Part 1. Overview Information

Key Dates

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 FOA or in a Notice from the NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) 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

Section I. Funding Opportunity Description

Background

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America’s seed fund, support US-owned and operated small businesses to engage in federal research and development that has a strong potential for commercialization. NIH’s SBIR and STTR programs invest over 1.2 billion dollars into health and life science companies that create innovative technologies that align with NIH’s mission to improve health and save lives. Specifically, the STTR program encourages public-private partnerships by funding cooperative research and development conducted jointly by start-up companies in early-stage technology and research institutions. Among other activities, the STTR program funds the systematic application of knowledge toward the production of useful materials, devices, and systems or methods. The IDeA program is a congressionally mandated program that builds research capacity in states that historically have had low levels of NIH funding. It supports basic, clinical, and translational research, faculty development, and infrastructure improvements. There are 24 IDeA-eligible jurisdictions located in four geographic regions: Northeast (Delaware, Maine, New Hampshire, Rhode Island, and Vermont); Southeast (Arkansas, Kentucky, Louisiana, Mississippi, Puerto Rico, South Carolina, and West Virginia); Central (Kansas, Nebraska, North Dakota, Oklahoma, and South Dakota); and West (Alaska, Idaho, Hawaii, Montana, New Mexico, Nevada, and Wyoming). These states and territory, collectively known as IDeA states, submit a low number of SBIR/STTR grant applications to the NIH and consequently receive a similarly low number of awards. NIH is strongly interested in strengthening IDeA states participation in the SBIR/STTR programs.

Recognizing the inequality in SBIR/STTR awards within IDeA states in the 2012 Defense Authorization Act (P.L. 112-81), this 2012 Act requires agency program coordination to better support IDeA states through the SBIR/STTR program (Div. E, Title LI, Sec. 5168, codified at 15 USC 638 note). The SBIR/STTR program was reauthorized through FY 2022 by the National Defense Authorization Act for FY 2017 (P.L. 114- 328). In response to this Congressional directive, NIGMS held a workshop in 2014, entitled Finding Ways to Foster SBIR/STTR Applicants from IDeA States , to identify approaches that would provide the most impact in increasing the participation of IDeA states in NIH SBIR/STTR programs. Participants of the workshop, including investigators from IDeA states and NIH staff, identified several factors with the most significant negative impact including: limited resources and expertise to support technology transfer and commercialization programs at academic institutions; an insufficient number of local technology businesses to create a critical mass of entrepreneurial expertise and culture; lack of access to education, training, and mentoring in areas such as patents, start-ups, business plans, venture capital and angel investors; limited knowledge of SBIR/STTR programs; and a lack of awareness of available resources at the state and local levels. Information from the workshop led to three recommendations: 1) create initiatives to generate infrastructure and build entrepreneurial programs in the IDeA states; 2) educate and train academic researchers about how to develop commercial products and apply for SBIR/STTR grants; and 3) increase outreach by the NIH to institutions in IDeA states.

To continue the NIH’s effort to strengthen entrepreneurship in IDeA states, NIGMS funded three IDeA Regional Entrepreneurship Development (I-RED) programs, one in each of the Southeast, Central, and West regions of IDeA states in FY2022. This FOA encourages meritorious applications in the Northeast region of IDeA states (ME, VT, NH, RI, and DE).

Definitions

This FOA for Fast-Track STTR UT2 cooperative agreement applications requires both Phase I and Phase II components be submitted together. UT2 Phase I supports activities and plans needed to prepare for UT2 Phase II. The Fast-Track mechanism requires that milestones of Phase I must be completed before Phase II funding will be released. For this funding opportunity announcement, UT2 Phase I and II refer to the project phases of the STTR program.

The UT2 is a cooperative agreement mechanism, with NIGMS Program staff participation in developing the project plan, monitoring research progress, and appropriate go/no-go decision-making. See Section VI. Award Administration Information for more information about the Cooperative Agreement Terms and Conditions of Award.

Program Description

This FOA is intended to fund I-RED programs that support the development of educational products to meet the needs of the Northeast region of IDeA state academic institutions in developing and/or strengthening technology transfer programs and the needs of IDeA state investigators to stimulate technological innovation by translating scientific discoveries and technologies from research laboratories into commercial products. Key features of the I-RED program are described as follows:

Applicant Organizations and Program Directors/Principal Investigators (PDs/PIs)

An applicant for an STTR award must be an Small Business Concern (SBC) that partners with an academic institution. For this FOA, an applicant SBC must be from the Northeast region of the IDeA states, and partner with one academic institution in the same IDeA region. An applicant SBC should have substantial expertise in technology transfer and commercialization and experience in developing and marketing entrepreneurship educational products. It should have a solid understanding of the biomedical research community, the business community, and health-related entrepreneurship needs of the Northeast region of IDeA states. It should be able to demonstrate an alignment between the company’s business plan and the goal of the I-RED program. The academic partner must be an institution with robust biomedical research programs and an established technology transfer office. The academic partner is expected to contribute significantly to the product development by providing additional expertise in the design, testing, and validation of the education products. An I-RED program must be led by a Program Director/Principal Investigator (PD/PI) from the applicant SBC. Additional PD(s)/PI(s) from either the SBC or the academic partner institution are encouraged. The PD(s)/PI(s) must possess the expertise and experience to drive the design, testing, validation, and commercialization of the health-related entrepreneurship educational products. The Northeast regional I-RED program is expected to collaborate with other funded I-RED programs and is encouraged to work with existing federal resources as appropriate such as the NIH IDeA Program (COBRE, INBRE and IDeA-CTR); NIH Research Evaluation and Commercialization Hub (REACH); NIH Centers for Accelerated Innovations (NCAI); and the NSF Innovation Corps program. They are also encouraged to work with local and state governments and non-governmental business-development organizations such as chambers of commerce.

Product Development

I-RED programs must develop entrepreneurship educational products that can be utilized by academic institutions, especially those in IDeA states, to inspire, train, and support their students and faculty to explore entrepreneurial opportunities. The products may be didactic or interactive forms of courses (in-person, virtual, or recorded), manuals, casebooks, databases, and/or algorithms, etc. They are expected to develop and/or enhance academic scientists entrepreneurial knowledge and skills such as patent filing, business plan development, capital raising, bookkeeping, financial management, business operation, and marketing. Products that develop and/or enhance skills to compete for SBIR/STTR grants and to pursue entrepreneurial interests in academic environments are strongly encouraged. The products are expected to be developed through a rigorous research and development (R&D) process and be marketed for commercialization.

Product Design: Entrepreneurship educational products to be developed by an I-RED program must meet the needs of the Northeast IDeA region, have commercialization potential, and enrich the knowledge base that helps turn biomedical research discoveries and technologies into products for enhancing human health. Thorough research, including but not limited to analyzing the gap assessment of the regional ecosystem resources and institutional needs that was completed by the IDeA Regional STTR Hub, should be conducted to inform the decision of what products to develop. Information about entrepreneurship educational materials currently utilized by other institutions, and that are available through commercial or non-commercial means, should be gathered and analyzed to help ensure adaptation of proven effective features and potential for commercialization of these products. The SBC and the academic partner must leverage their collective expertise and resources to assemble a team(s) that is capable of developing designs based on appropriate methodologies, building prototypes, and implementing a robust reiterative testing/assessing and adjusting process to refine the prototypes.

Prototype Testing: The prototypes of the educational products developed by an I-RED program must be tested at academic institutions in the Northeast IDeA region . The institutions in the Tech Transfer Network established by the Regional STTR Hubs should be leveraged for the testing effort. The SBC and the academic partner should assemble a testing team(s) to conduct entrepreneurship training to students and faculty in these institutions and other institutions appropriate in the region using testable prototypes of the educational products and additional educational materials through appropriate venues such as lectures, workshops, and consultation. Recognizing that effective testing of the prototypes may require concerted training on related entrepreneurship topics, training with educational materials in addition to the testable prototypes will be supported as integral components of the product testing. For example, to effectively test a product that enhances SBIR/STTR grant writing skills, a course on Small Business 101 might be a prerequisite for the participants. The testing teams should also develop methods and metrics to assess the effectiveness of the prototypes and carry out the assessment to enable refinement of the prototypes.

Product Validation: The efficacy of the educational product prototypes must be tested in a real world setting. The prototypes are expected to be used for the entrepreneurship training of a cohort of academic investigators who are likely to soon be in positions to translate technologies, devices, materials, and/or services into commercial products. To enable this efficacy testing, the I-RED program must support a pilot project program that develops the process and criteria to identify this cohort of investigators from institutions in the Tech Transfer Network and fund them with pilot project awards that accelerate the translation of their product ideas. The SBC and the academic partner should assemble a validation team with appropriate entrepreneurship and education expertise to provide entrepreneurship training to these investigators utilizing the products the program has developed and other necessary materials to meet their collective and individualized needs. The training is expected to be carried out through the course of the pilot projects and utilizing methods considered appropriate by the validation team such as lecturing, one-on-one consultation, and apprenticeship. The validation team should also develop methods, metrics, and milestones to assess the entrepreneurship growth of these investigators and the performance of their pilot projects throughout the product validation process.

Product Commercialization

The I-RED program must assemble commercialization teams with experience in marketing educational products and develop commercialization plans to market their products among IDeA state institutions and other institutions with similar needs. Acceptable commercialization outcomes of the educational products developed under this FOA include, but are not limited to, selling or licensing the products to academic institutions, and the SBCs continuing to deliver these products to academic institutions as fee-based services post the I-RED award. The commercialization plan should outline the planned path, efforts, timeline, and milestones toward reaching the commercialization goals.

Governance and Operation

The I-RED program is required to have a Steering Committee (SC), an Administrative Committee (AC), and an External Advisory Committee (EAC) for governance and operation:

SC: The SC is the governance body that provides scientific and administrative oversight of the I-RED program. It will establish the policies and operating procedures of the program. A product design must be reviewed and approved by the SC. The SC establishes rules defining the composition of the EAC and the tenure of its Chairperson. The SC is expected to seek the EAC’s advice on strategic decisions and critical activities, leveraging the expertise of the EAC. The SC is also responsible for the development and management of an Evaluation Plan to assess the progress and performance of the I-RED. The membership of the SC consists of the PD(s)/PI(s), a corporate officer of the SBC unless one of the PDs/PIs is one already, a member of the institutional leadership (e.g., dean, vice president for research, or their surrogate) from the academic partner institution, a representative from each state in the Northeast IDeA region and the NIH Project Coordinator. Each member of the SC has one vote. The PD/PI (or Contact PD/PI in case of Multiple PD/PI award) serves as the Chairperson of the SC. The SC will meet quarterly in the first year of the award and the frequency of meetings in succeeding years will be decided by the SC at the beginning of each budget period as described in Section VI.2 under Cooperative Agreement Terms and Conditions of Award.

AC: The AC is the administrative arm of the SC that administers the award in accordance with NIH policies and under the guidance of the SC. The PD/PI (or Contact PD/PI in case of Multiple PD/PI award) serves as the Chairperson of the AC. Other members of the AC should include the leads or representatives of the product design, testing, validation, and commercialization teams, the lead of the Pilot Project Program, and additional members deemed necessary by the Chairperson.

EAC: The I-RED program must establish an EAC to provide consultation and advice to the SC. Membership of the EAC consists of six to eight individuals not employed by the SBC and academic partner institution. Members are selected by the PD(s)/PI(s) in consultation with the SC. EAC members must have appropriate expertise including start-up, venture capital, technology, finance, academic technology transfer programs, etc. In addition to providing advice to the SC, the EAC may participate in or lead specific program activities at the SC’s request. For example, the SC may request the EAC to lead the Pilot Project evaluation and selection, assist in program evaluation, or participate in the assessments of product testing and validation.

Evaluation Plan

An evaluation plan must be developed to monitor and document the overall progress towards achieving target goals of the program. The program evaluation, to be led by the SC, should assess the fitness of products proposed, the quality of the product design, effectiveness of the product development process, whether the approaches taken are appropriate, and efforts devoted adequate to meet the goals of developing the products proposed. Entrepreneurship growth of academic investigators who receive the entrepreneurship training and benefit from the successes of pilot projects funded by the I-RED program provide the strongest validation for product commercialization. Effective evaluation metrics and criteria include, but are not limited to, numbers of investigators being trained, duration and frequency of training provided, new applications for SBIR/STTR funding submitted, new SBIR/STTR grants awarded, capital raised through other sources including venture capital and angel investments, number of patents filed, number of licensing agreements signed, and number of companies started.

Institutional Commitment and Regional Support

Applicants need to demonstrate evidence of strong and specific institutional commitment by the academic partner institution to support the I-RED program. This may include providing research infrastructure and complementary funds for pilot projects at their institutions, allowing entrepreneurial faculty release time, and recognizing faculty’s entrepreneurial efforts and success in forms of rewards/incentives/promotion. The institutions commitment to leveraging I-RED resources for undergraduate and graduate entrepreneurship courses related to biomedical technology and product development is highly valued and encouraged. Applicants should seek similar institutional commitment from other academic institutions including those in the Tech Transfer Network only after the awards are made. Support for the I-RED program from other local or regional sources such as state governments or business development organizations is also highly valued and encouraged.

Phase I Scope

The following activities must be completed during Phase I of the award. Additional activities to prepare for Phase II may also be proposed in the application.

• Establish functional SC, AC, and EAC
• Develop a Memorandum of Understanding (MOU)/contract describing the arrangements between the SBC and academic institutions, including the partner institution and the institutions in the Tech Transfer Network where product testing and validation will take place through conducting entrepreneurship training, and possible award(s) of pilot projects. This should be completed in the Phase I of the award, but not prior to the submission of the applications.
• Complete research and needs analyses to set product development goals
• Set product development goals
• Complete product design
• Develop prototypes
• Develop/adapt effective strategies and plans for product testing through conducting entrepreneurship training at academic institutions
• Develop a pilot project funding opportunity announcement and solicit applications from investigators at academic institutions. Establish a process to evaluate and select pilot projects for funding.
• Implement an evaluation plan to monitor the Phase I progress of the I-RED program

The length of Phase I should not exceed one year and can be shorter if milestones are met.

Phase II Scope

The following activities must be completed during Phase II of the award. Additional activities appropriate for Phase II may also be proposed.

• Continue the iterative process of product development, including testing at academic institutions, assessing the effectiveness of the products, and product refinement
• Fund pilot projects and testing the I-RED entrepreneurship training products, in conjunction with any other needed training materials, with the pilot project investigators to meet their entrepreneurship needs such as patent filing, business plan development, and raising capital, bookkeeping, financing, business operation, and marketing
• Test training products designed to build the skills needed to develop successful SBIR/STTR applications
• Advise pilot project investigators, in coordination with institutional technology transfer offices, to facilitate the commercialization of technologies and other products developed through the pilot projects
• Implement an evaluation plan to monitor the success of the I-RED program
• Develop and implement commercialization plans

UT2 Phase I/II Transition

An administrative review will be conducted by NIGMS Program staff to decide whether a project will be considered for transition from Phase I to Phase II. To be transition eligible, an I-RED must have completed all Phase I requirements.

Pre-Application Consultation

Applicants are strongly encouraged to consult with NIGMS Scientific/Research staff listed in Section VII when planning an application. Early contact provides an opportunity for NIGMS staff to provide guidance on program scope, goals, appropriate milestones, and budget.

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Only United States small business concerns (SBCs) from IDeA states in the Northeast region 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;
3. 1. 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
   2. 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
   3. 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.

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. This Transition Rate requirement applies to 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. For these companies, the benchmark establishes a minimum number of Phase II awards the company must have received for a given number of Phase I awards received during the 5-year time period in order to be eligible to apply for a new Phase I award Fast-Track, or Direct Phase II (if available). This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period.

Companies that do not meet or exceed the benchmark rate 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. 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 benchmark minimum Transition Rate is 0.25.

SBA calculates individual company Phase I to Phase II Transition Rates daily using SBIR and STTR award information across all federal agencies. For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.gov. Information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.

Applicants to this FOA that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past five (5) years should, prior to application preparation, verify that their company’s Transition Rate on the Company Registry at SBIR.gov meets or exceeds the minimum benchmark rate of 0.25.

Phase II to Commercialization Benchmark

In accordance with guidance from the SBA, HHS, including NIH, 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. The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 (78 FR 48537).

This requirement applies to companies that have received more than 15 Phase II awards from all agencies over the past 10 years, excluding the two most recently-completed Fiscal Years. 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. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10 year period, excluding the two most recently-completed Fiscal Years.

Information on the Phase II to Commercialization Benchmark is available at SBIR.gov.

Applicants to this FOA that may have received more than 15 Phase II awards across all federal SBIR/STTR agencies over the past ten (10) years should, prior to application preparation, verify that their company’s Commercialization Benchmark on the Company Registry at SBIR.gov meets or exceeds the benchmark rate listed above.

Applicants that fail this benchmark will be notified by SBA annually and 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.

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, are not 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 Section IV. Application and Submission Information, SF424(R&R) Other Project Information Component for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a 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 full SAM and Grants.gov registrations; 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. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.

2. Cost Sharing

This FOA 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.

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.

Requirements for Academic Partner Institution

The academic partner institution must have active biomedical research programs with NIH research project grant (RPG) funding averaging no less than $7.5 million in total costs (direct and F&A/indirect) per year over the last three fiscal years and an established technology transfer office. The academic partner must be from the same IDeA region as the applicant SBC.

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 FOA. 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 funding opportunity announcement 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:

Krishan K. Arora, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: arorak@nigms.nih.gov

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) SBIR/STTR Application Guide and should be used for preparing an application to this FOA.

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:

Facilities and Other Resources: Describe the program’s access to the existing educational and training programs and resources.

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:

The budget may include salary support for key person(s) including PD(s)/PI(s), R&D team (i.e., product design, prototype testing, and product validation) members, Commercialization team members, other persons essential for administering the award. Support for consultants not employed by the SBC or academic partner is allowed.

Up to 40% of the Phase II budget may be requested to support the Pilot Project Program.

Other allowable costs include, but are not limited to:

• Product development, including product design, testing, and validation
• Program evaluation
• Operations of the SC, AC, and EAC
• Travel to institutions in the regional Tech Transfer Network
• Travel of PD(s)/PI(s) (and other I-RED staff as appropriate) to attend I-RED program meetings organized by NIGMS, and other meetings directly related to entrepreneurship training

A detailed justification for each item requested must be provided.

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:

Specific Aims: The Specific Aims section should include separate aims delineated for each of the phases. A scientific hypothesis is not required.

Research Strategy: The Research Strategy should include the following subsections:

A. Overview: Program Goals and Participating Organizations Commitments

Applicants should provide an overview of the proposed program and describe how the goals of the program align with the business plans/goals of the applicant SBC. The SBC and the academic partner institution’s commitments, toward, as well as expertise relevant to, achieving the program’s goals should be described. A general plan on how to collaborate with academic institutions in the Tech Transfer Network should be described. However, these institutions should not be identified in the application and no specific commitment should be sought from these institutions until the awards are issued.

B. Program Organization, Operation, Governance, and Key Personnel

Describe the organization of the program. A clear delineation of the governance and operation committees responsibilities is required. Describe the expertise and experience that will be sought after for the EAC and how EAC members will be recruited. Do not contact potential EAC members or name them in the application.

Provide a summary of an operations plan. Describe the responsibilities and qualifications of key personnel including the PD(s)/PI(s), and the leads of the product design, testing, validation, and commercialization teams. Consultants may be contracted for needed expertise.

C. Product Development

Provide an outline of the entrepreneurship educational products to be developed. Describe how the products would address the needs of the Northeast region of IDeA state institutions, and the SBC and its academic partner’s core competencies for developing them. These proposed products may be modified and/or changed during the course of the product development process. However, the description and discussion required here allow applicants to demonstrate their knowledge and expertise relevant to the goals of the I-RED program.

Present a detailed plan for product design, which includes how to identify specific needs of institutions in the Northeast IDeA region that are not adequately addressed by available educational materials, how to assemble product design teams with adequate expertise and support, product designs based on appropriate methodologies, and a plan to develop testable prototypes during Phase I of the award.

Present a detailed prototype testing plan. Describe how a product testing team that can execute the testing plan will be assembled and supported. Describe the educational materials in addition to the prototype(s) the program will develop that may be included in the entrepreneurship training for effective product testing. A plan to recruit students and faculty to participate in the entrepreneurship training during the product testing process should be described. Describe the formats and number of entrepreneurship training sessions to be conducted, and the number of students and faculty expected to participate. Describe methods and metrics to assess the effectiveness of the prototypes.

Present a detailed plan to establish and support a pilot project program, including descriptions of how pilot project applications will be solicited, evaluated, and selected for funding. Describe the budget allocation to the pilot program and the number of projects anticipated to be funded. High-quality and reproducibility are essential cornerstones of the translational research enterprise. The I-RED program must ensure that pilot project investigators follow instructions to address rigor and reproducibility (http://grants.nih.gov/reproducibility/index.htm).

Present a detailed product validation plan. Describe how a product validation team, with demonstrated entrepreneurship expertise and education experience to provide entrepreneurship training, will be assembled. Describe the educational materials, in addition to the products the program will develop, that may be included in the entrepreneurship training to meet the pilot project investigators needs. Describe how the entrepreneurship training will be conducted. Describe the methods, metrics, and milestones that will be used to measure the entrepreneurship growth of these pilot project investigators and the performance of the pilot projects.

D. Program Evaluation

Describe an evaluation plan to assess program performance on an annual basis. This should include plans to obtain feedback from students and faculty participating in the testing and validation of the products about the effectiveness of the products and their overall training experience. Evaluation metrics should be tied to the goals of the program, such as number of products developed, commercialization outcome of the products, number of students and faculty being trained through the product testing and validation process, number of patents filed, number of SBIR/STTR applications submitted and awarded, and number of start-up companies launched.

Letters of Support: An application is required to include a letter of support from the academic partner, but not other academic institutions including those in the Technology Transfer Network. Letters of support from contractors and collaborators, as appropriate, should be included. No letters of support should be provided from partners in the Technology Transfer Network besides the main academic partner.

While non-Federal matching funds are not required, the application must show clear evidence of strong and specific institutional commitment. The application should include communication from a senior institutional official from the academic partner institution (e.g., President or Dean) outlining the resources and facilities that will be committed by the institution to support the program throughout the period of funding. Some examples of institutional commitments that may be documented include adequate space, available resources, release time agreements, providing entrepreneurial faculty recognition in terms of rewards/incentives/promotion, and additional financial support for pilot projects.

Letters indicating support or resources available from state or local government agencies or other groups (e.g., business development organizations) may also be included.

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

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.

SBIR/STTR Information

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

I-RED programs must assemble commercialization teams with experience in marketing educational products and develop commercialization plans to market their products among IDeA state institutions and other institutions with similar needs. Acceptable commercialization outcomes of the educational products developed under this FOA include, but are not limited to, selling or licensing the products to academic institutions, and the SBCs continuing to deliver these products to academic institutions as fee-based services post the I-RED award. The commercialization plan should outline the planned path, efforts, timeline, and milestones toward reaching the commercialization goals.

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 NIGMS. Applications that are incomplete and/or 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?)

In addition, specific to this FOA:

Do the products proposed address the Northeast region's IDeA state institutions needs effectively and efficiently?

Is the entrepreneurship training proposed for product testing and validation effective and efficient?

Will the products and training activities lead to substantial improvements of entrepreneurship in the Northeast region of IDeA state institutions? Is there potential for commercialization of the products?

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?

In addition, specific to this FOA:

Does the product design team lead possess the appropriate level of expertise and experience in designing entrepreneurship educational products?

Does the prototype testing team lead possess the appropriate level of expertise and experience to execute entrepreneurship training and assess product effectiveness?

Does the product validation team lead possess the appropriate level of expertise and experience to execute entrepreneurship training and assess the entrepreneurship growth of the investigators and the performance of the pilot projects?

Does the product commercialization team possess the appropriate level of expertise and experience to market the products?

How well do the applicants demonstrate that the program participants possess knowledge of, and relationships with appropriate stakeholders and user groups?

Do the applicants have a record of accomplishment for building multi-component partnerships and developing educational resources into commercial products?

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?

In addition, specific to this FOA:

Are the unique needs of the institutions and investigators in the Northeast region of IDeA states addressed in appropriately creative ways?

Does the program create and use innovative, new educational products that are uniquely targeted to the development of the skills necessary to bring discoveries to market?

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?

In addition, specific to this FOA:

Has a partnership with an academic institution in the Northeast IDeA region been established and will it be developed further in appropriate ways to achieve the program goals?

Are the plans for developing the External Advisory Committee appropriate for the project?

Are the proposed needs analyses adequate to inform decisions that maximize the possibility of developing products that meet the needs and have commercialization potential?

Do the proposed products and activities have the potential to educate and motivate the entrepreneurial process in the Northeast region of IDeA states?

Do the proposed products and activities build the needed skills of future academic entrepreneurs?

Are the proposed training and education activities for product testing and validation targeted to both students and faculty within the Northeast region of IDeA states?

For the pilot project program, do the applicants describe appropriate strategies for identification of projects, and assembling reviewers with appropriate expertise to effectively select and shepherd meritorious projects to test the validity and effectiveness of the educational products developed?

Is their strategy for funding projects (e.g., budget level, duration) appropriate?

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?

In addition, specific to this FOA:

How well will the constituent parts of the I-RED program work together to create synergies and economies of scale to maximize the likelihood of successful outcomes?

In addition to adequate institutional resources, have any other resources been identified that will improve the chances of success?

Do the applicants have plans to engage the business community in the development and operation of the I-RED program as either participants or as advisors?

Does the I-RED program have access to business expertise, subject matter experts, and mentors needed for the program's success?

Will state and local governments be engaged?

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.

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 Animal 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

Not Applicable

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.

Applications with Foreign Components

Not Applicable

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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan.

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 Center for Scientific Review (CSR), 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or 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

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

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 FOA 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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please 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 FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. 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 reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/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 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 judgement 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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for the activities indicated below:

The PD(s)/PI(s) will define objectives and approaches of the I-RED and plan, conduct, analyze, and publish results, interpretation, and conclusions of the studies. The primary responsibilities of the recipients are to:

• Establish a diverse EAC with appropriate expertise such as in product development, start-up, venture capital, financial, and business operations
• Define and monitor project milestones for prototype development and testing projects, with go/no-go decisions made within appropriate timeframes
• Serve as a voting member on the SC (Multiple PD/PI leadership will have one vote in total)
• Determine experimental approaches, design protocols, conduct experiments, and disseminate results
• Commercialize and market products resulting from the I-RED
• Obtain relevant IRB and IACUC approvals, regardless of whether subcontractors have separate approvals
• Participate in collaborative activities with other IDeA regional programs, REACH, and other relevant programs, as appropriate
• Develop and/or maintain external partnerships to assist in meeting goals
• Have processes in place to ensure that the EAC conducts reviews of pilot project applications in a manner that is fair, equitable, timely, and free of bias and conflicts
• Provide information to the NIH Program Official(s), and the NIH Grants Management Specialist concerning progress, go/no-go decisions, pilot projects evaluation processes, and the initiation of new projects
• Share best practices with other IDeA regional programs recipients and with the NIH

Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

NIH Staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIGMS will assign a Program Official, a Project Coordinator, and a Grants Management Specialist to each I-RED program.

An NIH Program Official will be responsible for the normal programmatic and scientific stewardship of the award and will be named in the award notice. The Program Official will:

• Enforce general statutory, regulatory, or administrative policy requirements
• Carry out a continuous review of all activities to ensure objectives are being met
• Help coordinate collaborative efforts that involve multiple recipients
• Review and approve/disapprove progress reports
• Review and approve/disapprove pilot projects proposed by the I-RED program

The Program Official will not participate in the administrative, steering, or advisory committees or other governance groups of the I-RED.

An NIH Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in the award. The NIH Project Coordinator will:

• Participate in and be a voting member of the SC
• Review and comment on critical stages in the development, testing, and dissemination of educational tools, resources, mentoring strategies, and new technologies by the I-RED
• Have the option to recommend to the Program Official withholding of support to a participating I-RED or partner if performance requirements are not met
• The Project Coordinator will not participate in making funding recommendations for awards for this FOA

An NIH Grants Management Specialist will be responsible for the business management and other non-programmatic aspects of the award and will be named in the award notice. The Grants Management Specialist will:

• Enforce general statutory, regulatory or administrative policy requirements
• Provide interpretation of grants administration policies and provisions
• Carry out a review of activities to ensure the terms and conditions of the award are being met
• Review and approve/disapprove progress reports
• Review and approve/disapprove the pilot project awards proposed by the I-RED

Areas of Joint Responsibility Include:

The PD(s)/PI(s) of the I-RED program will be responsible for forming an SC. The SC will act as the governance body for the I-RED award and will review the progress of the research activities, develop collaborative processes, identify impediments, and select strategies to surmount them and identify opportunities for sharing techniques and tools developed within the I-RED program.

The SC should meet at least quarterly in the first year of the award. The frequency of meetings in succeeding years will be decided by the SC at the beginning of each budget period. Each SC voting member will have one vote, and a majority will be required to accept and implement policies approved by the Committee. The NIH will have only one vote. The SC may, as it deems necessary, invite additional, non-voting scientific and commercial advisors to meetings at which research priorities and opportunities are discussed. The program PD(s)/PI(s) will be required to implement policies approved by the SC.

Dispute Resolution:

Disagreements between award recipients and the NIH that arise regarding matters related to the scientific direction of the funded program may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the Steering Committee without NIH staff or the recipient voting. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16

Post-Award Program Requirements for Pilot Projects

For the pilot project program that will be supported by the I-RED program during the award period, the scientific merit and commercial potential of the selected pilot project(s) must be reviewed by the EAC and approved by the SC.

Before the commencement of any SC-approved pilot project, the recipient must provide NIGMS staff descriptions of the proposed projects and recommendations from the EAC. Instructions regarding submitting this information will be provided in the Notice of Award.

3. 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.

4. Evaluation

In carrying out the stewardship of its grant programs, NIGMS will periodically evaluate the I-RED program, employing the measures identified below. In assessing the effectiveness of this program, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes.

In evaluating the I-RED program NIGMS expects to use the following measures:

• Number and type of products developed and their effectiveness.
• Number and type of institutions that participated in award-funded activities.
• Commercialization outcomes, including revenues and customers served.
• Number of entrepreneurship education sessions provided.
• Number of students and faculty who participated in entrepreneurship education sessions during product testing.
• Number of pilot projects supported for product validation.
• Number of pilot project investigators who participated in product validation.
• Number of SBIR/STTR applications submitted by participants of the Pilot Project Program.
• Number of SBIR/STTR awards received by participants of the Pilot Project Program.
• Number of patents filed by/granted to participants of the Pilot Project Program.
• Number of start-up companies launched by participants of the Pilot Project Program that supports product validation.

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: http://grants.nih.gov/support/ (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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Krishan K. Arora Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: arorak@nigms.nih.gov

Mark Caprara, Ph.D.
Center for Scientific Review (CSR)
Email: capraramg@mail.nih.gov

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Email: Christy.leake@nih.gov

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 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, and P.L. 115-232. The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.