PHS 2025-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
This grant provides funding to small U.S. businesses for developing innovative health-related technologies through collaborations with nonprofit research institutions, specifically for projects that require clinical trials.
The National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services, has forecasted the PHS 2025-2 Omnibus Solicitation for Small Business Technology Transfer (STTR) Grant Applications (R41/R42) that require clinical trials. This initiative supports the development of innovative biomedical and behavioral research solutions by small businesses with the potential for commercialization and significant public health impact. Participating NIH Institutes and Centers (ICs) include NEI, NHLBI, NHGRI, NIA, NIAAA, NIBIB, NICHD, NIDA, NIDCD, NIEHS, NIMH, NINR, NIMHD, NLM, NCCIH, NCI, and ORWH. The purpose of the STTR program is to foster collaborations between small businesses and nonprofit research institutions, leveraging the scientific and technological expertise in both sectors. It aims to translate research discoveries into viable commercial products. This forecasted opportunity supports Phase I, Phase II, Fast-Track, and Phase IIB grant mechanisms under activity codes R41 and R42. NIH encourages collaborative investigations that combine expertise across multiple disciplines or institutions. Funding under this solicitation targets a wide range of health-related research fields, as indicated by the variety of assistance listings (CFDA numbers) such as environmental health, mental health, drug and alcohol abuse, aging, child development, cancer research, and more. The exact funding amounts and number of awards have not been specified, and cost sharing or matching is not required. Eligibility is limited to United States small business concerns (SBCs). To qualify, businesses must be for-profit entities based primarily in the United States, with fewer than 500 employees, and primarily owned and controlled by U.S. citizens or permanent residents. Certain ownership structures involving joint ventures, trusts, and employee stock ownership plans are permissible, provided they meet detailed requirements. Businesses majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms are not eligible. The application process is expected to open on October 1, 2025, with a due date for submissions on January 5, 2026. Awards are anticipated to be announced on June 1, 2026, and project start dates are expected by July 1, 2026. This is a forecasted notice; thus, applications are not currently being solicited. Potential applicants are advised to begin preparing collaborations and proposals in advance of the official notice of funding opportunity. For more information, applicants can contact NIH SEED at [email protected] or by phone at 301-827-8595. The How to Apply β Application Guide will provide additional detailed instructions once the opportunity is officially published.
Award Range
Not specified - Not specified
Total Program Funding
Not specified
Number of Awards
Not specified
Matching Requirement
No
Additional Details
While exact amounts are not detailed, this is a Phase I/II STTR mechanism grant with support expected for clinical trials and collaborative technology development projects. Matching is not required.
Eligible Applicants
Additional Requirements
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture. Must be one of the following: a. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR b. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3(a) of this section. 4. Has, including its affiliates, not more than 500 employees. If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner. If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner. Definitions: Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm. Private equity firm has the meaning given the term private equity fund in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. Venture capital operating company means an entity described in 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. ANC means Alaska Native Corporation. NHO means Native Hawaiian Organization. SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The How to Apply Application Guide should be referenced for detailed eligibility information. Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.
Geographic Eligibility
All
Begin planning partnerships early; ensure compliance with eligibility restrictions; monitor for reauthorization of STTR program.
Application Opens
October 1, 2025
Application Closes
January 5, 2026
Grantor
US Department of Health & Human Services (National Institutes of Health)
Phone
301-827-8595Subscribe to view contact details