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
NIA Renewal and Revision Cooperative Agreements in AD/ADRD Research (U54 Clinical Trial Optional)
Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type
New
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
PAR-22-077
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) allows for renewal and competing revision applications, and their resubmissions, for funded U54 Specialized Center cooperative agreements that support large-scale, complex research projects with multiple highly integrated components focused on a common research question relevant to Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD). It is anticipated that such projects will likely involve an integrated multidisciplinary team of investigators within a single institution or a consortium of institutions, and will address one or more AD/ADRD implementation research milestones supporting the research goals of the National Plan to Address Alzheimer’s and Related Dementias.

Key Dates

Posted Date
December 22, 2021
Open Date (Earliest Submission Date)
February 15, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable March 15, 2022 Not Applicable July 2022 August 2022 December 2022
Not Applicable October 18, 2022 Not Applicable March 2023 May 2023 July 2023
Not Applicable February 15, 2023 Not Applicable July 2023 October 2023 December 2023
Not Applicable October 17, 2023 Not Applicable March 2024 May 2024 July 2024
Not Applicable February 15, 2024 Not Applicable July 2024 October 2024 December 2024
Not Applicable October 17, 2024 Not Applicable March 2025 May 2025 July 2025

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.

Expiration Date
October 18, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance toall 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. Applicationsthat 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. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose 

The purpose of this funding opportunity announcement (FOA) is to invite renewal and revision applications, and their resubmissions, for awarded U54 Specialized Center applications that support large-scale, high-quality, collaborative, and complex research projects with multiple highly integrated components focused on a common research question relevant to Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD). These Centers address one or more AD/ADRD implementation research milestones supporting the National Plan to Address Alzheimer’s and Related Dementias.   

Research Objectives and Scope 

In addition to the instructions below, the research objectives and scope of applications submitted through this FOA must adhere to the requirements outlined in the parent FOA under which the original application was funded.

This FOA allows for renewal and competing revision applications for awarded U54 Specialized Center applications focused on a common research question relevant to AD/ADRD. Such projects will likely involve an integrated multidisciplinary team of investigators within a single institution or a consortium of institutions. Resources and study expertise will be tightly coordinated across multiple sites or cores, such as: 

  • One or more coordinating centers. 

  • Clinical or study sites. 

  • Specialized cores, such as for data management and analysis, measurement and phenotyping, animal models, etc. 

  • Specialized Projects, including, but not limited to, the following: development of new animal models of AD/ADRD; the enablement and experimental validation of next generation AD/ADRD drug targets for the purposes of drug discovery and/or elucidation of AD/ADRD biology; development of large-scale AD/ADRD data infrastructure; and identification of targets and refinement of new non-pharmacological AD/ADRD prevention and dementia care interventions.

Specific areas of research interest include, but are not limited to:

  • Development of data infrastructure and platforms for AD/ADRD clinical trials and observational research through integration of multiple data sources. 

  • Collaborative research within and among health and long-term care systems to encourage pragmatic trials of innovative dementia care.  

  • Translation of basic science findings into pre-clinical or clinical studies, or of clinical findings into practice or community settings, for prevention, diagnosis, or treatment of AD/ADRD conditions, and/or care of persons living with dementia, requiring coordination of broad multidisciplinary expertise across multiple settings. 

  • Development of next generation animal models of AD; extensive characterization and clinicopathological staging of AD animal models using translatable biomarkers; development of translatable pharmacodynamic biomarkers for novel therapeutic targets; and rigorous preclinical testing of candidate AD therapeutics.  

  • Development of computational and experimental target enabling tools; characterization and experimental validation of candidate AD/ADRD drug targets; and advancing novel targets into drug discovery and preclinical drug development for the purpose of diversifying and reinvigorating the AD/ADRD drug development pipeline.  

  • Development, facilitation, and support of AD genetic activities for all phases of the Alzheimer’s Disease Sequencing Project (ADSP) such as quality control checking, data harmonization, and meta-analysis and the analysis of functional components of the human genome.
     

 

The structure and approach of the proposed center will vary depending on the research activities it is designed to support; however, it is expected that all components will focus on an overarching research goal that integrates all proposed activities into a unified whole. Specialized Centers with population-based studies are highly encouraged to include diverse participants or populations that are underrepresented in research or clinical studies. These include NIH-designated US health disparity populations (https://www.nimhd.nih.gov/about/overview/).

Additional Guidance 

All applications submitted to this FOA are required to adhere to any requirements described in the parent FOA under which the original application was funded. In addition:

Applicants are strongly encouraged to contact NIA Scientific/Research staff at least 12 weeks in advance of the anticipated application due date. This will help applicants ensure their prospective projects are aligned with NIA program priorities and consistent with administrative and budgetary policies. 

Successful projects are expected to have a sound scientific rationale based on adequate preliminary data; however, investigators may propose preliminary activities where necessary to refine methods or protocols, or to test the effectiveness of study component integration prior to full-scale study implementation. 

Centers that propose to use funds to support pilot or other research projects should articulate their process for soliciting and reviewing applications.  

In addition, investigators may choose to establish standing committees among study personnel for specialized cross-project functions such as a steering committee, data access and publications oversight, training of study personnel, etc. Applicants may also propose an external advisory committee to regularly review the progress of the multi-component project and provide non-binding recommendations for its activities. If an external advisory committee is already in existence, it should be named in the application. 

Studies involving human interventions should comply with NIH's and NIA's policies on human intervention studies, including development of a data and safety monitoring plan. Specific individuals who may constitute a data and safety monitoring board (DSMB) should not be named in the application or contacted prior to the review. 

Research infrastructure development necessary to achieve the scientific aims of the planned study may be proposed. 

Examples include: 

  • One or more coordinating centers. 

  • Clinical or study sites. 

  • Specialized cores, such as for: bioinformatics; computational biology; data management and analysis; training; pilot research support; measurement and phenotyping; developing animal models; dissemination of data/biosamples/other resources; assay development; structural biology; medicinal chemistry; development of large-scale AD/ADRD data infrastructure; and identification of targets and refinement of new non-pharmacological AD/ADRD prevention and dementia care interventions. 

Milestones 

Competing revision and renewal applications submitted through this FOA must adhere to all milestone requirements outlined in the parent FOA under which the original application was funded. 

Consortium Requirement 

Competing revision and renewal applications submitted through this FOA must adhere to consortium requirements and terms outlined in the parent FOA under which the original application was funded. It is anticipated that consortium partnerships may change during the renewal period.   

Level of Effort Requirement for Principal Investigator(s) and Core Leaders

The activities in this award demand complex management and coordination as many different entities will ultimately participate in the Collaboratory. Therefore, Program Director(s)/Principal Investigator(s) must commit and sustain sufficient effort throughout the award to manage this complex entity. Core directors will also need to coordinate activities across multiple organizations and must also commit and sustain sufficient effort to manage these cross-institutional and cross-organizational activities. 

Reproducibility and Translatability 

Responsive applications should include appropriate support for the annotation and curation of the molecular and clinical data types used and/or generated in the project in order to maximize the usability of the data by the broader research community. Center applications focused on AD/ADRD animal models development and AD/ADRD translational research must follow open-science, open-source principles and adhere to NIH guidelines for rigorous study design and transparent reporting to maximize the reproducibility and translatability of their findings. Please refer to the Resource Sharing Plan section of this FOA for detailed guidance. All studies should be conducted and reported in compliance with NIH guidance on rigor and reproducibility. In particular, investigators proposing animal model studies are expected to follow the general ARRIVE guidelines for rigorous animal research and the best practices guidelines for AD preclinical efficacy studies.

Any clinical trials must be performed following Good Clinical Practices (GCP) and in accord with NIH Policy for Data and Safety Monitoring.

For applications proposing research involving human subjects: 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.

Non-Responsiveness Criteria:

An application to this FOA must be a competing revision, a renewal, or a resubmission of a competing revision or renewal application to be considered responsive to this FOA. Applications for new cooperative agreements are not allowed and will be considered non-responsive to this FOA.

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

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

Renewal

Resubmission of Renewal

Revision

Resubmission of Revision

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).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIA appropriations and the submission of a sufficient number of meritorious applications.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

The maximum project period is 5 years. For revision applications, the project period of the proposed application must not exceed the remaining number of years on the parent grant. The parent grant must be active at the time of submission or resubmission of the revision application.

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 Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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 or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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:

Ramesh Vemuri, Ph.D. 
National Institute on Aging (NIA) 
Telephone: 301-496-9666 
Email: ramesh.vemuri@nih.gov

Page Limitations

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

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 12 Required 1 1
Admin Coordination Core - required for renewals and optional for revisions Admin Core 6 Varies 0 NA
Core - required for renewals and optional for revisions Core 6 Varies 0 NA
Project - required for renewals and optional for revisions Project 12 Varies 0 NA

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.

.

Renewal applications should consist of the following components:

  • Overall: required, maximum one
  • Administrative Core: required, maximum one
  • Cores: required, minimum one
  • Projects: required, minimum one

Revision applications must include an Overall component and the components that are affected by the revision.

Overall Component

When preparing your 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.

Other Attachments: The following should be submitted as an attachment to the application in the form of a PDF:

  • Center organization: A diagram should be provided with the organizational structure, leadership, and interactions between components, and, if applicable, the Steering Committee and External Advisory Board. This should reflect major decision points and demonstrate the collaborative nature of the center. Submit as a PDF entitled "Center Organization."
     

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 FOA) for the entire application.

The activities on this award demand complex management and coordination as many different entities will ultimately participate in the collaboration. Therefore, Program Director(s)/Principal Investigator(s) must commit and sustain sufficient effort throughout the award to manage this complex entity. Core directors will also need to coordinate activities across multiple organizations and so must also commit and sustain sufficient effort to manage these cross-institutional and cross-organizational 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.

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

PHS 398 Research Plan (Overall)

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

Specific Aims:

In addition to the instructions provided below, applications submitted through this FOA must adhere to the Specific Aims requirements outlined in the parent FOA under which the original application was funded.

State concisely the goals of the program and summarize the expected outcome(s), including the broad impact that the Center will have on research on AD/ADRD. These aims should be overarching, at a high level, and distinct from the aims of the individual components. Applications should also refer to the Center Organization PDF diagram requested above.

 

Research Strategy:

In addition to the instructions provided below, applications submitted through this FOA must adhere to the Research Strategy requirements outlined in the parent FOA under which the original application was funded.

The program overview should be presented in a concise overall vision and plan for the proposed program. Refer to the Program Organization PDF diagram requested above. This section should describe the framework for the program, overall experimental strategy, and how it will address the objectives of the program. Indicate why each component is essential for addressing the overall goal of the program. Describe the synergy to be achieved by the program and the multidirectional interactions between the Cores. Describe mechanisms and procedures that will promote strong collaborative interactions and "cross-fertilization" among program investigators and participating institutions.

The Research Strategy for center applications focused on AD/ADRD animal models development and AD/ADRD translational research must follow open-science, open-source principles and adhere to NIH guidelines for rigorous study design and transparent reporting to maximize the reproducibility and translatability of their findings. Please refer to the Resource Sharing Plan section of this FOA for detailed guidance. All studies should be conducted and reported in compliance with NIH guidance on rigor and reproducibility. In particular, investigators proposing animal model studies are expected to follow the general ARRIVE guidelines for rigorous animal research and the best practices guidelines for AD preclinical efficacy studies. These studies should include a power analysis and associated assumptions for the determination of sample size, statistical handling of the data (such as criteria for data inclusion or exclusion), procedures used for blinding and randomization, and whether studies were balanced for sex and were replicated.

Any clinical trials must be performed following Good Clinical Practices (GCP) and in accord with NIH Policy for Data and Safety Monitoring (https://grants.nih.gov/policy/humansubjects/policies-and-regulations/data-safety.htm).

Additional items to be addressed if applicable:

Milestones and Timeline: Describe the Center's five-year critical path with timelines and yearly milestones. The Center performance and timeline objectives should include a Gantt chart depicting the five-year critical path of the Center's program. Milestones should include detailed quantitative criteria by which milestone achievement will be assessed. Include milestones and timelines for open-science sharing of data, methods, and tools.

Letters of Support:

An institution applying to this FOA should demonstrate a commitment to the program’s success. Letter(s) of support from senior administration officials or other institutional officials from the PD(s)/PI(s)'s institution(s) should be provided. The letter(s) should describe the level of institutional support for the program including any leveraged funding or resources that may be provided by the institution(s). All letters of the support for Overall component should be uploaded as a single attachment.

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.

 

In addition to the instructions provided below, applications submitted through this FOA must adhere to the Data Sharing requirements outlined in the parent FOA under which the original application was funded.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

For AD/ADRD Center applications focused on animal models development, target enablement, and drug discovery, the following modifications apply:

Applicants will need to provide a timeline for data generation, tools development, and data deposition as part of a complete Resource Sharing Plan. Program staff may negotiate modifications to the plan prior to funding.  

Applicants should include appropriate funding support for annotation and curation of the molecular and clinical data types used and/or generated on the project to maximize the usability of the data by the broader research community.  

In keeping with NIA’s strategic goal to enable and promote open science practices and FAIR (Findable, Accessible, Interoperable, and Reusable) data practices, and the NIA/NIH goal to enhance transparent reporting and increase research rigor and reproducibility, Center awardees must make all data, analytical methods, network models, and research tools available to the broad scientific community via the NIA-supported AD Knowledge Portal, or through other NIH-designated data repositories, and/or open-source/open-access platforms operating under FAIR principles.  

To this end:  

  • All data sets used/generated on the project (such as data about clinical phenotypes and high-dimensional omic data, including genomic, proteomic, and metabolomic data generated from human samples or from cell-based and animal models) will be made accessible and reusable by qualified individuals other than the original data generators to enable multiple parallel approaches to data analysis and interpretation.  

  • All analytical methodologies will be made fully reproducible and transparent so that results can be vetted and existing analysis techniques can be quickly applied to new application area.  

  • All models of biological systems and networks will be openly available to users such that theoretical predictions can be rapidly validated experimentally.  

  • All biological samples used to generate data with this award will be made available to all awardees of this initiative and to other qualified investigators.  

  • All animal models and other research tools generated in the course of the project will be made freely available to qualified investigators to accelerate their characterization, validation, and translational utility.  

Awardees will be expected to make data, analytical results and research tools available after they have undergone quality control (no later than 6 months after data and research tools have been generated). Data will be accessible via open or controlled access, depending on the data type and source and as determined by the informed consent documents for each study guided by the local IRB. There will be no publication embargo for secondary users of data and research tools developed by the Centers.

All findings from animal model preclinical efficacy studies, including both negative and positive findings, are expected to be reported via NIA’s AlzPED Portal as a citable pre-print no later than 9 months after study completion or at the time of acceptance of the first manuscript, whichever comes first.   

While the awardees are allowed to develop IP for candidate therapeutics developed through the Center funding, they must implement open science-compatible intellectual property strategies to support advancing promising molecules developed with this award into the clinic. 

 

For AD/ADRD Center applications focused on AD genetics, the following modifications apply

Center applications focused on genetics must adhere to the NIA AD Genetics Sharing Plan. ADSP data are stored, curated, and shared by the NIA Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS) and/or another NIA approved site. Awardees are expected to adhere to the NIAGADS Data Distribution Agreement.

 

For AD/ADRD Center applications focused on behavioral and social research, the following modifications apply:

This FOA requires the sharing of 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. It is imperative that the program is set up in such a manner that will allow for such practice. Additionally, the program requires sharing study data in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the applicant  is expected to implement a Resources and Data Sharing Plan consistent with these program goals. 

 

  • Additionally, this program requires sharing software and codes that are developed or modified to accomplish the aims of this application. This may include, but is not limited to: software, tools, code sets for extraction, or definition of data from any data sources, including genetics, EHRs, clinical systems, and other health care data systems; implementation of new workflows for research studies; analytic and analysis programs; and tools  as applicable. The goals of software sharing under this program include: 1) broad availability to biomedical researchers, health care delivery organizations, research institutions, and government health care systems and researchers; 2) terms that permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages; and 3) terms of software availability that include the ability for individuals outside the applicant institution and its collaborating organizations to modify the source code, sharing modifications with others. While software development is not the primary goal of this program, it is expected that software or sets of code may be developed under this FOA, whether for pilot projects, clinical studies/trials, or pragmatic trials. Thus, grantees and their sub-contractors are required to implement software sharing plans consistent with the goals of this Program. 

 

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.

Core or Project Name

In addition to the instructions provided below, applications submitted through this FOA must adhere to the requirements for Components outlined in the parent FOA under which the original application was funded.

When preparing your application, use Component Type ‘Administrative Core,' 'Research Core,' 'Project,' 'Clinical Core,' 'Education Core,' as necessary ’

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

SF424 (R&R) Cover (Core or Project Name)

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 (Core or Project Name)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core or Project Name)

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) (Core or Project Name)

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 (Core or Project Name)

The activities on this award demand complex management and coordination as many different entities will ultimately participate in the Collaboratory. Therefore, Core and Project Leaders must commit and sustain sufficient effort throughout the award to manage this complex entity. Additionally, Core and Project Leaders will also need to coordinate activities across multiple organizations and so must also commit and sustain sufficient effort to manage these cross-institutional and cross-organizational activities.

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons, including the Core Lead, 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 (Core or Project Name)

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 (Core or Project Name)

Introduction to Application: For revision applications and resubmission applications, an Introduction to Application is allowed for each component. For renewal applications, the Background section of the application should include a summary of progress made during the initial funding period.

For the Specific Aims and Research Strategy, applicants should refer to the Research Plan instructions in the FOA under which their original application was funded.

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

In addition, applications submitted through this FOA must adhere to the Data/Resource Sharing requirements outlined in the parent FOA under which the original application was funded.

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 (Core or Project Name)

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 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go 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 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.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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 ramesh.vemuri@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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.

In addition, for applications involving clinical trials: 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 - Overall

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 - Overall

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?

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?

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?

Is the Center organizational diagram that depicts interactions of key components within and external to the Center adequate? How well are the Center components and the investigator team integrated to collectively support the overarching goals of the Center? Is there evidence of robust, multidirectional interactions between the Cores?

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?

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?

Additional Review Criteria - Overall

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.

 

Milestones

If the application has milestones as a part of the Research Plan, reviewers should evaluate whether the proposed milestones are appropriate for the scope and goals of the proposed project.

Consortium Agreement 

If the application has a consortium agreement with health systems as part of the Research Plan, the reviewers should evaluate whether the proposed consortium agreements are appropriate for the scope and goal of the proposed project. 

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

For Resubmissions of competing revision and renewal applications, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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 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 the National Institute on Aging, 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 will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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.
  • Compliance with data and resource sharing policies. 

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 theNIH 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 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: 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).

Milestones: Annual milestones, with accompanying success criteria, will be included in the Special Terms and Conditions of the Notice of Award. Failure to meet these annual milestones may delay or reduce the next year's award. In addition to milestones, the decision regarding continued funding will also be based on the overall progress of the Center.

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.

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: Generaland 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 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.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. 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.html and https://www.lep.gov.

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 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 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 recipients and the NIH as defined below.

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

  • 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.
  • Overall management of the study through the coordinating center and should agree to work cooperatively with the functions and clinical sites
  • Developing and implementing systems necessary for communications among the various study organizational components. The coordinating center will facilitate the design and refinement of all protocols, manuals of operations, and forms.

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

  • The designated NIA Project Scientist will serve as a member of the Steering Committee and have substantial scientific/programmatic involvement during conduct of the cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants. The recipient agrees to accept assistance from the designated NIA Project Scientist. This person will participate, through the Steering Committee, in the monitoring of issues relating to recruitment, follow up, and adherence to protocols and will assist in the development and/or adjustment of study protocols.
  • Additionally, an agency program official or NIA program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

  • The Steering Committee, comprised of the PD/PI of the cooperative agreement, the leader of the units and each of the clinical sites, and the NIA Project Scientist will have primary responsibility for finalizing standard definitions, procedures, and measures common for all the protocols. The steering committee will meet every three to six months, or as dictated by the needs of the study. Each full member of the Steering Committee will have one vote, and all major scientific decisions will be determined by majority vote of the Steering Committee. Recipient members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. Subcommittees appointed by the Steering Committee, comprised of appropriate staff from the functions and clinical sites, will be involved in the design of protocols and manuals of operations, and in ongoing functions of the study such as preparation of publications.
  • A Biospecimen Allocation Review Committee (BARC) may be required for some programs to oversee the allocation and distribution of biological specimens generated from the study. Applications submitted to this FOA must follow requirements for BARC activities described in the parent FOA under which the original application was funded. For questions regarding BARC requirements, applicants should contact Program staff listed on the Notice of Award of the most recent parent award.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award 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 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 75.113and 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.

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: 301-637-3015

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)

Suzana Petanceska, Ph.D.
Division of Neuroscience (DN)
National Institute on Aging (NIA)
Phone: 301-594-7754
Email: petanceskas@nia.nih.gov

Partha Bhattacharyya, Ph.D.
Division of Behavioral and Social Sciences (DBSR)
Phone: 301-496-3136
Email: bhattacharyyap@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)

Robin Laney
National Institue on Aging (NIA)
Phone: 301-496-1473
Email: robin.laney@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 and 2 CFR Part 200.

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