Part 1. Overview Information

Key Dates

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. 

The overarching goal of this NIH Science Education Partnership Award (SEPA) program is to support educational activities that increase understanding of biomedical research among pre-college (pre-kindergarten to grade 12) individuals, and to encourage awareness of and continued interest in careers in science, technology, engineering, and mathematics (STEM). 

SEPA supports education projects across two types of settings: 

1. Classroom-based education projects for pre-kindergarten to grade 12 (pre-college) students and teachers
2. Informal science education (ISE) projects conducted outside traditional classroom settings.  

Applications focused on quantitative and computational skills development are strongly encouraged. Applications from resource-limited institutions are also highly encouraged.

A SEPA application may focus on one or more of the following activities related to any area of biomedical research within NIH’s mission: 

• Courses for Skills Development: Courses in a specific discipline or research area that extend the STEM content normally taught in schools. 
• Research Experiences: Hands-on exposure to research for pre-college students and teachers. 
• Mentoring Activities: Providing participants with a perspective on biomedical research pathways and tools for overcoming challenges, navigating career transition points, and successfully transitioning into careers in the biomedical research workforce.
• Curriculum or Methods Development: STEM education resources to improve biomedical science education or develop novel instructional approaches or computer-based educational tools.
• Outreach: Dissemination of STEM education resources or biomedical research findings to students and teachers. 

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. 

Applicants are strongly encouraged to consult with the appropriate Scientific/Research Contact listed in Section VII. Agency Contacts to determine appropriate mission fit with participating institutes and centers. 

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

Section II. Award Information

Other Award Budget Information

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

Higher Education Institutions - Includes all types

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

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)

Local 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)

Federal Governments

• 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
• Public, Private and Charter schools 
• Focused Research Organizations 

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. 

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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.

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.

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)

Additional Eligibility Information:

• An individual may serve as the PD/PI on no more than one active SEPA at a time. Those who are already PD/PI on an active SEPA, are eligible to submit a new SEPA application as long as the new SEPA project is distinct from the active project and there is no more than six months overlap between the end date of the current SEPA and the potential start date of the new SEPA. Renewal applications are not accepted under this funding opportunity.
• An institution with an active SEPA that is within the 5-year project start and end dates is eligible to submit new applications in a different biomedical research area distinct from the active SEPA project and with PD/PIs distinct from other active SEPAs at the institution.  
• Organizations with a contractual fee for service or consortium partnership with an active SEPA may submit a SEPA application if the proposed new project is independent of the existing SEPA contractual fee-for-service, consortium partnership, and has a different PD/PI than the other active SEPAs.

Program Faculty

Researchers and mentors should have research expertise and experience relevant to the proposed program.

Participants

Participants in SEPA programs are pre-college students and teachers. 

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents. 

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.

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

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.

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

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

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.

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

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.

• The PD/PI must devote a minimum of 2.0 person months per year. Up to 4.8 person months PD/PI effort per year can be requested with justification. 
• In the case of multiple PD/PI (MPI) projects, each PD/PI must devote a minimum of 2.0 person months per year. Up to 4.8 person months per year can be requested for the combined MPI effort.
• Use the section on Participant/Trainee Support Costs to request support for participants in the program.

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

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

Research Strategy

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

• Proposed Research Education Program
• Program Director(s)/Principal Investigator(s) 
• Program Faculty
• Program Participants
• Institutional Environment and Commitment
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination Plan

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.

       The Proposed Research Education Program should address the following:

• Rationale for the proposed program. Describe the gap in biomedical research training that the program intends to address. The application should include literature support and, if possible, existing baseline data to provide a strong justification for the program.
• Objectives. State the specific, obtainable, and measurable short-term and long-term objectives of the proposed program. The objectives should align with the overarching goal of the SEPA program, be based on sound educational concepts and evidence-informed approaches and be likely to be effective. Explain why the educational objectives of the program are relevant at a regional or national level and why they cannot be met through existing widely-available programs.
• Scientific focus (if applicable). If a scientific focus is proposed, explain how the program aligns with mission areas of the NIH Institutes and Centers. If the proposed program’s plan is to recruit from only one biomedical discipline (for example, genetics, cell biology, etc.), describe the program’s relevance to the broader biomedical research enterprise.

Applicants who have had a prior SEPA, or an active SEPA that is ending before the next funding cycle, are strongly encouraged to utilize their SEPA-generated infrastructure, partnerships, and evaluation tools for the new SEPA. 

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. As applicable, describe the role of additional SEPA faculty. SEPA faculty are the individuals who assist the PD/PI to design and deliver the education activities and/or mentor participants. Faculty should have expertise relevant to the proposed program and a demonstrated history of, or the potential for, fulfilling their intended roles. 

If including near-peer mentors, describe how they will be included in the program and how they will be trained.

Program Participants. Applicants must describe the intended participants, the rationale for their selection and grade level(s). The organization is responsible for establishing clear eligibility and participant selection criteria consistent with applicable law. 

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, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only non-interactive instruction is not acceptable); 

2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, 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 and NOT-OD-22-055. The plan should be appropriate and reasonable for the nature and duration of the proposed program. 

Projects proposing a student or teacher laboratory internships component must include participant training plans to improve the culture and practice of laboratory safety through the implementation of best safety practices in the laboratory.

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

Evaluation Plan. Applications must include a plan for ongoing evaluations of the activities supported by the award, including explaining how efficacy or success of the program will be defined and determined. The application must specify baseline metrics (for example, numbers and educational levels of participants ), as well as measures to gauge the 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. The evaluation plan must assess the effectiveness of the program in terms of its impact on the participants' understanding of biomedical research and awareness of related careers within the topic area of the proposed program and relevant to the grade level of the participants. 

Dissemination Plan. A plan must be provided describing how results from or materials developed under the auspices of the research education program will be disseminated nationally to enable the potential for replication or adaption of the SEPA components at different locations or institutions. For example (but not limited to): sharing course curricula and related materials via web postings, presentations at scientific meetings and workshops, 

SEPA programs must include a website development plan for dissemination of resources developed. The website may be a new website or a SEPA-specific component added to an existing website. The SEPA website must be launched within 6 months from the award date. Credit text for NIH, NIGMS and SEPA must be displayed on the website Home Page and cited in publications generated by SEPA support. The website must be free and open to the public.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: ”Institutional Environment and Commitment.”) Letters of institutional commitment should include a discussion on the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. 

Applicants are encouraged to include 1-page letters of support, appropriate for the proposed SEPA project, from key partners and stakeholders. 

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, with the following modification:

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals: 

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others. 
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages. 
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Other Plan(s)

A Data Management and Sharing 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.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Some SEPA programs may meet the requirements of Human Subjects research. The NIH OER Human Subjects Research website and NIH Human Subjects Research Exemptions infographic may be useful for guidance but does not replace the necessity to consult with the organizational IRB.  

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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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. 

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.

For this particular announcement, note the following:

The goal of SEPA is to support educational activities that increase understanding of biomedical research among pre-college (pre-kindergarten to grade 12) individuals, and to encourage awareness of and continued interest in careers in science, technology, engineering, and mathematics (STEM). NIH recognizes that rigorous, well-designed research education programs that further the goal of the SEPA program can take place in a wide variety of organizational environments and with mentors who have varying levels of NIH research grant support. Reviewers should evaluate proposed programs considering their stated objectives, organizational context, available resources, and the capacity of those resources to meet the stated objectives. 

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.

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.

As applicable for the program 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.

As applicable for the program proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process 

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions consistent with applicable law:

• Scientific and technical merit of the proposed program as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed program to overall SEPA program, participating NIH Institutes and Centers, and NIH priorities.
• Portfolio balance.
• Geographical and institutional distribution of the awards.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

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

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.  

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

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

Not Applicable

3. Data Management and Sharing

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting. Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research in accordance with the RPPR Instruction Guide.

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

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

Other Reporting Requirements

A dedicated section must be included in the annual RPPR detailing the progress made toward the goals and measurable objectives as stated in the Evaluation Plan. As appropriate for cohort-based programs, the annual RPPR must include ongoing evaluation data that measures participant engagement and learning, and identifies opportunities for continuous program improvement based on participant feedback. This evaluation should be annual and culminate in the final year of the project period.

A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement Section 8.6 Closeout.

5. Evaluation

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the SEPA Program, employing the representative measures identified below. In assessing the effectiveness of research capacity building investments, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants’ subsequent outcomes.

The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

For Courses for Skills Development:

• Aggregate number and characteristics of participants 
• Educational level of participants
• Participants’ feedback on the program
• New knowledge or skills acquired

For Research Experiences:

• Aggregate number and characteristics of participants
• Education level of participants
• Participants’ feedback on the program
• New knowledge of skills acquired

For Mentoring Activities:

• Aggregate number and characteristics of mentors and mentees
• Education level of mentors and mentees
• Participants’ (i.e., mentors and mentees) feedback on the program
• New knowledge of skills acquired

For Programs Focusing on Curriculum or Methods Development:

• Aggregate number and characteristics of participants exposed to the new curricula or methods
• General educational level of participants
• Effectiveness of the new curricula or methods assessed by skills/competencies gained compared to existing curricula or methods
• Dissemination and/or adoption of new curricula or methods
• Feedback from users of the new curricula or methods

For Outreach Programs:

• Aggregate number and characteristics of individuals reached
• Educational levels of participants
• Assessment of increased awareness, knowledge, or understanding of science- or research-related concepts, processes, or careers

Section VII. Agency Contacts

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

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

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

NIGMS SEPA
National Institute of General Medical Sciences (NIGMS)
Email: NIGMS_SEPA@mail.nih.gov
 

National Human Genome Research Institute (NHGRI)
Scientific Program Contact:
Email: nhgri-research-funding@mail.nih.gov

Office of Research Training and Career Development 
National Institute on Drug Abuse (NIDA)
Email: NIDA_training@nida.nih.gov

National Center for Complementary and Integrative Health (NCCIH)
Email: nccihderinquiries@mail.nih.gov

NIMH Scientific contact: NIMHTraining@mail.nih.gov  

National Institute of Allergy and Infectious Diseases (NIAID)
Scientific/Research Contact:
AITrainingHelpDesk@niaid.nih.gov

Office of Research on Women’s Health (ORWH)
Email: orwhcareers@nih.gov

National Institute on Aging (NIA)
Email:  NIATraining@mail.nih.gov

Division of Interdisciplinary Training
National Instituter of Biomedical Imaging and Bioengineering (NIBIB)
NIBIB Research Education Email: NIBIBResearchEducation@nih.gov

ODSS - Office of Data Science Strategy
E-mail: ds-workforce@nih.gov

National Institute on Minority Health and Health Disparities (NIMHD)
Email: NIMHDtraining@mail.nih.gov

National Institute of Dental and Craniofacial Research (NIDCR)
Scientific Contact: NIDCRtraining@nidcr.nih.gov

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

NIGMS PPBC GAB NOFO
National Institute of General Medical Sciences (NIGMS)
Email: NIGMSPPBCGABNOFO@nih.gov
 

National Human Genome Research Institute (NHGRI)
Grants Administration Branch
Email: nhgrigab@mail.nih.gov

Chief, Grants Management Officer
National Institute of Drug Abuse (NIDA)
Email:nidagmbemail@nida.nih.gov

National Center for Complementary and Integrative Health (NCCIH)
Email: nccihderinquiries@mail.nih.gov

NIMH Grants management contact: NIMHNOFOGrantsManagement@mail.nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)
Financial/Grants Management Contact:
NIAIDFinancial-GrantsContact@mail.nih.gov

National Institute on Aging (NIA)
Email: NIA-NOFO-Grants@nih.gov

Chief Grants Management Officer
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Email: NIBIBChiefGrantsManagementOfficer@nih.gov  

National Institute on Minority Health and Health Disparities (NIMHD)
Email: NIMHD-CGMO@mail.nih.gov

National Institute of Dental and Craniofacial Research (NIDCR)
Grants Management: deeranotifications@nidcr.nih.gov

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52, 45 CFR Part 75 and 2 CFR Part 200.