Part 1. Overview Information

Key Dates

All applications are due 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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Evaluation and Commercialization Hub (REACH) program is a partnership program between NIH and the qualifying research institutions to accelerate the creation of small businesses and the transition of discoveries originating from academic research into products that improve patient care and enhance health. REACH Hubs foster the advancement of therapeutics, preventatives, diagnostics, devices, and research tools that address unmet patient and public health needs across the entire NIH mission. Applicants are encouraged to focus on building robust entrepreneurial ecosystems in the areas of highest U.S. burden of disease and disability and areas that historically attract lower levels of private biomedical capital investment.

The new REACH Hubs will build upon lessons learned from previous awardees to transition promising technologies to the next stage of commercialization. Proposed technology development projects should have already advanced from scientific discovery into the early stages of product development. As a guiding principle, proposed technology development projects should be within one or two steps of a commercial transaction (selling, partnering, licensing, startup, or entry into another suitable program to continue development), but require additional validation in order to be considered competitive for a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) award. Although every technology development project is unique, broad guidelines for different types of projects are as follows:

• Small Molecule Therapeutics: The compound is at the lead optimization or preclinical stage. The target is known, and/or there is some method or assay to determine its effect.
• Biologics or Cell Based Therapies: The biologic or cell population has been identified and some reasonable method of development, sourcing, manufacture, or proliferation is proposed. Mechanism of action has been determined to a sufficient level that there is a reasonable understanding of the product to be developed or tested in the project.
• Interventional Medical Device: The proposal includes prototype development and testing, either on the bench or in animals. Physiologic experiments have been conducted or reported in the literature, providing rationale for prototype development.
• Diagnostic Medical Device/IVD/MDx: The proposal includes prototype development and some method of testing.
• Health IT, Software, Apps, and Algorithms: The proposal should be beyond the concept stage and already have an existing code base. The idea should be grounded in previous experiments or solid peer reviewed evidence. The proposal should include steps to validate the technology by demonstrating its efficacy versus the standard of care or utility in pilot studies or user testing, or, if already validated, to refine the technology to make it appropriate for commercialization.

The program aims to strengthen and de-risk technologies toward this goal through a team-based developmental approach that addresses downstream requirements, including but not limited to intellectual property, regulatory, and reimbursement issues, and business case development. It is expected that spinout companies will be in a position to submit strong SBIR and STTR program applications. The Hubs will establish novel partnerships, strengthen existing alliances between stakeholders (including academic, non-profit, and industry sectors), provide entrepreneurial educational opportunities for innovators from diverse backgrounds, and create cultural and systemic changes to more rapidly transform breakthrough innovations into products that will have health, economic, and societal impact.

Background

NIH, as a major funder of biomedical research, is committed to examining and addressing the barriers that prevent the effective translation of basic science discoveries from academia to patient benefit. These barriers include:

• a lack of knowledge and understanding by academic innovators about how new technologies are brought to market;
• a lack of access to sufficient technology development and commercialization resources and expertise that are required for early-stage development and
• 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.

This FOA solicits applications to establish technology development consortia designed to address these barriers. The REACH program will function as 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) and reauthorized through FY2025 by Section 3 of the SBIR and STTR Extension Act of 2022 (P.L. 117-183).

Objectives and Requirements for this FOA

Each Hub will assemble a diverse group of experts in biomedical product development and will have the expertise to identify and source technology development 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 address the critical knowledge and funding gaps that hinder the early steps needed to turn novel discoveries into products with health, economic, and societal impact. The work supported by the REACH Hubs should include technical validation, facilitating business development opportunities, clarifying intellectual property and identifying barriers to entry, performing market research (including market needs and competitive advantages), and clarifying regulatory, manufacturing, clinical, or payer requirements.

Hubs must meet all the following requirements:

1) Hub Leadership: Be governed by leadership with a documented track record of success in biomedical product development.

2) Collaborations and Partnerships: Develop the necessary collaborations and partnerships with stakeholders (including academic, non-profit, and industry sectors) to meet the goals of this FOA. Each Hub is expected to partner with existing federal government resources, including those within the Hub’s ecosystem, as appropriate, such as: EDA’s Build to Scale (B2S), NSF’s Regional Innovation Engines, Innovation Corps (I-Corps ) and the National Innovation Network; SBA Growth Accelerators, SBA Federal and State Technology (FAST) Awardees, NCATS Clinical and Translational Science Awards (CTSA), NIBIB’s Concept to Clinic: Commercializing Innovation Program (C3i) and Point-of-Care Technologies Research Network (POCTRN); NIGMS Regional Technology Transfer Accelerator Hubs for IDeA States and IDeA Regional Entrepreneurship Development Program (I-RED), IDeA Networks of Biomedical Research Excellence (INBRE), IDeA Networks for Clinical and Translational Research (IDeA-CTR), and Centers of Biomedical Research Excellence (COBRE); NIH Centers for Accelerated Innovations (NCAI) and REACH, and the Coulter Translational Partnership Award in Biomedical Engineering (TP) or other appropriate programs identified by the Hub.

Hubs are strongly encouraged to partner with several educational institutions, particularly those that are Minority Serving Institutions [including but not limited to Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and/or Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)], those institutions that have not been major recipients of past NIH support, and/or institutions in IDeA states.

This FOA encourages cost matchingt. Each Hub is encouraged to have identified at the time of application and committed at the time of award a minimum of $250,000/year of matching funds to augment the federal investment for product definition studies. Matching funds can originate from any non-federal source (e.g., awardee institution, foundations, for-profit investors, state or local economic development resources).

3) Regional and Local Impact: Make a unique impact on small business development, entrepreneurial culture, workforce diversity, and health disparities. Hubs should serve innovators from diverse backgrounds (see Notice of NIH's Interest in Diversity) or meet pressing local or regional needs in areas such as economic development, entrepreneurial education, research funding, disease burden, and health disparities.

4) Technology Development: Demonstrate the ability to support technology development ranging from early-stage laboratory-based technology feasibility through pre-clinical testing for technologies across the breadth of the NIH mission. Hubs must provide infrastructure to solicit, evaluate, and select the most promising technology opportunities with health, economic, and societal impact that otherwise would not receive support for early-stage proof-of-concept work. In addition to supporting technology development projects from innovators within the Hub’s partner institutions, each Hub should develop and implement efficient strategies to support technology development projects from innovators at other institutions within their research and development ecosystem. The budget of any technology development project can utilize a maximum of $100,000 from the REACH award, with the balancing coming from the Hub’s matching funds. It is expected that Hubs will be continuously developing 4 6 technologies each year.

5) Project Management: Develop and implement milestone-driven, market-focused project management oversight and decision-making processes. Each Hub should use project management processes that enable continuous assessment of progress relative to established milestones in order to make strategic decisions regarding the support of each technology development project (e.g., discontinue a failing project early, pivot to a new application, or provide additional resources). Hubs are expected to provide agile management to assemble a package of resources and services tailored to each technology development project. Hubs are strongly encouraged to utilize project managers with formal project management training and or biomedical industry experience. Salary support for the project manager is considered to be part of the direct cost of each technology development project. The Hubs should leverage best practices from current pilot programs and any other relevant program to promote and facilitate the open exchange of information regarding the scope, methods, analysis, results, and lessons learned from each technology development project.

6) Educational Activities: Provide innovators from diverse backgrounds, including innovators from underrepresented groups access to skills development, hands-on entrepreneurial experience, and educational and networking activities. Each Hub must provide entrepreneurial educational opportunities to academic investigators at all career levels about the design and conduct of technology development projects and the commercialization processes required for transition promising technologies to the next stage of commercialization (e.g., additional financing, spinout company development, or university licensing). The Hub should catalyze professional development by:

• Training innovators to assess the commercial potential of their research discoveries and to develop comprehensive product development plans
• Bringing together experienced entrepreneurs and scientists to provide guidance and mentoring
• Providing the broader investigator community with access to forums, seminars, workshops, and related activities
• Providing connections between research performing institutions and life science businesses, industries, and sources of private capital
• Providing focused entrepreneur support and hands-on learning targeted at the needs of the innovator, so that scientists have the opportunity to engage in entrepreneurial activities. Cross-disciplinary (science, business, regulatory, reimbursement, etc.) career development is highly encouraged to achieve the goal of exposing innovators to the myriad processes required to translate discoveries into marketable products.

Applicants are encouraged to review examples of Healthcare Commercialization Programs, which are designed to teach innovators to identify valuable product opportunities resulting from academic research, and gain entrepreneurial skills through stakeholder discovery and guidance from development experts.

7) Sustainability Plan: Develop and implement a plan for ensuring that the capacity developed under their REACH award will be sustained at their institutions, including assimilation into existing or new innovation management strategies, academic entrepreneurship support functions, technology transfer or commercialization offices, and other supportive programs and policies at their institutions.

Each Hub should demonstrate the core competencies necessary to fulfill all the objectives of this FOA.

Enhancing Diverse Perspectives

This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material. Applicants are strongly encouraged to attend the Technical Assistance teleconference to ask for information on preparing a PEDP.

NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. See Notice of NIH's Interest in Diversity (NOT-OD-20-031).

To support the best science, NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include, but are not limited to:

• Transdisciplinary research projects and collaborations among investigators from different fields.
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

The primary applicant organization 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 award. Many NIH-supported universities or other research institutions will be eligible. Please contact the Scientific/Review staff listed below for clarification. Institutions in IDeA-eligible states are strongly encouarged to apply for this funding opportunity.

Non-eligible Organizations include:

• Non-domestic (non-U.S.) Entities (Foreign Institutions)
• Non-domestic (non-U.S.) components of U.S. Organizations
• Businesses are not eligible to serve as the primary applicant organization
• Previous recipients of NIH Centers for Accelerated Innovations (NCAI) and REACH awards are not eligible to serve as the primary applicant organization
• Government entities

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For 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.

2. Cost Sharing

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

This FOA encourages a minimum of $250,000 per year in matching funds. In-kind contributions that enable the Hub to meet the goals of this FOA are also encouraged.

3. Additional Information on Eligibility

Number of Applications

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

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) 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.

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

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

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

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

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

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

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

Other Attachments: The application must include the following attachment.

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

R&R or Modular Budget

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

Cost Matching: Cost matching of $250,000 per year is encouraged for applicants responding to this FOA. Institutions should document their actual contributions to the project and describet the organization(s) commitment to providing the funds for the duration of the award.

PEDP implementation costs: Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7)

R&R Subaward Budget

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, with the following additional instructions:

Research Strategy: Provide the overall objectives of the Hub, including the short and long-term goals. Identify the challenges facing the Hub’s entrepreneurial ecosystem and how the award will mitigate those obstacles. 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 products that will have health, economic, and societal impact.

Each of the following components should be addressed in the Research Strategy section using the headings 1 7 titled as noted for each.

1) Hub Leadership:

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 biomedical technologies from research performing institutions to the next stage of commercialization. Awardees will be required to participate in regular reporting of technology development project milestones and standardized program-wide outcome metrics, including tracking the progress of technologies after exit from the Hub.

A Program Steering Committee (PSC) will be created post-award, as described in Section VI.2 under Cooperative Agreement Terms and Conditions of Award, that includes NIH and other federal staff, all Hub PD(s)/PI(s), and other Hub staff as appropriate to provide scientific and administrative oversight. Hubs must include plans to coordinate with the PSC in their Hub Leadership plan.

2) Collaborations and Partnerships:

Hubs should provide details on how they will establish and effectively manage the range of collaborations and partnerships with stakeholders (including academic, non-profit, and industry sectors) necessary to achieve the objectives of the FOA. Examples of partnerships include, but are not limited to, other research institutions, business schools, state economic development agencies, local incubators or accelerators, private sector investment institutions/organizations, clinical research organizations, or other existing programs accessible by 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 (such as those listed in Section I). Describe the qualities and strengths that each partner brings to the Hub. Describe the anticipated role of the Hub in improving technology development and commercialization outcomes and rapid streamlined access to translational resources.

Applicants must indicate if they have an established and effective technology transfer or commercialization office and provide 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. Applicants should provide information on the intellectual property strategy and how intellectual property will be managed. 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. If applications contain multiple partnering research institutions for sourcing technology development projects, applicants must present a plan to ensure appropriate coordination and to facilitate licensing and technology transfer

3) Regional and Local Impact

Applicants should address features of the institution and its local and regional environment that would allow the Hub to make a unique impact on small business development, entrepreneurial culture, workforce diversity, and health disparities. Applicants should describe any innovators from underrepresented groups that would be served, as well as pressing local or regional needs in areas such as economic development, entrepreneurial education, research funding, disease burden, and health disparities.

4) Technology Development:

Applicants must provide detailed information on the infrastructure for soliciting, evaluating, and selecting the most promising technology development opportunities with health, economic, and societal impact that otherwise would not receive support for early-stage proof-of-concept work. This should include establishing a rigorous External Review Board (ERB) that includes a diverse group of 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, leveraging processes, practices and resources developed by the NCAI and current REACH awardees. Applicants should not contact potential ERB members or name them in the application. ERB recommendations will undergo secondary review by an NIH committee comprised of NIH staff and experts in all aspects of technology development and commercialization. The NIH committee will provide specific feedback to the Hubs that will inform funding decisions and development strategies.

Applicants should provide details on their ability to maintain a robust pipeline of candidate technology development projects at the appropriate stage of development (early non-hypothesis driven applied research) for entry into the Hub. Applicants should:

• Describe existing activities that foster the development of early-stage technologies across the NIH mission that are appropriate for further development.
• Describe the breadth of the available portfolio of early-stage technologies within the NIH mission available to the Hub.
• Provide a plan for soliciting, selecting, and supporting technology development projects, including projects from institutions beyond the Hub and subawardees. This should include a description of the proposed catchment area for technology development projects.

Applicants should describe a plan to provide funding and access to translational resources and services to individual investigators to conduct product development projects (feasibility, validation, prototype development, or proof-of-concept studies). Federal funding amounts per technology development project may include up to $100,000 direct cost from this award, and any amount of the Hub’s non-federal matching funds. Applicants should describe the resources and expertise available to the Hub to facilitate early technology development (including technical validation, facilitating business development opportunities, clarifying intellectual property and identifying barriers to entry, performing market research, and clarifying regulatory, manufacturing, clinical, or payer requirements) that enable the Hub to meet the goals of this FOA.

5) Project Management:

Applicants must describe 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 product development resources, describe technology development plans that include:

• Access to appropriate expertise for technology development, including project managers, and the ability to assemble project and innovator support teams comprised of industry, start-up, venture capital, technical, financial, business experts, regulatory, reimbursement, or other expertise required to develop the technology towards commercial potential.
• Project management processes to assess progress and make milestone-driven go/no-go decisions to terminate development of technology development projects and reallocate resources when necessary. Applicants should describe plans to support industry-experienced project managers necessary to establish and monitor project milestones and advice on go/no-go decisions.
• How data/information from both successful and failed technology development projects will 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 outcomes to the research community at large. Establishing or leveraging an existing open access repository for collecting such knowledge is encouraged.

6) Educational Activities:

Applicants must describe plans to implement or collaborate with existing resources to provide product development and entrepreneurial skills development, hands-on experience and educational and networking activities. Applicants should describe how the Hub will provide access to forums, seminars, workshops, and related activities. The plan should include outreach strategies and activities designed to attract and provide these activities to innovators from diverse backgrounds, the includes, for example, individuals from underrepresented groups and at all career levels. Applicants should provide a detailed discussion of how they plan to provide mentoring and training.

Describe an evaluation plan to review and determine the quality and effectiveness of educational activities. This should include plans to obtain feedback from current and former participants to help identify weaknesses and to provide suggestions for improvements. Specified education and training metrics should be tied to the goals of the program. In addition, the program’s procedures for responding to program evaluation findings should also be included.

7) Sustainability Plan

As part of the overall Hub design, applicants must articulate their guiding principles, management strategy, and approaches to cultivating a pipeline of technology development projects, providing the requisite support to those projects innovators, and providing skills development resources to build capacity and affect culture change. Sustainability specifically refers to the post-award durability of the principles, approaches, mechanisms, and resources developed or assembled over the course of the award. Applicants should describe how the capacity developed under their REACH award will endure at their institutions, including assimilation into existing or new innovation management strategies, academic entrepreneurship support functions, technology transfer or commercialization offices, and other supportive programs and policies at their institutions.

Letters of Support: Applicants must include documentation of support indicating:

• Support from sources of non-federal resources
• Institutional commitment to the program
• Participation of the technology transfer or commercialization offices.

Applicants are encouraged to also include letters supporting the Sustainability Plan.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, should address how relevant resources (e.g., training presentation slides or videos, template documents, best practice handouts, how and why go/no-go decisions are made, etc.) resulting from the award will be freely shared with the public.

Other Plan(s):

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

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide with the following modifications.

• Template or Sample Institutional Agreements: Template or sample institutional agreements to streamline interactions and decrease barriers to technology transfer and commercialization may be included in the Appendix. The role of such agreements should also be described in the Research Strategy.
• Non-Federal Matching Funding: Hubs are encouraged to obtain $250,000 of non-federal funding each year of the award to support technology development projects. 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 should include details on non-federal funding and resources that have already been secured or are anticipated during the project period. Applicants are encouraged to provide verifiable details on the sources of non-federal funding, including clearly itemizing the funding that will be secured, and indicate the total. 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 funding may include a term sheet and/or letter of commitment from the source of funds stipulating the terms of the proposed commitment/investment, although other forms of documentation may be considered.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

Part I. Overview Information contains information about Key Dates and times. 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) Application Guide.

5. Intergovernmental Review (E.O. 12372)

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

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

Section V. Application Review Information

1. Criteria

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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Overall Impact

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).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

To what extent has the applicant demonstrated the need for the proposed Hub? How will an award enhance the ability of the applicant and local or regional ecosystem to conduct technology development projects 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? Has the applicant described how the capacity developed under their REACH hub will be sustained at their institutions, including assimilation into existing or new innovation management strategies, academic entrepreneurship support functions, technology transfer offices, and other supportive programs and policies at their institutions? Will the hub help build the small business sector and entrepreneurial capacity in an underserved region or reach an underserved population? To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

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

Does the Hub leadership (including the PD(s)/PI(s)) demonstrate the necessary operational, scientific, and business expertise to run a Hub that will successfully transition technologies from research performing institutions to the next stage of commercialization? Does the Hub possess the required scientific, regulatory, reimbursement, business, legal, and project management experience? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

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?

Does the applicant create the unique public private partnerships and an integrated environment of resources required to inform the technology development projects in a way that will bridge the gap between the laboratory and market? Has the Hub proposed innovative methods for entrepreneurial training and education? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the applicant provide a robust plan that will allow the Hub to maintain a pipeline of candidate technology development projects across the entire NIH mission? Will the solicitation, selection, and technology development processes result in the identification and advancement of the commercial potential of technologies? Will the plan provided for soliciting, selecting, and supporting technology development projects not affiliated with the Hub or subawards efficiently and effectively allow for the support of technology development projects? Will the Hub's technology evaluation processes enable selection of promising technologies and diverse innovators for further development and testing? Are the proposed services of the hub designed to enhance small business activity and entrepreneurial culture in the region, leveraging local opportunities and overcoming regional challenges? Will the plans to capture and share lessons learned be easily accessible by research community in a timely manner?

Does the application demonstrate ability to effectively manage multidisciplinary technology development projects and deal with sensitive but critical go/no-go decisions in a team-based environment? 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? Does the applicant have appropriate decision-making processes in place to make timely milestone-driven go/no-go decisions about technologies being developed and provide access to resources and services? How adequate are the proposed evaluation plans and metrics? Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

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? Does the applicant provide a clear, concrete, actionable plan to provide educational activities to innovators from diverse backgrounds and career levels? Will the Hub provide the broader ecosystem with access to educational activities? Are the outreach strategies designed to promote these activities reasonable and likely to attract innovators from diverse backgrounds and career levels? Does the application include a rigorous evaluation plan to assess the quality and effectiveness of the proposed activates? Are effective mechanisms in place for obtaining the views of current and former participants?

How well does the applicant demonstrate the knowledge of and relationships with appropriate stakeholder and user groups? Does the applicant demonstrate the ability to access appropriate domain experts and mentors, including those with the appropriate business expertise? 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? How does the applicant propose to grow and develop new partnerships throughout the award?

Does the proposed Hub encourage the culture needed for sustained technology development where evaluation of innovations for commercialization becomes the norm? Does the applicant demonstrate a plan for sustainability of technology development and educational activities 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?

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? Does the applicant demonstrate and utilize its core competencies to maximize the chance of success? 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 products that will have health, economic and societal impact?

What is the quality of the applicant’s plan for engaging the technology transfer or commercialization office in the program’s implementation? Does the applicant demonstrate the necessary agreements and relationship with the technology transfer office(s) or commercialization office(s) to ensure the most appropriate path for product definition and exit? Is the intellectual property strategy and proposed management likely to allow for successful commercialization of technology development projects? Will the plan provided to establish and manage collaborations and partnerships with stakeholders be effective and provide the appropriate expertise? Does the applicant have the business alliances or partnerships to transition technologies from discovery to the next appropriate stage of financing?

Has the applicant demonstrated a commitment to local and regional economic development? Does the applicant serve a diverse group of innovators or regional needs that will benefit in important ways from the Hub's services? To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

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.

Collaborations and Partnerships

Does the proposed Hub maximize capital investments and leverage private with public investment?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

Applications may undergo a 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.

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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities, including:
  • Quality of the technology transfer or commercialization office and plan for engaging that office in the program’s implementation.
  • Demonstrated commitment to local and regional economic development.
  • Geographic and institutional diversity and distribution.
  • Ability to assemble project management boards comprised of industry, start-up, venture capital, technical, financial and business experts
  • Quality of the intellectual property rights strategy or office
  • Plan for sustainability beyond the duration of the funded award
  • The PEDP

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

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

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

The 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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.

Consistent with this concept, the dominant role and prime responsibility resides with the 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
• Oversee and monitor technology development project selection and management, including the evaluation of progress toward project milestones
• Obtain relevant overall Hub IRB and IACUC approvals, regardless of whether subcontractors have separate approvals, and ensure timely reporting of the change in status of the delayed onset technology development projects to NIH
• 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 current Hubs and NCAI or other relevant federal or non-federal program
• Ensure the timely reporting of standardized milestone-driven project management metrics, including the tracking the progress of technologies after exit from the Hub.
• Provide updates at least annually on implementation of the PEDP.
• 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 technology development projects
• Share best practices with other REACH awardees, the NCAI, with the NIH, the research community at large and the public.
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

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

The NIH Project Coordinator 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, provide feedback and guidance on product development project applications prior to their initiation, assessing mission fit, program balance, and priority to areas of greatest U.S. disease burden and rare disease
• Advise on Hub go/no-go decision-making during technology development
• Establish a customized development team to interact with PD(s)/PI(s) on a regular basis to facilitate access to NIH resources.
• 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)
• Advise the Program Steering Committee on drafting and applying 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

NIH Technology Guidance Committee will provide specific feedback to the Hub PD(s)/PI(s) that will inform funding decisions and development strategies. The NIH Technology Guidance Committee will meet as needed to provide technology selection recommendations to the Hubs.

Areas of Joint Responsibility include:

The Program Steering Committee (PSC), made up of the NIH Project Coordinator, PD(s)/PI(s), and NIH Small business Education and Entrepreneural Development (SEED) Director 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 PSC will meet once a year at a minimum, with additional meetings scheduled as necessary to accomplish the goals of the program.

Dispute Resolution:

Disagreements between award recipients and the NIH that arise regarding matters related to the scientific direction of the funded program may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the Steering Committee without NIH staff or the awardee voting. 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.

Post-Award Program Requirements for Technology Development Projects

The recipient must provide NIH with descriptions of the proposed technology development projects, recommendations from the ERB, and outcomes related to funding technology development projects. Instructions regarding submitting this information will be provided in the Notice of Award.

3. Data Management and Sharing

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

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the REACH program, employing the representative measures identified below. NIGMS will assess the effectiveness of the REACH program using information provided by the PDs/PIs and participants, as well as information from public databases. PDs/PIs and participants may be contacted after the completion of the grant period for updates on participants subsequent outcomes.

In keeping with recommendations that federal agencies adopt tools and approaches to simplify applicant reporting and improve the tracking of career outcomes, NIH introduced the option for PDs/PIs and other users to associate an ORCID identifier with their eRA Commons Personal Profile in 2017. ORCIDs are unique, persistent digital identifiers that distinguish individual investigators and can be used to connect researchers with their contributions to science over time and across changes of name, location, and institutional affiliation. NIH strongly recommends that awardees employ the use of ORCID IDs to facilitate the collection and reporting of skills development outcome metrics across the network.

Evaluation of the program will be based on metrics that may include, but are not limited to, the following:

• Characteristics of the participants in educational activities and applicants for technology development project support, such as:
  • Total number of participants
  • Innovator/trainee demographics
• Indicators of progression of technology development projects, such as:
  • Product types, therapeutic areas, and stages of development
  • Maturation of technologies
  • Follow-on funding secured for further technology development
  • Start-up company formation
  • Licensing and option-to-license agreements
  • SBIR and STTR applications and awards
  • Regulatory milestones and approvals, including technologies in clinical testing and technologies in the market
• Adherence to timeline and achievement of milestones identified in each Hub’s PEDP, and other meaningful indicators of progress towards outcomes anticipated from the PEDP activities, such as:
  • Variety of perspectives and participants in Hub activities
  • Diversity of participants in technology development project proposals from Hub member institutions
  • Number of participants directly impacted by PEDP activities that assume leadership or operational roles in the Hub or their institution(s).

A final RPPR, 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Eddie Billingslea, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: eddie.billingslea@nih.gov

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

Brett Hodgkins
National Institute of General Medical Sciences (NIGMS)
Email: hodgkinsb@mail.nih.gov

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 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. 117-183 (SBIR and STTR Extension Act of 2022). The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.