Request for Information; Clinical Research Infrastructure and Emergency Clinical Trials, 71368 [2022-25163]
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71368
Federal Register / Vol. 87, No. 224 / Tuesday, November 22, 2022 / Notices
OFFICE OF SCIENCE AND
TECHNOLOGY POLICY
Request for Information; Clinical
Research Infrastructure and
Emergency Clinical Trials
White House Office of Science
and Technology Policy.
ACTION: Request for information (RFI) on
clinical research infrastructure and
emergency clinical trials; extension of
comment period.
AGENCY:
On October 26, 2022, the
Office of Science and Technology Policy
(OSTP) published in the Federal
Register a document entitled ‘‘Request
for Information (RFI) on Clinical
Research Infrastructure and Emergency
Clinical Trials.’’ This RFI invited
comments on improving the U.S.
clinical trials infrastructure and in
particular, our ability to carry out
emergency clinical trials. In accordance
with the 2022 National Biodefense
Strategy for Countering Biological
Threats, Enhancing Pandemic
Preparedness, and Achieving Global
Health Security (National Biodefense
Strategy) and the American Pandemic
Preparedness Plan (AP3), OSTP, in
partnership with the National Security
Council (NSC), is leading efforts to
ensure that coordinated and large-scale
clinical trials can be efficiently carried
out across a range of institutions and
sites to address outbreaks of disease and
other emergencies. In response to
requests by prospective commenters
that they would benefit from additional
time to adequately consider and
respond to the RFI, OSTP has
determined that an extension of the
comment period until January 27, 2023
is appropriate.
DATES: The end of the comment period
for the document entitled ‘‘Request for
Information (RFI) on Clinical Research
Infrastructure and Emergency Clinical
Trials,’’ published on October 26, 2022
(87 FR 64821), is extended from
December 27, 2022 to January 27, 2023.
ADDRESSES: Comments submitted in
response to 87 FR 64821 should be
submitted electronically to
emergencyclinicaltrials@ostp.eop.gov
and should include ‘‘Emergency
Clinical Trials RFI’’ in the subject line
of the email. Due to time constraints,
mailed paper submissions will not be
accepted, and electronic submissions
received after the deadline cannot be
ensured to be incorporated or taken into
consideration.
Instructions: Response to this RFI (87
FR 64821) is voluntary. Each responding
entity (individual or organization) is
requested to submit only one response.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:11 Nov 21, 2022
Jkt 259001
Please feel free to respond to one or as
many prompts as you choose. Please be
concise with your submissions, which
must not exceed 8 pages in 12-point or
larger font, with a page number on each
page. Responses should include the
name of the person(s) or organization(s)
filing the comment.
OSTP invites input from all
stakeholders, including members of the
public, representing all backgrounds
and perspectives. In particular, OSTP is
interested in input from research
institutions, clinical trialists, health care
providers interested in clinical research,
contract research organizations (CROs)
and other clinical trial service
providers, pharmaceutical and
biotechnology companies, and
community health care organizations.
Please indicate which of these
stakeholder types, or what other
description, best fits you as a
respondent. If a comment is submitted
on behalf of an organization, the
individual respondent’s role in the
organization may also be provided on a
voluntary basis.
Comments containing references,
studies, research, and other empirical
data that are not widely published
should include copies or electronic
links of the referenced materials. No
business proprietary information,
copyrighted information, or personally
identifiable information should be
submitted in response to this RFI (87 FR
64821). Please be aware that comments
submitted in response to this RFI (87 FR
64821) may be posted on OSTP’s
website or otherwise released publicly.
In accordance with FAR 15.202(3),
responses to this notice are not offers
and cannot be accepted by the Federal
Government to form a binding contract.
Additionally, those submitting
responses are solely responsible for all
expenses associated with response
preparation.
FOR FURTHER INFORMATION CONTACT: For
additional information, please direct
questions to Grail Sipes at 202–456–
4444 or emergencyclinicaltrials@
ostp.eop.gov.
SUPPLEMENTARY INFORMATION: In
accordance with the 2022 National
Biodefense Strategy and the American
Pandemic Preparedness Plan (AP3),
OSTP, in partnership with NSC, is
leading efforts to ensure that
coordinated and large-scale clinical
trials can be efficiently carried out
across a range of institutions and sites
to address outbreaks of disease and
other emergencies. On October 26, 2022,
OSTP published in the Federal Register
a document inviting comments on
improving the U.S. clinical trials
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
infrastructure and in particular, our
ability to carry out emergency clinical
trials (87 FR 64821). The RFI was issued
to seek input from a broad array of
stakeholders on topics including the
potential establishment of a U.S.-level
governance structure; outreach to a wide
range of institutions, clinical trial
networks, and other potential trial sites
that can participate in emergency
research, both domestically and
internationally; and ways to expand
clinical research into underserved
communities, as well as increase
diversity among both trial participants
and clinical trial investigators. The
document stated that the comment
period would close on December 27,
2022. OSTP has received requests to
extend the comment period. An
extension of the comment period will
provide additional opportunity for the
public to consider the RFI and prepare
comments to address the topics listed
therein. Therefore, OSTP is extending
the end of the comment period for the
RFI from December 27, 2022 to January
27, 2023.
Submitted by the White House Office of
Science and Technology Policy on November
15, 2022.
Stacy Murphy,
Operations Manager.
[FR Doc. 2022–25163 Filed 11–21–22; 8:45 am]
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PEARL, LLC; Notice of Filing and
Immediate Effectiveness of a Proposed
Rule Change To Amend Rule 2614(f),
Self-Trade Protection Modifiers
November 16, 2022.
Pursuant to the provisions of Section
19(b)(1) of the Securities Exchange Act
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on November 7, 2022, MIAX PEARL,
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CFR 240.19b–4.
E:\FR\FM\22NON1.SGM
22NON1
]]>Agencies
[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Page 71368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25163]
[[Page 71368]]
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OFFICE OF SCIENCE AND TECHNOLOGY POLICY
Request for Information; Clinical Research Infrastructure and
Emergency Clinical Trials
AGENCY: White House Office of Science and Technology Policy.
ACTION: Request for information (RFI) on clinical research
infrastructure and emergency clinical trials; extension of comment
period.
-----------------------------------------------------------------------
SUMMARY: On October 26, 2022, the Office of Science and Technology
Policy (OSTP) published in the Federal Register a document entitled
``Request for Information (RFI) on Clinical Research Infrastructure and
Emergency Clinical Trials.'' This RFI invited comments on improving the
U.S. clinical trials infrastructure and in particular, our ability to
carry out emergency clinical trials. In accordance with the 2022
National Biodefense Strategy for Countering Biological Threats,
Enhancing Pandemic Preparedness, and Achieving Global Health Security
(National Biodefense Strategy) and the American Pandemic Preparedness
Plan (AP3), OSTP, in partnership with the National Security Council
(NSC), is leading efforts to ensure that coordinated and large-scale
clinical trials can be efficiently carried out across a range of
institutions and sites to address outbreaks of disease and other
emergencies. In response to requests by prospective commenters that
they would benefit from additional time to adequately consider and
respond to the RFI, OSTP has determined that an extension of the
comment period until January 27, 2023 is appropriate.
DATES: The end of the comment period for the document entitled
``Request for Information (RFI) on Clinical Research Infrastructure and
Emergency Clinical Trials,'' published on October 26, 2022 (87 FR
64821), is extended from December 27, 2022 to January 27, 2023.
ADDRESSES: Comments submitted in response to 87 FR 64821 should be
submitted electronically to [email protected] and
should include ``Emergency Clinical Trials RFI'' in the subject line of
the email. Due to time constraints, mailed paper submissions will not
be accepted, and electronic submissions received after the deadline
cannot be ensured to be incorporated or taken into consideration.
Instructions: Response to this RFI (87 FR 64821) is voluntary. Each
responding entity (individual or organization) is requested to submit
only one response. Please feel free to respond to one or as many
prompts as you choose. Please be concise with your submissions, which
must not exceed 8 pages in 12-point or larger font, with a page number
on each page. Responses should include the name of the person(s) or
organization(s) filing the comment.
OSTP invites input from all stakeholders, including members of the
public, representing all backgrounds and perspectives. In particular,
OSTP is interested in input from research institutions, clinical
trialists, health care providers interested in clinical research,
contract research organizations (CROs) and other clinical trial service
providers, pharmaceutical and biotechnology companies, and community
health care organizations. Please indicate which of these stakeholder
types, or what other description, best fits you as a respondent. If a
comment is submitted on behalf of an organization, the individual
respondent's role in the organization may also be provided on a
voluntary basis.
Comments containing references, studies, research, and other
empirical data that are not widely published should include copies or
electronic links of the referenced materials. No business proprietary
information, copyrighted information, or personally identifiable
information should be submitted in response to this RFI (87 FR 64821).
Please be aware that comments submitted in response to this RFI (87 FR
64821) may be posted on OSTP's website or otherwise released publicly.
In accordance with FAR 15.202(3), responses to this notice are not
offers and cannot be accepted by the Federal Government to form a
binding contract. Additionally, those submitting responses are solely
responsible for all expenses associated with response preparation.
FOR FURTHER INFORMATION CONTACT: For additional information, please
direct questions to Grail Sipes at 202-456-4444 or
[email protected].
SUPPLEMENTARY INFORMATION: In accordance with the 2022 National
Biodefense Strategy and the American Pandemic Preparedness Plan (AP3),
OSTP, in partnership with NSC, is leading efforts to ensure that
coordinated and large-scale clinical trials can be efficiently carried
out across a range of institutions and sites to address outbreaks of
disease and other emergencies. On October 26, 2022, OSTP published in
the Federal Register a document inviting comments on improving the U.S.
clinical trials infrastructure and in particular, our ability to carry
out emergency clinical trials (87 FR 64821). The RFI was issued to seek
input from a broad array of stakeholders on topics including the
potential establishment of a U.S.-level governance structure; outreach
to a wide range of institutions, clinical trial networks, and other
potential trial sites that can participate in emergency research, both
domestically and internationally; and ways to expand clinical research
into underserved communities, as well as increase diversity among both
trial participants and clinical trial investigators. The document
stated that the comment period would close on December 27, 2022. OSTP
has received requests to extend the comment period. An extension of the
comment period will provide additional opportunity for the public to
consider the RFI and prepare comments to address the topics listed
therein. Therefore, OSTP is extending the end of the comment period for
the RFI from December 27, 2022 to January 27, 2023.
Submitted by the White House Office of Science and Technology
Policy on November 15, 2022.
Stacy Murphy,
Operations Manager.
[FR Doc. 2022-25163 Filed 11-21-22; 8:45 am]
BILLING CODE 3270-F9-P
