Part 1. Overview Information

Key Dates

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

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

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

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

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The National Institute on Aging's (NIA's) Division of Behavioral and Social Research (BSR) supports basic behavioral, social, psychological, and economic research and research training on the processes of aging at both the individual and societal level. A summary of BSR research objectives is available on the NIA website and in the report from the2019 National Advisory Council on Aging Reviewof the BSR program. Though a significant portion of research supported by BSR in pursuit of NIA's mission falls within a specific discipline or field, the division encourages transdisciplinary approaches to behavioral and social research.

BSR’s AD/ADRD priority areas in Cognitive and Dementia Epidemiology and Behavioral and Social Pathways to AD/ADRD, as well as AD/ADRD milestones 1C. Diverse new cohorts and 2.J Disease mechanisms: Social and psychosocial factors motivate the goals of: 1) providing the research community with comparable estimates of AD/ADRD across countries, and 2) supporting cross-national research on AD/ADRD that can help us better understand how aging in different institutional, policy, environmental, economic, social, geographical, and cultural contexts can lead to different AD/ADRD-related outcomes for individuals and populations.

The Harmonized Cognitive Assessment Protocol (HCAP), a sub-study of the Health and Retirement Study (HRS), provides a framework to achieve these goals. HCAP seeks to measure and understand dementia risk by using a selected set of established cognitive and neuropsychological assessments, as well as informant reports, to better characterize cognitive function among older people.

While typical research grants support research and data production for many areas of behavioral and social science in aging, some emerging, transdisciplinary, and high-priority research areas require more nimble resources to flourish. NIA has successfully fostered such research areas through the development of research networks, flexible programs intended to support the creation of innovative research and research resources. BSR utilized the network approach to advance the adoption of the HCAP internationally, thereby accelerating the study of international differences in the prevalence, incidence, and outcomes of dementia globally with comparable data. The HCAP Network has facilitated the fielding of similar HCAP projects in multiple countries around the world through numerous coordination activities. To date, HCAP data has been collected in seven countries: the U.S., England, Mexico, Chile, India, China, and South Africa. In addition, data collection is planned or has been initiated in the Czech Republic, Denmark, France, Germany, Italy, Ireland, Northern Ireland, the Dominican Republic, Lebanon, and Nepal.

With additional waves of the HCAP studies across countries, harmonization of data and coordinated analyses will be vital. Thus, there is a need for continued support for a network focused on these activities.

Research Objectives

This NOFO invites applications to support the continuation of the HCAP Network. This network supports harmonization and collaboration across international studies conducting the HCAP, which provides new and rich data to study the prevalence, predictors, outcomes, and future trends in cognitive functioning and dementia, as well as cross-national comparisons.

Network support includes all activities designed to bring together leading scientists across disciplines and institutions to develop resources for HCAP Network members. The application should explain how the proposed network will have a substantial impact on the progress and quality of behavioral and social research on AD/ADRD using HCAP and associated HRS international studies by virtue of the proposed activities. Networks are intended to serve the broader community of behavioral and social researchers engaged in AD/ADRD-relevant research in cognitive and dementia epidemiology and are consequently unlikely to be limited to a single institution.

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

• Meetings, both large and small, to develop novel research areas and strategize on the development of infrastructure related to the HCAP.
• Small-scale pilots to test or tailor measures in new populations or contexts; develop data, theoretical frameworks, or empirical methods; or support the development of novel or high-risk approaches requiring interdisciplinary collaboration.
• Educational activities such as intensive summer institutes, series of workshops and related network activities, advanced seminars on methodology, or short-term residential opportunities including exchanges of scientists and trainees across the international partners.
• Development of guidance on selected topics such as biomarkers, diagnosis and classification of dementia, protocol development, fieldwork challenges, statistical harmonization, and analytic methods to current members of the HCAP International AD/ADRD Research Network as well to new/potential entrants into the HCAP family of studies.
• Dissemination and outreach activities to draw researchers from relevant disciplines into the field and broaden awareness of the HCAP.
• Coordination of activities with other related networks on AD/ADRD and other networks harmonizing the HRS family of studies.

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. Furthermore, the researchers that can support a successful network in an emerging area often span multiple disciplines and are rarely located at a single institution. Therefore, this NOFO is designed to provide the research resources and network development needed to create opportunities to shape the direction of an emerging field.

Resource Dissemination: A goal of network projects is to disseminate network resources to the field at large. 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 to support research; and harmonized versions of existing data or instruments.

Pilot Projects: 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 explain how pilot projects will be solicited and reviewed in the Approach section of the Research Plan.

Note on Key Personnel: To avoid establishing conflicts of interest throughout the emerging field, applicants are strongly encouraged to limit the number of key personnel on network applications. Except for those key personnel listed on the application, participation in network activities, including presentation at workshops, serving as faculty on summer institutes, or receiving pilot funding, will not constitute formal collaboration from the perspective of NIH. Network activities are intended to advance the field at large. 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.

For network activities that span multiple institutions, applicants are encouraged to propose how those activities will be coordinated across institutions and how the proposed activities will effectively engage with other relevant activities at participating institutions. Projects must propose a plan for dissemination of network products to the field at large.

NIA encourages potential applicants to contact the Scientific/Research staff listed in Section VII of this NOFO to discuss potential network development programs prior to submission of an application. NIA is committed to supporting a sustainable and diverse biomedical research workforce. Individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences research workforce are encouraged to apply (see NOT-OD-20-031 and NOT-OD-22-019).

Non-Responsiveness Criteria

The following types of applications will be considered non-responsive and will be withdrawn prior to review.

• Applications that do not propose network development activities (described above) for the HCAP International AD/ADRD Research Network.
• Applications that propose activities that only serve investigators at a single institution rather than the field at large.
• Applications that do not 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 sharing plans and data management and sharing plans (DMS Plans).
• Applications proposing pilot programs that do not describe approaches for soliciting and reviewing pilot proposals.

Investigators seeking support for traditional scientific meetings should usePA-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)."

Resources for Applicants

Background information on currently supported Behavioral and Social Research Networks

Background information on currently supported Data Resources for Behavioral and Social Research on Aging

Responses to Frequently Asked Questions about this NOFO

Infrastructure:

• Gateway to Global Aging
• HCAP Network
• Health and Retirement Studies Around the World Network

Studies that currently have HCAP data available:

• Chile-Cog
• China Health and Retirement Longitudinal Study (CHARLS-HCAP)
• English Longitudinal Study of Ageing (ELSA): Healthy Cognitive Ageing Project (ELSA-HCAP)
• Longitudinal Aging Study in India: Diagnostic Assessment of Dementia (LASI-DAD)
• Mexican Health and Aging Study: Cognitive Aging Ancillary Study (Mex-Cog)
• Health and Aging in Africa: Longitudinal Studies in Three INDEPTH Communities (HAALSI)
• Harmonized Cognitive Assessment Protocol (HCAP) (US)

Studies which will have HCAP data available soon:

• The Caribbean-American Dementia and Aging Study
• Survey of Health, Aging, and Retirement in Europe-HCAP (SHARE-HCAP)
• The Irish Longitudinal Study on Ageing
• The Northern Ireland Longitudinal Study of Ageing
• Lebanon Study on Aging and HeAlth
• Chitwan Valley Family Study (Nepal)

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

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
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

The purpose of this limited competition NOFO is to continue implementation of the HCAP Network. Continuation of this Network requires both familiarity with Harmonized Cognitive Assessment Protocol (HCAP) and experiencing leading networks. Therefore, this NOFO is limited to applicants with both sets of skills.

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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:

Minki Chatterji, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-8788
Email: [email protected]

Page Limitations

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

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

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.

The investigative team must include demonstrated experience and an ongoing record of accomplishments in managing transdisciplinary behavioral and social research projects and coordinating collaborative research. Applications must include evidence of how the investigators: (1) are established and emerging leaders in conducting and facilitating cross-country comparisons and individual country studies using the Harmonized Cognitive Assessment Protocol (HCAP) data; (2) have demonstrated experience in resource sharing through web-based platforms or other means; and (3) have demonstrated experience overseeing the selection and management of subawards, if pilot activities are proposed.

Note on Key Personnel: To avoid establishing conflicts of interest throughout the emerging filed, applicants are strongly encouraged to limit the number of key personnel on network applications. Except for those key personnel listed on the application, participation in network activities, including presentation at workshops, serving as faculty on summer institutes, or receiving pilot funding, will not constitute formal collaboration from the perspective of NIH.

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

Applications must propose the implementation of novel activities to advance AD/ADRD data harmonization in the HCAP Network. Activities can include meetings, conferences, small-scale pilots, short-term educational opportunities (such as intensive workshops, summer institutes, or visiting scholar programs), development of guidance on selected topics, dissemination activities, and coordination with other related networks on AD/ADRD to encourage growth and development of international AD/ADRD research and build resources for advancing aging-relevant research.

Applications must address how the proposed network will have a substantial impact on the progress and quality of cross-country comparisons and individual country studies using the HCAP data, by virtue of the proposed activities Networks are intended to serve the broader community of behavioral and social researchers engaged in aging-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. 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 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.

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 the 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.

NOTE: Network pilots involving human subjects must submit human subjects inclusion information in the annual RPPR. Progress on pilot projects must be reported in the annual RPPR.

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.

All applications, regardless of the amount of direct costs requested for any one year, must address Resource 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 produced by the project.

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

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the submission process and a definition of on-time submission are provided in 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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

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

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

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on 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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

2. Administrative and National Policy Requirements

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

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

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

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

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• The Principal Investigator(s) will have the primary responsibility for the design and details of the project funded from this NOFO and will retain primary responsibility for performance of the activities. The recipient(s) agree(s) to accept assistance from the designated NIH Program Official and Project Scientists in aspects of the scientific and technical management of the study/studies and in coordinating with other Federal agencies.
• After award, the PD/PI(s) should work with the study’s co-Investigators group plus experts in the scientific community and who are not connected with the project except in this capacity, to advise the PD/PI(s) on the overall scientific and financial management of the project and on the recruitment of new investigators to the project as necessary.
• The PD/PI(s) will provide details for what data 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. Network products should be discoverable and shared in a user-friendly fashion. Data Sharing Plan should in accordance with the NIH Data Sharing Policy.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• NIH Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH Project Scientist will assist in refining study objectives and activities, including pilot projects, representing the scientific objectives of Research Network for HCAP as they relate to the aims (e.g., recommendations on workshop topics, areas for collaboration, projects for dissemination, etc.).
• An NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award, including pilot projects. The NIH Program Official will approve all major stages of the project and all new major additions/changes to planned activities. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIH Program Official for any replacements of key personnel or other changes in subawards. The NIH Program Official will serve as the primary programmatic/administrative liaison to the Research Network for the HCAP project.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• None; all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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

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

4. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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.

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Minki Chatterji, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-8788
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: [email protected]

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]

Section VIII. Other Information

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

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