FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
Closed Special Notice Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- FDABAA-26-00123
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- 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
Notice details come from SAM.gov. Updated .
About this opportunity
The FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science is a solicitation issued by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services. Posted on November 21, 2025, with multiple amendments through January 16, 2026, this Special Notice seeks basic and applied research and development proposals to support regulatory science and innovation. The announcement operates under FAR 6.102(d)(2) and 35.016 and invites extramural research from eligible organizations to advance scientific knowledge in specific research areas that align with the FDA's mission to protect and promote public health. The opportunity is classified under NAICS 541714 (Research and Development in Biotechnology) and PSC code AJ11 (General Science and Technology R&D Services), though proposals are not limited to these categories. The BAA represents a government-wide effort to fund research addressing regulatory challenges across FDA-regulated domains.
The primary objective of this BAA is to advance scientific knowledge through research and development activities focused on three key charge areas: modernizing the development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. Eligible offerors include private sector organizations, Federally Funded Research and Development Centers, and academic institutions, with small businesses strongly encouraged to participate. Proposals must follow a two-stage submission process, with Stage One Submittal Packages due by February 24, 2026, including a checklist, concept paper, and full proposal; early applications are highly encouraged. The BAA encompasses multiple research priority areas including new approach methodologies, advanced manufacturing, analytical and computational methods, biomarkers, clinical outcome assessments, and emerging technologies. Multiple awards are anticipated, with funding subject to government discretion and availability, and the government has expressed a preference for cost-reimbursement contract types. The FDA hosted a virtual BAA day on January 20, 2026, to provide additional guidance to prospective contractors.
Notice text
4 versions
Update #4 · Latest ·
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.
Update #3 ·
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.
Update #2 ·
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.
Update #1 ·
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.
Files
| File | Type | Posted |
|---|---|---|
| FY26 BAA Notice_V3.pdf | ||
| Cost Appendix 8 Preaward Survey Accounting System.pdf | ||
| FY26 BAA Notice_V2.pdf | ||
| Attachment 6 SOW Template.docx | DOCX document | |
| Cost Appendix 7 Proposal Template.xlsx | XLSX spreadsheet | |
| FY26 BAA Notice V1.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | Award Notice | |
| This notice | Special Notice |
Similar open opportunities
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity