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NIA Small Business Programs Frequently Asked Questions

General Information about SBIR & STTR

Eligibility

Applications

Funded Companies

General Information

What types of research does NIA fund in its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs?

NIA funds grants and contracts for small businesses conducting research and development to develop interventions that support healthy aging or address aging-related diseases and conditions, including Alzheimer’s disease and related dementias. View NIA's small business research priorities.

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What is the difference between SBIR and STTR?

Through a competitive awards-based program, SBIR grants enable small businesses to explore their technological potential. SBIR grants serve to incentivize commercialization of aging and Alzheimer's disease-related products, services, and innovations. SBIR grants primarily fund the research and development (R&D) stage of bringing a product or service to market.

In contrast, the STTR program is focused primarily on the expansion of public-private partnerships to include collaboration with non-profit research institutions, particularly research universities. A unique feature of STTR is a provision that allows small businesses to appoint principal investigators who are primarily employed by the non-profit research partner. STTR projects require that the R&D effort be divided between the small business and the research partner.

For details about eligibility for SBIR/STTR grants, subcontracting requirements, and other terms of participation and award, see NIA Small Business Eligibility Requirements or NIH Small Business Eligibility Criteria.

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What are the different phases of the SBIR and STTR programs, and which should I apply to?

The SBIR and STTR programs are divided into several phases along the continuum to commercialization. These phases are not to be confused with the phases in clinical trials.

Phase I SBIR and STTR funding supports R&D that focuses primarily on the development and feasibility testing of prototypes (e.g., compounds, products, and services). The goal is to establish technical merit, feasibility, and potential for commercialization. The activity codes for Phase I are R43 for SBIR and R41 for STTR. Phase I funding is usually for up to 1 year with awards up to $300,000, or up to $500,000 for Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) research.

Phase II funding supports additional R&D of prototypes. Phase II projects can also accommodate simple between-group comparisons to demonstrate hypothesized features/benefits of the prototype. The activity codes for Phase II are R44 for SBIR and R42 for STTR. Phase II funding is generally 2 years and offers awards up to $2 million or up to $2.5 million for AD/ADRD research. Applicants must supply a commercialization plan in their submission.

Companies that have already performed the necessary research and testing to demonstrate feasibility and commercialization through other funding sources can apply for Direct-to-Phase II funding.

Another option is the Fast-Track program, in which the small business submits applications for Phase I (either STTR R41 or SBIR R43) and Phase II (either STTR R42 or SBIR R44) in one initial application. The Fast-Track program provides for simultaneous peer and secondary review of both the Phase I and Phase II applications, so applicants can plan and subsequently stage the proposed R&D across both Phase I and Phase II. If an applicant receives Fast-Track funding, the applicant can obtain Phase II R&D funding more quickly than applying separately (and consecutively) for a Phase I and then a Phase II award.

Phase II awardees can compete for additional funding via the Phase IIB program, in which applicants propose and conduct additional R&D to facilitate and accelerate the capital-intensive steps that are required to transition Phase II projects to the commercialization stage. Phase IIB projects should feature partnerships between Phase II awardees and third-party investors and/or strategic partners.

NIH’s Commercialization Readiness Pilot (CRP) program provides technical assistance and later-stage R&D support that is not typically provided under Phase II or Phase IIB awards. Budgets may not exceed $1,750,000 in total funding support in any year up to the funding opportunity award limit of $3,360,358 in total costs across all years. CRP applicants may apply for support on the following topics:

  • Technical Assistance: Get help developing your regulatory strategy, submitting to the Food and Drug Administration (FDA) for Investigational New Drugs or Investigational Device Exemption, intellectual property strategy and patent landscape analysis, manufacturing, and other support.
  • Late-Stage R&D: Secure assistance with independent replication of key studies, FDA and Good Manufacturing Practice compliance activities, quality control processes, optimization of device design, software design verification, and many other research studies and activities.

Finally, Phase II SBIR-STTR awardees can compete for additional SBIR-STTR funding via the NIH SBIR-STTR Phase IIB program. In the Phase IIB program, companies propose and conduct additional research and development to facilitate and accelerate the capital-intensive steps that are required to transition SBIR-STTR Phase II projects to the commercialization stage. Phase IIB projects should feature partnerships between SBIR-STTR Phase II awardees and third-party investors and/or strategic partners.

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Why a special focus on Alzheimer’s disease and related dementias?

NIA expects to provide over $100 million in annual funding for small business innovation in aging and AD in fiscal year 2018. NIA is the federal agency leading research on AD and AD-related dementias (ADRD) and has been granted significant additional R&D budget to address and develop interventions and therapeutics that prevent the onset of AD and ADRD, or that may lead to a cure.

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FAQs About Small Business Eligibility

Can my project include people or work that is done outside the U.S.?

In rare and unique circumstances—for example, if a supply or material or the study design (e.g., patient population) is not available in the United States—NIH may allow a small portion of the R&D to be performed by a foreign organization. Foreign involvement will be considered on a case-by-case basis and must be thoroughly justified in the application. Applicants should discuss their unique situations with NIH program staff prior to submitting the application. Whenever possible, non-SBIR/STTR funds should be used for work outside of the United States that is necessary to the overall completion of the project.

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Can my company be semi-virtual and exceed the sub-contracting limits?

Small business awardees are allowed to include fee-for-service activities as part of their Materials & Supplies budget under their direct costs which would count as the small business awardee’s portion of the work. Fee-for-service activities must meet the following parameters:

  1. It is a commercially available service
  2. All analysis is done by small business
  3. Billed on a fee-per basis (no indirect costs by fee for service providers)

Small business applicants are encouraged to contact NIA staff with specific questions as to what type of activities are defined as fee-for-service and what activities are defined as a subcontract.

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FAQs about Small Business Grant Applications

How can I apply to NIA's SBIR/STTR programs?

Before contacting NIA and submitting an application, applicants should:

  1. Review NIA’s open funding opportunities, including the annual NIH SBIR and STTR Omnibus Solicitation and NIA-only AD/ADRD opportunities;
  2. Review the NIH SBIR-STTR SF424 (R&R) application instructions and guidelines for completing the SBIR/STTR SF-424 application; and
  3. Access the Research Portfolio Online Reporting Tool (RePORT) system to determine if the proposal overlaps with an already-funded grant.


If there is no overlap, review the NIA Small Business Eligibility Requirements, including instructions for contacting contacting Michael-David A.R.R. Kerns to discuss your project.

Review the Tips for Applicants for resources to help you write a strong application.

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Can I see an example of a successful submission to guide my own application?

You can access successful sample applications from NIA as well as from the National Institute of Allergy and Infectious Diseases. These examples offer guidance in structuring your own application.

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What are the reviewers' qualifications, and how are they chosen to review?

Reviewers come from a wide range of organizations, including universities, non-profit advocacy and research organizations, and small businesses. Scientific Review Administrators (SRAs) from NIH's Center for Scientific Review select qualified reviewers and oversee the review process. Each reviewer is selected according to her or his relevant expertise and experience in the research.

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How do I ensure my application will come to NIA?

After potential applicants interact with NIA and learn whether the potential small business R&D would be appropriate for the Institute, they are encouraged to request NIA assignment by NIH's Center for Scientific Review in the PHS Assignment Request Form. The NIH Center for Scientific Review has exclusive authority and discretion over all application receipt, referral, and peer-review decisions.

After the application is submitted, the applicant will be notified of the following:

  1. That NIH received the application,
  2. To which Institute(s) it was assigned, and
  3. The name of and contact information for the SRA assigned to coordinate peer-review of the application.

If the application is not assigned to NIA, applicants may contact the Office of Receipt and Referral in NIH's Center for Scientific Review to request reassignment to NIA.

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Can I submit technology examples with my application?

Applicants who wish to submit supplemental materials should contact the SRA assigned to oversee the primary review of their SBIR/STTR applications to discuss and request permission to submit any supplemental materials. In addition, applicants should refer to NIH's recently published Notice on Post-Submission Materials.

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Who should submit a Fast-Track application?

Small businesses that are most competitive for a Fast-Track review are those that:

  1. Have completed some or part of the development of the prototype product, compound or service (or have some or part of the necessary product-development data) that needs further testing and development in the Phase II project, and
  2. Have a strong commercialization plan and the capability—including financial resources and/or third-party investment—to move quickly to realize commercial aims or outcomes.

If you’re considering applying for Fast-Track funding, contact the NIA Small Business Programs to discuss your project prior to submission.

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Who should submit a Direct-to-Phase II application?

Small businesses that are most competitive for an SBIR Direct-to-Phase II award are those that have already built a technology prototype and demonstrated its feasibility. These companies are ready to move directly into R&D that tests the functional viability of the prototype, eliminating the need to propose additional small feasibility studies.

Receipt of an SBIR Phase I award is not a requirement for a Direct-to-Phase II award. (Direct-to-Phase II funding is not available through the STTR program.)

If you’re considering applying for a Direct-to-Phase II award, contact the NIA Small Business Programs to discuss your project prior to submission.

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Does my small business need intellectual property agreements as part of my application?

Although it is not required as a part of the grant application, we strongly recommend that intellectual property agreements and arrangements be worked out among partners early on to ensure that the proposed project will be achievable. For an STTR award, which requires collaboration between a small business and a non-profit research institution, it is expected that intellectual property issues between the partners be addressed to ensure that the flow of the research, development, and commercialization of the project continues smoothly. Accordingly, small businesses and nonprofit research institutions should consider using the Model STTR Intellectual Property Agreement to address the allocation of rights in intellectual property and rights to carry out follow-on research, development, or commercialization for an STTR award. This model agreement may also be considered for addressing similar situations under SBIR awards that may involve subcontractors.

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How can I find the success rates for NIA SBIR/STTR program applicants?

You can find success rates organized by Institutes and Centers, mechanism/funding source, and activity code on the RePORT website. To find the latest data, search for the SBIR/STTR mechanism codes for each phase. The SBIR program uses R43 for Phase I and R44 for Phase II. The STTR program uses R41 for Phase I and R42 for Phase II.

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FAQs for Funded Companies

Can my small business file a patent if the work was funded by an SBIR/STTR grant?

Yes, small businesses normally retain principal worldwide patent rights and intellectual property developed with government funding.

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If my company is bought by another small company, can I continue to be the Principal Investigator in Phase II of my project?

SBIR/STTR grants are awarded to the applicant small business and not to the Principal Investigator. While working on any phase of an SBIR/STTR project, if the small business is acquired, or if the business status of the company otherwise changes in a fundamental way—namely, if ownership changes or the legal entity designation status changes—the project may be completed. However, if this change occurs while completing a Phase I and the company is acquired by a non-SBA-eligible company, applicants will not be eligible to submit a Phase II application.

For further information, contact Dr. Michael-David A.R.R. Kerns and the NIA Grants Management Specialist assigned to your award.

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How do I request a no-cost extension?

A first no-cost extension can be requested through eRA Commons and does not need staff approval. Additional no-cost extension requests should be sent to your NIA Program Officer and Grants Management Specialist, who are listed in eRA Commons.

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Do you handle money-related issues for my grant?

The NIA Small Business Programs address all questions and policies related to SBIR/STTR awards, including questions about funding and reporting requirements. The NIA Program Officer assigned to your grant addresses the scientific-related questions and issues. Finally, the Grants Management Specialist assigned to your grant addresses all money- and business-related questions.

Visit the NIH SBIR/STTR FAQs page for answers to more common questions.

Return to the NIA Small Business Main Page.

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