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 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this FOA is to support one shared STTR regional accelerator hub serving a network of institutions in each of the four Institutional Development Award (IDeA) regions. These regions are: Central (Kansas, Nebraska, North Dakota, Oklahoma and South Dakota); Northeast (Delaware, Maine, New Hampshire, Rhode Island and Vermont); Southeast (Arkansas, Kentucky, Louisiana, Mississippi, Puerto Rico, South Carolina and West Virginia) and Western (Alaska, Idaho, Hawaii, Montana, New Mexico, Nevada and Wyoming). NIGMS recognizes the importance of using available resources efficiently to provide maximal benefit to IDeA states, considering the vast geographical distances involved and the uneven entrepreneurial ecosystems present in these states. Many of the academic institutions in IDeA states do not have the infrastructure and expertise needed to move scientific and technological discoveries out of the laboratories towards the marketplace. The tech transfer accelerator hubs would act as regional consortia to provide expertise to develop the needed infrastructure and promote an entrepreneurial culture at the IDeA institutions in the region. They will help support the growth of businesses by facilitating networking and team formation between universities and small businesses, sharing and transferring information, best practices and guidelines. They will also provide assistance and one-on-one mentoring to investigators in the region, and facilitate information sharing on state and local resources and programs available, such as commercialization funds or state matching funds. Technology transfer accelerator hubs will be created by the awardee SBCs in partnership with academic institutions in IDeA states. The commercial product of these grants will be educational and training tools such as curricula, webinars, and texts that can be licensed or sold to other institutions throughout the U.S. that wish to create similar accelerator hub programs or develop their internal commercialization capacity.

The Institutional Development Award (IDeA) Program helps broaden the geographical distribution of biomedical research funding and promotes research and research training relevant to rural and medically underserved populations. The 23 IDeA states and Puerto Rico have historically had a disproportionately low number of SBIR/STTR awards (https://sbir.nih.gov/statistics/award-data). 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 STTR program helps foster regional economic and workforce development by spurring high-tech small business growth and lab to marketplace development.

The 2012 Defense Authorization Act (P.L. 112-81) reflected Congress' recognition of the inequality in SBIR/STTR awards within IDeA states, by requiring 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, including this requirement, was reauthorized through FY 2022 by the National Defense Authorization Act for FY 2017 (P.L. 114-328).

To respond to the 2012 Congressional directive, NIGMS held a workshop on August 21, 2014, entitled Finding Ways to Foster SBIR/STTR Applicants from IDeA States (https://www.nigms.nih.gov/Research/CRCB/IDeA/Documents/IDeASBIR-STTRWorkshopReportJan2015.pdf). The goal of this workshop was to gain greater insight into the types of activities that would provide the most impact for promoting and attracting entrepreneurs from IDeA states into the SBIR/STTR program and increasing the participation of IDeA states in these programs. This group identified several limiting factors, including the need for effective institutional offices of Technology Transfer and Commercialization; absence of a medical school in the campus and/or state; an insufficient number of local tech businesses to create a critical mass of entrepreneurial expertise and culture; lack of exposure to commercialization education, training, and mentoring (e.g., in areas such as patents, startups, business plans, venture capital and angel investors); limited knowledge of tech transfer and SBIR/STTR programs; and a lack of awareness of available resources at the state and local levels. The workshop made three major recommendations: 1) create IDeA Regional Network Incubators/Hubs to generate infrastructure and build entrepreneurial culture; 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 IDeA institutions.

The need to support regional networks of shared technology transfer accelerator hubs is consistent with the FY2017 Senate Appropriations Committee Labor-HHS Report, which stated, "Small Business Research Funding. --The Committee supports the initiative to direct small business research funding to IDeA States to foster the development of products to advance public health. The Committee asks NIGMS to consider allocating funding for one shared innovation incubator in each of the four IDeA regions that would be competitively bid among IDeA States and would serve IDeA States. NIH shall not use funding from its IDeA allocation for these grants."

Although NIH invests billions of dollars each year in biomedical research, leading to great advances in scientific tools and biological insights, there are barriers to effectively translating basic science discoveries from academia to products that benefit patients. These barriers include 1) a gap in funding between basic research discoveries and scientific proof of feasibility or validation studies required to define the product for early stage technology development; 2) a lack of knowledge and understanding by innovators about how technologies are brought to market; and 3) a lack of access to sufficient technology development and commercialization resources required for early-stage technology development. These barriers are particularly high in the 23 states and Puerto Rico that are eligible for the IDeA program, with limited expertise, incentives, and opportunities for technology transfer. For this FOA, therefore, a small business concern (SBC) from anywhere in the U.S. must collaborate with a non-profit university or research institution from an IDeA state, which in turn will partner with other academic institutions in that IDeA state region to develop programs that address a comprehensive set of activities that will facilitate and accelerate the translation of promising early-stage technologies into commercial technologies. The academic partners play a critical role in outreach to university investigators and in guiding the SBC partner to identify critical training needs and optimal curriculum components. The academic partners will also play an essential role in establishing and strengthening an institutional culture that recognizes and rewards faculty innovation and product development. Each accelerator hub program will be expected to serve a network of academic institutions throughout the IDeA states in the region where the academic partners are located. The Small Business Administration supports Small Business Development Centers (SBDC) (https://www.sba.gov/offices/headquarters/osbdc) in every state with the purpose of aiding existing and prospective small business owners. The tech transfer accelerator hubs do not seek to replicate or compete with existing resources such as the SBDC, although many of these may not have the expertise or knowledge specific for biomedical sciences.

This initiative will leverage the funded IDeA programs (IDeA Networks of Biomedical Research Excellence [INBRE], Centers of Biomedical Research Excellence [COBRE] and IDeA Clinical and Translational Research centers [IDeA-CTR]) with efforts that can identify and specifically assist academic investigators or groups by providing knowledge, development of business skills, information, networking, and business strategies that can result in more successful SBIR and STTR applications and new startups.

This FOA for a Fast-Track STTR UT2 cooperative agreement requires both Phase I and Phase II components. 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.

There will be one tech transfer accelerator hub in each IDeA region. For this FOA, an SBC from anywhere in the U.S. will collaborate with a non-profit academic partner in an IDeA state, which will partner with academic institutions in other IDeA states in that region to develop a regional network. The STTR SBC partner is expected to have substantial experience in all aspects of technology transfer, have knowledge of development of training materials, web sites, etc. The staff of the hubs will provide consulting services to the faculty and staff of colleges and universities in IDeA states, helping them establish small businesses based on their research or move their intellectual property into existing small businesses. They will also help institutions in each IDeA region set up the infrastructure they need for effective and efficient technology transfer and to promote entrepreneurship. The Hub staff will travel across the IDeA region to hold workshops, give seminars and consult with academic investigators, postdoctoral fellows and students about the design and conduct of product definition studies and the commercialization processes.

A regional accelerator hub should be organized as a spoke and wheel model in which the SBC is linked to technology transfer interests of each participating institution in the IDeA regional network. SBCs will work with institutional leadership to formulate a strategy that ensures the Hub and its activities function in the best interests of biomedical innovators at their institutions. The SBC, through collaboration with one academic partner, must include at least one institution from each IDeA state in the region as a part of the regional hub network. The Hub spoke and wheel model is critical for the success of the program. Hubs require adequate resources, support, and coordination to manage and conduct all program activities in a way that is not only tailored to each Hub’s ecosystem but also interacts across the Hubs, the NIH, and other partners.

Each Hub will 1) be governed by leadership experienced in translating biomedical technologies from research performing institutions to the commercial market; 2) develop the necessary collaborations and partnerships to meet the goals of this FOA; 3) provide and strengthen infrastructure for an Office of Technology Transfer Office and Commercialization at the academic institutions, to assist faculty in soliciting and selecting the most promising studies and technologies predicated on scientific merit, commercial potential, and medical need; 4) provide entrepreneurial educational opportunities for innovators and create cultural and systemic changes to move scientific advancements to products that will improve human health; 5) provide innovators with skills development, hands-on entrepreneurial experience, educational and networking activities with linkages to local or virtual resources; 6) develop courses at graduate and undergraduate levels to enhance student awareness skills for careers in industry; and 7) develop and implement a plan for transitioning to a self-sustaining structure at the IDeA institutions.

Hub leadership must possess the necessary operational, business, and scientific expertise with a documented track record of success in transitioning technologies from the discovery phase to product commercialization. The Hub must have the ability to help guide commercialization from projects at a range of stages of research and development, from early stage laboratory-based studies up to early phase clinical testing. Through a combination of in-house efforts and collaboration across the regional network, each Hub funded under this FOA will perform functions to specifically address the critical knowledge and resource gaps that hinder the identification, development, and commercialization of promising products and technologies at the partner institutions.

An important characteristic of the regional Hub is the ability to collaborate effectively with entities that possess the resources and expertise required to commercialize technologies developed through the IDeA institutions in the region. A Hub should have a structure that leverages technology development expertise and partnerships necessary to funnel discoveries into the commercialization pipeline. Hubs should consider working with existing NIH or federal resources as appropriate, including: NIH IDeA program (COBRE, INBRE and IDeA-CTR (https://www.nigms.nih.gov/Research/CRCB/IDeA/Pages/default.aspx); NIH Research Evaluation and Commercialization Hub [REACH] and Centers for Accelerated Innovations [NCAI] (https://ncai.nhlbi.nih.gov/ncai/); Clinical and Translational Science Awards [CTSA] (https://ctsacentral.org/); and Cancer Centers (https://cancercenters.cancer.gov/)). Each Hub should establish an infrastructure that will promote synergies that enable successful technology development. The cooperative approach outlined in this FOA also encourages interactions among four regional Hubs to promote the development of integrated plans, best practices, resource sharing, and strategies required for successfully reaching the goals of this funding announcement.

The regional Hubs must provide entrepreneurial educational opportunities to academic investigators, postdoctoral fellows and students about the design and conduct of product definition studies and the commercialization processes required for transitioning a study involving drug targets, biomarkers or technology out of academic labs to the private sector (either as startup small businesses or licensing opportunities). Cross-disciplinary (science, business, regulatory, etc.) career development is highly encouraged to achieve the goal of exposing innovators to the myriad processes required to translate discoveries into marketable products. Providing the broader investigator community (faculty, postdoctoral fellows and students), including those from under-represented backgrounds, access to forums, courses, seminars, workshops and related activities is encouraged.

Contractual arrangements or a Memorandum of Understanding (MOU) must be established between the SBC and the participating institutions as a part of Phase I scope. The MOU/contract must clearly describe the arrangements between the academic partner institutions and the SBC in terms of space, current resources available, and providing incentives, rewards and appropriate recognition to the faculty involved in the translational efforts. Each Hub will focus on infrastructure and training needs for entrepreneurial faculty and students, and develop a plan to address those needs.

The Hubs must build a governance team consisting of the Program Director/Principal Investigator (PD/PI) and the institutional leadership (e.g., deans, vice presidents for research or their surrogate) from the participating institutions to leverage existing resources and unique assets, while addressing the gaps and infrastructure needs that constitute barriers to efficient commercialization at the regional network institutions. Each Hub must have the following committees:

Administrative Committee: The Administrative Committee (AC) of the Hub will provide logistical support for the regional network and for the Internal Advisory Committee (IAC), Program Steering Committee (PSC) and External Advisory Committee (EAC). The AC will consist of the Program Director/Principal Investigator (PD/PI) and administrative staff at the SBC. The Administrative Committee Lead (Program Director/Principal Investigator (PD/PI)) is responsible for management, staffing and resource allocation, and for administering the award in accordance with NIH policies. The Administrative Committee Lead will serve as Chairperson of the Hub IAC and select EAC members in consultation with the IAC. The AC, in consultation with the governance team, will develop biomedical entrepreneurship training programs to meet the career building and enhancement needs of the research faculty, postdoctoral fellows, and graduate and undergraduate students including educational modules, workshops or short courses.

As communication among Hub network institutions is essential, the AC should provide electronic networking to inform investigators both within and outside the network of the availability of and access to technologies and resources both within the network and located at other sites around the country.

Internal Advisory Committee: The PD/PI will serve as Chairperson of the Internal Advisory Committee (IAC). The governance team from the regional network partners must participate as members of the Hub IAC. The IAC will include up to two members from each network partner institution: 1) a senior administrator and 2) a member with scientific expertise or an official from the partner institution's Office of Technology Transfer and Commercialization. The members of the IAC will establish the policies and operating procedures of both the IAC and the Hub. The IAC will meet at least four times during the first year of the award and at least semi-annually thereafter. The IAC will develop strategies as to how it will interact with the External Advisory Committee as described below. The Administrative Committee will provide logistical support to the IAC. The PD/PI, in conjunction with the IAC, will provide management oversight for the development of an Evaluation Plan to measure the impact of the regional Hub. The members of the IAC will regularly review the progress of the Hub activities. This oversight and input are in addition to that provided by the EAC and may not act as a substitute for the EAC.

External Advisory Committee: Each regional Hub must include an External Advisory Committee (EAC). The IAC should establish rules governing the composition of the EAC and the tenure of the Chairperson. The composition of the EAC is to include at least six to eight members with appropriate scientific/business and entrepreneurship expertise, who can provide advice to the IAC for these training programs and other matters. The EAC must meet at least twice per year. The EAC critiques the progress of the Hub activities and offers advice on these matters to the PD/PI. EAC activities include developing and planning concepts and programs, encouraging and assisting faculty development and enhancement, identifying resources, evaluating development of the network, and evaluating progress of the overall Hub program. The PD/PI will share the advice and critiques provided by the EAC with the IAC and other members of the Hub network. Video-, teleconferencing or other means may be used in situations where it would be difficult to hold an in-person meeting. A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.

Program Steering Committee: A Program Steering Committee (PSC) will be created that includes NIH and other Federal staff, Hub PD(s)/PI(s), members of the governance team and other Hub staff as appropriate to provide scientific and administrative oversight as described in Section VI.2 under Cooperative Agreement Terms and Conditions of Award.

The Administrative Committee is responsible for overseeing an evaluation plan for monitoring and documenting progress towards achieving target goals and timelines. The evaluation should assess whether the approach taken is meeting the goals or benchmarks for building an effective institutional and regional tech transfer Hub.

The success of researchers from the network partner institutions in the Hub may be measured by attainable metrics that are appropriate to the missions of their institutions. Criteria for evaluating the progress of these researchers may include number of participating faculty, new applications for SBIR/STTR funding, development of curricular materials, skills development materials and effective strategies, number of patents, number of licensing agreements, and number of startups.

Measures of success will be an increase in technology transfer from universities and research institutions in IDeA states into the private sector for commercialization and an increase in the creation of small businesses focused on biotechnology in these regions. In addition, an increase in SBIR/STTR applications and awards will be considered a measure of success. In the long term, the production of products that facilitate biomedical research and improve human health, and an increase in regional biotechnology related jobs and economic activity in IDeA states should be seen.

A program that fosters entrepreneurship in biomedical research should encompass: 1) workshops and course series provided by individuals with industry experience and university faculty; 2) individualized consulting and mentorship; and 3) institutional change that creates an environment that enables collaboration and development of fundamental or applied research into technologies and products. The product of the funded research will be educational tools i.e., curricula, texts, webinars resulting from the development and testing of research accelerator models. It is anticipated that the educational tools developed under this FOA will be licensed or sold to other institutions that wish to create similar programs. The SBC could also become a self-sustaining entity in the future by charging for its services.

Courses/skills development

A key Hub activity is the development of educational and training materials such as curricula, webinars, and texts, to provide opportunities for academic investigators to learn about the design and conduct of product definition studies and the commercialization processes required for transitioning a product and technology out of academic labs to the private sector (either as start-up businesses or licensing opportunities).

Some examples of workshop/course topics include, but are not limited to:

• How to determine if an idea or product is innovative, and how to protect intellectual property
• How to develop and implement a comprehensive biomedical entrepreneurship skills development program
• What it means to be a business entrepreneur, including business plan development, market research, project management, and financing
• How to use licensing and startups as alternative pathways to advance inventions
• How SBIR and STTR grants can fund startup companies and academic innovators
• How to pitch your invention
• How to pursue clinical studies and manage the FDA regulatory process
• Outreach activities, such as forums, seminars, and workshops at academic institutions throughout the IDeA states in the region

Mentoring

Mentoring of early-stage entrepreneurs could be achieved through one-on-one mentoring/coaching approaches with expert entrepreneurial consultants, through internships in small biomedical businesses, patent attorney offices, and other related activities (licensing, startup, finding the niche for the technology), and through mentoring on how to prepare an SBIR/STTR application.

Consulting and Advising

Hubs will serve as expert consultants and advisors to the partner academic institutions in areas such as establishing or improving the operations of technology transfer and commercialization offices, enhancing the support for faculty interested in commercialization of ideas and discoveries, leveraging other federal and non-federal resources, sharing of best practices and resources among institutions, and creation of an entrepreneurial culture.

Applicants need to demonstrate evidence of strong and specific institutional commitment by academic partners to support this effort. This may include adequate laboratory space, seed money for pilot projects at their institutions, providing entrepreneurial faculty release time and recognition in terms of rewards/incentives/tenure and promotion, creation of undergraduate and graduate courses in biomedical technology research, development, and entrepreneurship, and career development activities that enhance student awareness of scientific careers outside of academia. Further, it is expected that the regional Hubs will become financially self-sustaining through support from partnering institutions or other financial arrangements, such as agreements with the leadership of academic partners to allow for revenue from fees, licensing, milestone payments, royalties, or other mechanisms. Support for the goals of the Hubs from other local or regional sources such as state governments or business development organizations, while not required, could enhance program impact and would thus strengthen applications.

An optional element of the Hub is the funding of small pilot projects that help scientists gather data for feasibility studies that determine whether a nascent technology or product is worth pushing through the commercialization pipeline. These pilot projects are not to be proposed in the application. After the award is made, applications for pilot projects can be solicited from faculty at participating institutions and selected by the EAC. However, federal funding provided under this FOA may not be used to support pilot projects. If pilot project activities are proposed, it is expected that the Hub will have additional non-federal funding identified at the time of application and committed at the time of award to augment the federal investment for product definition and proof-of-concept studies.

Examples of activities that can be proposed during this Phase include, but are not limited to:

• Establishing Administrative Committee, Program Steering Committee, Internal Advisory Committee and External Advisory Committee and having regular meetings to establish Hub structure, governance and leadership plan
• Developing contractual arrangements or a memorandum of understanding (MOU) describing the arrangements between the SBC and academic partner institutions in the IDeA regional network
• Assessing infrastructure needs for technology transfer at the academic partner institutions in the regional network
• Assessing innovator skillsets and learning needs, the local ecosystem’s resources for relevant content, and developing new content for education and workshops
• Setting up systems for webinars and making plans for visits to academic institutions for outreach
• Developing a prototype for training and educational courses for faculty, postdoctoral fellows, graduate and undergraduate students
• Developing/adapting effective mentoring strategies
• Developing an evaluation plan to monitor the success of the regional Hub
• Developing strategies for soliciting, evaluating, and selecting scientific and technology development pilot projects
• Soliciting and selecting promising innovative pilot projects for funding using non-Federal sources

The length of Phase I can be brief depending on the maturity of the project at entry and how quickly milestones can be met.

Examples of activities appropriate for this Phase include, but are not limited to:

• Continued work with Technology Transfer and Commercialization Offices at the regional network institutions to establish infrastructure and train staff to provide advice on project management, regulatory pathways, and intellectual property rights to the faculty who want to commercialize their technologies, discoveries or other products
• Continued development and offering of educational courses, modules, workshops in person and via webinars
• Providing one-on-one mentoring and coaching to promising innovators
• Providing workshops on developing successful SBIR/STTR applications
• Working with institutional Technology Transfer or Commercialization offices to enable academic entrepreneurs to find the best path forward for commercialization of technologies, discoveries or other products
• Developing Standard Operating Procedures for technology transfer, management, small business finance and other business skills including mentoring and coaching for academic investigators
• Funding innovative pilot projects using non-Federal sources of funding
• Implementing an evaluation plan to monitor the success of the regional Hub
• Planning for outreach and dissemination to license or sell the products, i.e., curricula, texts, webinars to those who wish to create accelerator hubs or use the resources produced

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. Phase II eligible projects must have developed relationships with academic partner institutions in the region and complete needs assessments. Specifically, projects entering the Phase II must satisfy the following milestones:

• Functional Administrative Committee, Internal Advisory Committee, Program Steering Committee and External Advisory Committee that have established the Hub structure, governance and leadership plan
• Contractual arrangements/memoranda of understanding (MOU) between the SBC and academic partners in the IDeA region established and in place
• Assessment of the infrastructure needs at the academic partners and formulation of an implementation plan
• Assessment of the innovators skillset and learning needs, the local ecosystem’s resources for relevant content, and plan for developing additional content for education and workshops
• Develop a prototype for training and educational courses for faculty, post-doctoral fellows, graduate students and undergraduate students
• Establish a system for webinar delivery, organizing webinars, and visiting academic institutions for outreach

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 further guidance on program scope, goals, developing appropriate milestones, and budget.

The NIH will host a pre-submission webinar on November 15, 2017 from 3:00 - 4:30 p.m. (EST). To join the webinar follow the link below: https://nih.webex.com/nih/j.php?MTID=m5bc220e85d7c3aa1206db08b48d59fa9. This information will also be published as an NIH Guide Notice and posted at https://sbir.nih.gov and https://www.nigms.nih.gov.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

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;

3.

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), 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; 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.

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 receive a new Phase I award. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period.

Companies that apply for a Phase I award and do not meet or exceed the benchmark rate will not be eligible for a Phase I 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 Phase III Commercialization Benchmark

In accordance with guidance from the SBA, HHS, including NIH, SBIR/STTR Programs are implementing the Phase II to Phase III 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 Phase III 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 receive New Phase I, Fast-track or Direct Phase II 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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM, SBA Company registry, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• SBA Company Registry See Section IV. Application and Submission Information, SF424(R&R) Other Project Information Component for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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.

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

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. 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 (see NOT-OD-11-101).

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.

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.

Buttons to access the online ASSIST system or to download application forms 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.

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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)
Telephone: 301-594-3900
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.

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (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 Hub's access to the existing educational and training programs and resources.

Other Attachments:

1. SBA Company registry

All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to application submission and attach proof of registration. Completed registrations will receive a unique SBC Control ID and .pdf file. If applicants have previously registered, you are still required to attach proof of registration. The SBA Company Registry recommends verification with SAM, but a SAM account is not required to complete the registration. In order to be verified with SAM, your email address must match one of the contacts in SAM. If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site. Confirmation of your company's DUNS is necessary to verify your email address in SAM. Follow these steps listed below to register and attach proof of registration to your application.

a. Navigate to the SBA Company Registry.

b. If you are a previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided. Identify your company and click Proceed to Registration .

c. If you are a first time applicant, click the "New to the SBIR Program?" link on lower right of registry screen.

d. Fill out the required information on the Basic Information and Eligibility Statement screens.

e. Press Complete Registration on the lower right of the Eligibility Statement screen and follow all instructions.

f. Download and save your SBA registry PDF locally. The name will be in the format of SBC_123456789.pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID. DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.

g. When you are completing the application package, attach this SBA registry PDF as a separate file by clicking "Add Attachments" located to the right of the Other Attachments field on the Research and Related Other Project Information form.

For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir.gov/feedback?type=reg.

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.

Funds will be provided to develop and strengthen infrastructure and capacity at the IDeA regional academic partner institutions for tech transfer, small business finance and business skills needed to translate basic discoveries and technologies out of the lab to market.

Funds should be requested for the Hub PD(s)/PI(s) (and other Hub staff as appropriate) to attend the annual in-person Program Steering Committee meeting in Bethesda, Maryland.

Funds should also be requested for the operations of the External Advisory Committee.

Other allowable costs include, but are not limited to:

• Personnel
• Salary support for a Program Manager to coordinate regional Hub activities
• Developing and testing curricula, courses and educational tools/modules and resources
• Webinars
• Workshops
• One-on-one mentoring and coaching for academic entrepreneurs
• Outreach and dissemination
• Travel to regional institutions
• Travel for academic entrepreneurs to specialized meetings such as Biotechnology Innovation Organization (BIO), Bioinvestor, National and NIH SBIR/STTR
• Develop biomedical small business network to facilitate relationships between academic investigators and small businesses
• Program evaluation
• Consultant services
• Short-term specialized internships and training for faculty, postdoctoral fellows and students
• Equipment for training and teaching

A detailed justification for each item requested must be provided.

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.

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: Provide the overall objectives of the regional Hub, including the short-term and long-term goals. Describe how the Hub's expertise, capabilities, partnerships, and resources will enable it to significantly impact the pace and probability of success for discoveries and innovations being developed into commercial products at academic partner institutions in the regional network.

The Research Strategy should include the following subsections:

1) Leadership and Governance

Each Hub is required to demonstrate the core competencies necessary to fulfill the objectives of this FOA, including access to expertise in business plan development, market research, intellectual property protection, technology transfer, regulatory and reimbursement processes, project management, clinical studies, and appropriate domain experts.

A regional Hub should be led by an individual(s) experienced in translating biomedical technologies from research performing institutions to the commercial market. Applicants should provide an administrative plan appropriate for effective management of the Hub structure to establish infrastructure to maximize coordination among academic partners and achieve program goals.

Describe the leadership and governance team of the Hub, including institutional leadership (deans, vice presidents, etc.) who will be involved.

Describe the governance structure, including committees (AC, IAC, EAC, PSC) and reporting. Describe how the Hub will coordinate across team members and institutions involved in the Hub, including the mechanism and frequency of interactions. Describe how the Hub will structure and engage with its EAC. Indicate what expertise and experience will be sought for the EAC members and how they will be recruited. Do not contact potential EAC members or name them in the application.

Provide an overview of the proposed program. Describe the immediate and long-term objectives of the program, including activities and timelines that will be used to implement an effective entrepreneurship training development program, and how outreach efforts to disseminate these resources will be conducted.

Provide a description of how the Hub will collaborate with other institutions, organizations, and networks within the IDeA program.

Describe the plan to promote information exchange and the dissemination of training resources among partner institutions across the regional network.

2) Collaborations and Partnerships

Hubs are expected to drive innovation and entrepreneurship within their local ecosystems and should do this through collaboration with various stakeholders. Provide an outreach and communications approach for each stakeholder group to leverage existing resources, avoid duplication of effort, and spread awareness of the program. Examples of potential stakeholder groups include:

Within the regional Hub:

• All institutions comprising the consortium
• Technology Transfer Offices within each institution
• Relevant programs and schools at each Hub institution, such as business, engineering and medical schools
• Institutional business development offices that can help the Hub identify potential sources of funding
• Existing programs such as COBREs, INBRE and IDeA-CTR or other NIH programs such as REACH and CTSAs

Within the entire program:

• Other Hubs in the program
• NIH representatives on the Hub Program Steering Committee

Within the local and regional ecosystem:

• Local and regional incubators or accelerators
• Local and regional economic development agencies
• Investors and strategic partners
• Other state or local resources

Describe the qualities and strengths that each partner brings to the Hub. Describe how the Hub will facilitate and promote interaction with existing institutional, local, online, and NIH or other federal, state, or local government programs.

3) Skills Development, Education, Mentoring, Consulting and Advising

A Hub must provide skills development, hands-on experience, educational and networking activities in conjunction with local or virtual resources to build business acumen in academic innovators. Skills development offerings help each innovator grow their entrepreneurial skills. This is done by assessing the innovator’s skillset and learning needs, canvassing the local ecosystem’s resources for relevant content, and developing additional content as needed.

Each Hub needs to define the training expectations and program offerings for innovators who participate in the Hub, including how frequently the innovators engage in training, whether there is a core curriculum of courses, and what training channels are available. Example offerings include:

• Providing one-on-one coaching for the innovator
• Developing an advisory panel of biotechnology innovation experts and mentors who can coach the innovator throughout the commercialization process
• Webinars via online delivery platforms, e.g., Google+ Hangouts or YouTube
• Designing a Skills Development website for the Hub to allow innovators to access material at their own pace
• Developing a YouTube Channel to serve as an archive of webinars or other workshops
• Leveraging resources and courses from business schools, entrepreneurship programs, or REACH within the ecosystem
• Connecting with MBA programs to develop partnerships between MBA students and academic innovators, allowing both parties to grow their skills
• Identifying conferences for innovators to attend and coaching them on presentations
• Offering pitch deck training to prepare innovators to address potential funders and partners
• Providing training tools such as recorded webinars and YouTube videos to educate more academic entrepreneurs, both within and outside of the Hub program.

Describe plans to develop these activities or collaborate with existing resources to provide them to a diverse group of innovators and potential entrepreneurs, including women and members of underrepresented and socially and/or economically disadvantaged groups. For example, Hubs may pursue collaborations with existing NIH REACH hubs and Centers for Accelerated Innovations.

Provide a detailed discussion of how mentoring and the professional development of the academic entrepreneurs will be achieved.

Describe how the Hub will determine the skills needs of academic entrepreneurs at the network institutions. Include what diagnostic approaches will be used, and at what points in the program.

Describe how existing entrepreneurship training and mentoring programs or resources from the Hub’s local ecosystem (SBC and academic partners) can be leveraged for the program. List what additional resources or training materials will be developed during the grant period (Phase I and Phase II).

Describe the Hub’s expertise, resources and plans to advise academic partners on how to set up or improve the operations of technology transfer and commercialization offices. Provide relevant information on how the Hub will promote sharing and leveraging of partner institution and other resources, infrastructure and best practices to assist researchers in moving ideas, inventions and discoveries into commercialization. Explain how the Hub will promote a culture of entrepreneurship within the network.

Provide any other relevant information about the Hub s skills development and mentoring

activities.

4) Plan for self-sustaining operations

The IDeA Regional Hub is a three-year program intended to enhance the ability of academic institutions and their local ecosystems in IDeA states to promote entrepreneurship and move ideas, technologies and discoveries from the lab into commercialization. Hubs are expected to seek additional resources to maintain their operations and continue to have an impact after NIH funding sunsets.

Sources of support for program sustainability might include:

• Industry and strategic partners
• Local and state governments
• Economic development associations
• Foundations and private donors
• Other Federal funding sources
• Fee for services
• Licensing of intellectual property
• Sale of products

Include descriptions of all institutional support, financial arrangements, and agreements for equity positions or royalty payments that the Hub will receive. Appropriate documentation should be included in the application in the Letters of Support.

Provide any other relevant information about the Hub’s approach for self-sustaining infrastructure and operations.

5) (Optional) Pilot Projects

Regional Hubs may demonstrate institutional commitment by funding innovative pilot projects at the participating institutions. The pilot projects are not to be proposed in the application. After the award is made, applications for pilot projects can be solicited from faculty at participating institutions. If pilot project activities will be supported, applicants must include in the letters of support from partner institutions details on non-federal funding and resources that have been secured or are anticipated during the project period to support such studies. Sources of non-federal funding could include, but are not necessarily limited to, foundations, participating institutions, state or local government, angel investors, venture capital firms, individual benefactors, or any combination of the above. If the fundraising efforts of the participating institutions in the proposed regional Hub are in progress at the time of submission, and/or if the third-party funding is contingent upon NIH selecting the application for funding, then such plans should be clearly described in the letters of support.

If pilot projects activities will be supported during the award period, describe how the Hub will solicit and select applications with the most promising projects from the regional network partner institutions for submission to the EAC, including the members of the Hub’s review team, review criteria, and the process for assessing applications for scientific merit and commercial potential.

The partner institutions that fund the pilot studies should have a procedure and structure to provide assurance that these projects will be in full compliance with all applicable Federal policies, rules and guidelines for research involving human subjects, vertebrate animals, and/or biohazards as described in the SF424 (R&R) SBIR/STTR Application Guide.

6) Program Evaluation

Describe an evaluation plan to review Hub performance and outcomes and determine the effectiveness of the program on an annual basis. This should include plans to obtain feedback from institutional officials at the academic institutions in the Hub with which you have partnered and from the academic entrepreneurs participating in the skills development activities, to help identify weaknesses and to provide suggestions for program improvements.

Specific evaluation metrics should be tied to the goals of the program, such as number of academic entrepreneurs engaged and trained, success in increasing the number of SBIR/STTR applications submitted to the NIH, an increase in patents, an increase in technology transfer for commercialization from universities and research institutions in IDeA states, and an increase in the creation of startups focused on biotechnology in these regions.

Letters of Support: Applicants should include letters of support from academic partners, consultants, contractors, and collaborators as appropriate.

While non-Federal matching funds are not required, the application must show clear evidence of strong and specific institutional commitment. It is recognized that the availability of resources is variable among IDeA institutions. Consequently, the level of institutional commitment will differ among applicant institutions. At a minimum, the application should include communication from a senior institutional official from each of the partner institutions (e.g., President or Dean) outlining the resources and facilities that will be committed by the institution to support and sustain the regional Hub throughout the period of funding and beyond. 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 financial support for pilot projects.

As appropriate, letters of support from the Program Directors/Principal Investigators of other awardees of NIH and other Federal and non-Federal entities (e.g., COBREs, INBREs, IDeA-CTRs, REACH and CTSAs) may be included to indicate their role in assisting the regional tech transfer accelerator Hub. Letters of support indicating prior/current relationships with applicant SBCs (if any) may be included.

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 Plans: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) SBIR/STTR Application Guide,

Appendix:

Note that Phase I SBIR/STTR Appendix materials are not permitted. 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.

Not Applicable

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

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), SBA Company Registry, eRA Commons, and Grants.gov.

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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions. 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) SBIR/STTR 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 NIGMS, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 that the Hub described in the application will exert a sustained, powerful influence on how well the Hub's expertise, capabilities, partnerships, and resources will enable it to significantly impact the pace and probability of success for discoveries and innovations being developed into commercial products at academic partner institutions in the regional network, 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.

Does the proposed Hub address the needs of the regional network that it will coordinate, administer and serve? Is the scope of activities proposed for the Hub appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the regional network?

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?)

Will the Hub enhance cooperation and interaction within and among institutions in each IDeA region? Will the Hub facilitate the development of infrastructure and activities that are effective, efficient, sustainable and inclusive? Will the Hub increase the number, pace, and probability of success for scientific innovations and discoveries to be developed into commercial products?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Hub? Do they have appropriate experience and training, and have they demonstrated experience in operational, tech transfer, business, and scientific expertise necessary to run a Hub, including success in converting discoveries into commercial products? Do they have an ongoing record of accomplishments in managing an effective entrepreneurial research network? Do the investigators demonstrate significant experience with coordinating collaborative basic, clinical or translational research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Hub? Does the applicant have experience overseeing selection and management of subawards, if needed?

Can the governance team address training needs for academic entrepreneurs, and regulatory issues, such as guiding products through the regulatory process? Does the team contain the appropriate level of experience with technology transfer projects or hands-on entrepreneurial development?

Does the application propose novel organizational concepts, management strategies, and entrepreneurial training needs in coordinating the regional network the Hub will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies training materials proposed?

Does the Hub create partnerships of appropriate breadth, depth, and scope to enable scientists at IDeA institutions to bring discoveries from the laboratory to the commercialization pipeline?

Does the Hub create educational materials that are uniquely targeted to the development of the skills necessary to bring discoveries to market and are plans for dissemination of these materials to graduate and undergraduate students designed to enhance student awareness of the skills needed for careers in industry?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the regional network the Hub will serve? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed?

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 children, justified in terms of the scientific goals and research strategy proposed?

Will the Hub build, strengthen, and/or partner with technology transfer or commercialization office(s) at participating institution(s) in an effective way during the development and implementation phases of the project? Are the evaluation plans and metrics in place adequate to assess achievement of the goals and desired outcomes from Hub activities and training products? Does the applicant demonstrate a feasible plan for sustainability beyond the duration of the funding award? Are procedures in place to resolve disputes among Hub participants?

If pilot projects will be supported, will the Hub assemble review and project management boards with appropriate expertise to effectively select and shepherd pilot projects to commercialization? What are the processes that will result in the development and identification of meritorious projects? What processes will be implemented to develop and track milestones for each project and make go/no-go decisions about whether a project continues to develop?

Will the institutional environment in which the Hub will operate contribute to the probability of success in facilitating the regional network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Hub proposed? Will the Hub benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Do the applicants have a record of accomplishment for building multi-component partnerships that transform discoveries into commercial products? How well will the constituent parts of the Hub 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 local entrepreneurs in the development and operation of the Hub as either participants or as advisors?

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.

Hub Impact and Organization

To what extent will the award increase the potential to commercialize innovative technologies compared to what would likely be commercialized without an award?

What is the quality of the organizational structure of the Hub and does this structure indicate an ability to integrate the full range of Hub functions to achieve the specified goals and work effectively at the clinical/technology/business interface?

How does the quality of the information provided in the application demonstrate ability to effectively manage multidisciplinary projects and deal with sensitive but critical go/no-go decisions in a team-based environment?

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

Have plans been presented for outreach and the dissemination or sale of licenses or products, i.e., curricula, texts, webinars to those who wish to create accelerator hubs or use the resources produced?

Education and Skills Development

Do the proposed activities have the potential to educate and motivate the product and technology commercialization process in IDeA states, with the future potential for broader impact as a product to customers outside of the Hub?

Do the proposed activities provide a high-quality didactic, hands-on, and mentoring curriculum to build both hard and soft skills of future academic entrepreneurs?

Are the proposed activities targeted to a diverse group of individuals and institutions within the IDeA region?

Technology Transfer Capacity Development

Does the Hub create infrastructure that removes barriers to development of biomedical products from discoveries and create a culture of innovation where evaluation of laboratory research findings for commercial potential is commonplace?

Has the applicant developed or adopted streamlined IP strategies for licensing agreements and equity/royalty partitioning to enhance the success and sustainability of the Hub?

Does the Hub address institutional hurdles that de-incentivize commercialization, such as lack of consideration for faculty entrepreneurship in tenure and promotion decisions, allocation of space, and protected time?

Does the Hub have access to business expertise, subject matter experts, and mentors required for the Hub’s success?

Project Management, Mentoring, Consulting and Advising

Does the application describe a project management and mentoring structure that will efficiently and effectively promote the transition of early-stage biomedical products and technologies through development processes required for successful transition to the private sector? Is sufficient expertise available and is an adequate plan in place to provide the needed consulting and advising services to the partner institutions?

Not Applicable

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?

3. To what extent does the application provide a reasonable plan for transitioning to a self-sustaining structure, both at the IDeA institutions and the SBC?

For research that involves human subjects but does not involve one of the six 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 six 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.

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 children 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.

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.

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.

Not Applicable

Not Applicable

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.

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).

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.

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.

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

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 FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. 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.

Geographic distribution of awards as only one award will be made per IDeA region. If there are more than one applications from a region, preference will be given to the one which is meritorious and proposes to create an inclusive regional network for the technology transfer accelerator hub.

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.

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 grantee’s business official.

Awardees 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 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.

Cooperative Agreement Terms and Conditions of Award

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, 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees 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 Hub and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the studies. The primary responsibilities of the awardees are to:

• Establish an Internal Advisory Committee comprising members from each network partner institution, who will establish the policies and operating procedures of both the Internal Advisory Committee and the regional Hub
• Establish an External Advisory Committee comprising diverse experts (including local experts) in translational and proof of concept research, including industry, start-up, venture capital, technical, financial, and business experts and coordinate their meetings
• Define and monitor project milestones for prototype development and testing projects, with go/no-go decisions made in appropriate timeframes
• Serve as a voting member on the Program Steering Committee (Multiple PD/PI leadership will have one vote in total)
• Determine experimental approaches, design protocols, conduct experiments, and disseminate results
• Obtain relevant overall Hub IRB and IACUC approvals, regardless of whether subcontractors have separate approvals
• Participate in collaborative activities with other IDeA regional Hubs, 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 External Advisory Committee conducts reviews 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 Hub awardees and with the NIH

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

The NIH Project Scientist(s) will:

• Review and comment on critical stages in the research program on individual educational tools, mentoring strategies and new technologies
• In consultation with NIH staff, other Federal Agency staff, and non-NIH experts in the field, review and approve both educational tools and resources before implementation
• Participate in Hub go/no-go decision-making during the Phase I to Phase II decision
• Participate in selection of pilot projects prior to initiation (if applicable)
• Interact with PD(s)/PI(s) on a regular basis to monitor progress at the Hub
• Have the option to recommend to the Program Official the withholding of support to a participating Hub or Partner if technical performance requirements are not met
• Help organize the annual Program Steering Committee Meeting
• Help coordinate collaborative efforts that involve multiple awardees
• Be a voting member of the Program Steering Committee (the NIH will have only one vote)
• Help the Program Steering Committee draft and apply operating policies and policies addressing recurring situations that require coordinated action

The NIH Program Official will:

• Be responsible for the typical scientific and programmatic stewardship of the award
• Carry out continuous review of all activities to ensure objectives are being met
• Help coordinate collaborative efforts that involve multiple awardees
• Help organize the annual Program Steering Committee Meeting
• Be a non-voting member of the Program Steering Committee
• Help the Program Steering Committee draft and apply operating policies and policies addressing recurring situations that require coordinated action

Areas of Joint Responsibility Include:

The NIH Project Scientist(s), Program Official, and the PD(s)/PI(s) of each Hub funded under this FOA will be responsible for forming a Program Steering Committee (PSC). The PSC will act as the main governing board across the multiple awards 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 each Hub.

Each PSC 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 PSC may, as it deems necessary, invite additional, non-voting scientific and commercial (including industry) advisors to meetings at which research priorities and opportunities are discussed.

The Program Steering Committee will meet in person once a year at a minimum, with additional meetings scheduled as necessary to accomplish the goals of the program.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee'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.

If pilot projects activities will be supported by the Hub during the award period, the scientific merit and commercial potential of the selected pilot project(s) must be reviewed by the EAC. These pilot project(s) and recommendation from the EAC must be submitted to NIGMS for administrative review before these can be initiated.

Prior Approval of Pilot Projects

Before the commencement of any EAC approved pilot project(s), these will require submission to NIGMS staff for administrative review (see Notice NOT-GM-14-111 for details).

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension. When multiple years are involved, awardees 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-12-152)
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Federal Financial Report (FFR) replaced the Final Cash Transaction Report (PSC 272)
• Phase II Data Collection Requirement for Government Tech-Net Database

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

For details about each specific required report, see Part III. Section 5, "SBIR/STTR Award Guidelines, Reporting Requirements, and Other Considerations, in the Supplement Grant Applications For All Competing Applications and Progress Reports.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

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)
Telephone: 301-594-3900
Email: [email protected]

Joseph Gindhart, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0828
Email: [email protected]

Allen Richon, Ph.D.
Center for Scientific Review (CSR)
Telephone: 240-760-0517
Email: [email protected]

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-7706
Email: [email protected]

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 42 CFR Part 52 and 45 CFR Part 75.

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), and as reauthorized and extended under P.L. 114-328, Section 1834. The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.