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

Key Definitions for this Notice of Funding Opportunity (NOFO)

• Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD): ADRD include, but are not limited to, Frontotemporal dementia (FTD), Vascular Contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementias (LBD), and Multiple Etiology Dementias (MED).
• Underserved populations: Groups identified as Priority Populations in the National Institute on Aging’s (NIA's) Health Disparities Framework and/or other groups known to experience barriers to accessing needed health care services or to have inadequate health care coverage.
• Medically and/or socially vulnerable populations: Residents of nursing homes and assisted living facilities, and individuals who access care from adult day care centers or other professional care settings that serve individuals living with AD/ADRD.

Background

Dementia is a growing concern worldwide. According to the Alzheimer's Association, AD is responsible for 60-80% of all dementia cases, and the prevalence of this condition is expected to rise in the coming years. However, current treatments for AD have limited effectiveness, which highlights the need for exploring new health policies and interventions to accelerate innovation in AD/ADRD prevention, treatment, and care.

Further, as the population ages and the number of people living with AD/ADRD continues to increase, it is important to also measure the economic burden of dementia on patients and caregivers/care partners to develop policies that efficiently enhance access to, and quality of, care. It is projected that the economic cost of AD/ADRD will rise to over $350 billion by 2040, with most of the burden of formal costs falling on government programs such as Medicare and Medicaid. However, a significant fraction of AD/ADRD care is provided by informal caregivers. These caregivers substitute their time, sometimes at the expense of pursuing paid work, to provide care to a relative due to preference, cost barriers, or both. Therefore, it is essential to improve our understanding of how health policy and interventions that support care provision influence access to care and the labor force, both formal and informal, that provide care to individuals living with AD/ADRD. As noted in a recent workshop organized by the National Academies of Sciences, Engineering, and Medicine Board on Health Care Services, utilizing an economics framework can provide important insights into means of improving care for AD/ADRD patients and their care providers, both formal and informal.

Economic factors may also influence AD/ADRD risk factors. For example, some occupations may expose individuals to activities (e.g., cognitively challenging tasks) or environments (e.g., high risk of concussions) that may mitigate or exacerbate AD/ADRD risk. Further, economic circumstances may limit access to various types of healthcare services to prevent or treat conditions associated with AD/ADRD risk or serve as a direct risk factor (e.g., stress associated with economic uncertainty). Limited access to health services may also increase the likelihood that a person experiences symptoms of cognitive decline that may impair their ability to manage their work and financial lives. Economic methods and insights can serve as a useful tool to address these myriad questions regarding AD/ADRD prevention, treatment, and care.

Given that questions about these economic topics are often linked (e.g., features of the AD/ADRD care workforce are related to payment policies and access to services, etc.), establishing a consortium of research projects examining economics research on AD/ADRD prevention, treatment, and care has the potential to create synergies to better generate innovative projects and collaborations, as well as share findings, more rapidly. A consortium organized around a coordinating center could also serve as an incubator for new research that builds on consortium findings as well as bring new investigators to the topic to expand the network of experts studying the economics of AD/ADRD to provide an evidence base for policymaking and address NIA AD/ADRD research implementation milestones 1.P, 13.P, 13.M, and 13.N.

Purpose

This NOFO invites applications that propose to establish a coordinating center. The goal of the Center will be to advance economic research on AD/ADRD by supporting a consortium of research projects examining the development and diffusion of treatment/care innovations, payment and treatment models for care, care quality and access for people living with dementia PLWD and their caregivers, as well as economic factors influencing disease progression to address NIA's AD/ADRD Research Implementation Milestones 1.P, 13.P, 13.M, and 13.N. The Center will aim to accomplish the following:

• Foster collaboration and synergies across consortium member research projects,
• Initiate new research projects,
• Expand the network of researchers studying the economics of AD/ADRD, and
• Disseminate findings to key stakeholders to support policymaking.

Research Objectives and Vision

This NOFO, in conjunction with its companion NOFO, RFA-AG-24-031, aims to establish a consortium. The consortium's goal will be to establish a collaborative research network that unites a coordinating center with various research projects, all working towards the following: (1) creating evidence-based research for enhancing AD/ADRD prevention, treatment, and care, and (2) disseminating results to stakeholders. This NOFO invites applications to establish the coordinating center, and RFA-AG-24-031 invites applications proposing research projects that aim to advance economic research on AD/ADRD. NIA intends to fund 4-5 awards from RFA-AG-24-031. Included in RFA-AG-24-031 is a requirement that investigators submit plans to coordinate research activities with the coordinating center.

The coordinating center will be responsible for the following activities:

• Facilitating research meetings with consortium researchers
• Engaging stakeholders from research and policy communities,
• Providing workforce training to a multifaceted set of researchers,
• Translating research findings into practices, and
• Developing research projects via both national competitions and Center researchers.

The activities above will be conducted via the following core components: (1) Administrative Core; (2) Research Project Core; (3) Translation Core; and (4) Stakeholder Engagement Core. Details regarding each component are provided below, under the Organizational Structure heading. This multifaceted strategy will empower the consortium to develop evidence-based approaches with the potential to identify and manage risk factors to prevent or delay onset the of AD/ADRD, identify and employ new treatments to combat AD/ADRD, and transform the care landscape and mitigate disparities for AD/ADRD patients and their caregivers via economic research and multidisciplinary approaches informed by economics. Topic areas for economic research on AD/ADRD prevention, treatment, and care include, but are not limited to, the following:

• Cost of dementia care: This research area includes investigations of the economic impact of dementia on families, healthcare systems, and society as a whole. It can examine direct costs such as medical care and support services, as well as indirect costs such as lost productivity and wages of caregivers. Additionally, this research may explore the impact of health insurance access on health and wellbeing outcomes for PLWD, the cost of drug development, and the role of policies and payment models in shaping access to care.
• Health systems research: This research area includes investigations of how institutional factors, such as the organization of care, payment for care (e.g., Accountable Care Organizations, augmenting service coverage, etc.), and care coordination influence access, utilization, and outcomes (e.g., quality of life, morbidity, mortality, and health disparities) for PLWD and their families. This research may also explore how systemic or institutional incentive structures can improve care for persons with dementia and cost-effectiveness research utilizing data from the Long-Term Care Data Cooperative.
• Prevention and management of dementia: This research area includes investigations of the economic impact of prevention and management strategies for dementia, as well as the use of economic incentives, to modify individual or institutional actions. For example, researchers may investigate interventions such as lifestyle changes, medications, and non-pharmacological therapies. This research may also explore how policies of governments and other institutions influence access, use, and quality of health care, as well as how payment models impact what care is provided to whom.
• Long-term care: This research area includes investigations of the economic impact of long-term care for PLWD, including institutional care and home care, and comparing different models of care and transitioning from long-term care facilities to home or hospital. This research may also investigate the impact of how care is financed on access, long-term care outcomes, as well as how policies and payment models shape access to long-term care services.
• Impact of labor force participation/occupation on AD/ADRD risk: This research area includes investigations of the relationship between labor force participation, occupation, tenure, voluntary or involuntary interruption (e.g., unemployment, retirement, etc.), gig employment, job features/rules (e.g., shift work rules, etc.), and other aspects of employment over time on dementia risk and health outcomes. For example, researchers may investigate how the interaction between employment options and familial caregiving responsibilities impact related economic and health outcomes.
• Economic research on the dementia care workforce: This research area includes examinations of the economic and labor market factors that impact the recruitment, training, and retention of healthcare workers in the dementia care workforce. It includes investigations of the costs and benefits of different training and education programs on care worker retention and productivity, as well as the effectiveness of different incentive structures in promoting the recruitment and retention of skilled care workers. This research may also explore how changes in reimbursement rates and payment models impact the availability and quality of dementia care services. By better understanding the economic and labor market factors that influence the size and composition of the dementia care workforce, policymakers and healthcare providers can work together to develop more effective and sustainable strategies for ensuring high-quality care for PLWD.
• Economics of dementia drug development: This research area includes examinations of the economic aspects of drug development for dementia treatments, including the costs, incentives, and barriers associated with discovering and bringing new drugs to market, including issues of resultant access and coverage for patients. This research may also explore the impact of intellectual property rights, regulatory frameworks, and public-private partnerships on the economic viability and accessibility of dementia drugs, as well as the potential for international collaborations to promote more effective and equitable approaches to drug development for PLWD.
• Cross-national comparative studies of AD/ADRD risk factors and dementia care: This research area includes examinations of cross-national comparative studies of AD/ADRD risk factors and dementia care. By comparing and contrasting the economic and healthcare factors that impact dementia care across different countries, researchers can identify best practices and policy approaches that can be adapted in different contexts to improve care for PLWD. This research can also explore the similarities and differences in care delivery and healthcare utilization patterns by exploiting national policy differences.
• Demonstration projects and behavioral economics interventions in AD/ADRD care: This research area includes examinations of the economic and behavioral factors that influence healthcare utilization patterns of PLWD and can improve care for them. Interventions can include financial incentives, nudges such as the development of personalized feedback, and social support, which can promote healthy behaviors and improve health outcomes for PLWD by providing guideline concordant care to physicians, nurses, caregivers, or older adults. This research may also investigate the impact of modifications to insurance and payment models on healthcare utilization, as well as the role of statewide demonstration projects for improving care for PLWD. Please note that only Stage IV or Stage V clinical trials, as defined by the NIH Stage Model, are allowed.
• Economic modeling of future costs of AD/ADRD: This research area includes developing economic models to predict the future economic impact of AD/ADRD on individuals and society, considering demographic trends, development of potential drugs/interventions, changes in multiple comorbidities across cohorts, and changes in the prevalence of AD/ADRD. The models may also incorporate the impact of policies and payment models on the future burden of dementia and the provision of care, and account for drivers of disparities.
• Artificial Intelligence (AI) and big data for economic research on AD/ADRD: This research area includes utilizing advanced AI methods and big data analytics to gain deeper insights into the economics of dementia care. By implementing AI approaches, such as machine learning, natural language processing, and predictive modeling, researchers can detect patterns, trends, and potential policy interventions within large and multifaceted datasets related to dementia care and how to improve care for PLWD. This research might concentrate on areas such as healthcare utilization, cost-effectiveness, tailored care interventions, and refining incentive structures for enhanced care and outcomes for PLWD and their families. Moreover, AI-driven techniques can facilitate more efficient analysis of data from various sources, including electronic health records, administrative data, and longitudinal studies, leading to more comprehensive and actionable findings.

All applications, regardless of their specific focus, must address health disparities for underserved populations in their plans for research and research programs (see Research Project Core below). Further, researchers may investigate the effectiveness and cost-effectiveness of various interventions, and other strategies to improve access, equity, and outcomes in dementia care for populations experiencing health disparities and/or populations that are medically and/or socially vulnerable.

As detailed in NOT-OD-16-025, NIH accepts applications involving health economics research in which health outcomes and health-related behaviors are the primary focus, and the connection between the subject(s) of the study and improved understanding of health are clear and explicit. NIH may also fund health economics research that meets the mission-based priorities of individual NIH Institutes and Centers, exemplified by those outlined in NIA AD/ADRD research implementation milestones 1.S, 1.P, 13.F, 13.J, 13.M, 13.N, and 13.P. Potential applicants are encouraged to consult with the NIA scientific/research contact listed in Section VII of this NOFO if they have questions about the alignment of their proposal with NIA’s priorities.

Organizational Structure

Applications to this NOFO must describe activities to support a consortium coordinating center capable of engaging scientific expertise at the primary institution as well as external to the primary institution and has the flexibility to draw, as needed, on external scientific expertise to achieve the core functions of this NOFO. At minimum, the application must include the following components: (A) Administrative Core (including training); (B) Research Project Core; (C) Translation Core; and (D) Stakeholder Engagement core. The contents of each component are highlighted below.

A. Administrative Core

This component will provide administrative support for the cooperative agreement. Activities that will be supported under this component include governance for the cooperative agreement, coordination with the Consortium's research projects, developing a pipeline of early career investigators through workshops and research support, management of milestone reporting, administration of an External Advisory Panel (EAP), and information dissemination among other activities. A full list of required activities can be found in Section IV.

B. Research Project Core

This component will develop and support innovative research projects from Center investigators, Consortium members, and other qualified external researchers. This component must allocate $1,000,000 per year in total costs, starting in Year 1 and in subsequent years, to support research projects that must focus on the economics of AD/ADRD prevention, treatment, and care as described in the Research Objectives and Research section above (ideally designed to address relevant NIA AD/ADRD Research milestones). Individual projects may not exceed $200,000 in total cost per project. Multi-year research projects are not encouraged and need prior approval by the NIA Program Official before solicitation. NIA requires a national competition to invite research applications to be held on an annual basis, with scientific peer review managed by the Core. All project awards will require approval by the NIA Program Official. While Center investigators are eligible to compete for these awards, 70% of the awards must be assigned to institutions not directly affiliated with the Center.

To facilitate both appropriate and timely study implementation, applicants must propose a consolidated or centralized Institutional Review Board (IRB) approach consistent with the National Institutes of Health's (NIH) single IRB policy for multi-site research for study oversight.

C. Translation Core

This component will investigate and support activities that highlight economic causes of disparities to develop actionable insights that promote health equity. Addressing the mechanisms of disparities in AD/ADRD risk factors, treatment, and care is critical.

The Center will be responsible for supporting the development of an evidence base on Consortium activities to support policy at all levels intended to identify and mitigate AD/ADRD risk factors, develop and implement new treatments and support better efficient care for AD/ADRD patients and their caregivers. To achieve this objective, activities will support research perspectives related to the economics of AD/ADRD, including literature reviews and research studies. The goal of the activities is to facilitate translation of research into evidence-based practices that are accessible to a wide range of stakeholders (e.g., policymakers, healthcare providers, insurance companies, and caregivers). In sum, the activities of the Translation Core are expected to lead to dissemination of actionable economic insights of evidence-based practices in AD/ADRD prevention, treatment, and care.

The budget for this component is limited to $500,000 in direct cost for each year of the budget period.

D. Stakeholder Engagement Core

Involving key stakeholders in Consortium activities provides the opportunity to enhance the expertise and insights integrated into Consortium research projects and increases the likelihood of successful translation of the evidence produced by the Consortium into practice. To that end, this component is responsible for fostering open communication and collaboration intended to inform Center research priorities for AD/ADRD economic analysis via Core-supported programs to obtain stakeholder input. This process will involve a wide range of stakeholders, including public entities (e.g., the Centers for Medicare and Medicaid Services (CMS), Veteran’s Administration (VA), etc.); private organizations (e.g., insurance companies and health services providers); and representatives from various sectors such as academia and the pharmaceutical and nursing home industries. Additionally, input from professional associations, advocacy groups, and individuals directly affected by AD/ADRD, including their caregivers, will be integral to ensuring a comprehensive and inclusive approach. By engaging this wide array of stakeholders, this initiative aims to develop a robust understanding of the economic challenges and opportunities related to economics analyses, which may inform evidence-based policy.

The consortium will actively engage with national and international entities working in similar areas to stay informed of emerging experience, regulations, and technical advances that impact research in health economics and policy related to AD/ADRD. This may include collaborations with other NIH-funded AD/ADRD projects as well as federally and privately funded efforts, such as projects funded by the Center for Medicare and Medicaid Innovation Center (CMMI), CMS, VA, state agencies, and/or private foundations.

Experience and Knowledge

Applicants are required to possess significant experience and knowledge in areas including health economics (ideally related to AD/ADRD), AD/ADRD disparities, translation and dissemination of AD/ADRD research findings, project management, stakeholder engagement, and research study design. A full description of required experience of the PD/PIs can be found in Section IV.

External Advisory Panel

An External Advisory Panel (EAP) for the Center will be established to review the progress of the Center's milestones (as described below under the Milestones and Program Tracking heading) and provide recommendations to the PDs/PIs. NIA will appoint members of the EAP with input from the Center PI. Membership may include study investigators, representatives from relevant federal agencies, and independent scientific experts in areas appropriate to the multidisciplinary content of the Center. The EAP is expected to have 5 -7 permanent members; however, membership may expand permanently or on an ad hoc basis as determined by the NIA Program Official. The EAP will meet twice in year one, either virtually or in person, and once a year in subsequent award years. After each meeting, the EAP will make programmatic comments to NIA, and the PDs/PIs. These comments may include revising milestones or evaluation metrics (see Section I.6 for more details), priority research topics within scope of Center research aims, and future directions for Center activities for NIA to consider. At the end of Year 4, the EAP will provide recommendations for the continuation, continuation with conditions, or termination of the Center, including possible models for sustainability, if continuation is recommended.

NIA will appoint an executive secretary who will take notes and facilitate any travel for any in-person meetings. Additionally, applications should budget appropriately for secretarial support for note-taking and travel services for all other Center activities. See Section VI for full information and details.

Staff in the Office of Planning, Analysis, and Evaluation at NIA may conduct a program evaluation of the Center, in addition to the activities of the EAP.

Milestones and Program Tracking

A. Milestones

NIA will establish annual project milestones as part of the cooperative agreement for this NOFO and reserves the right to modify milestones, if needed. PD/PIs are required to propose additional milestones to support monitoring and measuring of the Center’s performance in meeting the proposed aims of the project. The EAP will comment on progress towards the milestones. Recipient’s progress toward milestone achievement will be informed by the EAP’s comments and assessed by the NIA Program Official. After the first year of the program, the NIA Program Official may require changes to annual milestones to ensure programmatic goals are achieved. At NIA’s discretion, aspects or conditions of the award may be modified, including award termination or a mid-project extension (without additional funds). A full list of required milestones can be found in Section VI.

B. Consortium Program Tracking

The Center must include a program tracking plan that clearly specify short-term and long-term goals and objectives, as well as specific indicators and metrics to track progress toward these goals. The Center is required to achieve consensus among the PIs of projects awarded under RFA-AG-24-031 regarding selecting the method for collecting and tracking metrics based on the milestone requirements of RFA-AG-24-031, as well as the frequency for the collection of this information. The Center is also charged with creating a system to maintain these data and share them with NIA. The Center application must include a strategy for the identification and use of common metrics and processes. Note that all PIs of projects awarded under RFA-AG-24-031 are required to collaborate with the Center to achieve this objective (see RFA-AG-24-031's Specific Research Objectives).

Possible metrics/measures include, but are not limited to, the following:

• Number and research area of Center and Consortium Research Projects to assist in assessing the research program coverage of the Consortium.
• Data on populations covered and subject representation across projects.
• Number and characteristics of research projects that lead to actionable insights as described in the Translation Core.
• Number and scientific backgrounds of investigators supported by the Consortium to conduct research through the Consortium.
• Number of Consortium Research Projects and Center research projects addressing AD/ADRD milestones, categorized by each specific NIA AD/ADRD milestone.
• Number and nature of collaborations among Consortium members and associated products.
• Number and nature of collaborations with other NIA or NIH funded projects and associated products.
• Number and nature of collaborations with stakeholders and associated products (see Stakeholder Engagement Core above).
• Number and characteristics of training sessions, workshops, and other activities including measures of impact (e.g., attendance, new Center projects, etc.).

Non-Responsiveness Criteria

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

• Applications that fail to propose research objectives utilizing economics methodology to provide evidence-based foundation for AD/ADRD prevention, treatment, and care, as well as addressing health disparities.
• Applications that do not propose the required organizational structure, including the Administrative Core, Research Project Core, Translation Core, and Stakeholder Engagement Core.
• Applications that do not include a plan for conducting a national competition for research project funding, with at least 70% of the awards assigned to institutions not affiliated with the cooperative agreement.
• Applications that do not propose a plan for stakeholder engagement, including engaging a wide-range of stakeholders such as public entities, private organizations, academia, professional associations, advocacy groups, and individuals directly affected by dementia and their caregivers.
• Applications that do not describe a plan for collaborating with Consortium Research Projects and NIA staff as described in the Research Strategy and Cooperative Award sections of this NOFO.
• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Clinical Research Operations Management System

NIA utilizes a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant, as described in NOT-AG-23-017. Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4.1.15.7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website.

When applicable, all NIA grantees must ensure:

1. The study’s Informed Consent Document (ICD) lists The National Institutes of Health (NIH) and its authorized representatives as one of the organizations that may look at or receive copies of information in participants study records. According to DHS HHS OHRP 45 CFR 46 46.116, all ICDs must contain A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. If using the NIA informed consent template please see Section 6: Statement of Confidentiality.

2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov.

Frequently Asked Questions

Responses to frequently asked questions about this NOFO will be posted here.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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 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:

Partha Bhattacharyya, 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.

Applicants for the consortium are required to possess significant experience and knowledge in the following areas to ensure the proposed team and its structure have the necessary depth of expertise:

• Experience in health economics, ideally related to AD/ADRD, with a focus on economic incentives, policy levers, and healthcare system design.
• Experience in conducting research on disparities in AD/ADRD risk factors, treatments and/or care, including understanding the underlying socioeconomic factors, geographical location, and cultural barriers.
• Proficiency in translating and disseminating AD/ADRD research findings to a wide range of stakeholders, including policymakers, healthcare providers, insurance companies, and patients living with dementia and their caregivers.
• Experience in project management, from idea conception through implementation, tracking, and completion, with a focus on research projects and funding competitions.
• Experience with engaging a wide-range of stakeholders, such as public entities, private organizations, academia, industry representatives, professional associations, advocacy groups, and individuals directly affected by dementia and their caregivers.
• Knowledge of, and experience in, study design, statistical expertise, and innovative research methodologies such as artificial intelligence and behavioral economics.
• Ability to foster collaboration and communication among various consortium components, including Consortium research projects, Translation Core, Stakeholder Engagement Core, and other related activities.
• Established experience working in research consortia or other collaborative projects, with a demonstrated ability to achieve shared goals and objectives.
• Understanding of the budgetary requirements and constraints for research projects and consortium cores, including direct cost limitations and funding allocations.
• Commitment to supporting and promoting health equity, diversity, and inclusiveness in research projects and consortium activities.

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.

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

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)

Specific Aims: The application must describe the aims of the overall Center and outline how the different Core components will contribute to these aims.

Research Strategy:

The application must address plans to achieve the overall objectives of the Center to create an evidence-base for enhancing AD/ADRD prevention, treatment and care and disseminating results to stakeholders as described in Section I. NIA will establish annual project milestones as part of the cooperative agreement for this NOFO and reserves the right to modify milestones, if needed. Required milestones are listed below. PD/PIs are required to propose additional milestones to support monitoring and measuring of the Center’s performance in meeting the proposed aims of the project. The application must describe plans for how the required milestones established by NIA as well as the milestones proposed by the investigative team will be met. The EAP will comment on progress towards the milestones. Recipient’s progress toward milestone achievement will be informed by the EAP’s comments and assessed by the NIA Program Official. After the first year of the program, the NIA Program Official may require changes to annual milestones to ensure programmatic goals are achieved. At NIA’s discretion, aspects or conditions of the award may be modified, including award termination or a mid-project extension (without additional funds).

Required milestones established by NIA include the following:

• Establish governance for the cooperative agreement within the first month.
• Develop and launch a public website for communication and sharing of activities, events, and resources within the first month.
• Nominate EAP members within the first month.
• Begin coordinating activities between the Center Cores and Consortium R01s, and facilitate networking, quarterly seminars within the first 3 months.
• Develop a stakeholder engagement strategy and plan within the first 3 months of the project.
• Establish a stakeholder advisory group consisting of a variety of representatives from identified stakeholder categories within the first 4 months of the project.
• Develop guidelines and criteria for the national competition to invite research applications within the first 4 months.
• Develop and maintain a dedicated platform (e.g., website) for stakeholder communication and resource sharing, to be launched within the first 5 months of the project.
• Conduct stakeholder meetings twice a year to foster open communication and collaboration, starting within the first 6 months of the project and continuing throughout the project duration. Gather input from stakeholders to establish key priorities for Center research.
• Propose awards of research projects to NIA PO, ensuring that 70% of the awards are assigned to institutions not affiliated with the cooperative agreement, within the first 8 months.
• Obtain NIA Program Official approval for all research projects before implementation within the first 9 months.
• Host research workshop and training session within the first 9 months of the project.
• Establish standards and mechanisms for publicly sharing data, resources, and codes within the first 9 months with input from consortium members.
• Launch the national competition to support a minimum of 5 scholars for up to two years, with each scholar awarded up to $50K in direct cost to pursue economics research related to NIA AD/ADRD milestones within the first 9 months.
• Coordinate two EAP meetings within the first 12 months.
• Host workshops and training sessions prior to national conferences (e.g., AAIC, ASHE, ASSA/AEA annual meeting) within the first 12 months.
• Plan and implement annual research meetings in Bethesda, MD, starting at the end of Year 1 with input from the NIA Program Official.
• Allocate a total of $1,000,000 per year in total costs for research projects, starting in Year 1 and in subsequent years.
• Conduct an annual comprehensive literature review on the economics of dementia and provide a broad perspective to the field of economics research.
• Monitor and provide annual written assessment of the impact of Translation and Stakeholder efforts and update the annual literature review.
• Facilitate economic analyses for the translation and dissemination of research, making findings accessible to stakeholders throughout the project duration.
• Facilitate presentations and webinars throughout the project duration highlighting relevant findings and resources for research throughout the project duration.
• Translate and disseminate research findings to empower stakeholders, such as insurance companies, CMS, and healthcare providers, to address disparities and improve care throughout the project duration.

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.

This NOFO REQUIRES the sharing of ALL resources with a broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program, unless prohibited under Bayh-Dole Regulations.

It is imperative that the data collection and permission/consents are set up in such a manner with respondents and institutions that will allow broad use of resource sharing.

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

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

Applications must address the following items:

• Indicate the repository/consortium/enclave where they will place the resource or have a clear plan and capacity to share from their own site(s). Working with an external repository or through a consortium can be advantageous for many investigators.
• Describe and justify the timetable to release the resource. Generally, the referenced resource from a publication should be made available by the on-line publication date unless NIH policy specifies an earlier date. Investigators should justify exceptions to that timing.
• Identify any restrictions on sharing and justify them. Restrictions might include, for example, no commercial use of the resource, only qualified users may access the material, or, no attempt to reveal personal or private information may be made. Investigators may also set different levels of access, for example, for expert users and novice users.
• Describe how all materials will be transferred to a new entity at the end of the project period to enable long-term follow up with survey respondents and institutional representatives.
• To ensure that qualified users will have easy access to the resource, describe either (1) how the investigators will curate the resource, what documentation they will provide about the resource and the format in which it will be provided, and whether any resource will be held back, and (2) if/how the investigators will work with the identified repository/consortium/enclave to prepare the resource and documentation.
• Address considerations of privacy-preserving linkages and how such keys will be transferred to various parties (e.g., consortium members, researchers) preserving PII for future follow-up.
• Address timely (i.e., within 30 days of NIA notice) execution of the material transfer agreement within and across the Consortium, and with third parties if directed by NIA. The material transfer agreement includes, but is not limited to, transfer of sampling frame and all resources generated by the grant.

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 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.

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.

SF424 (R&R) Cover (Administrative 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 Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

Application budges must include funds for planning and implementing annual Consortium research/business meetings in Bethesda, MD beginning in Year 1, including preparation of annual meeting notes and an annual meeting report.

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 (Administrative Core)

Specific Aims: The application must concisely state the goals of the proposed Administrative Core and summarize the expected outcome(s).

Research Strategy:

The goal of the proposed Center's administrative function is to provide effective governance and support for PI/PDs of the Center and Consortium research project. The application must include the following:

• A governance plan for the cooperative agreement.
• A plan to develop a public website for communication and sharing of activities, events, and resources of the program.
• Plans for coordination of activities among the Center components, Consortium Research Projects, and other related grants to facilitate networking, conduct quarterly research seminars highlighting findings and resources, and produce an annual research/business meeting of the Consortium as directed by the NIA Program Official.
• Outline processes to support collaboration and support across all component activities.
• A plan to develop and provide input to NIA staff regarding the necessary expertise for members of an External Advisory Panel (EAP) that will provide comments on the study activities to NIA and to the PDs/PIs. The plan should describe a process and not include recommendations of specific individuals to be members of the EAP.
• Plans to provide Center milestone reporting for all components to the Program Officer(s), Project Scientist(s), and the EAP.
• Propose standards and mechanisms to publicly share data, resources, and codes developed and utilized under this NOFO.
• Plans for working with NIA staff to develop agendas and materials for EAP meetings, which will take place in the vicinity of Bethesda, MD and are expected to last approximately 1.5 days.
• A proposal for planning and implementing annual Consortium research/business meetings in Bethesda, MD starting end of Year 1 with input from the NIA Program Official.Plans to host a research workshop and training session annually, at a national conference (e.g., AAIC, ASHE, ASSA/AEA annual meeting).
• Plans to hold a national competition to select a minimum of five scholars for up to two years. Each scholar must be awarded up to $50K in direct cost to pursue research on AD/ADRD prevention, treatment, and care. The plan should include the process of scholar selection that should focus on developing a pipeline of early career researchers from various backgrounds conducting economics research on AD/ADRD prevention, treatment, and care. All scholars should receive mentorship from an assigned member of the Consortium with relevant expertise facilitated by the Center.
• Plans for hosting seminars/webinars focused on Economics of AD/ADRD and are in line with Consortium research activities, with input from stakeholders, the EAP, and the NIA Program Official.
• Plans to develop and track milestones to support monitoring and measuring of the Center’s performance in meeting the proposed aims of the project. (see the information provided under the Milestones and Program Tracking heading in Section I). Applications are encouraged to provide appropriate milestones for each Core based on proposed activities.

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 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 Informationf orm 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 Project Core

When preparing your application, use Component Type "Research Core."

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

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.

SF424 (R&R) Cover (Research Project 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 Project Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project 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 Project 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 Project 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 Project 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.

This component must allocate $1,000,000 per year in total costs, starting in Year 1 and in subsequent years, to support research projects that must focus on the economics of AD/ADRD prevention, treatment, and care (as described in this NOFO). Individual projects may not exceed $200,000 in total cost per project. Multi-year research projects require prior approval by the NIA program official before solicitation and are not encouraged.

PHS 398 Research Plan (Research Projects Core)

Specific Aims: The application must concisely state the goals of the proposed Research Project Core and summarize the expected outcome(s).

Research Strategy:

The objective of the Research Project Core is to develop and support innovative research projects from Center investigators, Consortium members, and other qualified external researchers.

The application must include the following:

• A succinct description of the promotion process the Center will employ to solicit research projects within the scope provided in the NOFO (i.e., economic research on AD/ADRD prevention, treatment, and care).
• A description of how new research projects will be peer reviewed, awarded, and managed by the Center, including the receipt of prior approval from the NIA Program Official prior to award. Applicants must include a description of a national research project competition that reaches a multifaceted and national group of relevant researchers to invite applications on an annual basis. The application must describe how the national research project competition will contribute to developing an evidence-base of economic research in AD/ADRD prevention, treatment, and care. Plans should also establish a process to ensure that at least 70% of awards made under this component are assigned to institutions not directly affiliated with the Center.
• A description of the process for tracking outcomes from each research project supported by the Center.
• All applications, regardless of their specific focus, must address health disparities for underserved populations in their plans for research and research programs.

To facilitate both appropriate and timely study implementation, applicants must propose a consolidated or centralized Institutional Review Board (IRB) approach consistent with the revised Common Rule single IRB requirement for cooperative research (at 45 CFR 46.114) and the National Institutes of Health's (NIH) single IRB policy for multi-site research for study oversight.

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 Projects 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.

Translational Core

When preparing your application, use Component Type Translation Core.

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

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.

SF424 (R&R) Cover (Translation 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 (Translation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Translation 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) (Translation 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 (Translation 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 (Translation 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 for this component is limited to $500,000 in direct cost for each year of the award period.

PHS 398 Research Plan (Translation Core)

Specific Aims: The application must concisely state the goals of the proposed Translation Core and summarize the expected outcome(s).

Research Strategy:

Applicants should describe plans to develop and disseminate actionable economic insights of evidence-based practices, based on Center activities, in AD/ADRD prevention, treatment, and care.

Plans must include, but are not limited to, the following:

• Activities to support research perspectives for the economics of AD/ADRD (e.g., literature reviews and research studies led by the Center to facilitate translation) accessible to a wide range of stakeholders (e.g., policymakers, healthcare providers, insurance companies, and caregivers).
• Activities to address the mechanisms of disparities in AD/ADRD risk factors, treatment, and care to develop actionable insights that promote health equity.
• Activities to enhance the likelihood of translation of Consortium research findings into practice.
• Plans to interact with other Center Cores and Consortium Research Projects to support translation of research findings.

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 (Translation 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.

Stakeholder Engagement Core

When preparing your application, use Component Type "Stakeholder Core."

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

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.

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

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Stakeholder 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) (Stakeholder 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 (Stakeholder 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 (Stakeholder 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.

PHS 398 Research Plan (Stakeholder Engagement Core)

Specific Aims: The application must concisely state the goals of the proposed Stakeholder Engagement Core and summarize the expected outcome(s).

Research Strategy:

This component is responsible for fostering open communication and collaboration to inform Center research priorities for AD/ADRD economic analysis via Core supported programs. To accomplish this, stakeholder input should be obtained.

Applicants must describe their process for accomplishing the following:

• Selecting and engaging stakeholders, which includes, but is not limited to, the following: public entities, such as CMS and VA; private organizations like insurance companies and accountable care organizations (ACOs); and representatives from various sectors such as academia and the pharmaceutical and nursing home industries.
• Establishing relationships and engaging with professional associations, advocacy groups, and individuals directly affected by dementia, and their caregivers, to achieve core objectives.
• Incorporating feedback from the stakeholders to understand the challenges and opportunities which can inform economics analyses and provide evidence-based foundation to improve AD/ADRD prevention, treatment, and care.

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 (Stakeholder 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.

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

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?

Specific to this NOFO:

How adequately does the application address the plans to achieve the overall objectives of the Center to create an evidence-base for enhancing AD/ADRD prevention, treatment and care and disseminating results to stakeholders?

In addition, for applications involving clinical trials

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

Investigator(s)

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

Specific to this NOFO:

How adequately does the application propose key personnel with appropriate expertise in health economics and AD/ADRD research?

How adequately does the application propose key personnel with sufficient experience working in research consortia or other collaborative efforts to achieve a shared goal?

In addition, for applications involving clinical trials

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

Innovation

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

In addition, for applications involving clinical trials

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

Approach

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

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

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

Specific to this NOFO:

How adequately does the application provide adequate plans for addressing the establishment and tracking of required Milestones?

How adequately does the application adequately describe how the Center will address the management of the cooperative award, including interactions with NIA staff as described in the Cooperative Award section of this NOFO?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

In addition, for applications involving clinical trials

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

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

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

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

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.

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

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 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?

Specific to this NOFO:

How impactful will the proposed annual research workshop and training session at a national conference be in developing the research community?

How impactful will the proposed scholar program be in developing the research community?

How impactful will the proposed seminars/webinars focused on Economics of AD/ADRD be in disseminating Consortium research?

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 proposed governance plan for the Center?

How adequate are the plans for coordination of activities between the Center components and Consortium Research Projects?

How adequate are the plans to support the External Advisory Panel (EAP)?

How comprehensive and sufficient are the plans to host research workshop and training sessions annually at national conferences, including the support of scholars?

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 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 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 Project 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?

Specific to this NOFO:

How significant will the proposed national research project competition be in developing an evidence-base of economic research in AD/ADRD prevention, treatment, and care?

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?

Specific to this NOFO:

How innovative is the proposed approach to conduct a national research project competition? How likely is it to reach a multifaceted and national group of relevant researchers?

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 sufficient are the plans to conduct a national competition for research projects? How adequate is the promotion, review, and award process to achieve the research objectives of the Core?

How well does the application adequately describe a process for tracking the outcomes of each research project supported by the Center?

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 Project 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 Project 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 - Translation 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?

Specific to this NOFO:

How innovative are the specific activities intended to enhance the likelihood of translation of Consortium research findings into practice?

Approach

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

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

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

Specific to this NOFO:

How adequate are the proposed activities intended to translate Center research findings into practice? How likely is the process to sufficiently reach a wide array of relevant stakeholders?

How effectively do translation activities address disparities in AD/ADRD risk factors, treatment, and care in order to develop actionable insights that promote health equity?

How adequately do the Core plans describe interactions with other Center Core and Consortium activities?

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 - Translation 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 - Translation 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 - Stakeholder 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 proposed process of selecting and engaging stakeholders?

How sufficient are proposed activities to engage different stakeholder groups (e.g., public, private, academic, etc.)?

How adequate is the plan to incorporate feedback from the stakeholders to understand the challenges and opportunities which can inform economics analyses and provide evidence-based foundation to improve AD/ADRD prevention, treatment, and care?

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 - Stakeholder 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 - Stakeholder 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.

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 FOA

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this 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.

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

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

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

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

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

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.

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 (DHHS) grant administration regulations at 45 CFR Part 75 and 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 the 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 NIA Program Official and 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.
• 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 NIA 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.
• Obtaining prior approval from the NIA Program Official for any replacements of key personnel or other changes in subawards.
• Responding promptly and cooperatively to requests for information or input from NIA.
• Participating in ongoing conference calls with Project Scientist(s) and/or other NIA program staff, as scheduled and agreed upon.
• Retaining custody of, and having primary rights to, the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• NIA will assign a Project Scientist and a Program Official to assist recipients.
• An NIA Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIA Program Official will approve all major stages of the project and all new major additions/changes to planned activities, including approval of all collaborative studies and research awards 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. The NIA Program Official is an ex officio member of the EAP and will approve membership and agendas of the EAP.
• An NIA Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIA Project Scientist will assist in refining study objectives and activities.

Areas of Joint Responsibility include:

• Determining the process of setting Center priorities, deciding optimal administrative and governance approaches, and contributing to the adjustment of approaches as warranted.
• Organizing and coordinating meetings for the Center, as required.
• Participating in ongoing conference calls among PD/PIs, NIA Project Scientist(s), and/or other NIA program staff, as scheduled and agreed upon.
• Establishing milestones. NIA will establish project milestones, with the provision to modify them as necessary, and PD(s)/PI(s) will propose additional milestones.
• Coordinating and facilitating the interactions between participants under this cooperative agreement and other NIA recipients.
• Considering the working group and the EAP's comments for modifying the Center's focus to accommodate new scientific opportunities and directions.
• Sharing and reviewing annual progress among components of the Center, and with external stakeholders.
• Meeting at least once per month by teleconference.

External Advisory Panel (EAP)

• 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 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:
  • Communicate specific comments to NIA regarding priorities via executive (closed) 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, as well as activity milestones of the Center.
  • 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 economic research on AD/ADRD prevention, treatment, and care.
  • 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 EAP, 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/virtual 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 comments of the EAP regarding implementation of CC 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 the EAP by vote, when necessary. NIA will assist the EAP with developing a charter 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 the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 DHHS 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. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.

This NOFO REQUIRES the sharing of ALL resources with a broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program, unless prohibited under Bayh-Dole Regulations.

It is imperative that the data collection and permission/consents are set up in such a manner with respondents and institutions that will allow broad use of resource sharing.

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

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

Applications must address the following items:

• Indicate the repository/consortium/enclave where they will place the resource or have a clear plan and capacity to share from their own site(s). Working with an external repository or through a consortium can be advantageous for many investigators.
• Describe and justify the timetable to release the resource. Generally, the referenced resource from a publication should be made available by the on-line publication date unless NIH policy specifies an earlier date. Investigators should justify exceptions to that timing.
• Identify any restrictions on sharing and justify them. Restrictions might include, for example, no commercial use of the resource, only qualified users may access the material, or, no attempt to reveal personal or private information may be made. Investigators may also set different levels of access, for example, for expert users and novice users.
• Describe how all materials will be transferred to a new entity at the end of the project period to enable long-term follow up with survey respondents and institutional representatives.
• To ensure that qualified users will have easy access to the resource, describe either (1) how the investigators will curate the resource, what documentation they will provide about the resource and the format in which it will be provided, and whether any resource will be held back, and (2) if/how the investigators will work with the identified repository/consortium/enclave to prepare the resource and documentation.
• Address considerations of privacy-preserving linkages and how such keys will be transferred to various parties (e.g., consortium members, researchers) preserving PII for future follow-up.
• Address timely (i.e., within 30 days of NIA notice) execution of the material transfer agreement within and across the Consortium, and with third parties if directed by NIA. The material transfer agreement includes, but is not limited to, transfer of sampling frame and all resources generated by the grant.

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]

Partha Bhattacharyya, Ph.D.
Division of Behavioral and Social Research (DBSR)
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.