Part 1. Overview Information

Key Dates

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose: The purpose of the Notice of Funding Opportunity (NOFO) is to solicit applications for the NIMHD Research Centers in Minority Institutions (RCMI) Program to expand the national capacity for research in the health sciences by providing cooperative agreements to institutions that offer doctorate degrees in the health professions or in a health-related science and have a documented historical mission and commitment to educating underrepresented students and for institutions that provide clinical services to medically underserved communities.

Background

NIH established the Research Centers in Minority Institutions (RCMI) program in 1985 in response to Congressional interest in expanding the national capability for research in the health sciences by providing support to institutions that offer doctoral degrees in the health professions or health-related sciences and have a documented historical mission or historical commitment to educating underrepresented students or have a record of providing health care services to medically underserved communities. NIMHD recognizes the important role these institutions have played in supporting scientific research, particularly on diseases or conditions that disproportionately impact racial and ethnic minority populations and other U.S. populations that experience health disparities. 

NIH 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 participating RCMI institutions to facilitate the development of research capacity, research education of students, and the ability of 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.

Programmatic Approach

The primary goals of RCMI specialized center awards are 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 the recipient institution to compete successfully for 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 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. 

Minority health refers to distinctive health characteristics and attributes of racial and ethnic minority groups in the U.S. Minority health research is the scientific investigation of these distinctive health characteristics and attributes. Research may focus on risk or protective factors for conditions where outcomes may be worse or better, respectively, compared to an appropriate reference population, including projects that evaluate mechanisms and interventions to sustain or improve a health advantage. Research may also examine mechanisms and develop and evaluate interventions to reduce health and/or health care disparities within a particular group (or health care setting), defined as a preventable or avoidable health difference that adversely affects populations who experience greater obstacles to optimal health largely due to social, environmental, and/or economic disadvantage. Health disparities may be observed in the risks or prevalence for specific behaviors, as well as the incidence, prevalence, and mortality from conditions, diseases, and/or disorders. Health disparities also can be observed in healthcare access, quality, and utilization, and within the delivery of clinical care. More information is available at the following link: NIMHD Research Framework, https://nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html 

Required and Optional Cores of an RCMI Specialized Center:

The RCMI program allows flexibility at the applicant institution with respect to the types of research resources required to accomplish research and investigator development goals. The most important criterion for inclusion of any component in the proposed Center is the extent to which the activity or resource will enable the institution to achieve the stated goals.

The following components are required for each RCMI Center:

• Overall
• Administrative Core
• Research Capacity Core
• Investigator Development Core
• Community Engagement Core
• Research Project(s): Maximum three projects

In addition to these required components, applications may also include the following optional core:

• Recruitment Core 

Descriptions of Required Components

Overall

The Overall component provides an overview of the institutional characteristics and proposed activities of the Center to meet the institutional goals and objectives under the RCMI Program.

Administrative Core

The Administrative Core must be directed by the PD(s)/PI(s) of the Center and will provide administrative and logistical support for all Center activities, . In addition, this Core oversees an assessment of each proposed activity/core and the impact of the Center as a whole in terms of: 1) enhancing the institutional research capacity and environment necessary to facilitate biomedical research in the areas identified by the applicant; 2) increasing the productivity of investigators as indicated by peer-reviewed publications and discovery; and 3) increasing the institution's overall success in applying for and obtaining extramural research funding, especially from NIH.

For Research Projects and pilot projects collecting research data from human participants, the Administrative Core will facilitate the development or utilization of existing data standards, common data elements (CDEs), measures and data sharing policy. Applicants are strongly encouraged to use measures from the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org) to maximize use of CDEs in all data collection. 

Applicants are required to include an evaluation plan of the Center for each component in their application to monitor progress and impact. 

In addition, successful applicants will also be required to work closely with the RCMI Coordinating Center  (https://rcmi-cc.org/) and its successor to develop and implement common metrics, collect data and share data on programmatic outcomes over time for each Center component as part of overall program evaluation.

The Center PD(s)/PI(s) will also be expected to attend meetings multiple times per year (virtual and in-person) convened by the RCMI Coordinating Center including the annual in-person RCMI meeting to showcase the science being conducted at the Centers, promote collaboration amongst Centers and other research consortia and networks such as the RCMI Clinical Research Networks, share best practices for Center operations, and provide information about funding opportunities supported by other NIH Institutes, Centers and Offices (see  NOT-MD-23-019,  NOT-OD-23-123, and RFA-HG-22-026, for recent examples). RCMI Centers are encouraged to pursue  funding opportunities including supplements from other Institutes, Centers and offices at NIH. RCMI Centers are encouraged to collaborate with the RCMI Coordinating Center for collection of common data elements and other measures for overall program evaluation. 

Research Capacity Core: Methodology, Laboratory Technologies, Biostatistics, Data Science, Community-Engaged Methods, and Core Research Resources

The goal of the Research Capacity Core is to enhance the quality and productivity of the research projects, and the pilot projects, as well as link RCMI faculty members and scholars with other researchers at the applicant institution. Applicants may request resources to assist investigators with developing design and analysis plans for studies. Such resources may include faculty-level expertise in research methodology, specialized laboratory techniques, statistics, data science, health informatics, and community-engaged methods. Applicants may also propose activities that bridge research in study design, biostatistics, and research ethics with other NIH supported centers including the Clinical and Translational Science Awards (CTSA)Program, Institutional Development Award (IDeA) Clinical and Translational Research Programs, Resource Centers for Minority Aging Research Centers (RCMAR), the Multiple Chronic Disease Research Centers led by NIMHD, RCMI Clinical Research Networks, Center for AIDS Research (CFAR) Program, NIH Community Engagement Alliance (CEAL), Diversity Centers for Genome Research Consortium led by NHGRI, Partnerships to Advance Cancer Health Equity (PACHE) led by NCI, or Community Partnerships to Advance Science for Society (ComPASS), or the NIH Climate Change and Health Initiative. If biomedical informatics resources are requested, applicants should consider both internal, intra-institution and external interoperability to allow for communication among RCMI awardees and with other research partners (e.g., universities, government, clinical research networks, and pharmaceutical companies).

If core research resources are requested, they must be for multiple users, including infrastructure applicable to various departments and disciplines in the institution (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, social sciences, epidemiology, bioengineering) for the benefit of researchers and research projects. Standard operating procedures are required, and participation in national or international quality control and standardization efforts is encouraged where appropriate. Proposed resources should be fully justified within the context of the overall program goals, and not duplicate locally available resources. The level of support requested must be justified by the projected use by investigators from within the applicant institution. Laboratory equipment, supplies, statistical and database software, and personnel are all acceptable costs. Cost recovery for core support should be sought from funded investigators.

• For renewal applicants, it is important that the requested research capacity support for this application builds upon or is complementary to previous RCMI funding.

Minor alteration and renovation (A&R) to improve existing research/core laboratories or animal facilities are allowed. This NOFO will provide up to $500,000 in direct costs for A&R in addition to the overall direct cost cap, only in year one of the award period, as a one-time cost expenditure for a center. Funds designated for A&R under this NOFO cannot support construction, modernization, or major alterations and renovation of research facilities as defined in Section 10.1 of the NIH Grants Policy Statement. A&R costs will be approved only for facility improvements at the applicant organization. Proposed improvements at consortium sites are not allowed.

Investigator Development Core

 Investigator Development Core supports career enhancement activities for all investigators and fosters synergy with other ongoing career development activities at the institution including any other NIH grants. Resources may be requested to support seminars, workshops, and other career enhancement activities that promote the recruitment, advancement, and retention of investigators in health-related research careers. In addition, the Core supports a Pilot Project Program for postdoctoral fellows and early-stage investigators that allows: 1) the institution's or regional partnering institution's eligible early career stage researchers to conduct their own research project that either generates preliminary data for future grant applications and/or results in a peer-reviewed research publication; or 2) completion of existing data analyses that leads to a peer-reviewed publication and informs subsequent plans for submission of grant applications; or 3) development of new technologies or approaches that will better position researchers to conduct basic biomedical research. Such funds must be readily available and be accompanied by an organizational structure that supports full compliance with regulatory requirements. Pilot projects that focus on research related to diseases that disproportionately impact racial and ethnic minority populations or that address health disparities are strongly encouraged.

Community Engagement Core

The Community Engagement Core supports activities designed to establish long-term relationships with community-based organizations built on the foundation of mutual trust to (a) address community specific health concerns, (b) promote inclusive participation in research and recruitment and retention of study participants, and (c) disseminate findings from research projects. The core will coordinate engagement and dissemination activities with community members, partner organizations, and relevant service organizations or policymakers, as well as the scientific community. Activities will include presentation of findings from research projects and pilot projects to inform the community and translate findings into sustainable community and system-level changes at the local level and beyond. Core activities are expected to contribute to scientific advancements such as improved interventions based on local knowledge, improved cultural competence of investigators, and strengthened community-engaged research approaches.

• Direct funding of research projects is not allowed under the Community Engagement Core.

Research Project(s)

Minority health and health disparities research is a multi-disciplinary field of study devoted to gaining greater scientific knowledge about the influence of health determinants and defining mechanisms that lead to disparities in outcomes and how this knowledge is translated into interventions to reduce or eliminate adverse health differences. Centers are expected to support up to three research projects with an explicit focus on one or more of the following scientific areas : 1) basic biomedical research, and/or 2) behavioral or social science research or population science, and/or 3) clinical or health services research. This needs to emphasize research that directly interacts with participants.  To receive the maximum Center budget, applicants must propose one research project in each of the three scientific focus areas. 

Projects in the behavioral or social science or population science and clinical or health services research focus areas must emphasize minority health and/or health disparities while the basic biomedical research focus area does not have this requirement. Accordingly, such projects must include a focus on the health of one or more racial and ethnic minority groups and/or other populations that experience health disparities (see https://nimhd.nih.gov/). NIMHD considers race and ethnicity and socioeconomic status as the fundamental drivers of health disparities science. NIMHD wants to promote research on the intersectionality of race and ethnicity and socioeconomic status with other populations that experience health disparities (e.g., underserved rural populations, sexual and gender minority groups, and individuals with disabilities).

For additional information on the research interest areas, please visit NIMHD website https://www.nimhd.nih.gov/programs/extramural/research-areas/index.html.

For the purpose of this NOFO, the three types of proposed research focus areas 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. 

Applicants are encouraged to include projects of variable size and duration over the 5 years. While the Pilot Project Program in the Investigator Development Core focuses on early career stage investigators, the Research Projects may be led by more established investigators or senior scientists, or the most qualified scientist regardless of position, at the applicant institution.

Description of Optional Core

Recruitment Core

This core may support the hiring of investigators who have track records of independent research support that includes current or recent support (within the last two years) by NIH R-series, P-series, and/or U-series awards, or other federal or non-federal awards and who can serve as mentors to junior investigators.  While institutions may not select or hire faculty members based on their race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status), institutions should develop outreach and recruitment strategies intended to diversify the applicant pool by encouraging prospective applicants from underrepresented groups to apply (see the NIH Notice of Interest in Diversity, NOT-OD-20-031). The new faculty members may be provided up to $250,000 direct costs per year for up to two years to augment institutional support to establish their research laboratories or program, acquire specialized equipment or partially support a specialized collaborator, and support postdoctoral fellows and technical assistants.

Applications Not Responsive to this NOFO:

• Applications from ineligible organizations or that include foreign components.
• Applications that do not include an attachment to the Overall Component (see Section IV below) titled "Institutional Information" that describes the applicant institution's historical mission or historical commitment to educating students from groups nationally underrepresented in biomedical research, or efforts to provide clinical services to medically underserved communities.
• Applications that do not include all required Components.
• Applications that propose more than three Research Projects.

Non-responsive applications will not be reviewed. Applicants are encouraged to reach out to the NOFO scientific/research contact prior to submission to discuss whether their application is responsive.

Overall Program Evaluation 

The RCMI Specialized Research Centers program has undergone a retrospective evaluation and based on that a prospective assessment plan is being developed. A prospective overall program evaluation will be conducted by RCMI Coordinating Center in collaboration with the funded RCMI Centers and NIMHD. The prospective evaluation of the overall RCMI program is distinct from an individual Center’s outcome evaluation (described in Section IV). While both evaluations address Center outcomes, they differ in scope (individual award vs. national program) and have different timelines and metrics (PD/PI defined vs. programmatic goals specified below). 

 Assessment will be developed based on institutional changes that will include, but are not limited to:

• Increased collaborative basic biomedical, clinical, and/or behavioral research to improve minority health and/or reduce and eliminate health disparities through the implementation of pilot/developmental studies, NIH-funded studies and studies funded by other federal and non-federal agencies;
• Development of innovative research programs, new tools and technologies, and peer-reviewed publications in high impact journals as well as other indicators of scientific impact;
• Enhancement of institutional capacity for conducting biomedical research including but not limited to development of new cores and biomedical resources, increased research capacity to support multi-disciplinary research, and leveraging of resources with institutional and other NIH funded programs or consortia.

The findings of this program evaluation will determine whether the program is meeting its goals and or will need additional modifications. 

Technical Assistance Webinar

NIMHD will conduct a Technical Assistance webinar for prospective applicants on October 24th, 2024 at 1:30 PM EST. The webinar connections will open 15 minutes in advance of the start time. NIMHD staff members involved in this NOFO will provide orientation and technical assistance to potential applicants by explaining the goals and objectives of the RCMI Specialized Centers initiative and answering questions from attendees. Prospective applicants are encouraged to send questions, preferably at least 24 hours prior to the webinar, to the Scientific/Research Contact, Dr. Nathan Stinson, at [email protected] and/or Dr. Rina Das, at [email protected]

To Join the webinar, interested persons can use the Zoom meeting link or other connection information, as follows:   

Join Zoom Meeting
https://nih.zoomgov.com/j/1616745329?pwd=xvUMT2jOwaqesG5qPwksejHfzPsGaJ.1&from=addon

Meeting ID: 161 674 5329
Passcode: 555754
 

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

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

To be eligible for this NOFO, 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 or less than $25 million per year of R01 total costs 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, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities) or (1) has a documented historical commitment to educating 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.

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

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

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

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the 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 registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 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. 

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 Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

Only one application per organization (normally identified by having a Unique Entity Identifier (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 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).

Please note only applications submitted to previous RCMI NOFO(s) are eligible to submit a renewal or resubmission-  RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, RFA-MD-20-006, RFA-MD-22-002, RFA MD-23-001, RFA-MD-24-001, or any subsequent ones. 

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Research Capacity Core: required
• Investigator Development Core: required
• Community Engagement Core: required
• Recruitment Core: optional
• Research Projects: required (one minimum, three maximum)

Overall Component

When preparing the application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: The application must include a single attachment titled "Institutional Information" that provides a description and evidence of the institution's historical mission or historical commitment to educating students from groups nationally underrepresented in biomedical research, or efforts to provide services to medically underserved communities and its NIH funding support of an average of less than $50 million per year or less than $25 million per year of R01 total costs of NIH support for the past three fiscal years

• For institutions whose historical mission explicitly states that it was founded to educate students from groups nationally underrepresented in biomedical research (i.e., underrepresented racial and ethnic groups [African Americans, Hispanic or Latino, American Indians or Alaska Natives, Native Hawaiians, U.S. Pacific Islanders] and individuals with disabilities and/or students from disadvantaged backgrounds, as defined in NOT-OD-20-031), provide the institution's original mission statement and any other information that justified the institution's creation and describes its main functions and services provided.
• For institutions whose mission statement does not explicitly state that they were founded to educate any of the underrepresented groups mentioned above but have a demonstrated historical  commitment to educating underrepresented students, the institution must provide information regarding the institution's historical track record of educating underrepresented students in biomedical and behavioral-related sciences who pursued biomedical research careers. NIMHD requests historical information only.  NIMHD will not make eligibility or funding determinations based on the institution’s current student body. 
• For institutions that deliver health care services, provide information on clinical services to medically underserved communities.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

The PD/PI must serve a minimum level of effort of at least 3.6 person months (PM) unless there are two or more PD/PIs in multiple PD/PI applications. In such a case, the minimum level of effort can be reduced to 2.4 PM for each multiple PD/PI. If a PD/PI serves a role in multiple components, the effort that is served in each component can be combined to meet the requirement. Applicants are encouraged to allocated funds to implement the proposed data management and sharing plan.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims:  Describe the specific aims for the Center and summarize how the proposed components and activities will: 1) enhance institutional research capacity to conduct world-class basic biomedical, behavioral and/or clinical or health services research; 2) enable all levels of investigators to compete successfully for extramural research support, especially from NIH, particularly for research on diseases and conditions that disproportionately impact minority and health disparity populations; 3) foster environments conducive to career development and enhancement for post-doctoral fellows, junior faculty members, and other early stage investigators; (4) enhance the tools for, conduct of, and dissemination of research and specifically for advancing minority health and preventing and eliminating health disparities; and (5) establish sustainable relationships with community-based organizations that will partner with the RCMI Institution.

Research Strategy:

Provide a Program Overview describing the scientific focus area(s) to be supported by the Center (i.e., basic science, and/or behavioral research, and/or clinical or health services research) and the rationale for seeking support for the proposed focus area(s) within the context of the applicant institution's priorities, long-range goals and vision for health-related research. If multiple areas are proposed, provide a rationale for the importance of the Center's research program as a whole to the larger goals of the applicant institution. Describe and justify how existing and requested resources will be utilized and leveraged to implement the institutional plan to develop, expand, and maintain an environment and framework suitable for achieving the objectives of the Center.

Summarize relevant organizational, educational, and scientific strengths and weaknesses at the applicant institution and describe how the proposed activities will address perceived research infrastructure needs. Describe the overall goals for the Center during the proposed project period, the specific institutional commitments that will be made to help achieve those goals, and the key activities that will be conducted to achieve each of the proposed goals.

For renewal applicants, provide a Progress Report on previous RCMI funding. In addition to the overall section, a progress report can be also included for each component of the application, when applicable. 

Letters of Support:

Applications must include letters from the appropriate high-ranking applicant institutional official(s) that:

• Indicate the commitment of the applicant institution to the center goals and how the center 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.
• Indicate the commitment of the institution to participate in activities intended to foster and enhance RCMI programmatic coordination, communication and research collaborations across RCMI sites nationwide, as well as participate in other national consortia working towards developing, adopting and implementing best practices in basic biomedical, behavioral, and/or clinical research and training.

All other Letters of Support for all application components should be included within this section in the Overall component. Do not include letters of support in other components.

Applications that propose work with American Indian or Alaska Native populations, tribes or communities must include letters of support from the appropriate tribal officials and/or tribal organizations as applicable.

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 proposed 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.

The following modifications also apply:

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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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 (Overall)

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

Administrative Core

When preparing your application, use Component Type ‘Admin Core.’

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Administrative Core)

 Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core) 

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

 Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Administrative Core must be directed by the PD(s)/PI(s) of the Center.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO–specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete “Letters of Support” if there are no NOFO-specific instructions.

Specific Aims: Describe the specific aims for the Administrative Core.

Research Strategy:

Describe how the Administrative Core will manage, coordinate and supervise the entire range of proposed activities; monitor progress; and ensure that component plans are implemented. Explain the roles and responsibilities of core personnel, including scientific leadership, administrative management, and coordination of proposed activities.

Include a management plan describing the Center’s organizational and governance structure and plans to manage and, where necessary, reassign institutional resources among schools and/or departments to achieve Center goals. Describe the composition and roles of any committees proposed to help manage the Center activities. Each Center must have an Advisory Committee (AC). Depending on the scope and complexity of the center, the AC may consist of up to ten members. The AC should include representatives from the target communities, external scientific advisors with relevant expertise. The AC should review structure and progress and offer recommendations to the PD/PI(s) on an annual basis.  Applications must describe the types of expertise of the members that will be recruited for the AC; however, applicants should not list potential AC members in the application or contact them prior to peer review. 

Include an Evaluation Plan to facilitate ongoing Center performance and project management to ensure successful completion of the stated aims. Describe how the evaluation will be conducted, principal performance measures and metrics to be used to assess achievement of short- and long-term goals of each core and project, and potential sources of data. Describe plans and processes for developing or utilizing existing standards and other means to maximize interoperability between internal and external systems and foster collaborations with other research consortia and networks. Include plans for using common data elements (CDEs) and other standard measures. The productivity of investigators, including those with pilot projects, should include monitoring related publications, grant applications and awards. The plan should address administrative functioning (process) as well as scientific and developing investigator accomplishments (outcomes). Describe key milestones and expected outcomes for each area, as appropriate. For renewal applications, please include key lessons learned, and any modifications proposed based on the evaluation outcomes of the previous cycle.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall Component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core )

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Research Capacity Core

When preparing your application, use Component Type ‘Capacity Core.’

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Research Capacity Core)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Capacity Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Capacity Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Other Attachment: If funds are requested for minor alterations and renovations, the application must include a single attachment titled " Alterations and Renovations " that provides:

A description of the functional units, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project. Engineering criteria applicable to each component unit (mechanical, electrical, and utilities) must be included such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam. Applicants must also list appropriate architectural criteria (such as width of corridors and doors, surface finishes). All fixed equipment items requested for the renovated area must be listed and justified. If renovations to animal facilities are proposed, the proposed renovations must be related to the projected animal population by species and include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved must also be included.

Line drawings of the proposed renovation(s) must be legible, with the scale clearly indicated and adequate to explain the project. Drawings must indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated must also be given. The plan must indicate the location of the proposed renovation area in the building. Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished. Any changes or additions to existing mechanical and electrical systems must be clearly described in notes made directly on the plan or attached to the plan. Indicate the type(s) of new finishes to be applied to room surfaces. Applicants must relate the proposed renovations to the research projects that will use the facility and detailed cost estimates must be included. Provide vendor quotes when available.

Project /Performance Site Location(s) (Research Capacity Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Capacity Core)

In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Capacity Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Minor alteration and renovation (A&R) to improve existing research/core laboratories or animal facilities are allowed. This NOFO will provide up to $500,000 in direct costs for A&R in addition to the overall direct cost cap, only in year one of the award period, as a one-time cost expenditure for a center. Funds designated for A&R under this NOFO cannot support construction, modernization, or major alterations and renovation of research facilities as defined in Section 10.1 of the NIH Grants Policy Statement. A&R costs will be approved only for facility improvements at the applicant organization. Proposed improvements at consortium sites are not allowed.

PHS 398 Research Plan (Research Capacity Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims of the Research Capacity Core.

Research Strategy: Describe how the resources and services to be provided by the Core at the applicant institution will enhance the tools for, the conduct, quality and productivity of, and the dissemination of research generally, and especially for research projects and pilots seeking to advance minority health and prevent and eliminate health disparities.

Describe the services that the Research Capacity Core will provide, as applicable:

• Resources and services that will be offered, with plans for their prioritization, availability, management and tracking. Plans to ensure inclusion of infrastructure applicable to various disciplines in the institution for the benefit of researchers and research projects across a broad range of health-related research areas.
• The user pool for the requested resource that includes a description of the research projects, collaborators and funding sources.
• Services for study design and analyses with methodological and statistical expertise to support research projects, pilot studies and other investigators.
• Bioinformatics and data science support for data storage and common data elements.
• Health informatics and data analytic support for data resources such as electronic health records, public use sources, clinical studies, or other sources of health data on minority and other disparity populations.
• Common laboratory techniques to be used across basic science projects that require specialized skills.
• Laboratory equipment that will be used by RCMI investigators and fellows with pilot grants.
• Advice that may include but is not limited to conflict of interest, federal codes requirements, privacy and safety of research participants.
• Integration of research ethics into core services.
• Integration of resources with similar resources at the institution and any affiliates.
• Support provided for operations, administration and research activities.
• The process by which standards and other mechanisms will be developed and used to maximize interoperability between internal systems and systems in external organizations.
• Interactions with the RCMI program and other partners.
• Assessment of informatics performance with external partners- RCMI awardees, Clinical and Translational Science Awards (CTSA), Institutional Development Award (IDeA) Clinical and Translational Research Programs, Resource Centers for Minority Aging Research Centers (RCMAR), the Multiple Chronic Disease Research Centers led by NIMHD, RCMI Clinical Research Networks, Center for AIDS Research (CFAR) Program, NIH Community Engagement Alliance (CEAL), Diversity Centers for Genome Research Consortium led by NHGRI, Partnerships to Advance Cancer Health Equity (PACHE), or Community Partnerships to Advance Science for Society (ComPASS).
• Plans for cost recovery from funded investigators and/or specific institutional support for the core.
• Any minor alteration and renovation (A&R) to improve existing research/core laboratories or animal facilities.

For renewal applications, it is important to state how the current requested research capacity support builds upon or is complementary to previous RCMI funding.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Research Capacity Core)

Not applicable

Investigator Development Core

When preparing your application, use Component Type ‘Investigator Core.’

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Investigator Development Core)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Investigator Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Investigator Development Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Investigator Development Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Investigator Development Core)

In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Investigator Development Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Applicants may request support for up to five pilot projects per year in the Pilot Project Program. The combined direct costs allocated to pilot projects and required to be expended in the Pilot Project Program is up to $250,000 per year. Direct costs for each pilot project may range from a minimum of $25,000 per year to a maximum of $50,000 per year for up to two years. The direct costs and project period for a pilot project may not exceed those for an NIH R03 grant.

 Funds should not be requested to cover the cost of tuition, fees or stipends for students or trainees. Compensation for services rendered is allowable. Personnel and other costs needed to support the administration of the Pilot Project Program are also allowable Core costs.

PHS 398 Research Plan (Investigator Development Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims for the Investigator Development Core.

Research Strategy: 

Describe the programmatic activities (e.g., seminars, workshops or other activities) that will be undertaken to support career enhancement for post-doctoral level professionals and junior faculty from a variety of disciplines. Describe the academic qualifications, research experience, and productivity of mentors, including those from other institutions. Provide evidence of how the proposed activities will be integrated across the institution.

Describe a Pilot Project Program for postdoctoral fellows, junior faculty members, and other early-stage investigators, including the pool of potential applicants and how the Core will promote the receipt of pilot project applications from individuals from diverse backgrounds, including those from underrepresented groups in the biomedical research workforce (see Notice of NIH’s Interest in Diversity, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html.

Recipients of pilot funds will be expected to receive ongoing advice from RCMI faculty, meet on a regular schedule, participate in seminars and conduct their research pilot project. These investigators will be expected to work on publications based on their pilot project as well as collaborate on other projects. The goal is to successfully apply for external funding such as mentored K-award or a R01 equivalent grant as appropriate to their career level.

Applicants should describe the plan to solicit and review proposals, prioritize the pilot projects for funding and to review their methodology and research performance.  The description of the Pilot Project Program should include the scope; eligibility requirements; the limit on the dollars available and the number of years of support per pilot project; the solicitation, submission, review, and selection criteria and process; governance, oversight and evaluation procedures; and assurances that all pilot projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects and vertebrate animals.

Do not include detailed proposals or descriptions of specific pilot projects, as pilot projects should not be selected until after the Center grant is awarded.

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. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Investigator Development Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Community Engagement Core

When preparing your application, use Component Type ‘Community Core.’

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Community Engagement Core)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Community Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Community Engagement Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Community Engagement Core)

In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Engagement Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Community Engagement Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims for the Community Engagement Core.

Research Strategy: Without duplicating information in the Biographical Sketches, describe the leadership of this core, and the principles, policies, and practices that will guide its operation. Describe strategies for building and maintaining the coalition of local partners and/or collaborators designed to establish long-term relationships with community-based organizations and to promote participation in research including recruitment and retention of study participants. Describe how the Core will facilitate collaboration between coalition members and investigators on Research and Pilot projects. Describe the types of activities that will be conducted for the timely and appropriate dissemination of information generated by the Center, its research projects, pilot projects, and other activities for a broad range of audiences, including lay community audiences. Describe the expected outcomes of the proposed dissemination strategies and activities and how the impact of dissemination efforts will be assessed. Describe strategic planning processes to translate findings into sustainable community and system-level changes at the local level and beyond.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Community Engagement Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Recruitment Core (Optional)

When preparing your application, use Component Type ‘Optional Core.’

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Recruitment Core)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Recruitment Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Recruitment Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Recruitment Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Recruitment Core)

In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Recruitment Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Applicants may request up to $250,000 in direct costs per year for recruitment in two pre-designated years of the proposed project period.

PHS 398 Research Plan (Recruitment Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims for the Recruitment Core.

Research Strategy: If applicable, applicants should describe plans for recruiting and hiring additional research personnel that may be required to accomplish the goals of the center. This may include hiring of senior or mid-career investigators who have independent research support and can mentor junior investigators. These new faculty members may receive support to establish their research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants. If recruitment of new faculty members is proposed, the application must contain detailed planning and recruiting activities intended to diversify the applicant pool and encourage potential applicants from underrepresented groups to apply. The application must also describe the applicant's plans for advertisement, recruitment, interview and selection processes that are equitable and ethical. In addition, the applicant should describe career enhancement and retention plans for hired faculty members. Applicants must include a proposed timetable specifying the expected hiring date for each new faculty and/or staff member.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Recruitment Core)

Not applicable

Research Project

When preparing your application, use Component Type ‘Project.’

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Combined RCMI research project budgets should total 20-30% of maximum direct costs per year for the proposed center. Therefore, combined research project annual direct costs (not including consortium F&A costs) are limited to $450,000 for applications that encompass one research focus area, $750,000 for two research focus areas, and $1,050,000 for all three research focus areas.

PHS 398 Research Plan (Research Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims for the Research Project. 

Research Strategy: All projects in the focus areas of behavioral research or population science and clinical or health services research must address research questions related to the field of minority health and/or health disparities and have a primary focus on one or more NIH-designated U.S. populations that experience health disparities. Comparison groups are not required for such studies but may be included as appropriate for the research question(s) posed. Community-engaged research approaches are encouraged when applicable but are not required for every project. For Clinical focus areas the research must include patient oriented studies or clinical care or clinical outcomes research, Please refer to Section I for details on research focus areas.

Applicants are encouraged across Research Projects as applicable, to include CDEs from the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org). 

For the purposes of this NOFO, projects in the basic biomedical research focus area, including proposed animal studies, are not required to have direct relevance to minority health or health disparities.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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) using ASSIST or other electronic submission systems. 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 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.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in 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.

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

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 NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Significance

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 NOFO : To what extent is the proposed project likely to (1) enhance institutional research capacity to conduct world-class basic biomedical, behavioral, and/or clinical research, and (2) enable all levels of investigators at the applicant institution to compete successfully for extramural support, especially from NIH, for research on diseases and conditions that disproportionately impact populations that experience health disparities?

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?

Investigator(s)

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?

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?

Innovation

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?

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?

Approach

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 NOFO : How well does the selection of research projects support the overall goals of the proposed center? Is the rationale for selecting project(s) in basic science and/or behavioral research and/or clinical or health services research appropriate to the overall Center goals? If multiple areas are proposed, how important is the pursuit of a larger program to the overall goals? To what extent are the proposed activities likely to enhance the tools for and conduct of research and specifically for improving minority health and reducing health disparities at the applicant institution? To what extent are the proposed activities likely to enhance and sustain productive collaborations and partnerships with community-based organizations to promote research efforts and the dissemination of research findings? 

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?

Environment

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?

Specific to this NOFO : How likely is the proposed Center to foster and enhance environments conducive to investigator development, particularly for new and early career investigators? To what extent do the institutional letters of support indicate that the applicant institution is fully committed to achieving the goals and objectives of the proposed Center, and that the Center will be integral to achieving the broad institutional vision for health sciences? Is it clearly described how the Center will leverage existing NIH- or other federally funded projects and resources, including those from NIMHD, NIGMS, NCATS, NCI, NIA and other funders to conduct research and disseminate findings?

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 - Overall

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.

Study Timeline

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)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

Not Applicable

Not Applicable

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

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.

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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

Overall Impact - Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Cores collectively to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria. Criterion scores will not be provided for the Cores.

Review Criteria - Cores

Reviewers will consider each of the review criteria below in the determination of scientific merit.

Review Criteria - Administrative Core

Is an appropriate Management Plan provided describing the Center’s organizational and governance structure, including any advisory committees, and strategies for overseeing, managing and coordinating the entire range of proposed Center activities?

Are appropriate measures and procedures proposed for monitoring progress and ensuring that component plans are implemented?

Are the roles and responsibilities of core personnel clearly delineated and appropriate?

Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Is an evaluation plan provided that incorporates appropriate performance targets, objectives, and outcomes?

Are the proposed processes for developing standards and other means to maximize interoperability between internal and external systems feasible and likely to enhance collaborations with other research consortia and networks? Are appropriate plans provided to develop a standard set of common data elements and measures to be used.

Review Criteria - Research Capacity Core

Do core personnel have the appropriate background, training and experience to effectively provide the proposed research services and resources?

To what extent are the proposed plans for core operations, management, prioritization and tracking of services, and assessment of the core's effectiveness likely to enhance the quality and productivity of health-related research at the applicant institution?  

Does the description of the potential user pool support the likelihood that the core will enhance institutional capacity for conducting a broad range of health-related research?

Are the proposed resources likely to complement and be integrated with other research resources at the institution and any affiliates?

Are there well-considered plans for sustaining research capacity (e.g., shared core facilities) through cost recovery and/or institutional support?

 Review Criteria - Investigator Development Core

How likely is the proposed Pilot Project Program to promote and enhance career development and transition to independence for post-doctoral fellows, junior faculty members and other early-stage investigators (ESIs) consistent with the NIH's definition (see https://grants.nih.gov/policy/early-investigators/index.htm#definition)?

Are criteria and procedures for soliciting, submitting, reviewing and selecting pilot projects for funding, including the expected number, distribution, direct costs and duration of pilot projects, clearly described and adequately justified in the overall context of the Center’s proposed objectives?

Are appropriate advisory and technical support resources in place to support rigorous research design, appropriate statistical analyses, and compliance with applicable Federal laws, regulations and policies for research involving human subjects and live vertebrate animals?

To what extent are plans for overseeing and mentoring pilot award recipients, including commitment of the identified mentors, likely to enhance their professional development and address preparedness of the candidates to submit future grants?

Review Criteria - Community Engagement Core

To what extent are the proposed activities likely to successfully establish or enhance sustainable partnerships with community-based organizations and community members to address their health-related concerns and promote participation in the Center's research activities?

Are plans for dissemination of information to a broad range of audiences well described and consistent with the objectives of the Center?

Are plans to engage in strategic planning processes to translate findings into sustainable community and system-level changes at the local level and beyond described and realistic?

To what extent are the proposed activities likely to contribute to improved interventions based on local knowledge, improved cultural competency of investigators, and strengthened community-engaged research approaches?

 Review Criteria - Optional Recruitment Core

If a Recruitment Core is proposed, are plans for recruiting, hiring, and retention of additional research faculty and other personnel adequately justified in terms of accomplishing the goals of the Center?

If applicable, are the proposed investigator development plans likely to enhance the competitiveness of new faculty and promote their success as independent investigators?

Are the plans supportive to the establishment of a recruited faculty’s research program at the RCMI institution?

Are there appropriate timelines for hiring new faculty and/or staff members?

Overall Impact - Research Project

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 - Research Project

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.

Significance

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?

In addition, for projects 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?

Investigators

Are the Leads, 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?

Specific to this NOFO: Are the roles of academic, clinical, and community collaborators, if applicable, clearly described and appropriate?

In addition, for projects 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?

Innovation

Does the application 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?

In addition, for projects 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?

Approach

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 NOFO : For behavioral or clinical or health services research projects that involve human subjects, are plans to reach, recruit, and retain individuals from the target populations adequately described and appropriate?

In addition, for projects 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 approaches 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?

Environment

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?

In addition, for projects 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 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 – Research Project

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.

Study Timeline

Specific to projects 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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Biohazards

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

Additional Review Considerations – Research Project

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.

Select Agent Research

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).

Applications from Foreign Organizations

Not Applicable

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources

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.

Budget and Period of Support

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.

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 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 National Advisory Council on Minority Health and Health Disparities (NACMHD). 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.
• Geographic distribution of awardees.

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 their 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: Grantee 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).

Prior Approval of Pilot Projects

Recipient-selected pilot projects  require prior approval by NIH prior to initiation of the study. The recipient institution will submit the application package to NIH for review and approval including components on human subjects and live vertebrate animal studies as applicable.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.
• If live vertebrate animals are to be involved, follow NOT-MD-08-002 and NOT-OD-16-006.

2. Administrative and National Policy Requirements

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

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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.

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:

• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
• Coordinating project activities technically, scientifically and administratively at the recipient institution and coordinating project activities at other sites that may be supported by the award.
• Defining objectives and approaches; collecting and analyzing data; and publishing results, interpretations, and conclusions of studies conducted under the terms and conditions of the award.
• Ensuring that appropriate Institutional Review Board approvals and certifications for research involving human subjects for all participating sites, collaborators or partners are obtained.
• Selecting external members for and participating in the Advisory Committee.
• Organizing biannual meetings of the Advisory Committee.
• Consulting with NIMHD to ensure compliance with relevant grant policies and regulations.
• Participating in the Advisory Committee meetings and other PD/PI meetings convened by NIMHD.

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 (see below) and Project Scientist(s) to the award. The Project Scientist(s) that shall be named in the Notice of Award will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. Project Scientists(s) will:
• Review and comment on critical stages in the program implementation;
• Assist in the interaction between the recipient and investigators at other institutions to promote collaborations;
• Assist in coordinating access to other resources available through statewide, regional, or national specialized cores or resources;
• 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.

The Program Official will:

• Assist with the NIMHD’s monitoring of compliance of award-supported activities;
• 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;
• Help 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 center activities prior to implementation to ensure consistency with the goals of this FOA;
• Link the approaches developed from the center to other NIMHD-supported activities to ensure that information is shared and utilized on the widest basis possible;
• Monitor institutional commitments and resources to help ensure that the center receives the maximum chance of stabilization and success;
• Assist with the NIMHD’s monitoring of financial oversight of the Program.  Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the notice of award.

Areas of Joint Responsibility include:

• Establishing an Advisory Committee consisting of: 1) the PD(s)/PI(s); 2) up to six other members selected by the PD(s)/PI(s); and 3) the NIH Project Scientist(s). Each committee member will have one vote except for the NIH Project Scientist(s), who collectively will have one vote. In addition, the Program Official and other NIH staff members may participate in Advisory Committee meetings as non-voting members. The Advisory Committee will convene by telephone as needed and are expected to meet in person at least once a year.
• Identifying and facilitating partnerships with other NIMHD award recipients with expertise and/or interest health disparities or other relevant resources and expertise that could be leveraged to facilitate achievement of the center goals and objectives.
• Organizing and participating in the Advisory Committee meetings at least biannually to discuss matters of mutual interest and promote information exchange.

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. 

• 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.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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.

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]

Nathan Stinson, Jr., PhD, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8704
Email: [email protected]

Rina Das, PhD.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-3996
Email: dasr2@mail.nih.gov

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

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.

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.