FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

Project ID: FDABAA-26-00123 FederalOpportunitiesSpecial Notice
Overview
AgencyFDA Office of Acquisition and Grant Services
Deadline02/24/26
Posted01/06/26
Estimated Value$1,000,000 - $50,000,000 (AI estimate)
Set AsideNone
NAICS541714 - Research and Development in Biotechnology (except Nanobiotechnology)
PSCAJ11 - General Science And Technology R&D Services; General Science And Technology; Basic Research
LocationSilver Spring, MD 20993 United States
Description
Primary Latest Change

Posted: Nov. 21, 2025, 8:57 a.m. EST 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.

2 (Newest Update)

Posted: Dec. 16, 2025, 1:34 p.m. EST Amendment 01 - Updated the announcement document to version 2.0. Changes are highlighted throughout the document. 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.

3: Posted: Jan. 6, 2026, 8:54 a.m. EST Amendment 02 - Save the date! the FY26 Virtual BAA day - 20 January 2026! https://www.fda.gov/science-research/advancing-regulatory-science/2026-fda-broad-agency-announcement-day-01202026 Amendment 01 - Updated the announcement document to version 2.0. Changes are highlighted throughout the document. 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.
Current: Posted: Jan. 16, 2026, 7:42 a.m. EST Amendment 03 - Updated the announcement document to version 2.0. Changes are highlighted throughout the document. Amendment 02 - Save the date! the FY26 Virtual BAA day - 20 January 2026! https://www.fda.gov/science-research/advancing-regulatory-science/2026-fda-broad-agency-announcement-day-01202026 Amendment 01 - Updated the announcement document to version 2.0. Changes are highlighted throughout the document. 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.
Contacts
Contact nameIan Weiss
Contact emailian.weiss@fda.hhs.gov
Contact phone(301) 796-5728
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