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Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title
Resource Centers for Minority Aging Research (RCMAR) Coordinating Center (U24 Clinical Trial Optional)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Reissue of RFA-AG-18-004
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-AG-23-027
Companion Funding Opportunity
RFA-AG-23-025 , P30 Center Core Grants
RFA-AG-23-026 , P30 Center Core Grants
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications proposing to develop and maintain a coordinating center (CC) for the Resource Centers for Minority Aging Research (RCMAR) program. The RCMAR program supports behavioral and social research on aging, health disparities in older adults, and Alzheimer’s disease (AD) and AD-related dementias (ADRD), through the development of research infrastructure and the mentorship of early career scientists from diverse backgrounds, including, but not limited to, individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women (see, Notice of NIH's Interest in Diversity, NOT-OD-20-031). The primary responsibilities of the RCMAR CC are to: coordinate and provide logistical support to RCMAR Centers; facilitate cooperation and collaboration across RCMAR Centers; create and maintain an interactive RCMAR CC website; identify and share research and training resources; provide support, technical assistance, and resources to early career investigators; and perform program analysis and evaluation. Additionally, the CC will develop and implement strategies to enhance the visibility of the RCMAR program and behavioral and social research on aging and AD/ADRD as a whole, and to communicate the importance and value of diversity, equity, inclusion, and accessibility (DEIA) in the aging and AD/ADRD research enterprise.

Key Dates

Posted Date
August 05, 2022
Open Date (Earliest Submission Date)
September 21, 2022
Letter of Intent Due Date(s)

September 21, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 21, 2022 October 21, 2022 Not Applicable February 2023 May 2023 July 2023

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

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

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

Expiration Date
October 22, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Key Definitions for this Funding Opportunity Announcement (FOA)

Resource Centers for Minority Aging Research (RCMAR) Program: Refers collectively to a Center Core Grants (P30) program to mentor promising scientists from diverse backgrounds, including, but not limited to, individuals from underrepresented groups in the biomedical sciences (see the Notice of NIH's Interest in Diversity, NOT-OD-20-031) for sustained and impactful behavioral and social science research careers focused on aging, health disparities in older adults, and/or Alzheimer’s disease (AD) and AD-related dementias (ADRD). The program is supported by the Division of Behavioral and Social Research (BSR) at the National Institute on Aging (NIA). The program is comprised of the three following types of Centers that operate independently, and in cooperation with all the other Centers:

  1. RCMAR(s): P30 Center(s) that focus(es) on behavioral and social science research in a priority research area related to aging and/or to health disparities in older adults. The Center(s) is/are funded through RFA-AG-23-026. Hereafter, the Centers will also be referred to as "RCMAR Center(s)" or "Centers."
  2. AD/ADRD RCMAR(s): P30 Center(s) that focus(es) on research related to AD/ADRD in a selected area of behavioral and social science. The Center(s) is/are funded through RFA-AG-23-025. Hereafter, the center(s) will also be referred to as "AD/ADRD Center(s)."
  3. RCMAR Coordinating Center (CC): A center that provides leadership for the RCMAR program through a cooperative agreement with NIA. The CC is funded through this FOA, RFA-AG-23-027, using the Resource-Related Research Projects – Cooperative Agreements (U24) funding mechanism.

RCMAR Leadership: The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) of the CC, the RCMARs, the AD/ADRD RCMARs, and Core Leads within each Center.

Mentors: Individuals who possess research expertise and experience within the scope of the Center's selected area of interest and are members of a multidisciplinary team of RCMAR faculty committed to establishing long-term mentoring relationships with RCMAR Scientists and supporting their professional and scientific career development needs. Mentors provide guidance and advice to Scientists as they conduct RCMAR-funded pilot studies and continued mentorship to ensure successful competition for NIA-funded grants.

RCMAR Scientists: A diverse cohort of early career behavioral and social science faculty members (i.e., assistant professors) who participate in a mentorship program sponsored by a RCMAR Center to receive faculty and peer mentorship, guidance, training and support, and competitive pilot research awards to support preliminary data collection and/or analysis for larger projects proposed in NIA research or training grant applications focused on aging, AD/ADRD, and/or health disparities in older adults.

Background

The Resource Centers for Minority Aging Research (RCMAR) program at NIA is BSR's flagship infrastructure and mentoring program for scientists from diverse backgrounds, including, but not limited to, individuals from underrepresented groups who conduct behavioral and social research focused on aging, health disparities of older adults, and AD/ADRD. The goal of the RCMAR program is two-fold: (1) to diversify the research workforce in priority areas of social, behavioral, psychological, and economic research on aging by mentoring promising scientists from diverse backgrounds; and (2) to develop a research and mentoring infrastructure to foster rigorous behavioral and social science research on aging and AD/ADRD in high-priority research areas that can advance aging-relevant scientific discoveries, lead to the elimination of health disparities and health inequities, and improve the health and well-being of older adults who are members of NIA’s Priority Populations, as specified in the NIA Health Disparities Research Framework.

Funded continuously since its inception in 1997, the RCMAR program offers intellectual leadership, mentorship, training, career development opportunities, and pilot study funding for future leaders in aging research in the behavioral and social sciences who are at an early stage in their careers. In 2018, NIA established a RCMAR CC to promote cross-center collaborations among the leaders, mentors, and Scientists participating in the RCMAR program. The RCMAR CC also facilitates the sharing of unique research and training resources across all RCMAR Centers, with investigators in behavioral and social aging and AD/ADRD research outside the RCMAR network, and with the public.

Purpose

This FOA invites applications proposing to develop and maintain a CC for the RCMAR program. The RCMAR program supports behavioral and social research on aging, health disparities in older adults, and AD/ADRD, through the development of research infrastructure and the mentorship of early career scientists from diverse backgrounds, including, but not limited to, individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women (see, Notice of NIH's Interest in Diversity, NOT-OD-20-031). The primary responsibilities of the RCMAR CC are to: coordinate and provide logistical support to RCMAR Centers; facilitate cooperation and collaboration across RCMAR Centers; create and maintain an interactive RCMAR CC website; identify and share resources and materials for research and training; provide support, technical assistance, and resources to early career investigators; and perform program analysis and evaluation. Additionally, the CC will develop and implement strategies to (1) enhance the visibility of the RCMAR program and behavioral and social research on aging and AD/ADRD as a whole and (2) communicate the importance and value of diversity, equity, inclusion, and accessibility (DEIA) in the aging and AD/ADRD research community.

Applicants must demonstrate expertise in behavioral and social science research related to aging and/or to health disparities in older adults, including behavioral and social research on AD/ADRD, and a commitment to DEIA. Applicants are expected to be familiar with the structure, functioning, and activities of the RCMAR program, and to familiarize themselves with the companion FOAs. It is not necessary for applicants to be a part of an active RCMAR Center.

Prospective applicants are strongly encouraged to contact the NIA Scientific/Research Contact, identified in Section VII of this FOA, to verify that their intended application is consistent with the goals of this FOA and NIA programs.

RCMAR CC Functions and Activities

The primary responsibilities of the RCMAR CC are:

  1. Provide logistical support to RCMAR Centers and NIA program staff; coordinate communication, scientific meetings, and streamline information collection and compilation across the RCMAR program; and perform program analysis and evaluation. To meet this responsibility, the CC is expected to conduct the following activities:
  • Arrange and organize the annual meetings for the RCMAR Directors and RCMAR Scientists, as well as symposia at scientific conferences on topics of interest to RCMAR Scientists.
  • Facilitate and coordinate communication among the RCMAR Centers by organizing and conducting regular videoconferences with RCMAR directors, mentors, Scientists, and NIA staff, and provide periodic RCMAR-wide updates (e.g., e-newsletters).
  • Identify, with the cooperation of the RCMAR Centers' participating institutions, the following: 1) demographic, scientific (e.g., specific aims, publications, etc.), and collaborative performance data, as well as other relevant common metrics to be collected longitudinally in the RCMAR program, to track and monitor progress; 2) methods and criteria used to evaluate the short- and long-term success of Scientists and the impact of pilot projects; 3) skills, core competencies, and needs assessment tools for Scientists and mentors; and 4) best practices for creating equitable, inclusive, accessible, and varied mentorship opportunities and recommended training materials for Scientists and mentors.
  • Create and implement strategies and infrastructure, with the cooperation of the RCMAR Centers' participating institutions, to support and streamline the routine collection, management, and sharing of RCMAR-related information and data (e.g., the Scientists and mentors, study aims of pilots, other research projects, publications, and other accomplishments associated with each Center), which together can facilitate program evaluation for the RCMAR program as a whole, while providing ready-data for use in the preparation and publication of the RCMAR Annual Report on the RCMAR CC website.
  • Collect performance and metric data from each Center, describe trends in the RCMAR program, and conduct a comprehensive program evaluation of the RCMAR program on an annual basis.
  • Disseminate evaluation results to key stakeholders, including, but not limited to, the Centers, NIA, and the National Advisory Council on Aging.
  • Share benchmarking data with the individual Centers on an annual basis.
  1. Create and maintain an interactive RCMAR CC website to promote scientific exchange and facilitate identification of collaborators and mentors. The website should include created and curated content, a communications and collaborative platform, and data management functions to share research and training resources and materials with RCMAR Centers, other NIA and NIH center programs, and the broader aging research community and public. To meet this responsibility, the CC is expected to conduct the following activities:
  • Serve as the central repository for the dissemination of research and training information, resources, tools, and materials for the RCMAR program, behavioral and social science researchers in aging, AD/ADRD, and/or health disparities in older adults, faculty mentors, and the public.
    • Examples of research resources and materials include, but are not limited to, the following: scientific publications; measurement instruments and procedures; study forms, protocols, and templates; and strategies for recruitment and retention of study participants from heterogeneous populations..
    • Examples of training resources and materials include, but are not limited to, the following: webinars; quality and performance assessments; culturally aware and responsive tools for career development, mentoring, and addressing challenges in team science; and other innovative resources to address the training and career development needs of faculty and mentors.
  • Publish a dynamic and searchable database of current and former members of the RCMAR community, to facilitate the identification of mentors and collaborators.
  • Provide a forum for discussion, and a platform for scientific exchange, resource sharing, and collaboration among scientists, mentors, and directors within the RCMAR program.
  1. Provide support, technical assistance, and resources to early career investigators at Centers across the RCMAR program to promote scientific opportunities, advance professional and career growth, and develop and diversify the aging and AD/ADRD research workforce in the behavioral and social sciences. To meet this responsibility, the CC is expected to conduct the following activities:
  • Develop and maintain infrastructure and other strategic approaches, in consultation and with the cooperation of members from the RCMAR community, to identify, facilitate, and support opportunities for research collaboration, networking, career development, and mentoring for early career scientists from diverse backgrounds, including, but not limited to, from the groups identified as examples of underrepresented groups in the biomedical sciences in NOT-OD-20-031. Examples of strategic approaches include, but are not limited to the creation of the following: tools to match early career scientists to mentors and to facilitate the identification of potential collaborators; research exchange experiences; and mentorship opportunities across RCMAR Centers.
  • Organize, develop, and conduct workshops for RCMAR Scientists and other activities in conjunction with the annual RCMAR meeting; organize training webinars in areas of broad interest to the RCMAR scientist community; hold mock peer review sessions; and coordinate activities related to scientific writing, editing, and publishing.
  1. Facilitate and accelerate cooperative arrangements and identify and leverage existing resources to stimulate collaborative projects and research collaboration. To meet this responsibility, the CC is expected to conduct the following activities:
  • Coordinate communication among the following: the RCMAR Centers; the NIA Research Centers Collaborative Network (RCCN); NIH and institutional research centers with NIA- or NIH-funded research infrastructures or other federal or private organizations promoting aging-relevant, AD/ADRD-relevant, or health disparities research and/or training in the behavioral and social sciences; and other NIA-funded Centers and programs, including the following Alzheimer's Disease Research Centers (ADRCs), Centers on the Demography and Economics of Aging, Claude D. Pepper Older Americans Independence Centers (OAICs), Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging, Nathan Shock Centers of Excellence in the Basic Biology of Aging, etc.
  • Identify, support, and foster the inclusion and engagement of non-RCMAR participating senior and early career scientists and mentors from Historically Black Colleges and Universities (HBCUs), Tribal Colleges and Universities (TCUs), and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups. These institutions have played an important role in supporting scientific research, particularly on diseases or conditions that disproportionately impact racial/ethnic minorities and other U.S. populations that experience health disparities, though they often lack sufficient capacity to conduct and sustain cutting-edge health-related research. Their researchers are uniquely positioned to bring diverse perspectives and broaden the field of aging research, e.g., by engaging minority populations in research and helping to translate research advances into culturally competent, measurable and sustained improvements in health outcomes for underserved communities.
  • Identify, leverage, and disseminate internal and external research and training resources, including relevant NIH funding opportunities across the RCMAR program.
  • Administer and oversee the solicitation, review, selection, and funding of at least two applications per year in a small pilot project program that supports multi-Center collaborative pilot projects conducted in the RCMAR community. The investigative team must involve collaborations among researchers from multiple RCMARs, and/or collaborations with researchers affiliated with other NIH-supported research programs, and/or collaborations involving researchers from other local institutions, including HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups.
  1. Develop and implement strategies to enhance the visibility of the RCMAR program and behavioral and social research on aging and AD/ADRD as a whole and to communicate the importance and value of DEIA in the aging research enterprise. To meet this responsibility, the CC is expected to conduct the following activities:
  • Elevate the voices and broadly disseminate the findings and achievements of RCMAR scientists, collaborators, and mentors.
  • Promote culturally aware and responsive mentorship and professional development training geared toward early career faculty members.

Additional Activities

The CC may propose additional activities to promote collaboration among RCMAR Centers; encourage interactions between the RCMAR program and other NIH- supported centers, programs, and resources; enhance the value and visibility of the RCMAR program; contribute to the educational, training, and professional experiences of early career RCMAR Scientists and mentors; and promote DEIA integration in the aging research enterprise. Such additional activities may include, but are not limited to, the following:

  • Broaden communications among RCMAR- and non-RCMAR participating scientists to enhance cross-disciplinary collaborations relevant to the RCMAR program mission. Activities may include the following: expanding the scope of the annual RCMAR meeting; developing and supporting new meetings on specific cross-disciplinary research topics and/or cross-cutting scientific themes; enhancing virtual communicationsand information sharing, and other innovative activities; and facilitating presentation opportunities for scientists and mentors from HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups. HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups have played an important role in supporting scientific research, particularly on diseases or conditions that disproportionately impact racial/ethnic minorities and other U.S. populations that experience health disparities, though they often lack sufficient capacity to conduct and sustain cutting-edge health-related research. Their researchers are uniquely positioned to bring diverse perspectives and broaden the field of aging research, e.g., by engaging minority populations in research and helping to translate research advances into culturally competent, measurable and sustained improvements in health outcomes for underserved communities.
  • Enhance the rigor of DEIA mentorship and research training experiences by developing and administering certification programs that offer opportunities for specialized training, skill-building, and experiential learning to demonstrate core competencies.
  • Develop and provide additional resources to enhance the conduct of aging and AD/ADRD research studies at individual RCMAR Centers, support novel cross-RCMAR collaborations, or offer other useful resources that benefit the RCMAR network or that individual RCMAR Centers cannot feasibly supply on their own.
  • NIA established new policies and procedures for reporting human subject enrollment data in NIA-supported clinical research studies. The CC and RCMAR Centers may cooperate in developing guidance, templates, information system tools, or other resources, to help Centers comply with these and other policies.

Other Information

Where the CC provides funds to RCMAR Centers for pilot studies, the responsibility for conduct and oversight of such projects lies with the recipient RCMAR Center(s). This responsibility includes the following: reporting through the RCMAR Center's yearly progress report, seeking prior NIA approval for studies involving more than minimal risk human subjects research, and adhering to all relevant animal welfare requirements and human subjects research policies.

Clinical Research Operations Management System- The National Institute on Aging (NIA) supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of a CROMS data templates as specified.

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

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal

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

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

NIA intends to commit a total of $800,000 in fiscal year 2023 to fund one award.

Award Budget

The budget should be consistent with the work proposed, but it must not exceed $800,000 in total costs per year.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIA 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:

Melissa Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: melissa.gerald@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Describe the qualifications of the PD(s)/PI(s), collaborators, and other researchers without duplicating information in the biographical sketches. Describe the experience and training of key personnel in the early stages of their independent careers. Describe the ongoing record of accomplishments of established investigators that have advanced their field(s).

If the project is collaborative or multi-PD/PI, describe investigators' complementary and integrated expertise, leadership approach, and governance and organizational structure, and how activities promoting equity, diversity, and inclusion are carried out across all levels.

Senior/Key Personnel profiles should collectively reflect expertise and experience in the following:

  1. A track record of adaptive, effective, and resourceful leadership and the ability to coordinate and work cooperatively with multiple internal and external stakeholders.
  2. Scientific expertise and leadership in behavioral and social science research related to aging and/or health disparities in older adults, including behavioral and social research on AD/ADRD.
  3. A demonstrated commitment to integrating DEIA principles and practices.
  4. Expertise in program evaluation and analysis and program data management.
  5. Knowledge and practice in interactive web design and development, including designing and developing platforms that are accessible to all members of the public, including people with disabilities, and that depict the multifariousness of America.

R&R Budget

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

Budgets should include funds to support logistical and facilities expenses associated with the RCMAR Scientists' Annual Meeting and the RCMAR Directors’ Annual Meeting. Additional funds may be budgeted for travel awards to meritorious early career scientists attending the RCMAR Scientists' Annual Meeting. Travel for senior RCMAR personnel is the responsibility of each respective RCMAR site.

R&R Subaward Budget

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

Pilot project grants, and any other awards made by the RCMAR CC to recipient institutions, may use a different indirect cost rate than the recipient institution's federally negotiated rate for research. This rate should be specified in the CC's request for applications. Pilot projects are not expected to exceed $500K total costs per year, regardless of the number of awards issued.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims

Present the overall vision for the RCMAR CC and describe the proposed goals and objectives to be achieved by the CC. Describe how achieving these goals and objectives will contribute to advancing the goals, and enhancing the potential impact, of the RCMAR program as a whole.

Research Strategy

Significance: Describe the purpose and functions of the CC. Present a clear statement of how the goals of the CC relate to the goals of the RCMAR program, and how the CC will serve the community of behavioral and social science researchers in aging, AD/ADRD, and health disparities of older adults, within and outside the RCMAR network, and the public. Describe the potential for the CC to integrate DEIA in behavioral and social research on aging and AD/ADRD.

Approach & Innovation: Describe the strategy for addressing the aims of the CC, and the governing, administrative structures, and operation of the CC, and the plans for conflict resolution.

Describe the types of activities the CC will conduct to achieve its goals, the proposed activities of the CC that will be evaluated, and the metrics that will be used to assess performance and outcomes.

Describe the approach for conducting program evaluation and analysis for the RCMAR program.

Describe the approach and novel strategies the CC will employ to enhance the activities and the impact of the RCMAR program and the RCMAR scientists; foster new collaborations within and outside the RCMAR network; and communicate the importance and value of DEIA, to broaden and strengthen the reach of the RCMAR program.

Describe strategies and infrastructure that will be used to support and streamline the routine collection, management, and sharing of RCMAR-related information and data across the RCMAR program. Describe the approach for building consensus with the RCMAR Centers.

Describe proposed processes for soliciting, reviewing, selecting, and awarding direct support for multi-Center collaborative pilot studies involving RCMAR Center collaborations.

Describe strategies and opportunities in the CC for early career Scientists to foster career development and leadership skills, promote networking and collaboration, and enhance grant writing, science communication, and scientific collaborations.

Describe the approach for enhancing the visibility of the RCMAR program and behavioral and social research on aging and AD/ADRD as a whole, and for communicating the importance and value of DEIA in the aging and AD/ADRD research enterprise.

Resource and Coordinating Center Transition Plan

The application is required to describe a plan for the transition of information, materials, and infrastructure developed and produced by the CC through NIA-funding support to a potential successor, for the sustainability of RCMAR resources, regardless of whether a centralized coordinating effort continues at the end of the 5-year project period. This plan must describe approaches to facilitate the transition of the following:

  • The content of the CC’s public website and the CC data and information repository to a self-sustaining, publicly available source;
  • Ongoing documentation of required software, hardware, and licenses; and
  • Resource data and documentary materials regarding the functions, policies, decisions, procedures, operations, or other activities related to the CC, including the processes related to the ongoing maintenance of standard operating procedures, best practices, and documentation for the planning and management of the CC.

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

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIA , 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 NIA Referral Office by email at Ramesh.Vemuri@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed [Center] address the needs of the research [programs/projects/network/consortium/resource] that it will [coordinate/administer/serve]? Is the scope of activities proposed for the [Center] appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research [program/projects/network/consortium/resource]?

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?

Questions Specific to this FOA:

How well do the goals of the proposed CC address the goals of the RCMAR program?

Is the scope of activities proposed for the CC appropriate to meet those needs?

Will successful completion of the aims bring unique advantages or capabilities to the RCMAR program, and contribute to and enhance the goals of the RCMAR program?

Will the CC adequately serve the community of behavioral and social science researchers in aging, AD/ADRD, and health disparities of older adults, within and outside the RCMAR network, and the public?

How effectively will the CC integrate DEIA into behavioral and social research on aging and AD/ADRD?

Investigator(s)

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

In addition, for applications involving clinical trials

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

Questions Specific to this FOA:

Are the PD(s)/PI(s) and other personnel well suited to their roles in the CC? Does the applicant promote the integration of DEIA across activities? Do they have an established track record of adaptive, effective, and resourceful leadership; coordinating and working cooperatively with multiple internal and external stakeholders; and a commitment to DEIA?

Do PD(s)/PI(s) have appropriate expertise and an ongoing record of accomplishments in behavioral and social science research on aging, AD/ADRD, and health disparities in older adults? Is adequate expertise in place in the areas of program evaluation and analysis, program data management, interactive web design and development with DEIA integration, and relational database design and development?

If the project is collaborative or multi-PD/PI, does the applicant adequately describe investigators' complementary and integrated expertise, leadership approach, and governance and organizational structure, and how activities promoting equity, diversity, and inclusion are carried out across t all levels?

Innovation

Does the application propose novel [organizational concepts, management strategies, or instrumentation] in coordinating the research [program/projects/network/consortium/resource] the [Center] will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of [organizational concepts, management strategies or instrumentation] proposed?

In addition, for applications involving clinical trials

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

Question(s) Specific to this FOA:

Will the CC employ novel strategies to enhance the activities and impact of the RCMAR program, and of the RCMAR scientists; foster new collaborations within and outside the RCMAR network; and communicate the importance and value of DEIA, to broaden and strengthen the reach of the RCMAR program?

Approach

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

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?

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?

Questions Specific to this FOA:

How well-described are the types of activities the CC will conduct to achieve its goals, how the CC will evaluate those activities, and the metrics that will be used to assess performance and outcomes? Is the proposed evaluation strategy adequate?

How well-described and appropriate are the strategies and infrastructure that would be used to support and streamline the routine collection, management, and sharing of RCMAR-related information and data across the RCMAR program? Is the approach for building consensus with the RCMAR Centers well-articulated and reasonable?

How reasonable is the plan for soliciting, reviewing, selecting, and awarding direct support for multi-Center collaborative pilot studies involving RCMAR Center collaborations?

How reasonable are the strategies for: enhancing the activities, the visibility, and the impact of the RCMAR program; fostering new collaborations within and outside the RCMAR network; and communicating the importance and value of DEIA in the aging and AD/ADRD research enterprise? What is the likelihood of success of these strategies?

How reasonable and appropriate are the strategies and opportunities in the CC for early career scientists, to foster career development and leadership skills, promote networking and collaboration, and enhance grant writing, science communication and scientific collaborations?

How adequate is the proposed plan for facilitating the transition of information, materials, and infrastructure developed and produced by the CC at the end of the five-year project period?

Environment

Will the institutional environment in which the [Center] will operate contribute to the probability of success in facilitating the research [program/projects/network/consortium] it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the [Center] proposed? Will the [Center] benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

In addition, for applications involving clinical trials

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

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

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

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

Questions Specific to this FOA:

Will the institutional environment in which the CC will operate contribute to the probability of success in facilitating the RCMAR program? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the CC proposed? Will the CC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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

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

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

Not Applicable.

Renewals

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

Revisions

Not Applicable.

Additional Review Considerations

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

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

Authentication of Key Biological and/or Chemical Resources:

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

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 the National Institute on Aging (NIA), 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 FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging (NACA). The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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 award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

  • Determining the overall function, scientific and administrative leadership, governance structure, and objectives of the RCMAR CC.
  • Working collaboratively with RCMAR sites and NIA staff.
  • Maintaining a transparent and fair organizational structure for RCMAR program participants.
  • Including, as appropriate, all active RCMAR Centers in activities coordinated by the U24 coordinating center. A description of currently centers is on NIA's RCMAR webpage . Ensuring that the tools developed by the CC are freely available to all RCMARs and members.
  • Committing and maintaining, throughout the life of the award, the requisite personnel to carry out the proposed work.
  • Implementing procedures to solicit input and feedback from the RCMAR community (current and past affiliates), and, if appropriate, the larger behavioral and social aging and AD/ADRD research community, and integrating those ideas into the activities of the coordinating center.
  • Seeking opportunities for collaboration with NIH networks, consortia, and research resources. These activities may be facilitated by NIA program staff.
  • Agreeing to be an active participant in RCMAR activities, including attending the RCMAR Scientists' Annual Meeting, participating in other RCMAR-sponsored meetings and workshops, and participating in collaborative activities.
  • Planning for the solicitation, scientific review, and funding of applications for multi-site collaborative research pilot projects.
  • Planning for the organization of the RCMAR Scientists' Annual Meeting and RCMAR Directors' Annual Meeting.
  • Representing the RCMAR program by participating in NIA’s Research Centers Collaborative Network and communicating updates to the NIA Project Officer and the RCMAR program.
  • Reporting progress to the NIA program official on a monthly basis, or as needed, on RCMAR CC activities related, but not limited to, the following: research, outreach, collaboration, and other issues of importance to the RCMAR program; activities related to infrastructure development; and coordinating information, data collection, and resource sharing.
  • Providing annual external reporting, in the publication of the RCMAR Annual Report on the CC’s RCMAR website. on Scientists and mentors, study aims of pilots, other research projects, collaborations, and publications and other accomplishments associated with scientists and each Center, and DEIA integration in activities.
  • Annual internal reporting on the CC's progress in meeting the following: the RCMAR program goals ; key performance indicators;  achievements (i.e., number of high-impact publications, NIA/NIH-funded grants, etc.); significant collaborations; and improvements in longitudinal tracking and monitoring of Scientists, mentors, and the outcomes of pilot studies and collaborations.  In addition to the annual internal report, the information will be included in the annual Research Performance Progress Report (RPPR).
  • Collecting common metrics from each Center and sharing benchmarking data with the individual Centers on an annual basis.
  • Participating in twice-yearly video conferences with NIA program staff to coordinate efforts and provide updates on coordinating center activities.

The PD(s)/PI(s) may be expected to provide additional information, outside the scope of the standard reporting requirements, as needed and requested by program staff on a semi-annual basis

Recipients will retain custody of, and have primary rights to, the data and software developed under these awards, subject to government rights of access consistent with current DHHS, PHS, and NIH policies.

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

An NIA Health Scientist Administrator will be the NIA Project Scientist for this award and will be responsible for the following:

  • Providing substantial scientific and programmatic involvement in the conduct of the CC through technical assistance, advice, and coordination.
  • Aiding in coordinating activities with other NIH-supported resources.
  • Assisting, facilitating, and participating, together with the RCMARs and CC, in identifying potential areas of interaction and collaboration among the RCMARs.
  • Facilitating collaborative research efforts that involve multiple RCMARs and the CC.
  • Serving as a resource to recipients in facilitating their broader interactions with other NIH programs, to disseminate results, tools, and models from the RCMARs and take advantage of existing NIH resources and infrastructure.
  • Monitoring, in conjunction with the RCMAR directors, the operations of the CC, and participating in developing and prioritizing program activities and setting the overall direction for the RCMAR program.
  • Reviewing the progress of the CC and taking corrective actions as needed.
  • Participating in the organization of the RCMAR Scientists' Annual Meeting and the RCMAR Directors’ Annual Meeting, specialized workshops, and webinars of the RCMAR program.

Moreover, 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 award notice.

Areas of Joint Responsibility include:

  • Although all responsibilities are divided between recipients and NIH staff as described above, all parties will be active participants in the RCMAR Scientists' Annual Meeting, the RCMAR Directors’ Annual Meeting, specialized workshops, and webinars of the RCMAR program.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the coordinating center 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.All multi-year activity codes except R15 must get multi-year funding authorization from the OER and upload the approval into FOAM with the FOA.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Melissa Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: melissa.gerald@nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: john.bladen@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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