[Federal Register Volume 88, Number 57 (Friday, March 24, 2023)]
[Notices]
[Pages 17852-17853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-3319]


Framework for the Use of Digital Health Technologies in Drug and 
Biological Product Development; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the publication of a digital health technology (DHT) framework by the 
Center for Drug Evaluation and Research and the Center for Biologics 
Evaluation and Research. This framework is entitled ``Framework for the 
Use of Digital Health Technologies in Drug and Biological Product 
Development.'' This fulfills an FDA commitment under the seventh 
iteration of the Prescription Drug User Fee Act (PDUFA VII) 
reauthorization, incorporated as part of the FDA User Fee 
Reauthorization Act of 2022.

DATES: Either electronic or written comments on the framework must be 
submitted by May 23, 2023.

[[Page 17853]]


ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 23, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2022-N-3319 for ``Framework for the Use of Digital Health 
Technologies in Drug and Biological Product Development.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Ryan Robinson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3342, Silver Spring, MD 20993-0002, 240-
402-9756, [email protected]; or Diane Maloney, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    In connection with PDUFA VII, incorporated as part of the FDA User 
Fee Reauthorization Act of 2022, FDA committed to establish a framework 
that will guide the use of DHT-derived data in regulatory decision-
making for drug and biological products. FDA is publishing the 
``Framework for the Use of Digital Health Technologies in Drug and 
Biological Product Development'' to satisfy the PDUFA VII commitment.
    DHTs may provide opportunities for more efficient drug development. 
DHTs and DHT-derived data can be important tools in supporting timely 
access to safe, effective, and innovative new medicines for patients. 
Despite the potential advantages of DHTs, many challenges arise when 
incorporating DHTs and DHT-derived data into regulatory decision-
making. This framework outlines a multifaceted approach to 
collaboratively address these challenges with stakeholders. Through 
these joint efforts, FDA intends to advance the development of drugs 
and promote the public health.
    The framework will guide activities such as (1) defining objectives 
for workshops and demonstration projects, (2) developing methodologies 
for evaluating DHTs proposed as measuring key (primary or important 
secondary) endpoints or other important measures (e.g., for safety 
monitoring or baseline characterization) in clinical trials, (3) 
managing submissions with extensive and continuous data (e.g., in order 
to develop acceptable approaches to capture adverse events), and (4) 
developing a standardized process for data management and analysis of 
large datasets from DHTs.

II. Electronic Access

    Persons with access to the internet may obtain the ``Framework for 
the Use of Digital Health Technologies in Drug and Biological Product 
Development'' at https://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development.

    Dated: March 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06066 Filed 3-23-23; 8:45 am]
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