[Federal Register Volume 90, Number 126 (Thursday, July 3, 2025)]
[Notices]
[Pages 29561-29563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-12418]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0308]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Emerging Drug Safety Technology Meeting Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the Emerging Drug Safety Technology Meeting
(EDSTM) Program.
DATES: Either electronic or written comments on the collection of
information must be submitted by September 2, 2025.
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 September 2, 2025. 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-2025-N-0308 for '' Emerging Drug Safety Technology Meeting
Program.'' 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
[[Page 29562]]
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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Emerging Drug Safety Technology Meeting Program
OMB Control Number--New
The pharmaceutical industry is expanding its use of artificial
intelligence (AI) and other emerging technologies across the drug
product lifecycle. FDA is interested in accelerating its understanding
of the research, development, and use of AI and other emerging
technologies in the area of pharmacovigilance, including their
performance characteristics. The EDSTM program is a means by which
applicants and other relevant parties who meet the eligibility and
selection criteria for participation, can meet with the Center for Drug
Evaluation and Research (CDER) to share information about their use of
AI and other emerging technologies, and its potential application in
pharmacovigilance (PV).
The initial phase of the EDSTM program was announced in the Federal
Register on June 11, 2024 (89 FR 49179). CDER has received several
meeting requests and inquiries from the pharmaceutical industry and
other relevant parties, eager to share their latest applications of AI
in PV. The requests represent a diverse set of AI use cases that are of
interest to the Agency. Given the current level of interest in the
program expressed by respondents, FDA anticipates an increase in the
number of meetings granted to expand the Agency's understanding of how
AI-enabled tools and other emerging technologies are being used for
pharmacovigilance.
The goal of the EDSTM program is to facilitate mutual learning and
discussion on the opportunities and challenges with using emerging
technologies in PV. If selected for a meeting, application holders and/
or other relevant parties will meet with CDER staff to discuss their
research, development, and/or use of AI and other emerging technologies
in PV. FDA plans to leverage these learnings to help inform potential
regulatory and policy approaches relating to the use of AI and other
emerging technologies in PV. EDSTMs will collect information for the
following purposes: (1) serve as the central point of contact for
dialogue between industry and CDER on the use of AI and other emerging
technologies in PV; (2) enable knowledge management and transfer within
FDA specific to the context of use for AI or other emerging
technologies in PV; and (3) further thinking about policy and
application of potential regulatory approaches within the landscape of
AI and other emerging technologies.
Respondents include select applicants (applicant) with an approved
new drug application or biologics license application and/or other
relevant parties supporting industry's PV activities (e.g., academia,
contract research organizations (CROs), PV vendors, software
developers). Respondents will provide an initial submission to FDA
detailing their meeting proposal. We estimate this will require 10
hours to prepare. If selected for participation in the EDSTM, the
respondent will need to prepare and deliver a 20-50 minute
presentation, which will require an additional burden of 30 hours. FDA
estimates 25 organizations will submit requests to present at EDSTMs
per year, and a total of 12 meetings will be held per year.
FDA estimates the burden of this collection of information as
follows:
[[Page 29563]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
Activity Number of responses per annual Average burden Total hours
respondents respondent responses per response
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Industry request to give presentation 25 1 25 10 250
at EDSTM.............................
Industry preparing and delivering 12 1 12 30 360
presentation to EDSTM after the
request has been granted.............
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Total............................. 25 .............. 37 .............. 610
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 26, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12418 Filed 7-2-25; 8:45 am]
BILLING CODE 4164-01-P