NIH Small Business Technology Transfer Grant (Parent STTR [R41/R42] Clinical Trial Optional): PA-27-102

NIH Small Business Technology Transfer Grant (Parent STTR [R41/R42] Clinical Trial Optional): PA-27-102

The National Institutes of Health (NIH) Notice of Funding Opportunity PA-27-102 supports U.S. small business concerns (SBCs) that develop a commercial product through a formal research and development collaboration with a nonprofit research institution. The notice covers Small Business Technology Transfer (STTR) Phase I and Phase II awards, as well as NIH-only Direct to Phase II and Fast-Track applications. Clinical trials are optional for this parent notice, subject to the participating component’s rules. NIH makes any award to the small business, even when the principal investigator works at the partner institution.

The notice is open for applications. The first standard receipt date, September 5, 2026, has passed; the remaining dates in this cycle are January 5, 2027 and April 5, 2027. The next deadline is January 5, 2027, at 5:00 p.m. local time of the applicant organization. NIH expressly says it will not accept late applications. The notice expires April 6, 2027, one day after its final listed receipt date. The NIH parent-announcements listing and current full announcement identify PA-27-102 as active through that expiration date. Confirm the latest announcement and NIH policy notices before submitting.

This page summarizes the current official notice. It is not a substitute for the NOFO, the NIH SBIR/STTR application guide, or advice from a participating NIH Institute, Center, or Office (ICO). Each component has its own mission fit, funding considerations, and sometimes clinical-trial limits.

At a glance

What the STTR mechanism funds

STTR joins a small business that will develop and commercialize a product with a research institution that contributes research and development work. PA-27-102 is a broad parent notice rather than a topic-specific call. A proposal still needs to fit the mission and interests of a participating NIH component and make a credible case for both the research and the eventual product or service. NIH’s Center for Scientific Review receives applications and assigns them to an appropriate participating component. Applicants may request an assignment and are encouraged to contact the likely component before applying.

Phase I is for establishing the technical merit and feasibility of the proposed research and development. Phase II continues development toward commercialization. After Phase II, NIH expects the SBC to complete commercialization using funds outside the SBIR/STTR program. Fast-Track puts the Phase I and Phase II proposals together for review in one application. Direct to Phase II is available through NIH for a small business that has already demonstrated scientific and technical feasibility for the project but has not received a Phase I SBIR or STTR award for that project; it is submitted as a new application. When a project received a Phase I award, the regular Phase II application is generally submitted as a renewal, and only one Phase II award may be made for that project. Phase IIB Strategic Breakthrough is a separate SBIR opportunity, PA-27-101.

The STTR distinction matters for project design. The collaboration cannot be a nominal letter of support: the NOFO requires a single partnering research institution and minimum shares of the research or analytical effort. A business without a substantive nonprofit research collaboration may be better suited to the companion SBIR opportunity, PA-27-100. The award goes to the small business, which remains responsible for coordinating the funded project, partner relationship, milestones, and commercialization plan.

Eligibility and partnership requirements

Only U.S. small business concerns may apply. At the time of award, the applicant must be organized for profit, have a place of business in the United States, and operate primarily in the United States or make a significant contribution to the U.S. economy. The NOFO allows several legal forms, including a sole proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. A joint venture has a specific foreign participation restriction. The concern must satisfy the ownership and control conditions in the NOFO, including the permitted ownership categories, and have no more than 500 employees when affiliates are included. The small business must also meet the other applicable Small Business Administration rules in 13 C.F.R. Part 121. A company more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or a combination of them is not eligible for this NIH STTR program.

STTR also requires a formal relationship with one “partnering” nonprofit research institution. The NOFO includes qualifying federally funded research and development centers in this definition. At least 40% of the research or analytical effort must be performed by the SBC and at least 30% by the partner. The NOFO generally measures those shares using the direct costs, indirect costs, and fee attributable to each party unless the application describes and justifies another basis. Build the work plan and budget together so the division of effort is credible and visible in the application.

Foreign organizations and non-U.S. components of U.S. organizations are not eligible applicants. The notice says unfunded international collaborations or foreign components may be allowed under NIH policy. NIH will not issue awards under this notice involving foreign subawards or subcontracts, and such applications are noncompliant. A foreign consultant or purchase from a foreign vendor is not automatically the same thing as a foreign subaward, but applicants should follow the NOFO’s distinction and ask the relevant NIH contact when the structure is unclear.

A principal investigator may be employed by the SBC or the nonprofit partner, but must have a formal appointment with or commitment to the applicant business. Each PD/PI must commit at least 10% effort to the project, have an eRA Commons account, and link the profile to a valid ORCID. An individual serving as both PD/PI and organizational Signing Official needs separate eRA Commons accounts for those roles.

Budget and project duration

There is no single award amount for every applicant. The NOFO’s budget table gives total support guidance by participating component. The listed Phase I figures range from $400,000 to $700,000, while listed Phase II figures range from $2,500,000 to $3,000,000. Some components instead show “SBA Guideline” for one or both phases. The stated total includes direct costs, indirect costs, and fee. The NOFO notes that total support normally may not exceed the current SBA budgetary guidelines; NIH may allow higher amounts for specific topics or approved waiver topics.

Treat the table as component-specific guidance, not a guaranteed award or a universal cap. First determine which participating component’s mission fits the work. Then read its current funding considerations and contact staff early if the project needs a budget above the applicable guideline. The budget should be tied to the research plan and partner’s work share. The notice says award periods normally may not exceed one year for Phase I and two years for Phase II, and it asks applicants to propose a duration appropriate to the work.

The number of awards depends on NIH appropriations and the submission of a sufficient number of meritorious applications. Cost sharing is not required. A strong budget therefore explains the resources needed to meet the proposed technical milestones, pays for the documented collaboration, and stays within the relevant component’s guidance or explains any permitted exception.

Current dates and submission timing

The NOFO lists three standard receipt dates: September 5, 2026; January 5, 2027; and April 5, 2027. The first date has passed. For a new application or an allowed renewal, resubmission, or revision, the next listed date is January 5, 2027. The final listed standard date is April 5, 2027. The table pairs those dates with review and award cycles: applications submitted for the January date are scheduled for scientific merit review in March 2027, advisory council review in May 2027, and earliest start in July 2027; the April date is paired with July 2027 scientific review, August 2027 council review, and a December 2027 earliest start. The notice expires April 6, 2027.

Applications are due by 5:00 p.m. in the applicant organization’s local time. NIH encourages early submission to leave time to correct errors found during processing, and explicitly says late applications will not be accepted. Treat the date as a hard receipt deadline and make sure the Authorized Organization Representative can complete submission and corrections in time. Registration delays do not excuse a late application.

Registrations and application steps

Start with the organization’s registrations because the NOFO says they can take six weeks or more. The business needs an active SAM.gov registration and a Unique Entity Identifier. Use the same UEI across registrations and the application. Register with the SBA Company Registry, eRA Commons, and Grants.gov as well; all required registrations must be in place by submission. The NOFO notes SBA Company Registry registration does not have to precede SAM.gov, Grants.gov, or eRA Commons registration. Keep registrations active; SAM.gov renewal is annual and can take time.

The organization needs an eRA Commons Signing Official account and at least one PD/PI account. The PD/PI should affiliate their account with the applicant organization, link a valid ORCID, and confirm the required effort commitment. Start these checks before preparing the full package, especially if the PI will also be the Signing Official, because separate accounts are required for those two functions.

Next, confirm that the idea fits STTR, select the appropriate phase and application type, and contact the likely ICO about mission fit and funding considerations. Check whether the proposed work includes an NIH-defined clinical trial and whether the component accepts trials under this notice. Clinical-trial applications must include a two-page maximum Regulatory Plan attachment named RegulatoryPlan.pdf. It describes the regulatory pathway and timeline with discrete milestones, plus relevant interactions with regulatory authorities. Do not include that attachment when the application does not propose a clinical trial. If human subjects are involved, provide at least one human subjects study record or delayed onset study record in the required PHS forms.

Prepare the application using the SBIR/STTR (B) instructions in the NIH Application Guide and the program-specific directions in PA-27-102. Use the forms package reached through NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace. These are the routes named in the NOFO; an institutional grants office can tell the team whether its system-to-system route is available. Follow the page limits and form instructions. Phase I STTR applications may not include Appendix materials, and a Commercialization Plan is not allowed for Phase I. Phase II and Fast-Track applications have different required content, so match attachments to the chosen application type rather than copying a Phase I package unchanged.

Before submission, verify that the application identifies the small business and partner clearly, explains the allocation of work and requested costs, names the right phase and component fit, and includes all required registrations and attachments. Check for overlap with other applications: NIH will not accept identical or essentially identical submissions under this notice and another HHS opportunity at the same time, and it restricts substantially overlapping applications under review. Submit through one authorized route early enough to inspect status and correct errors before the deadline.

What the review will examine

NIH peer review evaluates scientific and technical merit in light of the proposed stage. Reviewers consider whether the product or service addresses an important problem or unmet need, whether supporting research is rigorous, and whether success could improve scientific knowledge, technical capability, or clinical practice. For Phase I, reviewers assess commercial potential. Phase II and Fast-Track applications need a Commercialization Plan that supports a high probability of commercialization and identifies a real product or service, target customers, and demonstrated customer need.

Reviewers also assess the investigators’ experience and contribution, the quality of the approach, resources and environment, and the fit between milestones and available time and budget. For an STTR, the division of labor and governance across the company and institution should be clear. A clinical-trial proposal should justify why the study is needed, use an appropriate design, and address regulatory requirements and execution readiness. A sound application ties these points together: the technical work resolves a defined uncertainty, the partner performs the work assigned to it, and the small business can take the resulting product toward market.

Practical fit check

PA-27-102 is worth considering when a U.S. small business has a research and development project that advances a participating NIH component’s mission, needs a substantive nonprofit research partner, and can explain a plausible commercialization route. Before committing to an application, confirm ownership and affiliation eligibility, partner status, work-share percentages, PI eligibility and effort, registration status, the component’s budget guidance, and whether that component accepts a proposed clinical trial. If the collaboration is not central to the project, review PA-27-100 instead. If an applicant is unsure about component fit, the NOFO encourages contact with program staff before submission.

Official source

• Revised PA-27-102 full announcement
• NIH parent announcements listing
• NIH SEED SBIR/STTR funding opportunities