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.

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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Background
Research Objectives
Non-Responsiveness Criteria
Resources for Applicants:
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Letter of Intent
SF424(R&R) Senior/Key Person Profile
PHS 398 Research Plan
Section V. Application Review Information
Section VI. Award Administration Information
2. Administrative and National Policy Requirements
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Recent clinical trials and observational studies suggest that targeting disease and modifiable risk factors in midlife or earlier can help prevent or delay significant cognitive and functional impairment in AD/ADRD. However, only 15% of AD/ADRD research has participants with a mean age of <60 years and only around3% has participants with a mean age of <50 years. The National Plan to Address Alzheimer's Disease's Milestone 8.D details the need for primary prevention trials for non-pharmacological interventions in midlife and describes successful trials as those that will provide evidence for potential therapeutic mechanisms (e.g., cognitive, behavioral, social, computational, biological) and include the collection of biomarker data for future validation and longitudinal follow-up within the trial cohort. However, evidence that would inform the design of such primary prevention trials in AD/ADRD, including leading therapeutic mechanisms, is mixed. A 2017 report from the National Academies of Sciences, Engineering, and Medicine (NASEM) suggested numerous ways to construct a stronger evidence base for the prevention of cognitive decline and AD/ADRD. This was followed by several meetings convened by the NIA, which emphasized that targeting measurement needs was a critical first step for a successful AD/ADRD primary prevention approach.  

In order to meet these goals, the field needs to develop, validate, and standardize measures for outcomes and mechanisms of action, as well as moderators for midlife trials. Mechanisms of action can include multiple levels of analysis (e.g. cognitive, behavioral, structural/social, computational, biological). Measurement methods can include considerations of study design, protocol development (e.g., devices for measures administration and data generation, software implementation of measures administration and data generation), and algorithmic approaches to address bias in measures and for harmonization purposes. Specific needs include: 1) measurement approaches to detect changes in function in those without evidence of disease (e.g., before 65 years, before dementia diagnosis), which are slow, subtle, and variable; 2) earlier detection of small changes in midlife to allow maximally responsive preventative interventions; 3) integration of cognitive and non-cognitive, biomarker, behavioral, psychosocial, and functional measures; 4) measures that eliminate, minimize, or rigorously account for ethnocultural bias; 5) brief, valid measures that relate to clinically meaningful outcomes and real-world function; 6) efficient measures developed using advances in measurement methods (e.g., multidimensional item response theory); and 7) rigorous, efficient, and flexible longitudinal study designs (e.g., ecological momentary assessment, intensive measurement burst designs) to optimize sensitivity, assessment across critical periods of change, and enable participant-centered research.  

Open principles and practices are central to this initiative. Network infrastructure will promote equity and innovation through an open-source model that emphasizes collaboration and transparency over traditional single-provider and proprietary models. Single-provider refers to a centralized system where all services and assessments are exclusively offered and controlled by one organization (e.g., academic institution, company). Open collaboration, including more inclusive and equitable research participation and practices, leads to more effective measurement development. When researchers from different fields, regions, and backgrounds collaborate, they can contribute unique insights and approaches to complex problems. Additionally, open collaboration facilitates transparency and improves the quality of research outcomes. Open software tools improve the quality and sustainability of research software in the face of ongoing technical enhancements and allow community development responsive to rapidly evolving needs. Open practices promote sharing of data, methods, and results, enabling other researchers to replicate and build upon existing work. It includes open measures and scoring algorithms, as well as open, but protected data.  

Research Objectives

One of the main deliverables of this Network is a core set of measures for AD/ADRD primary prevention trials that incorporates new targets for intervention. This will involve: 1) reviewing the existing measures and measurement methods that could be used to test outcomes and mechanisms of action (e.g, cognitive, behavioral, social/structural, computational, biological) in AD/ADRD primary prevention trials; 2) identifying existing measures for the  use, modification, repurposing, and/or development of new measures and measurement methods that can be used to measure outcomes and mechanisms of action (e.g, cognitive, behavioral, social/structural, computational, biological) in AD/ADRD primary prevention trials; 3) assessing the reliability, validity, usability, and acceptability of existing and/or developed measures and modifying, repurposing, and/or creating new measures when deemed necessary; and 4) supporting the adoption of developed instruments into ongoing research. The Network should support the plug-and-play capabilities of the NIH Toolbox or MobileToolbox with the extensibility to integrate new tools, norms, algorithms, and raw data as well as support new, innovative approaches to solving other measurement challenges (e.g., implementation across web, app, different operating systems, sites/locations) for NIA-supported non-pharmacological AD/ADRD primary prevention trials. The Network must also leverage existing NIA-supported measurement projects (e.g., NIH Toolbox, HRS-HCAP, Mobile Toolbox, NACC UDS, SOBC Measures Repository) to advance measurement goals. 

Network infrastructure should be open, transparent, extensible, customizable, and have a sustainability plan to support Network activities, including support for development and dissemination of the resources developed by the Network. The goal is to create infrastructure to support the coordination of measures and measurement methods development, validation, and standardization customized for individuals with different needs and linked to real-world function. The lack of comparable measures in clinical trials has made it difficult to detect and understand longitudinal changes in function, but recent advances in measurement methods and digital technology offer the possibility of improving future trials (Landscape of Early Neuropsychological Changes in AD/ADRD Project). Developing this Network infrastructure will address the National Plan to Address Alzheimer's Disease Milestones 8.D, 11.B, and 11.F.​ 

The Network must collaborate with other NIA-funded studies, networks, and programs to ensure interoperability; promote diversity, equity, inclusion, and accessibility (DEIA); and ensure the measures and measurement methods and resources are widely adopted by researchers and other stakeholders. This will include developing a platform and organizational and governance structure to support Network activities and disseminate Network resources and products to meet evolving community needs. 

The Network must enhance the sustainability and impact of research software tools by enabling the use of best practices and design principles in software development and by leveraging advances in computing in a modern data ecosystem. A successful Network will include collaborations between scientists and software engineers to optimize the design, implementation, and cloud-readiness of research software and to advance the principles and practices of open science. This initiative is aligned with the NIH Strategic Plan for Data Science, which describes actions aimed at building a better data infrastructure and a modernized data ecosystem as well as NIA Strategic Goal G: support the infrastructure and resources needed to promote high-quality research. 

The National Institutes of Health (NIH) promotes the sharing of research software and source code, developed under research grants or cooperative agreements in any stage of development, in a free and open format. Releasing the software source code in an open manner means that users are permitted to use, modify, and/or redistribute the code. Data Management and Sharing Plans for this initiative must indicate whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse, and the name of any required tool or software. Read about best practices for sharing research software, including NIA Research Software and Source Code Sharing Guidance.    

For Dissemination activities throughout the course of this initiative, applicants are encouraged to engage with a wide range of NIA-supported AD/ADRD infrastructure projects, such as the centers in the NIA Research Centers Collaborative Network (RCCN), and with other NIA-funded programs and centers, such as the following: 

• Resource Centers for Minority Aging Research (RCMARs) 
• Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging 
• Science of Behavior Change Resource Coordinating Center 
• Alzheimer's Disease Research Centers (ADRCs) 
• Alzheimer’s Clinical Trials Consortium (ACTCs) 

Non-Responsiveness Criteria 

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

• Applications that do not describe how the proposed Network will be able to achieve each of the three objectives and five required activities described below in Section IV: Application and Submission Information, PHS 398 Research Plan. 
• Applications that do not propose to assess reliability and validity of proposed measures in cognitively normal as well as cognitively impaired individuals. 
• Applications that do not propose a well-defined set of milestones and a timeline for accomplishing the network activities.  
• Applications that do not propose a plan that aligns with open science practices and principles as described above.  
• Applications that do not include a detailed data management and sharing plan for rapid and broad sharing of all guidance, practices, measures, and data developed by the Network.  
• Applications that do not include a sustainability plan to support Network activities and resources.

Resources for Applicants: 

• AD+ADRD Research Implementation Milestone Database  
• NIA AD/ADRD Prevention 
• NIA-supported measurement projects (e.g., NIH Toolbox, HRS-HCAP, Mobile Toolbox, NACC UDS, SOBC Measures Repository) 
• NIH Best Practices for Sharing Research Software 
• NIA Research Software and Source Code Sharing Guidance 
• Notice of NIH's Interest in Diversity  
• NIA Health Disparities Research Framework 
• Responses to frequently asked questions about this NOFO will be posted here. 

For more information, visit NIH's webpage and NIA's webpage on these topics. 

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 Organizations)

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• 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 How to Apply Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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).

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:

Luke Stoeckel, Ph.D. and Kristina McLinden, Ph.D.  
National Institute on Aging (NIA)
Email: NIAOpenMeasure@nih.gov 

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the Ho to Apply Application Guide must be followed, with the following additional instructions: 

Applicants must propose PD(s)/PI(s) and other personnel well suited to implement the activities of the Network. Specifically, the PD(s)/PI(s) must have the following experience: 

• Demonstrated experience, and an ongoing record of accomplishments, in managing measurement research projects including multi-level data (e.g., cognitive, behavioral, social/structural, computational, biological) and research resources 
• Experience coordinating collaborative research 
• Experience with open science practices and principles 
• Experience appropriate to support the development and implementation of relevant measurement resources 

Key personnel must include individuals with the following experience: 

• Demonstrated experience in the fields of cognitive, behavioral, social/structural, computational, biological research relevant to AD/ADRD 
• Demonstrated experience in resource sharing through web-based platforms or other means 
• Demonstrated experience overseeing the selection and management of subawards 

If the application is multi-PD/PI, the investigators must have complementary and integrated experience, as well as clear governance plans, for the administration of the proposed Network. 

NOTE: Applicants are strongly encouraged to limit the number of key personnel with substantial roles in the Network to avoid establishing conflicts of interest throughout the field. Participation in Network activities, including attending meetings to offer scientific consultation, receiving pilot funding, or collaborating on measure or data development activities will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application. 

Applicants should NOT name proposed members of the Network Advisory Committee referenced below in the Research Strategy instructions. The panel will be established post award in collaboration with NIA staff.   

R&R Budget

All instructions in the How to Apply Application Guide must be followed.

Applicants must budget for annual meeting activities.  

R&R Subaward Budget

All instructions in the How to Apply Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply Application Guide must be followed, with the following additional instructions:

Specific Aims

Applicants must develop a platform to meet evolving community needs, partner with other NIA-funded programs, and the specific aims page must directly address and describe the core functions and activities of the Network to achieve the following three objectives:   

1. Develop an organizational and governance structure to support Network activities. Propose activities to establish a framework that will facilitate the development of innovative strategies for standardization and use of methods and measures across NIA/NIH-supported AD/ADRD primary prevention projects and support activities for the discovery and development of innovative, novel measures and measurement methods, and data. 
2. Disseminate Network resources and products to the broader AD/ADRD research community.  
3. Ensure that all measures and methods development and validation occur in a racially, ethnically, geographically diverse set of participants, including members of NIH-defined Health Disparity Populations. This also includes establishing the acceptability and feasibility of using the proposed instruments in both cognitively normal individuals and persons living with cognitive impairment (PLWCI), including subjective cognitive decline. 

Research Strategy: 

Applicants must describe how the Network will create infrastructure that is open, transparent, extensible, customizable, and must include a sustainability plan to support Network activities, including support for the development and dissemination of resources developed by the Network. Applicants must also describe how the project will address an important problem or a critical barrier to progress in the field and how rigorous is the prior research that serves as the key support for the proposed project. Applicant must also describe if the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved, and how will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field. Applicants must also describe how Network developments, measures, methods, data, and resource development, management, and sharing will follow open science principles and practices.

The goal is to create infrastructure to support the coordination of measures and measurement methods development, validation, and standardization customized for individuals with different needs and linked to real-world function. Applications must describe how the Network will accomplish each of the following five required activities: 

1. Establish a core set of measures for AD/ADRD primary prevention trials that incorporates new targets for intervention. The development cycle for these core measures should include testing and validation, dissemination to researchers conducting primary prevention studies, and evaluation of initial findings and refinement of measures and measurement methods. The proposed development cycle should be multidirectional with evaluation at a later stage informing measures and measurement methods modification and testing before final implementation in trials. Final implementation and full operational infrastructure to support primary prevention trial measurement needs would be established by the end of the 5-year program. It is anticipated that new intervention targets will be discovered, potentially requiring new measures and measurement methods. Therefore, development and testing will focus on modification, repurposing, and new measures creation throughout the project period. 
2. Review the existing measures and measurement methods that could be used to test outcomes and mechanisms of action (e.g., cognitive, behavioral, social/structural, computational, biological) in AD/ADRD primary prevention trials. Applicants must assess whether and how these measures and measurement methods are currently customized for individuals with different needs and are linked to real-world function. This review and assessment should include measures and measurement methods across neuropsychological, biomarker, and functional domains to meet the goal of use in primary prevention of AD/ADRD centered around brain-health equity. The application must describe how any systematic review will be accomplished, how information from outside the Network will be requested and obtained, and what statistical or meta-analytical techniques will be used to derive constructs relevant to both changes in early AD/ADRD and primary prevention trials. The application mustalso describe a plan for making the materials and code required to perform this assessment and review available to outside researchers. 
3. Identify existing measures for use, modification, and repurposing, and develop new measures and measurement methods that can be used to measure outcomes and mechanisms of action (e.g., cognitive, behavioral, social/structural, computational, biological) in AD/ADRD primary prevention trials. The application must describe how the results of the review activities described above, as well as possible feedback given during the development process for this required activity will be used to identify existing and/or create new measurement instruments, and how the preliminary testing of these measures will be accomplished before approving these measures for broader dissemination. 
4. Assess the reliability, validity, usability, and acceptability of existing and/or developed measures and modify, repurpose, and/or create new measures when deemed necessary. The application must describe how the reliability, validity, usability, and acceptability of the existing and/or developed measures, including sensitivity to change and assessment burden (e.g., cost, time), will be determined in populations that would be the target of AD/ADRD primary prevention trials. Additionally, applications must describe how NIH-designated health disparities populations will be accounted for in the development of these assessments. Further, investigators must describe efforts to establish the acceptability and feasibility of using the proposed instruments in both cognitively normal individuals and PLWCI, including subjective cognitive decline. 
5. Support the adoption of developed instruments into ongoing research. In order to ensure the broadest adoption of the developed instruments, every effort should be made to minimize the use of items, tests, or scales that depend on intellectual property (IP) of network members or others unless such IP rights are explicitly waived for their use in the instruments under development. Open principles and practices are central to this initiative. Applications must describe activities that will enhance the adoption of instruments developed into ongoing or future clinical trial projects. Investigators must develop a website that will be public-facing and hyperlinked to Network-developed resources and reports, as well as any other sites that contain Network-relevant materials (e.g., code hosted on GitHub, datasets hosted by other established repositories). Investigators are also required to describe a plan for the sustainability of Network-developed resources, including a plan for preserving any code base supporting online or personal/mobile device collection of data.  

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

• Promotion of measures and measurement methods innovation, including identifying mechanisms (e.g., cognitive, behavioral, social/structural, computational, biological) and outcomes for trials and addressing unmet measurement needs in new ways.  
• Support for the development, adaptation, validation, and standardization of measures for trials across cognitive, behavioral, social/structural, computational, biological, and functional measurement types, including multi-level measurement (e.g., brain-behavior).  
• Approaches to measurement of structural and social determinants of health (SDOH), including identification of ethnocultural factors beyond race, language, ethnicity, and education that have critical roles as mediators of brain health, cognitive change, and midlife AD/ADRD risk. 
• Facilitation and support for discovery of new measurement types (e.g., digital, passive sensors) and methodological and analytical approaches for these high-dimensional data types.  
• Creation of a catalog of measures and annotated research resources relevant to the AD/ADRD primary prevention research community, including, but not limited to, measurement and analytic tools, research protocols, datasets, and measurement-focused communities.  
• Testing of pilot versions of measures and protocols to assess acceptability, utility, and feasibility.  
• Identification of issues that may impact validity of measurements, analytic tools, and research protocols. Development of retrospective solutions for existing datasets and prospective solutions for new data collection.  
• Developing a rigorous and sustainable indexing and tracking system for these resources that is accessible and usable to meet the needs of a diverse range of users.  
• Platform evaluation to enhance performance, to promote sustainability, and to ensure the platform can efficiently adapt to the evolving research environment and user needs in terms of volume and complexity.  
• Support for existing, new, and novel strategies for open science, for integrating measurement tools and environments (e.g., APIs, cloud and edge computing), and for development of sustainability models for the infrastructure.  
• Quality and usage metrics of the research resources, tools, and communities served to evaluate the value of the platform and identify needs for modification.  
• Development of user-friendly interactive feedback to assist users of the platform.  
• Establishing communication channels to collect community input and feedback to define AD/ADRD prevention-specific needs and develop strategies for effective research practices, including enhancing functionality, user experience, and usage of the platform.  
• Engaging the research community in partnership to create and share the platform and other research resources. Community partners may address known (and unknown) biases in data sources, analytical algorithms, interpretations, and applications of test results, as well as methodological limitations and questionable predictive validity, especially in groups that have historically been underrepresented in or excluded from participation in AD/ADRD research.  
• Promoting DEIA principles and practices, including enhancing the diversity of the AD/ADRD workforce involved in development and use of the platform and research resources. This includes following a plan for enhancing diverse perspectives to maximize the impact of this resource: https://braininitiative.nih.gov/about/pedp-key-elements-and-examples  

To meet the objectives of this NOFO, the Network must interact with experts engaged in NIA-supported projects, Center and Network programs, data sharing/discovery projects, and other technologies developed to support innovative research on primary prevention of AD/ADRD, including but not limited to, the following:  

1. NIH Program Staff: 
   • NIH Program Official(s) will be responsible for standard grant program management. 
   • NIH Project Scientist(s) will have substantial involvement providing recommendations/guidance on the conduct of aims (e.g., recommendations on dissemination, collaboration, and CDE development/implementation).
2. PIs of NIA-funded projects, Centers, and Network programs. 
3. A Network Advisory Panel comprised of independent scientific experts in areas appropriate to the multidisciplinary content areas of the Network relevant to AD/ADRD primary prevention research. 
4. The broader research community: 
   • Potential users of resources developed and disseminated by the Network.

Community Advisory Board: An independent Community Advisory Board will be established to address issues that span across the Network, provide input towards the policies and processes of the Network, and assist in dissemination of policies and processes that enable the initiative to achieve its objectives. The Community Advisory Board will include members of patient communities; experts in technology, bioethics, privacy/security, AD/ADRD, and brain health; and members of ethnically and linguistically diverse communities drawn from partnering communities. The Community Advisory Board will focus on tool accessibility, inclusion, bias, equity, as well as safety, privacy, and security to ensure the inclusion of diverse perspectives. 

This includes a major focus on brain-health equity promoted through the following:  

• Maximizing accessibility of tools (across devices, age, race/ethnicity, languages, education levels, ability levels, and resource levels), especially for communities that experience brain health disparities. 
• Inclusion of diverse communities in the design, development, validation, and dissemination of all tools, including in the research team, research participants, community advisors, and community partners. 
• Identification of bias and barriers to generalizability of tools, including comprehensive documentation of both steps taken to mitigate bias and broaden generalizability, as well as careful documentation of any potential biases or limits to generalizability (e.g., populations where full validation has not yet been conducted) that can be disseminated to users and updated as appropriate as new issues are identified, and existing issues are addressed. 

Milestones: Applicants must propose a series of specific, quantifiable, and scientifically justified milestones, and a timeline for milestone completion during the five-year award period to assess progress towards achieving the proposed collaboration, measurement and infrastructure development, and dissemination activities. The Network will also be expected to work with NIA and the Network Advisory Committee to further develop milestones relevant to the activities and refine the milestones as necessary. 

Annual Meeting Activities: Applicants must describe how the Network will implement annual meetings, planned in coordination with relevant NIH program staff. The meeting will be attended by PD/PIs of relevant projects and activities, members of the Network Steering Committee, members of the Network Advisory Panel, and NIA staff. The Network will create the agenda and chair the meeting, with guidance from NIH program staff. The annual meeting should feature a combination of Network investigators, PD/PIs of NIA-supported projects, pilot project awardees, and other relevant experts as appropriate to provide updates on, and inform, future activities to achieve the goals of the Network. Proceedings of each annual meeting should be recorded and subsequently made available through the Network website to promote dissemination of presentations and foster discussion within the research community. 

Goals of annual meetings should include, but not be limited to, the following: 

• Sharing updates and scientific advances. 
• Discussing and planning collaborative activities with NIA-funded studies, including the development/sharing of measures and measurement methods. 
• Hosting expert sessions on measurement advancement. 
• Presenting results from pilot projects, discuss and plan activities to develop new research activities to advance the field relevant to NIH research priorities, etc.    

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the  How to Apply Application Guide.

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 How to Apply 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. This Data Management and Sharing Plan must include plans for sharing any code(s) used to generate scores from raw data, and any code(s) used to obtain raw data from participants who respond to any of the new measurement instruments using a personal or mobile device or a website used to collect data and specify what open-source licenses will be employed to achieve these goals. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply 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 How to Apply 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 How to Apply 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 How to Apply Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply Application Guide.

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

See Part 2. 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. 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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply 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 How to Apply Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at ramesh.vemuri@mail.nih.gov 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 policies and practices, 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:

• Federalwide 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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.

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 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 following:

• 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 HHS, PHS, and NIH policies. 
• Designing the details of the Network funded through this NOFO and retaining primary responsibility for performance of the activities. 
• Determining approaches, designing and setting project milestones, and implementing the project plan for the Network. 
• Ensuring the Network goals and activities are consistent with open science practices and principles to be determined by the Network. 
• Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, and facilitating in-person, hybrid, or virtual work group meetings, Steering Committee meetings, and other proposed recurring meetings or conference calls, including preparing concise minutes or summaries of meetings with clear action items for distribution (except for the annual Network Advisory Panel meetings, which NIA will support). 
• Cooperating with all Network members in the publication and dissemination of program results and the eventual release of methods, tools, results, research protocols or approaches, and other resources to the research and other relevant stakeholder communities. 
• Designating investigators to serve as members on a Network Steering Committee and other subcommittees with NIH staff, as appropriate. 
• Considering the advice of the Network Advisory Panel and Community Advisory Board regarding implementation of study aims, as well as additions or changes to content and methods during the execution of the cooperative agreement(s). Network Advisory Panel and Community Advisory Board advice is not binding on the PD(s)/PI(s) who retain primary responsibility for scientific direction and implementation. 
• Responding promptly and cooperatively to requests for information or input from NIA. 
• Retaining custody and having primary rights to the data and software at the recipient institution developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies and goals of this program. All research, data (it is expected the Consortium will have a Data Management and Sharing plan that will protect human subjects), and resources generated must be expected to have broad availability through a public-facing website to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program. 
• Ensuring that all web resources developed are transferred to any subsequent award recipient should the program be continued beyond the project period. 

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

• NIA Project Scientists 
  • One or more NIA Project Scientists will participate as a member of the Network and assist the PD/PI(s) in identification of relevant NIA/NIH-funded researchers and research programs, studies, and consortia for potential involvement in Network activities. The NIA Project Scientist will serve as liaison to other NIA components to promote collaborations. The NIA Project Scientists will also facilitate involvement of representatives from other NIH institutes, as appropriate, in Network activities. 
  • The NIA Project Scientist(s) will work with the PD(s)/Pl(s) and participate in the Network Steering Committee to ensure the objectives of the program are being met. The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Project Scientist(s). 
  • NIA may designate additional staff to provide advice to the recipient on specific scientific and/or administrative issues to optimize the conduct of network activities. 
  • NIA will serve as a resource with respect to other ongoing NIH activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort. 
  • NIA staff will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and their staff. 
  • NIA staff (Project Scientist(s)) will provide input, expert advice, and suggestions in the design, development, and coordination and implementation of the network objectives. 
     
• NIA Program Official 
  • NIA will assign an NIAProgram Official(s) who will be responsible for retaining overall programmatic responsibility for the award and will clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority. 
  • Additionally, an NIA program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIA Program Official will make recommendations for continued funding based on a) overall networks progress; b) cooperation in carrying out the research; and/or c) maintenance of a high quality of research in alignment with the goals of this RFA. 

Areas of Joint Responsibility include the following:

• Organizing and coordinating scientific and annual meetings for the Network, as required.  
• Coordinating and facilitating the interactions between participants under this cooperative agreement and other NIA awardees.  
• Considering the Network and the Network Advisory Committee's recommendations for modifying the Network's focus to accommodate new scientific opportunities and directions.  
• Sharing and reviewing annual progress among components of the Network, and with external stakeholders.  
• Meeting at least once per month.  
• Cooperating in the reporting of the study progress and findings. Where warranted by appropriate participation, plans for joint publication with NIA Project Scientist(s) of the results and conclusions are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIH staff will apply in all cases. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts. 

Network Steering Committee 

A Network Steering Committee will be established to address issues that span across the Network, provide input towards the policies and processes of the Network, and assist in dissemination of policies and processes that enable the initiative to achieve its objectives. The Steering Committee may establish subcommittees as needed to advance the Consortium’s goals. The Steering Committee will be composed of the Network PDs/PIs, Community Advisory Board representative, and the NIH Project Scientist(s). The combined vote of NIH membership will not constitute a majority of eligible votes. Within the first six months of award, the Steering Committee will develop a process and periodicity for NIA Program Official approval of all Network activities prior to award.  

Network Advisory Panel 

To ensure that the Network achieves its objectives under the cooperative agreement, the Network Advisory Panel will consist of independent scientific experts in areas appropriate to the content areas of the Network. Experts, including, but not limited to, the PD(s)/PI(s), Co-Investigators, Community Advisory Board members, NIA staff, and invited independent experts, will make presentations to the Network Advisory Panel on scientific and administrative issues regarding the development and implementation of Network aims. The Network Advisory Panel will do the following: 

• Communicate specific comments to NIA/NIH regarding priorities via executive (closed) sessions of Network Advisory Panel meetings. 
• Review and comment on the conduct of the Network aims and discuss progress in meeting the goals of the initiative. 
• Where appropriate, provide recommendations on topics including, but not limited to, the following: 
  • Procedures and policies necessary to successfully accomplish the initiative.  
  • Activities to improve coordination to achieve the Network’s goals. 
  • New scientific opportunities and directions within the scope of the award, if applicable. 

Other guidelines for the Network Advisory Panel, such as a quorum and frequency and type of meetings (e.g., in-person, virtual, hybrid), will be determined at its initial meeting. NIA will assist the Network Advisory Committee with developing a charter that describes the selection, composition, tenure, and responsibilities of the Network Advisory Panel membership. It is anticipated that the Network Advisory Panel will meet at least annually, with intermittent conference calls or virtual meetings as needed. The Network Advisory Panel may establish subcommittees as needed to advance the Network’s goals. 

The NIA Program Official and the PI(s)/PD(s) may request the Network Advisory Panel’s assistance on specific issues related to the Network. The NIA Program Official and the investigators will consider the comments of the Network Advisory Panel regarding implementation of Network aims, as well as additions or changes to content and methods, during the execution of the cooperative agreement. Network Advisory Panel recommendations will not be binding on the PD(s)/PI(s) who will retain primary responsibility for scientific direction and implementation. 

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

Consistent with the 2023 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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

NIA will evaluate the effectiveness of the program, and determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program after sunset and review period. 

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: GrantsInfo@nih.gov (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: support@grants.gov

Luke Stoeckel, Ph.D. and Kristina McLinden, Ph.D.
National Institute on Aging (NIA)
Email: NIAOpenMeasure@nih.gov 

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

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.

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 2 CFR Part 200.