Required Application Instructions

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

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

America's prosperity has originated in part from the ability to capitalize economically on ground-breaking discoveries from science and engineering research. Simultaneously, a knowledgeable, creative U.S. workforce has maintained the country's global leadership in critical areas of technology. These important discoveries and capable workforce resulted from substantial, sustained investment in science and engineering. A strong capacity for leveraging fundamental scientific discoveries into powerful engines of innovation is essential to maintain our competitive edge in the future.

The National Institutes of Health (NIH) is the nation s medical research 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 R&D and to increase private sector commercialization of technologies developed through Federal R&D.

Through this funding opportunity announcement (FOA), the NIH and CDC seek 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. In particular, the I-Corps program is designed to support training, mentorship, and collaborations that will help project teams at NIH- and CDC-funded small businesses overcome key obstacles along the path of innovation and/or commercialization.

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 grantees 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, 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 other teams, gaining new insights into the prospective impact of the technology being developed under the SBIR or STTR grant. 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 at NIH 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. Two cohorts (24 teams per cohort) will be selected to participate in the I-Corps at NIH Program, which is expected to last approximately eight weeks. The NIH anticipates that applicants receiving administrative supplements under this FOA will be enrolled in the I-Corps at NIH Program in one of two cohorts in 2016.

Details for each cohort are given below:

Application Due Date	December 10, 2015	March 21, 2016
Phone Interview (estimated)	January 20-26, 2016	April 11-22, 2016
Notice of Award (estimated)	February 1, 2016	May 6, 2016
Kick-off/Close-out Venue	Washington, DC	San Francisco Bay Area
Course Kick-off	March 13-16, 2016	June 19-22, 2016
Web-Ex Courses (1-5PM ET)	March 23 March 30 April 6 April 13 April 20 April 27	June 29 July 6 July 13 July 20 July 27 August 3
Course Close-out/ Lessons Learned	May 2-3, 2016	August 8-9, 2016
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
• Industry Expert
• Program Director/Principal Investigator (PD/PI)

It is strongly recommended that the participating C-Level Corporate Officer should be the CEO of the applicant 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 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.

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 alternate C-Level Corporate Officer to lead the team.

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 to the appropriate NIH or CDC staff member at the Institute or Center that is funding the Phase I SBIR/STTR award (see the listing of relevant 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, the first cohort is planned for the DC/Maryland/Virginia region and the second for the San Francisco Bay Area region). 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 (in the same regional area as the kick-off workshop).

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 Team 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 seven areas:

• Value Proposition of the proposed product or service;
• Customer/User-case and pain point;
• Demand Creation;
• Channel Development;
• Revenue Model;
• Partnership Strategy; and
• Resource Requirement.

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 (estimated) program.

Online Curriculum

During the I-Corps Team Training Pilot Program, 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

Each team must attend a 2-day report-out session 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 NIH Scientific/Research staff for more information about this program before submitting an application.

Outcomes Evaluation

Outcomes resulting from the I-Corps at NIH Program (e.g., refined commercialization plans) will be carefully evaluated before the NIH considers the possible 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, 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.

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

All organizations administering an eligible parent award may apply for a supplement under this announcement.

For-Profit Organizations

• Small Businesses

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 either May 3, 2016 or August 9, 2016, in the case of applicants responding to the December 3, 2015 and March 21, 2016 deadlines, respectively, 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.

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, 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 apply for a Phase I award and do not meet or exceed the benchmark rate will not be eligible for a Phase I 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.

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. Any questions regarding eligibility should be directed to the Scientific/Research Contact at the IC for which the predicate Phase I project is funded.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. 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.
  • 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 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 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.

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.

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

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

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

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 either May 3, 2016 or August 9, 2016, in the case of applicants responding to the December 3, 2015 and March 21, 2016 deadlines, respectively, 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-funded SBIR/STTR Fast-Track grantees are eligible apply under this FOA provided that: (1) the applicant SBC is currently completing the Phase I portion of the award; and (2) the Phase I portion of the award extends (at least) through May 3, 2016 or August 9, 2016, as described above.

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

For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process.

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 or eRA Commons Administrative Supplement User Guide) 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.

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:

The Research Strategy section should not exceed 6 pages.

Electronic submission of request for administrative supplements is available. If the administrative supplement is submitted electronically, then you may either (A) submit using the SF424 (R&R) Application Forms and Grants.gov/Apply or (B) submit using the streamlined submission process of eRA Commons.

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, as described below, should be completed. One page of the Research Strategy should be dedicated to include a summary or abstract of the funded parent award or project; a brief description of the three proposed team members, their I-Corps roles, and why they are appropriate for their given roles; and a statement indicating that each team member is committed to the time requirements of the program. 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.

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

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) Industry Expert; and (3) PI.
• Provide clear statements to indicate that all team members are able to meet the time-intensive requirements of the training program (expected to be 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.

NOTE: Applicants are strongly encouraged to submit SBIR/STTR supplement applications via the electronic-based submission process.

• 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) Industry Expert; and (3) PI. You should not submit more than the three individuals who make up the I-Corps team.
• Budget forms (e.g., R&R Budget, PHS 398 Training 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 $40,000 per team.
  • Funds must be set aside for three persons (C-Level Corporate Officer, Industry Expert, and PI) for mandatory attendance at:
    (A) a kick-off evening reception plus a 3-day grantee entrepreneurial immersion workshop (exact location to be announced, the first cohort is planned for the DC/Maryland/Virginia region and the second for the San Francisco Bay Area region), followed, approximately six weeks later, by
    (B) a 2-day course Close Out/Lessons Learned workshop at the end of the course (in the same regional area as the kick-off workshop).
  • 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 3 team members.
  • In addition, proposed budgets should also include approximately $20,000 per team to cover workshop registration fees. ($20,000 out of the total budget allowed of $40,000)
  • 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 in the appropriate geographical regions within the U.S.
• 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.

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

NIH now 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.
  • 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 $40,000 per team.
  • Funds must be set aside for three persons (C-Level Corporate Officer, Industry Expert, and PI) for mandatory attendance at:
  • (A) a kick-off evening reception plus a 3-day grantee entrepreneurial immersion workshop (exact location to be announced, the first cohort is planned for the DC/Maryland/Virginia region and the second for the San Francisco Bay Area region), followed, approximately six weeks later, by
  • (B) a 2-day course Close Out/Lessons Learned workshop at the end of the course (in the same regional area as the kick-off workshop).
  • 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 3 team members.
  • In addition, proposed budgets should also include approximately $20,000 per team to cover workshop registration fees. ($20,000 out of the total budget allowed of $40,000)
  • 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 in the appropriate geographical regions within the U.S.
• There is no template or form available for subaward budget information; instead, all subaward information must be included as a separate attachment showing the funds requested (by budget period) 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: The Research Strategy should include a summary or abstract of the funded parent award or project. The following section describes the additional required elements of the Research Strategy.

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

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) Industry Expert; and (3) PI.
• Provide clear statements to indicate that all team members are able to meet the time-intensive requirements of the training program (expected to be 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.
• NOTE: Applicants are strongly encouraged to submit SBIR/STTR supplement applications via the electronic-based submission process.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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.

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted 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.

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. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the NIH and/or CDC. Applications that are incomplete or non-compliant will not be reviewed.

Not Applicable

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 small business concern assembled the appropriate I-Corps team members, including a C-Level Corporate Officer, Industry Expert, and PI?

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 Team Training Pilot 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 IP 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 most responsive and 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's background. What are the perceived strengths and weaknesses of the team?

How long have the team members known each other? Are all of the team members co-located? Who is driving the project?

Who is the visionary on the team? What gets this person excited about the proposed product/technology?

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 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?

Has everyone on the team read the I-Corps course syllabus, and is everyone aware of the time commitment (expected to be 20 hours per week per team member)?

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 (i.e., DC/Maryland/Virginia 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?

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

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.

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.

NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

Not Applicable

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.

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.

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.

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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Mildred Williams-Johnson, PhD
National Center for Injury Prevention and Control (NCIPC/CDC)
Telephone: 770-488-8806
Email: [email protected]

Steve Dearwent, PhD, MPH
National Institute for Occupational Safety and Health (NIOSH/CDC)
Telephone: 404.498.6382
Email: [email protected]

Christie Canaria, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5720
Email: [email protected]

Jennifer Shieh, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-2149
Email: [email protected]

Michael-David (M-D) Alphonsus Rodriguez Richardson Kerns, M.M., M.S., Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7713
Email: [email protected]

M. Katherine Jung, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-473-5526
Email: [email protected]

Dr. Natalia Kruchinin
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2919
Email: [email protected]

R. Dwayne Lunsford, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-2421
Email: [email protected]

Elena Koustova, PhD, MBA
National Institute on Drug Abuse (NIDA)
Telephone: 301-496-8768
Email: [email protected]

Daniel Shaughnessy, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-25069
Email: [email protected]

Scott Somers, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: [email protected]

Margaret C. Grabb, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: [email protected]

Stephanie Fertig, MBA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: [email protected]

Lili M. Portilla, MPA
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-217-2589
Email: lilip@nih.gov

Mildred Williams-Johnson, PhD
Centers for Disease Control and Prevention (CDC)
Email: [email protected]

Not Applicable

Shicann M. Phillips
National Center for Injury Prevention and Control (NCIPC/CDC)
Telephone: 770-488-2809
Email: [email protected]

Mary Pat Shanahan
National Institute for Occupational Safety and Health (NIOSH/CDC)
Telephone: 412-386-4453
E-mail: [email protected]

Jackie Boudjeda
National Cancer Institute (NCI)
Telephone: 240-276-6312
Email: [email protected]

Ann Marie Brasile Mejac, AA, CRA
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0164
Email: [email protected]

Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-402-7731
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Ms. Deanna L. Ingersoll
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2989
Email: [email protected]

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Diana Haikalis, MBA
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
Email: [email protected]

Pamela Clark
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7629
Email: [email protected]

Justin Rosenzweig
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0158
Email: [email protected]

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone : 301-443-2811
Email: [email protected]

Tijuanna DeCoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

Long Nguyen
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-402-6737
Email: [email protected]

Shicann M. Phillips
Centers for Disease Control and Prevention (CDC)
Telephone: 770-488-2809
Email: [email protected]

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

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

Special Award Conditions:

Online content establishing the process and progress tracking the post-award effort will be hosted by NIH or designee. Team progress may be tracked using a closed Wiki environment. Shared resources will only be accessible NIH, the entrepreneurial course instructors, and the peer teams that participate in the I-Corps at NIH Program cohort.

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, and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). 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 and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.