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)
National Eye Institute (NEI)
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 on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
National Heart, Lung, and Blood Institute (NHLBI)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID/CDC)
National Institute for Occupational Safety and Health (NIOSH/CDC)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Innovation Corps (I-Corps™) at NIH Program for NIH and CDC Translational Research (Admin Supp Clinical Trial Not Allowed)

Activity Code

Administrative Supplement

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


R41 Small Business Technology Transfer (STTR) Grant - Phase I only
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track

R43 Small Business Innovation Research (SBIR) Grant - Phase I only
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track

Announcement Type

Reissue of PA-18-517

Related Notices

Funding Opportunity Announcement (FOA) Number

PA-19-029

Companion Funding Opportunity

None

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

 93.393, 93.394, 93.395, 93.396, 93.397, 93.398, 93.399,93.084, 93.113, 93.121, 93.172, 93.173, 93.213, 93.242, 93.262, 93.273, 93.279, 93.350, 93.351, 93.846, 93.847, 93.853, 93.855, 93.866, 93.867,93.859, 93.837, 93.838, 93.839, 93.840, 93.23, 93.865

Funding Opportunity Purpose

 Through this I-Corps™ at NIH program Funding Opportunity Announcement (FOA), NIH and CDC provide administrative supplement awards to currently-funded SBIR and STTR Phase I grantees. The I-Corps at NIH program is focused on educating researchers and technologists on how to translate technologies from the lab into the marketplace. The program provides three-member project teams with access to instruction and mentoring in order to accelerate the translation of technologies currently being developed with NIH and CDC SBIR and STTR funding. It is anticipated that outcomes for the I-Corps teams participating in this program will include significantly refined commercialization plans and well-informed pivots in their overall commercialization strategies. Prospective applicants are strongly encouraged to contact Scientific/Research staff for more information about the program before applying.

Key Dates
Posted Date

October 17, 2018

Open Date (Earliest Submission Date)

October 19, 2018

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

November 19, 2018; January 28, 2019 by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

February 2019; April 2019

Expiration Date

January 29, 2019

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, eRA Commons Administrative Supplement User Guide or PHS 398 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 National Institutes of Health (NIH) is the nation's medical research funding agency, making important discoveries in basic research and translational medicine that improve health and save lives. Successful biomedical research depends on the talent and dedication of the scientific workforce, and the NIH supports many innovative training programs that foster scientific creativity and exploration, with the goals of strengthening our nation's research capacity, broadening our research base, and inspiring a passion for science in future generations of researchers.

    The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are NIH's engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat human disease. These are Congressionally-mandated set-aside programs for domestic small business concerns (SBCs) to engage in research and development that has the potential for commercialization. Both programs seek to increase the participation of small businesses in Federal research & development (R&D) and to increase private sector commercialization of technologies developed through Federal R&D.

    Through this funding opportunity announcement (FOA), the NIH, together with the CDC, seeks to accelerate the development and commercialization of new technologies, products, and services that arise from projects supported by currently funded SBIR and STTR Phase I grants. It is anticipated that NIH and CDC investments in the I-Corps at NIH program will strengthen the U.S. innovation ecosystem by addressing challenges inherent in the early stages of the innovation process. Uniformly, I-Corps provides teams with a great deal of understanding around concepts in the business model canvas including customer segments, key activities, and revenue streams. It also educates teams around important areas of commercialization relevant to life sciences, specifically medical reimbursements, regulatory strategy, and pre-clinical development. Another defining feature of the I-Corps program is the practice of customer discovery. Teams are expected to talk to at least 100 individual stakeholders in the ecosystem, and they are expected to branch out from their base institutions to conduct these interviews. As a result, teams build a wide network, and for some, the outcomes include securing revenue-generating service contracts and investment deals with strategic partners. Testimonials from previous participants may be found in archived webinar recordings: https://sbir.cancer.gov/programseducation/icorps/webinar.

    Program Description

    The goal of the I-Corps Program is to accelerate the translation of biomedical research to the marketplace by providing training to SBIR and STTR awardees in the areas of innovation and entrepreneurship. Under this program, the NIH and CDC foster the development of early-stage biomedical technologies, focus on teaching researchers how to gain a clearer understanding of the value of their inventions in the marketplace, and ultimately how to advance their technologies from the research lab into the commercial world. This program is designed to complement activities within the scope of the parent SBIR Phase I (R43) or STTR Phase I (R41) grant or the Phase I portion of an SBIR/STTR Fast-Track grant (R44/R42, respectively), to help accelerate the commercialization of new products and services derived from NIH- and CDC-funded technical feasibility studies.

    Through this program, I-Corps teams will participate in an entrepreneurial immersion course. The I-Corps curriculum uses a hypothesis-driven method of customer discovery in order to gain insights into the issues associated with technology commercialization. As part of this program, participants are required to get "out of the lab" and gather information by conducting a large number of interviews (i.e., 100+) with potential customers, strategic partners, and other third-party stakeholders. During the course, I-Corps teams share what they learn with instructors and other teams, gaining new insights into the prospective impact of the technology being developed under the SBIR or STTR grant. Instructors for the course are sourced from the National Science Foundation's National Innovation Network, and each instructor is trained in delivering the I-Corps curriculum. It is anticipated that the feedback and learning gained during the I-Corps program will help inform future Phase II SBIR/STTR projects and commercialization strategies.

    The I-Corps program will be supported through administrative supplement awards to active NIH or CDC SBIR and STTR Phase I grantees. Administrative supplement awards are intended only to support travel and other costs associated with the training program. A cohort (up to 24 teams per cohort) will be selected to participate in the I-Corps at NIH program, which is expected to last approximately eight weeks. 

    Details for the FY2019 cohorts are given below. All team members accepted to the I-Corps at NIH are required to participate in each of the program events given below. Additional dates will be released by Notice.

    Application Due Date

    November 19, 2018

    January 28, 2019

    Phone Interview

    December 17, 2018 (estimated)

    February 25, 2019 (estimated)

    Kick-off/Close-out Venue

    TBD

    TBD

    Course Kick-off

    February 19-22, 2019 (Tuesday-Friday)

    April 29-May 2, 2019 (Monday - Thursday)

    Web-Ex Courses

    Wednesdays, 1-5PM ET

    February 27

    March 6

    March 13

    March 20

    March 27

    April 3

    Wednesdays, 1-5PM ET

    May 8

    May 15

    May 22

    May 29

    June 5

    June 12

     

    Course Close-out/

    Lessons-Learned

    April 8-9, 2019 (Monday-Tuesday)

    June 17-18, 2019 (Monday-Tuesday)

    Cohort Size

    24 teams

    24 teams

    I-Corps Teams

    To apply under this program, eligible applicants must assemble three-member I-Corps teams that will work collaboratively to complete the activities and assignments required by the I-Corps training program. Applicants should designate teams consisting of the following members/roles:

    • C-level Corporate Officer
    • Program Director/Principal Investigator (PD/PI)
    • Industry Expert

    It is strongly recommended that the participating C-level Corporate Officer should be the chief executive officer (CEO) of the applicant small business concern (SBC); however, other C-level corporate officers may also serve in this role. In this context, C-level refers to "Chief" Technology Officer, "Chief" Operating Officer, or similar level officer. This person should have relevant knowledge of the technology and a deep commitment to investigate the commercial landscape surrounding the innovation. This person should have substantial decision-making authority within the company to implement changes in direction regarding the overall commercialization strategy for the project/technology. It is anticipated that the knowledge gained during the I-Corps training could have a significant impact on the corporate commercialization strategy; therefore, it is recommended that the C-level Corporate Officer should lead the three-member I-Corps team.

    The PD/PI on the SBIR/STTR Phase I award should participate as an active member of the I-Corps team. The PD/PI has primary responsibility for achieving the technical success of the project, while also complying with the financial and administrative policies and regulations associated with the SBIR/STTR award. In the scenario in which the PD/PI is also the CEO of the small business, applicants are encouraged to consider designating an additional scientific technical expert or C-level Corporate Officer to lead the team. In the scenario where the PD/PI of the grant is not a member of the team, an alternative team member may be an individual with understanding of the grant's underlying technology; in such case, the Research Plan must include justification for the team's personnel structure.

    The designated Industry Expert should be an experienced or emerging entrepreneur with proximity to the SBC and experience in translating technologies to the marketplace. The Industry Expert may be someone that has an established relationship with the company (e.g., Board Member), or this person may be selected as a third-party resource. Ideally, the Industry Expert should have prior experience in the development and commercialization of other products within the broader technology space related to the specific SBIR/STTR project under development.

    NOTE: It is anticipated that some applicants may benefit from additional guidance in determining how the organizational structure of their particular small business aligns with the expectations of the three I-Corps team members described above. Questions about the roles of each team member and how to consider individuals that can fulfill each of these roles should be directed as a general inquiry or to the appropriate NIH/CDC staff member at the Institute or Center that is funding the Phase I SBIR/STTR award (see the listing Scientific/Research staff under Section VII). In all cases, applicants are expected to designate a three-member team.

    Entrepreneurial Immersion

    The I-Corps curriculum provides real-world, hands-on, immersive learning about what it takes to successfully translate promising technologies into products or services that will benefit society. At the beginning of the training program, I-Corps team members will be required to attend an evening reception plus an intensive, 3-day kick-off Entrepreneurial Immersion course together (exact location to be announced). After the 3-day Entrepreneurial Immersion course, I-Corps teams will return to their home institutions for 6 weeks and will be required to conduct customer discovery activities as well as participate in weekly web-based conference meetings with the instructors. In addition, it is expected that I-Corps teams will take advantage of instructor office hours. At the completion of the course, I-Corps teams must also attend a 2-day final Course Close-out/Lessons-Learned workshop (anticipated Washington, DC area).

    The approach to develop the "technology disposition plan" will be a structured hypothesis/validation approach. Here, the term "technology disposition plan" is defined as the strategy that will be implemented to advance the commercialization of the product/technology following the completion of the I-Corps curriculum. The C-level Corporate Officer (or designated team representative) will be responsible for leading the team along a content-guided path (over the course of the I-Corps program), to develop a final technology disposition plan.

    The I-Corps training program will introduce the concept of a "Business Model Canvas," which provides the framework that guides the I-Corps learning. As part of this curriculum, each team must commit to pursuing a formal hypothesis-validation approach to identify and mitigate gaps in knowledge in the following nine areas:

    • Value Proposition of the proposed product or service;
    • Customer/User-case and pain point;
    • Key Activities;
    • Key Resources;
    • Key Partners;
    • Channels;
    • Customer Relationships;
    • Resource Streams; and
    • Cost Structure.

    To successfully complete the I-Corps at NIH program, the entire I-Corps team should be deeply committed and dedicated to the time-intensive curriculum. Each team member should plan to spend at least 20 hours per week on I-Corps activities and learning exercises for the full duration of the 8-week program.

    Online Curriculum

    During the I-Corps course, online content will be hosted by the NIH (or designee) to establish process and progress tracking. The team's progress will be shared with the entire cohort of I-Corps teams to facilitate group learning.

    Report-Out Session & Lessons Learned

    The members of each team must attend a 2-day Course Close-out/Lessons-Learned Workshop where final technology disposition plans are presented. It is anticipated that outcomes for the participating I-Corps teams will include enhanced understanding and validation of the key components of the Business Model Canvas, significantly refined commercialization plans, and well-informed "pivots" in the overall commercialization strategy. In this context, the term "pivot" is used to mean a reorientation or repositioning relative to the original commercialization strategy.

    Prospective applicants are strongly encouraged to contact Scientific/Research Contact(s) staff (as listed in Section VII) for more information about this program before submitting an application.

    Outcomes Evaluation

    Outcomes resulting from I-Corps at NIH program (e.g., refined commercialization plans) will be carefully evaluated as the NIH considers the continuation and further expansion of this program. As such, the NIH will seek to collect outcomes data from participating I-Corps teams immediately following the completion of the pilot program. Evaluations by the NIH may include customer evaluation surveys, interviews, and/or other approaches to obtain feedback on the overall effectiveness of the training. Outcomes data may also be collected by the NIH at different intervals following the completion of this pilot program. Short-term evaluation metrics may focus on such areas as the key pivots that occurred in the commercialization strategy during the training program. Mid-term metrics may focus on areas such as evaluating the relative success of participating teams in competing for future SBIR/STTR Phase II funding (as compared to SBIR/STTR Phase I grantees that did not participate in the I-Corps program). Longer-term metrics may focus on tracking the success of I-Corps teams in raising funds from third-party investors, as well as consummation of partnerships critical to the commercialization of the products/technologies under development.

    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.

    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.

    NIH and CDC intend to commit up to $1,200,000 in each fiscal year (FY 2019-2021) to fund up to 24 awards per year (72 awards over three fiscal years.)

    Award Budget

    Application budgets are limited to no more than $55,000 in total direct costs and must reflect the actual needs of the proposed project. Note in Section IV.2 that proposed budgets should also include $22,000 per team to cover workshop registration fees ($22,000 out of the total budget allowed of $55,000).

    Remaining budget should be allocated to cover travel costs to conduct on-site customer development interviews and personnel time for the I-Corps team members, as appropriate.

    No indirect costs should be requested.

    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:

    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 receive 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 or Fast-Track 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 awards for a period of one year. 

    IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

    This announcement is for supplements to existing projects. To be eligible, the parent award must be active, and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

    IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

    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. 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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. 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

    Only one supplement application per parent SBIR/STTR Phase I award is allowed under this FOA. Applicant organizations with multiple, currently-active SBIR and/or STTR Phase I awards from the different participating Institutes and Centers listed on this FOA may choose only ONE award to serve as the predicate for an administrative supplement to support the I-Corps at NIH program activity. The NIH and CDC will not fund multiple administrative supplement awards to the same applicant organization under this FOA.

    To apply for an administrative supplement award under this FOA, applicants must have received a prior SBIR or STTR Phase I grant from one of the participating ICs. The predicate Phase I grant must extend (at least) through the Lessons Learned workshop of the cohort schedule, and the grant should have remaining budget and R&D activities that extend at least until that date. Grant awards currently under a no-cost extension are eligible, provided they meet the above criteria.

    NIH- and CDC-funded SBIR Phase I contractors are not eligible to apply under this FOA.

    NIH- and CDC-funded SBIR/STTR Fast-Track grantees are eligible apply under this FOA provided that the Phase I portion of the award extends (at least) through the end of the Lessons Learned workshop as described above.

    The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will only support administrative supplements to Small Business Innovation Research (SBIR) Phase I grants or Fast-Track grants actively in the Phase I portion of award (R43). 

    The Office of Research Infrastructure Programs (ORIP) will support applications from Women-Owned and Socially and Economically Disadvantaged Small Business Concerns.

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

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

    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

    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, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions 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.

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

    Page Limitations

    All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

    Application Submission
    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:

    • 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.

    Research Strategy: The following section describes the required elements of the Research Strategy (One-page Executive Summary, plus five page I-Corps Team and Project Plan).

    Executive Summary of Predicate SBIR/STTR Phase I Grant and Team (one page only)

    Applicants should provide a one-page executive summary of the predicate SBIR/STTR Phase I award that will serve as the basis for the I-Corps Program. This summary should include a brief description of the specific aims of the Phase I project, and it should describe any progress that has been made toward achieving the specific aims (current as of the time of the supplement request). Applicants should also include a description of any technical, administrative, or commercial challenges that have been encountered and how those challenges have been addressed. In addition, applicants should include a brief introduction of the three proposed team members, their I-Corps roles, why they are appropriate for those roles; and a statement indicating that each team member is committed to the time requirements of the program.

    I-Corps Team and Project Plan (up to 5 pages)

    This section should include the following information:

    1. I-Corps Team

    • Describe the I-Corps team and provide the rationale for its formation, focusing on the team members' entrepreneurial expertise, experience bringing previous products to the market, relevance of the team's background to the innovation effort, and their experience in collaborating on previous projects. The composition of the I-Corps team should reflect the requirements listed above under Section I (Program Description), to include a: (1) C-level Corporate Officer; (2) PI; and (3) Industry Expert.
    • Provide clear statements to indicate that all team members are able to meet the time-intensive requirements of the training program (expected to be at least 20 hours per week per team member).
    • Briefly describe how the team will benefit from the I-Corps at NIH program.
    • Discuss the team's willingness to modify/refine the overall commercialization strategy, based on knowledge gained during the course of the I-Corps Program. 

    2. Potential Commercial Impact

    • Briefly describe how this research has led the team to believe that a commercial opportunity exists for the SBIR/STTR Phase I project moving forward.
    • Provide a brief profile of a typical customer of the proposed innovation.
    • Describe the customer need(s) that will be met by the proposed innovation.
    • Describe how the customer currently meets those needs.
    • What is the competitive advantage that is offered by the proposed product or service?
    • How much would a customer pay for the solution (current best estimate)?

    3. Project Plan

    • Describe the stage of development for the SBIR/STTR Phase I project that is currently under development (proof-of-concept, prototype stage, etc.)
    • Provide a brief description of the proof-of-concept or technology demonstration that will be provided by the end of the SBIR/STTR Phase I project.
    • Describe the next steps that the company will take to advance the project closer toward commercialization, assuming the outcomes of the SBIR/STTR Phase I award are promising.
    • 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.
    • Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). Also include the C-level Corporate Officer and Industry Expert being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each. The I-Corps team will consist of only three roles (as described above under Funding Opportunity Description): (1) C-level Corporate Officer; (2) PI; and (3) Industry Expert.  You should not submit more than the three individuals who make up the I-Corps team.
    • Budget forms (e.g., R&R Budget):
    • Only costs associated with participation in the I-Corps Program may be requested under this FOA. No recovery of indirect costs (F&A) will be allowed under this FOA. Proposed budgets may not exceed a total of $55,000 per team.
    • Funds must be set aside for three persons (C-level Corporate Officer, PI, and Industry Expert) for mandatory attendance at:

    (A) a kick-off evening reception plus a three-day grantee entrepreneurial immersion workshop (city and venue to be determined), followed, approximately six weeks later, by

    (B) a two-day course Close Out/Lessons Learned workshop at the end of the course (city and venue to be determined).

    • The intent of these workshops is to establish the foundation for the formal technology disposition of the project.
    • Applicants should estimate travel expenses for these two trips for all three team members.
    • In addition, proposed budgets should also include $22,000 per team to cover workshop registration fees ($22,000 out of the total budget allowed of $55,000).
    • Remaining budget should be allocated to cover travel costs to conduct on-site customer development interviews and personnel time for the I-Corps team members, as appropriate.

    Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

    NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User’s Guide for submitting through this system is available, with the following additional guidance:

    • Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
    • Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
    • Use the “Add Other Attachments” function to include the following PDF documents:
    • ·    Research Strategy including a summary or abstract of the funded parent award or project.
    • ·    If applicable, attach documents 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. 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 component.

    Research Strategy: The following section describes the required elements of the Research Strategy (One-page Executive Summary, plus five page I-Corps Team and Project Plan).

    Executive Summary of Predicate SBIR/STTR Phase I Grant and Team (one page only)

    Applicants should provide a one-page executive summary of the predicate SBIR/STTR Phase I award that will serve as the basis for the I-Corps Program. This summary should include a brief description of the specific aims of the Phase I project, and it should describe any progress that has been made toward achieving the specific aims (current as of the time of the supplement request). Applicants should also include a description of any technical, administrative, or commercial challenges that have been encountered and how those challenges have been addressed. In addition, applicants should include a brief introduction of the three proposed team members, their I-Corps roles, why they are appropriate for those roles; and a statement indicating that each team member is committed to the time requirements of the program.

    I-Corps Team and Project Plan (up to 5 pages)

    This section should include the following information:

    1. I-Corps Team

    • Describe the I-Corps team and provide the rationale for its formation, focusing on the team members' entrepreneurial expertise, experience bringing previous products to the market, relevance of the team's background to the innovation effort, and their experience in collaborating on previous projects. The composition of the I-Corps team should reflect the requirements listed above under Section I (Program Description), to include a: (1) C-level Corporate Officer; (2) PI; and (3) Industry Expert.
    • Provide clear statements to indicate that all team members are able to meet the time-intensive requirements of the training program (expected to be at least 20 hours per week per team member).
    • Briefly describe how the team will benefit from the I-Corps at NIH program.
    • Discuss the team's willingness to modify/refine the overall commercialization strategy, based on knowledge gained during the course of the I-Corps Program. 

    2. Potential Commercial Impact

    • Briefly describe how this research has led the team to believe that a commercial opportunity exists for the SBIR/STTR Phase I project moving forward.
    • Provide a brief profile of a typical customer of the proposed innovation.
    • Describe the customer need(s) that will be met by the proposed innovation.
    • Describe how the customer currently meets those needs.
    • What is the competitive advantage that is offered by the proposed product or service?
    • How much would a customer pay for the solution (current best estimate)?

    3. Project Plan

    • Describe the stage of development for the SBIR/STTR Phase I project that is currently under development (proof-of-concept, prototype stage, etc.)
    • Provide a brief description of the proof-of-concept or technology demonstration that will be provided by the end of the SBIR/STTR Phase I project.
    • Describe the next steps that the company will take to advance the project closer toward commercialization, assuming the outcomes of the SBIR/STTR Phase I award are promising.
    • 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.
    • Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). Also include the C-level Corporate Officer and Industry Expert being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each. The I-Corps team will consist of only three roles (as described above under Funding Opportunity Description): (1) C-level Corporate Officer; (2) PI; and (3) Industry Expert.  You should not submit more than the three individuals who make up the I-Corps team.
    • Budget forms (e.g., R&R Budget):
    • Only costs associated with participation in the I-Corps Program may be requested under this FOA. No recovery of indirect costs (F&A) will be allowed under this FOA. Proposed budgets may not exceed a total of $55,000 per team.
    • Funds must be set aside for three persons (C-level Corporate Officer, PI, and Industry Expert) for mandatory attendance at:

    (A) a kick-off evening reception plus a three-day grantee entrepreneurial immersion workshop (city and venue to be determined), followed, approximately six weeks later, by

    (B) a two-day course Close Out/Lessons Learned workshop at the end of the course (city and venue to be determined).

    • The intent of these workshops is to establish the foundation for the formal technology disposition of the project.
    • Applicants should estimate travel expenses for these two trips for all three team members.
    • In addition, proposed budgets should also include $22,000 per team to cover workshop registration fees ($22,000 out of the total budget allowed of $55,000).
    • Remaining budget should be allocated (as appropriate) to cover personnel time for the I-Corps team members, as well as travel costs to conduct on-site customer development interviews.
    Foreign Institutions

    Foreign (non-U.S.) institutions are not eligible.

    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.

    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 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:
    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.

    See more tips for avoiding common errors.

    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

    Applications received under this FOA will be reviewed in a Two-Stage Process.

    Stage I: In the first stage of review, NIH and CDC staff will evaluate the written application to consider the ability of the proposed supplement to increase the parent award's overall impact through the proposed team's participation in the I-Corps at NIH program. Specific criteria that will be considered will include the following:

    Has the applicant SBC assembled the appropriate I-Corps team members, including a C-level Corporate Officer, PD/PI, and Industry Expert?

    To what extent have the proposed team members indicated a deep commitment to the time-intensive requirements of the I-Corps training program and a sincere desire to investigate the commercial landscape surrounding the innovation?

    To what extent do these team members have the appropriate backgrounds and expertise to utilize the insights gained during the I-Corps program to advance the commercial goals of the predicate SBIR/STTR Phase I project?

    As appropriate for the specific project, to what extent does the (6-page) Research Plan clearly articulate: market opportunity; potential impact of the project/technology on patients; stage of technology development; competitive advantage of the technology and value proposition; skills and experience of the management team; commercial strengths (including the intellectual property portfolio and other proprietary technologies or trade secrets); key strategic partnerships and collaborations; and fundraising potential?

    To what extent will the company be able to "pivot" and refine its commercialization strategy if the information gained during the customer discovery process reveals commercial opportunities that had not previously been considered or pursued?

    Stage II: In the second stage of review, the best qualified candidates will be contacted by NIH staff to provide clarification on the information contained in the written application AND to provide responses to additional questions in a phone interview. All Team members must participate in the phone interview, to be scheduled as outlined above. Typical follow-up questions may include, but are not necessarily limited to, the following:

    • Introduce the team and provide a brief summary of the team members' background. What are the perceived strengths and weaknesses of the team and its members?
    • How long have the team members known each other? Are all the team members co-located? Who is driving the project?
    • Who is the visionary on the team?
    • What is the Industry Expert's experience with this product/technology space? Does the Industry Expert have prior experience with start-up companies in this technology space — what happened to those start-ups?
    • Provide an example where there was disagreement between the C-level Executive and the PD/PI and explain how the disagreement was resolved.
    • Why does the team believe that the product/technology is ready for translation to the marketplace? What customer "pain" will the proposed product/technology alleviate? Who are the first two customers?
    • If selected, can the team verbally commit to the I-Corps session/schedule that the NIH is recruiting for under this FOA?
    • Is the team prepared with the names of at least three customer contacts to visit in the city where the course will kick-off (e.g., Boston or San Francisco Bay Area)?
    • What does the team envision getting out of the I-Corps curriculum?
    • To what extent are the team members willing to "pivot" if the information gained during the customer discovery process reveals commercial opportunities that had not previously been considered or pursued?
    • Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
    • Is the team committed to getting out of the building to conduct in-person customer discovery?

    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 six 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 six 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 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

    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 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. 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, 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    Cooperative Agreement Terms and Conditions of Award

    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.

    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

    Scientific/Research Contact(s)

    Questions of a general nature about the I-Corps program may be directed to:

    Christie A. Canaria, Ph.D.
    National Cancer Institute (NCI)
    Phone: 240-276-5720 
    Email: canariaca@mail.nih.gov

    For Agency, Institute and Center Scientific/Research (Program) contacts, please see specific contacts here:

    Louis Quatrano, PhD
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-402-4221
    Email:  quatranol@nih.gov

    Christie A. Canaria, Ph.D.
    National Cancer Institute (NCI)
    Phone: 240-276-5720 
    Email: canariaca@mail.nih.gov

    Jerome Wujek, Ph.D.
    National Eye Institute (NEI)
    Phone: 301-451-2020
    Email: wujekjer@nei.nih.gov

    Heidi Sofia
    National Human Genome Research Institute (NHGRI)
    Phone: 301-480-3424
    Email: sofiahj@mail.nih.gov

     Michael-David A.R.R. Kerns, Ph.D.
    National Institute on Aging (NIA)
    Phone: 301-402-7713
    Email: Michael-David.Kerns@nih.gov

    Megan Ryan, M.B.A.
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Phone: 301-443-4225
    Email: mryan1@mail.nih.gov

    Natalia Kruchinin, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Phone: 240-669-2919
    Email: kruchininn@niaid.nih.gov

    Xibin Wang, Ph.D.
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Phone: 301-451-3884
    Email: wangx1@mail.nih.gov


    Roger L. Miller, Ph.D.
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Phone: 301-402-3458
    Email: Roger.Miller@nih.gov


    R. Dwayne Lunsford, Ph.D.
    National Institute of Dental and Craniofacial Research (NIDCR)
    Phone: 301-827-4635
    Email: lunsfordr@mail.nih.gov


    Daniel Gossett, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Phone: 301-594-7723
    Email: daniel.gossett@nih.gov


    Elena Koustova, Ph.D., MBA
    National Institute on Drug Abuse (NIDA)
    Phone: 301-496-8768
    Email: koustovae@nida.nih.gov

    Daniel T. Shaughnessy, Ph.D.
    National Institute of Environmental Health Sciences (NIEHS)
    Phone: 984-287-3321
    Email: shaughn1@niehs.nih.gov


    Margaret C. Grabb, Ph.D.
    National Institute of Mental Health (NIMH)
    Phone: 301-443-3563
    Email: mgrabb@mail.nih.gov


    Stephanie Fertig
    National Institute of Neurological Disorders and Stroke (NINDS)
    Phone: 301-496-1779
    Email: fertigs@ninds.nih.gov


    Merav Sabri, Ph.D.
    National Center for Complementary and Integrative Health (NCCIH)
    Phone: 301-496-2583
    Email: merav.sabri@nih.gov


    Lili M. Portilla, MPA
    National Center for Advancing Translational Sciences (NCATS)
    Phone: 301-827-7170
    Email: Portilll@mail.nih.gov


    Miguel Contreras, Ph.D.
    Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
    Phone: 301-594-9410
    Email: contre1@mail.nih.gov

    Paul Smutz Ph.D.
    National Center for Emerging and Zoonotic Infectious Diseases (NCEZID/CDC)
    Phone: 404-718-8830
    Email: wsmutz@cdc.gov

    Steve Dearwent Ph.D.
    National Institute for Occupational Safety and Health (NIOSH/CDC)
    Phone: 404-498-6382
    Email: SDearwent@cdc.gov 

    Dmitriy Krepkiy, Ph.D.
    National Institute of General Medical Sciences (NIGMS)
    Telephone: 301-435-0752
    Email: krepkiyd@mail.nih.gov

    Mike Pieck, Ph.D.
    National Heart, Lung, and Blood Institute (NHLBI)
    Office of Translational Alliances (OTAC)
    Phone: 301-496-2149
    Email: NHLBI_@SBIR@mail.nih.gov

    Peer Review Contact(s)

    Not Applicable

    Financial/Grants Management Contact(s)

    Mindy Bixby
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)  
    Telephone: 301-4025-3204
    Email: mindy.bixby@nih.gov

    Ms. Alania Foster
    National Cancer Institute (NCI)
    Phone: 240-276-5375
    Email: alania.foster@nih.gov
     
    Ms. Ashley Salo
    National Cancer Institute (NCI)
    Phone: 240-276-5656
    Email: ashley.salo@nih.gov

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

    Ms. Zephaun Harvey
    National Human Genome Research Institute (NHGRI)
    Phone: 301-435-7859
    Email: harveyz@mail.nih.gov

    Ms. Traci Lafferty
    National Institute on Aging (NIA)
    Phone: 301-496-8987
    Email: laffertt@mail.nih.gov

    Ms. Judy Fox
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Phone: 301-443-4704
    Email: Judy.Fox@nih.gov

    Mrs. Chernay L. Rogers
    National Institute of Allergy and Infectious Diseases (NIAID)
    Phone: 240-669-2992
    Email: Chernay.Rogers@nih.gov


    Ms. Aleisha S. James
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Phone: 301-594-3968
    Email: jamesaleisha@mail.nih.gov


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


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

    Ms. Pamela Love
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Phone: (301) 435-6198
    Email: lovepa@mail.nih.gov

    Ms. Amy Connolly
    National Institute on Drug Abuse (NIDA)
    Phone: 301-827-4457
    Email: connolla@mail.nih.gov

    Ms. Bryann Benton
    National Institute of Environmental Health Sciences (NIEHS)
    Phone: 919-323-5577
    Email: bentonb@mail.nih.gov


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


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


    Ms. Shelley Carow
    National Center for Complementary and Integrative Health (NCCIH)
    Phone: 301-594-3788
    Email: carows@mail.nih.gov

    Mr. Brian Quillin
    National Center for Advancing Translational Sciences (NCATS)
    Phone: 301-435-0844
    Email: brian.quillin@nih.gov


    Ms. Artisha Y. Eatmon
    Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
    Phone: 301-435-0845
    Email: artisha.eatmon@nih.gov


    Ms. Yolanda Sledge
    National Center for Emerging and Zoonotic Infectious Diseases (NCEZID/CDC)
    Phone: 770-488-2787
    Email: YSledge@cdc.gov

    Ms. Mary Pat Shanahan
    National Institute for Occupational Safety and Health (NIOSH/CDC)
    Phone: 412-386-4453
    Email: MShanahan@cdc.gov

    Justin Rosenzweig
    National Institute of General Medical Sciences (NIGMS)
    Telephone: 301-594-0158
    Email: rosenzwj@nigms.nih.gov

    Ms. Ann Marie Brasile Mejac, AA,CRA
    National Heart, Lung, and Blood Institute (NHLBI)
    Phone: 301-827-8016
    Email: brasilea@nhlbi.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

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

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