Division of Extramural Activities
Small Business Innovation Research and Technology Transfer
NIA's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs support small business concerns (SBCs) and nonprofit research organizations that conduct research proximately leading to the development of products and services that improve the health and well-being of older Americans.
The goal is to translate research on aging, aging-related medical conditions and diseases, and special problems and needs of older Americans into innovative programs, systems, networks, and other products or services needed by health-care professionals, informal caregivers, and older Americans to maintain and/or improve their health, and to maintain and/or improve their overall sense of well-being.
All applicants are expected to develop, implement, and test the efficacy of their products and services. The SBIR-STTR programs target early-stage research and research development and encompass a broad range of research topics and types of research/research development, including translational research/research development and secondary research/research development.
The SBIR and STTR programs consist of three phases: Phase I, Phase II, and Phase IIB.
The SBIR program is a highly competitive program that encourages domestic SBCs to engage in federal research and development that has the potential for imminent commercilization. Through a competitive awards-based program, SBIR projects enable small businesses to explore their technological potential and provide small businesses with the incentive to profit from commercialization. The SBIR program focuses on SBCs as the primary research and development resource and employer.
The STTR program is another program that expands funding opportunities in the federal innovation research and development marketplace. Central to the STTR program is expansion of the public/private-sector partnership to include collaboration with non-profit research institutions (including research universities). This unique-to-STTR feature is a requirement that also allows applicant SBCs to appoint principal investigators who may be employed by the non-profit research partner.
In the SBIR (R43 activity code) and STTR (R41 activity code) programs, Phase I research and development focus primarily on the development and feasibility-testing of prototypes.
In Phase II research and development, SBIR (R44 activity code) and STTR (R42 activity code), SBCs propose and conduct research and development that often features between-group comparisons and further demonstrates the hypothesized features-benefits of the health- and aging-focused prototype product and/or service,
In the Phase IIB program, open to both SBIR and STTR Phase II grantees, SBCs propose and conduct research and development that require extraordinary time and effort and may or may not require FDA approval for the development of such projects, including drugs, devices, vaccines, therapeutics, and medical implants related to the mission of NIA.
Furthermore, applicants to NIH-NIA's SBIR and STTR programs also may submit applications to NIH's SBIR-STTR Fast-Track program. In a Fast-Track application, the applicant SBC submits Phase I (either STTR R41 or SBIR R43) and Phase II (either STTR R42 or SBIR R44) applications in the initial application. The NIH Fast-Track program provides for simultaneous peer & secondary review of both the Phase I and Phase II application.
The simultaneous review and consideration for funding affords Fast-Track applicants the opportunity to plan and subsequently stage the proposed research and development across both Phase I and Phase II and, if a meritorious Fast-Track application is approved for funding, allows the SBC to obtain funding for the Phase II research and development more quickly than it would were it to apply separately (and consecutively) for a Phase I and then a Phase II award.
SBCs that have already completed the kind of research and development characteristic of Phase I projects may submit an SBIR application to the NIH-NIA SBIR Direct-to-Phase-II program. Note, however, that January 5, 2017 will be the final receipt date for the SBIR Direct-to-Phase-II program, as legislative authority for this program expires on January 6, 2017. The SBIR Direct-to-Phase II grant mechanism is intended to facilitate SBIR-type research and development, to expand research and development opportunities for applicant small business concerns (SBCs), and to enhance the pace of technology development and commercialization.
Potential applicants are strongly encouraged to refer to and closely read the comprehensive and detailed SBIR-STTR programmatic information and guidance posted to and readily accessible on the NIH SBIR-STTR Web site.
NIA recommends that potential applicants refer to & closely read the 2016 NIH SBIR and STTR Omnibus Solicitations, the 2016 NIA SBIR-STTR Research Topics, and the 2016 NIH SBIR Direct-to-Phase-II FOA:
- 2016 NIH SBIR Omnibus Solicitation
- 2016 NIH STTR Omnibus Solicitation
- 2016 NIA SBIR-STTR Research Topics (PDF, 1.4M)
- 2016 NIH SBIR Direct-to-Phase-II Solicitation
In addition to the NIH Omnibus SBIR-STTR FOAs & programs, in 2016 NIH and NIA launched the SBIR-STTR Commercialization Readiness Pilot (CRP) programs, which consist of two FOAs addressing post-Phase-II award technical and late-stage research and development. Note: The final receipt date for applications to both CRP FOAs will be April 6, 2017. NIA would welcome CRP applications for the January 5, 2017 and April 5, 2017 receipt dates. Please refer to and read the CRP FOAs here:
- SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance (SB1)
- SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late-Stage Development (SB1)
Finally, to enhance NIA's realization of its mission through its SBIR-STTR programs, NIA has developed and published targeted SBIR-STTR FOAs addressing two fundamental goals and domains of research and development:
Alzheimer's Disease (AD) and AD-related dementias (ADRD):
- Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R43/R44);
- Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42);
- Tools for Clinical Care and Management of Alzheimers Disease (AD) and its Comorbidities (R43/R44);
- Tools for Clinical Care and Management of Alzheimers Disease (AD) and Its Comorbidities (R41/R42).
- Translational Research on Aging:
After referring to and reading the NIH SBIR Web site, particularly the 2016 SBIR-STTR Omnibus Solicitations, the NIA SBIR-STTR Research Topics, the SBIR Direct-to-Phase-II Solicitation, and the NIA-issued SBIR-STTR FOAs, potential applicants are further encouraged to contact NIA's SBIR-STTR Program Coordinator to determine if their potential SBIR-STTR research and development would be appropriate for NIA.
Michael-David A.R.R. Kerns, M.M., M.S., Ph.D.
NIA SBIR-STTR Program Coordinator
National Institutes of Health: National Institute on Aging
- Small Business Innovation Research-Small Business Technology Transfer (SBIR-STTR) Policy
- What Is Expected of Applicants
- Toolbox for Applicants
SBIR-STTR Application-Submission Registration
Applicant organizations (small business concerns; SBCs) must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM, SBA Company registry, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- SBA Company Registry – New requirement. See Section IV. Application and Submission Information, “SF424(R&R) Other Project Information Component” for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.
- eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
- Currently, it takes 2-4 weeks to complete registration.
- Applicant SBCs are strongly encouraged to complete registration well in advance of the application-submission deadline.