NIA Research and Entrepreneurial Development Immersion (REDI): Entrepreneurial Small Business Transition Award

NIA Research and Entrepreneurial Development Immersion (REDI): Entrepreneurial Small Business Transition Award is sponsored by National Institutes of Health (NIH) - National Institute on Aging (NIA). This SBIR grant focuses on transitioning entrepreneurial researchers into small business owners, particularly for projects relevant to aging.

Decision support tools for healthcare, diagnostics, or patient management in an aging population could be relevant.

Expired RFA-AG-24-043: NIA Research and Entrepreneurial Development Immersion (REDI): Entrepreneurial Small Business Transition Award (R41/R42 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Notice of Funding Opportunity Title NIA Research and Entrepreneurial Development Immersion (REDI): Entrepreneurial Small Business Transition Award (R41/R42 Clinical Trial Optional) R41 / R42 Small Business Technology Transfer (STTR) Grant - Phase I and Fast-Track November 14, 2023 - Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements.

See Notice NOT-OD-24-029 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . June 12, 2023 - Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See Notice NOT-OD-23-139 .

February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants. See NOT-OD-23-092. Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity Small Business Innovation Research Grants (SBIR) - Phase I/ Small Business Innovation Research Grants (SBIR) - Phase II See Section III.

3. Additional Information on Eligibility . Assistance Listing Number Notice of Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) invites Research and Entrepreneurial Development Immersion (REDI) Small Business Technology Transfer Research (STTR) Grant applications.

The goal of this NOFO is to foster the career development of early-career scientists with an interest in entrepreneurship by simultaneously supporting their entrepreneurial development and facilitating their transition to industry.

This NOFO utilizes the R41/R42 Industry Development Award to provide small business concerns (SBCs) the opportunity to support the hiring and salary of postdoctoral fellows and early-career researchers as Principal Investigators/Program Directors (PIs/PDs) to increase their scientific research staff and support product development.

Additionally, a major component of this NOFO is a strong focus on entrepreneurial training, mentoring, and career development of the PD/PI. Early-career researchers, including graduate students and postdoctoral fellows, with strong research skills and experience in technology discovery, and who have an interest in growing their entrepreneurial skillset and working in the industry, are optimal PD/PIs for this award.

Given that the purpose of this NOFO is to facilitate the PDs/PIs' transition to the SBC, we strongly encourage that the majority of the PDs/PIs' employment is at the SBC. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Required Application Instructions It is critical that applicants follow the SBIR/STTR (B) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The number of available tenure-track faculty positions has not kept pace with the growing number of Ph. D. graduates in recent years.

This imbalance has created a highly competitive job environment, making it increasingly difficult for Ph. D. graduates to transition to academic appointments.

Doctoral and post-doctoral training programs have heavily revolved around developing skill sets that are directly relevant to academic research activities, such as the ability to publish rapidly and secure research funding.

Given that most of the available National Institutes of Health (NIH) training programs and fellowship opportunities are in place to train scientists for an academic career, these trainees may then lack the soft skills, such as the business acumen to think entrepreneurially and to innovate, and the know-how to transition to other scientific positions.

Also, modern academic positions have evolved to often include roles that are multidisciplinary and focused on translational research. These roles are optimally suited for individuals with a broad skill set and understanding of the cross-sector landscape.

University research fosters a substantial portion of industrial research and development (R&D) in the biotech industry, and university spin-offs employ high-tech talent, generate taxes, and act as economic hotbeds for the local economy. Also, spin-offs frequently catalyze the formation of technology-focused geographic clusters.

The biotech community has been essential in catalyzing academic discoveries and commercializing them into needed solutions that improve public health. This is especially true for neurodegenerative diseases and aging-based research, where there are significant unmet needs and the opportunities for product development are rapidly expanding.

Therefore, this STTR initiative addresses the need to facilitate the development and commercialization of academic technologies by supporting the transition and experiential entrepreneurial career development of early-career scientists while providing funding for small business R&D activities that could ultimately lead to commercialization of innovative technologies that address significant unmet needs.

Given their scientific acumen, early-career scientists have emerged as vital stakeholders in the spin-off generation process, as they have the potential to address the need for entrepreneurs in the aging research ecosystem.

The crucial role that early-career scientists play in the formation of spin-offs is mainly due to three factors: the accelerated rise of early-stage biotech investing, the rapid expansion of biotech incubators, and an increase in the number of early-career researchers with more varied career interests.

Since new biotech and medical tech companies require skilled researchers who can also perform duties related to business and product development, providing early-career scientists with entrepreneurial training and mentorship will broaden their career options and give the companies access to new workforce talent.

Therefore, supplementing the traditional postdoctoral or early-career research experience with training in entrepreneurship and innovation can help provide early-career scientists with both the scientific acumen and business skillset that may play a key role in turning an idea with translational potential into a commercialized innovation that adds major value to older adults and the longevity economy.

This training experience will not only increase the number and health of academic spinoffs but will also empower and enhance the employability and value offered by early-career scientists beyond academia.

The National Institute on Aging (NIA) seeks to use this initiative to address the growing need to foster the advancement and accelerate the commercialization of technologies generated from academic research laboratories by supporting both the transition of translational research into commercial products and services and the entrepreneurship training and mentorship of future and early-career scientists emerging as key leaders of the biotech landscape.

This NOFO utilizes the R41/R42 STTR Award to provide small business concerns (SBCs) the opportunity to increase their scientific staff by supporting the hiring and salaries of early-stage researchers, including late-stage graduate students and postdoctoral fellows, as Program Directors/Principal Investigators (PDs/PIs).

It is expected that each SBC will ensure robust entrepreneurial training for the PD/PI, while the PD/PI will bring extensive research knowledge and experience, as demonstrated by patents and publications and/or relevant technical training, to the SBC. The PD/PI may contribute to the SBC by increasing the technical know-how of the SBC and serving as a bridge between the SBC and academic institutions.

Analogous to other STTR opportunities, the award, as well as ensuing data generated by the award, will be retained by the SBC. This STTR NOFO will allow both Phase I and Fast-track applications. A key difference between this award and other STTR awards is that this opportunity is specifically aimed at early-career scientists that are interested in entrepreneurial training and mentorship.

Additionally, this award provides an opportunity for them to grow their entrepreneurial skills while serving as PDs/PIs. Entrepreneurial training and mentoring will be critical components of the peer review.

It is expected that the SBC ensures participation of the PD/PI in entrepreneurial training activities by utilizing locally and/or widely available entrepreneurship-focused courses and training programs, as well as by assembling a mentoring team that supports the career growth and development of the PD/PI. The proposed scientific projects must be in line with the stated purpose of this NOFO and the mission of NIA.

Therefore, applicants are encouraged to contact NIA program staff, using the information listed in Section VII of this NOFO, to discuss both their R&D ideas and career development plans. One primary criterion of this NOFO is mentorship. To be competitive, applications must identify at least one mentor.

The mentor will ensure the successful completion of the project, both from the technical and commercial points of view. In doing so, the mentor will also equip the PD/PI with key technical and business acumen. A letter of support from the mentor highlighting their commitment to the project, as well as to the PD/PI's professional growth, is required.

The mentor can be a co-founder, owner, or C-level executive in the SBC, although that is not necessary. The mentor is expected to have prior experience in mentoring entrepreneurs. Other mentors or mentoring teams that may provide additional focal points of guidance may be included by the applicant.

B. Entrepreneurship Training Another key component of the program is entrepreneurship training. Submission of a career development plan is required, and it should include a combination of coursework and workshops.

Mentors should play a key role in identifying appropriate coursework, training programs, and workshops to bolster both the technical and the business acumen of the PD/PI as well as the business development prospects of the proposed research.

Given that this NOFO supports the transition of early-career scientists into industry, the eligibility of the PD/PI is limited to early-career scientists, including late-stage graduate students and postdoctoral fellows.

E arly-career scientists from diverse backgrounds , including individuals from groups underrepresented in the U.S. biomedical, clinical, behavioral, and social sciences research enterprise, which includes individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds (see Notice of NIH's Interest in Diversity, NOT-OD-20-031 ), are encouraged to apply.

The transition candidate must be listed as the PD/PI on the application and is encouraged to be primarily employed by the SBC at the time of the award. Additional investigators can serve as co-investigators and provide support to the transition of the early-career scientist to a PD/PI role within a small business. C.

Scientific/Technical Scope Applications will be considered if they fall within the mission of NIA and the proposed technology falls within the scope of the traditional SBIR/STTR grant mechanisms.

Applicants are encouraged to partner with existing NIH, or other federal, resources and programs and leverage existing entrepreneurial training activities from both federal and private-sector partners, such as the NIH Proof of Concept Network which encompasses the NIH Centers for Accelerated Innovations ( NCAI ), NIH Research Evaluation and Commercialization Hubs ( REACH ), and the National Institute of General Medical Sciences' IDeA Regional Entrepreneurship Development (I-RED) Program ; the National Science Foundation’s Innovation Corps (I-Corps?)

; the A2 collective ; and the National Center for Advancing Translational Sciences' Clinical and Translational Science Awards ( CTSA ). Clinical Research Operations Management System NIA utilizes a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research.

NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects.

NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant and as described in NOT-AG-23-017 .

Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4. 1. 15.

7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website . When applicable, all NIA grantees must ensure: 1.

The study’s Informed Consent Document (ICD) lists The National Institutes of Health (NIH) and its authorized representatives as one of the organizations that may look at or receive copies of information in participants study records. According to DHS HHS OHRP 45 CFR 46 46. 116 , all ICDs must contain A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.

If using the NIA informed consent template please see Section 6: Statement of Confidentiality. 2. An assigned NIH ClinicalTrials.

gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials. gov. See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed New (Phase I, Fast-Track) Resubmission (All Phases) - Phase I and Fast-Track only The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for the NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NIA intends to commit $1. 5 million in fiscal year 2024 to fund 4 awards. Total funding support (direct costs, indirect costs, fee) normally may not exceed $295,924 for Phase I awards and $1,972,828 for Phase II awards.

For specific topics, NIH may exceed these total award amounts. The current list of approved topics can be found here . Applications that address the approved waiver topics may request total cost budgets up to $500,000 for Phase I and $2,500,000 for Phase II of a Fast-Track.

Applicants are strongly encouraged to contact program officials prior to submitting any application in excess of the total award amounts listed above early in the application planning process. In all cases, applications should propose a budget that is reasonable and appropriate for completion of the research project. Award durations of up to 2 years for Phase I and up to 3 years for the Phase II of a Fast-Track may be requested.

Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information 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; SBIR and STTR.

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 SBIR-only.

Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.

No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund , or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR SBIR and STTR.

Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121. 705(b) concerning registration and proposal requirements.

4. Has, including its affiliates, not more than 500 employees. If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV.

Application and Submission Information for additional instructions regarding required application certification. 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.

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 SF424 (R&R) SBIR/STTR 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.

Performance Benchmark Requirements Phase I to Phase II Transition Rate Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022.

The benchmark establishes a minimum number of Phase II awards the company must have received relative to a given number of Phase I awards received during the 5-fiscal year time period.

The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year.

The Transition Rate requirement, agreed upon and established by all 11 SBIR agencies, was published for public comment in a Federal Register Notice on October 16, 2012 (77 FR 63410) and amended on May 23, 2013 (78 FR 30951).

For SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0. 25 will not be eligible to apply for a Phase I, Fast-Track, or Direct Phase II (if available) award for a period of one year from the date of the application submission.

This requirement does not apply to companies that have received 20 or fewer Phase I awards over the prior 5-fiscal year period. For application deadlines that fall on or after April 5, 2023: For SBIR and STTR Phase I applicants that have received more than 50 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.

5 will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase I awards over the 5-fiscal year period. On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements.

SBA calculates individual company Phase I to Phase II Transition Rates using SBIR and STTR award information across all federal agencies. SBA will notify companies and the relevant officials at the participating agencies. More information on the Phase I to Phase II Transition Rate requirement is available at SBIR.

gov. Phase II to Commercialization Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Programs are implementing the Phase II to Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022.

The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 ( 78 FR 48537 ), with a reopening of the comment period published on September 26, 2013 (78 FR 59410).

For companies that have received more than 15 Phase II awards from all agencies over the past 10 fiscal years (excluding the two most recently-completed fiscal year): Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0. 15 (15%) patents per Phase II award resulting from these awards during the past 10- fiscal year period.

Applicants that fail this benchmark will not be eligible to apply for New Phase I, Fast-track or Direct Phase II (if applicable) awards for a period of one year. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.

For application deadlines that fall on or after April 5, 2023: For companies that have received more than 50 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently-completed Fiscal Year): Companies that meet this criterion must show an average of at least $250,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period.

Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.

For application deadlines that fall on or after April 5, 2023: For companies that have received more than 100 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $450,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period.

Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 100 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , may be allowed.

Applicant organizations 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 Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. System for Award Management (SAM) 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. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. SBA Company Registry See SF424 (R&R) SBIR/STTR Application Guide for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a UEI to complete this registration.

SBA Company registration is NOT required before SAM, Grants. gov or eRA Commons registration. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; all registrations must be in place by time of submission. 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 SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 .

For the STTR program, the PD(s)/PI(s) may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual.

Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. Multiple PDs/PIs are not allowed. Eligible PDs/PIs are those within ten years of completing their terminal research degree, including master's degree, at the time of application submission.

Currently enrolled master's and Ph. D. students are eligible to apply, though receipt of the award is contingent upon degree completion.

Enrolled master's and Ph. D. students applying are required to submit a letter of support from their mentor.

The letter should clearly state the student's expected graduation date. PDs/PIs may not currently hold or have held another SBIR/STTR award (R41-44)