RFA-DA-27-007-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Limited Competition: Growing Great Ideas: Research Education Course in Entrepreneurship and Product Development for Researchers Studying Drug Use, Drug Misuse, and Drug Addiction (UE5 Clinical Trial Not Allowed)

Activity Code

UE5 Education Projects - Cooperative Agreements

Announcement Type

Reissue of

RFA-DA-22-020

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-DA-27-007

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.279

Funding Opportunity Purpose

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding. This NOFO seeks to establish a course to equip researchers studying drug use, drug misuse, and drug addiction with the skills, knowledge, and practical tools needed to translate their scientific discoveries into impactful real world solutions. The course is envisioned to focus on building capacity in product development, entrepreneurship, and innovation pathways so participants can more effectively move biomedical ideas from early research toward implementation, or commercialization. By combining structured training, mentorship, and hands-on experience, the course is envisioned to accelerate the development of biomedical products that address the complex challenges of drug use, drug misuse, and drug addiction, while fostering an interdisciplinary community of investigators prepared to navigate the scientific, regulatory, and business aspects of this unique research field.

To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on:

Courses for Skills Development

Curriculum or Methods Development

Specifically, Curriculum Development involves the design or refinement of a customized curriculum in biomedical entrepreneurship, and product development for researchers studying drug use, drug misuse, and drug addiction, and Courses for Skills Development involve implementation of education program or short courses, including outreach strategy and networking infrastructure.

Eligible institutions must have established entrepreneurship education programs with demonstrated capacity to deliver integrated curriculum for researchers studying drug use, drug misuse, and drug addiction. The Principal Investigator must be from the school of business or entrepreneurship, with multidisciplinary collaboration strongly encouraged.

Funding Opportunity Announcement Goal(s)

To support basic, clinical, translational, and implementation research in the field of substance use. To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcomes, including HIV/AIDS. To support research training and research scientist development.

Key Dates

Posted Date

June 23, 2026

Open Date (Earliest Submission Date)

September 01, 2026

October 01, 2026

October 01, 2026

Not Applicable

July 2027

All applications are due by 5:00 PM local time of applicant organization.

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date

October 02, 2026

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from 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.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Other Award Budget Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

Drug use, drug misuse, and drug addiction continue to create a profound public health and economic burden in the United States. Despite major scientific advances supported by the National Institute on Drug Abuse (NIDA), many promising discoveries do not progress into practical tools, treatments, or technologies that can be used in real world settings. This gap between research and impact persists in part because biomedical products in addiction science face unique scientific, clinical, and commercial challenges. Researchers often lack formal training in product development, regulatory strategy, commercialization, and other early stage decisions that determine whether an idea can ultimately reach patients and communities. As a result, many innovations stall before they can be translated into meaningful solutions.

To address these barriers, NIDA created the Growing Great Ideas (GGI) program to provide researchers with structured training in biomedical entrepreneurship and early product development. Since 2017, the program has equipped hundreds of investigators with the skills needed to identify unmet needs, evaluate innovation opportunities, and advance early stage concepts toward viable biomedical products. Participants have gone on to launch companies, secure follow-on funding, and continue developing technologies that address drug use, drug misuse, and drug addiction. The program has also strengthened the national research community by fostering a shared translational mindset and building networks of scientists, educators, and innovators committed to advancing addiction-related biomedical solutions.

This NOFO seeks to sustain and expand this successful training model. NIDA invites applications from institutions capable of developing and delivering a high quality, multidisciplinary curriculum that prepares researchers to engage in early stage translational science and product development relevant to drug use, drug misuse, and drug addiction. The goal is to ensure that new cohorts of investigators gain the entrepreneurial skills necessary to move promising ideas toward real world impact.

Objectives Applicant institutions are expected to:

Special Considerations NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

Applications Not Responsive to this NOFO The following types of applications are not responsive to this NOFO and will not be reviewed:

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

New

Renewal

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trial(s). Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDA intends to commit $350,000 in FY2027 to fund one award.

Award Budget

Applicants may request up to $325,000 in direct costs per year.

Award Project Period

The maximum project period is 5 years. The first year may be devoted to curriculum development and planning, with courses held annually thereafter.

Other Award Budget Information

Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).

Participant Costs

Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget.

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.

While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition and other education-related expenses.

Expenses for foreign travel must be exceptionally well justified.

Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g.,T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

Other Program-Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

The cost of travel and housing must be covered for all the eligible participants and should be included as part of the budget in the grant application.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

Applicant institutions must have an established and well-recognized business and/or entrepreneurship teaching program, as well as demonstrated capacity and commitment to adapting and delivering an integrated curriculum for researchers studying drug use, drug misuse, and drug addiction.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Foreign Organizations/International Collaborations

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.

Required Registrations

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 registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

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.

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.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The Principal Investigator must be a faculty member of the school of business or entrepreneurship of the applicant institution.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review. (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Program Faculty The Principal Investigator must be a faculty member of the school of business or entrepreneurship of the applicant institution. The program faculty should consist of experts with various backgrounds (e.g., biomedical product development, regulatory, reimbursement, entrepreneurship) and should have research expertise and experience relevant to the proposed program, and demonstrate a history of, or the potential for, their intended roles in the program. The faculty must be committed to continuing their involvement throughout the total period that the participants are engaged in this award.

Participants Because this UE5 program is intended to facilitate the transition of the participants to entrepreneurship and primarily to the NIDA small business program, the participants must be U.S. citizens or permanent residents and have not received previous small business grant funding. The expected primary program participants are researchers studying drug use, drug misuse, and drug addiction interested in translating scientific knowledge and discoveries into biomedical product development (e.g., pharmacotherapies, medical devices, digital wellness applications). The participants should be interested in launching a small business company or currently working in a for-profit corporation. Individuals employed by not-for-profit or non-profit organizations and who are not interested in transitioning to a for-profit corporation are excluded as participants.

Section IV. Application and Submission Information

1. Requesting an Application Package 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 It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed in this Notice of Funding Opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

Page Limitations

All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

Follow all instructions provided in the How to Apply - Application Guide.

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the How to Apply - Application Guide.

SF424(R&R) Other Project Information Component

Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending (Other) Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the How to Apply - Application Guide.

R&R Budget

Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:

Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

Use the section on Participant Support Costs to include all allowable categories of funds requested to support participants in the program.

PHS 398 Cover Page Supplement

Follow all instructions provided in the How to Apply - Application Guide.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

Proposed research plans must describe the following components:

1. Curriculum Development Design or refinement of a customized curriculum in biomedical entrepreneurship, and product development specifically tailored for researchers studying drug use, drug misuse, and drug addiction interested in translating their research into commercial products (e.g., pharmacotherapies, medical devices, digital wellness applications).

Accessibility Requirements: The course should be designed to accommodate program participants with wide-ranging expertise and training levels, ensuring accessibility across career stages and disciplinary backgrounds.

Program Focus. The program should train researchers studying drug use, drug misuse, and drug addiction, including NIDA-funded investigators, to: (1) understand the market value of their research inventions; (2) develop early-stage biomedical technologies; and (3) advance technologies from the research laboratory to the commercial marketplace.

Core Curriculum Content. The curriculum should address the following critical competency areas, with special emphasis on challenges in the early stages of product development:

Instructional Approaches. The curriculum may employ multiple delivery formats, including reading materials, videos, exercises, lectures, and case studies. The curriculum should incorporate experiential learning approaches such as 1) case studies specific for drug use, drug misuse, or drug addiction, 2) one-on-one consultations with faculty experts, 3) meetings with individuals with lived experience of drug use, drug misuse, or drug addiction, and 4) site visits to gain insights into target markets and end-user needs.

The curriculum should enable participants to develop compelling pitches for their proposed technologies and to articulate clear value propositions that address real-world problems, critical barriers, or unmet needs in the field of drug use, drug misuse, or drug addiction.

2. Courses for Skills Development A plan for implementing the curriculum through education programs or short courses, including outreach strategies, participant engagement and selection, and opportunities for networking and mentorship.

Outreach and Recruitment Strategy: Applications must propose a comprehensive national outreach strategy targeting researchers studying drug use, drug misuse and drug addiction across the United States. The strategy must describe specific approaches to identify, engage, and recruit participants from various institutional types, career stages, and geographic locations. Recruitment methods may include dissemination through NIDA and NIH communication channels, professional networks, academic institutions, entrepreneurship programs, and relevant scientific and translational research communities.

Engagement with Entrepreneurial Community: The program must provide opportunities for participants to engage with the biomedical entrepreneurial community, including successful technology entrepreneurs, investors, venture capitalists, and regulatory experts, and must offer mechanisms for ongoing training and collaboration beyond the initial course.

Participant Selection: Selection will be conducted by the Program Director/Principal Investigator in collaboration with NIDA using publicly documented selection criteria and standardized scoring rubric. The selection criteria should emphasize alignment with NIDA goals, applicant's demonstrated interest in biomedical entrepreneurship and product development, and readiness to benefit from intensive training.

Cohort Size and Composition: The recruitment plan must target an annual cohort of at least 25 NIDA-sponsored participants. Maximum cohort size will be determined by available institutional resources. After enrolling all NIDA-sponsored participants, additional non-NIDA-sponsored participants may be included. The recruitment strategy must actively target both academic settings and non-academic settings (e.g., industry, clinical practice), to ensure various perspectives and expertise. The applicant must propose a mitigation plan to be implemented if recruitment falls below 20 NIDA supported participants prior to the start of the program.

Digital Networking Platform. Applicants should include a detailed plan to create and maintain a digital networking platform that connects program participants, alumni, faculty, and the broader biomedical community. The platform should:

The plan should demonstrate both how the platform will be developed initially and how it will be sustained throughout the project period and beyond.

Course Access and Fees. The course must be provided at no cost to NIDA-sponsored participants selected by the Principal Investigator in collaboration with NIDA. Applicants may propose mechanisms to allow additional participants to attend at their own expense as non-NIDA-sponsored participants, provided this does not compromise the core program objectives or participant experience.

Delivery Format and Timeline. A face-to-face, in-person component is required to ensure the most effective learning and networking opportunities. The recommended length of the in-person component is five days. Additional online programming may be proposed to extend learning, provide preparatory content, or offer follow-up support. The first project year may be devoted to curriculum development and planning, with courses to be held annually thereafter.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

Program Faculty. The Principal Investigator must be a member of the school of business or entrepreneurship of the applicant institution. The faculty should be multidisciplinary and could consist of experts from the schools of business, entrepreneurship, medicine, engineering, pharmacy, and sciences. The faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. The selection process and selection criteria for program participation should be clearly described. Identify the career levels for which the proposed program is planned.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under "Facilities & Other Resources" or the required "Institutional Commitment Letter of Support," described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five required instructional components outlined in the NIH policy:

1) Format - the required format of instruction. (A face-to-face in-person component is necessary. A plan with a hybrid of in-person and online training is acceptable. A plan with only online instruction is not acceptable;

2) Subject Matter - the breadth of subject matter (e.g., conflict of interest, authorship, data management, human subjects, research misconduct, research ethics;

3) Faculty Participation - the role of the program faculty in the instruction;

4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and

5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019.

The plan should be appropriate and reasonable for the nature and duration of the proposed program.

For Renewal (Type 2) applications: Describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from the materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops.

Letters of Support A letter of institutional commitment must be attached as part of Letters of Support (see section above: "Institutional Environment and Commitment)."

Resource Sharing Plan Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s) Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

A Data Management and Sharing Plan (DMS Plan) is not applicable for this NOFO.

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the How to Apply - Application Guide.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to submit 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. 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:

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 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.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure

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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this research education program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Significance

Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

Approach

Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Will the approaches employed achieve the stated goals and objectives, including reaching the audience at the intended educational level? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure an appropriate participant pool?

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there evidence of appropriate institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. 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

Reviewers 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.

Training in Methods for Enhancing Reproducibility

Does the Instruction in Methods for Enhancing Reproducibility plan describe how trainees will be instructed…