Part 1. Overview Information

Key Dates

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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) 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 Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose: The purpose of the STRONG-RLI Notice of Funding Opportunity (NOFO) is to invite applications to conduct biomedical research capacity needs assessments by Resource-Limited Institutions (RLIs) and then to use the results of the assessments to create action plans for meeting identified needs. The program’s goal is to increase competitiveness in the biomedical research enterprise and foster institutional environments conducive to research career development. Awards are intended to support RLIs in analyzing their institutional research capacity needs and strengths. Resource-Limited Institutions (RLIs) are defined for this NOFO as institutions with a mission to serve historically underrepresented populations in biomedical research that award degrees in the health professions or the sciences related to health, in STEM fields including social and behavioral sciences, and have received an average of $0 to $25 million (total costs) per year of NIH research project grant (RPG) support for the past three fiscal years (as defined in Section III -Eligibility).

Background:

NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission (see NOT-OD-20-031). NIH recognizes the importance of diversity in biomedical, clinical, behavioral, and social sciences (collectively termed "biomedical") research. This includes the diversification of NIH-funded institutions, where researchers with a wide range of skill sets and viewpoints can bring different perspectives, creativity, and individual enterprise to address complex scientific problems.

RLIs, as defined below, play an important role in supporting scientific research, particularly on diseases or conditions that disproportionately impact racial ethnic minority groups and other U.S. populations that experience health disparities. Although these institutions are uniquely positioned to engage underserved populations in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes, they may benefit from enhancing their capacity to conduct and sustain cutting-edge health-related research.

NIH is committed to assisting RLIs in building institutional research capacity. Scientists at RLIs are critical to advancing knowledge in the biomedical research enterprise. NIH has many programs designed to support researchers at RLIs and broaden the participation of researchers through inclusive excellence across regions, institutions, and demographic groups. The role of RLIs in the nation’s overall competitiveness in research is integrally related to current resources, departmental and disciplinary strengths and capabilities, and campus research support systems and infrastructure. It is critical that RLIs recognize and utilize their research and organizational capabilities so they can leverage existing strengths and develop strategic approaches in areas that require additional attention. Structured needs assessments to examine research and organizational capabilities can offer metrics for short-term/long-term action plans. These assessments will enable institutions to develop benchmarks and action items to increase their competitiveness for NIH, Federal, and other funding opportunities.

RLIs face unique challenges depending on the institution type, resources, infrastructure, and policies as they seek to acquire NIH or other federal agency funding. The areas at RLIs that need to be identified and addressed to reduce the barriers to scientific advancement and increase independent research funding can best be determined by the institution itself. A fundamental principle for organizational development and change is the use of a structured assessment to understand these barriers.

This Funding Opportunity will provide resources to the institutions to 1) conduct the assessment of research infrastructure and other requirements that will enhance administrative and research resources, institutional policies, and expanded opportunities for faculty and students in the biomedical research enterprise; and 2) Use the results of these institutional assessments to develop action plans that will support the conduct of high-quality biomedical research.

Program Objectives:

The purpose of this NIH-wide initiative, STRONG-RLI, is to support research active RLIs to;1. conduct rigorous research capacity needs assessments.2. use the results of the assessments to develop action plans for how to meet the identified needs.

Because of the significant variability in the types of RLIs, two separate categories have been created for this initiative. Please refer to Section III for eligibility criteria for RLIs.

The two categories of research active RLIs are defined in Section III of the NOFO:

1) Low Research Active (LRA): An RLI that is an undergraduate or graduate degree granting institution and has had less than six million dollars (total costs) in NIH research project grant (RPG) support per year in three of the last five years. In addition, undergraduate granting institutions must have at least 35% of undergraduate students supported by Pell grants.

2) High Research Active (HRA): An RLI that grants doctoral degrees and has had between six million and 25 million dollars (total costs) in NIH RPG support per year in three of the last five years.

Both LRA and HRA RLIs must have a historical mission to support underrepresented groups in biomedical sciences. Each institution should describe the specific category into which they fit and provide documentation to verify those requirements.

Each RLI will provide details on how they plan to conduct their needs assessments and create/use/adapt/ instruments to study research capacity at the institution. Please note that institutional climate or culture assessment is not a priority for this funding announcement.

As part of the funding announcement , the recipient institutions are expected to use the results of needs assessments to develop action plans for short term and long term goals, to meet the identified needs. Applicants are encouraged to provide detailed approaches for conducting the needs assessment and action plan development. The action plan should include identification of possible sources of funding for increasing research capacity. The implementation of the action plan is beyond the scope of this funding opportunity.

A. Institutional Needs-Assessment for research capacity

NIH recognizes and values the heterogeneity in institutional settings and the students they serve. Applicants must describe their distinctive biomedical research and research training environment and the current services to support them.

Applicants for this needs assessment can use any available tools, or adapt existing tools, to fit their context and needs.

B. Development of Institutional Action Plans

• After completion of the needs assessment, the recipient institutions are expected to develop an action plan. The Institutional Action Plan for research capacity is intended to serve as a roadmap for enhancing the infrastructure and capacity at the applicant institution.
• The outcomes of the needs assessment should determine the capacity building interventions that the institution can undertake to strengthen the institutional framework and research capacity. The Institutional Action Plan that will be developed is expected to be supported by an institutional leader, e.g., the Provost or President (see Letters of Support).

C. Needs assessment topics may include (but are not limited to):

The institution will determine the needs assessment foci but may include broad categories such as administrative/research/student/faculty.

Administrative topics may include -

• Establishing or enhancing the Office of Sponsored Programs (OSP), examining efficiencies and staffing requirements and personnel needs for administrative support
• Available resources for effective business practices, automation, information dissemination, documentation and tracking progress for research activities,
• Process management and process improvement for grant application, grant award, and grant administration.

Research topics may include-

• Research infrastructure may include physical research facilities, lab equipment, and computing resources, core facility for technology, support staff, professional development, laboratories. Appropriate physical research facilities and skilled research support to enable competitiveness.
• Research readiness in areas, such as basic, behavioral or clinical research, grantsmanship support, seminars and workshops for grant writing, for sharing research ideas to enhance knowledge in the field. Potential and current scientific research areas of interest.
• Capacity to conduct Human Subjects Research
• Capacity for Community Engagement research
• Partnerships/ collaboration with other academic institutions, the public sector, and community-based organizations that are sustainable and equitable

Student and faculty topics may include-

• Training needs, Mentoring/Sponsorship, faculty development.
• Student resources for research, support for research experiences, and for post-bac and graduate career progression in biomedical research and in STEM topics
• Research staff recruitment and benefits packages, retention bonuses,
• Faculty teaching workloads that allow time for research pursuits, and department/college-based research staff and administrative support
• Institutional policies for assessment of teaching versus research assignments and support
• Tenure evaluations of faculty services for research, committee, community engagement, etc., protected time for research program development

Technical Assistance Webinar:

NIH will conduct a Technical Assistance Webinar for prospective applicants on July 21st from 2-3.30pm EST. Please join the webinar using the link below:

Join Zoom Meeting
https://nih.zoomgov.com/j/1614627302?pwd=RmVXc0RjWjV2WTZsUzd1WmFSWU1NZz09&from=addon

Meeting ID: 161 462 7302
Passcode: 919936
One tap mobile
+16692545252,,1614627302#,,,,*919936# US (San Jose)
+16468287666,,1614627302#,,,,*919936# US (New York)

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

For this funding opportunity, an applicant must be a Resource-Limited Institution (RLI), defined as an institution with a mission to serve historically underrepresented populations that awards degrees in the health professions (and related sciences) and has received an average of $0 to $25 million per year (total costs) of NIH Research Project Grants (RPG) support for the past three fiscal years.

A mission to serve historically underrepresented populations may be demonstrated by a documented historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation NSF, see http://www.nsf.gov/statistics/wmpd/) (i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities) or by a documented record of recruiting, training and/or educating, and graduating underrepresented students as defined by NSF (see above), which has resulted in increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers.

RLIs, as defined above, are classified into the following two categories for this opportunity:

1) Low Research Active (LRA): An RLI that is an undergraduate or graduate degree granting institution and has had less than six million dollars (total costs) in NIH research project grant (RPG) support per year in three of the last five years. In addition, undergraduate granting institutions must have at least 35% of undergraduate students supported by Pell grants.

2) High Research Active (HRA): An RLI that grants doctoral degrees and has had between six million and 25 million dollars (total costs) in NIH RPG support per year in three of the last five years.

Institutional letters will attest to the category of the institution whether they are LRA or HRA and provide information to verify which can be included as an attachment.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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.

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

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 SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only one application per institution (normally identified by having a unique UEI number or NIH IPF number) is allowed.

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 SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Travel costs for attending any in-person meetings and STRONG Executive Steering Committee (SESC) meetings must be included.

Funds may not be used for:

• Research infrastructure (such as laboratory supplies, laboratory equipment)
• Alterations or renovations
• Research projects or pilot projects

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

Significance

Explain the needs for institutional research capacity and importance of the problem or critical barrier to progress that the proposed project addresses. Describe the benefits if the proposed aims are achieved with respect to enhanced biomedical research capacity.

Innovation

Applicants should address the innovative aspects of the proposed needs assessment plans for research capacity. For this program, innovation is considered the use of existing products, tools or processes or creating or adapting evidence-based tools to fit the context and needs of the institutions.

Approach:

A. Institutional Needs-Assessment for research capacity section describe:

• Physical research facility, research faculty support from institution, faculty teaching workload, human resources, Sponsored program
• Applicant must describe current methods of measuring student/faculty outcomes to take into consideration institutional missions, faculty investment, student populations, student needs, and institutional resource constraints.
• Tools and instruments for needs assessment, monitoring and evaluation of health research capacity development activities at the individual and organizational level
• The types of research facilities available for biomedical research and research training.
• The needs for research infrastructure to conduct biomedical, behavioral or clinical research, potential and current scientific research areas of interest.
• List and describe the outcomes of any capacity-building or infrastructure grants the institution has received over the past ten years, including the source and total costs of each award.
• The investigative team and their relevant expertise in conducting a needs assessment
• Student enrollment in the biomedical areas, including the number and percentage of undergraduate and graduate students, and the enrollment of students who are Pell-grant eligible (for LRA applications); and
• The current level of student and faculty participation in research.
• Describe the sponsored programs administration and how it will inform the needs assessment. The types of services provided by the existing sponsored projects administration (or similar entity). Current levels of sponsored programs productivity (e.g., number of applications submitted, number of applications funded, number of subcontracts).

B. Development of Institutional Action Plans

Describe the approaches for developing an Institutional Action Plan after completing needs assessment for research capacity. The Institutional Action Plan for research capacity is intended to serve as a roadmap for enhancing the infrastructure and capacity at the applicant institution. This section of the application should describe steps that will be undertaken to ensure identified needs assessment activities lead to action plans for the long-term strengthening of research capacity. It must include an institutional commitment to achieving the goals and objectives of the proposed project and activities signed by institutional leadership (e.g., President, Provost, and Deans (see Letters of Support).

C. Governance and structure of steering committees

The Steering Committee (SC) will serve as the primary governing and oversight board for the cooperative agreement funded under this NOFO.

• Describe the composition and the activities of the steering committee. Describe the desired expertise of its members. Include the frequency of meetings and any other relevant information.
  
• The membership of the SC consists of the PD(s)/PI(s), the NIH Project Coordinator, and any additional stake holders deemed necessary.

Timeline and Milestones:

Describe the timeline for the needs assessment and action plan activities. The timeline should be realistic given the time needed to develop the approaches/tools and collect the proposed data. Describe how the program goals/aims will be aligned with milestones and metrics.

Letters of Support: Provide letters of support for the proposed needs assessment activities following instructions in the SF424 Application Guide.

A. Institutional Eligibility Letter (1-page maximum). Submit a letter from the Provost or similar official with institution-wide responsibility that certify that the applicant organization qualifies as one of the following two categories of research active RLI specified in this NOFO:

A mission to serve historically underrepresented populations may be demonstrated by a documented historical and current mission to educate students from underrepresented populations in biomedical research.

The two categories of research active RLIs are:

1) Low Research Active (LRA): An RLI that is an undergraduate or graduate degree granting institution, with at least 35% of undergraduate students supported by Pell grants, and that has had less than six million dollars in NIH research project grant (RPG) support per year in three of the last five years.

2) High Research Active (HRA): An RLI that grants doctoral degrees and has had less than 25 million dollars in NIH RPG support in three of the last five years.

B. Institutional Commitment Letter. The application must include an Institutional Commitment Letter from the President or designated high-ranking official such as the Provost, Vice President or Dean. Describe how the proposed project aligns with the broad institutional vision for enhancing biomedical research. The letter should include a commitment to achieving the goals and objectives of the proposed project and activities.

The letters of support must be included with the application. Applications which lack this letter will be considered incomplete and will be withdrawn and will not be reviewed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 SF424 (R&R) 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.

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 SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

Part I. Overview Information 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 Policy on Late Application Submission.

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 SF424 (R&R) 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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. See Section III of this NOFO for information on registration requirements.

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 SF424 (R&R) 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.

In order to expedite review, applicants are requested to notify the NIMHD Referral Office by email at [email protected]when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, 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. For example, a project that by its nature is not innovative may be essential to advance a field.

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.

As applicable for the project 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 NIMHD, in accordance with NIH peer review policy and procedures, 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 . 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographical distribution of the portfolio
• Balance between HRA and LRA awards

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 VI. Award Administration Information

1. Award Notices

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee 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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will continue as a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The individual STRONG-RLI recipients will establish steering committees at their institutions with defined roles.

In addition, the PIs of the STRONG-RLI awards and involved NIH staff, and others as needed (ex-officio), will form a STRONG-RLI Executive Steering Committee (SESC) which will oversee the activities of the STRONG-RLI program recipients. There will be a yearly rotating chair of the SESC who will be nominated and selected from the PIs of the awards.

The PDs/PIs will have the primary responsibility for:

• Plan, organize, coordinate, and administer the described activities of the program, including setting project milestones with specific timelines and criteria for Institutional needs assessment and developing action plans.
• Establish Steering Committee, organize, and coordinate SESC meetings
• Ensure compliance with the applicable mandatory NIH regulations and policies
• Participate in the STRONG SESC meetings is a requirement for the PI/PDs.The purpose of the meeting is to share progress, best practices, and address common challenges.
• Work closely with the NIH Program Official and Project Coordinator (see below) in project coordination and management.
• Establish a separate site specific steering committee that will comprise of PI, institute leadership and NIH staff
• Evaluate progress using defined milestones and metrics. Recipients will provide NIH with progress reports at regular intervals as requested.
• Share needs assessment and action plan with the NIH during the award period.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH Project Coordinator will:

Work closely with individual PIs and NIH program officials (POs) to facilitate collaborations.

• Interact with each recipient, help coordinate approaches, and contribute to the adjustment of projects/programs or approaches as warranted.
• Advise the recipient in performing project activities (e.g., coordination among RLI recipients for needs assessments; provide access to NIH supported resources; identify other resources for the project);
• Facilitate, not direct, activities.
• Participate on the Steering Committee (see below) or in other functions to help guide the course of the program (e.g., Annual Program Meeting and other Program related meetings).
• Ensure that the directions taken are consistent with the NIH missions and goals.

The Project Coordinator will not participate in the oversight of the funding opportunity announcement, application review, or programmatic and budgetary stewardship of the award.

The Program Official will be responsible for the normal programmatic stewardship of the award, including funding decisions, and will be named in the award notice. The Program Official will not serve as a voting member of the Steering Committee or partake of the duties of the Project Coordinator.

Areas of joint responsibility

The SECS is the governing and oversight body for the Program. Members, who are appointed by the PDs/PIs of the award, will be comprised of the following:

• The PI of each award will serve as the SESC member.
• NIH Project Coordinators.
• Additional members from the NIH may be appointed, but the total number of NIH votes may not exceed 1/3 of the Executive Steering Committee voting membership. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions.
• Each recipient must plan regular meetings (no less frequently than monthly) to discuss the progress and direction of its activities and to ensure that the necessary interactions are taking place. Recipients will be expected to participate in STRONG RLI program-wide meetings. These meetings may be in the form of phone teleconferencing, videoconferencing, and/or web conferencing, as well as face-to-face meetings. Unwillingness or a consistent inability of a PD/PI to attend may be the basis for administrative action including termination of the award.

The SESC will:

• Serve as the primary steering and oversight board for the awards funded under this NOFO.
• Decide on the schedule of regular and annual meetings. The Executive Steering Committee may also call meetings to address urgent needs and will participate in network meetings and teleconferences as needed.
• Contribute to the development of a cohesive and sustainable program.
• Provide advice on key issues such as needs assessment administration, approaches, and tools for research capacity, and opportunities for growth.
• Ensure that the implementation of the Institutional Needs Assessments and Development of Sustainable Action Plan is occurring on schedule and continues to align with the applicant institution's strategic vision for biomedical research and/or research training.
• Alert NIH to emerging needs and impediments.
• Prepare concise (1-2 page) summaries of the Executive Steering Committee recommendations, which will be delivered to the PDs/PIs and members of the group within 30 days after each meeting.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to dispute resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be a designee of the STRONG Executive Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

The NIH reserves the right to withhold funding or curtail the program (of an individual award) in accordance with NIH policy.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

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

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.

A final RPPR, invention statement, 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. 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Brett Miller, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9849
Email: [email protected]

Rina Das, PhD.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-3996
Email: [email protected]

Behrous Davani, PhD.
National Cancer Institute (NCI)
Telephone: 240-276-6170
Email: [email protected]

Olga Kovbasnjuk, Ph.D.
National Institutes of General Medical Sciences (NIGMS)
E-mail: [email protected]

Nadra Tyus, DrPH, MPH
National Institute of Nursing Research (NINR)
Email: [email protected]

Anissa F Brown, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-594-5006
E-mail: [email protected]

Melissa C. Green Parker, Ph.D.
Office of Disease Prevention (ODP)
Phone: 301-480-1161
E-mail: [email protected]

Erica K Rosemond
NCATS - NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
Phone: (301) 594-8927
E-mail: [email protected]

Kristy M. Nicks, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Tel: 301-594-5055
Email: [email protected]

Carol Shreffler, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-3322
E-mail: s[email protected]

Aria Crump
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-443-6504
E-mail: [email protected]

Diane Adger-Johnson, MPH
Office of Research Training and Special Programs (ORTSP)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-5945
Email: [email protected]

Damiya Eve Whitaker, PsyD, MA
ORWH - Office of Research on Women's Health
Phone: 301-451-8206
E-mail: [email protected]

Damali Martin, Ph.D., MPH
NATIONAL INSTITUTE ON AGING (NIA)
Division of Neuroscience (DN)
Phone: 301-402-8310
E-mail: [email protected]

Judith Cooper
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 496-5061
E-mail: [email protected]

Xinzhi Zhang, M.D.
National Heart, Lung, and Blood Institute
Phone: 301-435-6865
Email: [email protected]

Brittany Haynes, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-496-2767
Email: [email protected]

Beda Jean-Francois, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: [email protected]

Elizabeth Powell, PhD
National Institute on Alcoholism and Alcohol Abuse (NIAAA)
Telephone: 301-443-0786
Email: [email protected]

Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Alania Foster
NIGMS - NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
E-mail: [email protected]

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: [email protected]

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: [email protected]

Leslie Le
NCATS - NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
Phone: (301) 435-0856
E-mail: [email protected]

Jenny L Greer
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984.287.3332
E-mail: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Samuel Ashe
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-4799
Email: [email protected]

Jeni Smits
NATIONAL INSTITUTE ON AGING (NIA)
E-mail: [email protected]

Anthony Agresti
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-827-8014
E-mail: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

Debbie Chen, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

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

Section VIII. Other Information

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

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