Written and maintained by CASRAI Editorial Board
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The FDA BAA is the Food and Drug Administration’s Broad Agency Announcement for extramural regulatory science research. It is a solicitation for research and development contracts, not grants, which changes how a grants office registers, submits, reports and is paid. This page uses the facts as described on the official FDA pages on 2026-10-29. Programs change, so check the current notice before you plan.
Not what you were looking for? This page is about the funding announcement, not a HIPAA business associate agreement (also abbreviated BAA). For that, see HIPAA covered entities and the minimum necessary standard.
What the FDA BAA is and who runs it
The FDA’s Office of Regulatory and Emerging Science (ORES) manages FDA-wide programs that fund extramural regulatory science. FDA says it uses various contract mechanisms and grants for this work, and that it has run the BAA since 2012 as a specialized contract mechanism. The BAA is posted as a solicitation on SAM.gov, and FDA’s page advises checking that the version date shown in the upper right of the SAM.gov notice is the most recent.
FDA organizes the work around three Regulatory Science Framework priorities:
- modernizing product development and evaluation;
- strengthening post-market surveillance and labeling;
- improving public health preparedness and response.
Related FDA programs listed alongside it are the Centers of Excellence in Regulatory Science and Innovation (CERSIs) and the Intramural Regulatory Science Programs. Compare the sister agency announcements in ONR BAA and the DoD research funding landscape, and the separate fellowship-style route in FDA ORISE.
Eligibility
FDA’s 2026 BAA Day page states: “The FDA BAA is open to all responsible sources, and small businesses are encouraged to respond.” Offerors may be single entities or teams drawn from private-sector organizations, Federally Funded Research and Development Centers (FFRDCs) and academic institutions.
FDA’s oncology researchers FAQ (written by the Oncology Center of Excellence, so oncology-specific in framing) adds that private-sector, academic and nonprofit organizations can apply, singly or as teams, and that international institutions may apply. It sets no specific education or experience requirement for principal investigators; capability and experience are instead evaluation criteria. Basic and applied research are both eligible, but the work must have a direct impact on FDA’s mission.
An institution must be registered in SAM.gov in time to receive funding. According to the FAQ, FDA cannot make an award until registration is complete and does not control the SAM.gov process.
What it funds and what it requires
Awards are research and development contracts. FDA’s oncology FAQ says the BAA mechanism results in a research contract rather than a grant. Reporting goes to the FDA Contracting Office. Projects can run up to five years. The BAA sets no funding cap, but budgets are limited.
BAA contract versus a grant, as described by FDA
| Point | FDA BAA (as described by FDA) | What a grants office should check |
|---|---|---|
| Instrument | R&D contract | Contract terms and clauses, not grant terms; see federal contracts vs grants |
| Where the notice lives | SAM.gov solicitation | Monitor the SAM.gov notice and its version date |
| Registration | SAM.gov registration needed before FDA can award | Confirm the institution’s registration is active well ahead of award |
| Reporting | To the FDA Contracting Office | Route deliverables and invoices through the contracts function |
| Duration | Up to five years | Plan the budget period structure accordingly |
| Funding level | No cap set by the BAA; budgets limited | Ask early whether the proposed budget is realistic for the topic |
Application steps
For fiscal year 2026, FDA’s program page describes a two-stage process with a freestanding Concept Paper and a freestanding Full Proposal. The optional early Concept Paper phase was removed in FY26.
- Concept Paper (Stage I). FDA gives Concept Papers a high-level evaluation; favorable ones go to a technical evaluation panel. For FY26 the Stage I due date was February 24, 2026, and FDA encouraged early submission. The Stage I evaluation criteria in the FAQ are scientific and technical merit, program relevance, and offeror capability and experience, with past performance and costs also analyzed (Part IV of the solicitation).
- Full Proposal (Stage II). A Full Proposal has Volume I (Technical Proposal) and Volume II (Cost Proposal), each with appendices. Revised proposals are generally due within 14 calendar days of FDA’s request unless the Contracting Officer specifies otherwise.
Packages received after February 24, 2026 are still accepted but may not be considered for FY26; they may be considered for FY27. Questions go to [email protected]. Before submitting, you may contact the relevant center about your area of interest; after submitting, all communication goes through the Contracting Office, and, per the oncology FAQ, Oncology Center of Excellence staff cannot be involved in drafting or commenting on a proposal. FDA also holds a virtual BAA Day (the 2026 session was January 20, 1 to 4 pm ET, free and recorded).
Typical timeline phases
Dates change every year, so use phases rather than dates: (1) the solicitation is posted and a BAA Day is held; (2) Concept Papers are submitted by the Stage I due date; (3) FDA evaluates and requests Full Proposals; (4) revised proposals follow within the window FDA sets; (5) the Contracting Office makes award decisions, subject to SAM.gov registration. Check the current SAM.gov notice for the real dates of the cycle you are targeting.
What FDA’s award statistics show
FDA publishes the number of applications received, the number awarded and the total funds for each year. The rates below are computed here from FDA’s published figures (awarded divided by received) and are not FDA’s own statements.
| Fiscal year | Applications received | Awarded | Total funds | Computed award rate |
|---|---|---|---|---|
| FY26 | 228 | 53 | $63,603,152.00 | 23.2% |
| FY25 | 308 | 15 | $16,737,952.78 | 4.9% |
| FY24 | 278 | 24 | $24,597,676.28 | 8.6% |
| FY22 | 181 | 45 | $142,495,425.15 | 24.9% |
| FY14 | 87 | 28 | $20,651,356.81 | 32.2% |
The pattern to take from the table is variability: the number of awards and total funds swing widely from year to year, so one year’s rate is a weak guide to the next. FDA posts the full award lists as PDFs for FY18 through FY26.
Common mistakes
- Treating it as a grant. It is a contract. Reporting, communication and payment run through the Contracting Office.
- Leaving SAM.gov registration late. FDA cannot award until it is complete, and FDA does not control it.
- Waiting for the deadline. FDA encouraged early submission, and late packages may roll to the next fiscal year.
- Asking program staff to help write the proposal. After submission, communication is through the Contracting Office, and, per the oncology FAQ, Oncology Center of Excellence staff cannot be involved in drafting or commenting on a proposal.
- Reading an old notice. Check the SAM.gov version date; FY26 removed the optional early Concept Paper phase.
Related programs
| Program | How it relates | On CASRAI |
|---|---|---|
| CERSIs | Listed by FDA as a related regulatory science program | – |
| Intramural Regulatory Science Programs | Listed by FDA as a related program | – |
| ONR Long Range BAA | Another agency’s broad agency announcement | ONR BAA |
| DARPA DSO | Office-level DARPA solicitations | DARPA DSO |
| FDA ORISE | FDA research participation program | FDA ORISE |
FAQ
Is the FDA BAA a grant?
No. FDA’s oncology FAQ states that the BAA results in an R&D contract, not a grant.
Who can apply?
FDA says the BAA is open to all responsible sources, and small businesses are encouraged to respond. Offerors can be single entities or teams of private-sector organizations, FFRDCs and academic institutions.
Is the FDA BAA the same as a HIPAA business associate agreement?
No. The funding announcement and a HIPAA business associate agreement share only the abbreviation. This page covers the funding announcement.
How long can a project run?
Up to five years, per FDA’s oncology FAQ.
When is the next deadline?
It changes each cycle. For FY26 the Stage I due date was February 24, 2026. For the current cycle, read the SAM.gov notice.
Sources
- FDA, Regulatory Science Extramural Research and Development Projects: https://www.fda.gov/science-research/advancing-regulatory-science/regulatory-science-extramural-research-and-development-projects (checked 2026-10-29).
- FDA, 2026 FDA Broad Agency Announcement Day: https://www.fda.gov/science-research/advancing-regulatory-science/2026-fda-broad-agency-announcement-day-01202026 (checked 2026-10-29).
- FDA Oncology Center of Excellence, FDA Broad Agency Announcement FAQ for oncology researchers: https://www.fda.gov/about-fda/oncology-center-excellence/fda-broad-agency-announcement-frequently-asked-questions-oncology-researchers (checked 2026-10-29).
