Notice2022-25163
Request for Information; Clinical Research Infrastructure and Emergency Clinical Trials
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 22, 2022
Issuing agencies
Science and Technology Policy Office
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 224 (Tuesday, November 22, 2022)</title>
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[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Page 71368]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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 <a href="/cdn-cgi/l/email-protection#2d4840485f4a48434e544e414443444e4c41595f444c415e6d425e595d0348425d034a425b"><span class="__cf_email__" data-cfemail="aacfc7cfd8cdcfc4c9d3c9c6c3c4c3c9cbc6ded8c3cbc6d9eac5d9deda84cfc5da84cdc5dc">[email protected]</span></a> 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
<a href="/cdn-cgi/l/email-protection#5c3931392e3b39323f253f303532353f3d30282e353d302f1c332f282c7239332c723b332a"><span class="__cf_email__" data-cfemail="482d252d3a2f2d262b312b242126212b29243c3a2129243b08273b3c38662d2738662f273e">[email protected]</span></a>.
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
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