Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)  

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)
National Eye Institute (NEI)
National Institute on Aging (NIA)
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)
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 of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Advancing Translational Sciences (NCATS)

Funding Opportunity Title

Regenerative Medicine Innovation Project (RMIP) (U44 - Clinical Trial Not Allowed)

Activity Code

U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Fast-Track

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-HL-18-035

Companion Funding Opportunity

RFA-HL-18-030, U01 Research Project – Cooperative Agreements

RFA-HL-18-031, UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

RFA-HL-18-033, UT2 Small Business Technology Transfer (STTR) Cooperative Agreement – Fast-Track

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

93.837; 93.840; 93.839; 93.838; 93.233; 93.867; 93.286; 93.350; 93.847; 93.866; 93.853; 93.121; 93.173; 93.242; 93.846; 93.856; 93.855

Funding Opportunity Purpose

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U44) applications to support small business research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness.

Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.

Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA.

Key Dates
Posted Date

August 1, 2018

Open Date (Earliest Submission Date)

September 19, 2018

Letter of Intent Due Date(s)

September 19, 2018

Application Due Date(s)

October 19, 2018, 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)

October 19, 2018 by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related 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.

Scientific Merit Review

January 2019

Advisory Council Review

January 2019

Earliest Start Date

April 2019

Expiration Date

October 20, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the SBIR/STTR (B) Instructions in the SF424 (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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 National Institutes of Health (NIH) participating Institutes and Centers (ICs), in coordination with the U.S. Food and Drug Administration (FDA), invite cooperative agreement (U44) applications to support small business research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies, contribute an enhanced understanding of stem cell product attributes, and promote data sharing. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness.

    Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell line and clinical-grade stem cell product for in-depth and independent characterization through the RM Innovation Catalyst.

    This FOA utilizes the U44 activity code and will thereby support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies.

    Background

    This FOA, issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a new statutory provision set forth in the 21st Century Cures Act.

    Given the potential of RM to enhance human health and treat disease, in the 21st Century Cures Act Congress authorized a total of $30 million in fiscal years 2017 through 2020 for the funding of clinical research to further the field of RM using adult stem cells, including autologous cells. The 21st Century Cures Act stipulates that awards must be contingent upon the recipient procuring non-Federal contributions in an amount not less than $1 for each $1 of Federal funds (total Direct and Indirect/Facilities & Administrative (F&A) costs) provided in the award (i.e., a matching funds requirement). Additional information is provided in the FAQs and Matching Requirement section below.

    Research projects responsive to this FOA are expected to involve both of the following: (1) human subjects or material of human origin, such as cells, tissues, and specimens; and (2) human stem cells that are not of embryonic or fetal origin. Research projects involving induced pluripotent stem (iPS) cells may be supported if the cells used to generate the iPS cells were not of fetal or embryonic origin. Applicable research on adult human stem cells may encompass, for example, research on biologics (e.g., growth factors, cytokines) and biomaterials (e.g., extracellular matrix, scaffolds) that stimulate host adult stem cell self-renewal, proliferation, differentiation, and/or function or otherwise directly act upon adult stems cells to support innate host healing mechanisms, treat disease, and/or restore function. Funding could be used, for example, for the appropriate chemistry, manufacturing, and controls development to support the production of such products for clinical trials using phase-appropriate current good manufacturing practices (cGMP). Funds may not be used for research involving human cells of embryonic or fetal origin.

    This FOA seeks highly meritorious research projects proposing to explore and enable the development of safe and effective RM interventions. In addition to being subject to the standard NIH review criteria, applications submitted in response to this FOA will also be assessed according to the following criteria:

    • Addresses critical issues relevant to clinical research and regulatory submissions including those related to product development. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and in-depth characterization of product manufacturing, quality, safety, or effectiveness;
    • Helps to significantly advance the field of RM by addressing a well-recognized challenge in clinical development, including the development and evaluation of safe and effective RM products; and
    • Contributes to breadth/diversity of RM science.

    Regenerative Medicine Innovation Catalyst

    To catalyze the efficient development of safe and effective adult stem cell-based therapies and further the field of RM, NIH intends to establish an RM Innovation Catalyst to provide critical services to RMIP awardees (for both non-clinical trial research and clinical trials). Toward these ends, the RM Innovation Catalyst will offer, at no cost, regulatory support services and may also provide assistance for the development of phase-appropriate clinical-grade product. Applicants interested in the services offered by the RM Innovation Catalyst are requested to contact their NIH Scientific/Research Contact as early as possible in the application process for further details regarding these services.

    In addition, to inform future studies and ultimately advance the field, applicants will be expected to provide representative samples of the source stem cell line and clinical-grade stem cell product for in-depth characterization by the RM Innovation Catalyst. The RM Innovation Catalyst will:

    • Conduct in-depth and independent characterization of the source stem cell line and stem cell products being administered to research subjects
    • Provide a resource for sharing and analysis of clinical trial and cell product characterization data, thereby potentially enabling correlation of stem cell attributes with clinical outcomes (see Resource Sharing Plan)
    • Ultimately create a foundation for enhancing our understanding of clinical outcomes and refining production methods.

    The in-depth characterization assays conducted by the Catalyst will be performed in parallel with the study or post-hoc. Because in-depth characterization assays may identify cell attributes for which the clinical significance is not currently known, these results are not intended to inform decisions during the conduct of the study, nor are they intended to factor into the normative oversight requirements and processes for the source study. Assay results will be returned to the study investigators as they become available. In order to accelerate the field and inform oversight of future studies, assay results will be made available to the broader research community via the Catalyst one year following the end of award (or as appropriate).

    See relevant FAQs for additional details.

    Collection and Sharing of Resources

    Materials

    Awardees will be required to make available representative samples of the source stem cell line and clinical-grade stem cell product for in-depth and independent characterization. Details regarding the provision of stem cell samples will be communicated to awardees by NIH staff. Results of cell characterization will be provided to the study investigator when available and are anticipated to be made available to the research community one year following the end of award.

    Research Examples

    Applicants are strongly encouraged to submit research applications that demonstrate potential to catalyze sustained and accelerated development of the RM field through contributing to the knowledge critical for clinical testing, stem cell characterization and authentication, cGMP compliant stem cell production, in vivo stem cell tracking and monitoring, data standards development, and data sharing. It is expected that submitted applications will address the following:

    • Preclinical studies that contribute to conducting clinical trials that address specific clinical indications;
    • Testing human adult stem cells in well-developed animal models;
    • Monitoring stem cell function and integration in vivo;
    • Methods for in-depth stem cell characterization and deep fingerprinting, and utilization of standards;
    • Interactions with FDA regarding a future IND or IDE application (such as having had a pre-IND meeting and other communications);
    • Further development of standards and cGMP for adult stem cell-based RM products;
    • Leveraging extant cell production facilities for product preparation and qualification; and
    • Contributing to a better and shared understanding of current technical and operational barriers as well as regulatory science issues and how to overcome them.

    Matching Requirement

    An application funded under this announcement is required to match all federally awarded dollars (total costs: total Direct and Indirect/F&A costs) with at least an equal amount (1:1) of non-Federal contributions, as mandated by the 21st Century Cures Act. Qualifying non-Federal contributions may include state and local funding not originating from Federal funds, private-sector investments, in-kind contributions, and donations from foundations. See 45 CFR 75.306, as well as relevant FAQs, for additional details. The applicant will be required to demonstrate that funds and in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source, type, and amount of funds proposed to meet the matching requirement and explain how the value of in-kind contributions was determined.  Applications must also include letter(s) of support confirming that the required matching contributions (cash or in-kind contributions such as salary, consultant costs, equipment) are available. See additional details and instructions in in Section IV.2 and Section VI.3.

    Definitions

    Adult stem cells are defined, for the purpose of this FOA, as stem cells (including iPS cells) that are not of fetal or embryonic origin or derived from embryonic or fetal stem cells.

    Total project budget is the total amount of financial resources allocated for the project. This includes Federal funds, as well as cash and in-kind contributions from non-Federal sources for direct and indirect expenses.

    Total Federal budget is the Federal share of the total project budget.

    Applications Not Responsive to this FOA

    The following types of applications will be considered non-responsive to this FOA:

    • Any research using human embryonic or fetal stem cells. Such projects are non-responsive.
    • Applications that do not include a plan to make available representative samples of the source stem cell line and clinical-grade stem cell product for in-depth characterization by an NIH-designated core facility (RM Innovation Catalyst). Such applications are incomplete. See additional details and instructions in Section IV.2.
    • Applications that do not include a letter(s) of support confirming that the required matching contributions (cash; in-kind contributions such as salary, consultant costs, equipment) are available. Such applications are incomplete; see additional details and instructions in Section IV.2.

    Consultation

    Potential applicants to this FOA are strongly encouraged to consult with the Scientific/Research Contact(s) for the area of science for which they are planning to develop an application. Early contact is encouraged as it provides an opportunity for NIH staff to discuss the scope and goals of the project and to provide guidance to applicants.

    For more information please refer to specific FAQs for the FOAs.

    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 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 (Fast-Track)

    The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

    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

    NIH intends to commit total funds of up to $28,000,000 in FY 2019 and anticipates issuing up to 15 awards for projects submitted to this FOA and the three Companion Funding Opportunities listed in this FOA.

    Award Budget

    The total budget (Federal award and non-Federal matching contributions) should reflect the actual needs of the proposed project. While annual project budgets should reflect the actual costs anticipated in each year, the Federal share of this award must not exceed $225,000 in total funding support (i.e., Direct, Indirect/Facilities & Administrative (F&A) costs and fee) for Phase I of the award and $675,000 in total funding support for all years of Phase II. Total funding support may not exceed $900,000 for all years of the award that includes both Phase I and Phase II.

    The recipient is required to provide at least a 1:1 match of the Federal funds requested (for total Direct and Indirect/F&A costs) in the form of non-Federal contributions.

    Award Project Period

    According to statutory guidelines, award periods normally may not exceed 1 year for Phase I and 2 years for Phase II. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project.

    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

    Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

    1.    Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;

    2.    Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;

    3.     

                          i.        SBIR and STTR.  Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR

                        ii.        SBIR-only.  Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.  No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR

                       iii.        SBIR and STTR.  Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.

    4.    Has, including its affiliates, not more than 500 employees.

    If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.

    If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.

    If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.

    Definitions:

    • Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
    • Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
    • Private equity firm has the meaning given the term "private equity fund" in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
    • Venture capital operating company means an entity described in § 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

    SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

    Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.

    Phase I to Phase II Transition Rate Benchmark

    In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011.   This Transition Rate requirement applies to SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years, excluding the most recently-completed fiscal year.  For these companies, the benchmark establishes a minimum number of Phase II awards the company must have received for a given number of Phase I awards received during the 5-year time period in order to be eligible to apply for a new Phase I award.  This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period. 

    Companies that do not meet or exceed the benchmark rate will not be eligible to apply for a Phase I Fast-Track, or Direct Phase II (if available) award for a period of one year from the date of the application submission.  The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year.  The benchmark minimum Transition Rate is 0.25.   

    SBA calculates individual company Phase I to Phase II Transition Rates daily using SBIR and STTR award information across all federal agencies.  For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.gov.   Information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov. 

    Applicants to this FOA that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past five (5) years should, prior to application preparation, verify that their company's Transition Rate on the Company Registry at SBIR.gov meets or exceeds the minimum benchmark rate of 0.25. 

    Phase II to Phase III Commercialization Benchmark

    In accordance with guidance from the SBA, HHS, including NIH, SBIR/STTR Programs are implementing the Phase II to Phase III Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011. The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 (78 FR 48537).

    This requirement applies to companies that have received more than 15 Phase II awards from all agencies over the past 10 years, excluding the two most recently-completed Fiscal Years. Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0.15 (15%) patents per Phase II award resulting from these awards. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10 year period, excluding the two most recently-completed Fiscal Years.

    Information on the Phase II to Phase III Commercialization Benchmark is available at SBIR.gov. 

    Applicants to this FOA that may have received more than 15 Phase II awards across all federal SBIR/STTR agencies over the past ten (10) years should, prior to application preparation, verify that their company's Commercialization Benchmark on the Company Registry at SBIR.gov meets or exceeds the benchmark rate listed above.

    Applicants that fail this benchmark will be notified by SBA annually and will not be eligible to apply for New Phase I, Fast-track or Direct Phase II (if applicable) awards for a period of one year. 

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

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

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

    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.

    Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.

    The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.

    2. Cost Matching

    This FOA requires cost matching as defined in the NIH Grants Policy Statement. More information on the cost matching requirement is in Section IV.2 R&R Budget.

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

    NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

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

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

    A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively.    

    Contractual/Consortium Arrangements

    In Phase I, normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (Direct and Indirect/F&A costs and fee).

    In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (Direct and Indirect/F&A costs and fee).

    A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above.  A Federal laboratory, as defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

    The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in "Consortium/Contractual Arrangements" of the PHS 398 Research Plan component of SF424 (R&R) application forms.

    Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the SBIR/STTR (B) Instructions in the SF424 (R&R) SBIR/STTR Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

    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
    National Heart, Lung, and Blood Institute
    6701 Rockledge Drive, Room 7214
    Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
    Telephone: 301-435-0270
    Email: NHLBIChiefReviewBranch@nhlbi.nih.gov

    Page Limitations

    All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

    Instructions for Application Submission

    The following section supplements the instructions found in the SF 424 (R&R) SBIR/STTR Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    Other Attachments:

    1. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms.

    Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive.  Follow the instructions below. 

    Applicants small business concerns who are more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it their application package.

    a.   Download the "VCOC Certification.pdf" at the NIH SBIR Forms webpage. 

    b.   Answer the 3 questions and check the certification boxes.

    c.   The authorized business official must sign the certification.

    d.   Save the certification using the original file name.  The file must be named "SBIR Application VCOC Certification.pdf".  DO NOT CHANGE OR ALTER THE FILE NAME.  Changing the file name may cause delays in the processing of your application.

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

    SF424(R&R) Senior/Key Person Profile Expanded

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

    R&R Budget

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

    Applicants must submit budgets that clearly document the total costs, the source and amount of matching funds, and how valuation was determined in the case of in-kind contributions, as well as the Federal and Institutional (non-Federal) components of the budget.

    Include budget support for the PD/PI to participate in an NIH-held RM innovation meeting or workshop once each budget year in the Washington, DC/Metropolitan area.

    Cost Matching Requirement

    Cost matching is required for applicants responding to this FOA. The awardee is required to match (at least 1:1) the total Federally-awarded amount (total Direct and Indirect/F&A costs). Institutions must be able to document their actual contributions, which may include in-kind contributions, to the project and provide assurances that the organization(s) are committed to providing the funds and resources for their share of the project.

    Federal funds may not be used as a source of matching funds. Generally, cost matching requirements may not be met from the following sources:

    • Costs borne by another Federal grant or sub award
    • Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds
    • Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient)
    • Program income
    • Patient incentives

    Applicants must submit budgets that clearly document the total costs, the source and amount of matching funds, and how valuation was determined in the case of in-kind contributions, as well as the Federal and Institutional (non-Federal) components of the budget.

    Budget Justification: A total project budget (i.e., the requested budget plus the cost-matching budget) must be provided and must document the cost-matching (non-Federal) component and the Federal (non-cost matching) component. The amount of matching is subject to adjustment based on total allowable costs incurred. All costs and contributions used to satisfy the matching requirement must be documented by the recipient, including how the value for in-kind contributions was determined, and are subject to audit. The cost matching requirement is not negotiable.

    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) SBIR/STTR Application Guide must be followed.  

    PHS 398 Research Plan

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

    Research Strategy:

    Describe how the proposed project will:

    • Advance the field of RM and contribute to foundational knowledge
    • Address well-recognized challenges in clinical development
    • Evaluate safety and effectiveness RM products

    Describe how the proposed project will address critical issues relevant to clinical research and regulatory submissions, including those related to RM product development (e.g., improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness).

    Letters of Support: Non-Federal sources of matching or partial funding must provide Letter(s) of Support signed by an authorized organization representative (AOR).

    A non-Federal funding entity with a peer review process that cannot be concluded by the application deadline but that will be concluded in time to meet the Post Submission Materials, may provide a letter of support indicating it is considering a funding request from the applicant for the project. The letter must be signed by an AOR and must state the name of the applicant, project title, dollar amount or value of the in-kind contribution under consideration, and the date a decision will be made. A letter indicating the funding decision must be provided to NIH no later than December 10, 2018.

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

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • To be considered complete, applications are expected to include a plan to make available representative samples of the source stem cell line and clinical-grade stem cell product for in-depth and independent characterization, as appropriate and consistent with achieving the goals of the program.

    Appendix:

    Note that Phase I SBIR/STTR Appendix materials are not permitted.  Limited items are allowed in the Appendix of other small business applications.  The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.

    PHS Human Subjects and Clinical Trials Information

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

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

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

    PHS Assignment Request Form

    All instructions in the SF424 (R&R) SBIR/STTR 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), SBA Company Registry, eRA Commons, and Grants.gov.

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and time. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.  Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) SBIR/STTR Application Guide.

    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) SBIR/STTR Application Instructions. Paper applications will not be accepted.

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

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) SBIR/STTR Application Guide.

    See more tips for avoiding common errors.

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

    Post Submission Materials

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

    Amended letter(s) of support indicating whether an applicant successfully competed for non-Federal funds will be accepted as post-submission materials if received by December 10, 2018.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    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 there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?) 

    Specific to this FOA:

    How likely is it that the proposed project will significantly advance the field of RM by contributing to foundational knowledge while addressing a well-recognized challenge in clinical development, and evaluation of safe and effective RM products? To what extent does the application address critical issues relevant to the fundamental scientific understanding of the safety, quality, and effectiveness of adult stem cell-derived products used in clinical research and regulatory submissions, including those related to RM product development (e.g., improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness)?

    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?     

    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?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? For a Phase I application, are there clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

    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 arrangement?   

    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.

    Phase II Applications

    For Phase II Applications, how well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

    Phase I/Phase II Fast-Track Applications

    For Phase I/Phase II Fast-Track Applications, reviewers will consider the following:

    1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

    2. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization?

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Children

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

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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

    Phase IIB Competing 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.

    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. In particular, reviewers will comment on the following:  Plan to make available representative samples of the source stem cell line and clinical-grade stem cell product to an NIH-designated entity (RM Innovation Catalyst) for in-depth and independent characterization.

    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 the National Heart, Lung, and Blood Institute, 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 committee 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.
    • All regulatory requirements have been met.
    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.

    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.

    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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at 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.

    Report fraud, waste and abuse

    The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs.  The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.

    Cooperative Agreement Terms and Conditions of Award

    NIH Cooperative Agreements are subject to terms and conditions in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budgets (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 grants 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 primary responsibility for:

    The PD(s)/PI(s) will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.

    Awardees agree to participate in the overall coordination of research efforts. This participation includes collaboration and consultation with NIH staff, and the sharing of information, data, and research materials, as appropriate and consistent with achieving the goals of the research program.

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

    The NIH Program Official will be responsible for the normal program stewardship of the cooperative agreement, and will be in the Notice of Award. However, NIH may elect to have a dual-role approach where a single individual may act as both the NIH Project Scientist and Program Official. Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NIH staff other than the Project Scientist. The responsibility for final decision making will be determined by Institute/Center leadership and may reside with senior management, separate organizational components, and/or oversight committees. Because it is anticipated that the Program Official will participate in activities that rise to a level of involvement (i.e., additional role as Project Scientist) that results in conflicts of interest, for example, co-publication, other staff members such as direct line supervisors and/or other Senior NIH Program management staff will serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award.

    The NIH reserves the right to phase out or curtail the study (or an individual award) in the event of (a) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (b) human subject ethical issues that may dictate a premature termination, or (c) results that substantially diminish the scientific value of study continuation.

    Areas of Joint Responsibility include:

    Responsibilities that are shared between awardees and NIH staff will require close coordination. Responsibilities will be divided between awardees and NIH staff, as described above. Individual awardees will be required, in coordination with NIH staff, to develop and finalize plans for submission of their representative samples of the source stem cell line and clinical-grade stem cell product for in-depth and independent characterization as described in this FOA.

    Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. NIH will partner with the PD/PI to ensure that the dataset preparation is congruent with requirements for NIH data repository datasets and associated documentation for submission to an NIH-designated data repository. Awardees should work closely with NIH staff to establish common data elements, data standards, metadata requirements, controlled vocabularies, and quality control metrics for all data to ensure that the data are Findable, Accessible, Interoperable, and Reusable (FAIR) to ensure the data and results are maximally useful to the public.

    Study investigators are strongly encouraged to publish and to publicly release and disseminate results, tools, resources and other products of the study, in accordance with the study protocols and governance. It is expected that all methods, analyses, software, and algorithms will be made available in a timely matter to the scientific community. Within 3 years of the end of the period of NIH support for the project, data not previously released and other study materials or products not previously distributed are expected to be made available to individuals who are not study investigators in accordance with the NIH IC Data Sharing Policy.

    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 awardee, an NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    Matching:

    Matching funds (1 to 1 match) will be required (as per the 21st Century Cures Act) for the specific project awarded in each budget period (i.e., at least 100% match). Matching funds must be non-Federal funds set aside for this project and are available from the source(s) identified in the application, as committed to by the recipient. Cost matching will be evaluated on an annual basis by the awarding office to ensure that this requirement is being met. Compliance with the matching requirement must be verified in each budget period by showing the amount of Federal and non-Federal contributions and must be documented in the annual FFR.

    The Recipient agrees that if matching funds become unavailable and replacement matching is not secured within 90 days of them becoming unavailable, the award is subject to being phased out at the end of those 90 days. During that period no Federal funds may be drawn down, pending receipt a new matching agreement. Failure to notify the NIH may result in disallowed costs during any period in which matching funds are not available, and other enforcement actions as described in the NIH GPS.

    3. Reporting

    NIH requires that SBIR/STTR grantees submit the following reports within 120 days of the end of the grant budget period unless the grantee is under an extension. When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    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 on-time submission, 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 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

    SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
    Website to Email: http://sbir.gov/feedback?type=reg

    Scientific/Research Contact(s)

    Martha Lundberg, Ph.D.
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0513
    Email: lundberm@nhlbi.nih.gov

    Steven Becker, Ph.D.
    National Eye Institute (NEI)
    Telephone: 301-496-2234
    Email: beckersteven@nei.nih.gov

    Candace Kerr
    National Institute on Aging (NIA)
    Telephone: 301-827-4474
    Email: Candace.kerr@nih.gov

    Nancy Bridges, M.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-627-3535
    Email: NBridges@niaid.nih.gov

    Fei Wang, Ph.D.
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Telephone: 301-594-5055
    Email: wangf@mail.nih.gov

    Rosemarie Hunziker, PhD
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Telephone:  301-451-1609
    Email: hunzikerr@mail.nih.gov

    Nancy L. Freeman, Ph.D.
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-402-3458
    Email: FreemanN@mail.nih.gov

    Nadya Lumelsky, Ph.D.
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-594-7703
    Email: nadyal@nidcr.nih.gov

    Deborah K. Hoshizaki, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-7712    
    Email: dkhosh@nih.gov

    David Panchision, Ph.D.
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-5288
    Email: panchisiond@mail.nih.gov

    Timothy LaVaute, Ph.D.
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-3765
    Email: lavautetm@ninds.nih.gov

    Philip J. (P.J.) Brooks, Ph.D.
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-443-0513
    Email: pjbrooks@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Anthony Agresti
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-827-8014
    Email: agrestia@nhlbi.nih.gov

    Karen Robinson Smith
    National Eye Institute (NEI)
    Telephone: 301-451-2020
    Email: kyr@nei.nih.gov

    Mitchell Whitfield 
    National Institute on Aging (NIA)
    Telephone: 301-496-1472
    Email: mitchell.whitfield@nih.gov

    Donna Sullivan
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-2979
    Email: DSullivan@niaid.nih.gov

    Andrew Jones
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Telephone: 301-435-0610
    Email: jonesan@mail.nih.gov

    Katie Ellis
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Telephone: 301-496-8521
    Email: kellis@mail.nih.gov

    Christopher Myers
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-435-0713
    Email: myersc@mail.nih.gov

    Diana Rutberg
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-594-4798
    Email:  rutbergd@mail.nih.gov

    Aretina Perry-Jones
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-8862
    Email: PerryA@extra.niddk.nih.gov

    Rebecca Claycamp
    National Institute of Mental Health (NIMH)
    Telephone:  301-443-2811
    Email:  rclaycam@mail.nih.gov

    Tijuanna DeCoster
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-9231
    Email: decostert@mail.nih.gov

    Gloria Velez
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-435-0875
    Email: velezgf@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.

    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 SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), and as reauthorized and extended under P.L. 114-328, Section 1834. The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.

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