Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

Funding Opportunity Title
John Lewis NIMHD Research Endowment Program (S21 Clinical Trial Not Allowed)
Activity Code

S21 Research and Institutional Resources Health Disparities Endowment Grants – Capacity Building

Announcement Type
Reissue of RFA-MD-17-004
Related Notices

NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

Funding Opportunity Announcement (FOA) Number
RFA-MD-22-010
Companion Funding Opportunity
None
Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.307
Funding Opportunity Purpose

The purpose of the John Lewis NIMHD Research Endowment Program is to strengthen the research infrastructure and training capacity at eligible institutions of higher education to facilitate minority health and health disparities research and enhance the diversity of the scientific workforce.

Key Dates

Posted Date
November 07, 2022
Open Date (Earliest Submission Date)
December 17, 2022
Letter of Intent Due Date(s)

December 17, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
January 17, 2023 January 17, 2023 Not Applicable March 2023 May 2023 July 2023

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

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

No late applications will be accepted for this Funding Opportunity Announcement.

Expiration Date
January 18, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

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.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The Minority Health and Health Disparities Research and Education Act of 2000 (Public Law 106-525) authorized the National Center on Minority Health and Health Disparities (NCMHD) Research Endowment Program to facilitate minority health and health disparities research through the creation of an endowment fund in institutions with Centers of Excellence funded by the Health Resources and Services Administration (HRSA) under sections 736 of the Public Health Service (PHS) Act. The initial awards were issued in Fiscal Year 2001. On March 23, 2010, the Patient Protection and Affordable Care Act (Public Law 111-148) re-designated NCMHD as NIMHD and expanded eligibility for research endowment grants to include institutions with Centers of Excellence funded by NIMHD under sections 464z-4 of the PHS Act. Recently, the John Lewis NIMHD Research Endowment Revitalization Act of 2021 (Public Law 117-104) expanded eligibility of this program to public/private institutions of higher education with current or former HRSA Centers of Excellence awards and current or former NIMHD Centers of Excellence awards. Regulations for this endowment program are set forth at 42 CFR Part 52i. Institutions eligible for these awards are uniquely positioned to engage populations that experience health disparities in research and in the translation of research advances into culturally competent interventions leading to measurable and sustained improvements in health outcomes. Due to his long-standing support for the NIMHD Research Endowment Program it has been re-named in honor of the late Congressman John Lewis.

NIMHD Interest In Diversity

Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. 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). This funding opportunity provides support for the enhancement of institutional endowments to facilitate the development of research capacity and research education of students from diverse backgrounds, including those from underrepresented groups, and faculty to pursue basic biomedical, behavioral, population, and/or clinical/health services research, including but not limited to research related to minority health and health disparities.

Program Objectives

The purpose of the John Lewis NIMHD Research Endowment Program is to strengthen the research infrastructure and training capacity at eligible institutions of higher education to facilitate minority health and health disparities research and enhance the diversity of the scientific workforce. Specific strategic objectives include: 1) improving the institutional physical infrastructure and research equipment acquisition; 2) developing research-enabling technical expertise; 3) expansion of academic programs; and 4) recruitment of individuals from groups underrepresented in the scientific workforce as potential candidates for open faculty positions. The John Lewis NIMHD Research Endowment Program does not directly support research projects.

Specific Areas of Interest

Specific activities may be designed to include, but are not limited to:

  • Enhancement of facilities through minor renovations and alterations, acquisition of instruments and equipment, or administrative research stewardship
  • Development of resources such as faculty-level expertise in research methodology, study design, specialized laboratory techniques, biostatistics, data science, health informatics, research ethics, and/or community-engaged research methods.
  • Enhancements to the academic environment through the creation of challenging courses or programs in such topics as research methodology, grant writing course, and health disparities science as additions to the curriculum
  • Structured engagement of scientists with communities that fosters participation in minority health and health disparities research
  • Implementation of institutional efforts to support individuals from diverse backgrounds, including those from groups underrepresented in the scientific workforce
  • Recruitment and career development of established scientific faculty with exceptional expertise in the clinical, behavioral, social, and population sciences or facilitate the recruitment of new scientists in these disciplines.

Applications Not Responsive to the FOA:

  • Applications from institutions without a current or former NIMHD or HRSA Center of Excellence award.
  • Applications from institutions with endowments above the statutory limits.
  • Applications without a 5-year NIMHD Research Endowment Strategic Plan.

Non-responsive applications will not be referred for peer reviewed.

Technical Assistance Webinar

A technical assistance webinar for prospective applicants will be held by NIMHD staff members involved in this FOA. The webinar will provide orientation and technical assistance to potential applicants by explaining the goals and objectives of the John Lewis NIMHD Research Endowment Program and answering questions from attendees. Date and time of the webinar will be posted on the NIMHD website at www.nimhd.nih.gov. Prospective applicants are encouraged to send questions, preferably at least 24 hours prior to the webinar, to the Scientific/Research Contact.

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIMHD intends to commit $12,000,000 in FY 2023 to fund six awards.

Award Budget

Application institutions may request up to $2,000,000 in direct costs annually. Indirect costs may not be requested.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

Applicants may receive a warning, which can be ignored, if the project period is 4 or 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

Pursuant to Public Health Service Act section 464z-3(h), 42 USC 285t(h), as amended by Public Law 117-104, applicants for this program may include eligible public/private institutions of higher education that have current or former HRSA Centers of Excellence awards under Section 736 of the Public Health Service (PHS) Act and current or former NIMHD Centers of Excellence awards under Section 464z-4 of the PHS Act. (see the list of institutions with current or former HRSA Centers of Excellence and NIMHD Centers of Excellence on the NIMHD website). Eligible institutions must have an endowment that is equal to or less than 50 percent of the national median of endowment funds at institutions that conduct similar biomedical research and training of health professionals (see additional information below).

Foreign Institutions

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. 

Required Registrations

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 full SAM and 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her 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.

The contact PD/PI should be a senior administrative official such as the President, Chancellor, Academic Vice President, or Dean of the applicant institution.  

2. Cost Sharing

This FOA 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 number 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).

Institutional Endowment Assets

Pursuant to Public Health Service Act section 464z-3(h), 42 USC 285t(h), the institutional endowment must be less than/or equal to one-half of the national median of endowment funds at institutions that conduct similar biomedical research or training of health professionals. "Institutional endowment" refers to corporate or system-wide endowment fund that is the sum total of the endowment assets of all campuses and their components. This includes, but is not limited to, endowments managed by an institution’s foundations/associations as well as state university systems. For the purpose of determining the endowment threshold for eligibility under this FOA, the endowment assets of institutions categorized as Doctorate-Granting Universities and Special Focus Institutions (Health Professionals, Medical Schools and Centers, or Other Health Professional Schools) by the Carnegie Classification of Institutions of Higher Learning were assessed. The data for this assessment were taken from the results of the National Association of College and University Business Officials (NACUBO) and TIAA 2021 Study of Endowments (2021 NACUBO-TIAA Public Tables). The NACUBO-TIAA Study of Endowments is widely recognized as the industry standard for tracking the performance and management of college and university endowment assets.

Based on the NIMHD analysis, the estimated median value of corporate endowment assets of $603,010,000 will be considered the “national median;” and $301,505,000 is fifty percent of that amount. Therefore, institutions with corporate or system-wide endowments that exceed $301,505,000 may not apply for an endowment grant award under this FOA.

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 FOA. 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 funding opportunity announcement 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: liuyujin@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following additional instructions:

  • For this specific FOA, the Research Strategy section is limited to 12 pages.

Instructions for Application Submission

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

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, with the following additional instructions:

Are Human Subjects Involved: Answer to human subject involvement must be "NO".

Other Attachments: Two Other Attachments are required and must be submitted as separate files:

  • Institutional Corporate Endowment Assets. A certified or notarized letter/report from an independent audit with original signatures must state the dollar amount of the applicant’s institutional corporate endowment assets. This document must include a statement reflecting the dollar amount of all endowment funds of the corporate institution that are managed by the applicant institution, private non-profit foundations and/or public entities established by or for the benefit of the institution.
  • Investment Policy Statement. An investment plan for the proposed endowment corpus must indicate long-term and short-term investment goals and expected rate of return. The investment plan should be balanced and take into consideration the volatility of markets. Given the high significance placed on retaining the market value of the endowment corpus, at a minimum, care should be taken to develop an investment and spending plan to ensure that the market value of the corpus is not invaded. In addition, the plan should address strategic steps to be implemented in a challenging investment environment. Institutions with limited experience in establishing and managing endowment funds are encouraged to consult with institutions and/or other entities that have expertise in establishing and managing such funds. It is permissible to pool the NIMHD endowment awards with other endowment assets held by the institution for investment purposes. In these cases, the proportionate income (or units) of the NIMHD endowment corpus should be separately accounted for and used only for the purposes specified within this FOA. Additions to the fund from any successive NIHMD endowment award should be administered in accordance with this practice.

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:

This FOA calls for the budget to be itemized in multiple sections. Each budget section addresses a specific aspect of the grant. With regard to the initial budget period, spell out and justify the actual budget request (which is the same as the requested endowment corpus). The direct costs requested for each year of the project period should reflect only the endowment corpus – not projected income. These yearly requested direct costs are entered under the appropriate year on F. Other Direct Cost, Line 8. Indirect costs are not allowed.

This budget justification should specify how projected endowment income, at a given level, will be spent to support programmatic activities and achieve program objectives. The budget justification should relate project expenses to grant objectives and describe what objectives and program purposes are being supported by the grant and/or the institution and to what extent.

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: Applicants must describe a 5-Year NIMHD Research Endowment Strategic Plan that establishes priorities for the use and growth of endowment fund income. Any endowment income realized in the initial year following the grant award shall not be expended to support programmatic activities until after conclusion of the initial year of the grant (42 CFR 52i.9(a)). Note: Since the John Lewis NIMHD Research Endowment Program is designed to strengthen the overall research and training infrastructure of an institution, endowment fund income cannot be used to directly fund research projects of any type. The required elements of the Plan are:

  • The institution’s Mission Statement for the Plan.
  • An Overview of the institution’s strategy for building research infrastructure and capacity to facilitate minority health and health disparities research and enhance the diversity of the scientific research workforce.
  • The Area(s) of Emphasis in priority order addressed by the Plan.
  • The Rationale that explains the need, scientific opportunity, and /or the institution’s reason for pursuing the area(s) of emphasis. This should include an explanation as to how the plan will contribute to improving minority health and health disparities research activities and enhance the diversity of the scientific research workforce .
  • Clearly identified Objectives related to the area(s) of emphasis, with an indication of relative priority. Include an estimate of total dollars needed to achieve each objective for each of the five years of the Plan
  • An Action Plan that consists of:

(1) A description of the concrete activities that will enhance and expand the institutional research capacity in minority health and/or health disparities and enhance the diversity of the scientific research workforce your institution will take to achieve each objective. For example, these may include research training opportunities for students, post-doctoral trainees and assistant professors working with established investigators, enhancement of research methods training in the academic curriculum, and/or recruitment/retention of accomplished scientists in the fields of behavioral, social sciences, population sciences, and clinical research;

(2) A timeline for achieving key targets of the objective; and

(3) An estimated date by which the objective is expected to be accomplished.

  • A description of Performance Measures (process and outcome) that will be utilized to demonstrate the accomplishments of each objective.
  • Projected Impact of the endowment income including explanation of the institution’s commitment to the programmatic aspects of the proposed endowment fund program contained in the Plan.

For Renewal applicants, provide a Progress Report on previous NIMHD Research Endowment funding. Please provide details on the ability to manage the endowment corpus and generate income yearly and a description of the outcomes of the programs and activities supported by the generated endowment income.

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.

Appendix:

Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) 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 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 FOA 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 and responsiveness by NIMHD. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to 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).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:To what extent will the 5-Year NIMHD Research Endowment Strategic Plan enhance and expand institutional resources to facilitate capacity in minority health/health disparities research and/or enhance the diversity of the scientific workforce?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Will the activities identified in the 5-year NIMHD Research Endowment Strategic Plan enhance and expand the institutional research capacity in minority health and/or health disparities research (e.g., research training opportunities, improvements in the physical plant, equipment acquisition, enhancement of academic curriculum, and/or recruitment/retention of accomplished scientists in the fields of biomedical, behavioral, and social sciences research)?

Is the proposed management of the endowment fund and effectiveness of investment strategy appropriate to achieve appropriate growth potential while taking into consideration the potential for volatility of the markets?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

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

 

Not applicable.

 

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

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

 

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

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

Not applicable.

 

For Renewals, the committee will consider the progress made in the last funding period.

 

Not applicable.

Additional Review Considerations

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.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Not applicable.

 

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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.

For purposes of this FOA, all applications filed in accordance with the instructions and meeting the minimal eligibility requirements shall be evaluated and recommended by technical and scientific peer review. The review evaluation shall take into account, among other pertinent factors: (a) the scientific and technical merit of the proposed project to facilitate minority health disparities research and other health disparities research; (b) the likelihood of its producing meaningful results; (c) the adequacy of the applicant’s resources available for the project; and (d) the adequacy of the applicant’s plan for managing the endowment fund.

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Minority Health and Health Disparities.

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.

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

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: Generaland 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:

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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 FOA.

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.

NIMHD Research Endowment awards are made to the existing institutional endowment fund to support institutional resources and research capacity building and are subject to program regulations set forth at 42 CFR Part 52i. Endowment income, which may be expended each year after the first year of award, is to be determined pursuant to spending rules under the law of the State in which the institution is located, subject to the special limitation on expenditures during the first year following the Notice of Award letter, which is set forth below. To ensure maximum growth of the endowment fund, the following guidelines govern how an NIMHD Research Endowment is to be implemented. The following Terms and Conditions will be incorporated into the Notice of Award letter:

  • Direct costs of this award are restricted. The endowment corpus may not be expended for any reason during the period of award and must be maintained for a total of 20 years from the end of the project period pursuant to 42 CFR 52i.8.
  • Funds to be utilized will be the income and capital appreciation distributable under the institution’s spending rule as a result of the investment of the endowment corpus as proposed in the grantee’s 5-year NIMHD Research Endowment Strategic Plan that is part of the application and that establishes priorities for the use of the endowment fund. Income and capital appreciation earned must be reported as Program Income in accordance with the NIH Grants Policy Statement guidelines.
  • Funds must be invested, according to the Investment Policy Statement and the 5-year NIMHD Research Endowment Strategic Plan included in the grantee’s application, no later than 90 days after the start date of the endowment grant.
  • Any income and capital appreciation realized in the initial year of the award is not to be expended to support programmatic activities until it has accrued for one full year from the budget period start date listed on the initial Notice of Award. For each year of funding during its project period, programmatic activities may be supported, in general, by part of the income and capital appreciation earned on the previous year’s investment as determined under the institutional spending rule. For instance, if an institution receives an award of $2 million per year, for five consecutive years, no programmatic activities can receive support from the endowment income and capital appreciation until Year 2. Year 2 programs would be supported by distributions of the income and capital appreciation earned on the initially invested $2 million under the institution’s spending rule. Programmatic activities in subsequent years could be similarly supported by income and capital appreciation earned on the endowment corpus.
  • In the case of situations in which investment conditions result in the endowment corpus having a net market value less than the value of the funds at the time of their receipt, action should be taken in order to preserve the endowment corpus.
  • Prior written approval is required from NIMHD for any deviations from the 5-year strategic plan submitted in the competing application.
  • For renewal awards, the endowment amount for the new project period is added to the previous accumulated endowment corpus and only a single continuation progress report that encompasses all activities is submitted.
Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. 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.

Prior written approval from the NIMHD is required for any deviation from the 5-year NIMHD Research Endowment Strategic Plan as submitted in the competing application. In addition to the standard reports required of all grantees, research endowment grantees need to provide specific information related to the type and amount of investments of the fund, the amount of fund income (including the 12-month income since the last reporting period for all prior years awarded) and the amount and purpose of expenditures of fund income.

Due to the unique nature of the endowment program, 20 years of annual progress reporting is required after the end of the project period. The entire endowment fund corpus must be maintained and not spent for twenty years after the grant’s project period end date. After the end of the twenty-year period, while the grantee institution is encouraged to preserve the corpus, the institution may use the endowment fund corpus for any purpose that expands or develops the institution’s minority health and/or health disparities research capacity.

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 FOAs 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.

Application Submission Contacts

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

Nancy L. Jones, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
nancy.jones@nih.gov

Peer Review Contact(s)

Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: liuyujin@mail.nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.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.

Authority and Regulations

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.

Additional authories are Section 464z-3(h) of the Public Health Service Act as amended (42 USC 285t(h)) and under Federal Regulations 42 CFR Part 52i.

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