Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the How to Apply - Application Guide, as appropriate except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

Purpose

The NIH, and the CDC seek to accelerate the development and commercialization of innovations that arise from currently funded Phase I SBIR (NIH and CDC) and STTR (NIH only) projects. NIH and CDC investments in the I-Corps at NIH program strengthen these projects by addressing challenges inherent in the early stages of product development with a focus on the commercial feasibility of the end products.

The I-Corps at NIH program provides biomedical entrepreneurs with a proven methodology to develop an evidence based strategic business model through intensive customer discovery. During the practice of customer discovery, teams are expected to interview at least 100 individual stakeholders in the biomedical ecosystem to identify unmet clinical needs.  The I-Corps methodology provides teams with an understanding of concepts critical to start-up success, such as creating a business model canvas, customer segmentation, strategic partnerships, and revenue modeling. It also educates teams on aspects of commercialization specific to life science markets, with respect to pre-clinical development, regulatory strategy, and medical reimbursement.

I-Corps participants begin with a postulate of how their innovations will help impact clinical needs. Over the course of the 8-week program, insights gained from the 100 stakeholder interviews help the teams modify and fine-tune their null-hypothesis resulting in evidence-based business models and commercialization plans. Teams also build expansive networks, that enhance their downstream potential for securing follow-on investments or other relationships with strategic partners.

Background

The National Institutes of Health (NIH) is the nation's medical research funding agency, spearheading important discoveries in basic research and translational medicine that advance clinical practice and improve public health. The NIH also 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 expanding the breadth and skill set of the scientific workforce. As the nation’s health protection agency, the Centers for Disease Control and Prevention (CDC) safeguards the health security of our nation. To accomplish its mission, CDC conducts and supports critical research and monitoring to provide life-saving information in response to dangerous health threats as they arise.

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are engines of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat human diseases. 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.

Program Description

The I-Corps Program accelerates the translation of biomedical research to the marketplace by providing entrepreneurship training to SBIR and STTR recipients. In most cases instructors have direct personal experience as biomedical entrepreneurs and/or investors. I-Corps enables the development of early-stage biomedical technologies by focusing on developing a clear understanding of the market value of an innovation, and ultimately on how to navigate the advancement of a technology from the research lab into the commercial sector. I-Corps at NIH is designed to complement activities within the scope of the parent SBIR / STTR Phase I grant or the Phase I portion of an SBIR/STTR Fast-Track grant, to help accelerate the commercialization of new products and services derived from NIH and CDC-funded technical feasibility studies. Insights gained during the I-Corps program inform and improve the commercialization strategies of follow-on Phase II SBIR/STTR applications.

I-Corps teams participate in an entrepreneurial immersion course using a hypothesis-driven methodology of customer discovery to better understand the issues associated with technology commercialization. Participants are required to conduct one hundred or more interviews with potential customers, strategic partners, and other third-party stakeholders. Collectively the I-Corps cohort share their findings with instructors and other teams, integrating those insights into the iterative refinement of their business thesis on a weekly basis. 

The I-Corps program will be supported through administrative supplement awards to active SBIR (NIH and CDC) and STTR (NIH only) Phase I recipients. Administrative supplement awards are intended only to support travel and other direct 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 lasts approximately eight weeks.

Scheduling details for the FY2025 cohorts are provided in the table below. All team members accepted to the I-Corps at NIH are required to participate in each of the scheduled program events.

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 (CLO)
• Technical Lead/Expert (TL)
• Industry Expert (IE)

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 substantial decision-making authority within the company to implement changes in direction regarding the overall commercialization strategy. In the event that findings gained during the I-Corps program have a significant impact on the underlying business thesis, 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 a Technical Lead/Expert (TL) of the I-Corps team. The TL 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 may designate the PD/PI as the CLO and recruit an additional scientific technical expert to serve as TL; or the PD/PI may serve as TL and another C-level Corporate Officer may 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 a strong understanding of the grant's underlying technology; in all cases, 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 IE 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 IE 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: Additional guidance in determining how to structure an I-Corps team is provided in the I-Corps FAQs on the NIH SEED website at: I-Corps FAQ, Additional questions about the roles of each team member and how to consider individuals that can fulfill each of these roles may be directed as a general inquiry to seedinfo@nih.gov 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). 

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, all I-Corps team members are required to attend an in-person kick-off reception followed by an intensive, 3-day workshop (exact locations to be announced). After the workshop, I-Corps teams are required to spend the next 6 weeks conducting customer discovery activities as well as participating 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 for individualized consultations and mentoring. At the completion of the course, I-Corps teams must attend a 2-day finale Course Close-out/Lessons-Learned Workshop in Bethesda, MD. Customer discovery activities may take place in person or via video conferencing, as scheduling allows. Teams are also encouraged to take advantage of any scientific/industry conferences and  meetings that are scheduled concurrently with the program, to facilitate customer discovery. 

The approach to develop the "business thesis" will be a structured hypothesis/validation approach. Here, the term "business thesis" is defined as a short description of the company represented by the idea/technology/service explored during the I-Corps program. 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 business thesis.

The I-Corps 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 points;
• 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 25 hours per week on I-Corps activities and learning exercises for the full duration of the 8-week program. Unexcused absences may result in a team being withdrawn from the program.

Online Curriculum

During the I-Corps program, online content will be hosted by the designated content purveyor 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 at which final business theses are presented. I-Corps teams typically demonstrate an 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 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 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 recipients 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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this Notice of Funding Opportunity (NOFO).

Section III. Eligibility Information

1. Eligible Applicants

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

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: 

1. 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. 

2. Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm. 

3. 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. 

4. 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. 

5. ANC means Alaska Native Corporation. 

6. NHO means Native Hawaiian Organization. 

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

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

Phase I to Phase II Transition Rate Benchmark 

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

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

This funding opportunity 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 recipient in the supplement application must be within the original scope of the NIH-supported grant project.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registration in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.
• SBA Company Registry – See How to Apply – Application Guide for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a UEI to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

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 recipient organization 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 How to Apply - Application Guide for more information.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms. 

3. Additional Information on Eligibility

Number of Applications

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

Only one supplement application per parent SBIR/STTR Phase I award is allowed under this NOFO. Applicant organizations with multiple, currently-active SBIR and/or STTR Phase I awards from the different participating Institutes and Centers listed on this NOFO 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 NOFO.

To apply for an administrative supplement award under this NOFO, 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 NOFO.

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

The following participating organizations have additional eligibility guidance:

• 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.
• The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) will only support administrative supplements to SBIR/STTR Phase I grants or Fast-Track grants actively in the Phase I portion of the award during the originally approved project period. NIAMS will not support administrative supplements to grants in no-cost extension.
• The Centers for Disease Control and Prevention (CDC) will only support administrative supplements to SBIR Phase I grants in the Phase I portion of the award during the originally approved period of performance. CDC will not award administrative supplements to grants during a no cost extension period.
• The National Institute on Alcohol Abuse and Alcoholism (NIAAA) will only support administrative supplements to SBIR/STTR Phase I grants or Fast-Track grants actively in the Phase I portion of the award during the originally approved project period. Grants in no-cost extension are not eligible.

Contractual/Consortium Arrangements

In Phase I, normally, two-thirds or 67% of the research or analytical effort is carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort is generally not more than 33% of the total amount requested (direct, F&A/indirect, and fee).

In Phase II, normally, one-half or 50% of the research or analytical effort is carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort is generally not more than 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

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

For STTR:

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

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must prepare applications using current forms in accordance with the How to Apply - Application Guide.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. 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 and the How to Apply - Application Guide, as appropriate. except where instructed in this NOFO 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.

All page limitations applicable to the parent award as described in the Application Guide and the How to Apply - Application Guide for the activity code of the parent award must be followed, with the following exceptions or additional requirements, except where instructed in a Notice of Special Interest (NOSI) to do otherwise.

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

Use the “Apply” button(s) in Part I of this NOFO 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 NOFO. Follow all instructions in the How to Apply - Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

SF424 (R&R) Cover Form: Select “Revision” in the “Type of Application” field. The "Descriptive Title of the Applicant's Project" must match the title of the currently funded grant.

SF424 (R&R) Senior/Key Person Profile (Expanded) Form: List the PD/PI (of predicate Phase I grant) 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) Technical Lead/Expert; and (3) Industry Expert. You should not submit more than the three individuals who make up the I-Corps team.

R&R Budget Form: Only costs associated with participation in the I-Corps Program may be requested under this NOFO. Proposed budgets may not exceed a total of $55,000 per team.

Proposed budgets must include $25,000 per team to cover workshop registration fees ($25,000 out of the total budget allowed of $55,000). In addition, budget funds must be set aside for the three team members (C-level Corporate Officer, Technical Lead, and Industry Expert) mandatory attendance at the evening reception and 3-day kick-off entrepreneurial immersion workshop (dates and locations as noted in Section I of this announcement), followed approximately six weeks later by the two-day course Close Out/Lessons Learned workshop at the end of the course in Bethesda, Maryland.

Any 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.

PHS 398 Research Plan Form: At a minimum, the Research Strategy or Program Plan section, as applicable, must 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.

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

Applicants should provide a one-page executive summary of the predicate SBIR or 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) Technical Lead/Expert; and (3) Industry Expert.
• Provide clear statements to indicate that all team members are committed to meeting the time-intensive requirements of the training program (expected to be at least 25 hours per week per team member), including attending all scheduled program events and webinars.
• 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 or 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 or 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. 

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

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 How to Apply - Application Guide. 

5. Intergovernmental Review (E.O. 12372)

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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted using the instructions specified above.

Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.

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

Important reminders:

For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the eRA 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

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 NOFO 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, Technical Lead/Expert, 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 or 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 public health; 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 agency staff to provide clarification on the information contained in the written application AND to provide responses to additional questions in a scheduled phone interview. All Team members must participate in the phone interview. 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? 
• 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? 
• 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?
• Does the team verbally commit to the I-Corps session/schedule as published under this NOFO? 
• 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? 

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. 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 is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions. 

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Any application awarded in response to this NOFO 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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. 
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

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

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

 SBIR and STTR recipients may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. An acceptable Data Management and Sharing plan can reference and incorporate these data rights. Further information about SBIR and STTR data rights are enumerated in the NIH GPS.

4. 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 Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting. 

Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

Disclosure of Foreign Relationships Reporting Requirements 

Recipients are responsible for monitoring their relationships with foreign countries of concern post-award, for any changes that may impact previous disclosures. SBCs receiving an award under the SBIR/STTR program are required to submit an updated Disclosure Form to report any of the following changes to NIH, CDC, and FDA throughout the duration of the award: 

any change to a disclosure on the Disclosure Form; any material misstatement that poses a risk to national security; and any change of ownership, change to entity structure, or other substantial change in circumstances of the SBC that NIH, CDC, and FDA determine poses a risk to national security. Regular, annual updates are required at the time of all SBIR/STTR annual, interim, and final Research Performance Progress Reports (RPPRs). For changes that occur between RPPR submissions, recipients must request prior approval from NIH for legal actions such as merger, acquisition, and successor-in-interest or any other change in ownership, entity structure, covered individual, or other substantive changes in circumstances no later than 30 days before the proposed change. See NIH Grants Policy Statement 8.1.3 Requests for Prior Approval and NIH Grants Policy Statement 18.5.2.2 Change in Organization Size & Change of Recipient Institution Actions for more details. Disclosure Forms are required for any changes as described above. Recipients are required to upload these updated disclosures using the Additional Materials (AM) tool in eRA Commons. 

If the recipient reports a covered foreign relationship that meets any of the risk criteria prohibiting funding described in this NOFO, NIH, CDC, and FDA may deem it necessary to terminate the award for material failure to comply with the federal statutes, regulations, or terms and conditions of the federal award. Refer to NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support for more information. Recipients are encouraged to monitor their covered foreign relationships post-award and avoid entering into relationships, both funded and unfunded, that may pose a security risk and jeopardize their ability to retain their award. 

Agency Recovery Authority and Repayment of Funds 

An SBC will be required to repay all amounts received from NIH, CDC, and FDA under the award if either of the following determinations are made upon assessment of a change to their disclosure: 

the SBC makes a material misstatement that NIH, CDC, and FDA determine poses a risk to national security; or 

there is a change in ownership, change in entity structure, or other substantial change in circumstances of the SBC that NIH, CDC, and FDA determine poses a risk to national security. The repayment requirements and procedures provided in Section 8.5.4 Recovery of Funds of the NIH GPS apply and may also be subject to additional noncompliance and enforcement actions as described in Section 8.5.2 of the GPS. Recipients are required to follow the repayment procedures provided in the Guidance for Repayment of Grant Funds to the NIH.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

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

Eric Padmore, MHSA
NIH Office of Extramural Research
Small Business Education and Entrepreneurial Development (SEED)
Email: icorps@mail.nih.gov

For Agency, Institute and Center Specific Scientific/Research (Program) contact(s), please see below:

Ian Curtis Nova
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 240-987-2885
E-mail: ian.nova@nih.gov

Megan Ryan, MBA
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4225
Email: megan.ryan@nih.gov

Saroj Regmi, Ph.D.
National Cancer Institute (NCI)
Telephone: 240.276.7289
Email: saroj.regmi@nih.gov
 

Orlando Lopez, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 402-4243
E-mail: orlando.lopez@nih.gov

Rajesh Kumar, PhD
National Institute on Aging (NIA)
Email: niasmallbusiness@nih.gov

Emily Caporello, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1778
Email: Emily.caporello@nih.gov

Paekgyu Lee
NEI - NATIONAL EYE INSTITUTE
Phone: (301) 435-8164
E-mail: paek.lee@nih.gov

Paige Anderson, MS
National Institute of Mental Health (NIMH)
Phone: (301) 827-6550
Email: paige.anderson@nih.gov

Daniel Gossett, Ph.D.
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301-594-7723
E-mail: daniel.gossett@nih.gov

Amy Yang, PhD
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Centers for Disease Control and Prevention (CDC)
Phone: 404-718-8836
Email: vdz9@cdc.gov  

Xibin Wang, Ph.D.
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS)
Phone: 301-451-3884
E-mail: wangx1@mail.nih.gov

Roger Miller
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301.402.3458
E-mail: roger.miller@nih.gov

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

Amy Yang, PhD
National Center for Immunization and Respiratory Diseases (NCIRD)
Centers for Disease Control and Prevention
Phone: 404-718-8836
Email: vdz9@cdc.gov  
 

Eddie Billingslea, Ph.D.
National Institute of General Medical Sciences (NIGMS)"
Email: Eddie.billingslea@nih.gov
 

Lingamanaidu Ravichandran, PhD
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-3309
Email: lingamanaidu.ravichandran@nih.gov

Emrin Horgusluoglu, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Phone: 240-383-5302
Email: emrin.horgusluoglu-moloch@nih.gov 

Miguel Contreras, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-9410
Email: contre1@mail.nih.gov

Steve Dearwent, PhD
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention
Phone: 404-498-6382
Email: SED7@cdc.gov 
 

Amy Yang, PhD
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Centers for Disease Control and Prevention
Phone: 404-718-8836
Email: vdz9@cdc.gov  
 

Julia Berzhanskaya, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-443-3707
Email: julia.berzhanskaya@nih.gov

Krishna Balakrishnan, Ph.D.
National Center for Advancing Translational Science (NCATS)
Telephone: 301-827-7149
Email: krishna.balakrishnan@nih.gov 

Elena Koustova
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301 496-8768
E-mail: koustovae@mail.nih.gov

LCDR Michael J. Banyas, USPHS, MPA
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-402-1366
E-mail: michael.banyas@nih.gov

Sai Majji, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-661-9816
Email: sai.majji@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Deanna L Ingersoll
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7858
E-mail: deanna.ingersoll@nih.gov

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

Sean Hine
National Cancer Institute (NCI)
Telephone: 240.276.6291
Email: hines@mail.nih.gov
 

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: hidalgoge@mail.nih.gov

Jessi Perez
National Institute on Aging (NIA)
Telephone: 301-402-7739
Email: perezj@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov

Jane Lin
National Institute of Mental Health (NIMH)
Phone: 301-443-2229
Email: linja@mail.nih.gov

Christina Coriz
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301-594-8848
E-mail: corizc@mail.nih.gov

Angie Willard, Team Lead
Office of Financial Resources
Centers for Disease Control and Prevention (CDC)
Phone: 770-498-2596
Fax: 770-488-2778 
Email: AEN4@cdc.gov  

Victoria Matthews
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS)
Phone: 301-594-5032
E-mail: victoria.matthews@nih.gov

Samantha J Tempchin
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-1404
E-mail: tempchins@mail.nih.gov

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

Angie Willard, Team Lead
Office of Financial Resources
Centers for Disease Control and Prevention (CDC)
Phone: 770-498-2596
Fax: 770-488-2778 
Email: AEN4@cdc.gov  

Grants Administration Branch National Institute of General Medical Sciences (NIGMS)
Email: NIGMS_GAB_SBIR@nigms.nih.gov

Clark Phillips
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-4037
Email: clark.phillips@nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Kenneth Holiness
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-6854
Email: holinesskd@nih.gov

Brownie Anderson-Rana
Office of Financial Resources
Centers for Disease Control and Prevention (CDC)
Phone: 770-488-2771
Email: BAndersonRana@cdc.gov 
 

Angie Willard, Team Lead
Office of Financial Resources
Centers for Disease Control and Prevention (CDC)
Phone: 770-498-2596
Fax: 770-488-2778 
Email: AEN4@cdc.gov  
 

Ann Marie Brasile Mejac
National Heart, Lung, And Blood Institute (NHLBI)
Phone: (301) 827-8016
E-mail:brasilea@nhlbi.nih.gov

Imoni Williams, J.D.
National Center for Advancing Translational Science (NCATS)
Telephone: 301-435-2939
Email: imoni.williams@nih.gov  

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@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.

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 2 CFR Part 200.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, and P.L. 117-183. The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR and STTR Policy Directive.

The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, P.L. 107-50, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, and P.L. 117-183. The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) SBIR and STTR Policy Directive.