[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7738-7739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0043]


Understanding Priorities for the Development of Digital Health 
Technologies To Support Clinical Trials for Drug Development and 
Review; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Understanding Priorities for the 
Development of Digital Health Technologies To Support Clinical Trials 
for Drug Development and Review.'' Convened by the Duke-Robert J. 
Margolis, MD Center for Health Policy and supported by a cooperative 
agreement between FDA and Duke-Margolis, the purpose of the public 
workshop is to understand the priorities for the development of Digital 
Health Technologies (DHTs) to support clinical drug trials, including 
accessibility, diversity, and clinical outcome measures using DHTs. 
Additionally, this public workshop meets a Prescription Drug User Fee 
Amendments (PDUFA VII) commitment to convene the first of a series of 
public workshops by the end of the second quarter (Q2), fiscal year 
(FY) 2023.

DATES: The public workshop will be held virtually on March 28, 2023, 
and March 29, 2023, from 1 p.m. to 5 p.m., Eastern Time. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held virtually using the Zoom

[[Page 7739]]

Platform. The link for the public workshop will be sent to registrants 
upon registration.

FOR FURTHER INFORMATION CONTACT: Capt. Dianne Paraoan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301-796-
3161, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The seventh iteration of the Prescription Drug User Fee Amendments 
(PDUFA VII), included as part of the FDA User Fee Reauthorization Act 
of 2022, highlights the goals of facilitating timely access to safe, 
effective, and innovative new medicines for patients. The commitments 
in the PDUFA Reauthorization Performance Goals and Procedures Fiscal 
Years 2023 Through 2027 document (available at: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027) focus on activities to enhance the use of DHTs to support 
drug development and review, including working with the Digital Health 
Center of Excellence.
    To meet a PDUFA VII commitment, FDA agreed to convene a series of 
five public workshops with key stakeholders including patients, 
biopharmaceutical companies, DHT companies, and academia to gather 
input into issues related to the use of DHTs in regulatory decision-
making. The objective of this first workshop is to understand 
priorities for the development of DHTs to support clinical drug trials, 
including the potential for DHTs to increase clinical trial 
accessibility and diversity, as well as the use of DHTs to capture 
clinical outcome measures. The public workshop scheduled for March 28 
and 29, 2023, fulfills the commitment to convene the first of a series 
of five public workshops by the end of Q2, FY 2023.

II. Topics for Discussion at the Public Workshop

    At the public workshop, FDA plans to discuss with stakeholders 
priorities and challenges for the development of DHTs to support 
clinical drug trials, including, but not limited to:
     improving participant access, increasing diversity, and 
facilitating engagement through remote trial-related measurements;
     understanding patient and industry perspectives;
     understanding opportunities for remote data acquisition 
directly from trial participants; and
     using DHTs to capture clinical outcomes measures.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://duke.is/pzkwx. Please provide complete 
contact information for each attendee, including name, title, 
affiliation, and email.
    Registration is free and people interested in attending this public 
workshop must register to receive a link to the meeting. Registrants 
will receive a confirmation email after they register.
    If you need special accommodations, please contact 
[email protected] no later than March 7, 2023. Please note, 
closed captioning will be available automatically.

    Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02479 Filed 2-3-23; 8:45 am]
BILLING CODE 4164-01-P