# 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.
**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 *https://www.reginfo.gov/public/do/PRAMain.* 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, *[email protected].*
**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) <sup>1</sup> 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:
| Activity | Number of respondents | Number of | Total | Average burden per response | Total hours |
| --- | --- | --- | --- | --- | --- |
| Industry request to give presentation at EDSTM | 25 | 1 | 25 | 10 | 250 |
| Industry preparing and delivering presentation at EDSTM after the request has been granted | 12 | 1 | 12 | 30 | 360 |
| Total | | | 37 | | 610 |
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.