Part 1. Overview Information

Key Dates

No late applications will be accepted for this Funding Opportunity Announcement.

It is critical that applicants follow the SBIR/STTR (B) Instructions in the SF424 (R&R) SBIR/STTR 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 2. Full Text of Announcement

Purpose

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI), National Institute of Biomedical Imaging and Bioengineering (NIBIB), and National Institute on Drug Abuse (NIDA) intend to support early-career academic scientists interested in transitioning to entrepreneurship while also supporting the transfer of technology from academic laboratories into small businesses. For the purposes of this funding announcement, eligibility as an early career scientist is limited to applicants with 10 years, or less, of post-graduate experience.

This NOFO proposes a new and unique Fast-Track only award structure comprised of a Phase I STTR that transitions to a Phase II SBIR. Only small businesses can apply for and receive SBIR or STTR awards. However, this RFA utilizes an STTR in phase I because the STTR program is intended for projects in which the awardee small business is working closely with a university and therefore allows more work to be completed at the university as well as allowing more flexibility in terms of PI employment. Awards made under this NOFO will begin as a Phase I STTR to allow the early career scientist PI, or candidate, complete proof of concept studies at the academic site and prepare the technology to move into the small business. Upon successful completion of the STTR phase I activities, awards that transition to Phase II will convert to an SBIR award, requiring the PI to move their place of employment to the small business and limiting university involvement.

Mentoring is a key component of Small Business Transition Grant awards. Traditionally, mentoring has not been a factor in SBIR/STTR funding decisions, however, because mentoring is critical to facilitate the transition from junior academic scientist to entrepreneur, a mentoring plan is required in the application and included in the peer review scoring criteria for this NOFO. The ideal candidate for a Small Business Transition Grant award is a postdoctoral researcher who participated in technology discovery during their academic work and is now ready to move to a small business with the support of an experienced team to advise them.

To be responsive to this NOFO, proposed projects MUST pertain to the mission space of one of the participating Institutes and propose the development of a technology that fits into the technology categories described below under additional Institute/Center Priorities. Furthermore, all proposals must include clear, quantitative milestones (i.e. a quantitative definition of success) for each aim. In some cases, additional milestones or timelines may be requested as part of the Just In Time process or post-award. For awards made under this NOFO, transition from phase I to phase II will only occur after demonstration that all of the following criteria have been met; the candidate continues to receive mentoring support by both technical and business development (BD) mentors, all necessary IP agreement(s) are updated to reflect the next award phase timeline, a demonstration that all phase I technical milestones have been achieved (more information under Section IV. Application Submission Information).

Background and Rationale

Academic laboratories are critical partners for U.S. small businesses that are supported by the NIH SBIR/STTR Programs. These academic laboratories fulfill many roles, including both as the technology originators and collaborators of U.S. small businesses. This NOFO was developed, with the participation of multiple NIH ICs, to support a changing landscape of entrepreneurship where universities are increasingly encouraging junior scientists to become entrepreneurs.

Specific Areas of Research Interest from the participating NIH ICs of this NOFO are listed below. Applicants are strongly encouraged to contact the Scientific/Research Contacts from various NIH ICs listed in Section VII prior to submission to discuss IC program relevance.

The National Cancer Institute (NCI) SBIR/STTR programs support the development, translation, and commercialization of novel therapeutics, devices, diagnostics, and processes that are aimed at reducing the burden of cancer. A retrospective economic impact analysis of NCI SBIR/STTR Phase II grants from 1998-2010 indicated there was a substantial rate of commercialization, with 247 products commercialized from 690 Phase II grants. Sales of products and services associated with these grants were reported at $9.1 billion. Based on the reported sales, economic modeling calculated that over 107,000 jobs were created and $26.2 billion of economic output was produced.

The National Institute on Drug Abuse (NIDA) is the Federal Government’s lead agency for supporting scientific research on drug abuse and addiction. Over the last two decades, these research efforts, primarily conducted by academic institutions, have led to a substantial advance in the fundamental understanding of the neurobiological basis of substance use disorders (SUD). However, these insights and scientific breakthroughs have not been efficiently translated into scalable and effective solutions for SUD. For example, there are no pharmacotherapies approved to treat cannabis or stimulant use disorders, and the efficacy of available therapies for other SUDs such as opioid use disorder is limited. Through participation in this funding opportunity announcement, NIDA aims to empower the biomedical small business propagation in SUD fields and efficient technology transfer from academic labs.

The Small Business program at the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is used to achieve the mission of the institute by supporting innovative technologies through various stages of commercial research and development. The NIBIB welcomes SBIR and STTR applications from small businesses proposing ideas relevant to its scientific program areas. Please contact program staff if you have questions about which institutes(s) would be the best fit for your technology.

NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. Within these areas, approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or functions may be in scope for NHGRI. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.

Institute/Center Priorities

National Cancer Institute (NCI)

NCI encourages proposals that fall into several technology areas, including; (1) Cancer Therapeutics and Preventative Agents; (2) Cancer Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; (3) In Vitro and Ex Vivo Cancer Diagnostics and Prognostics; or (4) Technologies for Cancer Prevention and Control, Supportive Care, and Survivorship.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

National Institute on Drug Abuse (NIDA)

NIDA encourages proposals that fall into the following categories: Pharmacotherapeutic approaches for prevention and/or treatment; 2) Therapeutic and Diagnostic Devices, including Imaging Technologies, or (3) In Vitro and Ex Vivo Diagnostics.

National Human Genome Research Institute (NHGRI)

NHGRI encourages proposals that fall into the following research areas: 1) Genomic Technology and Methods Development; 2) Bioinformatics, Computational Genomics, and Data Science; 3) Population Genomics and Genomic Medicine; 4) Ethical, Legal, and Social Implications of Genomics; and 5) Genomics Training and Education.

Research Objectives and Requirements

Objectives of this NOFO

This NOFO has two simultaneous objectives; (1) to support the transition of early-career scientists from academia to entrepreneurship, and (2) to support the advancement of technologies out of academic research laboratories into small U.S. businesses.

Key Requirements for this NOFO

A. Requirement for strong mentors

Mentoring is a key component of this NOFO, and review of the mentors and mentoring plan is included in the scored peer review criteria. While candidates must have independent oversight over the project, each proposal must identify at least two mentors, one mentor who will advise the candidate on technology development, and one mentor who will advise the candidate on business development. More specifically, the purpose of the technical mentor is to help the candidate devise the best technical path forward by providing feedback on the appropriate assays and models to reach each developmental milestone. The purpose of the business development mentor is to help the candidate maintain a milestone-driven R&D plan and advise the candidate on which R&D milestones are appropriate for commercial development. Each mentor must provide a letter of support that outlines their commitment to the development of the technology and to the candidate. The identified mentors must meet the following criteria:

Technical mentor: The technical mentor should be the head of the academic laboratory from where the technology originated or be recognized as a key opinion leader in the same field as the technology being developed. This person may also be a co-founder, owner, or a C-level executive in the small business.

Business Development (BD) Mentor: The BD mentor could be an experienced BD executive, an experienced entrepreneur, an employee of a university’s technology transfer/innovation office, or an entrepreneur-in-residence (EIR). The BD mentor must have experience in an appropriate biotech sector relevant to the technology under development and should have experience as an executive in an industry setting or experience mentoring startups. Ideally, a BD mentor would have a track record of mentoring emerging entrepreneurs.

Other mentors: Applicants can include, but are not required to include, additional mentors or mentoring teams that will help them identify appropriate milestones and/or development strategy. The application must describe how each mentor will contribute to the success of the candidate and the success of the technology.

B. Eligibility

The purpose of the Small Business Transition Grant is to support early-career scientists who are transitioning from an academic research setting to a small business. Therefore, eligibility is limited to early-career scientists. For more information on who qualifies as an early career scientist, see eligibility in section III below.

C. Scientific/Technical Scope

Applications will be considered if they are within the mission of one of the participating Organizations/Institutes as described above under "Additional Institute/Center Priorities."

Additional Institute/Center Requirements

National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI), and National Institute on Drug Abuse (NIDA)

Each grant awarded through NCI or NHGRI or NIDA will be required to complete I-Corps at NIH (https://sbir.cancer.gov/programseducation/icorps). I-Corps at NIH is an entrepreneurial training program in which participants are required to interview at least 100 stakeholders to better identify market needs and therefore product-specific commercialization opportunities. Completion of I-Corps at NIH is required during the Phase I performance period and projects that do not fulfill the I-Corps at NIH requirement will not transition to phase II. In some circumstances when the project team has already completed a non-NIH I-Corps program prior to award, the project teams may be given an exemption from the I-Corps at NIH training requirement. An exemption request must be submitted in writing to the awardee's assigned NIH Program Officer. I-Corps at NIH exemptions will only be considered for awardees and will not be considered prior to application submission. Exemptions from I-Corps at NIH are case by case and are not guaranteed even if the project team has previously completed an I-Corps program.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Each grant awarded through NIBIB will be required to completed one of the two C3i programs at NIH (https://www.nibib.nih.gov/research-program/c3i-program). The NIH C3i program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). There are two versions of this program, the educational C3i (eC3i) program is a 10-week virtual program, which the C3i Validation/Execution program is a 24-week in-depth commercialization course. Both programs require 10 hours of work each week divided by the team members.

In some circumstances when the project team has already completed a non-NIH entrepreneur training program prior to award, the project teams may be given an exemption from the NIH C3i program requirement. An exemption request must be submitted in writing to the NIBIB small business office ([email protected]). Exemptions will only be considered for awardees and will not be considered prior to application submission. Exemptions from NIH C3i program are case by case and are not guaranteed even if the project team has previously completed an entrepreneur training program.

Evaluation of Transitioning from Phase I to Phase II

The transition from phase I to phase II will only occur after the following criteria are met and documentation approved by a transition committee coordinated by the funding IC; (1) a phase I final progress report that includes a description of the phase I success criteria and a demonstration that the success criteria were met, as well as a description of key learnings experiences of the Candidate (see description below); (2) an updated commercialization plan that identifies changes from the original commercialization plan including changes based on learnings from I-Corps at NIH or C3i program as well as other entrepreneurial activities and events; (3) an updated IP agreement and an updated letter of support from the university that describes the current status of the IP, e.g. license option extension or executed license, etc., the metrics that the university used to evaluate the IP and verification that the university continues to support the small businesses efforts to develop and commercialize the technology; (4) updated letters of support from the technology mentor and BD mentor that describe the professional growth of the Candidate during the phase I project period, and a description of the mentoring relationship in phase II based on the needs of the Candidate; (5) full participation and completion of I-Corps at NIH or C3i program, unless exempted in writing from their program officer; (6) Verification that all SBIR eligibility requirements are met as all awards must transition to SBIR in phase II (see below for SBIR eligibility criteria).
Because of the dual focus on mentoring and product development, it is expected that the phase I portion of several applications may propose fairly high-risk activities. While high-risk activities are allowed in phase I, transition to phase II is dependent upon demonstrating adequate technical success in phase I, projects that fail to meet their success criteria or do not demonstrate adequate technical progress in phase I as determined by the transition committee, will not transition to phase II.

Section I. Notice of Funding Opportunity Description

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

1. Eligible Applicants

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:

1. 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;
2. 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;

i. 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

ii. 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

iii. 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.

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 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.

On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements. SBA will notify companies and the relevant officials at the participating agencies. More information on the Phase II to Commercialization requirement is available at SBIR.gov.

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

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 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.

• 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.

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.

It is not expected that the PI/PD hold a specific title within the company, however, the PI/PD must demonstrate in the application that they have decision-making authority over the project. In cases where the PI/PD is junior and holding a C-level executive title within the company, the mentoring plan should demonstrate that the PI/PD has sufficient professional experience to be effective in this role, or sufficiently strong mentoring relationships to help them transition into a C-level decision making role within the company.

The Principal Investigator (PI) on the application must have no more than ten years of postdoctoral or post-graduate research experience as of the relevant application due date regardless of whether it is a new or resubmitted application. Multiple PIs are not allowed. Only individuals who are mentored non-independent researchers are eligible to serve as PD/PI on a Small Business Transition Grant application. Requests for change in PI will not be accepted during the duration of this award. Parental, medical, or other well-justified leave for personal or family situations of generally less than 12 months duration is not included in the 10-year eligibility limit, nor is clinical training with no research involvement (e.g., full-time residency training). Part-time postdoctoral research training, related to personal or family situations or occurring during a research residency or fellowship, will be prorated accordingly. In addition, time spent conducting postgraduate clinical training that does not involve research is not considered part of the 10-year research training eligibility limit. Only time dedicated to research activities would count toward the 10-year limit.

Individuals are NOT eligible if they:

• Are not a U.S. Citizen or Lawful Permanent Resident;
• Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
• Have more than 10 years of related postdoctoral research training at the time of initial application; or
• Have been an independent PD/PI on NIH research grants (e.g. R01, R21, R41, R43, etc.), NIH career development awards (e.g., K01, K07, K08, K23, K25), or other peer-reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or Project Leads on sub-projects of program project (P01) or center (P50) grants.

It is recognized that in some institutions junior researchers in mentored non-independent positions can hold a variety of titles. Candidates that are in mentored non-independent researcher positions are encouraged to obtain confirmation of their eligibility from the relevant IC before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that his or her position complies with the intent of this eligibility requirement. If a potential candidate is in a position that is not clearly identified as a postdoctoral training position, the applicant should submit an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postgraduate research training position, or attain a letter from someone in a leadership position in the institution, such as a department chairperson, verifying that the applicant is not independent and continues to receive career mentoring.
Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. Clinicians are defined by individuals with an M.D., D.D.S, D.V.M. or other licensed professional degree in a position that is not designated as a postdoctoral position. A clinical faculty member who does not hold an independent research faculty position may be eligible for a small business transition grant award and should contact a Program Director at the relevant NIH Institute for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications.
The following is provided as an aid to distinguish independent from non-independent positions. However, it is not sufficient merely to cite one or more of the following items to document eligibility.

Evidence for non-independence may include:

• The candidate’s research is entirely funded by another investigator’s grants.
• The candidate’s research is conducted entirely in another investigator’s assigned space.
• According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students.
• According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01).

Conversely, evidence for independence, and therefore lack of eligibility, includes:

• The candidate has a full-time faculty position.
• The candidate received a start-up package for support of his/her independent research.
• The candidate has research space dedicated to his/her own research.
• The candidate may hire technical support and postdoctoral fellows, supervise laboratory staff, and attend faculty meetings.
• The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review.

A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively.

Mentor(s)

Before submitting the application, the candidate must identify two mentors who will advise them on their transition from discovery-based academic researcher to milestone-based product developer/entrepreneur. The role of each mentor should be clearly consultative and not in a position of authority over the project if an award is made.

Technology Mentor: Each proposal must identify a technical mentor, ideally the head of the academic laboratory from which the technology originated. In rare cases the technology mentor can be an active investigator that is not affiliated with the partnering university, however in this case the technology mentor must be actively engaged in research and recognized as a leader in an appropriate technical field for the proposed project. The technical mentor must document the availability of sufficient research support and facilities for high-quality research if their facilities are used as a collaborator site. The goal of the technology mentor is to advise the candidate on the approach and execution of the research.

Business Development (BD) Mentor: The second mentor that must be identified in each proposal is the candidate's business development mentor. The business development mentor should have demonstrated experience in developing products or advising small businesses on product development. The business development mentor must have experience relevant to the technology being developed, preferably with a prior track record of commercialization.

Both mentors must be committed to the goals of the small business transition grant, namely the career development of the candidate as well as the commercial development of the product. The mentors are required to be listed as key personnel with a time commitment of at least 5% or 0.6 calendar months. Mentors are encouraged but not required to participate in I-Corps at NIH or C3i unless they have a decision-making role within the company that is weighted more heavily than the candidate in which cases their participation is mandatory. More information on I-Corps at NIH and C3i can be found here: https://sbir.cancer.gov/programseducation/icorps, https://www.nibib.nih.gov/research-program/c3i-program.

Mentors are only allowed to advise one candidate at a time, and inclusion of a mentor that is already listed on another active small business transition grant will render the application ineligible to receive funding. Because mentors are advising the candidate on R&D-related activities, mentors are allowed to request salary support on the award, but it is not required.

To meet the mentoring requirement, candidates may identify a group of mentors, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and career development of the candidate. In such cases, one individual must be identified as the primary technology mentor and another individual as the primary business development mentor. Mentor statements from each primary mentor are required in the application as described above.

In Phase I and Phase II, at least 40% of the research or analytical effort must be performed by the small business concern and at least 30% of the research or analytical effort must be performed by the single, partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS 398 Research Plan component of the SF424 (R&R) application forms.

A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS 398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the SBIR/STTR (B) Instructions in the SF424 (R&R) SBIR/STTR Application Guide, except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:
Saroj Regmi, Ph.D.
National Cancer Institute (NCI)
Email: [email protected]

All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed with the following additional instructions:

Candidate Career Development Plan:

A candidate career development plan is required for all small business transition grant applications in response to this NOFO. The Candidate's career development plan cannot exceed two pages, and should be organized into four sections, following the headings and specified order below with each point below discussed.

Section 1: Candidate's Background

Describe the candidate’s scientific history, when and how the product discovery was made, the role the candidate played in the discovery of the product, and why this candidate is the right person to move with the product into a small business setting. In cases where the candidate lacks a publication record, provide a description of how the candidate has demonstrated productivity.

Section 2: Candidate's Career Goals and Objectives

Describe the candidate’s current and long-term research and career objectives. Present a scientific history that shows a logical progression from the candidate’s prior research and training experiences toward a career in product development. Describe how the candidate plans to separate from his/her academic mentor and oversee the project within the small business.

Section 3: Candidate's plan for professional growth during the award period

A systematic plan should be presented for obtaining the appropriate training and experience to launch the stated independent career in a small biomedical business. Describe current activities and how they relate to the candidate’s career development plans and career goals. Describe proposed activities, e.g., those that will lead to new and/or enhanced research skills and knowledge, as well as related skills such learning about regulatory (e.g. FDA) requirements, understanding markets, customers, competition, and small business financing. The career development plan must be specifically tailored to meet the needs of the candidate and the goal of achieving experience in building small biomedical businesses. Describe how the mentors will be utilized based on the roles of the mentors, e.g. will the mentors be conducting these activities along with the Candidate, or will the Candidate be leading these efforts with advice from the mentors?

Section 4: Mentor Utilization and Lines of Authority

Describe how the candidate plans to utilize the expertise of each mentor during the project and when differing technical approaches and priorities are presented, how the candidate will make a determination on the best path forward. This section should also indicate which mentors will be part of the I-Corps at NIH or C3i team. If any of the primary mentors will not be on the I-Corps at NIH or C3i, this section should discuss who will take their place and why they will be a good fit for the I-Corps or C3i program.

Mentor Statements:

Each complete application must include two mentor statements: one from the Candidate's primary technical mentor and one from the Candidate's primary business development mentor. The two mentor statements along with the candidate's career development plan are the parts of the application that will be used by peer reviewers to evaluate the professional development environment for the Candidate. Each mentor statement should be tailored to the needs of the individual candidate. Each mentor statement should not exceed two pages and should include the three sections and information disused below.

Section 1: Mentor Background

Describe the mentor's professional history, the mentor's relationship with the technology and the SBC including any formal roles within the SBC and if the mentor has an equity stake in the SBC.

Section 2: Mentor Goals and Objectives

Describe the historic and current relationship between the mentor and the candidate, outline the experiences thus far that make the candidate a strong choice to lead a small business transition grant, and the key areas where the mentor's experience will add value to the candidate's professional growth and understanding of product development.

Section 3: Mentoring Plan

Describe the frequency and type of interactions, e.g. in person, virtual, one-on-one, group settings, etc. Mentors should discuss their expectations for technical and/or business development progress over the entire period of the proposed project. The mentoring plan must also include a statement describing any commitment the mentor has to completing I-Corps at NIH or C3i program.

Facilities & Other Resources (Applicable to applications submitted for due dates on or after September 5, 2023)

In addition to describing the scientific environment and the company support, the applicant must describe the business environment and resources, or how the company will obtain access to the appropriate business resources, for completing and commercializing the proposed product or service. This includes any relevant intellectual property associated with the project necessary to facilitate commercialization.

Other Attachments:

1. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms

Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive. Follow the instructions below.

Applicants small business concerns who are 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), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it their application package.

1. Download the VCOC Certification.pdf at the NIH SBIR Forms webpage.
2. Answer the 3 questions and check the certification boxes.
3. The authorized business official must sign the certification.
4. Save the certification using the original file name. The file must be named SBIR Application VCOC Certification.pdf . DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.
5. When you are completing the application package, attach this certification as a separate file by clicking "Add Attachments" located to the right of Other Attachments field on the Research and Related Other Project Information form.

2. Statement of eligibility. Applicants that are employed by the partnering university at time of application must submit an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents their current position as a mentored, postgraduate research training position, or attain a letter from someone in a leadership position within the university, such as a department chairperson, verifying that the applicant is in a training position and not an independent academic researcher.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

Project Summary/Abstract:

The abstract should be a succinct and accurate description of the work as well as how the work and the small business transition fellow PI will be supported by the team.

SPECIFIC AIMS

The Specific Aims page should outline the overarching goals of the project including key milestones that will serve as benchmarks for accomplishing these Aims. Each aim should include success criteria that will be used to identify that a milestone has been achieved.

RESEARCH STRATEGY

The research strategy should provide a detailed rationale, experimental approach, and expected/alternative outcomes for the proposed studies. Although it is anticipated that candidates will be best able to describe their current and past research, the research plan for the phase II portion of the proposal should be described in sufficient detail for reviewers to evaluate the merit of this component of the application. In accordance with the Application Guide, the Research Strategy section should be split into three sections; 1) Significant, 2) Innovation, and 3) Approach. The innovation section of the research plan must include a brief discussion of the academic research that led to the discovery of the product. In cases where ongoing discovery research in the technical mentor's lab is complementing the candidate's product development activities, the candidate may also briefly describe the complementary nature of the research at the two institutions in the approach section, if it will help to understand all product development activities.

Letters of Support:

Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.

SBIR/STTR Information

COMMERCIALIZATION PLAN

The commercialization plan section should include the following additional information in the sections described below

a. Value of the SBIR/STTR Project, Expected Outcomes, and Impact:

- A concise description of the current development stage of the technology (e.g. concept, prototype, preclinical, etc.)

- A brief description of the next inflection point for the technology and how the intended product development milestones in the application, if successful, will move the technology toward this inflection point

b. Company

A project management plan must be included in the "company" section of the Commercialization Plan. The project management plan must identify the role of the candidate within the company as well as the role of each of the two primary mentors within the company. In cases where the Candidate is a direct report of one or both mentors, the management plan should lay out a plan for ensuring that the Candidate has authority over the small business transition grant project in the event of funding. Finally, the management plan should identify a hierarchy of decision making when the two mentors are in conflict and this should include the role of the entrepreneurial fellow PI as the leading authority on the project if funded.

Resource Sharing Plans:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s)

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) applicants are required to address a Data Management and Sharing Plan, regardless of the amount of direct costs requested for any one year. However, SBIR and STTR recipients may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. An acceptable Data Management and Sharing plan can reference and incorporate these data rights. Further information about SBIR and STTR data rights are enumerated in the NIH GPS.

Appendix:

Note that Phase I SBIR/STTR Appendix materials are not permitted. Only limited items are allowed in the Appendix of other small business applications. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and time. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) SBIR/STTR Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field?Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)

Specific for this NOFO:

How reasonable is it to assume that the proposed product would be adopted into practice if fully developed? How high is the likelihood that the career development plan will enable the candidate to gain substantial product development knowledge and therefore add value to this small business and/or subsequent small businesses?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific for this NOFO:

How well does the candidate demonstrate through information provided in the application, or through publication history, that they have the appropriate technical experience to lead the proposed project? In cases where the candidate lacks a publication history, how adequate is the explanation of the candidate’s productivity? How sufficient is the candidate’s technical knowledge to support this product? How appropriate are the candidate’s independence and oversight over the project? How appropriate are the milestones and success criteria in the application, such that if they were achieved the product would reach a commercial development inflection point?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? For a Phase I application, are there clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?

Specific for this NOFO:

How experienced and knowledgeable are both of the primary mentors in their field to support the candidate and the development of the proposed product? How appropriate is the technical mentor’s background to the project? How committed is the technical mentor to the success of the project and the candidate? How appropriate is the BD mentor’s expertise to understand the market sector and appropriate product development milestones? How sufficient is the time dedicated by the mentors to the project in order to adequately advise the candidate? How clearly do the mentor statements provided by the mentors indicate that they understand the candidate's needs and tailor their mentoring plan to meet these needs? How supportive is the academic institution of the product development activities taking place at the small business as demonstrated through letters of support and/or an IP agreement?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

How clearly is the phase I success criteria stated and appropriate for the project? How appropriately balanced is the focus of the application between mentoring and product development? How reasonable and clear are the technical success criteria at the end of phase I to be used to evaluate transition to phase II? How well does the phase II portion of the application outline clear milestones with appropriate success criteria? How clearly does the application layout a plan for the candidate to advance their knowledge of both product development and small business development? How clear are the roles of both mentors? How well does each mentor add value to the development of the candidate and the technology?

Candidate's Career Development Plan
Are the content and duration of the proposed components of the career development plan appropriate and well-justified for the candidate’s current stage of scientific and professional development and proposed research career goals?
To what extent does the proposed career development plan enhance or augment the candidate’s research training and skills acquisition to date?
Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate, and facilitate their successful transition to independence in a biomedical small business?

Phase I/Phase II Fast-Track Applications

For Phase I/Phase II Fast-Track Applications, reviewers will consider the following:

1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

2. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Phase IIB Competing Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Small business and/or candidate diversity. Reviewers should consider the location of the small business if it is operating in an NIH-designated IDeA state, or a historically underutilized HUBzone . Reviewers should also consider the candidate's background and their access to available resources

Applications with Foreign Components

Reviewers will consider whether work to be performed outside of the United States is thoroughly justified, based on a rare and unique circumstance, and necessary to the overall completion of the project.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI , in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Security risk as assessed by the HHS Due Diligence Program (for due dates on or after September 5, 2023).

Disclosure Requirements Regarding Ties to Foreign Countries (Applicable for applications submitted for due dates on or after September 5, 2023)

Upon request applicants are required to disclose all funded and unfunded relationships with foreign countries, using the Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form (referred to as the "Disclosure Form" hereafter), for all owners and covered individuals. A "covered individual" is defined as all senior key personnel identified by the SBC in the application (i.e., individuals who contribute to the scientific development or execution of a project in a substantive, measurable way).

Upon request, applicants must submit the completed Disclosure Form and any additional agency-specific information electronically in eRA Commons via the Just-In-Time (JIT) process as described in the NIH Grants Policy Statement (GPS) Section 2.5.1 Just-in-Time Procedures. Applicants must continue to comply with NIH Other Support disclosure requirements as provided in NIH GPS Section 2.5.1 and may be required to provide similar information on the Disclosure Form for covered individuals identified in the application. If participating in this NOFO, SBC applicants applying to CDC and FDA will follow each agency's policies for submitting additional documents during the pre-award process. Applicants that do not submit the completed Disclosure Form during the JIT process will be deemed noncompliant and not be considered for funding.

Denial of Awards (Applicable for applications submitted for due dates on or after September 5, 2023)

Applicants are encouraged to consider whether their entity's relationships with foreign countries of concern will pose a security risk. Prior to issuing an award, NIH (and CDC or FDA, as applicable) will determine whether the SBC submitting the application:

• has an owner or covered individual that is party to a malign foreign talent recruitment program;
• has a business entity, parent company, or subsidiary located in the People's Republic of China or another foreign country of concern; or
• has an owner or covered individual that has a foreign affiliation with a research institution located in the People's Republic of China or another foreign country of concern.

A finding of foreign involvement with countries of concern will not necessarily disqualify an applicant. NIH (and CDC or FDA, as applicable) will provide SBC applicants the opportunity to address any identified security risks prior to award. Final award determinations will be based on whether the applicant's involvement falls within any of the following risk criteria, per the Act:

• interfere with the capacity for activities supported by NIH, CDC, or FDA to be carried out;
• create duplication with activities supported by NIH, CDC, or FDA;
• present concerns about conflicts of interest;
• were not appropriately disclosed to NIH, CDC, or FDA;
• violate Federal law or terms and conditions of NIH, CDC, or FDA; or
• pose a risk to national security.

NIH, CDC, and FDA will not issue an award under the SBIR/STTR program if the covered relationship with a foreign country of concern identified in this guidance is determined to fall under any of the criteria provided above, and the risk cannot be resolved.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

For applications submitted for due dates on or after September 5, 2023, SBIR and STTR applicants under consideration for award will be required to submit the SBA U.S. Small Business Administration (SBA) issued the Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form during the JIT process. Applicants that fail to submit a Disclosure Form will not be considered for funding.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

• Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. SBIR and STTR recipients may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. An acceptable Data Management and Sharing plan can reference and incorporate these data rights. Further information about SBIR and STTR data rights are enumerated in the NIH GPS.

4. Reporting

NIH requires that SBIR/STTR recipients submit the following reports within 120 days of the end of the grant budget period unless the recipient is under an extension. When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

• Final RPPR (requirements have recently changed - please see the NOT-OD-17-085)
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Federal Financial Report (FFR)
• SBIR.gov
• Quarterly reports are due to the Payment Management System 30 days following the end of each calendar quarter.

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Disclosure of Foreign Relationships Reporting Requirements (Applicable for applications submitted for due dates on or after September 5, 2023)

Recipients are responsible for monitoring their relationships with foreign countries of concern post-award, for any changes that may impact previous disclosures. SBCs receiving an award under the SBIR/STTR program are required to submit an updated Disclosure Form to report any of the following changes to NIH (and CDC or FDA, as applicable) throughout the duration of the award:

• any change to a disclosure on the Disclosure Form;
• any material misstatement that poses a risk to national security; and
• any change of ownership, change to entity structure, or other substantial change in circumstances of the SBC that NIH, CDC, and FDA determine poses a risk to national security.

Updated Disclosure Forms are required within 30 days of any change in ownership, entity structure, covered individual, or other substantive changes in circumstance, as described above. Recipients are required to upload these updated disclosures using the Additional Materials (AM) tool in eRA Commons. In addition, regular updates are required at the time of all SBIR/STTR annual, interim, and final Research Performance Progress Reports (RPPRs).

If the recipient reports a covered foreign relationship that meets any of the risk criteria prohibiting funding described in this NOFO, NIH, CDC, and FDA may withhold funding until the covered relationship has been dissolved. The recipient will be required to submit documentation verifying the relationship has been terminated. If the risk cannot be resolved, NIH, CDC, and FDA may deem it necessary to terminate the award for material failure to comply with the federal statutes, regulations, or terms and conditions of the federal award. Refer to NIH GPS Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support for more information. Recipients are encouraged to monitor their covered foreign relationships post-award and avoid entering into relationships, both funded and unfunded, that may pose a security risk and jeopardize their ability to retain their award.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Saroj Regmi, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7289
Email: [email protected]

Lisa Chadwick
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7275
E-mail: [email protected]

Kari Rich Ashmont
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: 301-496-1447
E-mail: [email protected]

Tam L Nguyen
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-451-1203
E-mail: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: [email protected]

Deanna L Ingersoll
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7858
E-mail: [email protected]

James E Huff
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: (301) 451-4786
E-mail: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 45 CFR Part 75 and 2 CFR Part 200.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, and P.L. 117-183. The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.

The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, P.L. 107-50, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, and P.L. 117-183. The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.