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
High-Priority Behavioral and Social Research Networks in Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (R24 Clinical Trial Optional)
Activity Code

R24 Resource-Related Research Projects

Announcement Type
Reissue of RFA-AG-19-016
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-AG-22-012
Companion Funding Opportunity
RFA-AG-22-013 , R24 Resource-Related Research Projects
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications to develop new research and research infrastructure via networks for behavioral and social research on Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD); attract new researchers into behavioral and social research on AD/ADRD; infuse a focus on health disparities into AD/ADRD research; and address ongoing needs for harmonization and biomarker collection in large population panel studies to support AD/ADRD research as recommended by the 2019 BSR NACA Review. Network/infrastructure-building activities include, but are not limited to: meetings to develop novel research areas and interact on the development of infrastructure; small-scale pilots; dissemination and outreach activities; and educational activities. NIA seeks to renew critical ongoing network efforts as well as initiate new networks limited to the following priority areas: decision neuroscience and aging; measurement for dementia care in home and community-based services (HCBS); the dementia care workforce; and education and AD/ADRD.

Key Dates

Posted Date
March 18, 2021
Open Date (Earliest Submission Date)
May 23, 2021
Letter of Intent Due Date(s)

May 23, 2021

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, 2021 June 23, 2021 Not Applicable November 2021 January 2022 April 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Expiration Date
June 24, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) invites applications to provide infrastructure support for advancing the development of specific high-priority areas of behavioral and social research relevant to Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD), as well as integrate a focus on health disparities. The infrastructure support will facilitate research networks through meetings, conferences, small-scale pilots, short-term educational opportunities (such as intensive workshops, summer institutes, or visiting scholar programs), and dissemination to encourage the growth and development of the specified priority areas and build resources for the advancement of aging-relevant research in the field at large. Responsive applications must propose network activities in one of the four priority areas listed below and include attention to integrating a focus on health disparities among NIA-defined priority populations within the priority area of interest.

  1. Decision Neuroscience and Aging: This network will incorporate perspectives from psychology, neuroscience, economics, and behavior change in order to promote basic and translational research on decision making in aging, with a focus on the implications for mild cognitive impairment (MCI) and AD/ADRD through scientific meetings, conferences, methods workshops, and small grant competitions. The network is intended to address NIA AD/ADRD Milestone 9.H, "Extend ongoing research on social and emotional functioning and decision-making in MCI/AD to identify early behavioral markers of disease," and Milestone 13.B, "Launch research programs to develop and validate assessments of the psychological, financial, and physical health impact of caregiving."
  2. Measurement for Dementia Care in Home and Community-Based Services (HCBS): This network will focus on improving the measurement of HCBS processes and outcomes (e.g., quality of life and well-being for persons living with dementia (PLWD) and their care partners, economic indicators, service quality measures, disparities in service access and utilization, etc.). Dementia care HCBS researchers often utilize different approaches to data collection, measures and outcomes, and analysis. This network will formalize communications among these investigators on measurement development, such as alignment and crosswalk of data elements across the research community to improve detection of change in the population as well as standardized measures for PLWD and caregivers/care partners. The network is intended to address NIA AD/ADRD Milestone 13.C, "Establish data infrastructure for the study of dementia caregiving."
  3. Dementia Care Workforce: This network will focus on developing innovative research that addresses the skills that the dementia care workforce will need as the population of PLWD grows. Considerations include specialization of treatment; development of data resources to support research, skill matches, and mismatches; the potential impact of worker certification; disparities in access to high-quality work; and the gathering of researchers thinking about how the growth of dementia care will impact the workforce and care of PLWD and providers. The network is intended to address NIA AD/ADRD Milestone 13.J, "Expand research on the care workforce and supply of skilled labor."
  4. Education and AD/ADRD: This network will provide opportunities for collaboration and scholarly exchange between two largely separate research communities, each with unique strengths to address unanswered questions about the education-AD/ADRD relationship: (1) leaders of prospective, population-based studies that follow individuals in early life educational settings into later life; and (2) scholars with expertise on the measurement of cognitive function, decline, and AD/ADRD, as well as mechanistic understanding of potential protective factors and processes. Together, these scholars will develop network activities to produce research resources to advance the study of the relationship between education and AD/ADRD by using and enhancing related NIA-supported data assets. The network is intended to address NIA AD/ADRD Milestone 1.I, "Assess epidemiology and mechanistic pathways of disparities in health burden of AD/ADRD."

Background

The National Institute on Aging, Division of Behavioral and Social Research (BSR) supports research and initiatives on the social, behavioral, and economic factors pertaining to cognitive health and AD/ADRD at both the population and individual levels. A summary of BSR AD/ADRD research objectives is available on the NIA website and in the summary of the 2019 National Advisory Council on Aging Review of the BSR program. Though a significant portion of research supported by BSR in pursuit of the NIA mission falls within a specific discipline or field, BSR encourages transdisciplinary approaches to behavioral and social research. BSR also supports data resources to support analyses that span disciplines. Importantly, BSR encourages cross-cutting research areas, including research on health disparities. The aforementioned 2019 NACA review of BSR cited health disparities among racial/ethnic groups, geographic regions, rural versus urban residents, education levels, immigrant groups, language-use groups, sexes, genders, and socioeconomic statuses as an urgent issue for health research. In response to the recommendations of the review, BSR seeks to integrate a focus on health disparities into our network initiative in order to rapidly enhance resources to study health disparities that can identify pathways to interventions that have the potential to close these health gaps in AD/ADRD research areas. Therefore, all applications must integrate health disparities either through integration of health disparities in the development of an evolving research agenda within a high priority area or as a specific aspect of research resource development proposed.

BSR supports a range of initiatives to seed integrative and transdisciplinary research that exploits new methodologies and knowledge as well as infrastructure development in emerging and high-priority areas of behavioral and social science related to aging. These areas are typically developing rapidly and require ongoing, flexible, and dynamic infrastructure support in order to advance the production of high-quality research and facilitate collaborations between scientists whose diverse areas of expertise are essential for actualizing innovative research in the field. They also require training new investigators and recruiting the best scientists to aging research to ensure continued growth in these fields. Similarly, BSR supports data infrastructure intended to support its behavioral and social research mission: large, representative, longitudinal, multidisciplinary studies integrating biomarkers with comparator studies fielded in several countries around the world. Maintaining and enhancing these data collection efforts is central to supporting cutting edge behavioral and social research in AD/ADRD.

Background information on currently supported BSR networks can be found here.

Background information on currently supported BSR Data Resources for Behavioral and Social Research on Aging can be found here.

Scope

This FOA is designed to address the network development needs of researchers interested in advancing transdisciplinary AD/ADRD-relevant research and innovative research resources in the social and behavioral sciences. Applications must propose efforts to advance one of the above-listed, high-priority, AD/ADRD-relevant research areas in the behavioral and social sciences.

Network support includes all activities designed to bring together leading scientists across disciplines and institutions in order to develop an emerging priority AD/ADRD area. This program is intended to be flexible and support the creation of innovative networks that will propose activities and bring unique resources necessary to advance a set of well-articulated research goals. Applications should be designed to have a substantial impact on the progress and quality of behavioral and social research in AD/ADRD and the development of applicable research resources by virtue of the proposed activities. As networks are intended to serve and support the broader community of behavioral and social researchers engaged in AD/ADRD-relevant research in the designated scientific area, they are consequently unlikely to be limited to a single institution. The networking, education, and infrastructure-building activities required for these efforts are rarely covered under an individual grant, and often do not fit the timelines for typical support mechanisms. Therefore, this FOA is designed to provide research resources that create opportunities to shape the direction of an emerging field by addressing the network and infrastructure development needs required. Applicants must articulate criteria for assessing this progress of network activities advancing the designated high priority area of the proposed project.

Examples of network support activities include, but are not limited to, the following:

  • Meetings, both large and small, to discuss the development of novel research areas and infrastructure.
  • Small-scale pilots to develop data, theoretical frameworks, and/or empirical methods, or support the development of novel or high-risk approaches requiring interdisciplinary collaboration.
  • Dissemination and outreach activities to draw researchers from relevant disciplines into the field.
  • Educational activities such as intensive summer institutes, a series of workshops and related network activities, advanced seminars on methodology, or short-term residential opportunities.

A goal of network projects is to disseminate network resources to the field at large, so each application must provide a dissemination plan. These resources can include, but are not limited to, meeting papers/summaries; scientific publications; web resources; tools or guides to support research or data enhancement; data sets ranging from public-access "user-friendly" research data to meta-data, macro data, or other aggregations of data and supporting documentation to support research; and harmonized versions of existing data or instruments. Dissemination of network resources should be designed to be user-friendly, discoverable by the research community, and easy to access by analysts at all career stages.

Networks may propose to support small-scale pilot projects. Network funding for pilot projects should either advance broad network goals or support preliminary studies with potential to form the basis for independent research applications consistent with network goals. Projects proposing small-scale pilot programs must propose how pilot projects will be solicited and reviewed in the Approach section of the Research Plan. For applications that propose pilot projects with interventions, NIA is interested in Stage I behavioral intervention development, in accordance with the NIH Stage Model which capitalizes on and integrates basic research to inform the development of efficacious interventions for individuals as they age. Pilot studies to develop behavioral interventions that elucidate the social/behavioral mechanisms that account for outcomes are particularly encouraged.

For network activities that span multiple institutions, applicants must describe how those activities will be coordinated across institutions and how the proposed activities will effectively engage with other relevant activities at participating institutions.

NIA encourages potential applicants to contact Scientific/Research staff listed in Section VII to discuss potential network development programs prior to submission of an application. NIA encourages network applicants to support activities that will foster diversity of the scientific workforce.

NOTE: Applicants are strongly encouraged to limit the number of key personnel with substantial roles in the project to avoid establishing conflicts of interest throughout the emerging field. Participation in network activities, including presenting at workshops, serving as faculty on summer institutes, or receiving pilot funding will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application. An important consideration in developing a network is the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team.

Non-Responsive Applications:

  • Applications that do not propose network activities (described above) in one of the four priority aging-relevant areas identified in the Purpose section (i.e., decision neuroscience and aging; measurement for dementia care in home and community-based services (HCBS); dementia care workforce; and education and AD/ADRD).
  • Applications that do not propose to develop research infrastructure in one of the relevant areas identified.
  • Applications that do not propose network activities related to health disparities, either through integration of health disparities in the development of an evolving research agenda or as a specific aspect of research resource development.
  • Applications that propose activities that only serve investigators at a single institution rather than the field at large. Further applications must describe how the proposed activities will have the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team.
  • Applications that do not include a dissemination plan (including a network website) as well as resource and data sharing plans (see Resource Sharing Plan below).

Investigators seeking support for traditional scientific meetings should use PA-20-207 "NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed)". Investigators who wish to seek support for a pre- and post-doctoral research training program should use PA-20-142 "Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32)."

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

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

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?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIA intends to commit $1,275,000 in FY2022 to fund 3 to 4 awards.

Award Budget

Application budgets are limited to $250,000 direct costs 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 Governments

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

Other

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

  • 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) – 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 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.

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

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:

John W. R. Phillips, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-827-4137
Email: John.Phillips@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.

Senior/Key Person profile(s) should include demonstrated experience and an ongoing record of accomplishments in managing transdisciplinary behavioral and social research projects and coordinating collaborative research; include evidence of how they are both established and emerging leaders in the scientific area of focus; include demonstrated expertise in resource sharing through web-based platforms or other means; and include demonstrated experience overseeing the selection and management of subawards, if pilot activities are proposed.

Applicants are strongly encouraged to limit the number of key personnel with substantial roles in the project to avoid establishing conflicts of interest throughout the emerging field. Participation in network activities, including presenting at workshops, serving as faculty on summer institutes, or receiving pilot funding will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application.

R&R Budget

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

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

The application should address how the proposed network activities will advance an emerging field of research relevant to AD/ADRD or enhance/innovate existing research resources. In doing so, the aims must integrate a focus on health disparities into the network activities in order to rapidly enhance resources to study health disparities and, in turn, identify elements of interventions that have the potential to close health gaps in AD/ADRD research areas (e.g., health disparities in racial/ethnic groups, geographic regions, rural versus urban residents, education levels, immigrant groups, language-use groups, sex, gender, and socioeconomic status). The application should propose the implementation of novel activities to advance the aforementioned high-priority topic areas described in the Funding Opportunity Description. Activities can include meetings, conferences, small-scale pilots, short-term educational opportunities (such as intensive workshops, summer institutes, or visiting scholar programs), and dissemination activities to encourage growth and development of specified priority areas and build resources for advancing AD/ADRD-relevant research.

Networks are intended to serve the broader community of behavioral and social researchers engaged in AD/ADRD-relevant research in the designated scientific area and are consequently unlikely to be limited to a single institution. For network activities that span multiple institutions, applicants must explain how those activities will be coordinated across institutions and how the proposed activities will effectively engage with other relevant activities at participating institutions.

The application must include plans for dissemination and access to ensure that the network and its products will be appropriately targeted for the highest impact to potential participants and beneficiaries.

The application must describe how the proposed activities will have the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team.

Network funding for pilot projects should either advance broad network goals or support preliminary studies with potential to form the basis for independent research applications consistent with network goals. Projects proposing small-scale pilot programs must include a description for how pilot projects will be solicited and reviewed in the Approach section. Clinical trials are not permitted for small-scale pilot projects.

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

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, must address both Resource and Data Sharing Plans. The plans should provide details for what will be shared, how it will be organized to enhance the user experience, and any limitations/restrictions on access to resources and data produced by the project.

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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.

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the proposed network address the needs of the research area that it intends to develop? Is the scope of activities proposed for the network appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the emerging field/research resource?

In addition, for applications involving clinical trials

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

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the network? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing transdisciplinary behavioral and social research projects and coordinating collaborative research? Does the team include both established and emerging leaders in the scientific area of focus? Does the team include expertise in resource sharing through web-based platforms or other means? If the Network 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 network? Does the applicant have experience overseeing selection and management of subawards, if needed?

In addition, for applications involving clinical trials

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the application propose novel approaches to advancing interdisciplinary research or develop innovative research resources in the defined high priority scientific area the network will serve? Does the application address how the proposed networking activities will advance an emerging field of research relevant to AD/ADRD and why these goals cannot be met through existing institutional programs or structures? Does the application propose new high impact activities that are not feasible with existing resources?

In addition, for applications involving clinical trials

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the network? Does the application appropriately address how the proposed network will have a substantial impact on the progress and quality of behavioral and social research of relevance to AD/ADRD, by virtue of the proposed activities?

Are the proposed network activities likely to serve the broader community of behavioral and social researchers engaged in AD/ADRD-relevant research in the designated scientific area beyond a single institution or set of institutions? For applications that span multiple institutions, are appropriate procedures in place for coordination across institutions and for effectively engaging with other relevant activities at participating institutions?

Is there an appropriate plan for dissemination of network products to the field at large that will ensure that the network and its products will be appropriately targeted to potential participants and beneficiaries with the highest impact? Does the application address how the proposed activities will have the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team? Are the resource/data sharing plans sufficiently developed to ensure network products are discoverable and shared in a user-friendly fashion.

If small scale pilot projects are proposed, is the approach for soliciting and reviewing pilot projects appropriately aligned with networks goals and likely to advance progress in the field at large?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Will the institutional environment in which the network will operate contribute to the probability of success in facilitating progress in the field? Are the institutional support, equipment and other physical resources available to the investigators adequate for the network proposed? Will the network benefit from unique features of the institutional environments, infrastructure, or personnel? Are resources available within the participating scientific environment to support electronic information handling and development of web resources for dissemination of network products?

In addition, for applications involving clinical trials

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

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

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

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

Additional Review Criteria

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

Integration of Health Disparities Research

Does the application effectively integrate health disparities into the network model for developing a defined high-priority area?

Study Timeline

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

 

Renewals

 

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

Revisions

Not Applicable

 

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For 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 Insitute 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 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.

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.

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

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 “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 submission by the due date, and post-submission issues)

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

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

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

Scientific/Research Contact(s)

John W. R. Phillips, PhD
National Institute on Aging (NIA)
Telephone: 301- 827-4137
Email: John.Phillips@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: Ryan.Blakeney@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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