Part 1. Overview Information

Key Dates

Dates in bold and italics reflect changes per NOT-AG-24-091.

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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

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

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

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The Alzheimer’s Disease Sequencing Project (ADSP), established in 2012, aims to sequence and analyze the genomes of well-characterized individuals with the objective of identifying risk and protective genetic variants associated with Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD). The ADSP provides resources to the broader research community for AD/ADRD research. The overarching goals of the ADSP are to:

• Identify new genetic variants and genes contributing to increased risk of or protection against developing AD/ADRD.
• Provide insight as to why individuals with known risk variants either escape or have delayed AD/ADRD onset, and examine these factors to identify new genetically driven pathways leading to potential therapeutic approaches to disease prevention.
• Examine these factors in multi-ethnic populations.

To achieve the goals of ADSP, NIA has funded many initiatives, including the following:

• PAR-16-406 Limited Competition: Additional Sequencing for the Alzheimer's Disease Sequencing Project (U01)
• PAR-17-214 Limited Competition:Analysis of Data from NIA's Alzheimer's Disease Sequencing Project Follow-Up Study (U01)
• PAR-18-890 Limited Competition:Additional Sequencing for the Alzheimer's Disease Sequencing Project: Opportunity for Revision Requests for Active Cooperative Agreements (U01)
• PAR-19-234 Limited Competition: Additional Sequencing for the Alzheimer's Disease Sequencing Project (U01)-competitive supplements to existing awards
• PAR-19-269 Cognitive Systems Analysis of Alzheimer's Disease Genetic and Phenotypic Data (U01)
• PAR-20-110 National Institute on Aging Genetics of Alzheimer's Disease Data Storage Site (U24)
• PAR-20-099 Harmonization of Alzheimer’s Disease and Related Dementias (AD/ADRD) Genetic, Epidemiologic, and Clinical Data to Enhance Therapeutic Target Discovery (U24 Clinical Trial Not Allowed)
• PAR-21-212 Limited Competition: Alzheimer’s Disease Sequencing Project Follow-Up Study 2.0 (ADSP FUS 2.0): The Diverse Population Initiative (U01 ClinicalTrial Not Allowed)
• RFA-AG-21-006 Alzheimer’s Disease Sequencing Project Functional Genomics Consortium (U01)
• RFA-AG-22-001 Limited Competition: National Institute on Aging (NIA) Late Onset of Alzheimer’s Disease (LOAD) Family-Based Study (FBS) (U24 Clinical Trial Not Allowed)

These funded initiatives have significantly expanded the research efforts under the ADSP umbrella over the past several years. The Follow-Up Study 2.0 Diversity Initiative (PAR-21-212) provides comprehensive support for recruitment of diverse populations, large scale sequencing capacity, genetic and omics data acquisition, and subsequent data analysis. The Phenotype Harmonization consortium, as outlined in PAR-20-099, aims to harmonize clinical and phenotypic data across all ADSP subjects. The Artificial Intelligence (AI)/Machine Learning (ML) initiative (PAR-19-269) supports projects that develop advanced computational approaches to identify genes and variants via analysis of a variety of genetic, genomic, and clinical data. The Functional Genomics Initiative (RFA-AG-21-006) aims to characterize genetic variations and understand their functional impact on the pathogenesis and progression of AD/ADRD. In addition, the Collaborative for Alzheimer’s Disease Research (CADRE) and the Cohorts for Heart and Aging Research (CHARGE) consortia, components of the ADSP, are conducting large-scale genetic analysis and gene discovery.

NIA-funded ADSP projects from these initiatives collectively work towards expanding ethnically diverse cohorts; generating genetic data through short and long sequencing; and identifying and characterizing risk and/or protective variants and genes utilizing a variety of in silico, in vitro, and in vivo approaches. The sequencing, genetic, and phenotypic data are being collected, processed, harmonized, and shared with the scientific community through the NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS).

A major driver of the ADSP in its second decade is to ensure that scientific findings not only represent the diversity of the U.S. and the world, but also inform personalized solutions for diagnosis and treatment of AD/ADRD. Searching for risk and protective variants in diverse populations will help improve representation and lead to the discovery of new genetic drivers and novel mechanisms in AD/ADRD, paving the way for translational and clinical studies. NIA-funded ADSP initiatives support a wide range of research areas including sequencing of diverse populations, in-depth and trans-ethnic genetic analyses, data harmonization, machine learning of genetic and phenotypic data, and functional studies. The future success of ADSP is critically dependent on the formation of a highly interactive and collaborative environment that enables synergy and integration of all these efforts. 

Objectives and Scope

The Coordination Center for the Alzheimer’s Disease Sequencing Project Consortium (hereafter referred to as the ADSP Consortium Coordination Center) will be responsible for the administration and coordination of the ADSP consortium. The ADSP consortium includes the following major components: 

• Diverse cohort studies 
• Genetic analysis projects
• Phenotype harmonization consortium
• Functional genomics consortium
• Artificial intelligence and machine learning consortium
• Infrastructure supporting data collection and sharing

The ADSP Consortium Coordination Center will lead and manage cross-consortium functions, including effective communication, collaboration, outreach, dissemination, training, and coordination across the components of the ADSP. The Center will be the main conduit for collaboration with the NIH- and NIA-funded relevant programs and the global AD genetics research community. The Center must have a clear strategy for building trust, emphasizing a culture of collaboration and responsibility, and aligning all the stakeholders to the overall mission of the ADSP.

The overall goal of the ADSP Consortium Coordination Center is to integrate the efforts of all the ADSP projects, and, through innovation, to promote a research environment that facilitates synergy, collaboration, and communication among ADSP investigators. Through the development and administration of the ADSP website and other communication channels, the ADSP Consortium Coordination Center will serve as the community-wide resource and externally facing point of access to the resources and products developed by the ADSP. The ADSP Consortium Coordination Center will also be responsible for publicizing information related to the ADSP to the broader research community.

Applications are sought from multidisciplinary teams with national and global expertise in genetics of AD/ADRD, organizational management, team science, communications, outreach and engagement, training, and website development. The team should demonstrate the capability to support a wide range of activities and take a flexible, adaptive approach to coordinating the ADSP consortium. 

Responsibilities of the Coordination Center for the Alzheimer’s Disease Sequencing Project Consortium

Administration and Coordination

The administration and coordination function will focus on developing the overall organizational framework of the ADSP, providing administrative and logistical support for the activities of the ADSP in collaboration with NIA program staff, and fostering synergy across the components of the ADSP. Specific responsibilities will include, but are not limited to, the following:

• Provide leadership, expertise, and project management of ADSP administration, reporting, coordination, engagement, outreach, and dissemination activities.
• Develop and maintain a comprehensive organizational structure for the ADSP, including defining roles, responsibilities, and communication channels for the ADSP components and all consortium members.
• Identify and track program metrics to assess consortium progress and success.
• Facilitate and implement an ADSP governance structure, including scheduling and organizing meetings, coordinating and documenting decision-making processes, developing guidelines for policies on ADSP-wide matters, and maintaining records of all consortium activities.
• Ensure compliance with all regulations and requirements set forth by NIA.
• Prepare and submit timely reports, including progress reports, publications, data submission, and other documentation as required by NIA.
• Keep records of all consortium activities, decisions, and communications for transparency and accountability. Prepare and distribute reports and data summaries to consortium members and NIA Program Staff and Project Scientist(s) on progress, publications, presentations, and innovations across the ADSP.
• Coordinate with NIA program staff to plan, facilitate, and manage ADSP consortium annual program meetings (in-person or virtual, as appropriate). The ADSP Consortium Coordination Center will be expected to budget for meeting support, other logistics, and arrange and support the travel costs of approximately eight ADSP External Advisory Board (EAB) members per year to the meetings, starting in year 2 of the award.
• Provide administrative and logistic support as well as project management to all the ADSP working groups to address specific scientific challenges, share best practices, and promote the integration of cross-disciplinary ideas and methodologies. The ADSP Consortium Coordination Center will be expected to budget for working group support starting in year 2 of the award.

Collaboration and Communication

The collaboration and communication function will serve as a unifying force that brings together diverse expertise and fosters a culture of cooperation, transparency, and innovation within the ADSP and with the AD/ADRD research community on a global scale. Specific responsibilities will include, but are not limited to, the following:

• Act as a central point of contact for the ADSP members, NIA program staff, and external stakeholders. Facilitate communication and collaboration among all parties. Ensure that information flows smoothly and that all stakeholders are kept informed of consortium activities, decisions, and progress.
• Promote synergy and coordination across the various components of the ADSP. Organize workshops and symposia that bring together consortium members, fostering interdisciplinary collaboration and knowledge exchange.
• Work with all ADSP consortia for coordinated submissions of posters and oral presentations at major meetings and conferences such as those organized by AAIC, ASHG, or AD/PD, to cite a few. Coordinate post-conference reporting to the ADSP and NIA program, and publicize key numbers (such number of talks and posters, awards, etc.) to highlight the impact of ADSP at the various meetings and conferences.  
• Identify collaborative opportunities and foster collaborations and partnerships with NIH- and NIA-funded programs and the global AD research community.
• Provide project management support to collaborative efforts aimed at addressing the ADSP goals by integrating expertise and analytical approaches from multiple ADSP components.
• Support pilot projects that explore innovative ideas integrating genetics, Artificial Intelligence/Machine Learning, and functional studies to identify causal AD risk or protective factors. The ADSP Consortium Coordination Center will develop a description of the organizational and governance structure, explanation of the roles and responsibilities, and plans for the evaluation of the pilot projects. The ADSP Consortium Coordination Center is expected to provide funding for the pilot projects led by non-ADSP independent Early Stage Investigators (ESI; see NIH definition), including those from Low and Middle Income Countries (LMICs), who play a leading role in the project. 
• Coordinate with ADSP sequencing projects in identifying and recruiting cohorts that are representative of the population affected by AD/ADRD and that are appropriately inclusive of racial and ethnic groups and other populations experiencing health disparities.
• Lead efforts to identify and incorporate emerging cutting-edge, cost-effective sequencing technologies to enhance sequencing data quality, improving rare/risk/protective variant identification, complex structural variant detection, and downstream analysis efficiency.
• Coordinate and lead collaborative analyses such as GWAS association analysis, trans-ethnic analyses, and novel gene identification and annotation across the ADSP and in collaboration with the global AD genetic research community.
• Coordinate with NIAGADS to facilitate the collection, processing, quality control, release, and sharing of ADSP data including whole genome sequencing data and associated metadata, genotyping data, imputation panels, GWAS, biomarkers, and clinical data. Ensure that the data be managed and shared using the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles.
• Work collaboratively with and provide technical, design, and other support to investigators of the broader AD genetic research community.
• Develop and implement a multipronged communication and dissemination plan to maximize the impact of ADSP activities and resources.

Resource Dissemination

The resource dissemination function will focus on developing and disseminating resources generated from the ADSP through a website that is intuitive and readily accessible by the broader research community. This central hub will facilitate information dissemination, collaboration, and outreach and will foster engagement with the ADSP members and the scientific community. Specific responsibilities will include, but are not limited to, the following:

• An external website for public engagement. Develop and maintain an organized and up-to-date website to boost ADSP’s visibility and impact. This public website must provide clear information about the ADSP's mission, organizational structure, governance, research areas, and impact. This website must include information covering all the components of the ADSP, including diverse cohort studies, genetic analysis projects, phenotype harmonization consortium, functional genomics consortium, artificial intelligence and machine learning consortium, and data infrastructure.
• Share ADSP research findings, products, and resources, including details on funded projects, collaboration opportunities, meetings, news, publications, policies, as well as research resources such as protocols, reagents, data, and computational tools.
• Develop and maintain an internal website tailored for use by ADSP members and NIA program staff. This website will serve as a centralized resource hub, containing essential information for consortium members. It must include documents, meeting minutes, details on working groups and their associated information, points of contact, mailing lists, and comprehensive information about the annual program meetings conducted by various ADSP consortia.
• Develop and maintain a comprehensive catalog detailing ADSP cohort studies and their associated grant information. This catalog must encompass comprehensive descriptions of the cohorts, including information on the racial and ethnic groups involved, the status and progress of biospecimen collection, sequencing efforts, data types generated, and other relevant specifics. Ensure that this information is regularly updated and readily accessible to the broader scientific community. Produce routine reports for distribution to consortium members and to the NIA program staff to keep them informed of the progress and developments within the ADSP.
• Coordinate with NIAGADS and other NIA-funded resources and repositories, including the National Alzheimer's Coordinating Center (NACC), National Cell Repository for Alzheimer's Disease (NCRAD), Laboratory of Neuro Imaging (LONI), and AD Knowledge Portal (ADKP) to promote interoperability and connectivity of information and data across repositories, and to facilitate easy discovery and access of data by the broader scientific community.

Education and Training

The education and training function will develop, identify, and support education and training resources and opportunities that align with the ADSP research priorities. Specific responsibilities will include, but are not limited to, the following:

• Facilitate training, mentorship, and professional development in AD/ADRD genetic research, especially among professionals from underrepresented groups. Promote diversity in AD/ADRD research workforce.
• Develop and deliver distance learning and mentorship opportunities to facilitate collaboration across the ADSP consortium and with other collaborators.
• Promote collaborations between LMIC scientists and researchers from other parts of the world. Provide training opportunities and encourage intellectual exchange and data sharing.
• Develop and share education and training content, curricula, knowledge, skill-building, and educational resources on the ADSP public-facing website.

Non-responsiveness Criteria

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

Applications that do not include proposals that address all the key functions of the coordination center, including Administration and Coordination, Collaboration and Communication, Resource Dissemination, and Education and Training.

Applicants are strongly encouraged to consult with the scientific contact to develop an application prior to submission.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

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

Other

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

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Since the overall purpose of the Coordination Center is to provide leadership and technical expertise in all aspects of ADSP research, it is imperative that applicants clearly demonstrate in their application their familiarity with the broad research scope and the projects and consortia under the ADSP umbrella and their experience of leading a large consortium on a global scale. 

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the 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:

Michael Bennani, Ph.D.
National Institute on Aging (NIA)
Division of Neuroscience (DN)
Telephone: 301.448.0128
Email: [email protected]

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must have a track record of research in the genetics and genomics of AD/ADRD and have demonstrated experience in leading large-scale, multi-site research consortia in the U.S. and globally, including in and Middle-Income Countries (LMICs. The PD(s)/PI(s) must devote sufficient time to ensure that the aims are met and the required functions are carried out efficiently. Senior/key personnel must have demonstrated experience managing multiple internal and external collaborations and communication channels.

R&R or Modular Budget

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

PD/PIs: The ADSP Consortium Coordination Center Director must devote a minimum of 1.8 person months of effort to the Center through the individual components. For applications with multiple PDs/PIs, a minimum effort of 1.2 person-months is required for the Contact PD/PI, and 1 person-month of effort per additional PD/PI is required.

Program Manager: Based on the complexity of the ADSP consortium, a full-time Program Manager to manage day-to-day operations and work with the ADSP Consortium Coordination Center team, the ADSP consortium, and NIH staff is required to efficiently and effectively manage and coordinate the activities of the ADSP consortium.

Annual Program Meeting: The ADSP Consortium Coordination Center is responsible for supporting the annual program review meeting. The ADSP Consortium Coordination Center is expected to budget for meeting support and other logistics, and arrange and support the travel costs of approximately eight ADSP External Advisory Board (EAB) members per year to the program meetings, starting in year 2 of the award.

ADSP Working Groups: The ADSP Consortium Coordination Center is responsible for providing administrative and logistics support as well as project management to all the ADSP working groups. The ADSP Consortium Coordination Center is expected to budget for working group support starting in year 2 of the award.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Research Strategy

Outline and describe the goals and significance of the ADSP Consortium Coordination Center and its role in achieving the overall goals of the ADSP consortium. Identify any challenges for the ADSP consortium and propose strategies for addressing these challenges.

Describe plans, strategies, and approaches on how the ADSP Consortium Coordination Center will fulfill its core functions as described in Section I. Funding Opportunity Description. Include plans for carrying out the main functions of the ADSP Consortium Coordination Center according to the subsections below.

Administration and Coordination activities should, at minimum, describe:

• The organizational and governance structure of the ADSP.
• An organizational chart of the tasks for what will be accomplished overall and for each ADSP Consortium Coordination Center function, including the types of staff associated with each task and their respective roles and responsibilities.
• Research administration and coordination efforts that integrate all components of the ADSP and support dynamic global genetic research for AD/ADRD.
• Plans for leading and providing project management for the reporting, coordination, engagement, outreach, training, and dissemination activities of the ADSP.
• Plans and processes for supporting ADSP meetings and working groups.
• Metrics for assessing and tracking consortium progress and success.

Collaboration and Communication activities should, at minimum, describe:

• Plans for facilitating synergy and collaboration across the ADSP.
• Plans for creating opportunities to collaborate with NIH- and NIA-funded programs and the global AD genetic research community.
• Plans for leading and coordinating ADSP efforts in sequencing of diverse populations, in-depth and trans-ethnic genetic analyses, and data harmonization and sharing.
• Plans to establish, manage, and promote collaborative efforts and pilot projects across the ADSP and with the global AD genetic research community.
• Strategies to establish and implement appropriate modes of communication for the rapid dissemination of information and scientific discoveries across the ADSP.

Resource Dissemination activities should, at minimum, describe:

• A catalog of ADSP research projects, grants, personnel, cohort studies, sequencing status, protocols, tools, publications, research resources, training opportunities, meetings, and news.
• A plan for developing and maintaining an external website for public engagement and information dissemination with the broader scientific community.
• A plan for developing and maintaining an internal website for use by ADSP members and NIA program staff, including resources and information for collaboration and internal communication.
• Plans for coordinating with other NIA-funded resources and repositories to facilitate interoperability, connectivity, and sharing of information and data.
• A plan for long-term sustainability of the resources generated by the ADSP beyond the current funding period.

Education and Training activities should, at minimum, describe:

• Plans for developing, implementing, and managing training research opportunities to support career development of pre/post-doctoral students and early-stage investigators.
• Plans for promoting diversity in the AD/ADRD research workforce.
• Plans for educating and collaborating with LMIC researchers.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

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

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

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

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

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

Post Submission Materials

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

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.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

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

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

2. Review and Selection Process

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

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

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

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

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

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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

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

Successful recipients under this NOFO agree that:

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

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

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

Successful recipients under this NOFO agree that:

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

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

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

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

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

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

• Retain the primary authority and responsibility for the project as a whole, develop plans and approaches to accomplish the aims and objectives of the NOFO, and prepare publications.
• Provide, in addition to standard annual progress reports (see Section VI.4. Reporting), progress on the annual milestone and other relevant information to the NIH Project Scientist(s) or Program Officer, and coordinate and cooperate with NIH staff and other members of appropriate collaborating NIH programs.
• Establish reporting timelines and provide reports and data in a timely fashion and in a standard format, as agreed upon by the NIA program staff.
• Plan, coordinate, and participate in appropriate coordinating meetings and/or working groups, and/or teleconferences as needed.
• Be prepared for annual administrative site visits or virtual visits by NIH staff.
• Agree to participate in the collaborative activities of the consortium and agree not to disclose confidential information obtained from other members of the consortium including, without limitation, unpublished data, tools, protocols, data analysis, confidential exchanges between members of the consortium, as well as any confidential information received by third party collaborators.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies.

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

• NIA Program Officer (PO) – The PO will be responsible for normal scientific and programmatic stewardship, including monitoring progress and compliance with general statutory, regulatory, or policy requirements; discussing and approving milestones and significant changes to the project; and technical assistance to correct performance and facilitate interactions. The PO must approve in advance and in writing annual milestones and any significant changes to the award. The program officer will also be responsible for making funding recommendations and otherwise providing programmatic approvals and recommendations. The PO will have programmatic authority, including fiscal oversight, over the ADSP Consortium Coordination Center and receive input from other NIA program staff.
• NIA Project Scientist (PS) – The PSs will provide substantial NIH scientific, programmatic involvement with the awardee that is anticipated during the performance of the activities supported by a cooperative agreement, including reviews of milestones. The PSs will work closely with the PO and the PIs of the ADSP Consortium Coordination Center to maximize progress towards the goals of the program. It is expected that the PSs will participate in teleconferences with PDs/PIs and key personnel of the ADSP Consortium Coordination Center and attend relevant ADSP meetings in-person or virtually. Consistent with ICO publication policies, PSs may contribute, as appropriate, to scientific manuscripts and other scientific and scholarly activities (e.g., oral presentations, poster presentations) resulting from the ADSP Program.
• Additionally, an agency program official or IC 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 PD(s)/PI(s) and NIA program staff will be jointly responsible for participating in Consortium-wide activities and for establishing collaborations across the Consortium and with other related activities.

Dispute Resolution:

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

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

In carrying out its stewardship of this NOFO, the NIH or its Institutes and Centers may request information essential to an assessment of the effectiveness of this program from the participants (e.g., consortium investigators). Participants may be contacted during and after the completion of this award for periodic updates and other information helpful in evaluating the impact of the program. NIH and its ICs will use this information to determine overall success for the coordination center and for supporting the activities of the Alzheimer's Disease Sequencing Project. 

Section VII. Agency Contacts

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

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

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

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

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

Michael Bennani, Ph.D.
National Institute on Aging (NIA)
Division of Neuroscience (DN)
Telephone: 301-448-0128
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]
 

Jeni Smits
National Institute on Aging (NIA)
Telephone: 301-827-4020
Email: [email protected]    
 

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.