Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title
Network for Personalization of Diagnostic Tests for Alzheimer’s Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD) in Older Adults with Multiple Chronic Conditions (MCCs) (U24 Clinical Trial Optional)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-AG-23-032
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications to establish a network that will conduct transdisciplinary aging diagnostic biomarker and/or imaging research projects focused on Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD) in persons living with multiple chronic conditions (MCCs). The aim of the network and its projects is to better align diagnostic testing with the needs and priorities of an aging population. The national consortium will: 1) assemble existing data and acquire real-world data to ensure that the research sample is large with adequate representation of older adults living with well-characterized MCCs, and incorporate pre-specified subgroup analyses; 2) analyze data for performance and accuracy of biomarkers, including blood, cerebrospinal fluid (CSF), and imaging, in older patients living with MCCs; and 3) conduct pilot studies involving specific AD/ADRD imaging and/or biomarkers in persons living with MCCs.

Key Dates

Posted Date
June 14, 2022
Open Date (Earliest Submission Date)
September 17, 2022
Letter of Intent Due Date(s)

September 17, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 17, 2022 Not Applicable Not Applicable February 2023 May 2023 July 2023

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 Funding Opportunity Announcement

Expiration Date
October 18, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Diagnostic testing is crucial for detecting new health conditions as they arise and selecting their treatments, yet test performance and clinical utility can shift with aging-related biological changes and in the context of multiple co-occurring chronic conditions (MCCs). Biomarker- and imaging-based testing has become a major part of chronic disease management, including for major diseases that are strongly associated with aging. A diagnostic biomarker is defined, by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) Biomarker Working Group, as a biomarker used to detect or confirm presence of a disease or condition of interest or to identify individuals with a subtype of the disease.

Older persons have a greater prevalence of comorbid diseases and geriatric syndromes (e.g., frailty, physical and cognitive impairments, and sarcopenia) that commonly confound interpretations of traditional disease assessments. MCCs have been observed in about 2/3 of older adults in population studies, making it the “most common chronic condition.” Dementia is a growing public health problem, and its diagnosis in primary care relies mostly on clinical suspicion based on patient symptoms or caregivers’ concerns. Persons newly diagnosed with Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD) typically have 3-4 other chronic conditions or geriatric syndromes. MCCs may affect the expression of AD pathology in ways such as worsened cognitive function, disease stage, and neuropathological burden (Wallace et al. Lancet Neurol 2019;18:177-84). The “normal” ranges for biomarkers and imaging metrics are often broader in older populations, where prevalence of MCCs reaches >85%, such that they overlap with abnormal values in younger persons, further reducing specificity. MCCs are also clinically significant in course, severity, and therapy with multiple medications, or polypharmacy.

AD/ADRD studies of diagnosis and therapeutics have not adequately addressed differences by age and sex and frequently exclude persons living with a variety of comorbidities. As with many other chronic diseases, biomarker- and imaging-based testing has become a major part of disease management for those living with AD/ADRD. The diagnostic criteria for several causes of dementia have been updated in recent years but are not yet well-adapted for clinical application. AD biomarkers under consideration by the Alzheimer's Association in their novel diagnostic criteria for the disease can be grouped as aggregated amyloid beta or tau, associated pathologic state, or neurodegeneration or injury, as measured through imaging and cerebrospinal fluid sources, with expedited development for biomarker tests in blood, including in plasma, ongoing. Research suggests an increase in diagnostic confidence or diagnostic certainty and prescription of anti-AD medication after amyloid PET testing, but a study of the link to health outcomes is still underway. The prescription of aducanumab, a novel treatment available for AD, may be predicated on biomarker testing, which could lead to considerable demand, and raises 1) questions about biomarkers’ clinical utility and 2) the urgency of this research need.

The American Geriatrics Society (AGS) developed Guiding Principles for the Care of Older Adults With Multimorbidity to provide a framework for decision making for clinicians who provide care to older people living with MCCs. AGS' recommendations include: (1) identify and communicate patients' health priorities; (2) stop, start, or continue care (including diagnostics) based on health priorities, potential benefit versus harm and burden, and health trajectory; and (3) align decisions and care among patients, caregivers, and other clinicians with patients' health priorities. The context of MCCs is crucial for this work and requires accurate diagnosis, and consideration of potentially burdensome diagnostic tests (e.g., those involving exercise, patient risk of harm, or high expense) within the framework. Notably, decision making is more uncertain for older adults with MCCs than for other populations due to lack of applicable evidence, including for diagnosis, and limitations of disease‐based decision-making.

The 2020 AD/ADRD care summit examined the potential for identifying persons living with AD/ADRD in health care settings, noting problems with the conceptual process of diagnosis and the low rates of detection in community-dwelling persons. Speakers at the summit identified opportunities for linking electronic health record (EHR) mining, screening, and more sophisticated tools to imaging and biomarkers. The 2021 AD/ADRD summit examined the potential for diagnostic biomarkers to advance toward acceptance as a diagnostic standard and indicated the need for larger studies, as well as the need to leverage interventional studies. The advancement of diagnostic biomarkers for AD/ADRD is a necessary underpinning for advancing beyond the current syndromic approach and toward a personalized medicine approach. In addition, as discussed in a workshop hosted by the National Academies of Sciences, Engineering, and Medicine (NASEM) titled Clinical Practice Implications of Biomarker and other Preclinical Diagnostics of AD/ADRD, studies around the detection of AD/ADRD need to evaluate very sensitive markers and include persons based on age, gender, race/ethnicity, and comorbid disease.

Purpose/Research Objectives

This Funding Opportunity Announcement (FOA) invites applications to establish a national consortium that will conduct transdisciplinary aging diagnostic biomarker and/or imaging research projects focused on AD/ADRD and MCCs. The focus of the network is on the complex older patient who lives with MCCs and is being evaluated diagnostically for cognitive impairment or dementia. The aim of the research is to better align diagnostic testing with the needs and priorities of an aging population. The accurate integrated assessment of MCC severity, risk factors, biomarkers, frailty, and cognition is necessary for a personalized medicine approach to AD/ADRD. AD/ADRD diagnostic biomarkers and imaging research has the potential to advance the care of persons with multiple chronic conditions. The priorities of this initiative include developing adequate representation of heterogeneous older adults in studies of diagnostic testing strategies and modalities, including imaging and biomarkers, and incorporating pre-specified subgroup analyses by age and MCCs into study design. It is also important to develop better tools for assessing prognosis for AD/ADRD by integrating geriatric factors, such as MCCs, geriatric syndromes, and physical function. The context of MCCs requires accurate diagnosis and consideration of potentially burdensome diagnostic tests (e.g., those involving exercise, patient risk of harm, or high expense). Notably, decision making is more uncertain for older adults with cognitive impairment and MCCs than for other populations due to a lack of applicable evidence, including for diagnosis, and limitations of disease‐based decision-making. Some challenges of imaging potentially more common in persons with MCC include obesity, medical implants, claustrophobia, inability to lie still, unwillingness to receive radiation dose, and allergic or injection site reactions.

Researchers must leverage or build upon existing networks that include older adults living with AD/ADRD and MCCs to enable progress on this important topic. The network is required to:

  • Assemble existing data and acquire real-world data to ensure that the research sample is large, with adequate representation of older adults living with well-characterized MCCs, and incorporate pre-specified subgroup analyses;
  • Analyze data for performance and accuracy of biomarkers, including blood, cerebrospinal fluid (CSF), and/or imaging, in real-world older patients living with MCCs; and
  • Conduct pilot studies involving specific AD/ADRD imaging and/or biomarkers in persons living with MCCs.

Investigators

Investigators must have sufficient expertise, commitment of effort, organizational structure, and operational effectiveness to successfully implement a plan for this undertaking. It is expected that investigators from a variety of professional backgrounds and research expertise across multiple institutions will form an interdisciplinary consortium. Examples of the kinds of investigators who could be included in this network include neuroscientists, radiologists, biomarker specialists, epidemiologists, biostatisticians, clinical trialists, neurologists, geriatricians, pharmacists, and social workers, to name a few. Where appropriate, involvement of collaborators or consultants from industry or other private sector organizations is permissible. A multiple Program Director/Principal Investigator model of leadership may be proposed, if warranted.

Organization

Applicants must propose a network of investigators and resources that span multiple institutions. The institutions might include, but are not limited to, academic medical centers and health and long-term care systems that provide dementia care. A successful network will likely have an organizational structure that effectively addresses the proposed aims and integrates personnel, resources, and infrastructure across institutions. Examples of the organizational components that could contribute to a successful network include a leadership or steering body to coordinate planning, evaluation, resource allocation, and administrative oversight; a data coordination body that oversees standardization of data, houses informatics resources, and coordinates exchange of data, biospecimens, and other research resources; and a dissemination body that coordinates timely and effective information sharing with relevant stakeholders. Applicants may also consider establishment of an external advisory committee. These are merely examples and are not intended to prescribe a specific organizational structure. Investigators should propose the components and functions that best suit the aims of the network.

Specific Areas of Research Interest

Potential areas of research of successful applications may include, but are not limited to, the following:

  • Delineate normal values and/or ranges for test results across age, sex, and racialand ethnic groups, including persons ≥85 years of age
  • Develop tools and methods to integrate MCCs and biomarkers into AD/ADRD care pathways
  • Develop better models for assessing pre-test probability prior to AD/ADRD biomarker testing in older adults living with MCCs
  • Conduct analysis to inform clinical decision-making on low-value testing in older adults living with MCC-related competing risks, and/or limited life expectancy, integrating prognosis and patient preferences
  • Evaluate novel AD/ADRD biomarkers in persons living with MCCs
  • Develop evidence that would advance Medicare coverage for AD/ADRD biomarkers

This network may plan one or more definitive multicenter randomized clinical trials of diagnostic testing for AD/ADRD in persons living with MCCs, but the funds for this network are only intended for the planning (e.g., protocol development, pilot and feasibility testing, data system development) and not the conduct of such a definitive trial.

Pre-Application Webinar

An optional webinar is planned to provide prospective applicants the opportunity to receive information and ask questions about the scientific scope of this FOA and technical details for applying.

Prospective applicants may visit http://www.nia.nih.gov/research/dgcg/diagnostics-rfa for more information about the webinar, including information about timing and access.

Non-Responsiveness Criteria

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

  • Applications that propose activities that only serve investigators at a single institution, or a small number of institutions, rather than the field at large
  • Applications that include plans to conduct definitive multicenter randomized clinical trials
  • Applications that do not include all of the following components:
    • Plans to assemble existing data and acquire real-world data to ensure a large sample with adequate representation of older adults living with well-characterized MCCs and incorporate pre-specified subgroup analyses
    • Plans to analyze data for performance and accuracy of biomarkers, including blood, CSF, and/or imaging, in real-world older patients living with MCCs
    • Plans to conduct pilot studies of specific AD/ADRD imaging and/or biomarkers in persons living with MCCs

Clinical Research Operations Management System

The National Institute on Aging (NIA) supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the 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. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of a CROMS data templates as specified.

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

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIA intends to commit $1,750,000 in fiscal year 2023 to fund one award.

Award Budget

Application budgets are limited to $1,150,000 in direct costs and need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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 Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

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. 

Required Registrations

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 Policy on Late Submission of Grant 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 full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIA 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:

Marcel E. Salive, M.D., MPH
National Institute on Aging (NIA)
Telephone: 301-496-5278
Email: saliveme@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must have appropriate experience and training, with demonstrated experience and an ongoing record of accomplishments in managing transdisciplinary clinical research projects and coordinating collaborative research at a national level.

The team must include both established and emerging leaders in the scientific area of focus; expertise in data extraction from EHRs and other clinical systems; experience in design, conduct, and analysis of clinical research studies; experience in collaborative research with a variety of stakeholders and background in MCCs and AD/ADRD research.

If the network is multi-PD/PI, the investigators should have complementary and integrated expertise and skills, and plans must include an appropriate leadership approach, plans for conflict resolution, and organizational and governance structure.

The PD(s)/PI(s) should have experience overseeing selection and management of subawards.

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

The application should identify the specific problems or limitations that will be addressed by the proposed network, with attention to the role of multiple chronic conditions in the diagnosis of AD/ADRD. The application should describe areas of opportunity that will be fulfilled by specific activities of the network, including how it will challenge and take into account current AD/ADRD and MCC research or clinical practice paradigms, enlarge participation in clinical research, and impact current AD/ADRD data management strategies.

The application must describe the strategy for addressing the aims of the network. The application should describe how existing components at center sites and newly proposed components supported through this FOA will interact to accomplish the goals of the network. The application should identify metrics that will be used to assess progress toward specific goals. The application should provide timelines and an organizational chart, referencing, but not repeating, information submitted on PHS Human Subjects-Clinical Trial Information form.

The application should describe the organizational structure of the network, including a leadership body that will have primary responsibility for overseeing the network. The application must describe plans for day-to-day operations overseen by the leadership body, such as the following:

  • Coordination across multiple centers programs
  • Allocation and review of resource utilization across the network
  • Convening of an external advisory panel, as appropriate
  • Review and selection of pilot projects
  • Preparation and submission of administrative documents related to the award

The application should describe other infrastructure and specific activities that will be established within the network, how they will function, and how they will interact with existing and newly created components. The proposed network activities must serve the broader community of clinical, neuroscience and epidemiological researchers engaged in NIA-relevant research beyond a single institution or set of institutions. The outreach plans must reach and include a broad swath of MCC-rich AD/ADRD datasets, completed or ongoing, collected over a range of age groups, and include populations defined by the NIA Health Disparities Framework.

If the network will support scientific meetings, the application should describe procedures for developing and selecting meeting topics, identifying potential participants, developing meeting agendas, selection of venues, and monitoring and dissemination of meeting outputs.

If the network will award pilot projects, the application must describe the types of projects that will be supported. The application should provide a plan describing processes for solicitation, review, selection, and monitoring of pilot projects. The application should describe plans for monitoring progress of pilot projects and translating their results into subsequent applications for funding where appropriate. Brief descriptions of potential projects should be illustrative.

NIA's process for approval of pilot projects may be developed after award.

The application should describe the leadership role played by PD/PI and other Senior/Key personnel, if applicable, and the impact it would have on the success of their center as well as on the overall network.

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The plans should provide details for what will be shared, how it will be organized to enhance the user experience, and any limitations/restrictions on access to resources and data produced by the project. Plans should adhere to NIA’s Guidance on Sharing Data and other Resources (https://www.nia.nih.gov/research/grants-funding/nia-specific-funding-policies#datasharing).
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Overall Impact

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).

Scored Review Criteria

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 proposed application address the needs of the research network that it will administer? Is the scope of activities proposed for the network appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?

For this particular FOA, note the following additional questions:

How well do the proposed activities advance collaboration and coordination among longitudinal studies of AD/ADRD and MCCs? 

Does the application appropriately address how the proposed network will have a substantial impact on the progress and quality of clinical research of relevance to biomarker development and diagnosis of AD/ADRD in persons with MCCs? 

Will the resulting network and infrastructure promote and sustain productive collaborations across multiple, NIA-funded, relevant longitudinal studies of AD/ADRD and MCCs and allow for future incorporation of other datasets nationally and internationally?

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) and other personnel well suited to their roles in the network? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the network is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach and organizational structure appropriate for the network? Does the applicant have experience overseeing selection and management of subawards, if needed?

For this particular FOA, note the following additional questions:

Do the personnel have the appropriate breadth of expertise and experience, including but not limited to, experience with data extraction in meaningful ways from EHRs and other clinical systems, experience in design, conduct, and analysis of clinical research studies, experience in collaborative research with a variety of stakeholders and background in MCCs and AD/ADRD research? 

Are the proposed leadership approach, staffing, governance and organizational structure appropriate for the project?

Have they demonstrated an ongoing record of accomplishment in support of coordination, collaboration, and communication of national-level inclusive networks or consortia? Are the investigators willing to collaborate with the Pilot Project awardees, and NIA-funded AD/ADRD studies to meet the goals and objectives of this program?

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 propose novel organizational concepts or instrumentation in coordinating the research network? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or instrumentation proposed?

For this particular FOA, note the following additional questions:

Does the application challenge and take into account current AD/ADRD and MCC research or clinical practice paradigms, and enlarge participation in clinical research by utilizing novel theoretical concepts, approaches, methodologies, interventions, or tools?

Does the application challenge and seek to impact current AD/ADRD data management and research implementation strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools?

Does the application include mechanisms for leveraging novel collaboration and communication strategies for AD/ADRD and MCC researchers?

Does the application indicate creativity and flexibility to innovate on an ongoing basis?

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

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, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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?

For this particular FOA, note the following additional questions:

Are the proposed network activities likely to serve the broader community of clinical, neuroscience and epidemiological researchers engaged in NIA-relevant research beyond a single institution or set of institutions?

Are outreach plans designed to reach and include a broad swath of MCC-rich AD/ADRD datasets, completed or ongoing, collected over a range of age groups and priority populations defined by the NIA Health Disparities Framework?

Are appropriate procedures in place for coordination across institutions and for effectively engaging with other relevant activities at participating institutions and across the field at large?

Are the plans for pilot projects likely to reach and include a broad range of investigators from diverse fields, backgrounds, and career stages?

Is the approach for soliciting and reviewing pilot projects appropriately aligned with networks goals, appropriately impartial and rigorous, and likely to advance progress in the field at large?

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 institutional environment in which the network will operate contribute to the probability of success in facilitating the research network? Are the institutional support, equipment and other physical resources available to the investigators adequate for the network proposed? Will the network benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

For this particular FOA, note the following additional questions:

Are resources available within the participating scientific environment to support electronic information handling and development of web resources for dissemination of network products?

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

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?

Additional Review Criteria

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

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 Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For [programs/projects/networks/consortia/resources] 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 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 FOA. 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 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.5. 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 FOA 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: Recipient 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).

2. Administrative and National Policy Requirements

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

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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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.

Cooperative Agreement Terms and Conditions of Award

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, 2 CFR 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's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award 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 awardees and the NIH as defined below.

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

  • Developing objectives, approaches, and goals for network infrastructure development, including all required components.
  • Designating investigators to serve as members on a Network Steering Committee and other subcommittees with NIH staff, as appropriate.
  • Complying with Federal regulatory requirements, including, but not limited to, those relating to human subjects protections.
  • Attending quarterly (or as needed) virtual Network Steering Committee meetings.
  • Accepting the participatory and cooperative nature of the collaborative research process and complying with policies and practices of NIH. Agreeing to accept close coordination, cooperation, and management of the project with NIA Staff. The PD/PI(s) will be expected to maintain close communications with the NIA Project Scientist(s) and, where appropriate, the Program Officer. The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
  • Cooperating in the reporting of the study progress and findings. Where warranted by appropriate participation, plans for joint publication with NIA of the results and conclusions are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIH staff will apply in all cases. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.
  • Overseeing the overall budget, activities, and performance of the cooperative agreement.
  • Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved sharing policies for NIH.
  • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

NIA Project Scientist

  • The NIA Project Scientist will participate as a member of the resource development network and assist the PD/PI(s) in the identification of relevant NIA/NIH-funded researchers and longitudinal studies for potential involvement in Network activities. The NIA Project Scientist will serve as liaison to other NIA components to promote collaborations. The NIA project scientist will also facilitate the involvement of representatives from other NIH institutes, as appropriate, in Network activities.
  • The NIA Project Scientist(s) will work with the PD(s)/Pl(s) and participate in the Network Steering Committee to ensure the objectives of the program are being met. The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the awardee and the NIH Project Scientist(s).
  • NIA will assign a Program Officer(s) who will be responsible for retaining overall programmatic responsibility for the awardand will clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
  • NIA may designate additional staff to provide advice to the recipient on specific scientific and/or administrative issues to optimize the conduct of network activities.
  • NIA will serve as a resource with respect to other ongoing NIH activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort.
  • NIA staff will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and his/her staff.
  • NIA staff (Project Scientist(s)) will provide input, expert advice, and suggestions in the design, development, and coordination, and implementation of the network objectives.

NIA Program Official

  • 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 Officer will make recommendations for continued funding based on: a) overall networks progress; b) cooperation in carrying out the research; and/or c) maintenance of high quality of research in alignment with the goals of this RFA.

Areas of joint responsibility include:

  • The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Project Scientist(s).

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. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs 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 $25,000.  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 Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions 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.

Application Submission Contacts

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Marcel E. Salive, M.D., MPH
National Institute on Aging (NIA)
Telephone: 301-496-5278
Email: saliveme@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

E.C. Melvin
National Institute on Aging (NIA)
Telephone: 301-480-8991
Email: ec.melvin@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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.

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