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

Demography and Economics of Aging and AD/ADRD Coordinating Center (R24 Clinical Trial Not Allowed)

Activity Code

R24 Resource-Related Research Projects

Announcement Type

New

Related Notices
  • November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228.
Funding Opportunity Announcement (FOA) Number

RFA-AG-20-003

Companion Funding Opportunity

RFA-AG-20-001, P30 Center Core Grants

RFA-AG-20-002, P30 Center Core Grants

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866  

Funding Opportunity Purpose

This FOA invites applications for a Demography and Economics of Aging and AD/ADRD Coordinating Center (CC) whose purpose is to act as a hub, serving the needs of both traditional Centers on the Demography and Economics of Aging (D&E Centers) and Centers on the Demography and Economics of Alzheimer's Disease and Alzheimer's Related Dementias (D&E Centers on AD/ADRD), as well as the needs of NIA program staff. The goals of the overall D&E Center program are to seed new lines of research in a) the demography and economics of aging and b) demography, economics and health services research relevant to AD/ADRD, and to grow the number of researchers engaged in these fields through a variety of research and infrastructure activities that are built around specific research themes. The purpose of the CC is to work collaboratively with all participating Center sites to: maintain an active multi-center website; disseminate Center research advances, activities and resources to the research community, policymakers and other relevant stakeholders; maintain a centralized database to track and synthesize progress and outcomes of Center and CC activities for the purpose of annual reporting to individual Centers and to NIA Program Staff, and for future program evaluation by NIA; arrange an annual in-person meeting; foster communication and collaborative activities within and across both D&E Center programs and with other NIA research Centers; serve as the point-of-contact for the overall D&E Centers program by NIA staff, other NIA Centers and the broader scientific community.      

Key Dates
Posted Date

October 30, 2018

Open Date (Earliest Submission Date)

May 3, 2019

Letter of Intent Due Date(s)

May 3, 2019

Application Due Date(s)

June 3, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2019

Advisory Council Review

January 2020

Earliest Start Date

April 2020

Expiration Date

June 4, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 the 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 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    Purpose

    This FOA invites applications for a Demography and Economics of Aging and AD/ADRD Coordinating Center (CC) whose purpose is to act as a hub, serving the needs of both traditional Centers on the Demography and Economics of Aging (D&E Centers) and Centers on the Demography and Economics of Alzheimer's Disease and Alzheimer's Related Dementias (D&E Centers on AD/ADRD), as well as the needs of NIA program staff. The goals of the overall D&E Center program are to seed new lines of research in a) the demography and economics of aging and b) demography, economics and health services research relevant to AD/ADRD, and to grow the number of researchers engaged in these fields through a variety of research and infrastructure activities that are built around specific research themes. The purpose of the CC is to work collaboratively with all participating Center sites to: maintain an active multi-center website; disseminate Center research advances, activities and resources to the research community, policymakers and other relevant stakeholders; maintain a centralized database to track and synthesize progress and outcomes of Center and CC activities for the purpose of annual reporting to individual Centers and to NIA Program Staff, and for future program evaluation by NIA; arrange an annual in-person meeting; foster communication and collaborative activities within and across both D&E Center programs and with other NIA research Centers; serve as the point-of-contact for the overall D&E Centers program by NIA staff, other NIA Centers and the broader scientific community.

    Background

    The Centers on the Demography and Economics of Aging (P30) Program was initiated in 1994 to seed new lines of research in the demography and economics of aging and grow the number of researchers engaged in the field through a variety of activities, as described below. In 2017, the NIA evaluated the D&E Centers program and found that the program has been successful as the primary mechanism for incubating the development of research in demography and economics of aging. Information on the 11 currently-active D&E Centers is available at https://www.nia.nih.gov/research/dbsr/centers-demography-and-economics-aging. The 2017 NIA evaluation also determined that research on Alzheimer's Disease and Alzheimer's Related Dementias (AD/ADRD), such as vascular dementia, Lewy body dementia or frontotemporal degeneration, could be significantly enhanced by expanding the NIA D&E Centers program to include Centers focused exclusively on demography, economics and health services research relevant to AD/ADRD (henceforth referred to as D&E Centers on AD/ADRD). Therefore, the current cycle of funding will support two sorts of D&E Centers, one that has a broad focus on demography and economics of aging and one that will focus on AD/ADRD topics.

    Goals of NIA Center Programs on Demography and Economics of Aging and Demography and Economics of AD/ADRD 

    Both the D&E Centers Program and the D&E Centers on AD/ADRD Program are designed with two mandatory Cores (Administrative and Research Support and Program Development/Pilot) to support the infrastructure and pilot data necessary for research and program development, around selected research themes, by investigators within an institution and/or across domestic and international institutions. Centers may also choose among three optional Cores: External Innovative Network Core, External Research Resources Support and Dissemination Core, and Data Enclave Core. Through the mandatory and optional Cores, NIA hopes to achieve the following objectives: establish innovative national and international networks of researchers to advance scientific discourse in selected areas; recruit new researchers into demography and economics of aging; recruit new researchers into demography, economics and health services research relevant to AD/ADRD; convene innovative conferences, workshops and meetings to advance new areas of research; develop and enhance sharing of relevant databases; support the rapid application of research results from these databases; and develop remote data enclaves and data sharing methods for the analysis of large-scale, often-longitudinal, databases with linked administrative, electronic health record, biological and/or genetic information. 

    Center applications must select research theme(s) and topic areas of focus around which the Center Cores are designed. 

    Examples of research themes for D&E Centers include but are not limited to:

    • Determinants of population trends at older ages in physical and cognitive functioning (including AD/ADRD), disability, morbidity, mortality, health and well-being.
    • Life course pathways by which social, behavioral, environmental and structural risk and protective factors lead to disparities in health outcomes.
    • Mechanisms through which socioeconomic status, race/ethnicity, and other factors operate as risk factors for poor health and health disparities at older ages.
    • Interrelationships between work, family and health, and the consequences of work trajectories for health outcomes at older ages.
    • How environmental, social, economic, institutional, structural, and other factors affect health and well-being, including health-related behaviors, healthcare utilization, health disparities, and responses to public health interventions.
    • Influence on the aging process and aging outcomes of different social, economic, familial, environmental, geographic, cultural and institutional contexts.
    • Consequences of U.S. and global population aging/demographic change for the care and well-being of older people with disease and disability, including AD/ADRD.
    • Integration of genetic approaches and data on biological risk into social science population research on aging. 
    • Effects of population-level interventions on health, health delivery, quality of care, and disparities.
    • Impact of health care services, the health care system, and long-term supports and services, including organizational influences, on the health and well-being of older persons with chronic disease, disability and AD/ADRD, and on their care providers.

    Areas of focus that are especially encouraged are: a) socioeconomic status (SES) disparities at older ages, including geographic disparities; b) the reasons for poor U.S. performance in health and mortality in international comparisons; c) trends and dynamics in old-age disability; d) cohort trends in obesity and its sequelae; e) family demography including the demography of care and caregiving for chronic disease, disability and AD/ADRD, and; f) long-term supports and services for the disabled elderly population.

    Examples of research themes for D&E Centers on AD/ADRD include but are not limited to:

    • National and international population trends and trajectories in cognitive aging and AD/ADRD, including causes and consequences of disparities by race/ethnicity, gender, and socioeconomic status. Research in this area should consider factors such as advances in treatment for chronic conditions that affect risk of dementia, changes in behavioral risk factors, and innovations in diagnosis and treatments.  Research is also encouraged on methodological factors that influence population estimates such as dementia ascertainment, mode of response, interview characteristics, interview setting, proxies, etc.
    • National and international projections of dementia caseload, incidence and prevalence useful for planning appropriate public and private sector responses to the disease.
    • Demography of dementia care and caregiving.
    • Economic burden of AD/ADRD.  Examples include improved methods for measuring quality of life of persons with dementia and their caregivers; and improved methods for developing measures of the costs of dementia and how they are met over the entire course of disease by individuals, families, communities, and/or health systems.
    • Impact of health care systems and long-term supports and services (LTSS) on outcomes for persons with dementia and their care providers; this includes how outcomes differ for people living alone.
    • Impact of health care financing policies on outcomes for persons with dementia and their care providers.
    • Impact of regulatory and economic incentives on access, quality and health outcomes in health and long-term care systems for persons with dementia.
    • Disparities in quality and access to dementia care.  Examples include the mechanisms and risk factors that explain disparities in service access and quality for persons with dementia and their caregivers; and how institutional and social contexts influence disparities in service access and quality.
    • Effects of population-level health delivery and care interventions on outcomes of persons with dementia. 

    Center themes may, as relevant, be advanced by collaborations, data sharing and interdisciplinary interactions with related scientific fields as long as they are designed to advance research on how demographic, social, economic, institutional, geographic and other factors at the population level influence health at older ages. "Health” is broadly defined to include physical and cognitive functioning (including Alzheimer’s Disease and Alzheimer's-Related Dementias, AD/ADRD), disability, morbidity, and well-being. Collaboration is encouraged with other D&E Centers as well as other NIA-funded Centers programs, and comparative international research is encouraged. 

    Research Objectives

    The Demography and Economics of Aging and AD/ADRD Coordinating Center (CC) is intended to serve as a hub for the overall D&E Centers program, serving the needs of both traditional Centers on the Demography and Economics of Aging (D&E Centers) and the Centers on the Demography and Economics of Alzheimer's Disease and Alzheimer's Related Dementias (D&E Centers on AD/ADRD), as well as the needs of NIA program staff. Examples of Coordinating Center functions include but are not limited to:

    • Maintaining an active multi-center website with links to each D&E Center and D&E Center on AD/ADRD site and to the NIA. The website will serve as the source of information dissemination to scientific and lay audiences and will be accessible and readily identifiable.
    • Developing research briefs, blogs or other means to highlight and disseminate Center research advances, activities and resources to the research community, policymakers and other relevant stakeholders and to demonstrate to a broad and diverse audience the overall Center program's impact upon the health and well-being of older people.
    • Developing and maintaining a centralized database through which progress and outcomes of Center Core activities (including activities of the CC) can be tracked and synthesized for annual reporting by the CC to Centers and to NIA program staff, and for future program evaluation by NIA. In order to achieve this objective, it is expected that the CC will develop a standardized reporting template for Centers to use that is designed to facilitate annual reporting and future NIA program evaluation. Examples of potential metrics/measures include: number and outcomes of pilot projects funded; number of new researchers brought into social science aging research topic areas; scientific impact of publications directly supported by Center pilot projects and networks; number of users of Remote Enclaves; number of scientific publications that were made possible by D&E Center-supported Remote Enclaves; number and impact of workshops, seminars, research networks; number of data resources and data users supported; impact of research dissemination activities, etc.   
    • Arranging one annual in-person meeting at the Population Association of America or at NIH to be attended by PD/PIs and other representatives of the D&E Centers and the D&E Centers on AD/ADRD In coordination with Center PD/PIs and NIA program staff, the CC will create the agenda for and chair that meeting. The purpose of the annual meeting is for Centers to share updates and scientific advances, discuss and plan cross-Center collaborative activities, discuss and plan activities that are relevant to NIA/NIH research priorities, etc. The CC will set aside a portion of its funds to support the annual meeting.
    • Fostering communication and collaborative activities within and across both D&E Center Programs and with other NIA research Centers (e.g., Edward R. Roybal Centers for Translational Research on Aging, the Resource Centers for Minority Aging Research, the Claude D. Pepper Older American Independence Centers, the Alzheimer's Disease Research Centers, and the National Archive of Computerized Data on Aging). This may include facilitating the networking of Center researchers for the purpose of advancing innovative pilot projects or workshops; coordinating workshops or conferences; and sponsoring multi-Center activities such as pilot projects or workshops (including travel to workshops), etc., based upon available funds.   
    • Arranging and hosting Center PD/PI and Center Administrator conference calls, as needed.
    • Responding to queries by the NIA Program Official on behalf of both D&E Center Programs.
    • Working closely with the NIA Program Official and, in coordination with all Center sites, respond to requests generated by key site personnel, NIA, NIH, the scientific community, and the general public. 
    • Linking other NIA- and NIH-supported research activities and Centers to the unique expertise of the D&E Centers and D&E Centers on AD/ADRD.

    Additional activities or functions may be proposed to promote collaboration across Center sites (both D&E Centers and D&E Centers on AD/ADRD), encourage interactions between the D&E Center programs and other NIA and NIH-supported resources, and to enhance the value and visibility of both D&E Center Programs.

    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

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    NIA intends to commit $250,000 in direct costs in FY 2020 to fund 1 award.

    Award Budget

    Application budgets are not limited but need to reflect the actual needs of the proposed project.

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)

    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)
    • 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 not allowed.

    Required Registrations

    Applicant Organizations

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

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – 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. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

    The PD/PI and the CC team are expected to have significant knowledge about priority areas in social science research on aging; experience in promoting collaboration across different research groups or institutions; and experience in program management and coordination.

    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.  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 NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms 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 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.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    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:

    Georgeanne E. Patmios

    National Institute on Aging (NIA)
    Telephone: 301-496-3136
    Email: PatmiosG@mail.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. 

    R&R Budget

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

    The CC application budget should include funds for organizing and attending a joint, in-person, annual meeting of the D&E Centers and the D&E Centers on AD/ADRD. The CC is not responsible for the travel of participants from individual Center sites to the annual meeting.

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Research Strategy: Describe plans, including the organizational plan and management structure, for accomplishing the following objectives:

    Working in collaboration with approximately 11-14 traditional D&E Centers and D&E Centers on AD/ADRD to: maintain an active multi-center website; disseminate Center research advances, activities and resources to the research community, policymakers and other relevant stakeholders; maintain a centralized database to track progress and outcomes of Center and CC activities for the purpose of annual reporting to individual Centers and to NIA Program Staff, and for future program evaluation by NIA; arrange an annual in-person meeting; foster communication and collaborative activities within and across both D&E Center programs and with other NIA research Centers; and serve as the point-of-contact for the overall D&E Centers program by NIA staff, other NIA Centers and the broader scientific community.

    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, with the following modification:

    • 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 NIH-defined human subjects research, clinical research, and/or 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

    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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number 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 components of participating organizations, 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

    Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Coordinating Center 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 Centers that it will coordinate and serve? Is the scope of activities proposed appropriate to meet those needs? Will successful completion of the aims bring added value or unique advantages or capabilities to the scientific activities and accomplishments of the Center programs served? 

    Does the proposed Coordinating Center address the reporting and evaluation needs of the NIA? Is there strong evidence of the availability of sufficient scientific expertise and of the ability to work with scientists to serve as the overall D&E Centers' point-of-contact for a broad scientific and policy-oriented community?    

    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 social science research? Do the investigators demonstrate significant experience with coordinating collaborative social science research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

    Does the investigative team have relevant experience and expertise in project management and coordination required for this Coordinating Center? Will the investigative team proposed be able to facilitate cooperation across a wide range of social science fields? 

    Innovation

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

    Approach

    Are the overall strategy, operational plan and organizational structure well-reasoned and appropriate to accomplish the goals of the Coordinating Center and the goals of the Center Programs that the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Coordinating Center and the Center Programs the Coordinating Center will serve, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Coordinating Center is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Coordinating Center? 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?

    To what extent will the Coordinating Center facilitate the effectiveness and impact of the Centers on Demography and Economics of Aging and the Centers on Demography and Economics of AD/ADRD? Is the approach to the coordinating functions effective? Are the proposed procedures for communication, cooperation, and fostering collaboration among the Centers adequate? Are there appropriate plans to coordinate interaction between the overall D&E Centers program and other NIA Center programs? Are there appropriate plans to collect, maintain and synthesize data to achieve NIA's reporting and program evaluation needs? 

    Environment

    Will the institutional environment in which the Coordinating Center will operate contribute to the probability of success in facilitating the research activities of the Centers 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 Coordinating Center 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 six 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 six 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 Children 

    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 children 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

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

    As applicable for the Coordinating Center 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 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 the National Institute on Aging, 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:

    • 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.
    • Will receive a written critique.

    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 grantee’s business official.

    Awardees 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.

    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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 “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. Reporting

    When multiple years are involved, awardees 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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 on-time submission, 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 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)

    Georgeanne E. Patmios
    National Institute on Aging (NIA)
    Telephone: 301-496-3136
    Email: PatmiosG@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Nia Pree
    National Institute on Aging (NIA)
    Telephone: 301-827-6374
    Email: nia.pree@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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