It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Purpose

The purpose of the administrative supplement is to provide support for NIH-funded investigators to participate in an entrepreneurship training course, the Concept to Clinic: Commercializing Innovation (C3i) Program. The C3i Program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). Through this program, the NIH fosters the development and commercialization of early-stage biomedical technologies by engaging investigators who are interested in better understanding the value of their innovation in addressing an unmet market need. The curriculum and customized mentoring provided by the C3i Program are intended to guide investigators as they assess the commercial viability and potential business opportunity for their innovation. It is anticipated that the learning gained during the C3i Program will help inform future SBIR/STTR projects and commercialization strategies.

Background

The National Institutes of Health (NIH) is the nation's biomedical 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. Through this funding opportunity announcement (FOA), the NIH aims to accelerate the development and commercialization of new technologies, products, and services that arise from projects supported by currently funded research grants. It is anticipated that NIH investments in the C3i Program will strengthen the U.S. innovation ecosystem by addressing challenges inherent in the early stages of the innovation process. In particular, the C3i program is designed to support training, mentorship, and collaborations that will help NIH-funded project teams overcome key obstacles along the path of innovation and/or commercialization.

Program Description

The C3i Program is a 24-week entrepreneurial training course, divided into two 12-week phases, and consists of two in-person events, weekly teleconferences, lectures, and coursework. Participants in the C3i Program will develop a comprehensive set of core skills that will enable them to: 1) evaluate whether a compelling unmet market need exists for their proposed solution, 2) assess whether there is a viable business opportunity that can be built to meet this need, 3) build a compelling pitch presentation to secure support from potential investors and other business partners. The teams will be guided through a series of lectures and interactive exercises, pressure-testing commercial viability of ideas using universal business criteria as well as the unique requirements of medical device commercialization. Participants also work with experienced business advisors and subject matter experts who provide insights into the market sector, intellectual property, regulatory, and reimbursement requirements specific for their projects.

The first 12 weeks, Phase I of the course, will focus on characterizing the unmet market need, identifying the customer and stakeholder segments, conducting customer and stakeholder interviews, and validating the business opportunity. The second 12 weeks, Phase II of the course, will provide commercialization planning support, covering intellectual property strategy, regulatory and reimbursement requirements, risk assessment, milestone creation and valuation, and preparations for pitching to investors and/or strategic partners.

The C3i Program will be supported through administrative supplement awards to active NIH-funded research projects. Administrative supplement awards are intended only to support costs associated with the training program. Up to 24 project teams will be selected to participate in the C3i Program in 2018. All project teams selected will participate in Phase I of the C3i Program, running from September 12, 2018 through December 14, 2018. Up to 16 of the participating project teams will be offered acceptance into Phase II, based on outcomes from Phase I (e.g. market potential, business model validation, and commitment to the coursework). Phase II will run from January 7, 2019 through March 29, 2019.

Details of the schedule, as well as the coursework, are presented below.

Application Due Date	June 1, 2018
Notice of Award (estimated)	September 1, 2018
Phase I
Course Kick-off (Boot Camp 1)	September 12-14, 2018
Weekly One-on-Ones/Stakeholder Interviews	September 17 - December 14, 2018
Group Teleconferences	Week of October 15 Week of November 12
Lectures	Week of November 12
Phase I Final Presentations	Week of December 10
Phase II
Weekly One-on-Ones	January 7 - March 22, 2019
Group Teleconferences	February 6
Lectures	January 3 January 17 January 24 February 7
Consulting Hours	February 11 - March 22
Course Close-out (Boot Camp 2)	March 28-29, 2019

Boot Camp 1

Project Teams kick-off their C3i Program experience with an intensive, 2.5-day, in-person workshop. Through a series of lectures and interactive exercises, Project Teams are introduced to key concepts and tools they can use to validate the unmet need and the business opportunity. During the exercises, Project Teams receive mentoring from Business Advisors, as well as feedback from other participating Project Teams.

Weekly One-on-Ones/Stakeholder Interviews

Following the completion of Boot Camp 1, Project Teams meet weekly with their Business Advisors throughout the course. These weekly one-on-one meetings are held via web or teleconference. During this time, Project Teams delve into validating both the unmet need and business opportunity of their technology, identifying and learning from the key stakeholder groups and organizations that will influence the commercialization success of their product. Due to the complexity of the health care system, the analysis of key stakeholders and how they stand to benefit or lose from the adoption of new technology is critical to understanding the potential business opportunity and to informing the go-to-market strategy, if there is one.

In between each weekly session, Project Teams conduct interviews with key stakeholders and report back how the findings have helped inform or refine the commercialization landscape for their envisioned product. It is recommended that a Project Team speak with at least 30 stakeholders to gather sufficient breadth of perspective. It is equally important that these interviews are held with various stakeholder groups, as applicable for the envisioned product (e.g. health care provider, referring providers, patients, health care payor, purchasing agent or other entities with direct buying authority, potential strategic partner, potential investor, etc.).

Group Teleconferences

Following several weeks of stakeholder interviews, groups of Project Teams meet via web conference to present what they have learned from their stakeholder interviews. The goal of these group meetings is to share progress, receive feedback and coaching, and learn from the entire Business Advisor group. Several group teleconferences are held throughout the course on topics relevant to the business model and final pitch preparation.

Lectures

There are eight lectures given throughout the course, addressing specific topics related to medical device commercialization. These lectures average 30 minutes in length with additional time for questions and discussion directly following the lecture. Subject matter experts are recruited to deliver these lectures. Some of these lectures are given during the Boot Camps and some are given via web conference.

Boot Camp 2

The final event of the Program consists of a 1.5-day, in-person workshop, in which teams reconvene to deliver final pitch presentations focused on the value proposition and the investment opportunity. As they have throughout the Program, Business Advisors will be on hand to provide real-time feedback and guidance.

Business Advisors

C3i Business Advisors serve as a critical and knowledgeable resource with direct and extensive experience in biomedical technology commercialization, particularly working with early-stage innovators and small companies. The role of the Business Advisor is to: 1) enhance the Team's understanding of the biomedical technology commercialization process, 2) hone the Team's business case and investor pitch, and 3) increase the Team's chance of securing follow-on funding, through SBIR, VC, strategic partners, and other capital sources. Each Project Team is assigned 2 Business Advisors with the assignments largely based on the closest match between the business experience of the Business Advisor and the product the Project Teams are seeking to commercialize (e.g. devices, diagnostics, imaging).

Domain Experts

In addition to the Business Advisors, the C3i Program relies heavily on Domain Experts, which include Regulatory and Reimbursement specialists, SBIR/STTR consultants, and Quality Systems advisors. In Phase II of the course, each Project Team is provided with a total of 10 hours of one-on-one consultation time with the Domain Experts. The 10 hours can be allocated among the various Domain Experts in one-hour increments, as pertains to the specific needs of their project.

Project Teams

The C3i Program is designed for medical device innovators who are interested in understanding whether they have a compelling commercialization opportunity and how they can package this opportunity to interest investors and/or business partners. More than two-thirds of the course is dedicated to validating the basis for further investment of time, energy, and money by the Project Team and future business partners. Throughout the course, Project Teams are pushed to question and challenge the fundamental assumptions and basis for the 'business hypothesis' they are trying to validate during the Program.

It is strongly recommended that Project Teams consist of at least two members:

• Inventor or Technical Lead
• Business Lead

The Inventor or Technical Lead has primary responsibility for achieving the technical success of the project. The Technical Lead should be the PD/PI for the parent award project, or a co-investigator, with in-depth knowledge of the technology or innovation. The Business Lead has primary responsibility for guiding the overall business development and commercialization strategy for the project. For existing companies, the Business Lead should be the Chief Executive Office (CEO) or other C-level officer (e.g. Chief Technology Officer or Chief Operating Officer). For academic teams, the Business Lead should be an individual with a deep commitment to investigate the commercial landscape surrounding the innovation and would be most likely to take on the role of CEO if a company were to be formed. In the scenario in which the Technical Lead (PD/PI) might also serve as the Business Lead (CEO) for the project, applicants are encouraged to consider identifying an additional Project Team member with considerable commitment to the project. Project Team members are not required to be key personnel on the parent award project.

While the C3i Program is designed for interactive learning and one-on-one coaching elements, there is a structure and cadence to the course such that consistent participation is required across the exercises and sessions, which build upon each other. Thus, the Program is only recommended for Participants who can commit the time and effort to actively and consistently participate in the Boot Camps and one-on-one coaching sessions (estimated 10-15 hours per week).

Prospective applicants are strongly encouraged to contact NIH Scientific/Research staff for more information about this program before submitting an application.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institute of Neurological Disorders and Stroke (NINDS), will support administrative supplement applications from active parent grant awards encompassing all activity codes listed above.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will support administrative supplement applications from Phase I, Phase II, or Fast-Track SBIR or STTR grantees. The NIDDK and NICHD encourages Phase II SBIR and STTR grantees to first consider the NIH Commercialization Accelerator Program (CAP): https://sbir.nih.gov/cap and to speak with their program officer about these programs.

The National Institute of Mental Health (NIMH) will support administrative supplement applications from active parent grant awards encompassing R41, R42, R43, R44, U01 and R01 activity codes. Please contact NIMH program staff prior to submitting to ensure your award is eligible.

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

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

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

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.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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

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

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.

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

Only one supplement application per parent award is allowed under this FOA. To apply for an administrative supplement award under this FOA, applicants must have received a prior grant from one of the participating ICs. The predicate grant must extend (at least) through March 31, 2019, and the grant should have remaining budget and R&D activities that extend at least until that date. Grant awards under a no-cost extension are eligible, provided they meet the above criteria.

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

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

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

It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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:

Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. Administrative supplement requests for multi-project activity codes must be submitted using the paper submission process. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.

Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

Instructions for Electronic Application Submission through Grants.gov

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

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

• R&R Cover form: Select "Revision" in the "Type of Application" field.
• Research Plan form: At a minimum, the Research Strategy section should be completed and should address the following elements:

1. Problem/Unmet Need

Describe the scope and nature of the problem you are trying to address.

2. Proposed Solution

Describe your proposed solution and the innovation.

3. Impact/Significance

Define the impact that you hope to accomplish using metrics most appropriate for you- morbidity, mortality, time, efficiency, costs, etc.

4. Competition

Describe known approaches (current, competing, and "work-arounds") to address the problem.

5. Status/Intellectual Property (IP)

Describe status of your work and any disclosures or patent applications protecting your solution.

6. Key Challenges

What are the key challenges that you hope the C3i Program experience can help you address?

7. Team

Briefly describe the team members who will be participating in the C3i program, identifying their roles and experience as it relates to the commercialization effort. Provide clear statements to indicate that all team members are able to meet the time-intensive requirements of the training program (expected to be 10-15 hours per week per team member).

• 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 other Project Team members being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each. You should not submit more than the three individuals who make up the Project Team.
• Budget forms (e.g., R&R Budget): Only costs associated with participation in the C3i Program may be requested under this FOA. Proposed budgets may not exceed $30,000 in direct costs and should include $25,000 per team to cover course registration fees and up to $5,000 per team to cover travel expenses to the two in-person meetings.

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

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

• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
• Only costs associated with participation in the C3i Program may be requested under this FOA. Proposed budgets may not exceed $30,000 in direct costs and should include $25,000 per team to cover course registration fees and up to $5,000 per team to cover travel expenses to the two in-person meetings.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the "Add Other Attachments" function to include the following PDF documents:
• Research Strategy that addresses the following elements:

1. Problem/Unmet Need

Describe the scope and nature of the problem you are trying to address.

2. Proposed Solution

Describe your proposed solution and the innovation.

3. Impact/Significance

Define the impact that you hope to accomplish using metrics most appropriate for your technology - morbidity, mortality, time, efficiency, costs, etc.

4. Competition

Describe known approaches (current, competing, and "work-arounds") to address the problem.

5. Status/Intellectual Property (IP)

Describe status of your work and any disclosures or patent applications protecting your solution.

6. Key Challenges

What are the key challenges that you hope the C3i Program experience can help you address?

7. Team

Briefly describe the team members who will be participating in the C3i program, identifying their roles and experience as it relates to the commercialization effort. Provide clear statements to indicate that all team members are able to meet the time-intensive requirements of the training program (expected to be 10-15 hours per week per team member).

• Include a biographical sketch for each Project Team members being added through this supplement, or for whom additional funds are being requested through this supplement. You should not submit more than the three individuals who make up the Project Team.

Instructions for Paper-based Submissions using the PHS 398 Application Forms

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:

• Checklist: Select "Revision" in the "Type of Application" field.
• Face Page (Form Page 1): On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.
• Research Plan: At a minimum, the Research Strategy section should be completed and should address the following elements:

1. Problem/Unmet Need

Describe the scope and nature of the problem you are trying to address.

2. Proposed Solution

Describe your proposed solution and the innovation.

3. Impact/Significance

Define the impact that you hope to accomplish using metrics most appropriate for your technology - morbidity, mortality, time, efficiency, costs, etc.

4. Competition

Describe known approaches (current, competing, and "work-arounds") to address the problem.

5. Status/Intellectual Property (IP)

Describe status of your work and any disclosures or patent applications protecting your solution.

6. Key Challenges

What are the key challenges that you hope the C3i Program experience can help you address?

7. Team

Briefly describe the team members who will be participating in the C3i program, identifying their roles and experience as it relates to the commercialization effort. Provide clear statements to indicate that all team members are able to meet the time-intensive requirements of the training program (expected to be 10-15 hours per week per team member).

• Project/Performance Sites section (Form Page 2): 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 section (Form Page 2): List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget for Entire Proposed Project Period (Form Page 5): Only costs associated with participation in the C3i Program may be requested under this FOA. Proposed budgets may not exceed $30,000 in direct costs and should include $25,000 per team to cover course registration fees and up to $5,000 per team to cover travel expenses to the two in-person meetings.
• The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

Todd Merchak

National Institute of Biomedical Imaging and Bioengineering (NIBIB)
6707 Democracy Blvd, Suite 200
Bethesda, MD 20892-7922 (Express mail zip: 20817)
Telephone: 301-496-8592
Email: [email protected]

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the Application Guide.

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 SF424(R&R) Application Guide.

For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 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. For assistance with application submission contact the Application Submission Contacts in Section VII.

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

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

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award's overall impact through participation in the C3i Program:

• To what extent has the team clearly identified and described an unmet need?
• To what extent does the research strategy clearly articulate: 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; the IP portfolio and other proprietary technologies or trade secrets)?
• What does the team envision getting out of the C3i program?
• To what extent have the proposed team members indicated a commitment to the time-intensive requirements of the C3i curriculum?
• 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) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

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

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

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

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

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 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
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Todd Merchak
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8592
Email: [email protected]

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

Daniel Gossett, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-569-0395
Email: [email protected]

Louis Quatrano, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-4221
Email: [email protected]

Mike Pieck
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-496-2149
Email: [email protected]

Not Applicable

Florence Turska
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-9314
Email: [email protected]

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

Pamela Love
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-6198
Email: [email protected]

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Ann Marie Brasile Mejac
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0164
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.