Notice2026-03093
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emerging Drug Safety Technology Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 18, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 91 Issue 32 (Wednesday, February 18, 2026)</title>
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[Federal Register Volume 91, Number 32 (Wednesday, February 18, 2026)]
[Notices]
[Pages 7501-7502]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03093]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0308]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Emerging Drug Safety
Technology Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by March 20, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Emerging Drug Safety Technology Program.''
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-1244,
<a href="/cdn-cgi/l/email-protection#227270637156434444624446430c4a4a510c454d54"><span class="__cf_email__" data-cfemail="b1e1e3f0e2c5d0d7d7f1d7d5d09fd9d9c29fd6dec7">[email protected]</span></a>.
[[Page 7502]]
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Emerging Drug Safety Technology Program
OMB Control Number 0910-New
FDA has a longstanding commitment to ensure medicines marketed in
the United States are safe through continued surveillance and research
following approval. In the postmarket setting, regulated industry (per
21 CFR 314.80, 314.98, and 600.80) is obligated to review all adverse
drug experience information received or otherwise obtained and submit
reports to FDA. Both industry and regulatory authorities face
challenges with timely and efficient collection, processing, and
evaluation of single and aggregate patient safety data compounded by
ever-increasing case volumes. Advances in emerging technology have the
potential to address some of these challenges by creating more
efficiencies within a pharmacovigilance (PV) surveillance system. The
pharmaceutical industry is expanding its use of artificial intelligence
(AI) and other emerging technologies across the drug product lifecycle,
including PV.
FDA is interested in accelerating its understanding of how AI-
enabled tools and other emerging technologies are being used for PV,
their associated risks and benefits, model evaluation processes
(including performance characteristics), and barriers to
implementation. The Emerging Drug Safety Technology Program (EDSTP) \1\
is a means by which applicants and/or other relevant parties who meet
the eligibility and selection criteria for participation can meet with
the Center for Drug Evaluation and Research (CDER), through Emerging
Drug Safety Technology Meetings (EDSTMs), to share information about
their use of AI and other emerging technologies, and their potential
applications in post-market PV.
The initial phase of the EDSTP was announced in the Federal
Register on June 11, 2024 (89 FR 49179). Since then, CDER has received
numerous meeting requests and inquiries from the pharmaceutical
industry and other relevant parties, seeking to discuss their latest
applications of emerging technologies in PV. The requests represent a
diverse set of 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 in PV.
The purpose of the EDSTMs is to facilitate discussion and mutual
learning of the pharmaceutical industry's application of these
technologies in PV. If selected for a meeting, participants 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
around the use of AI and other emerging technologies in PV.
The EDSTP 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 applicants with at least one approved
application regulated by CDER and/or other relevant parties supporting
industry's PV activities (e.g., academia, contract research
organizations (CROs), PV vendors, software developers) who develop,
leverage, or intend to leverage AI or other emerging technologies that
can be used to satisfy the postmarketing reporting requirements in 21
CFR 314.80, 314.98, and 600.80.
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 an 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
12 meetings will be held per year.
In the Federal Register of July 3, 2025 (90 FR 29561) FDA published
a 60-day notice soliciting comment on the proposed collection of
information. FDA received one comment. The submitter provided
supportive comments of the FDA's EDSTP. However, the one comment was
not responsive to the four collection of information topics solicited
and therefore will not be further discussed in this document.
FDA estimates the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
Activity Number of responses per annual burden per Total
respondents respondent responses response hours
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Industry request to give presentation at EDSTM... 25 1 25 10 250
Industry preparing and delivering presentation at 12 1 12 30 360
EDSTM after the request has been granted........
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Total........................................ ............ .............. 37 ........... 610
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03093 Filed 2-17-26; 8:45 am]
BILLING CODE 4164-01-P
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