[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Notices]
[Pages 69351-69352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25166]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Request for Information (RFI) on Data Collection for Emergency 
Clinical Trials and Interoperability Pilot; Extension of Comment Period

AGENCY: White House Office of Science and Technology Policy (OSTP).

ACTION: Request for Information (RFI) on Data Collection for Emergency 
Clinical Trials and Interoperability Pilot; extension of comment 
period.

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SUMMARY: On October 28, 2022, the Office of Science and Technology 
Policy (OSTP) published in the Federal Register a document entitled 
``Request for Information (RFI) on Data Collection for Emergency 
Clinical Trials and Interoperability Pilot.'' This RFI, issued by OSTP 
in partnership with the Office of the National Coordinator for Health 
Information Technology (ONC), invited comments on how to optimize data 
collection for clinical trials carried out across a range of 
institutions and sites, both in emergency settings and in the pre-
emergency phase. OSTP and ONC are seeking input on viable technical 
strategies to distribute clinical trial protocols and capture clinical 
trial data using common application programming interfaces (APIs). OSTP 
and ONC also seek information about whether there is value in a pilot 
or demonstration project to operationalize data capture in the near 
term, for

[[Page 69352]]

example within 6-12 months of the close of comments on the RFI. 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 Data Collection for Emergency 
Clinical Trials and Interoperability Pilot,'' published on October 28, 
2022 (87 FR 65259), is extended from December 27, 2022 to January 27, 
2023.

ADDRESSES: Comments submitted in response to 87 FR 65259 should be 
submitted electronically to 
[email protected] and should include ``Data 
Collection for 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 65259) 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 10 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 health information technology (health 
IT) companies, app developers, clinical trial designers, and users of 
health IT products. 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 65259). 
Please be aware that comments submitted in response to this RFI (87 FR 
65259) 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 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.\1\ On 
October 28, 2022, OSTP, in partnership with ONC, published in the 
Federal Register a document inviting comments on how to optimize data 
collection for clinical trials carried out across a range of 
institutions and sites, both in emergency settings and in the pre-
emergency phase (87 FR 65259). OSTP and ONC are seeking input on viable 
technical strategies to distribute clinical trial protocols and capture 
clinical trial data using common APIs. OSTP and ONC also seek 
information about whether there is value in a pilot or demonstration 
project to operationalize data capture in the near term, for example 
within 6-12 months of the close of comments on the RFI. The RFI was 
issued to seek input from a broad array of stakeholders on a range of 
topics related to data capture in the clinical trials context, 
including ways in which ONC standards and frameworks for 
interoperability might be leveraged to further the goals of the RFI. 
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.
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    \1\ See Notice of Request for Information (RFI) on Clinical 
Research Infrastructure and Emergency Clinical Trials, published 
October 26, 2022 (87 FR 64821).

    Submitted by the White House Office of Science and Technology 
Policy on November 15, 2022.
Stacy Murphy,
Operations Manager.
[FR Doc. 2022-25166 Filed 11-17-22; 8:45 am]
BILLING CODE 3270-F1-P