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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

RWD holds substantial promise as a valuable resource for generating Real-World Evidence (RWE) that extends beyond conventional randomized controlled trials and surveys. RWD encompasses data concerning patient health status and healthcare delivery, routinely gathered from a number of sources and from heterogeneous patient populations. Examples of RWD include Electronic Health Records (EHR), claims and billing data, registry data, public health data, genomic and genetic data, patient-generated data from home-use settings, as well as data collected through mobile devices, wearables, and Digital Health Technologies. Besides individual private health insurance claims, CMS's Medicare and Medicaid data are the most widely used claims data in research. The CMS Chronic Conditions Warehouse (CCW) provides researchers access to various Medicare and Medicaid claims data, such as Part A, B, C, and D.  

Unlike data derived from controlled clinical trials, where study design controls variability, RWD originates within the context of the routine delivery of care. When combined with NIA-funded studies, RWD has the potential to unveil actionable healthcare insights that are not conventionally attainable through traditional research methodologies. For instance, the incorporation of social determinants of health (SDOH) data beyond zip code is vital to address health disparities comprehensively. The United States Core Data for Interoperability (USCDI) mandated by the Office of the National Coordinator’s (ONC) Health IT Certification Program includes SDOH elements like education, living arrangements, and economic security. Clinical tools, such as the Protocol for Responding to & Assessing Patients’ Assets, Risks & Experiences (PRAPARE), Hunger Vital Sign, and Accountable Health Communities Health-Related Social Needs (AHC-HRSN) screening, facilitate the systematic evaluation of SDOH domains in RWD. Structured and unstructured data within EHR, including social risk factors and non-health metrics not typically available in claims, offer additional insights into the prevalence of the determinants of AD/ADRD health disparities. 

In addition, RWD may provide added value for detecting the co-occurrence of two or more chronic conditions, also known as multimorbidity or multiple chronic conditions (MCCs), when combined with NIA-funded studies. Multimorbidity has been observed in about two thirds of older adults in population studies, making it the "most common chronic condition," and it has been observed in the majority of persons with AD/ADRD. MCCs have a substantial human burden in terms of symptoms, medications, treatment costs, and quality of life. The routine measurement of MCCs can facilitate a better understanding of potential causes and interactions and promote more effective treatment and improved outcomes. Beyond determining the presence of specific diseases, greater access to patient health information through RWD may also facilitate measuring disease severity in some instances. 

In the domain of AD/ADRD, the vast range of conditions and disease stages result in inconsistent RWD that often misses crucial information about persons living with dementia. Such inconsistency in RWD hinders accurate identification of the same individuals across NIA-funded datasets due to variability on identification data or the absence of common or consistent identifiers. Additionally, the non-uniform coding and structural organization of data pose significant challenges in data harmonization. These barriers not only hamper current research, but also thwart potential analyses aimed at identifying targets and new approaches for prevention and treatment of AD/ADRD, and ways to improve care for those living with AD/ADRD. 

CDEs, which are defined as data elements or variables applied to data collection procedures and representation, offer a solution to the challenge of data unalignment across and among NIA-funded studies and RWD. Serving as indivisible units of data, CDEs, or harmonization, promote data interoperability, data sharing, and data reuse, and can be applied to evolving data collection models. CDEs and harmonized data from NIA-funded studies linked with RWD may allow us to conduct consistent cross-sectional and longitudinal analyses, and thereby enhance the efficiency of research and enable the production of RWE at an expedited pace. 

In February 2023, NIA convened a Technical Expert Panel (TEP) focused on CDE development for harmonizing RWD from healthcare claims and EHRs for AD/ADRD research. Challenges identified included data definition heterogeneity, a lack of a cohesive framework for data element mapping, and the complexities in utilizing CDEs for longitudinal observational and non-pharmaceutical intervention studies. The TEP recommended strategies like leveraging interoperability standards and utilizing mapping systems and data harmonization to develop cross-sectional and longitudinal data applicable CDEs for RWD analyses. The TEP underscored the significance of capturing data across the following seven domains:  

1. Patient and caregiver demographic information
2. Disease characterization, including AD/ADRD diagnosis and MCCs
3. Health assessment (e.g., Activities of Daily Living (ADL), Instrumental ADL, cognitive function, etc.)
4. Biomarkers, genetics, and genomics relevant to AD/ADRD
5. Treatment for all conditions
6. Patient and caregiver health outcomes
7. Social determinants of health (e.g., financial, education, and living arrangements), but not environmental data (e.g., weather data, pollutant data)  

Throughout this NOFO, the seven domains listed above will be referred to as "the seven domains."

Purpose

This NOFO invites applications that aim to develop CDEs for NIA-funded studies on AD/ADRD using RWD from electronic health records and claims data from CMS. The CDEs will foster data harmonization and interoperability across and among NIA studies that involve disparate and unaligned data fields and RWD. By reducing the efforts required for data harmonization in using studies and RWD for cross-sectional and longitudinal analysis, this NOFO may enable researchers to utilize studies data and RWD more efficiently and produce RWE in a timely manner with longitudinal data from NIA-funded studies and RWD.

When CDEs are not viable, applicants may harmonize data.     

Research Objectives

The following are the objectives of this NOFO:

1. Identify Research Questions and Use Cases: 
   • Collaborate with stakeholders (e.g., NIA-funded longitudinal studies, health and social care professionals, people living with dementia, caregivers, policymakers, EHR vendors) and researchers to identify research questions and use cases that can be addressed by data harmonization and CDEs 
   • Align selected use cases with AD/ADRD research milestones 1.J, 3.B, 11.B, and 13.Q and integrate various RWD sources to NIA-funded studies to produce a comprehensive inventory of data sources for aging populations 
   • Evaluate the feasibility, availability of data, and acceptability within the research community for each use case 
      
2. Develop CDEs Encompassing Research Domains: 
   • Utilize insights from the TEP meeting to create CDEs encompassing the seven domains
   • Harmonize data from NIA-funded studies and create CDEs  
      
3. Create Applicable Longitudinal Files and CDEs : 
   • Utilize CMS CCW files to establish AD/ADRD research longitudinal files. If CMS CCW files are not available, then researchers will be expected to utilize the NIA Data LINKAGE Program
   • Develop CDEs that consider evolving coding schemes of NIA-funded studies linked with CMS data over time to ensure accuracy and relevance 
      
4. Evaluate and Refine Developed CDEs: 
   • Rigorously test the developed CDEs and iteratively refine them based on findings and updates in coding schemes 
   • Ensure compatibility with various NIA RWD infrastructures established under other systems set up by NIA-funded researchers. NIH staff will facilitate collaboration with other infrastructures as needed 

Structure and Required Activities

This NOFO supports the creation of a research coordinating network designed to develop CDEs and harmonized data sources for AD/ADRD using NIA-funded studies linked with RWD from EHRs and CMS claims and promote their use through the following required activities:

Administration: 

• Organize and lead a governance structure to facilitate research, administration, innovation, and dissemination activities 
• Host virtual meetings to address research and administrative matters and foster interactions among current grants that harmonize NIA-funded studies, RWD users, stakeholders, and NIH staff 
• Manage interactions with NIH staff, maintain subject-matter expert panels, and provide insights to inform project activities 

Innovation: 

• Collaborate actively with researchers and stakeholders to develop longitudinal files of NIA-funded studies linked with RWD
• Develop guidance for data harmonization of NIA-funded studies linked with RWD, facilitate utilization, and hold learning labs
• Use artificial intelligence (AI), machine learning (ML), and natural language processing (NLP) to create longitudinal datasets of NIA-funded studies linked with RWD 
• Validate data generated with application of AI, ML, and NLP manually as needed 
• Encourage data harmonization and the adoption of developed CDEs in AD/ADRD research. The research program will support up to six new research studies per year (as outlined under the Innovation heading of the Research Strategy subsection of Section IV. Application and Submission Information). Research studies are expected to be selected through a nation-wide open solicitation and awarded beginning in Year 2. Research studies are required to use data produced from this project or generate data that will be contributed to this project.   

Dissemination: 

• Establish a comprehensive website showcasing all project-supported products, including harmonization and CDEs guidance, codes used to generate longitudinal files, and evaluation outcomes 
• Organize an annual national data harmonization and CDE User Meeting at NIH to share updates, scientific advances, and engage stakeholders 
• Implement additional dissemination strategies, such as research briefs, blogs, and other means, to enhance awareness and usage among researchers, policymakers, and stakeholders 

A Steering Committee may be proposed by the cooperative agreement recipient. The committee may address issues that span activities, provide input for research study solicitations, and review research study applications.   

An External Advisory Panel (EAP) will be established to review the project progress in meeting its objectives and provide recommendations to the PD(s)/PI(s). NIA will appoint members of the EAP. Membership may include NIA-funded study investigators, representatives from relevant federal agencies, and independent scientific experts in areas appropriate to the multidisciplinary content of the Consortium.  

Staff in the Office of Planning, Analysis, and Evaluation at NIA may evaluate the research coordinating network and may provide recommendations for continuation of the network.

NIA encourages collaborative, multidisciplinary proposals that align with the stated objectives and required activities. This initiative aims to significantly contribute to advancing AD/ADRD research through the development of data harmonization and the creation of CDEs that facilitate effective utilization of RWD to generate RWE.  

Milestones

The application must propose plans to meet project milestones. Milestones must be specific, quantifiable, and scientifically justified. The application must include a timeline for milestone completion to assess progress towards achieving the proposed administration, innovation, and dissemination activities. Required project milestones are outlined in Section IV of this NOFO. 

Non-Responsiveness Criteria

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

• Applications that do not include the following:
  • Plans to use EHRs and CMS claims data (i.e., CCW data or data from NIA's LINKAGE program) to harmonize and develop CDEs 
  • Plans that use AI, ML, and NLP and data validation (i.e., any application of generative artificial intelligence must include validation) 
  • Provide preliminary data highlighting application of AI, ML, and NLP to generate harmonized variables or CDEs and validation techniques.
  • Plans to use all types of CMS files (i.e., Part A, B, D, OASIS, etc.) and NIA-funded studies linked with CMS data
  • Plans to develop CDE in the seven domains to achieve the objectives of this NOFO
  • Plans to share resources (i.e., codes) and longitudinal data as applicable
  • Plans to collaborate with other NIA-funded awards in similar domains
  • Plans to allocate $750,000 in direct costs per year for annual national competition for up to 6 external awards, beginning in Year 2, for research studies 
  • Research, administration, innovation, and dissemination activities
  • A well-defined set of milestones and a timeline for accomplishing the administration, innovation, and dissemination activities 

Resources for Applicants

• A pre-application webinar will be held to discuss this NOFO and answer prospective applicants' questions. Information about the pre-application webinar and answers to frequently asked questions regarding this NOFO can be here. Applicants are encouraged to check this site periodically, as it will be updated regularly.

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) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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, and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 How to Apply - 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:

Mir M. Ali, Ph.D
Division of Behavioral and Social Research
National Institute on Aging (NIA)
Email: [email protected]

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed,with the following exceptions or additional requirements:

For this specific NOFO, the Research Strategy section is limited to 30 pages. 

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.

Applications must describe how the institutional environment is appropriate for leading, coordinating, and managing a highly collaborative research project.  

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 How to Apply - Application Guide must be followed.

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

• Demonstrated experience, and an ongoing record of accomplishments, managing social, behavioral, clinical, and data harmonization research and research resources 
• Experience coordinating collaborative research 
• Experience appropriate to support the development, implementation, and dissemination of CDEs  

Key personnel must include individuals with the following experience: 

• Demonstrated experience in the fields of social, behavioral & clinical research; data harmonization; AD/ADRD; real-world data (EHRs and claims); bioinformatics; therapeutics; biostatistics; and multi-comorbidity  
• Demonstrated experience and expertise in leveraging AI, ML, and NLP technologies to harmonize data and or create CDEs to advance research in 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 expertise, as well as clear governance plans, for the administration of the proposed activities. 

NOTE: Applicants are strongly encouraged to limit the number of key personnel with substantial roles to avoid establishing conflicts of interest throughout the field. 

R&R Budget

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

Applicants must budget for up to six new research studies (as defined in the Innovation section of the Research Strategy instructions below) per year. Research studies are expected to be awarded beginning in Year 2. NIA requires applicants to budget for approximately six one-year awards per year in Years 2-5, totaling $750,000 in direct costs per year. Research studies that need more than one year require prior approval from NIH. It is expected that a minimum of 15 - 25% of additional funds in outyears will be devoted to supporting research studies (through open competition) to achieve the aims of the program (i.e., generation of CDEs or harmonized files using AI, ML, NLP and validating usage or use or data/or codes produced through this cooperative agreement). Individual research studies may not exceed $100,000 in direct costs per study. Research study funds may support salary, CMS Virtual Research Data Center (VRDC) access, support for computational resources, research expenses, travel, equipment, and supplies, as appropriate to the project.  

Inflationary Increases for Future Years: Inflationary salary increases for future year commitments are not allowed for applications submitted to this NOFO. However, necessary increases for other costs (e.g., supplies, equipment, etc.) are allowable as long as the out-year increase for a specific cost is well justified in the Budget Justification. For additional information, click here. 

Application budgets must include funds for planning and implementing annual national CDE user meetings virtually in Year 1 and in-person (hybrid if needed) in Bethesda, MD starting Year 2, including the preparation of annual meeting notes and an annual meeting report.  

Note that application budgets do not need to include funds for meeting logistics, travel, or notetaking for the EAP meetings.  

Requested costs should reflect the proposed dissemination activities, such as dissemination of CDEs and codes, the creation of a website that is sustained beyond the award period, as well as other forms of outreach.  

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:

The specific aims page must directly describe the objectives of the overall project and outline how the different required activities will contribute to these objectives. 

Research Strategy:

The application must explain how the proposed activities will contribute to the development, utilization, and dissemination of longitudinal harmonized variables and CDEs in the research community as articulated in the 4 elements under “Research Objectives” in Section I of this NOFO. The application must describe how the seven domains will lead to scientific advances in harmonization of NIA-funded studies of RWD for AD/ADRD research. The application must explain how the seven domains will enable efficient utilization of RWD across the broad spectrum of scientists seeking to advance research on prevention and treatment of AD/ADRD and care for individuals living with AD/ADRD. The application must describe how the proposed activities will enable the project team to lead, coordinate, and manage the development and use of CDEs. 

The research strategy must describe the approaches that will be taken to support the activities below. Additionally, the research strategy must describe how the approaches are innovative. 

Administration  

Applicants must propose an organizational governance structure to support proposed research, administration, innovation, and dissemination activities.  

Administrative activities must include, but are not limited to, the following:  

• Hosting virtual meetings to address research and administrative matters, fostering interactions between current grants that harmonize NIA-funded studies, RWD users, stakeholders, and NIH staff
• Responding to queries from NIA staff and information requests generated by NIH, the scientific community, and the public 
• Planning and administering project aims in collaboration with NIH staff in accordance with the terms and conditions of the cooperative agreement 
• Organizing, maintaining, and engaging a panel of subject-matter experts (SMEs) to provide insights regarding the activities and priorities to the NIH and the project team 

Framework for Development and Adoption of Novel Activities 

Applicants must propose activities intended to support the development and use of CDEs in research related to the prevention and treatment of AD/ADRD, and for future adoption by the research community. 

Innovation activities must include, but are not limited to, the following: 

• Collaboration activities – The application must include the following:
  • Plans to actively engage NIA longitudinal studies integrated with RWD, researchers, and stakeholders to identify and select use cases for data harmonization and CDEs to align with AD/ADRD research 
  • A description of initial targets for use cases with ongoing development enhanced via interactions with NIA and the SME panel  
  • Plans to use AI, ML, and NLP for the creation of longitudinal datasets of NIA-funded studies linked with RWD
  • Plans to test and iteratively refine AI, ML, and NLP technologies to enhance the accuracy and utility of the developed harmonized data sets and CDEs
  • Plans to incorporate innovative applications of AI, ML, and NLP technologies to advance research and data harmonization in AD/ADRD
  • Plans to work with researchers and stakeholders to develop and evaluate CDEs encompassing the seven domains
  • Plans to validate data generated with the application of AI, ML, and NLP manually as needed  
  • Plans to work with researchers and stakeholders to identify relevant CMS CCW files for AD/ADRD research and create longitudinal files and CDEs  
  • Plans to obtain all types of CMS CCW data (i.e., Part A, B, D, OASIS, etc.) or data from NIA LINKAGE program
  • Plans to evaluate the developed CDEs and to update/maintain CDEs and harmonized data on annual basis
  • Plans to interact and collaborate with multiple longitudinal studies and other NIA RWD infrastructures to support the adoption of harmonized data and the CDEs  
     
• Guidance activities – Applicants must describe plans to accomplish the following: 
  • Develop guidance for collection and use of harmonized data sets and CDEs with RWD via the SME panel and expert workshops  
  • Develop guidance for using the codes to create CCW longitudinal files and share longitudinal files when feasible 
  • Develop guidance for data harmonization of NIA-funded studies linked with RWD and facilitate utilization and hold learning labs
     
• Research study program activities – The research study program will facilitate the dissemination of harmonized data from NIA-funded studies and CDEs to the research community. It will provide opportunities for researchers to understand CDEs and harmonized data, and learn how to operationalize them in research. The research study must focus on AD/ADRD research using RWD. Applicants must describe plans to accomplish the following:
  • Manage a research study program that encourages researchers to create and use harmonized data of NIA-funded studies and develop CDEs with RWD in AD/ADRD research 
  • Issue a nation-wide open solicitation. At least 80% of the research studies must be awarded to researchers who are not affiliated with the U24 institution because the intent is to encourage the uptake and contributions of harmonized data and CDEs  
  • Establish an optional Steering Committee consisting of a subset of key personnel and NIH Program Official and Project Scientist(s) to review and select research studies via national competition. The final selection of research studies will require prior approval from NIH 
  • Assess efficiency of research by external investigators (e.g., time and effort) of utilizing harmonized NIA-funded studies and CDEs and codes to create longitudinal files as key components in the dissemination plan
  • Incorporate research study findings and lessons learned to update harmonized data and CDEs as needed

Dissemination 

Applicants must describe the innovative approaches to ensure wide dissemination of all products and resources developed by the project to the research community, policymakers, and other relevant stakeholders. Applicants must also propose strategies for increasing the use of the developed CDEs by researchers. 

Dissemination activities must include, but not be limited to, the following: 

• Creation of a website – A website that includes all products supported by the project (e.g., guidance, data harmonization, harmonized data (when applicable), CDEs, workshop summaries, codes to create longitudinal files, evaluation results). The website must include a CDEs database that categorizes CDEs by domains and includes key information to support research use (e.g., data source, coding scheme). The website must include codes that researchers can use to create longitudinal CCW files or from the LINKAGE platform.  
• Annual National CDE User Meeting – Applicants must describe approaches for planning and hosting annual meetings at NIH in coordination with NIH program staff. The annual meeting, which will be attended by the broader research community and the EAP, will be held virtually in Year 1, and in-person (hybrid if needed) in Bethesda, MD starting Year 2. The project team must organize the meeting with guidance from NIH program staff, this includes creating the agenda. The purpose of the annual meeting will be to share updates and scientific advances; discuss and plan collaborative activities with researchers and stakeholders; host expert sessions on CDE development advancement; present results from the evaluation, etc.   
• Additional dissemination – Applicants must propose a plan for other types of dissemination (e.g., research briefs, blogs, or other means to highlight and disseminate advances, activities, and resources) via the website and other platforms to the research community, policymakers, and other relevant stakeholders. 

 Milestones:

In the Research Strategy section, the application must propose plans to meet the following project milestones:

1. Establishment of  a public-facing website with an overview of the project within two months of the award 
2. Submission of CMS CCW data request and/or LINKAGE data request within two months of the award
3. Partnership with NIA-funded studies within the first three months in order to harmonize data and create longitudinal files
4. Hosting of an annual national Data harmonization and CDE User Meeting beginning in Year 1 
5. Development of CDEs encompassing the seven domains ready for the research studies to use by the end of Year 1
6. Development of harmonized longitudinal data sets or codes of NIA-funded studies
7. Posting of data harmonization codes, CDE domains and codes as well as other resources (e.g., longitudinal file creation codes) on the public-facing website by the end of Year 1. This can also include securely posting longitudinal files of NIA funded studies 
8. Award up to 10 research studies each year beginning in Year 2 via national competition  
9. Update harmonized data from NIA-funded studies, CDEs, data (when applicable), codes, and relevant documentation beginning in Year 2    

Milestones must be specific, quantifiable, and scientifically justified. The application must include a timeline to assess progress towards achieving the proposed administration, innovation, and dissemination activities. The timeline must be appropriate and feasible for milestone completion.    

Applications may suggest additional milestones for consideration by NIA program staff and peer reviewers. 

Letters of Support:

The application must include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts or consultants. For activities to be conducted at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the institutional officials, must be submitted with the application.

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.

This NOFO requires sharing software and codes that are developed or modified to accomplish the aims of this program, unless prohibited under Bayh-Dole Regulations.

Applications must address the following items:

• Describe and justify the timetable to release the resource. Generally, the referenced resource from a publication should be made available by the on-line publication date unless NIH policy specifies an earlier date. Investigators should justify exceptions to that timing
• Describe how all materials including web resources will be transferred to a new entity at the end of the project period for sustainability
• Address timely (i.e., within 30 days of NIA notice) execution of the material transfer agreement within and across the project, and with third parties if directed by NIA. The material transfer agreement includes, but is not limited to, transfer of all resources generated by the grant. 
• Identify any restrictions on sharing resources and justify them. Restrictions might include, for example, no commercial use of the resource, only qualified users may access the material, or, no attempt to reveal personal or private information may be made. Investigators may also set different levels of access, for example, for expert users and novice users
• To ensure that qualified users will have easy access to the resource, describe either (1) how the investigators will curate the resource, what documentation they will provide about the resource and the format in which it will be provided, and whether any resource will be held back, and (2) if/how the investigators will work with the identified repository/consortium/enclave to prepare the resource and documentation 

Other Plan(s): 

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 NOFO requires adoption of Findable, Accessible, Interoperable, and Re-usable (FAIR) data principles when addressing each application component and encourages PD/PIs to store data in repositories that hold a Core Trust Seal.

Applications must address the following items:

• Indicate the repository/consortium/enclave where they will place code to create longitudinal files or have a clear plan and capacity to share from their own site(s). Working with an external repository or through a consortium can be advantageous for many investigators
• Identify any restrictions on sharing data and justify them. Restrictions might include, for example, no commercial use, only qualified users may access the data, or no attempt to reveal personal or private information may be made. Investigators may also set different levels of access, for example, for expert users and novice users
• To ensure that qualified users will have easy access to the data, describe either (1) how the investigators will curate the data, what documentation they will provide about the data and the format in which it will be provided, and whether any data will be held back, and (2) if/how the investigators will work with the identified repository/consortium/enclave to prepare the data and documentation 

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.

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 [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

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

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• 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 Laws and Regulations Enforced by 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

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:

Designing the details of the project and retaining primary responsibility for performance of the activities.

• Accepting and participating in the cooperative nature of the project   
• Fully disclosing all database schema, algorithms, software source code, and methods to NIH program staff and the broader scientific community for purposes of scientific evaluation
• Responding promptly and cooperatively to requests for information or input from NIH
• Retaining custody of, and having 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:

• NIA will assign a Project Scientist and a Program Official to assist the award recipient
• An NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Program Official will approve all major stages of the project and all new major additions/changes to planned activities, including approval of all collaborative studies and research study awards for compliance with NIA/NIH requirements prior to funding. 
• NIH Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH Project Scientist(s) will assist in refining study objectives and activities. The Project Scientist(s) will participate in review of research study applications. In addition, the Program Scientist(s) will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIH Program Official(s) for any replacements of key personnel or other changes in subawards. The NIA Program Official(s) will approve membership and agendas of the EAP

Areas of Joint Responsibility include:

• Determining the process of setting priorities, deciding optimal administrative and governance approaches as well as scientific and technical management of the study/studies, and contributing to the adjustment of approaches as warranted
• Participating in regular conference calls among PD/PIs, NIA Project Scientist, and/or other NIA program staff, as scheduled and agreed upon in a kickoff meeting to be held within the first two months of award. The purpose of the regular conference calls is to review progress on milestones and facilitate interactions between the study and other NIA-funded researchers  
• Monitoring progress toward milestones and modifying milestones as needed
• Considering the Steering Committee and the EAP input for modifying the project’s focus to accommodate new scientific opportunities and directions
• Coordinating and facilitating the interactions between stakeholders under this cooperative agreement with other NIA recipients and other Federal agencies  

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.

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 NOFO requires adoption of Findable, Accessible, Interoperable, and Re-usable (FAIR) data principles when addressing each application component and encourages PD/PIs to store data in repositories that hold a Core Trust Seal.

Applications must address the following items:

• Indicate the repository/consortium/enclave where they will place code to create longitudinal files or have a clear plan and capacity to share from their own site(s). Working with an external repository or through a consortium can be advantageous for many investigators
• Identify any restrictions on sharing data and justify them. Restrictions might include, for example, no commercial use, only qualified users may access the data, or no attempt to reveal personal or private information may be made. Investigators may also set different levels of access, for example, for expert users and novice users
• To ensure that qualified users will have easy access to the data, describe either (1) how the investigators will curate the data, what documentation they will provide about the data and the format in which it will be provided, and whether any data will be held back, and (2) if/how the investigators will work with the identified repository/consortium/enclave to prepare the data and documentation 

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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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.

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]

Mir M. Ali, Ph.D
Division of Behavioral and Social Research
National Institute on Aging (NIA)
Email: [email protected]
 

Nadezda Radoja, PhD 
Division of Neuroscience 
National Institute on Aging (NIA)
Email: [email protected] 
 

Marcel Salive, MD, MPH 
Division of Geriatrics and Clinical Gerontology
National Institute on Aging (NIA)
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
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 2 CFR Part 200.