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

National Institutes of Health (NIH)

Centers for Disease Control and Prevention (CDC)

Components of Participating Organizations

National Cancer Institute (NCI)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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)

National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

National Library of Medicine (NLM)     

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

National Center for Injury Prevention and Control (NCIPC)

National Center for Environmental Health (NCEH)

National Institute for Occupational Safety and Health (NIOSH)

Funding Opportunity Title

Administrative Supplements to Promote Diversity in Research and Development  Small Businesses-SBIR/STTR (Admin Supp Clinical Trial Not Allowed)

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent awards using the following Activity Code(s). Note, however, that not all participating NIH Institutes and Centers (ICs) support all the activity codes listed below. Applicants must therefore consult the Table of IC-Specific Information, Requirements and Staff Contacts for more details.

Administrative supplement requests may be submitted electronically for the following activity codes:

R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track
U43 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase I

U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II

Announcement Type

Reissue of PA-18-837

Related Notices

June 30, 2020- Notice of Requirement for Electronic Submission of all Administrative Supplements. See Notice NOT-OD-20-128.

Funding Opportunity Announcement (FOA) Number

PA-21-345

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.350, 93.213, 93.070, 93.393, 93.395, 93.394, 93.396, 93.136, 93.867, 93.172, 93.837, 93.838, 93.839, 93.840, 93.233, 93.866, 93.273, 93.855, 93.846, 93.286, 93.865, 93.279, 93.173, 93.121, 93.847, 93.113, 93.859, 93.242, 93.307, 93.853, 93.361, 93.262, 93.879,93.351

Funding Opportunity Purpose

 The National Institutes of Health (NIH) hereby notify Small Business Concerns (SBCs) holding Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants that funds are available for administrative supplements to enhance the diversity of the research and entrepreneurial workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research or in the SBIR and STTR programs. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project.

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Key Dates
Posted Date

September 10, 2021

Open Date (Earliest Submission Date)

Submission dates vary by awarding IC. See Table of IC-Specific Information, Requirements and Staff Contacts for more details.

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Applications are accepted on a rolling basis at any time starting 30 days after the Open Date until the expiration date, unless otherwise noted in Institute specific language. Please consult with Scientific contacts listed in Section VII.

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

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

Start dates vary by awarding IC. See Table of IC-Specific Information, Requirements and Staff Contacts for more details.

Expiration Date

September 10, 2024

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, as appropriate) 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

    Background

    The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are congressionally mandated set-aside programs for U.S. small businesses to engage in research and development (R&D) that has a strong potential for commercialization.  The SBIR program is intended to meet the following goals: stimulate technological innovation in the private sector; strengthen the role of small business in meeting Federal research or R&D needs, increase the commercial application of Federally-supported research results; foster and encourage participation by socially and economically disadvantaged and women-owned small businesses.  The STTR program is intended to stimulate a partnership of ideas and technologies between innovative small business concerns and non-profit research institutions through Federally funded R&D.  By providing awards to small businesses for cooperative R&D efforts with non-profit research institutions, the STTR program assists the small business and research communities by commercializing innovative technologies.

    Fostering diversity by encouraging the participation of individuals from nationally underrepresented groups in the scientific research workforce, is longstanding interest of Congress, and a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital (e.g., Public Law 114-329, American Innovation and Competitiveness Act of 2017, and Notice of NIH's Interest in Diversity,?NOT-OD-20-031). Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems.?Increasing participation by socially and economically disadvantaged and women-owned small businesses is also critical to the success of the SBIR and STTR programs.?See, Committee on Capitalizing on Science, Technology, and Innovation: An Assessment of the Small Business Innovation Research Program—Phase II; Board on Science, Technology, and Economic Policy; Policy and Global Affairs; National Academies of Sciences, Engineering, and Medicine. SBIR/STTR at the National Institutes of Health. Washington (DC): National Academies Press (US); 2015 Nov 12. 6, Participation of Women and Minorities. Available from: https://www.ncbi.nlm.nih.gov/books/NBK338149/.

    Purpose

    The National Institutes of Health (NIH) hereby notify Small Business Concerns (SBCs) holding Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants that funds are available for administrative supplements to enhance the diversity of the research and entrepreneurial workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research, women, and socially or economically disadvantaged individuals. Administrative supplements must support work within the scope of the original project.

    This administrative supplement is designed to provide support for research and entrepreneurial experiences for individuals from the diverse backgrounds throughout the continuum from undergraduate to the faculty level. Continuation of this program in the future will depend on evaluation of the career outcomes of the supported individuals as well as continuing assessments of the diversity of the small business programs by the SBA and National Academies.

    In all cases, the proposed research experience must be an integral part of the approved ongoing research of the parent award and must have the potential to contribute significantly to the research career development of the candidate.

    Note: This FOA is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

    All applicants are encouraged to contact program staff listed in Section VII. Agency Contacts

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

    Section II. Award Information
    Funding Instrument

    The funding instrument will be the same as the parent award. 

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    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

     

    Non-competing Administrative Supplements

    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 number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    Award Budget

    Application budgets are limited to no more than the amount of the current parent award and must reflect the actual needs of the candidate’s research and training. Direct costs for individual administrative supplements vary from less than $5,000 to more than $100,000 depending on the career level of the candidate. Budget requests may also be limited by the awarding IC. See Table of IC-Specific Information, Requirements and Staff Contacts for more details.

    The Small Business Administration (SBA) has approved waivers to allow businesses to exceed the overall budget caps on their award for particular topic areas. The current list of approved topics can be found at https://sbir.nih.gov/sites/default/files/NIH_Topics_for_Budget_Waivers.pdf. Applicants are strongly encouraged to contact NIH program officials prior to submitting any application.

    The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

    Award Project Period

    The project and budget periods must be within the currently approved project period for the existing parent award.

     

    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:

    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;

    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;

    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), an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR

    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, unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR

    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.

    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.
    • ·        ANC mean Alaska Native Corporation.
    • ·        NHO means Native Hawaiian Organization.

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

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

    Phase I to Phase II Transition Rate Benchmark

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

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

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

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

    Phase II to Commercialization Benchmark

    In accordance with guidance from the SBA, HHS, including NIH, SBIR/STTR Programs are implementing the Phase II to 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 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, 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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

    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)

    Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.


    For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    A parent award may support more than one individual on a supplement; however, each request must be strongly justified and include assurances that each candidate will receive appropriate mentoring. Investigators are encouraged to recruit more than one undergraduate student for support by a supplemental award. Appointment of more than one individual to a single award above undergraduate level depends on the nature of the parent grant, the circumstances of the request, and the program balance of the NIH awarding component. Candidates may receive support from only one administrative supplement at a time but may be supported by more than one supplement during the development of their research careers. Support under the supplement is not transferable to another individual or transportable to another institution.

    Since applications in response to this announcement will only receive administrative review by the awarding Institute or Center, and will not receive peer review, the NIH policy on resubmissions will not apply. However, applications not accepted by the Institute or Center for review or not funded by the Institute or Center should not be submitted again without either responding to any written concerns or contacting the awarding Institute or Center for instructions first.

    Eligible Candidates for the Supplement Program

    For the purpose of this announcement, SBCs are encouraged to identify individuals who will enhance diversity of the research and entrepreneurial workforce, including those from groups that have been shown to be underrepresented in health-related research, women, and socially or economically disadvantaged individuals. For the purpose of this FOA, the NIH is utilizing the SBA definition of socially or economically disadvantaged individuals. (https://www.sba.gov/contracting/government-contracting-programs/8a-business-development-program/eligibility-requirements/social-disadvantage-eligibility). The strength of an institution's description of how the candidate furthers the goals of the program and justification for the appointment of the identified candidate will be judged along with all other aspects of the proposed experience (see Review Criteria in Section V. Application Review Information).

    Supplemental awards under this announcement are limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of a Permanent Resident Card, Form I-551). This program may not be used to provide technical support to NIH-supported investigators.

    Note: PD(s)/PI(s) should encourage candidates to submit applications for fellowships, career development awards, research grants, and other sources of independent support before the supplement period ends.

    PD(s)/PI(s) are encouraged to consider administrative supplements under this program for candidates at the following career levels:

    Undergraduate Students: As part of this supplement program, undergraduate students with a demonstrated interest in or desire to pursue research training in health-related sciences and entrepreneurship, may participate in a research project during the summer months and/or the academic year. This experience is separate from any requirement of the regular academic program. The student may be affiliated with either the small business concern or another academic institution. Any eligible undergraduate student interested in health-related research and entrepreneurship is encouraged to participate in this program.

    Baccalaureate and Master's Degree Holders: This supplement will provide opportunities for baccalaureate or master's degree holders who have demonstrated an interest in and wish to pursue research training in health-related sciences and entrepreneurship. The duration of the program is normally 6 months to 1 year, but the research experience can be extended for an additional year if evidence is provided to show that the candidate is actively pursuing entry into a graduate, business, or a health professions school or is pursuing development of a small business concern. Students who plan to attend medical, dental or other professional schools are encouraged to use this program to gain research experience.

    Graduate (Predoctoral) and Health Professional Students: The objective of this program is to support graduate students in biomedical, behavioral, clinical or social sciences, and health professional students who wish to develop their research and entrepreneurial capabilities. However, because this program is not intended to provide an alternative or additional means of supporting individuals who receive support from an NIH research grant, a Ruth L. Kirschstein National Research Service Award (Kirschstein-NRSA), or any other PHS funding mechanism, students who are supported by an institutional Kirschstein-NRSA may not be transferred to supplemental support prior to the completion of their appointed period of training. In addition, individuals may not be transferred to a supplement to increase the availability of funds to the parent grant for other uses.

    Individuals in Postdoctoral Training: These supplements support individuals in the postdoctoral phase of their training who wish to participate as researchers in ongoing research projects and career development experiences in preparation for an independent career leading health-related research and development small businesses. This experience must serve as a means of assisting the postdoctoral fellow's development into a productive researcher in health-related science at a small business. Because this program is not intended to provide an alternative or additional means of supporting individuals who receive support from PHS funding mechanisms, individuals in postdoctoral training who are supported by an institutional Kirschstein-NRSA may not be transferred to supplemental support prior to the completion of their appointed period of training. In addition, individuals may not be transferred to a supplement to increase the availability of funds to the parent grant for other uses. The individual in postdoctoral training may be affiliated with either the SBC or some other institution. Only under extraordinary circumstances, which must be well justified in the application, would it be acceptable for the postdoctoral candidate to work with his/her former predoctoral mentor.

    Investigators Developing Independent Research Careers: These supplements provide either short or long-term research support for individuals who wish to participate in ongoing research projects while further developing their own research potential, to enhance their research and entrepreneurial skills, and establish an independent research career.

    1. Short-term Investigator Research Supplement: This supplement provides short-term support for individuals to conduct full-time research in the biomedical, behavioral, clinical or social sciences for three to five months each year during the summer or another portion of the academic year, over a maximum period of four years at a SBC.

    2. Long-term Investigator Research Supplement: This supplement provides long-term research support for individuals to conduct research in the biomedical, behavioral, clinical or social sciences. Support is usually provided for up to two years at a minimum of 9 person months (equivalent to 75% effort) during each 12-month period.

    In either case (1 or 2 above), the investigator may be affiliated with the SBC or some other institution. The investigator must be beyond the level of a research trainee. An individual who has received previous funding from NIH as an independent PD/PI on a research grant (e.g., R01), as the project leader on a component of a program project or center grant (e.g., P01, P50, G12), or as PD/PI on an individual research career development award (e.g., K01, K02, K07, K08, and K23), or as a Scholar on an Institutional Career Development Award (K12, KL2) is not eligible.

    Eligible Awards

    For eligible awards, see the listing of Activity Codes under "Part 1. Overview Information." Note however that not all participating components support all the activity codes listed in this FOA. PD(s)/PI(s) at SBCs who hold an active grant or cooperative agreement may be eligible to submit a request for an administrative supplement to the awarding component of the parent award. In all cases, the mechanism of support under this program is the supplemental award. At the time of a supplemental award, the parent award must have support remaining for a reasonable period, which may vary by IC. See Table of IC-Specific Information, Requirements and Staff Contacts for more details.

    Proposed Research

    In all cases, the proposed research experience must be an integral part of the approved, ongoing research of the parent award, and it must have the potential to contribute significantly to the research career development of the candidate. Applications for supplements must include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the selected area of biomedical, behavioral, clinical or social sciences science as well as business and entrepreneurship. It must also provide evidence of a focus on the enhancement of the research and entrepreneurial capability of the individual and that the experience is intended to provide opportunities for development as a productive researcher and leader at a small business. In addition, it must demonstrate that the PD(s)/PI(s) is willing to provide appropriate mentorship.

    Contractual/Consortium Arrangements

    For the SBIR in Phase I, normally, two-thirds or 67% of the research or analytical effort is 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 is generally not more than 33% of the total amount requested (direct, F&A/indirect, and fee). In Phase II, normally, one-half or 50% of the research or analytical effort is 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 is generally not more than 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

    Deviations from these requirements may be considered on a case by case basis. Please contact a program officer for additional information. Deviations must be approved in writing by the Grants Management Officer (GMO) after consultation with the agency SBIR Program Manager/Coordinator.

    For the STTR in Phase I and Phase II, at least 40% of the research or analytical effort must be performed by the small business concern and at least 30% of the research or analytical effort must be performed by the single, “partnering” research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct F&A/indirect costs and fee attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS 398 Research Plan component of the SF424 (R&R) application forms.

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

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

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

     

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

    Applicants must prepare applications using current forms in accordance with the Application Guide.

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

    2. Content and Form of Application Submission

    All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

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

    Page Limitations

    All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits for the activity code of the parent award must be followed.

    Application Submission

    Administrative supplement requests must be submitted through Grants.gov using electronic submission processes.

    Instructions for Electronic Application Submission through Grants.gov

    Use the “Apply” button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

    Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

    • ·    SF424 R&R Cover form:  Select “Revision” in the “Type of Application” field.
    • ·    Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities. Applications for supplements must include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the selected area of biomedical, behavioral, clinical or social science as well as business and entrepreneurship. It must also provide evidence of a focus on the enhancement of the research and entrepreneurial capability of the student, postdoctorate, or individual and that the experience is intended to provide opportunities for development as a productive researcher and leader at a small business. In addition, it must demonstrate that the PD(s)/PI(s) is willing to provide appropriate mentorship and has developed a mentoring plan to facilitate the research and career development of the candidate.
    • ·    Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
    • ·    Senior/Key Personnel Profile (Expanded) form: List the PD/PI as the first person (regardless of their role on the supplement activities). List the candidate to be supported through this supplement as the second person; if the SBC would like to request support for multiple individuals, it must submit a separate application for each.

    o   List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement.

    o   Note: Candidates for supplement support must have an eRA Commons account and the candidate's Commons Username must be entered in the Credential field. Candidates should designate their specific role in the context of the project.  Candidates are encouraged to have an ORCID iD linked to the individual's eRA Commons Personal Profile. Candidates are encouraged to follow the ORCID link from their Personal Profiles in the eRA Commons, where they can either link their eRA profiles to existing ORCID accounts or create ORCID profiles and link them back to the eRA Commons. 

    o   Biographical Sketch: Include a biosketch for the candidate, any mentors, and any senior or key persons directly involved in activities related to the supplement.  Biosketches of mentors and other senior and key persons should provide evidence of past mentoring experience.  The personal statement of the candidate's biographical sketch should address: 1) Evidence of scientific achievement or interest. 2) Any source(s) of current funding. 3) A statement from the candidate outlining her/his research objectives and career goals.

    • ·    Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
    • ·    R&R Other Project Information form: If applicable, attach PDF documents in the "Other Attachments" field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents "IACUC Documentation.pdf" and/or "IRB Documentation.pdf". Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects' involvement is planned for the supplement.

    o   Candidate Eligibility Statement: A signed statement from the PD(s)/PI(s) and a business official establishing the eligibility of the candidate for support under this program that must include clearly presented information on citizenship, and other eligibility criteria.  See, Eligible Candidates for the Supplement Program section, above.  The strength of this statement will be considered by the NIH administrative review committee along with all other material provided.

    o   Home Institution Approval: Under unusual circumstances where the applicant and mentor would be at a site other than the grantee SBC, an appropriately signed letter from the institution where the research is to be conducted must also be submitted.  The request must be signed by the PD/PI, the candidate, and the appropriate institutional business official(s).

    o   Sub-recipient Approval: If any of the research is to be conducted at an organization other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must be submitted.  The request must be signed by the candidate, the PD/PI, and the appropriate institutional business official(s).

    • ·    PHS Human Subjects and Clinical Trials Information form: Only include a new or revised human subjects study record if these items do not change the scope of the approved project (e.g., new clinical trials cannot be added through an administrative supplement). If new recruitment or use of an additional existing dataset or resource is proposed in the supplement application, Section 2.4 should be revised and new Inclusion Enrollment Reports created, as appropriate.
    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 electronic 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.

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

    For electronic application 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.

    Awards are based on the current programmatic needs of the NIH awarding component, therefore investigators must contact their program officials at the NIH before applying (see Table of IC-Specific Information, Requirements and Staff Contacts).

    Supplements for Established Investigators Who Are or Become Disabled

    Support will be limited to items that will permit the investigator to complete the remaining years of a currently funded research project. This might include: salary support for an individual who can assist the Established Investigator in meeting the goals of the research project, specialized equipment, or modifications of the working environment. In all cases, the requested support must be consistent with the type of disability and the nature of the approved research. The total amount of support requested under this supplement must be reasonable in relationship to the direct costs of the parent award and the Established Investigator's role and effort on the project. In future competing applications, funds for continuation of the accommodations provided under this supplement must be requested in the parent grant application and may NOT be requested as a research supplement.

    Reasonable Accommodations: As part of these awards, funds may be requested to make changes or adjustments in the research setting that will make it possible for a qualified individual with a disability to perform the essential functions associated with his/her role on the project. The accommodations requested under this program must be directly related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under these awards include: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested from the supplement must be reasonable in relationship to the direct costs of the parent grant and the nature of the supplement award.

    Undergraduate Students: The salary for an undergraduate student should be consistent with SBC salary policies. Rates for undergraduate salary that exceed $12 per hour must be justified. An additional amount of $200 per month for supplies and travel may also be requested. Students are expected to devote the equivalent of at least three months of full-time effort to the research project and related activities in any one year; in most cases, the period of support for any individual should last at least two years. Exceptions to these requirements will be considered, depending on the circumstances of the applicant, the parent grant, and the specific request.

    Baccalaureate and Master's Degree Holders: The salary for baccalaureate and master's degree holders should be reasonable and consistent with the SBC salary policies. Additional funds up to $3,000 per year may be requested for supplies and travel.

    Graduate (Predoctoral) and Health Professional Students: The NIH will provide salary support in addition to other necessary expenses, such as supplies and travel, to enable the individual to participate as a graduate research assistant in a funded research project. The NIH will provide compensation that (1) conforms to the established, consistently applied salary and wage policies of the SBC and (2) reflects the percentage of time devoted to the PHS-funded project. Additional funds up to $4,000 per year may be requested for supplies and travel.

    Individuals in Postdoctoral Training: The NIH will provide support for salary in addition to other necessary expenses, such as travel and supplies, to enable the candidate to participate as a postdoctoral research assistant or associate on the funded research project. The requested annual salary and fringe benefits must be in accordance with the salary structure of the SBC, consistent with the level of effort, and may not exceed the maximum allowable NRSA stipend level for postdoctoral fellows in effect at the time of appointment (see: https://grants.nih.gov/training/nrsa.htm). However, exceptions to this rule may be made. Applicants must check with their program officials at the NIH before submitting an application. The supplement budget may include up to $6,000 for supplies and travel for the candidate.

    Investigators Developing Independent Research Careers: The requested salary and fringe benefits for an investigator should be consistent with the level of support provided by NIH Career Development Awards. Participating NIH Institutes and Centers have varying salary caps (see: Table of IC-Specific Information, Requirements and Staff Contacts). Salary and fringe benefits must be in accordance with the salary structure of the SBC and must be consistent with the level of effort. Additional funds of up to $10,000 may be requested for supplies and travel. Equipment may be purchased but requires prior approval of the NIH awarding component. The maximum period of support for any investigator is usually two years.

    Initial and Continued Funding

    In most cases, during the first budget period for the supplement, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on continued funding of the parent grant and cannot extend beyond the current competitive segment of the parent grant and the availability of funds.

    In Renewal (Type 2) applications, funds for continuation of support of the supplemental award will depend on the successful renewal of the parent grant and will be handled as follows:

    • ·        Funds for the continuation of support for students must be requested as a new diversity supplement. The request must be submitted promptly in anticipation of a renewal award to avoid an interruption of support. Additional time may be considered for individuals with disabilities but must be well justified.
    • ·        Funds for continued support for a postdoctoral fellow or an investigator must be requested by name in the parent grant application at the time of renewal and may not be requested as a research supplement. Postdoctoral fellows and investigators are expected to be fully integrated in the research laboratory when considered for continuation of support.
    7. Other Submission Requirements and Information

    Applications must be submitted using the instructions specified above.

    Applicants must complete all required registrations prior to submission. 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:
    For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(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 (SAM). Additional information may be found in the Application Guide.

     

    Post Submission Materials

    Not Applicable

    Section V. Application Review Information
    1. Criteria

    Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

    The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

    Budget and Period of Support

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

    Overall Impact

    NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

    • ·    The qualifications of the candidate including career goals, prior research training, research potential, and any relevant experience.
    • ·    Evidence of educational achievement and interest in science (if the candidate is a student).
    • ·    Evidence of interest in business and entrepreneurship.
    • ·    The strength of the description of how this particular appointment will promote diversity in small business, particularly with regards to entrepreneurship.
    • ·    The plan and timeline for the proposed research and career development experiences in the supplemental request and their relationship to the parent grant.
    • ·    Evidence that the proposed experience will expand and foster the research and entrepreneurial capabilities, knowledge, and/or skills of the candidate.
    • ·    Evidence that the activities of the candidate will be an integral part of the project.
    • ·    Evidence of adequate mentoring experience and success.
    • ·    Evidence that the candidate will receive research and entrepreneurial career mentoring.
    • ·    Evidence of the mentoring experience of the PD/PI.

    In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

    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, NIH staff 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, NIH staff 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.

    Vertebrate Animals

    NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (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

    NIH staff 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.

    2. Review and Selection Process

    Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

    3. Anticipated Announcement and Award Dates

    Not Applicable

    Section VI. Award Administration Information
    1. Award Notices

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’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. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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

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

    Cooperative Agreement Terms and Conditions of Award

    Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

    3. Reporting

    Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required 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.

    4. Evaluation

    In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

    Within ten years of making awards under this program, NIH will assess the program's overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program.  Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program. 

    In evaluating this program, NIH expects to use the following evaluation measures:

    Undergraduate Students:

    • ·        Aggregate number and demographic characteristics of participants 
    • ·        Subsequent educational/career progress, including:
    • ·        Successful completion of an undergraduate degree in a STEM field
    • ·        Enrollment in an advanced degree program in a STEM field

    Graduate Students:

    • ·        Aggregate number and demographic characteristics of participants 
    • ·        Subsequent educational/career progress of participants, including:
    • ·        Successful completion of a STEM graduate program 
    • ·        Subsequent participation in a formal research training or career development program in a STEM field
    • ·        Subsequent participation in research 
    • ·        Subsequent employment in a research or research-related field
    • ·        Subsequent authorship of scientific publications in a STEM field
    • ·        Subsequent independent research grant support from NIH or another source
    • ·        Participation in an SBIR or STTR grant
    • ·        Entrepreneurial activities  

    Postdoctorates and Early Career Investigators:

    • ·        Aggregate number and demographic characteristics of participants 
    • ·        Subsequent educational/career progress of participants, including:  
    • ·        Subsequent participation in research
    • ·        Subsequent employment in a research or research-related field
    • ·        Subsequent authorship of scientific publications in a STEM field
    • ·        Subsequent independent research grant support from NIH or another source
    • ·        Participation in an SBIR or STTR grant
    • ·        Entrepreneurial activities
    • ·        Obtaining a permanent position at an SBC
    • ·        Advancement or appointment to a C-level position at an SBC  
    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)

    See Table of IC-Specific Information, Requirements and Staff Contacts

    Stephanie Davis

    National Heart, Lung, and Blood Institute

    Phone: 301.496.8412

    Email: stephanie.davis3@nih.gov

    Anne Marie Brasile Mejac

    National Heart, Lung, and Blood Institute

    Phone: 301.827.8016

    Email: brasilea@nhlbi.nih.gov

    Peer Review Contact(s)

    Not Applicable

    Financial/Grants Management Contact(s)

    See Table of IC-Specific Information, Requirements and Staff Contacts

    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.

    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. The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive

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