Almost all HHS SBIR and STTR money moves through two NIH parent grant notices that fund your own idea three times a year: September 5, January 5 and April 5. CDC and FDA buy through the SBIR parent too, without Fast-Track or Direct to Phase II, and FDA takes no clinical trials. There is no pitch gate: you send a full application, and NIH assigns it to an institute. Since the April 13, 2026 reauthorization, institutes may exceed the SBA guideline of $335,937 for Phase I and $2,239,578 for Phase II, up to $700,000 and $3 million. HHS now accepts at most nine new or resubmitted Phase I, Fast-Track and Direct to Phase II applications per company each fiscal year, and it screens every likely awardee for foreign ties, with no chance to fix a problem before denial. ACL and ARPA-H run their own smaller calls. The common mistake is writing to NIH in general instead of to one institute's priorities and budget cap, and skipping the program officer call.
National Institutes of Health
NIH, CDC and FDA SBIR Parent Grant (PA-27-100, Clinical Trial Optional)
National Institutes of Health — SEED Office (Parent SBIR, with CDC and FDA)
Phase I up to $335,937 and Phase II up to $2,239,578 at the SBA guideline (total costs, including fee); many institutes allow more: up to $700,000 for Phase I at NCI, NIA, NIAID, NIGMS, NIMH, NINDS and NCCIH, and up to $3,000,000 for Phase II at NHLBI, NIA, NIAID, NIDCD, NIDA, NIGMS, NIMH and NINDS. CDC and FDA stay at the SBA guideline. Phase I normally runs 6 months, Phase II 2 years
GrantEquity-freePhase IPhase IIFast-TrackDirect to Phase II
The catch: HHS accepts at most nine new or resubmitted Phase I, Fast-Track and Direct to Phase II applications per company per fiscal year, across all HHS components and contract proposals included. Before award you file the SBA foreign-affiliation disclosure and pass HHS foreign-risk due diligence; an owner or key person in a malign foreign talent program or affiliated with a research institution in China or another country of concern bars the award, and HHS gives no chance to fix it first. No foreign subawards; FDA takes no clinical trials.
Next deadline: Jan 5, 2027 · Three standard dates a year: Sept 5, Jan 5, Apr 5 (moved to the next business day when one falls on a weekend or federal holiday)
Applicant tip: Size the budget from the institute table in Section II of the notice, not the SBA figure: the same Phase I can ask for $700,000 at NCI or NINDS but only $335,937 at NIBIB or NIEHS. You can add up to $6,500 of TABA money in Phase I and $50,000 in Phase II for vendors or staff doing regulatory, IP, market or cybersecurity work.
Eligibility, how to apply, past winners
- Eligibility
- A U.S. for-profit with 500 or fewer employees including affiliates, more than 50% owned by U.S. citizens or permanent residents (majority ownership by several VC, hedge fund or private equity firms is allowed with a signed certification). The PI must be primarily employed by the company, which normally does at least 67% of Phase I and 50% of Phase II work. Phase II is a Renewal for Phase I awardees, due within six due dates of the Phase I budget end. Direct to Phase II needs feasibility already shown without an SBIR/STTR Phase I for that project. Fast-Track and Direct to Phase II are NIH only.
- How to apply
- Direct application: submit through Grants.gov (NIH ASSIST, Workspace or a system-to-system tool) after SAM.gov with a UEI, the SBA Company Registry, eRA Commons and ORCID are in place; NIH's Center for Scientific Review assigns the application to an institute, and you can request one.
- Program fit
- SBIR
- Equity taken
- None
NIH STTR Parent Grant (PA-27-102, Clinical Trial Optional)
National Institutes of Health — SEED Office (Parent STTR)
Phase I up to $335,937 and Phase II up to $2,239,578 at the SBA guideline (total costs, including fee); the same institute caps as the SBIR parent apply, up to $700,000 for Phase I and $3,000,000 for Phase II at the institutes that allow it. Phase I normally runs up to 1 year, Phase II 2 years
GrantEquity-freePhase IPhase IIFast-TrackDirect to Phase II
The catch: NIH only: CDC and FDA do not take STTR applications. The same nine-application HHS limit per fiscal year and the same pre-award foreign-risk due diligence apply, and the research partner's people count as covered individuals when they contribute substantively. No foreign subawards.
Next deadline: Jan 5, 2027 · Three standard dates a year: Sept 5, Jan 5, Apr 5 (moved to the next business day when one falls on a weekend or federal holiday)
Applicant tip: Choose STTR only when the project depends on the university partner; NIH tells you to apply to the SBIR parent otherwise, and an STTR budget must show at least 30% of the work going to that one institution.
Eligibility, how to apply, past winners
- Eligibility
- The SBIR small-business test, plus a formal partnership with one U.S. nonprofit research institution or FFRDC: the company does at least 40% and the institution at least 30% of the work in each phase. The PI may be employed by either party, with at least 10% effort and a formal tie to the company. Companies majority-owned by multiple VC, hedge fund or private equity firms cannot apply to NIH STTR.
- How to apply
- Direct application: submit through Grants.gov (NIH ASSIST, Workspace or a system-to-system tool) after SAM.gov with a UEI, the SBA Company Registry, eRA Commons and ORCID are in place; the award goes to the company even when the PI works at the university.
- Program fit
- STTR
- Equity taken
- None
NIH SBIR Phase IIB Strategic Breakthrough Award (PA-27-101)
National Institutes of Health — SEED Office (Phase IIB Strategic Breakthrough)
Up to $30,000,000 in total costs over up to 4 years (notice ceiling); institute caps are lower: NCI $15,000,000; NHLBI and NIAAA $4,500,000; NIA, NIAID, NICHD, NIDDK, NIGMS, NIMH, NINDS and NCATS $3,000,000; NEI, NIMHD, ORIP and ORWH at the SBA Phase II guideline
GrantEquity-freePhase IIB / follow-on
The catch: You must show at least 100% matching funds from new private capital or a new non-SBIR government award, and commercial potential is weighted heavily in review. Outside NCI the institute caps sit far below the $30 million ceiling, and NCATS and ORIP take no clinical trials under this notice.
Next deadline: Jan 5, 2027 · Three standard dates a year: Sept 5, Jan 5, Apr 5 (the notice runs through the April 5, 2029 date)
Applicant tip: If you lack the match or need to outsource most of the work, apply to the CRP (PAR-27-098) instead or as well; NIH will review a Phase IIB and a CRP for the same Phase II project at the same time if they are scientifically distinct.
Eligibility, how to apply, past winners
- Eligibility
- Prior NIH SBIR or STTR Phase II recipients only (grant, cooperative agreement or contract), applying within the first six due dates after the Phase II budget period ends. One Strategic Breakthrough award per project, made only after the Phase II has ended.
- How to apply
- Direct application: prior NIH Phase II awardees submit a Renewal application (a New application when the Phase II was a contract) through Grants.gov; NIH urges a program officer call first.
- Program fit
- SBIR, STTR
- Equity taken
- None
SBIR/STTR Commercialization Readiness Pilot (CRP) Program (PAR-27-098)
National Institutes of Health — SEED Office (Commercialization Readiness Pilot)
Up to $4,479,156 over up to 3 years (the SBA limit NIH cites for the CRP); institute caps: $2,000,000 at NIAID, NIAMS, NICHD, NIDCD, NIDDK, NINDS and ORIP; $500,000 at NEI, NHLBI, NHGRI, NIBIB, NIEHS and NCATS; NCI, NIA, NIAAA, NIDCR, NIGMS, NIMH, NIMHD and ORWH at the SBA limit
GrantEquity-freePhase IIB / follow-on
The catch: CRP money cannot pay filing fees, including FDA submission fees, and you cannot add separate TABA funds. You may outsource much of the work but must oversee all scientific, financial and administrative matters yourself; NIH will not fund a company that is only a conduit to contractors.
Next deadline: Jan 5, 2027 · Three standard dates a year: Sept 5, Jan 5, Apr 5 (the notice runs through the April 5, 2029 date)
Applicant tip: Unlike the Strategic Breakthrough, the CRP can start during an active Phase II and needs no match, so it fits IND- or IDE-enabling studies, independent replication, manufacturing scale-up or regulatory work handed to CROs.
Eligibility, how to apply, past winners
- Eligibility
- Companies with an active NIH SBIR or STTR Phase II or Phase IIB grant, cooperative agreement or contract from a participating institute within the last 36 months, including current awardees. One CRP award per project.
- How to apply
- Direct application: submit a New (Type 1) SB1 application through Grants.gov for technical assistance, later-stage R&D or both; no matching funds are required.
- Program fit
- SBIR, STTR
- Equity taken
- None
Small Business Transition Grant for New Entrepreneurs (PAR-27-039 SBIR, PAR-27-040 STTR; forecast)
National Institutes of Health — SEED Office (Small Business Transition Grant)
Varies — check official page (the forecasts give no amount; Phase I and Fast-Track awards under SBIR and STTR budget rules)
GrantEquity-freePhase IFast-Track
The catch: Training is part of the award: the PI carries out a career development plan with the mentor. Fast-Track is NIH only. Until the notices post, amounts, participating institutes and review criteria are not confirmed, and the application counts toward the nine-per-year HHS limit.
Next deadline: Expected: January 2027 · Expected to use the standard dates: Sept 5, Jan 5, Apr 5 (forecast first due date January 5, 2027)
Applicant tip: Line up the industry mentor now: NIH posted the forecast early so applicants could find mentors and career development resources before the notice opens, and the mentor's effort has to appear in the budget.
Eligibility, how to apply, past winners
- Eligibility
- The PI must be an early-career scientist who has never been an independent PI on a major research grant and is a U.S. citizen or permanent resident; key personnel must include a mentor with measurable effort. The company must pass the SBIR or STTR small-business test; NIH and CDC take the SBIR version, NIH alone the STTR version.
- How to apply
- Direct application: once the notices post, apply through Grants.gov under PAR-27-039 (SBIR) or PAR-27-040 (STTR) with a mentoring and career development plan.
- Program fit
- SBIR, STTR
- Equity taken
- None
NCI SBIR Innovative Concept Award (contract solicitation 75N98026R00109)
National Institutes of Health — National Cancer Institute SBIR Development Center
$300,000 contract (FY2027 call), plus added funds for the NIH I-Corps training participants are expected to take
R&D contractEquity-freePhase I
The catch: You are expected to join NIH I-Corps. Review is weighted for innovation and NCI expects a high risk of failure; as a contract it pays against deliverables and reports, and the proposal counts toward the nine-per-year HHS limit.
Next deadline: Expected: September 2027 · Annual contract solicitation (late summer or fall); FY2027 proposals were due Sept 21, 2026, FY2026 Oct 17, 2025, FY2025 Sept 23, 2024
Applicant tip: The focus changes with each call (FY2027 was limited to pediatric and rare cancers), so read the new SAM.gov solicitation before reusing an old proposal, and remember you may not contact NCI program staff during the solicitation, only the contracting officer.
Eligibility, how to apply, past winners
- Eligibility
- A small business of 500 or fewer employees including affiliates that meets the SBA SBIR rules. The FY2027 call sought highly innovative technologies for pediatric and rare cancers; preliminary data is not required or used in review.
- How to apply
- Direct application: respond to the SAM.gov solicitation and upload the proposal to NIH's electronic Contract Proposal Submission (eCPS) site; questions go to the contracting officer only.
- Program fit
- SBIR
- Equity taken
- None
I-Corps at NIH (2027 cohorts)
National Institutes of Health — SEED Office (I-Corps at NIH)
No cost to the company: a $25,000 stipend covers program costs for the 8-week virtual cohort
OtherEquity-freeTABA / assistance
The catch: All three team members, including the industry expert, must attend every weekly session; absences need pre-approval, and only medical or family emergencies are excused.
Next deadline: Dec 18, 2026 · Three cohorts a year with request deadlines in December, February and July (2027 cohorts: Dec 18, 2026; Feb 19, 2027; Jul 16, 2027)
Applicant tip: Apply while you are still in Phase I: once NIH awards a Phase II for the project you lose eligibility. The Feb 19, 2027 request deadline feeds a cohort that kicks off the week of May 3, 2027.
Eligibility, how to apply, past winners
- Eligibility
- A Phase I SBIR or STTR (or the Phase I part of a Fast-Track) from NIH, CDC, FDA or ACL that is or was active within two years of the request deadline, with no Phase II yet for that project; one request per Phase I award. The team is a C-level officer, the technical lead and an industry expert with business development experience.
- How to apply
- Direct application: submit the online I-Corps request by a cohort deadline; requests are judged on eligibility documents, team strength, the customer-discovery plan and likely effect on commercialization.
- Program fit
- SBIR, STTR
- Equity taken
- None
NIH SEED Needs Assessment Program (formerly NICHE Assessment)
National Institutes of Health — SEED Office (Needs Assessment Program)
A free third-party report (no cash) on gaps in IP, market awareness, regulatory/manufacturing/clinical plan and business model, followed by a consult with a SEED Entrepreneur in Residence and your program officer
OtherEquity-freeTABA / assistance
The catch: The report only names the gaps; it contains no market data or solutions. Taking TABA money in the Phase I budget makes the project ineligible.
Next deadline: Rolling · Rolling (requests accepted at any time)
Applicant tip: Request it at least six months before your Phase II deadline, as SEED advises, so the findings can shape the Commercialization Plan and the Phase II TABA request.
Eligibility, how to apply, past winners
- Eligibility
- An NIH SBIR or STTR Phase I (grant, contract or Fast-Track) that is active or was active within the past two years, with no TABA funding in the Phase I budget and no earlier Needs Assessment or NICHE Assessment for the same project.
- How to apply
- Direct application: request a report through the SEED Needs Assessment form; RTI International prepares it under an NIH contract.
- Program fit
- SBIR, STTR
- Equity taken
- None
Administration for Community Living
NIDILRR SBIR Phase I (HHS-2027-ACL-NIDILRR-BISA-0308; forecast)
Administration for Community Living — National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)
$95,000–$100,000 for a 6-month project; 11 awards expected ($1.1 million in all)
GrantEquity-freePhase I
The catch: The forecast window is short: the FY2025 call was open for two months. Awards are small next to NIH, and HHS says its nine-applications-a-year limit covers all HHS components.
Next deadline: Expected: December 2026 · Annual (fall); FY2025 call posted Oct 17, 2024 and closed Dec 16, 2024; no FY2026 call during the authorization lapse
Applicant tip: Plan the Phase II route now: NIDILRR's Phase II call also takes Phase I grantees from other agencies whose projects serve people with disabilities, so a Phase I here is not the only way in.
Eligibility, how to apply, past winners
- Eligibility
- A small business concern under SBA rules at the time of award; foreign entities cannot apply. The R&D has to improve the lives of people with disabilities.
- How to apply
- Direct application: apply on Grants.gov once the FY2027 notice posts.
- Program fit
- SBIR
- Equity taken
- None
NIDILRR SBIR Phase II (HHS-2027-ACL-NIDILRR-BISB-0309; forecast)
Administration for Community Living — National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)
$280,000–$287,500 over 24 months (two 12-month budget periods); 4 awards expected ($1.15 million in all)
GrantEquity-freePhase II
The catch: Only four awards are planned, and about $287,500 over two years is small for a device or software build, so scope the work to fit. The project must address the health and function, community living or employment of people with disabilities.
Next deadline: Expected: February 2027 · Annual (winter); FY2025 call posted Jan 3, 2025 and closed Mar 10, 2025
Applicant tip: Check the completion window: only Phase I grants finished between Oct 1, 2024 and Dec 31, 2026 qualify for this call, so a Phase I ending in 2027 waits for the next one.
Eligibility, how to apply, past winners
- Eligibility
- SBIR Phase I grantees from NIDILRR or any other agency that completed Phase I between October 1, 2024 and December 31, 2026, whose project aims to improve the lives of people with disabilities and who are still small business concerns; foreign entities cannot apply.
- How to apply
- Direct application: apply on Grants.gov once the FY2027 Phase II notice posts.
- Program fit
- SBIR
- Equity taken
- None
Advanced Research Projects Agency for Health
ARPA-H SBIR/STTR Solicitation (SAM.gov notice 7599226SN106)
Advanced Research Projects Agency for Health — Small Business Program
Contracts generally up to $600,000 for Phase 1 and $3.5 million for Phase 2, paid against milestones
R&D contractEquity-freePhase IPhase II
The catch: Topics are narrow (the 2026 round named seven, from a fertility test to neurosurgical robotics, plus an open Lineage topic), and payment depends on hitting ambitious milestones. ARPA-H applies the same HHS foreign-risk review before award.
Next deadline: Not announced — the 2026 solicitation 7599226SN106 took solution summaries through July 17, 2026 and final submissions through Oct 1, 2026 · Topic-based solicitations at irregular intervals; 2026 round: solution summaries due July 17, 2026, final submissions Sept 16 and Oct 1, 2026
Applicant tip: Watch SAM.gov and the ARPA-H page, not Grants.gov or eRA Commons: the solicitation lives on SAM.gov and submissions go through solutions.arpa-h.gov.
Eligibility, how to apply, past winners
- Eligibility
- 500 or fewer employees, majority owned by U.S. citizens or another U.S. small business, all work in the U.S. SBIR: the PI is more than 50% employed by the company, which does over 66% of Phase 1 and 50% of Phase 2 work. STTR: a research institution partner does at least 30% and the company at least 40%.
- How to apply
- Pitch gate: submit a solution summary against a listed topic on the ARPA-H Solutions site; proposers encouraged after that stage send a technical deck, cost proposal and task description, then pitch.
- Program fit
- SBIR, STTR
- Equity taken
- None