[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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