating
to the protection of human subjects and IRBs have been approved under
OMB control number 0910-0130; and the collections of information in
FDA's guidance for industry on ``Individual Patient Expanded Access
Applications: Form FDA 3926'' have been approved under OMB control
number 0910-0814.
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: June 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12429 Filed 6-8-20; 8:45 am]
BILLING CODE 4164-01-P
