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 Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

There is an urgent need to better understand what works in terms of AD/ADRD care coordination, care integration, and care transitions in community settings across the United States. Dementia care coordination refers to the deliberate organization of dementia care activities and the sharing of individual concerns to achieve more effective care; care integration refers to increasing the collaboration between professional and care organizations, thereby improving continuity of care; and care transitions refer to the movement of an individual from one care setting to another. PLWD need care that maintains their safety; promotes human dignity, autonomy, and quality of life; limits medical error and unnecessary care transitions; and can be delivered in a fiscally responsible manner. All available evidence suggests that lack of care coordination and integration is frustrating, costly, and reduces safety and quality of care for PLWD. Community-level care integration offers the promise of helping people with AD/ADRD access the services and supports they need in the setting of their choice. However, there is wide variation in state policies and payment that support care coordination and integration. Moreover, racial and ethnic minorities and rural PLWD are less likely to have access to well-integrated care. Many states and sub-state entities work to improve dementia care coordination, integration, and transitions through the use of long-term services and supports (LTSS) in the community and/or institutional settings (e.g., nursing homes), but these efforts vary across and within states.

Examining this important topic in the context of states is critical to our increased understanding of how different states are meeting the challenges and opportunities in AD/ADRD care provision. Existing efforts focused on the national level have left many research and research infrastructure gaps, in part because care coordination planning and programmatic decisions are often made at the state or local level; moreover, gaps in program data and analysis persist. A state or regional approach should include inputs from multiple stakeholders that can provide much-needed insights on what works and for whom in terms of AD/ADRD care. The engagement of healthcare systems and social service systems and their providers at the state and sub-state level are critical to scientific advances in this area.

To provide an example, Massachusetts is a state that offers many care integration options, with several programs allowing individuals with AD/ADRD to access services and supports in the community, while not all states provide this level of support. The Massachusetts Program of All-inclusive Care for the Elderly (PACE) integrates Medicare and Medicaid benefits for the lowest-income individuals. For low-income individuals who exceed the poverty threshold, the state offers the Moving Forward Plan (MFP) in the form of MFP Residential Supports and MFP Community Living. The residential supports program is for those who need around-the-clock assistance, similar to the level of care available in a nursing home. The community living waiver is for those seniors who can live in the community with the right combination of support services. Depending on the program, MFP may directly pay some of the costs of an assisted living community that provides support for activities of daily living.

While evidence from Massachusetts offers insights on structuring payment programs to pay for community-based services for PLWD, there is a lack of knowledge on state-level variation in payment for care integration services, and differential practices across state and local entities confounds a single national assessment. Services that are known to enhance safety and positive outcomes for older adults as they transition across care settings include medication reconciliation and falls assessment and risk mitigation. Yet, little is known about state-to-state variation in community-based provision of care and payment for such services among PLWD. The context AD/ADRD care is provided in (access, coverage/payment, etc.) influences quality of outcomes. Variation in rules and resources state-by-state influence that context. Analyses using a national lens will miss the variation that no doubt drives differences. Looking within states to examine outcomes allows researchers to consider which factors across states may drive better outcomes.

Research shows that most older adults prefer to remain in their home and receive care at home, instead of moving to an extended living facility. While many of the same custodial, hygiene, and nutrition services that are provided in long-term care settings can be delivered at home, the logistical hurdle of scheduling these services can be challenging for families. Furthermore, because payment for home and community-based services comes from numerous sources that vary across states, it can be difficult for researchers to access the necessary data to determine whether home and community-based services truly can serve as substitutes for long-term care. Thus, we lack knowledge on the care practices and state payment policies and programs that support safe, integrated, fiscally responsible care in home and community settings. The aim of this initiative is to integrate data that are already available from in-patient and long-term care settings with data from home, community, and office-based settings, and data on state and local policies, so that an assessment of what works to support successful care coordination, care integration, and care transitions across settings can be made. Given national variation in payment and services, incentivizing research at the state level to enable research on AD/ADRD care holds promise for providing a national evidence base about the most effective practices to key stakeholders who can improve care for PLWD. Such an evidence base may be used to improve dementia care coordination, integration, and care transitions in community settings, as well as inform policymaking and program decisions.

Objectives

This NOFO invites applications for a State Dementia Care Research Center which will support research on social services and health systems within states. The specific objectives of the Center are to: (1) facilitate state-based research on dementia care coordination, integration, and transitions; (2) create and integrate within-state data on home and community-based services and health care data; and (3) support the dissemination of findings. The Center will build investigator capacity, support AD/ADRD care research on state-level and sub-state-level data, and maintain the resource and knowledge base for AD/ADRD state- and regional-level research through the four Center cores. The Center will produce research that focuses on understanding structural, institutional, and resource-related factors that influence quality and access to care for those living with dementia and their care partners to build an evidence base for policymakers and other key stakeholders.

The Center's primary goals are to address data and measurement to support research exploiting state and regional differences and changes in policy and practice as they pertain to dementia care coordination, integration, and care transitions to develop an evidence base intended to improve care for PLWD and their families. To inform research, the Center will build research-supporting partnerships and disseminate results and bring together scientists and community stakeholders from across settings (e.g., home, adult day care, social services, home health agencies, primary care, hospitals, health care systems, nursing homes, assisted living facilities (ALFs), and hospice providers). This Center will overcome existing research and data limitations by integrating program data with Medicare/Medicaid data within states to identify approaches that improve dementia care access, cost of care, and quality of care as PLWD go through various transitions of care in the community.

Applications should address forming research partnerships within institutions and across organizations at the state or sub-state level. At least two different states should be proposed in an application, with the goal of including more states in the Center over time. Each state should have pre-established within-state partnerships (e.g., state and/or county governments, adult day care, social services, home health agencies, primary care, hospitals, health care systems, nursing homes, ALFs, and hospice providers).

The Center should advance research on good dementia care in order to promote the well-being of PLWD, care partners, and caregivers, supporting research that examines the extent to which dementia care programs meet any of the key components of dementia care, supports, and services put forward in a 2021 National Academies of Science, Engineering, and Medicine report, Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers:

• Detection and diagnosis
• Assessment of symptoms to inform planning and deliver care, including financial and legal planning
• Information and education
• Medical management
• Support in activities of daily living
• Support for care partners and caregivers
• Communication and collaboration
• Coordination of medical care, long-term services and supports, and community-based services and supports
• A supportive and safe environment
• Advance care planning and end-of-life care

Organizational Structure

The Center will be comprised of four core components which will incorporate the features highlighted in the Objectives above: (A) Administrative and Dissemination Core; (B) Partnership and Engagement Core; (C) Data Core; (D) Research/Pilot Core. Applicants should refer to Section IV for specific requirements for each Core.

Applicants should propose a minimum of two states for inclusion in the Center. For each state, partners that represent the heterogeneity found in states should be included. Applicants should be intentional in the coverage of proposed states in terms of not only regional diversity, but also in other areas where disparities exist, such as race/ethnicity, income, rurality, and other characteristics, as described in the NIA Health Disparities Research Framework. It is not expected that the Center will involve all 50+ states and territories; applicants should propose a process to identify and establish partnerships for research and data access/sharing and build on successes to encourage other state entities to follow suit and become part of the Center.

An Administrative & Dissemination Core will oversee the operations of the Center and work to disseminate research findings to a wide range of stakeholders and promote use of Center-developed tools and infrastructure by the broader research and stakeholder communities.

The Partnership & Engagement Core has two goals: 1) establish state-based partnerships, and 2) encourage stakeholder engagement through a PLWD and care partner engagement panel. Partnerships: The Core will build partnerships with institutions/programs (e.g., home health agencies, public health programs, ALFs, state-level data providers, social services providers, Area Agencies on Aging) within states to obtain access to program and other relevant data and expertise to facilitate research, aiming to support five to seven such state/sub-state partnerships over the proposed grant period. Engagement: The Core will stand up a PLWD and care partner engagement panel. Applicants may propose that other individuals or organizations should be part of the panel (e.g., paid caregivers, payers, social service and health care providers).

The Data Core will coordinate knowledge about data used by individual projects and may act as a data and/or code repository where applicable. Based on provider data access and integration rules, the Center will either serve as a direct hub for data sharing or as a source of discovery/guidance for use of data from providers. In any case, the Data Core will facilitate research access and enhance usability/replicability via support tools for researchers (e.g., development of user-friendly files or supplemental documentation). The Data Core includes data representing the context of care and resources within a state (e.g. health care systems interactions, social service data, and data on services paid for by Medicaid captured in state to county-based systems).

The Research/Pilot Core will stimulate rigorous, reproducible research on topics that deepen our understanding of what works in terms of dementia care coordination, integration, and transitions. Research/pilot projects must use data and/or resources associated with the Center, and research topics must focus on policy or contextual factors that influence successful or unsuccessful dementia care and caregiving coordination, transitions, and/or integration. Study design, data sharing, and research topic should be considered in the research/pilot application and review process.

Projects may focus on understanding drivers of successful approaches to managing dementia care coordination, integration and transitions. Care transitions is one research area of interest that can address the following research topics:

1. Transitioning into palliative care for PLWD: what state-level policies and programs work and how?
2. Care transitions for PLWD across community settings.
3. The economics/payment of care transitions and Medicare Advantage/plan variation.

Non-Responsiveness Criteria

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

• Applications that do not propose all required Cores: Administration and Dissemination, Partnership and Engagement, Data, and Research/Pilot Cores.
• Applications that do not focus on AD/ADRD care populations, data, and research.
• Applications that do not address forming research partnerships within institutions and across organizations at the state or sub-state level, including at least two initial partnerships with entities from two different states.
• Applications that do not include populations that experience AD/ADRD care disparities and inequities, as described in the NIA Health Disparities Research Framework.

Resources for Applicants

• AD/ADRD Research Implementation Milestone database
• 2021 NASEM report, Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers
• NIA Health Disparities Framework
• NIA's webpage for information regarding the Decadal Survey of Behavioral and Social Science Research on AD/ADRD
• NIA's webpage for information regarding the 2020 National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers
• NIA’s webpage for information regarding the 2023 National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers
• NIA's Guidance on Sharing Data and other Resources
• Responses to frequently asked questions about this NOFO will be posted here.

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Elena Fazio, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

The application must describe how the PD/PIs expertise is relevant to the goals of the Center and provide examples of successfully working with social and governmental systems.

The application must describe the experience of the proposed team members with respect to working in research consortia or other collaborative efforts to achieve a shared goal.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the specific aims for the proposed Center. The Center must create a dynamic infrastructure for developing an evidence base and supporting AD/ADRD state- or regional-level research with multiple social service systems, state government, care providers, and/or health systems that will facilitate translation into policies, strategies, or programs for improving care coordination, integration, and care transitions for PLWD and their caregivers/care partners.

The Center goals are to produce research that focuses on understanding structural, institutional, and resource-related factors that influence quality and access to care for patients with dementia to build an evidence base for policymakers and other key stakeholders. Over time, the states represented in the Center may produce cross-state comparisons.

Research Strategy:

Applications must:

• Address overall objectives and long-term goals of the Center.
• Propose plans starting in Year 2 to establish future collaborations and maintain the Center.
• Include sustainability plans addressing post-award efforts. Sustainability may include letters of support from partnering institutions/social service systems/health systems as specified in the Letter of Support section below.
• Describe how the Center will engage nationally with others working in similar areas to stay abreast of emerging experience, regulations, and technical advances that impact the ability for research to be conducted in social service and health care settings. This could include other NIH-funded AD/ADRD projects (e.g., NIA's IMPACT Collaboratory, projects supported through RFA-AG-24-009), but also other federally and privately funded efforts, such as projects funded by the Center for Medicare and Medicaid Innovation (CMMI) and/or private foundations.

Letters of Support: At the time of application, the PD/PI must submit letters of support that demonstrate collaborations with at least 2 initial states to support within-state research on dementia care research. Over time, the number of states represented in the Center will likely grow. Comparison of research across states is a goal of the Center.

The state or sub-state entities that demonstrate within-state partnerships could come from places such as state government/program offices, academic institutions, third-party data providers, health systems, etc. The letters of support must indicate institutions that are willing to join the Center if funded by NIA in the first year.

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

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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

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

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Administrative & Dissemination Core

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative & Dissemination Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative & Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative & Dissemination Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative & Dissemination Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative & Dissemination Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

The PD/PI(s) must have demonstrated experience in establishing effective collaborations, including descriptions of the motivation for initiating the collaboration, the goals defined for the collaboration, and the outcomes achieved.

Budget (Administrative & Dissemination Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

The budget must include funds to organize and support meetings and prepare meeting summaries. Funds must be set aside for annual travel to Center meetings if travel is required (in addition to virtual meetings). The meetings may be face-to-face and/or virtual. The location of the meeting will be in the vicinity of Bethesda, MD, or a participating state for face-to-face meetings, and each meeting is expected to last approximately 1 day. In the first year, two meetings will be held (a kickoff within 3 months of award and a year-end meeting), followed by annual meetings of similar length in the remaining years.

Funds must be set aside reflecting the costs for communicating with and convening an External Advisory Committee (EAP), which may meet virtually or in-person and must meet annually. Note: Applicants should NOT name proposed members of the EAP; rather a description of required expertise should be provided and proposed members should not be contacted prior to peer review. The panel will be established post award in collaboration with NIA staff. Center PIs may convene the EAP at the same time as the Center’s annual meeting; 1 day for each group (EAP and Center affiliates).

Applications must allocate a maximum of 1/3 of their Direct Cost budget to the Administrative Core, in each year.

Applications must propose dissemination activities with associated budget starting in Year 2 and continuing through the final award year.

PHS 398 Research Plan (Administrative & Dissemination Core)

Specific Aims: Identify general objectives planned for the Administrative and Dissemination Core along with the main benchmarks that would indicate the accomplishment of these objectives, including a timeline. Describe how the proposed Core addresses the needs of the Center that it will coordinate and how the scope of activities proposed for the Core is appropriate to meet those needs. Explain how successful completion of the aims brings unique advantages or capabilities to the center.

An administrative core oversees the operations of the Center, including dissemination activities, so the description of this core must include a governance plan that, at minimum, details the processes for problem-solving, communication, and prioritization of work.

Applications must state the goals of the proposed Administrative and Dissemination Core concisely and summarize the expected outcome(s) in a timeline that covers the requested budget periods.

Research Strategy: Applications must include plans for meeting the following required objectives and features of this Core. Applicants are encouraged to provide any additional objectives or features as appropriate. Required objectives and features include:

• Providing a public website for communication and sharing of activities, events, trainings, publications, and program resources. The Center website should be functional within 4 months after the start of Year 1 award.
• Convening and managing the following meetings:
  • A project kickoff meeting within three months of grant award date for all key personnel and associated stakeholders to meet with NIH staff and Center affiliates. Agenda items should include: discussion of the Center website; introduction of Core responsibilities and staff; discussion of Center processes (e.g. research/pilot process, stakeholder engagement process); plans for stakeholder engagement groups; and attention to the Center’s inclusion of underrepresented populations and associated health disparity research.
  • A meeting at the end of the Year 1 project year to share progress made to date and plans for the next project year. A meeting summary should be prepared.
  • Annual Center research meetings held virtually or in Bethesda, MD for approximately 1.5 days starting in Year 2. These meetings should include Cores, EAP members, and NIA program staff, and meeting agendas and summaries should be prepared.
  • Quarterly meetings with the EAP. Meeting summaries should be provided to NIA program staff.
• Coordinating and collaborating with Core leaders to facilitate the alignment of tactical and strategic process goals.
• Providing organizational and logistical support for Cores, Project Scientist(s), Steering Committee activities, and EAP activities.
• Developing high-quality communication materials, including guidance documents, training materials, promotional materials, and presentations.
• During Years 2 through 5, producing progress reports twice a year for submission to NIA program staff.
• Processes for disseminating research and data findings (this might include scientific papers, scientific webinars, podcasts, lay-friendly briefs for those interested in adopting programs and/or strategies, and/or conference presentations).
• Plans to host Center webinars no less than two times per year to share scientific and/or data findings with Center affiliates, the broader research community, and the general public as appropriate.
• Processes for collaborating and offering input for data infrastructure building during the planning phase of projects.

Letters of Support: Only letters of support specific to Administrative Core" should be attached to this section.

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

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative & Dissemination Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Partnership & Engagement Core

When preparing your application, use Component Type Core.

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

SF424 (R&R) Cover (Partnership & Engagement Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Partnership & Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Partnership & Engagement Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Partnership & Engagement Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Partnership & Engagement Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Partnership & Engagement Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

The Core budget must include funds to organize and establish within-state partnerships. Funds to support the development of partnerships must not exceed $200,000 in direct costs per state and $1,000,000 in total costs per state, per year, starting in Year 1.

PHS 398 Research Plan (Partnership & Engagement Core)

Specific Aims: State the goals of the proposed Partnership and Engagement Core concisely and summarize the expected outcomes.

The Partnership and Engagement Core has two goals: 1) establish state-based partnerships, and 2) encourage stakeholder engagement through a PLWD and care partner engagement panel.

State-based partnerships will capture program data and support growing interaction of key stakeholders to facilitate the sharing of relevant data for use in targeted research on dementia care within states to capture the context in which care is provided. The Research/Pilot core (below) will initiate projects within five to seven states and coordinate their research and data efforts with assistance from the Partnership & Engagement Core to identify and facilitate collaborations for entities receiving research/pilot support.

The goal of engaging the PLWD/care partner panel is to hear about quality of life and outcomes that matter for PLWD and care partners as well as to ensure that the challenges of finding, paying for, and maintaining treatment and care for AD/ADRD are adequately captured in the research proposed by Center applicants. Through this panel, PLWD and care partners (and possibly care providers as identified by the applicant team, e.g., home health aides, geriatricians) will provide input on the services, treatments, and processes that PLWD and care partners must navigate.

Research Strategy: Applications must include plans for meeting the following required objectives and features of this Core. Applications are encouraged to provide any additional objectives or features as appropriate. Required objectives and features include:

Partnerships:

• Building state-based and sub-state-based partnerships to capture program data and support growing engagement of key stakeholders to facilitate the sharing of relevant data for use in targeted research on dementia care within states to capture the context in which care is provided.
• Engaging with a wide range of stakeholders and stakeholder organizations, including representatives from communities that have been historically underrepresented in research, to invite new Center-affiliated organizations and individuals to bring expertise on data sharing and knowledge creation and to gather stakeholder input on the topics of dementia care coordination, integration, and transitions.
• Integrating stakeholder feedback to develop better understanding of state-level policies that impact the health and well-being of PLWD, caregivers, care providers, payers, and insurers.
• Providing a plan for when and how to, as appropriate, return results or information back to community stakeholders. This plan must incorporate input from the EAP and NIA program staff.
• Coordinating with the Administrative Core to recommend a governance structure for the Center.

Partnering organizations may include but are not limited to:

• State government organizations (e.g., service providers, data collection organizations, State Units on Aging, state regulatory agencies, Medicaid agencies)
• Local social service and health care providers (e.g., home, adult day care, social services, home health agencies, primary care, hospitals, health care systems, nursing homes, ALFs, emergency departments, and hospice providers)
• Area Agencies on Aging (AAAs)
• Federally Qualified Health Centers (FQHCs)
• Within-state professional organizations such as those representing adult day care, social services, and/or home health agencies
• Scientists/academics
• Community stakeholders from across settings.

Representatives from partner organizations (data providers, program/policy experts, dementia care researchers, etc.) should collaborate to develop research projects that investigate research questions addressing the goals of this program and engage stakeholders in the dissemination of findings. Optimally, the Center will work with partners from different states to facilitate comparative research.

Engagement Panel:

Applications must include an explanation of how each stakeholder group will be engaged through the Partnership and Engagement Core and the plan for approaching and seeking PLWD and care partners for the engagement panel.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Partnership & Engagement Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Data Core

When preparing your application, use Component Type Core.

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

SF424 (R&R) Cover (Data Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Data Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Data Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Data Core)

Specific Aims: Identify general objectives planned for the Data Core. Describe how the Core will support data needs for the Center.

The Data Core coordinates knowledge about data used by individual research/pilot studies and may act as a data and/or code repository where applicable.

This Core will interact with three streams of data: 1) person-level primary data, 2) data files that are maintained by state entities or the Center, but will be made accessible to Center affiliates, and 3) data that addresses state variation. (e.g., the compilation of state or sub-state-level policies that influence the health and social services made available to PLWD and their families). The Core will facilitate linking the three data streams to administrative, health care, and policy data and enable access to public use files and restricted data through a cloud interface.

The Core will organize partnerships with regional data providers and researchers to address stated research objectives. Based on provider data access and integration rules, the Core will either serve as a direct hub for data sharing or as a source of discovery/guidance for the use of data from providers.

Research Strategy:

Applications must address the following three potential data streams:

1. Person-level primary data collection: Though less of a focus than the other two data types, the Data Core may support primary data collection from adults/PLWD, caregivers, and/or systems. In these instances, the Data Core should:
   • Support Core investigators as they consider privacy concerns as they relate to any new data collection and possible storage.
   • Where applicable, automate extraction of demographic and clinical information for reporting and analysis from multiple data systems, generally at the state level.
   • Where applicable, ensure that the Center and its associated investigators share or provide access to all generated data resources.
   • Release all data products in a timely manner.
2. Existing data files that are maintained by state entities or the Center: Data files may be maintained by states and sub-state entities and not directly shared with the Center’s Data Core; however, in these cases, a process should be described to allow all Center affiliates access to these data. There may also be secondary data sources that are maintained by the Center and not the state or sub-state entities.
   • For data resources that are not held by the Center, but by third-party providers under data use agreements, the Center is responsible for facilitating access to such data via guidance on establishing use agreements and supports for re-use/replicability of data used for any study supported by the Center (e.g., code to allow a user to replicate the analysis data of a pilot project, freezing analytical files, etc.).
   • Facilitate data linkages between existing data sources and combinations of data from relevant sources within states, such as state government organizations and state/county-level service providers.
   • Release all data products in a timely manner.
   • Integrate data at a state level, with the intention of capturing state-level Medicaid payments, along with payments from Medicare. Incorporating within-state professional organizations such as those representing adult day care, social services, or home health agencies may enable analysis of out-of-pocket payments for non-medical social support services that are often used as a substitute for, or in conjunction with, unpaid family caregiving.
   • Support interactions between Center investigators and a CMS data enclave. Topics for support may include data interoperability to permit cross-organization collaboration.
   • For those data that are housed within the Center, share guidance for social service and health systems data vendors to standardize data structures that capture relevant health outcomes for research on the health of PLWD and their caregivers. Data should be tied to AD/ADRD health policy decisions. For the purpose of this announcement, policy is defined as a law, regulation, procedure, administrative action, incentive, or voluntary practice of governments and other institutions (Centers for Disease Control and Prevention, Office of the Associate Director for Policy and Strategy).
   • Describe the approach for a competitive process to select an organization(s) to link the survey and program/social service data to administrative data (e.g., possibly through a CMS/NIA data enclave) and to support curation of within-state contextual data describing relevant care environment (e.g., policies, resources, etc.), including data cleaning and consolidation, as necessary to support research objectives.
   • Address how data interoperability between social service systems, state-level program and policy makers, health systems, and CMS claims data will be achieved, as well as how the Center will work with the NIA-funded Real World Data (RWD) initiative to access or link to data resources housed within the RWD platform.
3. Data that addresses state policy variation: A unique and important feature of the Center is its ability to compare state-level policies over time. One source of data will be state-specific dementia care coordination and integration policies. This Core should compile these data in a meaningful way and allow for Center PI access.
   • Produce and maintain a database of state-specific policies as they relate to dementia care services and supports.
   • Release all data products in a timely manner.

Across all three data streams(noted above), within one month of the start of Years 2-5 of the award, PDs/PIs must provide a timeline for when public and/or restricted data will become available for research use.

Propose a consolidated or centralized IRB approach consistent with the NIH single IRB policy for multi-site research for study oversight to facilitate both appropriate and timely study implementation.

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

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Data Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Research/Pilot Core

When preparing your application, use Component Type Core.

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

SF424 (R&R) Cover (Research/Pilot Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research/Pilot Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research/Pilot Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research/Pilot Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research/Pilot Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research/Pilot Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Research projects must not exceed $100,000 in direct costs per project and $800,000 in total costs across all projects per year starting in Year 1.

PHS 398 Research Plan (Research/Pilot Core)

Specific Aims: Identify general objectives planned for the Research/Pilot Core. Describe how the proposed Core addresses the needs of the Center that it will coordinate and how the scope of activities proposed for the Core is appropriate to meet those needs. Explain how successful completion of the aims brings unique advantages or capabilities to the Center. State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed. Applications must state, within their Specific Aims, how state-level or sub-state-level data will be used in this Core.

The Research/Pilot Core initiates projects on topics to inform stakeholders on approaches to improve dementia care within states. Dementia care coordination, integration, and transition research topics to be addressed by research/pilot grantees and the Center are broad in scope but should focus on understanding structural, institutional, and resource-related factors that influence quality and access to care for patients with dementia to build an evidence base for policymakers and other key stakeholders. These factors could include person/patient-level factors and program-level factors. Informed by state-level Medicaid and social services data, the Center will support research/pilot projects to understand programmatic structures in participating states, with the goal of capturing replicable state program components that are linked to higher access and quality of dementia care or greater efficiency. Research topics should be addressed in the context of an individual state (i.e., state level representation). Topics to be addressed include those informed by the 2020 and 2023 Dementia Care and Caregiving Research Summits (e.g., health care navigators, technology, improved dementia care coordination, and carve out versus add-in models of care). All research/pilots should be associated with one or more AD/ADRD research implementation milestones. Milestones can be found here: https://www.nia.nih.gov/research/milestones.

Projects should be informed by an understanding of what constitutes key components of ideal dementia care and services (see NASEM 2021 report, Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers for components).

Applications should explain how research/pilot grants will be reviewed and administered within the Center and outline the characteristics of a good research/pilot application. For example, topics such as study design, data sharing and code sharing could be included in pilot research applications.

Research Strategy: This Core will support innovative research projects that will be required to use the data generated from this cooperative agreement. Research projects may not exceed $100,000 in direct costs per project and $800,000 in total costs per year starting in Year 1. The Core PI team shall review the proposed science, and the NIH Program Officer shall have final say over the scope of the research/pilot awards.

Applications must address the following:

• Describe how research projects will be solicited and reviewed and the process for selecting meritorious projects.
• Describe how the Core will manage awards to support research projects to completion, including dissemination of findings.
• Present a plan for ensuring that research projects are designed to inform NIA AD/ADRD research implementation milestones.

Applications for research/pilot projects must be solicited and submitted in Year 1 of the Center award. Selected research/pilot projects will conduct their research across Years 2 through 5 of the Center award. The Data Core will coordinate knowledge about data used by individual projects and may act as a data and/or code repository.

Multi-year research/pilot projects are not encouraged and will require prior approval by the NIA PO.

States that do not participate directly in the Research/Pilot Core may nonetheless gain policy insights from the pilot core findings to reproduce them in their own state.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research/Pilot Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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

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 FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

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.

Significance

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

Investigator(s)

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

Specific to this NOFO:

How relevant is the PD/PIs expertise to the goals of the Center? How well-described is the experience of the proposed team members with respect to working in research consortia or other collaborative efforts to achieve a shared goal?

Innovation

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

How likely is the application to lead to a dynamic infrastructure for developing an evidence base and supporting AD/ADRD state- or regional-level research with multiple social service systems, state government, care providers, and/or health systems that will facilitate transition into policies, strategies, or programs for improving care coordination, integration, and care transitions for PLWD and their caregivers/care partners? How well does the application address the overall objectives and long-term goals of the Center? How well-described are the plans starting in Year 2 to establish future collaborations and maintain the Center? How adequate are the sustainability plans addressing post-award efforts? How well-described is the plan for the Center to engage nationally with others working in similar areas to stay abreast of emerging experience, regulations, and technical advances that impact the ability for research to be conducted in social service and health care settings?

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria - Administrative & Dissemination Core

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

Significance

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

Investigator(s)

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

Specific to this NOFO:

How well-described is the PD/PI(s) experience in establishing effective collaborations, including descriptions of the motivation for initiating the collaboration, the goals defined for the collaboration, and the outcomes achieved?

Innovation

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

How well-described is the governance structure for the Center, including the processes for problem-solving, communication, and prioritization of work? How successful is the proposed governance structure likely to be? How well-described are plans to develop a public website for communication and sharing of activities, events, and program resources? How adequate are the plans for convening and managing the following meetings: project kickoff meeting, meeting at the end of Year 1 to share progress made to date and plans for next year, annual Center research meetings starting in Year 2, and quarterly meetings with the EAP? How well-described are the processes for coordinating and collaborating with Core leaders to facilitate the alignment of tactical and strategic process goals? How adequate are the plans to provide organizational and logistical support for Cores, Project Scientist(s), Steering Committee activities, and EAP activities? How well-described are the plans to develop high-quality communication materials, including guidance documents, training materials, promotional materials, and presentations? How well-described are plans to produce progress reports twice a year during Years 4-6 for submission to NIA program staff? How adequate are the processes for problem-solving, communication, and prioritization of work? How well-described and adequate are the processes for disseminating research and data findings (this might include scientific papers, scientific webinars, podcasts, lay-friendly briefs for those interested in adopting programs and/or strategies, and/or conference presentations)? How well-described are plans to host Center webinars no less than two times per year to share scientific and/or data findings with Center affiliates, the broader research community, and the general public as appropriate? How adequate are the processes for collaborating and offering input for data infrastructure building during the planning phase of projects?

Environment

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

Additional Review Criteria - Administrative & Dissemination Core

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Administrative & Dissemination Core

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria - Partnership & Engagement Core

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

How adequate is the plan to build state-based and sub-state-based partnerships to capture program data and support growing engagement of key stakeholders to facilitate the sharing of relevant data for use in targeted research on dementia care within states to capture the context in which care is provided? How adequate are the plans to engage with a wide range of stakeholders and stakeholder organizations, including representatives from communities that have been historically underrepresented in research, to invite new Center-affiliated organizations and individuals to bring expertise on: data sharing, knowledge creation, and stakeholder input on the topics of dementia care coordination, integration, and transitions? How likely is the plan to integrate stakeholder feedback to develop better understanding of state-level policies that impact the health and well-being of PLWD, caregivers, care providers, payers, and insurers to succeed? How adequate is the plan for when and how to, as appropriate, return results or information back to community stakeholders, incorporating input from the EAP and NIA program staff? How well-described are the plans to coordinate with the Administrative Core to recommend a governance structure for the Center? How well-described is the explanation of how each stakeholder group will be engaged through the Partnership and Engagement Core and the plan for approaching and seeking PLWD and care partners for the engagement panel?

Environment

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

Additional Review Criteria - Partnership & Engagement Core

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Partnership & Engagement Core

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria - Data Core

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

How well-described and adequate is the plan for the Core to interact with the following three streams of data: 1) person-level primary data collection, 2) data files that are maintained by state entities or the Center, but will be made accessible to Center affiliates, and 3) data that addresses state variation? How adequate are the plans to facilitate linking the three data streams to administrative, health care, and policy data and enable access to public use files and restricted data through a cloud interface? How adequate are the plans to organize partnerships with regional data providers and researchers to address stated research objectives?

Environment

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

Additional Review Criteria - Data Core

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Data Core

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria - Research/Pilot Core

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

How adequate is the plan for how research/pilot projects will be solicited and reviewed and the process for selecting meritorious projects? How well-described is the plan for the Core to manage awards to support research projects to completion, including dissemination of findings? How adequate is the plan for ensuring that research projects are designed to inform NIA AD/ADRD Research implementation milestones?

Environment

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

Additional Review Criteria - Research/Pilot Core

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Research/Pilot Core

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

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

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

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

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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.

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.
• Applicants must submit pilot/research projects to NIH for prior approval within the annual RPPR.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Designing the details of the project funded by this NOFO and retaining primary responsibility for performance of the activities.
• Accepting assistance from the designated NIH Program Official and NIH Project Scientist in aspects of the scientific and technical management of the study/studies and in coordinating with other Federal agencies.
• Accepting and participating in the cooperative nature of the Center.
• Participating with NIH staff and the External Advisory Panel (EAP) in determining the process of setting Center priorities, deciding optimal administrative and governance approaches, and contributing to the adjustment of approaches as warranted.
• Developing the Center's initial website and making it discoverable within the first year of the award.
• Establishing metrics and timelines for accomplishing the activities and achieving the objectives of the Center.
• 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.
• Planning and participating in outreach and dissemination activities, including developing, hosting, and maintaining a public website for the Center hosting and attending meetings to discuss the project's progress; coordinating the publication of research results; and other coordination, outreach, and dissemination activities.
• Responding promptly and cooperatively to requests for information or input from NIH.
• Participating in ongoing conference calls with Project Scientist(s) and/or other NIH program staff, as scheduled and agreed upon.
• Convening the first meeting of the Center and NIH program staff within 4 months of the award.
• 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.
• 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.

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 recipients.
• 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 final approval of all research/pilot studies for compliance with NIA/NIH requirements prior to funding. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIH Program Official for any replacements of key personnel or other changes in subawards. The NIH Program Official is an ex officio member of the EAP and will be consulted as to the membership and agendas of the EAP.
• The NIH Project Scientist will assist in refining study objectives and activities, including pilot projects, representing the scientific objectives of the project as they relate to the aims (e.g., recommendations on workshop topics, areas for collaboration, products for dissemination, etc.).

Areas of Joint Responsibility include:

• Organizing and coordinating scientific and annual meetings for the Center as required.
• Coordinating and facilitating the interactions between participants under this cooperative agreement and other NIA awardees.
• Considering Center affiliate recommendations for modifying the Center’s focus to accommodate new scientific opportunities and directions.
• Sharing and reviewing annual progress among components of the CC, and with external stakeholders.
• Meeting at least once per month by teleconference.

External Advisory Panel:

• In order to ensure that the Center achieves its objectives under the cooperative agreement, the EAP will be comprised of independent scientific experts in areas appropriate to the multidisciplinary content areas of the Center. Experts, including, but not limited to, the Principal Investigator, Co-Investigators, NIA staff, and invited independent experts, will make presentations to the EAP on scientific and administrative issues regarding the development and implementation of Center aims. The EAP will do the following:
  • Report to NIA and will communicate specific recommendations to NIA regarding priorities via executive sessions of EAP meetings.
  • Review and comment on the conduct of the Center aims and discuss progress in meeting the innovation and dissemination goals of the initiative.
  • Where appropriate, provide recommendations to the Principal Investigator on procedures and policies necessary to successfully accomplish the initiative; this is not binding on the Principal Investigator who retains primary responsibility for scientific direction and implementation.
  • Recommend activities to improve coordination approaches to achieve the Center's goals, and advance relevant scientific approaches to exposome research.
  • Make recommendations for redirecting the Center’s focus to accommodate new scientific opportunities and directions within the scope of the award.
  • Other guidelines for the Center, such as a quorum and frequency and type of meetings (in-person, remote), will be determined at its initial meeting. It is anticipated that the EAP will meet at least annually, with intermittent conference calls as needed.
  • The EAP may establish subcommittees as needed to advance the Center’s goals.
• The NIA Program Official and the PIs may request the EAP’s assistance on specific issues. The NIA Program Official and the investigators will consider the recommendations of the EAP regarding implementation of Center’s aims, as well as additions or changes to content and methods, during the execution of the cooperative agreement. Any new EAP Chair and members will be appointed by NIA when necessary. NIA will provide a charter for the EAP that describes the selection, composition, tenure, and responsibilities of the EAP membership.

Dispute Resolution:

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

3. Data Management and Sharing

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

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

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.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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

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

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

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

Elena Fazio, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
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 45 CFR Part 75 and 2 CFR Part 200.