National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
UT2 Small Business Technology Transfer (STTR) Cooperative Agreement – Phase II
Reissue of RFA-GM-18-001 - Regional Technology Transfer Accelerator Hubs for IDeA States (STTR) (UT2 - Clinical Trial Not Allowed)
This Funding Opportunity Announcement (FOA) solicits applications to strengthen the regional technology transfer accelerator hubs for Institutional Development Award (IDeA) states. Accelerator hubs funded by the awards under this FOA are expected to develop, refine, and implement comprehensive programs for fostering biomedical entrepreneurship which will promote technology transfer, small business finance and management, and other business skills needed to move basic discoveries and technologies out of the lab into commercial products that improve patient care and enhance human health. Each Hub will serve a network of multiple institutional sites across the IDeA states in one of the four regions where the academic partners are located. The goals of this FOA are to: 1) build on regional technology transfer programs to further strengthen the capacity to bring scientific results from academic institutions into the market; 2) fund a pilot project program for product definition studies (e.g., feasibility studies, prototype development, proof-of-concept, and preclinical studies); 3) provide access to expertise and resources in areas required for early stage technology development; 4) provide skills development and hands-on experience in entrepreneurship; and 5) promote a sustainable culture of biomedical entrepreneurship within IDeA states. It is anticipated that the educational tools developed under this FOA will be licensed or sold to other institutions that wish to create accelerator hubs. Establishing public-private partnerships and securing additional non-federal funds will be critical for long-term success.
January 5, 2021
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
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.
The purpose of this FOA is to support STTR regional technology transfer accelerator hubs 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 technology transfer accelerator hubs are regional consortia that provide expertise to develop the needed infrastructure and promote an entrepreneurial culture at the IDeA institutions in the region. They support the growth of businesses by facilitating networking and team formation among universities, venture capital groups, business development organizations, and small businesses, sharing and transferring information, best practices, and guidelines. They also provide assistance and one-on-one mentoring to investigators in the region, and facilitate information sharing on regional, state, and local resources and programs available such as commercialization funds or state matching funds. Technology transfer accelerator hubs are created by the awardee Small Business Concerns (SBCs) in partnership with academic institutions in IDeA states.
The overall goals of the networks that will be supported through this FOA are to: 1) build on regional technology transfer programs to further strengthen the capacity to bring scientific results from academic institutions in IDeA states into the market; 2) fund a pilot project program for product definition studies (e.g., feasibility studies, prototype development, proof-of-concept, and preclinical studies); 3) provide access to expertise and resources in areas required for early stage technology development; 4) provide skills development and hands-on experience in entrepreneurship; and 5) promote a sustainable culture of biomedical entrepreneurship within IDeA states. Establishing public-private partnerships and securing additional non-federal funds will be critical for long-term success.
The commercial product of these grants will be educational and entrepreneurial 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 in states that historically have received low levels of NIH funding. The 23 IDeA states and Puerto Rico have historically had a disproportionately low number of SBIR/STTR awards from NIH (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.
NIH invests billions of dollars each year in biomedical research, leading to great advances in scientific tools and biological insights. However, 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, where there are limited expertise, incentives, and opportunities for technology transfer.
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 request, 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 technology transfer and SBIR/STTR programs; and a lack of awareness of available resources at the state and local levels. One of the major recommendations made by the workshop attendees was to create sustainable Regional Technology Transfer Hubs in IDeA states to generate infrastructure, build an entrepreneurial culture, and educate and train academic researchers about how to develop commercial products and apply for SBIR/STTR grants.
The need to support regional networks of shared technology transfer accelerator hubs was 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."
In response to the Congressional request, in FY 2018, NIGMS made new grant awards to support the creation of one shared STTR accelerator hub in each of the four IDeA regions (RFA-GM-18-001). These hubs provide infrastructure and expertise, and produce educational tools through the development and testing of models to accelerate technology transfer that are needed to promote commercialization of academic research and to build an entrepreneurial culture at IDeA institutions .
For this FOA, SBCs 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 as a part of the regional network program. In each IDeA region, the technology transfer accelerator hub is organized as a “spoke and wheel” model in which the SBC is linked to the technology transfer offices of each participating institution in the regional network. The SBC partner is expected to have substantial experience in all aspects of technology transfer and commercialization and have knowledge of the development of training materials and their deployment. 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 companies. 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 hold workshops, give seminars, and consult with academic investigators, postdoctoral fellows, and students across the IDeA region about the design and conduct of product definition studies and the commercialization processes.
The academic partners in a Hub 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 is expected to serve all academic partners in the region.
Each Hub is governed by leadership experienced in translating biomedical technologies from research performing institutions to commercialization. The 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 for projects at a range of stages of research and development, from early stage laboratory-based studies to early phase clinical testing. Through a combination of in-house efforts and collaboration across the regional network, each Hub 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 leverage technology development expertise and partnerships necessary to funnel discoveries into the commercialization pipeline.
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 biotechnology out of academic labs to the private sector (either as startup small businesses or through licensing opportunities). Cross-disciplinary (science, business, regulatory, etc.) career development is highly encouraged to achieve the goal of exposing innovators to the processes required to translate discoveries into marketable products. Providing the broader investigator community (faculty, postdoctoral fellows, and students), including those from underrepresented groups, access to forums, courses, seminars, workshops, and related activities is encouraged.
These Hubs should leverage and strengthen the links with 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]). These efforts should 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.
Hubs are expected to work with existing NIH or federal resources as appropriate, including: NIH Research Evaluation and Commercialization Hub [REACH] and Centers for Accelerated Innovations [NCAI]; Clinical and Translational Science Awards [CTSA]; and Cancer Centers . Although not required, leveraging existing entrepreneurial training activities, such as the NSF I-Corps, NCAI, REACH, CTSA, or other similar programs is encouraged.
Under this FOA, regional Hubs are to:
expand their current network of academic institutions to additional institutions and colleges including under-represented minority serving institutions;
strengthen the current and develop new collaborations and partnerships to meet the goals of the program;
provide and strengthen the infrastructure for Technology Transfer and Commercialization office 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;
provide innovators with skills development, hands-on entrepreneurial experience, educational, and networking activities with linkages to local or virtual resources;
provide entrepreneurial educational opportunities for innovators to move scientific advancements to products that will improve human health;
develop/adapt curricula at graduate and undergraduate levels to enhance student awareness and skills for careers in industry and provide students internships;
fund a pilot project program to perform feasibility and proof-of-concept studies, prototype development, and preclinical studies;
work with academic partners to strengthen an institutional culture that recognizes and rewards faculty innovation and product development; and
develop and implement a plan for transitioning to a self-sustaining structure in each IDeA region.
The cooperative approach outlined in this FOA also encourages interactions among four regional networks to promote the development of integrated plans, best practices, resource sharing, and strategies required for successfully achieving the goals of this program.
Contractual arrangements or a Memorandum of Understanding (MOU) must be established between the SBC and the participating institutions. 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 program will focus on infrastructure and training needs for entrepreneurial faculty and students, and implement a plan to address those needs and support product definition studies through the Pilot Project Program.
Each Hub must have the following three committees for its governance:
Steering Committee (SC): The SC is the governance body that provides scientific and administrative oversight to the Hub. It will establish the policies and operating procedures of the Hub. The membership of the SC consists of the (PD(s)/PI(s)), a member of the institutional leadership (e.g., deans, vice presidents for research, or their surrogate) from the lead academic partner institution, a representative from each state in the IDeA region, and the NIH Project Coordinator. Each member of the SC has one vote. The UT2 PD/PI (or Contact PD/PI in case of Multiple PD/PI award) serves as the Chairperson of the SC. The SC will meet quarterly in the first year of the award and frequency of meetings in succeeding years will be decided by the SC at the beginning of each budget period as described in Section VI.2 under Cooperative Agreement Terms and Conditions of Award. The SC will regularly review the progress of the Hub activities. The SC establishes rules defining the composition of the External Advisory Committee (EAC) and the tenure of its’ Chairperson.
Administrative Committee (AC): The AC of the Hub will provide logistical support to the regional network and Steering Committee (SC) and External Advisory Committee (EAC). The AC will consist of the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)), technical and administrative staff at the SBC, and representatives from the lead partner institution(s). The AC Lead UT2 PD/PI (or Contact PD/PI in case of Multiple PD/PI award) is responsible for management, staffing, resource allocation, and for administering the award in accordance with NIH policies. The AC is also responsible for the development and management of an Evaluation Plan to measure the impact of the regional Hub. As communication among Hub network institutions is essential, the AC should provide electronic communication to inform investigators both within and outside the network of the availability of, and access to, technologies and resources.
External Advisory Committee (EAC): Each regional Hub must include an EAC with six to eight members from organizations not participating in the network. Members of EAC, selected by the UT2 PD/PI (or Contact PD/PI in case of Multiple PD/PI award) in consultation with the SC, must have appropriate scientific/business and entrepreneurship expertise including industry, start-up, venture capital, technical, financial, and business experts, or university technology transfer. The EAC provides advice to the PD(s)/PI(s) on scientific, management and training matters. The EAC critiques the progress of the Hub activities and offers advice on these matters to the PD(s)/PI(s). EAC activities also include developing and planning concepts and programs, encouraging and assisting faculty development and enhancement, identifying resources, evaluating pitches by innovators for pilot funding, and evaluating progress of the overall Hub program. The UT2 PD/PI (or Contact PD/PI in case of Multiple PD/PI award) will share the advice and critiques provided by the EAC with the SC. The EAC must meet at least twice per year. Video-, tele-conferencing, or other means may be used in situations where it would be difficult to hold an in-person meeting.
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; 3) institutional change that creates an environment that enables collaboration and development of fundamental or applied research into technologies and products; and 4) pilot project program implementation and management. Under this award, the Hubs will support development and offering of educational courses, modules, workshops in person and/or via webinars; plans for outreach and dissemination to license or sell the products, e.g., curricula, texts, webinars to those who wish to create accelerator hubs or use the resources produced.
One of the key Hub activities is the development and implementation 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
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 raise capital from non-federal sources
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 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.
Pilot Project Program
Each Hub must have a pilot project program with an internal mechanism for obtaining applications and awarding funding for projects that help scientists in the IDeA region gather data for feasibility and proof-of-concept studies to determine whether a nascent technology or product is worth pushing through the commercialization process. These pilot projects are not to be proposed in the application. Each Hub must demonstrate access to adequate numbers of such projects/technologies of broad strategic interest to the NIH at the academic partner institutions. After the award is made, applications for pilot projects can be solicited from innovators (faculty, postdoctoral fellows, and students) at network participating institutions and selected by the EAC.
Each Hub should provide infrastructure and expertise that will promote leveraged interaction to successfully develop the pilot projects/technologies funded through this FOA. Applicants to the pilot project program should be encouraged to seek matching funds either by pitching their ideas to entrepreneurs using the skills learned from what the Hubs provide (preferred) or by seeking matching funds from their institutions.
Evaluation Plan and Metrics
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 approaches taken are meeting the goals and benchmarks for building an effective regional technology 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. Each Hub should develop metrics tailored to the development of their entrepreneurial educational resources, regional databases, and pilot project program.
Criteria for evaluating the progress of the Hubs may include the number of participating faculty, postdoctoral fellows and students in entrepreneurial activities, new applications for SBIR/STTR funding, development of curricular materials, skills development materials and effective strategies, number of patents, number of licensing agreements, number of successful funded projects/technologies transitioned to the next level, and number of startups.
Measures of success will be: production and dissemination of educational products and services; 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 launching 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 evident.
Institutional Commitment and Regional Support
Applicants need to demonstrate evidence of strong and specific institutional commitment by academic partners to support this effort. This may include adequate laboratory space, complementary funds 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.
Supplements to UT2s
UT2 awards may be considered for administrative supplemental funding that will provide support above the cost limit of this FOA, depending on the need, and intention and constraints of the particular supplement program.
Demonstrating Program Readiness
Only one award will be made per IDeA region. In order for an application to be accepted for review and considered for funding, the proposed regional program must be ready for immediate implementation. The application must demonstrate readiness to start the project with immediate effect, if awarded, as described in Part 2. Section IV.2 Other Project Information. Other Attachments. Accordingly, applicant programs must have achieved the following milestones:
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, FOA requirements, developing appropriate milestones, and budget.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for the FOA.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NIGMS intends to fund 4 awards, corresponding to a total cost of $6.8 million, for fiscal year 2021. Future year amounts will depend on annual appropriations.
Budgets up to $1.7 million total costs (direct costs, F&A and fee) per year may be requested.
Budgets must be submitted in accordance with participating IC-specific budget limitations described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC and FDA.
A project period of up to 4 years may be requested.
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:
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.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.
Phase I to Phase II Transition Rate Benchmark
In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011. This Transition Rate requirement applies to SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years, excluding the most recently-completed fiscal year. For these companies, the benchmark establishes a minimum number of Phase II awards the company must have received for a given number of Phase I awards received during the 5-year time period in order to be eligible to apply for a new Phase I award Fast-Track, or Direct Phase II (if available). This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period.
Companies that do not meet or exceed the benchmark rate will not be eligible to apply for a Phase I Fast-Track, or Direct Phase II (if available) award for a period of one year from the date of the application submission. The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year. The benchmark minimum Transition Rate is 0.25.
SBA calculates individual company Phase I to Phase II Transition Rates daily using SBIR and STTR award information across all federal agencies. For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.gov. Information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.
Applicants to this FOA that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past five (5) years should, prior to application preparation, verify that their company’s Transition Rate on the Company Registry at SBIR.gov meets or exceeds the minimum benchmark rate of 0.25.
Phase II to 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 apply for New Phase I, Fast-track or Direct Phase II (if applicable) awards for a period of one year.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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.
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.
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.
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 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.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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.
All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) SBIR/STTR Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed with the following additional instructions:
Facilities and Other Resources: Describe the Hub's access to the existing educational and training programs and resources.
To demonstrate readiness, as described in Part 2. Section I, all applications must include information on the following items as attachments. Applicants are urged to be succinct but must follow the page limits as specified for each attachment.
Applications that lack the Regional Network attachment are incomplete and will not be peer reviewed.
Applications that lack the Contractual Arrangements attachment are incomplete and will not be peer reviewed.
Applications that lack the Infrastructure Needs attachment are incomplete and will not be peer reviewed.
Applications that lack the Training Prototype attachment are incomplete and will not be peer reviewed.
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 may be requested to develop and strengthen infrastructure and capacity at the IDeA regional academic partner institutions for technology transfer, small business financing and development of 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 NIGMS Program Meeting in Bethesda, Maryland.
Funds to compensate members of the External Advisory Committee should be requested in the Administrative budget. EAC members can be compensated as consultants via a fee-for-service arrangement.
Other allowable costs include, but are not limited to:
A detailed justification for each item requested must be provided.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
In addition, the following instructions must be followed:
Specific Aims: Provide specific aims for the Regional Technology Transfer program.
Research Strategy: Provide the overall objectives of the regional network, including the short-term and long-term goals of the program including activities and timelines that will be used to implement effective entrepreneurship and commercialization training programs. Describe how the program'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
The application must demonstrate the core competencies of the Hub 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 and strengthen infrastructure, to maximize coordination among academic partners, and achieve program goals.
For competing renewals, describe changes, if any, in the SC (governance body), AC, and EAC. 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 established EAC. New or replacement EAC expertise is allowed but do not contact potential EAC members or name them in the application.
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. Describe the existing network established by the applicant in the IDeA region and how these partnerships will be strengthened and benefit the regional hub. Describe existing communications infrastructure already established by the Hub applicant for use with the IDeA region network.
Examples of potential stakeholder groups include:
Within the regional Hub:
Within the entire program:
Within the local and regional ecosystem:
Describe the qualities and strengths that each new partner brings to the Hub. Describe how the Hub will facilitate and promote interaction with existing or new institutional, 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 should be 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 institutions and 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:
Describe the gap analyses that have been conducted to date and their key findings. Describe plans to further develop, refine, and offer needed 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 are encouraged to collaborate with NIH REACH networks and Centers for Accelerated Innovations or CTSAs.
Describe any new needs that have become apparent since the last gap assessments and how these will be addressed in this award.
Provide a detailed discussion of how mentoring and the professional development of the academic entrepreneurs will be achieved.
Describe how the Hub will continue to assess 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) will be leveraged for the program. List what new resources or training materials will be developed during this grant period.
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 including outcomes of previous and ongoing projects with the applicant's partner organizations within the IDeA region.
4) Pilot Project Program
Describe strategies for 1) soliciting applications with the most promising projects from the regional network partner institutions; 2) evaluating for scientific merit and commercial potential; 3) selecting for submission to the EAC; and 4) management processes to assess progress. Describe the types of projects that will be sought for support (e.g., rapid prototyping or proof-of-concept R&D), the likely duration for support of each project (e.g., 3-6 months), and the range of budgets that would be awarded (e.g., $20,000-50,000). The pilot projects are not to be proposed in the application. Describe the breadth and diversity of the accessible portfolio of pilot projects/technologies within the NIH mission available from the partner institutions. If the applicant has experience supporting similar pilot projects within the IDeA region, describe the outcomes from those awards.
If the pilot project program will be supplemented with additional funds, applicants must include letters of support from partner institutions with 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 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
High-quality and reproducible product definition studies are an essential cornerstone of the translational research enterprise. Attention to principles of study design and transparency is essential to enable stakeholders to assess the quality of the experimental design and scientific findings. In support of this important goal, the Hubs applicants should ensure that pilot project investigators will follow instructions to address rigor and reproducibility (http://grants.nih.gov/reproducibility/index.htm).
5) 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 and awarded by the NIH, an increase in patent application filings, an increase in technology transfer for commercialization activities from universities and research institutions in IDeA states, and an increase in the creation of startups focused on biotechnology in these regions, production and dissemination of educational tools.
Current Hub awardees should describe the results and status of the current evaluation plan and what changes will be made in a Competing Renewal.
6) Plan for self-sustaining operations
The Regional Hubs are expected to seek additional resources to maintain their operations and continue to have an impact after the NIH funding sunsets.
Sources of support for program sustainability may include:
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.
Current Hub awardees should describe status of the current sustainability plan and what new approaches will be taken in a Competing Renewal.
Letters of Support: Applicants should include letters of support from academic partners, consultants, contractors, and collaborators, as appropriate.
Securing non-federal funds is highly encouraged under this FOA. 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/tenure, and other financial support for pilot projects.
As appropriate, letters of support from the Program Directors/Principal Investigators of other awards from 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 technology 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 Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Note that Phase I SBIR/STTR Appendix materials are not permitted. Only limited items are allowed in the Appendix of other small business applications. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), eRA Commons, and Grants.gov
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 Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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. 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. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers, in consideration of the following review criteria, will provide an overall impact score to reflect their assessment of the program described in the application as to how well the Hub's expertise, capabilities, partnerships, and resources will enable it to significantly impact the pace and probability of success for discoveries being developed into commercial products at academic partner institutions.
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 project address an important problem or a critical barrier to progress in the field?Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)
For this FOA::
How 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 of scientific innovations and discoveries being developed into commercial products? Will the Hub enhance cooperation and interaction within and among institutions in each IDeA region?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
For this FOA:
Can the governance body 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 hub leadership already have well-established relationships with a network of academic institutions in the IDeA state region?
How well do the applicants demonstrate that the Hub participants possess knowledge of, and relationships with, appropriate stakeholders and user groups?
Do the applicants have a record of accomplishment for building multi-component partnerships that transform discoveries into commercial products?
If the applicants propose any changes to the current team, are these appropriate to achieve the program goals?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
For this FOA:
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?
Are the unique needs of IDeA state institutions and investigators addressed in appropriately creative ways?
Does the Hub create and use innovative, new educational materials that are uniquely targeted to the development of the skills necessary to bring discoveries to market; are plans for dissemination of these materials to graduate and undergraduate students designed to enhance student awareness of the skills needed for careers as entrepreneurs?
Does the Hub create infrastructure that removes barriers to development of biomedical products from discoveries and create a culture of innovation?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? For a Phase I application, are there clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
For this FOA:
Has an in-depth gap analysis been conducted to determine the needs of the institutions, investigators and students in the IDeA region and have the results of this analysis been used to appropriately inform the approach proposed?
Are the needed partnerships with academic institutions, businesses and other organizations in the IDeA region in place and will they be developed further in appropriate ways?
Do the proposed activities have the potential to educate and motivate the product and technology commercialization process in IDeA states?
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? If the applicants propose any changes to the curricula, are these appropriate to achieve the program goals?
Are the proposed activities targeted to a diverse group of individuals and institutions within the IDeA region?
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?
Is sufficient expertise available and is an adequate plan in place to provide the needed consulting and advising services to the partner institutions?
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?
For the pilot project program, do the applicants describe strategies for identification of projects, and assembling review and project management groups with appropriate expertise to effectively select and shepherd meritorious projects to commercialization? Is their strategy for funding projects (e.g., budget level, duration) appropriate?
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?
Are outcomes of previous work with IDeA state institutions in the region presented that give confidence that the proposed Hub will be able to rapidly make progress on their stated goals with little to no lag time required for set up?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?
For this FOA:
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?
Does the Hub have access to business expertise, subject matter experts, and mentors for the program success?
Is the existing communications infrastructure (websites, etc.) sufficient to support the needed interactions between the Hub and its partner institutions and to allow the Hub to hit the ground running?
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.
For Phase II Applications, how well did the applicant demonstrate progress toward meeting the Phase I (or Phase I-like) objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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.
The committee will consider the progress made during the current funding period.
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).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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.
2. Review and Selection Process
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:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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:
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH Staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NIGMS will assign a Program Official, a Project Coordinator, and a Grants Management Specialist to each Hub.
An NIH Program Official will be responsible for the normal programmatic and scientific stewardship of the award and will be named in the award notice. The program official(s) will:
The Program Official will not participate in the administrative, steering, or advisory committees or other governance groups for the Hub.
An NIH Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in the award. The NIH Project Coordinator will:
An NIH Grants Management Specialist will be responsible for the business management and other non-programmatic aspects of the award and will be named in the award notice. The grants management specialist(s) will:
Areas of Joint Responsibility:
The PD(s)/PI(s) of each Hub will be responsible for forming a Steering Committee (SC). The SC will act as the governance body for each Regional Hub award and will review the progress of the research activities, develop collaborative processes, identify impediments and select strategies to surmount them, and identify opportunities for sharing techniques and tools developed within each Hub.
The Steering Committee should meet at least quarterly in the first year of the award. Frequency of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period. Each SC voting member will have one vote, and a majority will be required to accept and implement policies approved by the Committee. The NIH will have only one vote. The SC may, as it deems necessary, invite additional, non-voting scientific and commercial (including industry) advisors to meetings at which research priorities and opportunities are discussed. The Hub network PD(s)/PI(s) will be required to implement policies approved by the Steering Committee.
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. 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.
NIH requires that SBIR/STTR grantees submit the following reports within 120 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.
Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.
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.
In the RPPR, include progress towards goals of the Hub outlined in this Funding Opportunity Announcement to assist in evaluating the program. Progress reports should describe results on the evaluation plan and associated metrics, and also status of the projects funded through the pilot project program. 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.
Post-Award Program Requirements for Pilot Projects
For the pilot project program that 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.
Prior Approval of Pilot Projects
Before the commencement of any EAC approved pilot project(s), the descriptions of the proposed projects and recommendations from the EAC must be submitted to NIGMS for administrative review and approval (see Notice NOT-GM-14-111 for details).
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
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)
Joseph Rudolph, Ph.D.
Center for Scientific Review
National Institute of General Medical Sciences (NIGMS)
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), as reauthorized and extended under P.L. 114-328, Section 1834, and P.L. 115-232. The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.
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