[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.

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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 [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