Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI) National Eye Institute (NEI) National Heart, Lung, and Blood Institute (NHLBI) National Human Genome Research Institute (NHGRI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) National Institute of General Medical Sciences (NIGMS) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) National Institute of Nursing Research (NINR) National Institute on Minority Health and Health Disparities (NIMHD) National Library of Medicine (NLM) National Center for Complementary and Alternative Medicine (NCCAM) National Center for Advancing Translational Sciences (NCATS) Office of Research Infrastructure Programs (ORIP)
Funding Opportunity Title	NIH Research Evaluation and Commercialization Hub (REACH) Awards (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	December 17, 2018 - This RFA has been reissued as RFA-OD-19-014. November 20, 2018 - Notice of Intent to Publish a Funding Opportunity Announcement for Research Evaluation and Commercialization Hubs (REACH) program. See Notice NOT-OD-19-033. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. May 1, 2014 - Notice of Change in Eligibility for RFA-OD-14-005. See Notice NOT-OD-14-087.
Funding Opportunity Announcement (FOA) Number	RFA-OD-14-005
Companion Funding Opportunity	None
Number of Applications	Only one application per institution as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.350, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879
Funding Opportunity Purpose	The NIH Research Evaluation and Commercialization Hub (REACH) program will support proof-of-concept centers (Hubs) that facilitate and accelerate the translation of biomedical innovations into commercial products that improve patient care and enhance health. The REACH Hubs will provide qualified institutions with the initial investment and resources to nurture innovators to develop high priority early-stage technologies within the NIH s mission by providing: (1) infrastructure for identifying the most promising technologies, (2) funding for product definition studies (e.g. feasibility studies, prototype development, or proof-of-concept studies), (3) coordinated access to expertise in areas required for early stage technology development (including scientific, regulatory, reimbursement, business, legal, and project management), and (4) skills development and hands-on experience in entrepreneurism. Establishing public-private partnerships and providing additional non-federal funds will be critical for success.

Posted Date	April 25, 2014
Open Date (Earliest Submission Date)	May 26, 2014
Letter of Intent Due Date(s)	May 26, 2014
Application Due Date(s)	June 26, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	November, 2014
Advisory Council Review	January, 2015
Earliest Start Date	April, 2015
Expiration Date	June 27, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) 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 NIH Research Evaluation and Commercialization Hubs (REACH Hubs) will foster the development of therapeutics, preventatives, diagnostics, devices, and tools that address diseases within the NIH’s mission in a manner consistent with business case development. The work supported by the REACH Hubs may include technical validation, market research, clarifying intellectual property position and strategy, and investigating commercial or business opportunities. A primary outcome of the Hubs will be the translation of promising technologies to the private sector, either through a viable start-up company or licensing opportunity. The Hubs should establish novel partnerships, strengthen existing alliances between stakeholders (including public, private, non-profit, and academic sectors), provide entrepreneurial educational opportunities for innovators, and create cultural and systemic changes to more rapidly move from breakthrough innovations to products that will have health, economic, and societal impact.

Although NIH invests billions of dollars a year in biomedical research, which has led to great advances in scientific tools and biological insights, there are barriers to effectively translating basic science discoveries from academia to patient benefit. 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 new technologies are brought to market; and (3) a lack of access to sufficient technology development and commercialization resources that are required for early stage technology development. This FOA is designed to address these issues by establishing a Phase 0 Proof of Concept Partnership pilot program in accordance with Section 5127 of the 2011 SBIR/STTR Reauthorization Act (P.L. 112-81).

Each Hub will assemble diverse experts in translational and proof of concept research who have the knowledge required to identify and develop promising early stage technologies in order to accelerate their translation into commercial technologies to enhance human health. Each Hub will focus on research projects that have progressed to a point where a potential commercial product can be envisioned, but additional research and development efforts are required to define the product (demonstrate feasibility and proof-of-concept). Through a combination of in-house efforts and collaboration, each Hub funded under this FOA will perform functions to specifically address the critical knowledge and funding gaps that hinder the early steps needed to turn novel discoveries into technologies for biomedical advancement and patient care. 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 infrastructure for soliciting and selecting the most promising technologies predicated on medical need, scientific merit, and commercial potential.

4) Provide the funding, resources and expertise required for early stage technology development.

5) Develop and implement market-focused project management oversight and decision making processes.

6) Provide innovators with skills development, hands-on entrepreneurial experience, educational and networking activities with linkages to local or virtual resources.

7) Implement a plan for transitioning to a self-sustaining structure.

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. In addition, 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, IP protection, regulatory and reimbursement processes, project management, clinical studies, and appropriate domain experts. REACH will have the ability to support projects that cover various facets of technology development ranging from early stage laboratory-based technology feasibility or validation studies up to early phase clinical testing. The successful REACH applicant will support the development of relevant technologies using a milestone-driven approach to transition technologies from the Hub to the next appropriate source of independent financing or strategic partner with the ultimate goal of commercialization.

An important characteristic of the REACH is the ability to collaborate effectively with entities that possess the resources and expertise required to commercialize technologies developed through the Hub. A Hub should have a structure that takes into account the full range of technology development expertise and partnerships necessary to facilitate identifying and developing discoveries into technologies that address defined medical and scientific needs. Hubs should consider leveraging and partnering with existing NIH or federal resources as appropriate, including: the NIH Centers for Accelerated Innovations (NCAI) (http://ncai.nhlbi.nih.gov/); Clinical and Translational Science Awards (CTSA) recipients (https://www.ctsacentral.org); Therapeutics for Rare and Neglected Diseases (TRND) (http://www.ncats.nih.gov/research/rare-diseases/trnd/trnd.html); Bridging Interventional Development Gaps (BrIDGs) (http://www.ncats.nih.gov/research/reengineering/bridgs/bridgs.html); Centers for AIDS Research (http://www.niaid.nih.gov/labsandresources/resources/cfar/Pages/default.aspx); Cancer Centers (http://cancercenters.cancer.gov/cancer_centers/); eligible Institutional Development Award (IDeA) program participants including the Centers of Biomedical Research Excellence (COBRE; http://www.nigms.nih.gov/Training/IDeA/pages/COBRE.aspx) and IDeA Networks of Biomedical Research Excellence (INBRE; http://www.nigms.nih.gov/Training/IDeA/pages/INBRE.aspx) Department of Commerce i6 awardees (http://www.eda.gov/challenges/i6/); and appropriate clinical trial networks. Each Hub should establish an infrastructure that will promote this type of leveraged interaction to successfully develop the technologies accepted into the Hub. The cooperative approach outlined in this FOA allows for interactions among successful applicants to promote the development of integrated plans and processes required to conduct product-definition studies that facilitate translation and commercialization.

Each Hub must demonstrate access to adequate numbers of technologies of strategic interest to the NIH such that projects not meeting milestones can be discontinued and funds can be rapidly transitioned to another meritorious project.

REACH Hubs must provide entrepreneurial educational opportunities to academic investigators about the design and conduct of product definition studies and the commercialization processes required for transitioning a 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, including those from traditionally under-represented backgrounds, with access to forums, seminars, workshops and related activities is encouraged.

Although not required, participation or planned participation in the National Science Foundation I-Corps Site program will be viewed as a strong component of a comprehensive educational and skills development program. Applicants with established and proven innovation or entrepreneurial units are encouraged to submit concurrent applications to the I-Corps Site Solicitation (I-Corps will not fund the creation of such an innovation or entrepreneurial unit) (http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504802) and to submit a summary of their I-Corps Site participation or planned participation and how it fits into their larger education and skills development efforts in part 6 of their Research Strategy (see Section IV.2 Research Plan). Applicants are strongly encouraged to contact the appropriate NSF Program Officer listed in the I-Corps Site Solicitation prior to submitting an I-Corps Site application.

Federal funding provided under this FOA for the REACH is not expected to be adequate to fully fund the completion of the high quality work necessary for a technology to exit the Hub. Hence, 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 that can augment the federal investment for product definition studies. Further, it is expected that the REACH will become financially self-sustaining through support from partnering institutions or other financial arrangements that may include agreements with the source institutions allowing for revenue from licensing, milestone payments, royalties, or other mechanisms.

NIH is especially interested in promoting participation of Institutional Development Award (IDeA) states and programs in the REACH Hubs, and encourages applications from eligible IDeA states as well as outreach from non-IDeA based applicants to existing IDeA programs.

Applicants are strongly encouraged to contact the appropriate NIH Scientific/Research contact listed in Section VII. The NIH will host a pre-submission webinar on May 14, 2014 at 3pm ET. Further information about the webinar will be posted at http://sbir.nih.gov.

Funding Instrument	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.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of sufficient meritorious applications. The participating Institutes and Centers intend to commit an estimated total of $9,000,000 to fund up to three awards.
Award Budget	The maximum budget for a Hub is $1,000,000 total costs per year.
Award Project Period	The maximum project period is 3 years.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Applicants must be a university or other research institution that participates in the NIH STTR program. Participation means that a university or other research institution has been a formal partner to a small business on an STTR grant. Many NIH-supported universities or other research institutions will be eligible. Please contact the Scientific/Review staff listed below for clarification.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 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.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• 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 institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) 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:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express mail zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

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

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

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

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

Funds should be requested for the Hub PD(s)/PI(s) (and other Hub staff as appropriate) to attend the yearly in-person Program Steering Committee meeting in Bethesda, Maryland. Funds should also be requested for the operations of the External Review Board.

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

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

Research Strategy: Provide the overall objectives of the Hub, including the short and long-term goals. Describe how the Hub's expertise, capabilities, partnerships, and resources will enable it to have a significant influence on accelerating the pace and increasing the probability of success for discoveries and innovations being developed into commercial products.

Each of the following components should be addressed in the Research Strategy section:

1) Leadership and governance

A REACH Hub should be governed by leadership experienced in translating biomedical technologies from research performing institutions to the commercial market. Provide a detailed description of the Hub’s leadership team. Applicants should provide an administrative plan appropriate for effective management of the Hub structure. Hub leadership, including PD(s)/PI(s), should demonstrate the necessary operational, business, and scientific expertise with a documented track record of success in transitioning technologies from the discovery phase to commercialization. Define appropriate short- and long-term metrics to evaluate the overall success of the Hub in achieving short- and long-term goals, including tracking the progress of technologies after exit from the Hub.

The Hubs should promote and facilitate the open exchange of information regarding the scope, methods, analysis, results and lessons learned from each project. Data from failed projects should be collected and analyzed to capture lessons learned from those experiences. The applicant should describe the plan to promote information exchange and the dissemination of research outcomes to the research community at large. Establishing or leveraging an existing open access repository for collecting such knowledge is encouraged.

A Program Steering Committee (PSC) will be created that includes NIH and other Federal staff, Hub PD(s)/PI(s), 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.

2) Collaborations, partnerships, and non-Federal funding

A critical aspect of the Hub's administrative function is to establish and effectively manage a range of collaborations and partnerships with other institutions and the community to ensure an adequate supply of technologies at the appropriate development stage and to help advance technologies toward commercialization. Examples of partnerships include, but are not limited to, other research institutions with appropriate technologies, law schools or business schools, state economic development agencies, local incubators or accelerators, clinical research organizations, clinical trials networks or other existing programs in place at the Hub. The Hub is encouraged to pursue collaborations with existing NCAI, NIH CTSA, COBRE, or INBRE recipients. 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, virtual, and NIH or other federal, state, or local government programs. In addition, applicants should demonstrate a commitment to local and regional economic development.

If applications contain multiple partnering research institutions for sourcing technologies, the applicant must present a plan to ensure appropriate communication and to facilitate licensing and technology transfer.

REACH Hubs are expected to obtain non-federal funding equal to or exceeding the funding requested from NIH. Applicants must include details on non-federal funding and resources that have already been secured or are anticipated during the project period to support product definition studies. Provide a detailed description of available resources and evidence of non-federal investments that will allow the applicant to meet the requirements of this FOA. Verifiable details on sources of non-federal funding that have already been secured or are anticipated during the project period should be provided. Include letters of support in the Letters of Support attachment of the PHS 398 Research Plan form. Place documentation of support from non-federal resources and funders, such as term sheets or redacted bank statements, in the Appendix materials.

Sources of non-federal funding could include, but are not necessarily limited to, foundations, participating institutions, a State or local governmental body, angel investors, venture capital firms, individual benefactors, or any combination of the above. Applicants may also value in-kind support if it represents a substantial resource available to the Hub in meeting the requirements of this FOA. Applicants should clearly itemize the resources and funding that will be secured and indicate the total value (applicants can include additional budget pages in the Appendix). If the fundraising efforts of the 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.

Examples of adequate documentation of planned (i.e., future/expected) non-federal resources and funding may include a term sheet and/or letter of commitment from the source of funds or resources stipulating the terms of the proposed commitment/investment, although other forms of documentation may be considered. At the time of application, evidence of a firm non-federal funding commitment is ideal, but not required. Appropriate documentation of non-federal resources and funding support may include a conditional letter of commitment stating that the third-party commitment/funding is contingent upon NIH selecting the application for an award.

3) Technology solicitation and selection (External Review Board)

A REACH Hub must provide infrastructure for soliciting and selecting the most promising technologies predicated on medical need, scientific merit, and commercial potential. A Hub should establish a rigorous External Review Board (ERB) 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 university technology transfer officials. Applicants should describe the process for establishing the ERB, the expertise that will be represented on the board, and the processes by which the Hub will solicit appropriate technologies and the ERB will use to evaluate them. Applicants should not contact potential ERB members or name them in the application.

4) Funding, resources and expertise for technology development

Each Hub must provide appropriate funding, resources and expertise required for early stage technology development. Applicants should describe a plan to provide funding to individual investigators to conduct product definition studies (feasibility, validation, prototype development, or proof of concept studies). Funding amounts may include up to $100,000 from this award, but can be subsidized by other sources available to the Hub. Applicants should describe the resources and expertise available to the Hub to facilitate early technology development [scientific, business plan development, market research, intellectual property (IP) protection, regulatory submission, reimbursement, legal, project management, etc.].

5) Project management and technology development

Each Hub must develop a market-focused project management oversight process to enable early stage technology development, including the ability to make rapid decisions to terminate further development and reallocate resources. Recognizing that technology development requirements will differ depending on the technology type, the developmental stage, the innovator s experience, and the ecosystem resources, describe technology development plans that include:

• A demonstration that applicants have an established and proven technology transfer or commercialization office and a plan for engaging that office in the program’s implementation. The technology transfer or commercialization office should enable the best path forward for technologies developed with REACH funding. Use or development of standardized simplified institutional agreements to streamline interactions and decrease barriers to technology transfer and commercialization is strongly encouraged. Any agreements designed to reduce the burden of licensing and hurdles to downstream commercialization of technologies should be described. Example agreements may be included in the Appendix. Applicants should demonstrate institutional commitment to this effort.
• Processes for providing funding (both federal and non-federal) and resources for conducting the scientific and business oriented research required to achieve successful exits from the Hub.
• Access to appropriate expertise for technology development, including the ability to assemble project management boards comprised of industry, start- up, venture capital, technical, financial, and business experts.
• Processes to assess progress and make milestone-driven go/no-go decisions to terminate development of projects and reallocate resources when necessary.

6) Skills development, education, and mentoring

A Hub must provide skills development, hands-on experience, educational and networking activities with linkages to local or virtual resources. Applicants should 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 socially and/or economically disadvantaged groups. For example, Hubs may pursue collaborations with existing NIH Centers for Accelerated Innovations. Applicants should provide a detailed discussion of how mentoring and the professional development of the technology Innovators will be achieved.

Although not required, if applicants plan to submit a concurrent application to the I-Corps Site Solicitation (http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504802) or already participate as an I-Corps Site, they should briefly describe their existing or proposed I-Corps Site and how it fits into their broader Hub education and skills development efforts. Applicants are strongly encouraged to contact the appropriate NSF Program Officer listed in the I-Corps Site Solicitation prior to submitting an I-Corps Site application.

7) Plan for self-sustaining infrastructure

It is expected that a REACH Hub will become self-sustaining and a suitable sustainability plan must be presented. Sustainability may include support from partnering institutions or other financial arrangements. Include descriptions of all institutional support, financial arrangements, and agreements for equity positions or royalty payments that the Hub will receive from successfully commercialized technologies and how the Hub will support future product definition studies and related activities. Appropriate documentation (Letters of Support from institutional leaders and others, Agreements, and Memoranda of Understanding) should be included in the application in the Letters of Support or Consortium/Contractual Agreements sections as appropriate.

Letters of Support: Include documentation of support for the Hub for sources of non-federal resources as well as institutional commitment to the program and oversight of the TTO. Also include letters supporting the sustainability plan.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

• The Data Sharing Plan should include processes to disseminate best practices and information related to how and why go/no-go decisions are made.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Applicants should include documentation of support from non-federal resources and funders, such as term sheets or redacted bank statements. Applicants may also include additional budget pages itemizing the resources and funding available from third-parties.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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) 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) 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 Applying Electronically.

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. See Section III of this FOA for information on registration requirements.

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. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and responsiveness by the NHLBI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Evaluation of Responsiveness

Prior to peer review, the NHLBI Office of Scientific Review and Program staff will determine whether applications are responsive to this FOA. All applications will be administratively evaluated to determine whether applicants:

• Proposed to support technology development focused on product definition studies. (Applications that proposed hypothesis-driven research will not proceed to review)
• Responded to each of the research strategy requirements (Section IV.2).
• Provided letters of institutional commitment as required in this FOA.
• Included evidence of access to non-federal funds or fundraising plans.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Specific for this FOA: How will an award enhance the applicant’s ability to conduct the scientific feasibility studies in a way that will further the goals of this FOA? Will the structure and processes of the proposed Hub have a significant influence on accelerating the pace and increasing the probability of success for discoveries and innovations being developed into commercial products?

Investigator(s)

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

Specific for this FOA: Does the Hub leadership (including the PD(s)/PI(s)) demonstrate the necessary operational, business and scientific expertise to run a Hub with a documented track record of success in transitioning technologies from the discovery phase to commercialization? Does the Hub have the ability to address regulatory issues, including but not limited to knowledge of guidelines and experience taking products through the regulatory process?

Innovation

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

Specific for this FOA: Does the applicant create the unique public private partnerships with an integrated environment of resources required to inform the scientific feasibility studies in a way that will bridge the gap between the laboratory and market?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

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?

Specific for this FOA: Will the solicitation, selection and technology development processes result in the identification and advancement of relevant technologies? Does the applicant have appropriate decision-making processes in place to make timely milestone-driven go/no-go decisions about technologies being developed? How adequate are the proposed evaluation plans and metrics? Does the applicant have an established and effective technology transfer or commercialization office and what is the quality of the applicant’s plan for engaging that office in the program’s implementation? What is the quality of the applicant’s commitment to local and regional economic development? Does the applicant provide a quality plan to assemble review and project management boards comprised of industry, start-up, venture capital, technical, financial, and business experts? Does the applicant demonstrate a plan for sustainability beyond the duration of the funding award?

Environment

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

Specific for this FOA: Does the applicant have the business alliances or partnerships to transition technologies from discovery to the next appropriate stage of financing? Does the applicant demonstrate and utilize its core competencies to maximize the chance of success? Does the applicant demonstrate the necessary agreements and relationship with the Technology Transfer Office(s) to ensure the most appropriate path for product definition and exit? Does the proposed Hub add value and economy of scale to the product definition process? Does that enhance the probability of successful technology development towards commercialization?

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.

Review Criteria for Hub Leadership and Governance

To what extent will the award increase the potential to commercialize new 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 possesses knowledge of and relationships with appropriate stakeholders and user groups?

Review Criteria for Technology Solicitation and Selection

Will the Hub's technology evaluation processes enable selection of promising technologies for further development and testing?

Review Criteria for Technology Development

Does the proposed Hub bridge the gap between the lab and the market, create unique public-private partnerships with an integrated environment of resources that maximize capital investments and leverage private with public investment? Does the proposed Hub remove barriers to translate knowledge into useful medically relevant products, and encourage the culture needed for sustained technology development where evaluation of innovations for commercialization becomes the norm? 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?

How reasonable are the plans for obtaining non-federal funds to perform the scientific feasibility studies, acquiring community resources or promoting community involvement in the Hub’s activity?

How well do the applicants demonstrate ability to access appropriate domain experts and mentors?

How well does the application support the ability of the Hub to access required business expertise as expected in this FOA?

Review Criteria for Project Management

Does the application describe a project management structure that will efficiently and effectively promote the transition of early stage technologies through development processes required for successful transition to the private sector?

Review Criteria for Skills Development

Are the plans for entrepreneurial education for innovators structured in a way that facilitates the transfer of knowledge about technology development and commercialization to the Innovator? Do the broader skills development plans reach a diverse group of Innovators and potential entrepreneurs? If appropriate, does the applicant provide a description of their application to the NSF I-Corps Site program and how participation in that program would bolster their educational and skills development effort?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• 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 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 National Heart, Lung, and Blood Advisory 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.

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.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 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:

• Determine experimental approaches, design protocols, conduct experiments, and disseminate results
• Define and monitor project milestones for prototype development and testing projects, with go/no-go decisions made in appropriate timeframes
• Obtain relevant overall Hub IRB and IACUC approvals, regardless of whether subcontractors have separate approvals
• Ensure utilization of rigorous methodologies for clinical needs assessments with appropriate representation of users and/or stakeholders
• Serve as a voting member on the Program Steering Committee (Multiple PD/PI leadership will have one vote in total).
• Establish an External Review Board and coordinate their meetings
• Participate in collaborative activities with other Hubs and NCAI
• Develop and/or maintain external partnerships to assist in meeting goals
• Have processes in place to ensure that the external review committee conducts reviews in a manner that is fair, equitable, timely, and free of bias and conflicts.
• Provide information to the NIH Program Officer(s), and the NIH Grants Management Specialist concerning progress, go/no-go decisions, technology evaluation processes, and the initiation of new projects
• Share best practices with other REACH awardees, the NCAI 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 technologies
• In consultation with NIH staff, other Federal Agency staff, and non-NIH experts in the field, review and approve new technologies for development and testing technology plans prior to initiation
• Participate in Hub go/no-go decision-making during technology development
• Interact with PD(s)/PI(s) on a regular basis to monitor progress at the Hub
• Have the option to recommend to the Program Officer 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 Officer will:

• Be responsible for the normal 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 Officer, 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 protocols, identify technological impediments to the progress, 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 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.

NIH is responsible for organizing and providing overall support for the Hubs.

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.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

Kurt W. Marek, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-443-8778
Email: [email protected]

Director, Office of Scientific Review
Heart, Lung, and Blood Institute (NHLBI)
?Telephone: 301-435-0270
Email: [email protected]

John Diggs
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-4267
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 Parts 74 and 92.

The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, P.L. 107-50 and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.