FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

Closed Special Notice Posted Oct 3, 2024

This opportunity was awarded. See the award notice from Nov 24, 2025.

Solicitation number: FDABAA-25-00123
Agency: FDA Office of Acquisition and Grant Services Food and Drug Administration, Department of Health and Human Services
Responses due: Mar 4, 2025, 11:59 PM ET
Set-aside: No set-aside

Opportunity facts

NAICS code: 541714 Research and Development in Biotechnology (except Nanobiotechnology)
PSC: AJ11 General Science And Technology R&D Services; General Science And Technology; Basic Research
Place of performance: Silver Spring, Maryland 20993, United States
Points of contact: Ian Weiss ian.weiss@fda.hhs.gov (301) 796-5728

Notice details come from SAM.gov. Updated Feb 26, 2025.

About this opportunity

Written by GovTribe AI · Feb 26, 2025

The US Food and Drug Administration (FDA), an agency within the Department of Health and Human Services, has issued a Fiscal Year 2025 Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. This special notice solicits basic and applied research and development proposals to support regulatory science and innovation across multiple research domains. The BAA is designed to advance scientific knowledge in specific research areas that serve the FDA's mission of protecting and promoting national health. Published on October 3, 2024, the BAA invites proposals from various research organizations and institutions. The announcement follows the Federal Acquisition Regulation (FAR) guidelines for research acquisition.

The BAA focuses on three primary research charges: modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and enhancing public health preparedness and response. Eligible offerors include private sector organizations, Federally Funded Research and Development Centers (FFRDCs), and academic institutions, with small businesses strongly encouraged to participate. Contractors must submit proposals through a two-stage process, with an optional early concept paper due by November 8, 2024, and full proposals required by February 24, 2025 at 11:59 PM EST. The FDA anticipates multiple awards using procurement contracts, with a preference for cost reimbursement over firm-fixed-price contracts. A virtual BAA Day event scheduled for November 17, 2024, will provide additional information about the application process and research priorities. Proposals will be evaluated based on scientific/technical merit, program relevance, and the capabilities and experience of the offeror.

Notice text

7 versions

As posted on SAM.gov.

Update #7 · Latest · Feb 26, 2025

Amendment 05 - The BAA Notice has been updated to version 6 with various changes throughout.

Amendment 04 - The BAA Notice has been updated to version 5 with various changes throughout. Table 1 and attachment 5 have also been updated and included seperately. The response date has been changed to March 04th at 1159 PM EST.

Amendment 03 - The BAA Notice has been updated to version 4 with various changes throughout, Table 1 and attachments 4 and 5 have also been updated and included seperately.

Amendment 02 - The BAA Notice has been updated to version 3 with various changes throughout.

Amendment 01 - The BAA Notice has been updated to version 2 with various changes throughout, and table 1 has been updated and included seperately.

In accordance with FAR 6.102(d)(2) and 35.016, the US Food and Drug Administration (FDA) solicits for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). Research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. Proposals submitted under this announcement are not limited solely to the PSC code "AJ11" specified in this announcement.

FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us to learn more about the FY 2025 BAA, and how to apply.

Save the date for the 2024 FDA Broad Agency Announcement (BAA) Day! November 14th, 2024. BAA Day for FY25 2024 will be hosted on November 14th, 2024, as a virtual only event and will provide an opportunity to learn more about the application process and FDA’s priorities for regulatory research.