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
Edward R. Roybal Coordinating Center (R24 - Clinical Trial Not Allowed)
Activity Code

R24 Resource-Related Research Projects

Announcement Type
Reissue of RFA-AG-19-008
Related Notices

NOT-OD-22-195 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy

NOT-OD-22-198 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

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

Funding Opportunity Announcement (FOA) Number
RFA-AG-24-008
Companion Funding Opportunity
RFA-AG-24-006 , P30 Center Core Grants
RFA-AG-24-007 , P30 Center Core Grants
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This FOA invites applications from qualified institutions to create a Roybal Center Coordinating Center (CC), serving the needs of the Roybal Centers for Translational Research on Aging program as well as the Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, and Prevention of Alzheimer’s Disease and Related Dementias (AD/ADRD). The Roybal Coordinating Center will serve as the hub for the Roybal Center grant program. Roybal Center programs conduct translational research in the behavioral and social sciences of aging and AD/ADRD, structured in accordance with the NIH Stage Model. Roybal Center program resources are intended for foundational translational research at Stages 0 through V of the behavioral intervention development pipeline, with the goal of producing implementable interventions that are defined by their principles and that improve the health and well-being of mid-life and older people. The Roybal Coordinating Center will facilitate and coordinate trans-Roybal activities, foster collaboration, highlight and disseminate significant Roybal Center research and findings, and create and maintain a system for continued evaluation of Roybal Center progress and products. The Center will work closely with the NIA Program Officer and, in coordination with all Roybal sites, will be responsive to requests generated by key Roybal site personnel, NIA, NIH, the scientific community, and the general public.

Key Dates

Posted Date
March 03, 2023
Open Date (Earliest Submission Date)
May 23, 2023
Letter of Intent Due Date(s)

May 23, 2023

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 23, 2023 June 23, 2023 Not Applicable September 2023 January 2024 April 2024

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
June 24, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This FOA invites applications to establish a Roybal Center Coordinating Center (CC), serving the needs of the Roybal Centers for Translational Research on Aging as well as the Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, and Prevention of Alzheimer’s Disease and Related Dementias (AD/ADRD). The Roybal CC will facilitate and coordinate trans-Roybal activities, foster collaboration, highlight and disseminate significant Roybal Center Program research and findings, establish procedures for ongoing evaluation of program processes, and create and maintain a database of Roybal Program activities and accomplishments to facilitate NIA’s evaluation of Roybal Center progress and products. The Roybal CC will work closely with the NIA Program Officer(s) and, in coordination with all Roybal sites, will be responsive to requests generated by key Roybal site personnel, NIA, NIH, the scientific community, and the general public.

The Roybal CC will facilitate and coordinate all trans-Roybal activities, including virtual and in-person meetings. The Coordinating Center should have requisite expertise in relevant areas across the behavioral intervention development pipeline, from Stage 0 (basic behavioral science) through Stage V (research on strategies for dissemination and implementation), as defined by the NIH Stage Model, to support Roybal Centers in achieving the common goal of developing interventions that are defined by the principles/mechanisms underlying their effects, and of advancing understanding of the Mechanisms of Behavior Change (MoBC).

Need for the Program

The?Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences of Aging?program was authorized by Congress in 1993 and named for the Chair of the former House Select Committee on Aging, Edward R. Roybal. In 2022, NIA evaluated the Roybal program and found that the program has been successful in translating basic behavioral and social science into interventions, programs, and practices that improve the health and well-being of adults as they go through the aging process. NIA considers the Roybal program as a model for translational behavioral and social intervention development research relevant to aging and AD/ADRD.

Roybal Program Goals

The overall goal of the Roybal Centers is to conduct foundational research to develop potent and scalable, principle-defined behavioral interventions, programs, or practices that promote healthy aging and address the burden of AD/ADRD at the individual, group, systems, institutional, or population level. Roybal Centers conduct clinical trials to create, modify, adapt, refine, optimize, and test behavioral interventions to improve the lives of mid-life and older people. Roybal Centers also offer critical research infrastructure to advance progress on translational research priorities in accordance with the?NIH Stage Model. Because Roybals conduct clinical trials in Stages 0 through V of the?NIH Stage Model, the Roybal CC is expected to have appropriate expertise at all relevant Stages.?

The?NIH Stage Model?of behavioral intervention development:?The NIH Stage Model provides a translational framework that integrates basic behavioral science and clinical science to produce principle-driven behavioral interventions. The Model encompasses the full range of behavioral intervention development, from basic psychological science through intervention development, efficacy testing, effectiveness testing, and implementation. It helps to describe where a behavioral intervention is in the developmental pipeline and specifies research activities appropriate for different stages of behavioral intervention development. ("Behavioral" is defined broadly here, including behavioral, psychological, interpersonal, social, or institutional processes and may be designed for use at the individual, family, dyad, group, community, or health systems level). The Model provides a common language to facilitate communication about intervention development research among the scientific community, including applicants, reviewers, and funders. Developing an understanding of the MoBC of an intervention is critical to the NIH Stage Model, so an examination of the MoBC(s) or the principle(s) underlying an intervention is encouraged in every Stage of behavioral intervention development.

For more information on the NIH Stage Model, please see:??https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development and RFA-AG-24-006 and RFA-AG-24-007.

Research Objectives

The Roybal CC is intended to serve as a hub and provide support for all Roybal Centers funded under RFA-AG-24-006 and RFA-AG-24-007 by reinforcing the goals of the NIH Stage Model and facilitating and coordinating trans-Roybal activities.

The Roybal CC will support the individual Roybal Centers by performing the following necessary functions:

Administration: The CC will provide centralized administrative support across the distributed set of Roybal and AD/ADRD Roybal Centers. Administrative responsibilities should include:

  • Supporting a standing Data & Safety Monitoring Board (DSMB) to serve all Roybal Centers. The CC will set aside a portion of its funds to support virtual DSMB meetings.
  • Maintaining a centralized database through which the Roybal Centers and AD-ADRD Roybal Centers can track clinical trial progress, including recruitment and retention data. Facilitate Roybal Center communication with NIA’s Clinical Research Operations & Management System (CROMS).
  • Scheduling and hosting PD/PI recurring (e.g., monthly) virtual meetings, as well as as needed virtual meetings.
  • Arranging a yearly Roybal meeting where scientific advances are shared. In coordination with Roybal Centers for Translational Research on Aging and Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, and Prevention of AD/ADRD, PD/PIs, and NIA program staff, the CC will create the agenda for and chair that meeting. The CC will set aside a portion of its funds to support the Annual Investigators' meeting, to be held at the NIH in Bethesda, MD, or at another site agreed to by the PD/PIs and the NIA.

Coordination: The CC will create mechanisms for maintaining active involvement for all sites in all aspects of the program. Such involvement should include:

  • Facilitating communication and collaboration among the Centers through tools such as list-servs, use of on-line platforms for teamwork, cross-center working groups, etc.
  • Sharing best practices for conducting translational behavioral intervention research in line with the NIH Stage Model.
  • Fostering the use of valid, reliable and harmonized measures of mechanistic targets and clinical outcomes.
  • Fostering communication and cooperative arrangements between all Roybal Centers and other NIA research Centers and Programs (e.g., NIA Research Centers Coordinating Network (RCCN), NIA IMPACT Collaboratory, Resource Centers for Minority Aging Research (RCMAR), Alzheimer's Disease Research Centers (ADRCs), Nathan Shock Centers, Claude D. Pepper Centers, etc.).
  • Developing joint activities between various Roybal sites, based upon available funds. This may include supporting pilot funding, workshops, joint publications, or other collaborative efforts serving the broader Roybal program.
  • Coordinating timely announcements from each Roybal Center for clinical trial applications from individuals outside their Roybal institution and reviewing the requirements for such applications.

Training:

  • Support educational/training activities, including conference symposia and webinars, to foster rigorous, mechanism-focused intervention development science in accordance with the NIH Stage Model.
  • Provide consultation services to answer queries from the scientific and lay communities about the program.

Dissemination: The CC will be proactive in establishing a mechanism for informing and making visible scientific advances of Roybal scientists to the research community, policymakers, and other relevant stakeholders. The CC will:

  • Create and/or maintain centralized infrastructure, resources, and sharing of best practices in the development of principle-based interventions with the NIH Stage Model conceptual framework.
  • Link other NIA-supported research activities and Centers to the unique expertise of the Roybals.
  • Highlight Roybal and AD/ADRD Roybal research advances related to relevant research areas identified by the Program Officer, including advances related to the National Advisory Council on Aging recommendations from their 2019 review of the Division of Behavioral and Social Research, AD/ADRD Research Implementation Milestones, etc.??
  • Keep all Roybal Centers apprised of other participating Roybal Center's scientific activities. Efforts in this regard should involve other NIA-funded Centers and major research projects, such as the Science of Behavior Change initiative, the NIA IMPACT Collaboratory, as well as the broader research community, at relevant national and international scientific meetings.
  • Maintain an active Roybal website with links to each Roybal Center site and the NIA. The website will serve as the source of information dissemination to scientific and lay audiences and will be accessible and readily identifiable. Information should be drawn from the websites of individual Roybal and AD/ADRD Roybal Centers and may include, but is not limited to:
    • PDs/PIs of clinical trials
    • Clinical trial study Stage and proposed pathways through the Stages of intervention development
    • Clinical trial study aims and hypotheses regarding the MoBC and mechanistic targets
    • Descriptions of interventions and outcome measures used in Roybal clinical trials
    • Procedures for training research staff and community providers to deliver interventions with fidelity
    • Publications and other products and accomplishments associated with each Roybal Center
    • Events: Seminars, webinars, conference symposia, etc.
  • Actively demonstrate to a broad audience the Roybals' impact upon the health of mid-life and older Americans through research briefs, press releases, social media, and other means.

Goals and Evaluation of Outcomes

The Roybal CC must include a program evaluation plan which specifies clearly defined short-term and long-term goals and objectives for the Roybal, as well as the specific indicators and metrics that will be used to track progress toward those goals. The routine collection and management of Roybal information for ongoing program evaluation across the Roybal program requires the identification and use of common metrics and processes. The Roybal CC is required to take the lead in reaching a consensus among Roybal Centers on evaluation metrics, and the frequency and method for collection and maintenance of this information. The Roybal CC application should include a strategyfor the identification and use of common metrics and processes. The CC is also charged with creating a system to maintain these data and to share them with NIA to facilitate ongoing and future NIA Roybal program evaluation. All Roybal Centers are required to share information necessary for ongoing evaluation with the Roybal CC.

Possible Roybal potential metrics/measures include, but are not limited to:

  • Number and characteristics of Roybal studies designed to test a hypothesized mechanism of action of an intervention.
  • Number and characteristics of Roybal clinical trials designed to identify the essential components of an intervention.
  • Number and characteristics of fully powered Roybal clinical trials.
  • Data on inclusion and representation and appropriateness of interventions to different social groups for all Roybal clinical trials.
  • Number and characteristics of Stage I clinical trials creating and/or adapting and pilot testing the efficacy training procedures for community providers to deliver an intervention correctly (with sustained fidelity).
  • Number and characteristics of Stage III clinical trials testing the efficacy of training procedures for community providers to deliver an intervention correctly (with sustained fidelity).
  • Number and characteristics of Stage I clinical trials that have been followed by a study testing the efficacy (Stage II or III) of the intervention or the effectiveness (Stage IV) of the intervention.
  • Number of funded (or to-be-funded) (e.g., R01, SBIR, or non-federally funded) clinical trials based upon findings from a Roybal clinical trial.
  • Number and characteristics of clinical trials that have produced data resulting in the successful uptake of a behavioral intervention in the community.
  • Characteristics of strategies used to promote DEIA in the behavioral and social intervention development workforce.
  • Number and scientific backgrounds of investigators supported to develop or conduct clinical trials through the Roybal Center.
  • Number and nature of collaborations with other Roybal Centers; products resulting from collaborations with other Roybal Centers.
  • Number and nature of collaborations with other NIA or NIH funded projects; products resulting from collaborations with other NIA or NIH funded projects.
  • Number and nature of collaborations with organizations outside NIH; products resulting from collaborations with organizations outside NIH.

Frequently Asked Questions?

Responses to frequently asked questions about this FOA will be posted?here.?

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal

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

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

NIA intends to commit $750,000 in fiscal year 2024 to fund 1 award.

Award Budget

Application budgets are limited to $750,000 in total costs per year and need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the 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 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.

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 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:

Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: lisa.onken@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.

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.

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, with the following additional instructions:

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

The CC team is expected to have significant experience and knowledge in the NIH Stage Model and behavioral intervention development research designed to ascertain the mechanisms of behavior change of interventions. The CC team must also include expertise on behavioral and social science research on aging and AD/ADRD, in program management and coordination, and in the evaluation of scientific research programs.

R&R Budget

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

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Present the overall vision for the Roybal CC and describe the proposed goals and objectives to be advanced by the CC. Describe how the Roybal CC will assist in advancing the goal and objective of the Roybal Center program of conducting foundational translational research, in accordance with the NIH Stage Model, to produce implementable interventions that are defined by their principles, and that improve the health and well-being of mid-life and older people. Describe how the CC will contribute to enhancing the potential impact of the Roybal Centers for Translational Research on Aging program, the Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, and Prevention of AD/ADRD, and the Roybal program as a whole.

Research Strategy:

Significance: Describe the purpose and functions of the Roybal CC. Present a clear statement of how the major goals/specific aims of the Roybal CC relate to the goals of the Roybal program, and how the CC will serve the community of behavioral intervention development researchers in aging, in behavioral interventions to prevent AD/ADRD, and in dementia care and caregiver support behavioral intervention research, within and outside the Roybal network, and the public.

Approach & Innovation:

  • Describe the strategy for addressing the aims of the Roybal CC and the governing, administrative structures, and operation of the CC, and the plans for conflict resolution.
  • Describe the types of activities the Roybal 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 Roybal program.
  • Describe the approach and novel strategies the Roybal CC will employ to enhance the activities and the impact of the Roybal program and the Roybal scientists; foster new collaborations within and outside the Roybal network; and communicate the importance and value of mechanism-focused behavioral intervention development, in accordance with the NIH Stage Model, to broaden and strengthen the reach of the Roybal program.
  • Describe strategies and infrastructure that will be used to support and streamline the routine collection, management, and sharing of Roybal-related information and data across the Roybal program. Describe the approach for building consensus with regard to information and data sharing across the Roybal Centers.
  • Describe proposed processes for facilitating multi-Center collaborative studies among two or more Roybal Centers.
  • Describe the approach for enhancing the visibility of the Roybal program.
  • Describe the approach for enhancing the potential impact of the Roybal Centers for Translational Research on Aging program, the Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, and Prevention of AD/ADRD, and the Roybal program as a whole.
  • Describe a plan to support educational/training activities, including conference symposia and webinars, to foster rigorous, mechanism-focused intervention development science in accordance with the NIH Stage Model, and to provide consultation services to answer queries from the scientific and lay communities about the Roybal program.??
  • Describe the CC's plan for establishing a mechanism for informing and making visible scientific advances of Roybal scientists to the research community, policymakers, and other relevant stakeholders.

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 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.
Appendix:

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

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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

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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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 Coordinating Center address the needs of the research programs that it will 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?

Specific to this FOA:

How well-described is the overall vision and the proposed goals and objectives to be advanced by the Coordinating Center?

Is the Coordinating Center likely to assist in advancing the goal and objective of the Roybal Center program of conducting foundational translational research, in accordance with the NIH Stage Model, to produce implementable interventions that are defined by their principles, and that improve the health and well-being of mid-life and older people?

Does the application describe how the Coordinating Center will contribute to enhancing the potential impact of the Roybal Centers for Translational Research on Aging program, the Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, & Prevention of AD/ADRD, and the Roybal program as a whole?

Are the major goals/ specific aims of the Coordinating Center well-aligned with the goals of the Roybal program?

Is the Coordinating Center likely to serve the community of behavioral intervention development researchers in aging, in behavioral interventions to prevent AD/ADRD, in dementia care and caregiver support behavioral intervention research, within and outside the Roybal network, and the public?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Coordinating Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing mechanism-focused behavioral intervention development research? Do the investigators demonstrate significant experience with coordinating collaborative 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?

Innovation

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

Approach

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

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

Specific to this FOA: How well-developed is the strategy for addressing the aims of the Coordinating Center including governance, administrative structures, operation, and plans for conflict resolution? How well-described are the activities the Coordinating Center 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? Is the approach for conducting program analysis and evaluation for the Roybal program logical and appropriate? Are the strategies the Coordinating Center will employ to enhance the activities and the impact of the Roybal program and the Roybal scientists; foster new collaborations within and outside the Roybal network; and communicate the importance and value of mechanism-focused behavioral intervention development, in accordance with the NIH Stage Model, to broaden and strengthen the reach of the Roybal program likely to be successful? Does the application include processes for facilitating multi-Center collaborative studies among two or more Roybal Centers? Is the approach for enhancing the visibility of the Roybal program adequate? How well-described is the plan to support educational/training activities, including conference symposia and webinars, to foster rigorous, mechanism-focused intervention development science in accordance with the NIH Stage Model, and to provide consultation services to answer queries from the scientific and lay communities about the Roybal program? How well-described is the approach for enhancing the potential impact of the Roybal Centers for Translational Research on Aging program, the Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, and Prevention of AD/ADRD, and the Roybal program as a whole?

Environment

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

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.

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 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

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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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 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. 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.

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

2. Administrative and National Policy Requirements

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

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

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

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

Not Applicable

3. Data Management and Sharing

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

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

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH 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: 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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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)

Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: lisa.onken@nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Jeff Ball
National Institute on Aging (NIA)
Telephone: 301-402-7732
Email: BallJ@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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