Department of Health and Human Services
Part 1. Overview Information

 

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 Integrative Health (NCCIH)

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 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

 Reissue of RFA-OD-14-005

Related Notices

November 20, 2018 - Notice of Intent to Publish a Funding Opportunity Announcement for Research Evaluation and Commercialization Hub (REACH) program. See Notice NOT-OD-19-033

Funding Opportunity Announcement (FOA) Number

RFA-OD-19-014

Companion Funding Opportunity

None  

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.286, 93.233, 93.837, 93.838, 93.839, 93.853, 93.859, 93.361, 93.855,

93.866, 93.242, 93.121, 93.279, 93.393, 93.394, 93.395, 93.396, 93.399,

93.173, 93.307, 93.213,93.879, 93.847, 93.172, 93.113, 93.273, 93.350

93.867, 93.846, 93.351, 93.865

Funding Opportunity Purpose

This FOA announces the renewal of the NIH Research Evaluation and Commercialization Hub (REACH) program, established to facilitate and accelerate the translation of academic biomedical discoveries into products that improve patient care and public health. Through this program, NIH will provide the qualifying institutions with the funds to seed the creation of academic entrepreneurship Hubs. Hubs will be responsible for providing innovators with both the initial investment and resources to support the proof of concept work and the mentorship in product development and commercialization needed to develop high priority technologies that address the highest US disease burden within the NIH’s mission. Funded Hubs are intended to work as a consortium to enable: (1) the infrastructure for identifying the most promising technologies, (2) funding for product definition studies (e.g. feasibility studies, prototype development, proof-of-concept studies) provided to individual researchers, (3) 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 entrepreneurship.  Establishing public-private partnerships and providing additional non-federal funds will be critical for success.  

Key Dates

 

Posted Date

December 17, 2018

Open Date (Earliest Submission Date)

February 19, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

March 19, 2019 by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

June 2019

Advisory Council Review

August 2019

Earliest Start Date

September 2019

Expiration Date

March 20, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    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


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
     Purpose

    The NIH Research Evaluation and Commercialization Hub (REACH) program is envisioned as 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 health. REACH Hubs will foster the advancement of therapeutics, preventatives, diagnostics, devices, and tools in a manner consistent with business case development, that address the needs of patients and public health. Applicants are encouraged to focus on building entrepreneurial communities in the areas of highest US burden of disease and disability that historically attract lower levels of private capital investment and otherwise would likely not receive support. The new REACH Hubs will build upon lessons learned from previous awardees to transition promising technologies to the next source of independent financing, such as the private sector, through a viable start-up company competitive for a small business award,  or a licensing opportunity. The program aims to strengthen the technology through a team based developmental approach that addresses downstream requirements, including intellectual property, regulatory, and reimbursement issues and business case development to facilitate handoff to the private sector and formation of strong companies. It is expected that spinout companies will be in a position to submit strong small business applications (SBIR and STTR), including to Phase I, Fast-Track and Direct-to-Phase II programs. The Hubs will establish novel partnerships, strengthen existing alliances between stakeholders (including public, private, non-profit, and academic sectors), provide entrepreneurial educational opportunities for diverse innovators, and create cultural and systemic changes to more rapidly move from breakthrough innovations to products that will have health, economic, and societal impact.

    Background

    NIH, as a major funder of biomedical research, is committed to purposefully examining and addressing the barriers that prevent the effective translation of basic science discoveries from academia to patient benefit. These barriers include (1) a lack of knowledge and understanding by academic innovators about how new technologies are brought to market; (2) a lack of access to sufficient technology development and commercialization resources and expertise that are required for early stage development and (3) 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 is reauthorized through FY 2022 by H.R 5515 Sec 854 (P.L.115-232). The REACH program meets FY2020 administration priorities described in M-18-22, Administration Research and Development Budget Priorities, including educating and training a workforce for the 21st century economy, transferring technology from the laboratory to the marketplace, and partnering with industry and academia to advance the US R&D enterprise. 

    REACH Overview

    The REACH program will address the problems that hinder the critical, early steps necessary to translate novel scientific advances into commercially viable diagnostics, devices, therapeutics, and tools that improve patient care and improve public health. Applicants from the qualifying institutions are invited to submit grant applications to accelerate the transition of research discoveries into impactful products that address unmet medical needs.

    Each Hub will assemble diverse experts in biomedical product development, and will have the expertise to identify and source 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. The work supported by the REACH Hubs may include technical validation, market research, clarifying intellectual property position and strategy, clarifying regulatory or payer requirements, and investigating commercial or business opportunities. 

    Each Hub will:

    1)   Be governed by leadership experienced in biomedical product development with a specific focus on bringing biomedical technologies from research institutions to promising products that improve patient care and enhance health.

    2)   Develop the necessary collaborations and partnerships to meet the goals of this FOA.

    3)   Provide infrastructure and “know how” for soliciting, evaluating and selecting the most promising technology opportunities predicated on US disease burden medical need, scientific merit, and commercial potential that otherwise would not receive support for early-stage proof-of-concept work.

    4)   Establish processes to review and award funds to individual academic researchers and provide the resources and expertise required for early stage technology development.

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

    6)   Provide diverse academic innovators, including students and post-docs, access to 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 products that improve health. 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 development, market research, IP protection, regulatory and reimbursement processes, project management, pre-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 through pre-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 further advance 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 medical and scientific needs that address the greatest US burden of disease across the breadth of the NIH mission. Hubs are expected to leverage and partner with existing federal or non-federal resources as appropriate, such as: EDA’s Regional Innovation Strategies (RIS) Program i6 Challenge, NSF Innovation Corps (I-Corps™) and its National Innovation Network, SBA Growth Accelerators, NCI-designated Cancer Centers, NIAID Centers for AIDS Research (CFAR), 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, IDeA Networks of Biomedical Research Excellence (INBRE), and Centers of Biomedical Research Excellence (COBRE); current 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.

    1. Each Hub should systematically solicit, select, and support technology development projects that address diseases or conditions that (a) create a high burden on the US healthcare system or (b) address diseases or conditions that do not have an apparent broad commercial market, but compelling reasons exist for continued development.

    The REACH Hub will be expected to support each project with a maximum of $100,000 from the NIH award and at least an equal cash match (an additional $100,000) from non-federal sources (e.g., recipient institutions, foundations, for-profit investors, other state resources) for individual technology development projects to conduct feasibility studies or develop prototypes. Collaborative relationships with ecosystem partners result in vested shared interests, and access to a more robust technology pipeline and complementary technology development expertise and resources for successful development. REACH Hubs should advance technologies to a stage suitable to continue product development in the private sector (e.g., spinning out a small business to continue development, licensing to a for-profit or not-for-profit entity, or securing additional non-federal funding for continued product development).  NIH expects each Hub to be continuously working on a minimum of 4 – 6 technologies each year of the award.

    Each Hub should provide access to expertise and mentoring related to:

    product development

    business development and commercial strategy

    entrepreneurship

    regulatory submission, evaluation, and review

    market and commercial evaluation

    intellectual property protection

    reimbursement strategy

    pre-clinical studies

    Each Hub should use project management processes that enable continuous assessment of the progress of the studies relative to established milestones in order to make strategic decisions regarding each project (e.g., discontinue a failing project early or “quick kill’), direct a project to additional sources of support (e.g., disease advocacy organization, NIH), or provide additional resources.

    Each Hub 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). The Hub should catalyze professional development by training and mentoring innovators to allow them to assess the medical and commercial potential of their research by bringing together experienced entrepreneurs and scientists and by providing connections between the businesses, industries, sources of private capital, and research performing institutions. Furthermore, a Hub would provide 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. Although not required, leveraging existing entrepreneurial training activities, such as the NSF I-Corps, NCAI, CTSA or other similar programs is encouraged.  Applicants are encourage to review examples of Healthcare Commercialization Programs (HCP), which are designed for innovators to learn to identify valuable academic research borne product opportunities and gain entrepreneurial skills through stakeholder discovery and guidance from development experts.

    Each Hub is expected to expand the participation of women and individuals from underrepresented groups in innovation, technology translation, and entrepreneurship and include students and post-docs.  Providing the broader investigator community, including those from traditionally under-represented backgrounds, with access to forums, seminars, workshops and related activities is required.

    NIH is 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.  Although not required, collaboration with NIGMS’ Regional Technology Transfer Accelerator Hubs for IDeA States for scalable skills development strategies will be viewed as a strength.

    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 product development in the academic setting.

    Each Hub must demonstrate access to adequate numbers of technologies of broad strategic interest to the NIH as described above such that projects not meeting milestones can be discontinued and funds can be rapidly transitioned to another meritorious project.  Establishing partnerships to ensure access to adequate numbers of technologies that have advanced beyond the discovery stage to early non-hypothesis driven applied research suitable for acceptance into the Hub is encouraged. Each Hub is expected to be continuously developing 4 – 6 technologies per year. 

    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 required 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, fund raising, or other mechanisms.

    Applicants are strongly encouraged to contact the appropriate NIH Scientific/Research contact listed in Section VII.

    The NIH will host a free pre-submission webinar on January 23, 2019 at 1pm ET. Registration information and link are below.

    Please register for the REACH Pre-Submission Webinar on Jan 23, 2019 1:00 PM EST at: 

    https://attendee.gotowebinar.com/register/432135952668370946

    After registering, you will receive a confirmation email containing information about joining the webinar. See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    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. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The participating Institutes and Centers intend to commit an estimated total of $20,000,000 to fund up to five awards, over 4 years at $5 million per year.

    Award Budget

     The maximum budget for a Hub is $1,000,000 total costs per year.

    Award Project Period

     The maximum project period is 4 years.  

    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
    Eligible Organizations

    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

    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-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
    • Current NCAI and REACH awardees are not eligible to serve as the primary applicant organization
    • Government entities
    Foreign Institutions

    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.

    Required Registrations

    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)– 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.
    • o    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 to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 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.

    Eligible Individuals (Program Director/Principal Investigator)

    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.

    2. Cost Sharing

    This FOA requires cost sharing as defined in the NIH Grants Policy Statement.

    This FOA requires a minimum of a 1:1 cash match of the direct costs of the award and must be included in the application as well as reported.  In-kind contributions that enable the Hub to meet the goals of this FOA are allowed and encouraged, though not required. In-kind contributions do not apply to the cash matching requirements. Any in-kind contributions volunteered by the applicants/recipients do not need to be reported to the NIH.

    3. Additional Information on Eligibility
    Number of Applications

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

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    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 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.

     
    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • Descriptive title of proposed activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

     The letter of intent should be sent to:

    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: nhlbichiefreviewbranch@nhlbi.nih.gov

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements:

    For this specific FOA, the Research Strategy section is limited to 30 pages.

    Instructions for Application Submission

    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.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

    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 and must include the following:

    Cost Matching Requirement:

    Cost matching is required for applicants responding to this FOA. The awardee is required to provide a minimum 1:1 cash match of the direct costs of the award. Institutions must be able to document their actual contributions to the project and provide assurances that the organization(s) are committed to providing the funds for their share of the project.

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

    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 products that improve health.

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

    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. Awardees will be required to participate in regular collection and reporting of milestone-driven project management and standardized metrics across the network during development and including tracking the progress of technologies after exit from the Hub.

    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 project. Describe how data/information from both successful and failed 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 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 for access to appropriate expertise, and to ensure an adequate supply of technologies at the appropriate development stage to help advance technologies toward treatments and cures. 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, private sector investment institutions/organizations, clinical research organizations, or other existing programs accessible by the Hub. The Hub is encouraged to pursue collaborations with existing NCAI, REACH, NIH CTSA, COBRE, or INBRE and other program recipients and resources described in Section I; REACH Overview. 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 total direct cost 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 funds 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 should clearly itemize the 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 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. At the time of application, evidence of commitment of access to non-federal funding that at least equals the direct costs of the year one award is required. Matching funds should not be incumbent on the individual innovators to secure. 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

    A REACH Hub must provide infrastructure for soliciting and selecting the most promising technologies that address unmet medical needs for diseases of high burden on the US healthcare system with apparent commercial potential, or address diseases or conditions that do not have an apparent broad commercial market, but compelling reasons exist for continued development. 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, leveraging processes, practices and resources developed by the NCAI and current REACH. 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.

    Access to Technologies

    Applicants should provide details on their ability to maintain a robust pipeline of candidate technologies 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 NIH mission-relevant technologies appropriate for further development within the Hub.

    Describe the breadth and diversity of the accessible portfolio of early stage technologies within the NIH mission available from the Hub.

    Provide in the Appendix a table of examples of technologies that are ready to enter development at the Hub using the Technology Table provided at https://sbir.nih.gov/sites/default/REACH/TechnologyTableREACH.xlsx

      The table includes instructions and examples of information desired.  The table is a requirement and must be included in the Appendix.

    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). Federal funding amounts per project may include up to $100,000 from this award, and at least an equal cash match is expected from non-Federal 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.] that enable the Hub to meet the goals of this FOA.

    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 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 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.

    Rigor and Reproducibility

    High-quality and reproducible product definition studies are an essential cornerstone of the translational research enterprise. Attention to principles of study design and transparency is essential to enable stakeholders to assess the quality of the experimental design and scientific findings. In support of this important goal, investigators must follow instructions to address Rigor and Reproducibility (http://grants.nih.gov/reproducibility/index.htm).

    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, students and post-docs. For example, Hubs may pursue collaborations with existing NIH Hubs, NIH Centers for Accelerated Innovations, and other related programs. Applicants should provide a detailed discussion of how mentoring and the professional development of the technology innovators will be achieved.

    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 as provided in the SF424 (R&R) Application Guide, with the following modification:

    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 shared with the public.

    Appendix:

    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:

    Applicants must include documentation of support from non-federal resources and funders, such as term sheets or redacted bank statements and the table of example technologies ready to enter the Hub. Applicants may include example institutional agreements and additional budget pages itemizing the resources and funding available from third-parties.

     
    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or 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

    PHS Assignment Request Form

    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

    4. Submission Dates and Times

    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.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

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

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 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.

    Evaluation of Responsiveness

    Prior to peer review, the Office of Scientific Review and NIH 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 for the duration of the award.
    Post Submission Materials

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

    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?

    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 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?

     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 commercializable products? 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? Will the plans to capture and share lessons learned be easily accessible by research community in a timely manner? 

    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? 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?

    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 products that enhance patient care and public health?

    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.

    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 and diverse innovators 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?

    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.

    Additional Review Considerations

    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)  Genomic Data Sharing Plan (GDS).

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

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    3. Anticipated Announcement and Award Dates

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

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

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

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    Cooperative Agreement Terms and Conditions of Award

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

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

    Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

    The 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 current Hubs and NCAI or other relevant federal or non-federal program
    • 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, with the NIH, the research community at large and the public.
    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, ensuring mission fit, program balance and priority to areas of greatest US disease burden and rare disease
    • Participate in 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 monitor progress at the Hub and facilitate access to NIH resources such as NIH Entrepreneurs-in-Residence, BrIDGs, BPN, and TRND.
    • 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
    NIH Technology Review Committee will provide specific feedback to the Hub key leadership that will inform funding decisions and development strategies. The NIH Technology Review Committee will meet as needed to provide technology selection recommendations to the Hubs.
     
    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.

    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

    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.

    3. Reporting

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

    In addition to the annual progress report, an interim report containing updates of agreed upon elements will be required

    A final RPPR, invention statement (FIS) for the Federal share, and the expenditure data portion of the Federal Financial Report, including Federal and non-Federal share for the 1:1 match 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.

    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.

    Application Submission Contacts

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

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

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

    Scientific/Research Contact(s)

    Dr Kathleen Rousche
    National Heart, Lung, and Blood Institute (NHLBI)
    Scientific Program Manager
    Kathleen.rousche@nih.gov

    Peer Review Contact(s)

    Director, Office of Scientific Review
    Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0270
    Email: nhlbichiefreviewbranch@nhlbi.nih.gov

    Financial/Grants Management Contact(s).

    John Diggs
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-402-4267
    mail: diggsjw@nhlbi.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.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

    The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, P.L. 107-50, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), and as reauthorized and extended under Public Law 114-328, Section 1834 and P.L. 115-232. The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.

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