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
Limited Competition: Research Centers in Minority Institutions (RCMI) Coordinating Center (U24 - Clinical Trial Optional)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Reissue of RFA-MD-20-007
Related Notices
  • April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
  • August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-MD-24-011
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

NIMHD invites applications from eligible institutions to establish a national coordinating center (CC) for NIMHD-funded Research Centers in Minority Institutions (RCMIs). The RCMI CC will work closely with key personnel at all RCMI Specialized Centers and with NIMHD staff to help the centers collectively achieve their primary goals to: (1) enhance institutional research capacity to conduct world-class basic biomedical, behavioral, population, and/or clinical patient-centered or health services research; (2) enable all levels of investigators at recipient institutions to become more successful in obtaining competitive extramural support, especially from NIH, for research on diseases and conditions that disproportionately impact populations that experience health disparities; (3) foster institutional environments conducive to research career development and enhancement for post-doctoral fellows, junior faculty members, and other early-stage investigators; (4) enhance the tools for and conduct of research generally and specifically for improving minority health and reducing health disparities; and (5) establish sustainable partnerships with community-based organizations to promote research efforts and the dissemination of research findings that partner with RCMI centers, and (6) centralize and harmonize study operations, coordinate data management, provide biostatistical support to facilitate rapid development and implementation of minority health and health disparity studies conducted in the RCMI-CRNHE (Clinical Research Network for Health Equity) (see RFA-MD-22-006), and also manage a Network Steering Committee. The RCMI CC will be responsive to requests generated by RCMI site key personnel, NIMHD, NIH, the scientific community, and the general public. Eligible applicant institutions for this NOFO are limited to recipients of RCMI awards through RFA-MD-17-003RFA-MD-17-006RFA-MD-18-012RFA-MD-20-006PAR-11-132RFA-MD-22-002RFA-MD-23-001, or RFA-MD-24-001.

Key Dates

Posted Date
December 09, 2024
Open Date (Earliest Submission Date)
December 25, 2024
Letter of Intent Due Date(s)

December 25, 2024

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
January 25, 2025 * January 25, 2025 * Not Applicable July 2025 October 2025 December 2025

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

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

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

Expiration Date
January 26, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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. Notice of Funding Opportunity Description

 Background

The NIH established the Research Centers in Minority Institutions (RCMI) program in 1985 in response to Congressional interest in expanding the national capacity for research in the health sciences by providing support to eligible institutions that offer doctorate degrees in the health professions or health-related sciences and have a documented historical mission or historical commitment to educating underrepresented students and, for institutions that deliver health care services, have a record of providing clinical services to medically underserved communities. NIMHD recognizes the important role such institutions play in supporting scientific research and providing health care in underserved communities. These institutions are uniquely positioned to engage minority populations and other U.S. populations that experience health disparities in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes.

NIMHD Interest in the RCMI Program

The NIMHD's mission is to conduct and support research, training, health information dissemination, and other programs with respect to minority health and health disparities. This funding opportunity seeks to support an eligible institution to establish a national coordinating center that will work closely with key personnel at all RCMI Specialized Centers and with NIMHD staff to help facilitate enhancement of research capacity and faculty development in RCMI institutions to pursue basic biomedical, behavioral, and/or clinical research (patient-oriented research and health services research), particularly on diseases and/or conditions that disproportionately impact racial and ethnic  minority populations and other populations that experience health disparities.

Programmatic Objectives

The RCMI Coordinating Center (CC) will serve as a national resource to help RCMI U54 centers achieve their primary goals to: : (1) enhance institutional research capacity to conduct world-class basic biomedical, behavioral, population and/or clinical patient-centered or health services research; (2) enable all levels of investigators at recipient institutions to become more successful in obtaining competitive extramural support, especially from NIH, for research on diseases and conditions that disproportionately impact populations that experience health disparities; (3) foster institutional environments conducive to research career development and enhancement for post-doctoral fellows, junior faculty members, and other early-stage investigators; (4) enhance the tools for and conduct of research generally and specifically for improving minority health and reducing health disparities; (5) establish sustainable partnerships with community-based organizations to promote research efforts and the dissemination of research findings; and (6) centralize and harmonize study operations, coordinate data management, provide biostatistical support to facilitate rapid development and implementation of minority health and health disparity studies conducted in the RCMI-CRNHE (Clinical Research Network for Health Equity) (see RFA-MD-22-006), and also manage a Network Steering Committee. The RCMI CC will collectively advance the science of minority health and health disparities through intellectual exchange and collaborative interactions that enhance research capacity and competitiveness at participating institutions.

As mentioned in the Notice of Funding Opportunity focused on Research Centers in Minority Institutions (RCMI) (see RFA-MD-24-012), the three types of proposed research focus areas under the RCMI program are defined as follows:

  1. Basic Biomedical Research: Systematic study directed toward greater knowledge or understanding of the fundamental biological processes and mechanisms, without a specific application or product in mind, essentially focusing on the core principles underlying living organisms, laying the foundation for future advancements in disease diagnosis, treatment, and prevention. This type of research could include cell, animal or human or secondary data-based research focused on fundamental science.
  2. Behavioral or Social Science or Population Science Research that could include epidemiological or community-engaged, or population research. Behavioral and social sciences research involves the systematic study of understanding and/or modifying behavioral or social phenomena relevant to health. Basic behavioral research involving psychological processes (e.g., emotion, judgment, decision-making, bias) to help predict, prevent, and manage illness through observational, mechanistic or intervention studies. Research to develop and evaluate interventions delivered in community settings to improve the health of individuals, families, communities, and populations. Population and epidemiological science research include analyses of existing databases that leverage de-identified data from populations such as the National Health Interview Survey, claims data from Medicare or other health insurance providers, or data from health-related factors such as air pollution and the built environment.
  3. Clinical Research: Research with human participants that is:
    1. Patient-oriented research. Research conducted with human participants (or on material of human origin, such as tissues, specimens, and cognitive phenomena) for which an investigator directly interacts with the patients and includes ascertainment of clinical outcomes. Excluded from this definition are in vitro studies that use human tissues (or other biospecimens or human pathogens) that cannot be linked to a living person, or studies in which the interaction with patients or persons is for the sole purpose of obtaining any biospecimens. Patient-oriented research includes (i) mechanisms of human disease (for example, mechanistic trials), (ii) therapeutic interventions, (iii) clinical trials, or (iv) development of new technologies. Behavioral research in a clinical setting is included.
    2. Outcomes research and/or health services research.

Note: Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research under this definition. Therefore, studies involving deidentified human health data are not considered clinical research. 

Evaluation of the RCMI Consortium

  • The RCMI CC will conduct prospective evaluation of the overall RCMI program and coordinate establishment of common metrics to measure effectiveness of the Program, collection, analysis of data from the awarded RCMI centers and generating regular reports. Supporting information exchange, sharing of scientific expertise and best practices, leveraging of research resources, and scientific dissemination across RCMI sites are considered essential to the success of the RCMI CC program. The RCMI CC will monitor the extent to which investigator development activities at the RCMI U54 sites, including but not limited to pilot project programs, lead to impactful scientific publications and to extramural research grant awards from NIH and other sources to RCMI investigators. It will also monitor the extent to which community engagement activities at RCMI U54 sites foster sustainable relationships with community-based organizations, enhance participation of minority populations as human subjects in clinical trials, and promote dissemination of research findings to communities to address their health-related concerns. In addition, the RCMI-CC will work with RCMI U54 centers to develop common outcomes and performance metrics for project evaluation in each of the four key domains noted above that can provide information for RCMI national program evaluation. It will also maintain a centralized database through which RCMI sites and NIMHD can track recruitment and retention of participating investigators, including investigators from underrepresented groups (see, NOT-OD-20-031) and their career trajectories, along with outcomes of RCMI-supported projects such as peer-reviewed publications and grant awards supporting RCMI investigators. These data should be collected and maintained in standardized, structured formats that are easily analyzable and shareable to better evaluate the progress and successes of the RCMI program. The RCMI CC will use this information to prepare annual reports for NIMHD highlighting significant program developments by individual RCMI U54 centers and collectively across the RCMI program.

Investigator Development

The RCMI CC is expected to help RCMI investigators take advantage of research and career development opportunities and address research needs as they arise in priority areas of basic biomedical, behavioral and clinical sciences. This can include professional development and mentoring promoting submission of applications by organizations supporting RCMI investigators to relevant NIH funding opportunity announcements, as well as to ongoing NIH programs to support the development of early-career scientists, such as Research Supplements to Promote Diversity in Health-Related Research and mentored career development awards (K01, K08, K23, and K99) and research educational programs like the NIMHD Health Disparities Research Institute and other NIH-supported opportunities.

Capacity Building

The RCMI CC will also assist efforts to build capacity in RCMI U54 centers to not only engage communities in research as partners and participants but also to effectively communicate and disseminate their research findings that advance scientific knowledge at all levels to their communities. Specific discoveries that are useful to the community and have the potential to benefit health and well-being at the neighborhood, community and population levels can be promoted.

RCMI-CC Core Activities

RCMI CC activities are expected to align with and support the objectives of the RCMI U54 centers in four key domains: (1) project administration and coordination among sites, (2) research resources to support scientific projects, (3) early-stage investigator development and mentoring, and (4) community engagement. Toward that end, the RCMI CC must have the following essential functions:

  • Organize and convene an annual grantees meeting bringing together RCMI U54 PDs/PIs and other senior scientists from each site, research project leaders, pilot project awardees, key community partners, and NIH staff to exchange information and discuss opportunities for collaboration and strategies for solving shared challenges in each of the four key domains noted above.
  • Organize and convene monthly conference video calls with the U54 principal investigators to discuss strategies, directions, and future directions of the Consortium.
  • Support a Clinical Research Pilot Project Program that provides opportunities for post-doctoral fellows, early career faculty, or other early stage investigators as defined by NIH (see https://grants.nih.gov/policy/early-investigators/index.htm#definition), including outreach efforts to recruit prospective investigator participants from groups underrepresented in the biomedical research workforce (see Notice of NIH’s Interest in Diversity) to consider applying for available opportunities. Scholars should be recruited from the RCMI institutions, from affiliated institutions, and from community-based researchers and organizations. Pilot projects are each expected to range from $100,000 to $150,000 direct costs per year for project periods of one to two years, with two new pilot projects supported each year across the RCMI Consortium that can be in the areas of biomedical, behavioral, and/or clinical research (patient-oriented research and health services research).
  • Serve as a resource for connecting RCMI U54 sites and investigators to a broader spectrum of scientists and community partners to promote research collaborations and the development and adoption of best practices to improve minority health and address health disparities. The RCMI CC will foster linkages with other NIH programs such as NIMHD Centers of Excellence on Minority Health and Health Disparities; NIMHD Multiple Chronic Disease Research Centers; NIMHD-NIEHS Environmental Disparities Centers; the NIMHD-NHLBI Community Engagement Alliance (CEAL); NCATS Clinical and Translational Science Awards (CTSA); NIGMS Institutional Development Award (IDeA) program centers and networks; NIA Resource Centers for Minority Aging Research (RCMAR), Alzheimer's Disease Research Centers, and the NIA Research Center Collaborative Network; NIAID Centers for AIDS Research (CFAR); NIDDK Network of Minority Health Research Investigators (NMRI); NHLBI minority cohort studies (e.g., Jackson Heart Study, Hispanic Community Health Study[HCHS]/Study of Latinos [SOL], Multi-Ethnic Study of Atherosclerosis [MESA], STRONG Heart Study); NCI Comprehensive Cancer Centers; NCI U54 Partnership Grants; the Adolescent Brain Cognitive Development (ABCD) Study; the NIDA Native Collective Research Effort to Enhance Wellness (N CREW) Program, the NHGRI Diversity Centers for Genome Research, the All of Us Research Program, and others.
  • Facilitate collaboration and resource sharing between the RCMI Centers, other academic institutions, community-based organizations, federal agencies or programs, and industry partners who are engaged in research, training and educational activities focused on reducing disparities and improving the health status of minority populations.
  • Establish standardized master clinical trial agreements and other agreements with the RCMI network study sites and develop and implement a plan to reduce the start-up time of each network project using these standardized agreements as well as help to resolve any issues associated with these agreements.
  • Develop standard operating procedures (SOPs) or best practices in the settings of research projects that are carried out across two or more RCMIs.
  • Expand the size and scope of the annual RCMI scientific meeting that is annually organized by the RCMI CC to include all RCMI initiatives and partners.
  • Facilitate research collaboration across RCMI sites through periodic web-based and face-to-face meetings inclusive of the three broad RCMI program research themes of basic biomedical research, behavioral and social science, and clinical/health services research, as well as cross-cutting themes and specific scientific topics of shared interest.
  • Convene periodic meetings of RCMI U54 core directors and staff to discuss administrative issues, core facility management, opportunities for sharing access to specialized equipment and other technical resources, mentoring strategies and resources, best practices for community engagement, and program evaluation.
  • Facilitate broad access to research mentors and other resources, including the NIH-funded National Research Mentoring Network, that can enhance career development, particularly for early-stage RCMI investigators and more-established RCMI investigators seeking to expand their skill sets.
  • Provide methodological consultation to RCMI investigators on study design, regulatory compliance, biostatistics, bioinformatics and computational biology, data science, data management and analysis including but not limited to analysis of multi-omic datasets and other high-dimensional data, geographic information systems, health economics, or other technical areas.
  • Facilitate RCMI collaborations with other academic institutions, community-based organizations, federal/state/local agencies or programs, and industry partners engaged in research, training and educational activities focused on reducing health disparities and improving the health of underserved populations.
  • Coordinate and enhance communication, marketing and outreach of RCMI activities and research findings nationwide through a public website, newsletters, and social media. The RCMI CC will maintain an active RCMI program website with links to each RCMI U54 site and the NIMHD. The website will serve as the source of information dissemination to scientific and lay audiences and will be accessible and readily identifiable.

Additional activities may be proposed to promote collaboration among RCMI U54 sites, contribute to the professional development of RCMI investigators, encourage interactions between the RCMI program and other NIMHD- and NIH-supported resources, and enhance the value, visibility and scientific impact of the RCMI program. Examples include but are not limited to:

  • Providing visiting scientist opportunities across RCMI U54 centers for pilot project recipients to foster collaboration and career development, and for senior investigators to promote mentorship and scientific exchange. 
  • Assist in coordinating submission of peer-reviewed manuscripts by RCMI investigators for publication in thematic special issues of scholarly journals, with the RCMI-CC organizing one special issue per year for RCMI-led research.
  • Fostering new or existing partnerships with local, county, or state health departments and small, for-profit businesses to address community health concerns.
  • Assist efforts of RCMI U54 centers to assess or characterize improvements, relative to established baselines, in health-related knowledge and health outcomes at the community/neighborhood and higher levels resulting from dissemination of research advances.
  • Increased access to research mentors and other available resources, such as expert consultation on study design and other technical areas, that can enhance the competitiveness and career development of early-stage RCMI investigators.
  • Enhanced or expanded partnerships with community-based organizations and members of underserved communities to increase participation of minority populations as human subjects in clinical trials and promote effective dissemination of research findings to address community partners’ health-related concerns.
  • Increased dissemination and promotion of RCMI program activities, research resources, and research advances nationwide to increase the visibility and scientific impact of RCMI institutions and investigators.

In terms of coordination of the RCMI-CRNHE, the RCMI CC is expected to perform the following activities:

  • Facilitate coordination of research activities including support for the RCMI- CRNHE Steering Committee and workgroups established for specific areas of collaborative research within the RCMI- CRNHE.
  • Assist the RCMI- CRNHE in the identification of network personnel and clinicians who will participate on the study teams as key contributors to study development and implementation, as needed.
  • Work collaboratively in the development of manual of operations and standardized protocols for data/biospecimen collection from study participants (including consent forms and IRB approvals), especially for studies performed across the RCMI- CRNHE sites.
  • Work collaboratively with each RCMI- CRNHE to help implement the proposed projects while providing technical, design, quality control and assurance, and coordination support.
  • Maintain a data management system needed for study data collection, including image capture and multiple types of data relevant to individual studies, as needed and with guidance from NIMHD.
  • Collaborate with the RCMI- CRNHE in the development and standardization of protocols for the definition and collection of CDEs whether involving direct data/biospecimen collection from study participants and/or data extraction from electronic health records for demographics, social determinants of health (ideally aligned with those listed in the PhenX toolkit), behavioral and clinical outcomes, and other variables of interest as agreed and recommended by the RCMI- CRNHE research teams.
  • Provide biostatistical support to RCMI- CRNHE research teams for study design, implementation (including but not limited to randomization) and analyses, as needed.
  • Provide subject matter expertise advice regarding the establishment and maintenance of the research infrastructure at every RCMI- CRNHE site, including electronic health data harmonization, creation of data dictionaries, and data science expertise, and other related expertise, as needed.
  • Coordinate common data sharing plans among the RCMI- CRNHE sites.
  • Maintain a secure infrastructure for storing and providing access to study-related documents and materials, including IRB communication and data that might include identifiable for the use of such materials and for providing a secure means for approved users to access those materials.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal

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

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIMHD intends to commit $5 million in FY 2025 to fund one award.

Award Budget

Application budgets cannot exceed $3,500,000 annually in direct costs.

Award Project Period

The proposed project period cannot exceed five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

To be eligible for this FOA, the applicant institution must be a domestic institution located in the United States and its territories which:

  • Has received an average of less than $50 million per year of NIH support for the past three fiscal years;
  • Awards doctorate degrees in the health professions or the sciences related to health; and
  • Has a documented historical 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 (1) has a documented historical commitment to educating and/or training underrepresented students as defined by NSF (see above) who pursue biomedical research careers and, (2) for institutions that deliver health care services, has a record of providing clinical services to medically underserved communities.

Eligible applicant institutions for this FOA are limited to recipients of RCMI awards through RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, PAR-11-132, RFA-MD-20-006, RFA-MD-22-002, RFA-MD-23-001, or RFA-MD-24-001.

Foreign Organizations

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

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

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from 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, and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions 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 How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The PD/PI of the RCMI CC must be the lead Director of the CC and is the person responsible for the overall management of the CC; if there are multiple PDs/PIs of the CC, the MPIs will serve as co-Directors. The relationship between the RCMI CC and the RCMI U54 centers should be one of equal and substantial partners in all joint activities.

The RCMI CC team is expected to have significant experience and knowledge in (1) priority areas of basic biomedical research, behavioral and social sciences, and clinical research, including research on minority health and health disparities; (2) in program management, evaluation and coordination; and (3) in support of activities to promote diversity, equity, inclusion, and accessibility in the scientific research workforce.

R&R Budget

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

The RCMI CC will be responsible for organizing and attending annual face-to-face meetings meant to facilitate coordination among RCMI U54 centers and any subcommittees in which they participate. The RCMI CC application budget should include funds for organizing the annual meeting and for travel of the RCMI CC PD(s)/PI(s) and other key personnel to the meeting. The RCMI CC is not responsible for the travel of participants from individual RCMI U54 sites.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

Describe how the RCMI CC will work in close collaboration with approximately 22 RCMI U54 centers to facilitate and coordinate RCMI program activities nationally. Include plans for fostering communication and collaborative research arrangements between the U54 centers, such as through arranging and hosting monthly PD/PI conference calls as well as similar calls and support for the various U54 Cores as needed, as well as providing logistical support to the U54 centers and NIMHD staff to arrange a yearly RCMI grantee meeting. Include plans and mechanisms for maintaining active involvement of all U54 sites in all aspects of the program.

Describe plans and mechanisms for providing methodological consultation to RCMI investigators on study design, regulatory compliance, biostatistics and other technical areas to augment expertise and research resources at individual U54 sites.

Describe plans for developing and maintaining a secure database to collect information from RCMI U54 centers on scientific advances from full research projects and pilot projects, as well as career development of pilot award recipients. Include plans for working with U54 centers to develop, adapt or use existing common structured data elements and performance metrics to assess progress on achieving programmatic objectives and evaluation of the overall RCMI program. Describe plans for conducting yearly evaluation, analysis and reporting the data to NIMHD.

Describe how the RCMI CC will support RCMI activities aimed at diversifying the scientific workforce in basic biomedical research, behavioral and social sciences, and clinical research. While the RCMI CC and U54 centers may not select, hire, or determine eligibility for training or mentoring programs based on an investigator’s race, ethnicity or sex (including gender identity, sexual orientation, or transgender status), as part of the research strategy description, i.nclude plans and mechanisms to facilitate broad access to research mentors and other resources that can enhance the competitiveness and career development of early stage investigators. Highlight how the relevant expertise of the RCMI CC team will support these activities.

Describe plans to assist community engagement efforts at RCMI U54 sites to (1) develop/maintain strong working relationships with community partners, (2) increase participation of minority populations as human subjects in clinical trials, and (3) promote timely dissemination of research findings to communities to help address their health-related concerns.

Describe how the RCMI CC will function to serve as the RCMI program’s point-of-contact for linking the U54 centers with other NIMHD-funded centers, other major NIH extramural programs, and the broader scientific community to promote collaborations in priority areas of basic biomedical research, behavioral and social sciences, and clinical research, especially in topics related to minority health and health disparities.

Describe plans and mechanisms for informing and making visible scientific advances of RCMI investigators and affiliated scientists to the broader research community, policymakers, and other relevant stakeholders. Include plans for maintaining an up-to-date RCMI website with links to each RCMI U54 site and the NIMHD.

Describe the organizational plan and management structure for providing leadership and administrative support for RCMI CC activities and interactions with the U54 centers and NIMHD. Delineate the roles and responsibilities among key personnel atparticipating organizations. Include plans for ensuring accountability for achieving program objectives. Describe how the Steering Committee and any other advisory group(s) will be used to ensure successful completion of the stated aims. Applicants should avoid naming potential members of an advisory group, unless such persons have been consulted or contacted.

Describe the plans of the coordination center to centralize and harmonize study operations, coordinate data management, and provide biostatistical support to facilitate rapid implementation of minority health and health disparity studies conducted in the RCMI-CRNHE as well as manage a Network Steering Committee.

Applications must include a plan for evaluating all activities supported by the RCMI CC, in line with the broader RCMI program goals. The evaluation plan must specify baseline metrics to be included for the participating RCMI U54 centers, e.g., numbers of research grant applications submitted and funded, research publications and other forms of scientific dissemination, scientific collaborations and partnerships, utilization/expansion of shared research resources and databases, as well as measures to gauge the short- and long-term success of the RCMI CC in achieving its objectives.

Letters of Support: Applicants must provide letter(s) from the appropriate high-ranking institutional officials that:

  • Indicate the commitment of the institution(s) to the RCMI CC goals and how its activities will be integral to the broad institutional vision for biomedical, behavioral, and/or clinical research.
  • Specify any institutional support, for example financial support, dedicated space, salary support for professional or administrative staff, interface with other grants, centers, and initiatives, etc.
  • Indicate the commitment of the institution(s) to participate in the RCMI program nationally and other national consortia working towards developing, adopting and implementing best practices in basic biomedical, behavioral, and/or clinical research and training.

Inclusion of Letters of Support in the application should adhere to the SF424 instructions and be combined into a single file attachment. The Letters of Support attachment should begin with a table of letter authors, their institutions, and the type of each letter (institutional commitment or resources; collaboration or role in the project; potential or current user of a resource or service provided in the application). 

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

Other Plan(s): 

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

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - 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 How to Apply - Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. 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 How to Apply - Application Guide.

See more tips for avoiding common errors.

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

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]

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. While any information in the application relevant to the program goals can be included as part of the review process, the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of PD/PIs, RCMI CC team members, or other participants may not, in and of themselves, be used as factors in the evaluation of applications.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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 proposed Coordinating Center address the needs of the research programs (i.e., the RCMI U54 Centers and the CRN-HEs) that it will coordinate? Is the scope of activities proposed for the Coordinating Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research programs?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

 

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Coordinating Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing basic or clinical research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

 

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research programs (i.e., the RCMI U54 Centers and the CRN-HEs) the Coordinating Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

 

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs (i.e., the RCMI U54 Centers and the CRN-HEs) the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the programs, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

 

Will the institutional environment in which the Coordinating Center will operate contribute to the probability of success in facilitating the research programs (i.e., the RCMI U54 Centers and the CRN-HEs) it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Coordinating Center proposed? Will the Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

 

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

 

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

 

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

 

For programs, projects, networks, consortia, and/or resources 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 a Scientific Review Group 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.

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

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

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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

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

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support

Cooperative Agreement Terms and Conditions of Award

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 (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the 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 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 NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Supporting the essential functions of the RCMI Coordinating Center (RCMI CC);
  • Working towards developing, adopting and implementing the agreed-upon policies, procedures, best practices, or other measures;
  • Providing information to the NIH Program Official and Project Scientist(s) concerning progress;
  • Participating in the overall coordination of NIMHD efforts in minority health and health disparities research; this participation may include collaboration and consultation with other research awardees, and the sharing of information, data and research materials.
  • Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

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

NIMHD will assign a Program Official, Project Scientist(s), and a Grants Management Specialist to the RCMI CC.

NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. NIH Project Scientists(s) will:

  • Review and comment on critical stages in the program implementation;
  • Assist in coordinating activities with other ongoing studies supported through statewide, regional, or national programs to avoid duplication of efforts and encourage sharing and collaboration in the development of new research resources and methodologies;
  • Assist in the interaction between the awardee and investigators at other institutions to promote collaborations;
  • Assist in coordinating access to other research resources available through NIMHD-andNIH-fundedextramuralprograms;
  • Retain the option of recommending termination of support if technical performance or implementation falls below acceptable standards, or when specific key resources cannot be effectively implemented in a timely manner;
  • Retain the option to recommend additional infrastructure support within the constraints of the approved research and negotiated budget;
  • Convene meetings/workshops to address emerging areas of high priority.

An NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The Program Official will:

  • Assist in enforcing general statutory, regulatory or administrative assistance policy requirements;
  • Evaluate progress by reviews of technical or fiscal reports or by site visits to determine that performance is consistent with objectives, terms and conditions of the award;
  • Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer reviewed funding mechanisms;
  • Provide assistance in reviewing and commenting on all major transitional changes of RCMI CC activities prior to implementation to ensure consistency with the goals of this FOA;
  • Link the approaches developed by the RCMI CC to other NIMHD-supported extramural programs to ensure that information is shared and utilized on the widest basis possible;
  • Monitor institutional commitments and resources to ensure that the RCMI CC receives the maximum chance of stabilization and success;
  • Assist with financial oversight of the Program.

Additionally, the NIH Program Official may recommend the termination or curtailment of an activity in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

Areas of Joint Responsibility include:

  • Establishing a Steering Committee consisting of: (a) the PD(s)/PI(s); (b) up to six other members selected by the PD(s)/PI(s); and (c) the NIH Project Scientist(s). Each committee member will have one vote except for the NIH Project Scientists, who collectively will have one vote. In addition, the NIH Program Official and other NIH staff members may participate in Steering Committee meetings as non-voting members. The award recipient agrees to governance, through voting and decision making, of the RCMI CC through this Steering Committee.
  • Identifying and facilitating partnerships between RCMI awardees and other NIMHD award recipients in the respective regions with expertise and/or interest in health disparities or other relevant resources and expertise that could be leveraged to facilitate achievement of RCMI program goals and objectives.
  • Organizing and participating in Steering Committee meetings to discuss matters of mutual interest and promote information exchange across RCMI sites. Quarterly meetings of the Steering Committee will be held in the first year of the award, one of which must be an in-person meeting in Bethesda, MD. The frequency and venue(s) of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the 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 HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

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: 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]

Scientific/Research Contact(s)

Rada K. Dagher, Ph.D., M.P.H.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
Email: [email protected]

Peer Review Contact(s)

Maryline Laude-Sharp, Ph.D.
Telephone: 301-451-9536
Fax: 301-451-4484
Email: [email protected]

Financial/Grants Management Contact(s)

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

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 2 CFR Part 200.

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