Part 1. Overview Information

Key Dates

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

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

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

It is critical that applicants follow the 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The Alzheimer's Disease Centers of Excellence Program was initiated in 1984 when Congress directed NIH and, in particular, NIA to foster further research related to AD. The NIA ADRC program is authorized by the Public Health Service Act, Section 445, and currently includes 35 NIA funded ADRCs. NACC was first established by NIA in 1999 to facilitate collaborative research across the growing ADRC program, making clinical and neuropathological data on all ADRC participants available to researchers in a central resource. NACC, with guidance from a NIA-appointed Clinical Task Force, facilitated the development of the Uniform Data Set and currently collects this information from 35 ADRCs across the country. Additionally, it has supported the development of a frontotemporal dementia (FTD) module and a Dementia with Lewy Bodies (DLB) module and with the Alzheimer's Biomarker Consortium for Down Syndrome (ABC-DS), a Down Syndrome (DS) module, each to be collected and submitted voluntarily by ADRCs that have focus in these areas. The Coordinating Center also has been instrumental in streamlining ADRC collaborations by supporting and managing interest groups and steering committees working to maximize the resources of the Centers to advance AD/ADRD research.

NACC has been and will continue to interact with multiple NIA-funded research resources, including multiple national AD/ADRD genetic projects such as the NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS), the Alzheimer's Disease Genetics Consortium (ADGC), the National Centralized Repository for Alzheimer’s Disease and Related Dementias (NCRAD), and the Standardized Centralized Alzheimer's and Related Dementias Neuroimaging (SCAN). NACC is responsible for helping to ensure that the ADRC program is aligned with the key recommendations from the NIH AD and ADRD Research Summits. NACC will continue to enable NIA to strengthen the ability to capitalize on the unique resources available through the ADRC program, namely by leveraging the numerous strengths of the Centers network to provide large numbers of samples and standardized clinical data collection from well-characterized participants followed to autopsy, as well as a large pool of potential participants for future AD-related research. 

Purpose

A National Alzheimer's Coordinating Center (NACC) is to serve NIA as:

1) a national data resource, collecting data from the ADRCs and their affiliated data and sample repositories; 
2) a facilitator of current and future research on AD/ADRD; and 
3) the central hub for organizing and enabling communication within and outside the ADRC program, including annual meetings and steering committees. 

The goal of the overall ADRC program is to serve as major sources of discovery regarding the nature of AD/ADRD and the development of more effective approaches to prevention, diagnosis, care, and therapy. The ADRCs contribute significantly to the development of shared resources that support dementia-relevant research, and they collaborate to coordinate their research efforts with other NIH-funded programs and investigators. They also provide substantial support to increase the number of researchers engaged in these fields through a variety of research and infrastructure activities.

Structure

NACC will include the following three teams: Administrative, Database and Computing, and Research and Consulting.

Administrative Team

NACC will financially and logistically support semiannual in-person meetings, including support for outside speakers.

NACC will support a wide variety of communication functions for the overall ADRC program, including the following:

• Serve as the point of contact for NIA, other NIA funded Centers and programs, and the broader scientific community, including the Research Coordinating Center Network (RCCN).
• Provide a user-friendly web interface to serve the lay public as well as ADRCs and other investigators wishing to access ADRC clinical, neuropathological, neuroimaging, and biomarker data. The website should provide documentation such as coding guidebooks and data dictionaries as well as forms and instructions.
• Conduct outreach activities to raise awareness of the availability of the data, including providing database training and support instructional webinars that bring new users to the data.
• Track usage of the website and data resources, maintain a library of ADRC program activities, and follow up to early career investigator awards.
• Maintain and update, as needed, interest group and Core Leader communications, support core steering committee elections, and organize and coordinate steering committee activities.
• Maintain and regularly update the ADRC personnel directory.

Support the following additional administrative activities:

• Solicit and support the review process and funding for peer-reviewed Early Career Investigator projects utilizing NACC data and affiliated resources.
• Support subcontracts with each of the ADRCs to enable availability of rapid multi-center/national efforts and ensure timely and efficient data submission.
• Ensure that copyrights for any assessment tools allow for broad sharing of the tools as well as the resulting data.
• Ensure that data use agreements and safeguards are in place to prevent inadvertent release of personally identifiable information (PII).
• Provide timely responses to inquiries from interested researchers.
• Provide administrative support for the NACC Steering Committee, External Advisory Committee, Clinical Task Force, and collaborative activities as described below.
• Prepare, conduct and analyze survey data as requested by Steering committees.
• Plan for and advance future research needs for the ADRC program through the collaborative activities as described below.

Database and Computing Team

The Database and Computing Team will be responsible for ensuring the quality and accessibility of data, both for ADRC submission and for outside researcher access, as follows:

• Maintain high standards of data quality for all new and existing NACC data.
• Use modern database structures and functions, including streamlining of data submission and access processes, expanding version control, and developing automated processes for users.
• Provide high-security-compliant, high-capacity informatics infrastructure suitable for data integration, storage, management, and sharing and ensure that the data meet findable, accessible, interoperable, and reusable (FAIR) principles.
• Support collection and facilitate availability of digital biomarker data, as available and connected to other data on each participant.
• Support collection of a standard set of imaging data as described by the ADRC Imaging Steering Committee, and coordinate with SCAN to analyze and provide data from images collected across the ADRCs (e.g., obtain segmented volumes for existing MRIs).
• Implement and utilize global unique identifiers (GUID) collection throughout the ADRC program, facilitate deidentified submission to NACC and integration into the NACC database, and coordinate with other related data and sample resources such as NIAGADS and NCRAD.
• Manage continuous improvements and expedite data distribution, e.g., quick access full data download for users.
• Provide advanced online query and data visualization capabilities, investigator training, and instructions for data access.
• Provide a plan for receiving and storing other imaging and biomarker assay data (in anticipation of future NIA, Clinical Task Force (CTF), or NACC Steering Committee directives).
• Augment the ability to include legacy and other non-UDS data (currently held at individual sites) from participants already included in the national database, particularly access to item-level data.
• Enhance and support data harmonization and integration with other NIA-funded programs (e.g., SCAN, NCRAD), as well as linkages with administrative data sources.

As a national data resource, NACC must foster communication and collaborative activities within and across ADRCs and interact with other connected national resources, including:

• The National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD) to allow samples from the ADRCs to be connected with the data at NACC.
• The National Institute on Aging Genetics of Alzheimer's Disease Data Storage Site (NIAGADS) and the Alzheimer's Disease Genetics Consortium (ADGC) to connect genetic information with other participant data.
• Standardized Centralized Alzheimer's Neuroimaging (SCAN) to develop standardized magnetic resonance imaging (MRI) and positron emission tomography (PET) neuroimaging protocols at participating ADRCs, then harmonizing this neuroimaging data so that it can be shared and used by the scientific community. NACC will be responsible for the collection and management of new neuroimaging data by creating a repository, ensuring its integrity, and providing qualified investigators access to the neuroimaging data and any associated non-neuroimaging data.

Research and Consulting Team

• Promote and conduct research using NACC data.
• Develop statistical/research methodology important to the research field.
• Facilitate standardization of data collection and sharing processes throughout the ADRC program, where deemed appropriate by NIA and the NACC Steering Committee.
• Provide monthly and annual data summaries to individual ADRCs and to NIA; seek novel ways to communicate and display summary information.
• Plan to support data evaluations for future recommended changes to UDS or added data and data types to be collected.
• Provide in-depth consultation to researchers interested in utilizing the NACC data for research questions.
• Support planning and consultation for potential future ADRC applicants.

Pre-Application Webinar

A webinar is planned to provide prospective applicants with the opportunity to receive information and ask questions about the scientific scope of this NOFO and technical details for applying. The webinar will be open to all prospective applicants. Participation in the webinar is not a prerequisite to applying to this NOFO, but prospective applicants will need to register in order to participate in the webinar. Prospective applicants are also encouraged to submit their questions regarding the NOFO in advance of the webinar; further details on where to submit the questions will be provided once the webinar has been scheduled. Please click here for further details on the pre-application webinar, including the time and date, and registration information.

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 - Includes all types

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

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 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 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 NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed.

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).

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 How to Apply - 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:

Cerise Elliott Ph.D
National Institute on Aging (NIA)
Telephone: 301-496-9350
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.

Facilities & Other Resources:

• Describe the scientific environment that supports the electronic information handling.
• Describe the logistical and administrative assistance as well as operational support, including, but not limited to, website maintenance, meeting support, maintenance of documents and email listservs, and coordination of Steering Committees, that will maximize the utility of the Coordinating Center.
• Describe how the facilities and resources can accommodate growth of the Coordinating Center and the ADRC program.

Other Attachments:

Submit the following as separate attachments:  

1. Overall organizational chart with responsibilities for each role. Please name your file "Organizational Chart.pdf".
2. Provide a plan for the appointment of an External Advisory Committee including composition of the committee, roles, responsibilities, and desired expertise of committee members; frequency of committee meetings; and other relevant information. Describe how the EAC will provide feedback to NACC. New applications should not include the names of proposed Advisory Committee members and potential members should not be contacted prior to peer review. Committee membership will be determined after award in consultation with NIA. Please name your file "External Advisory Committee.pdf".
3. Leadership succession plan to assure continuity in the event of unexpected situations with training and mentoring plans/activities included. Please name your file "Leadership Succession.pdf".
4. List of expected collaborative activities that will be managed during the project period. Please name your file "Collaborations.pdf".
5. Description of monthly reporting plan to NIA and to each ADRC including enrollment, submission statistics, and other data summaries. Please name your file "Monthly Reporting to NIA.pdf".
6. Description of an annual summary report for NIA, across all ADRCs that evaluates the strengths, weaknesses, and completion of objectives for each collaborative activity. Please name your file "Annual Summary Report.pdf".
7. Description (or sample) of an annual report intended for the public that summarizes overall accomplishments/activities of the full ADRC program. Please name your file "Annual Summary Report Public.pdf".
8. Description of the tracking and synthesis of progress and outcomes of ADRC and NACC activities. Please name your file "Standard Process and Outcomes.pdf".

SF424(R&R) Senior/Key Person Profile

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

The application must detail the team’s experience and expertise.

The proposed team must have relevant experience and expertise in project management and coordination to facilitate cooperation across a wide range of relevant research fields.

There must be sufficient scientific expertise and the ability to work with scientists to serve as the overall ADRC point of contact for a broad research community.

R&R Budget

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

NACC should provide sufficient resources to, at minimum:

• Support semiannual ADRC network meetings
• Provide at least 2 Early Career Investigator awards per year  
• Employ a database trainer and provide database training materials
• Conduct outreach to promote NACC and its resources, including a presence (booth) at major national and international meetings
• Secure Uniform Data Set (UDS) licensing, as needed
• Support data and sample collection at ADRCs as well as assuring secure transmission of de-identified data from ADRCs to NACC
• Support known and future collaborative relationships
• Travel for staff to include:
  • Semiannual ADRC meetings
  • Site visits to conduct scientific review of Early Career Investigator award applications
  • Large national and international meetings to promote the availability of NACC data

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:

Specific Aims: Describe the specific aims of the NACC with respect to oversight and coordination of the ADRC program.

Research Strategy:

In a clearly labeled section entitled “Administrative Plan”:

• Describe the administrative and organizational structure of the NACC Administrative and Leadership Team (NACC Admin Team). Include the unique features of the organizational structure that serve to facilitate accomplishment of the stated goals and objectives. 
• Describe relevant experience in project management, coordination, the facilitation of cooperation and scientific expertise to work with a broad research community.
• Describe how communications will be planned, implemented, and provided to ADRCs, collaborators, outside researchers and the public. Specifically address how the NACC Admin Team will communicate with ADRCs and NIA to ensure coordination and collaboration across the ADRC Program, including steering committees for each of the required cores for ADRCs.
• Highlight how the proposed staffing plan incorporates and leverages scientific and administrative expertise and experience to fulfill the goals.

In a clearly labeled section entitled "Database and Computing Plan": This plan is distinct from the Data and Management Sharing (DMS) Plan. 

• Describe the staff roles responsible for building data submission, quality control, and data access systems that are consistent with the goals of the program and FAIR principles.
• Describe internal and external data acquisition strategies to achieve harmonization of systems and procedures for data management, data quality, data analyses, and dissemination of data and data-related materials generated by the ADRCs. 
• Indicate the extent to which dedicated systems or procedures will be utilized to harmonize the acquisition, curation, management, inventory, and storage of data and connections with samples and genetic, imaging, and other data. 
• Describe the novel strategies that will innovate data management and coordination that facilitates outside researchers' attempts to address unique and novel ideas.
• Describe how training on data collection and use, including adaptation to changes such as availability of point-of-contact primary data collection options, will be provided to all staff, including those at enrollment sites.
• Describe quality control procedures for the data, including how to identify and resolve issues with quality control in a manner that maintains the integrity of the data.

In a clearly labeled section entitled "Research and Consulting Plan":

• Describe the Research and Consulting Team staffing plan and processes that will facilitate interaction with current and future interested researchers both within and outside the ADRC community. Specific research to be conducted by NACC staff may be proposed, but is not required.

In a clearly labeled section entitled "Early Career Investigator Award Plan":

• Outline the processes that will be used to solicit, review, and select at least 2 Early Career Investigator awards per year.

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.

7. Other Submission Requirements and Information

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.

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

Section V. Application Review Information

1. Criteria

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

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.

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 NIH’s Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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

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

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.

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. 

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:

The Program Director(s)/Principal Investigator(s) will have primary responsibility for defining the details of the projects within the guidelines of this NOFO. The PD(s)/PI(s) will agree to accept the close coordination, cooperation, and participation of NIH staff (Project Scientist) in those aspects of scientific and technical management of the projects described below. Specifically, the PD(s)/PI(s) supported by this NOFO will:

• Retain primary authority and responsibility for the project as a whole and development of the methods, procedures to accomplish the aims and objectives of the NOFO, and preparation of publications.
• Provide, in addition to standard annual progress reports (see Section VI.3. Reporting), other relevant information to the NIH Project Scientist(s) or Program Officer, as well as coordinate and cooperate with NIH staff and other members of appropriate collaborating NIH programs.
• Work directly with the NIH Project Scientist(s) on the coordination of intra-program activities and the integration of ADRCs as well as other relevant NIH programs.
• Manage the coordination, collaboration, and organization of the ADRC program, in consultation with the Steering Committees comprised of elected ADRC staff and core leaders.
• Establish the agendas, in consultation with the Steering Committees, for joint meetings held twice annually.
• Create and participate in the appropriate coordinating meetings and/or working groups that will advance the aims of the Coordinating Center and maximize the use of the data resources stored at the Coordinating Center.
• Agree not to disclose confidential information obtained from other members of the ADRC program and extended research network.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. 

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

One designated NIH Program Staff member, acting as the Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The role of the Project Scientist will be to facilitate and not to direct. This includes facilitating the partnership relationship between NIH, ADRCs, and the Coordinating Center. The Project Scientist's role includes helping to maintain the overall balance in the program commensurate with the functions and scope of NACC activities; facilitating communication and coordination between the NACC, ADRC Data Cores, and ADRC Directors; and ensuring that the activities of the awardee are consistent with the mission of NIA. Specifically, the NIH Project Scientist will:

• Provide technical assistance and advice to the NACC awardee as appropriate to achieve the aims of the cooperative agreement.
• Work directly with the awardee to facilitate their interactions with ADRCs and ADRC Steering Committees.
• Promote and help coordinate collaborative efforts that involve interactions with other members of the AD/ADRD and aging research communities, as well as with other NIH-sponsored programs, projects, and centers where appropriate.
• Assist in the interaction between the awardee and investigators at other institutions, as appropriate for the program.
• Assist in avoiding unwarranted duplication of effort.

To help carry out these duties, the Project Scientist may consult with non-NIH experts in the field.

The NIH Project Scientist will perform the initial analysis of awardee research strategy and will work with the Program Officer on any strategy renegotiations. 

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 NIH Project Scientist(s) and the PD(s)/PI(s) of NACC will be jointly responsible for the coordination of intra-program activities and the integration of individual projects with other appropriate NIA and NIH programs. Joint responsibilities include:

• Developing working groups, coordinating committees, and/or trans-project and/or Center efforts as needed.
• Organizing and conducting regular meetings to share progress and foster collaborations with the ADRCs, by teleconference, videoconference, or face-to-face, as needed.
• Organizing workshops to promote outreach and database user training.
• Convening to assess progress, discuss data resources, establish priorities, review policy recommendations, propose publication guidelines, and discuss strategies.
• Meeting in person, virtually, or by teleconference, with additional NACC staff and/or NIH staff, on a schedule to be determined.

The NIH Project Scientist may additionally form an External Scientific Panel (ESP) composed of senior non-federal scientists who are not directly involved in the activities of the NACC. The ESP would update NIH on the progress of the Coordinating Center and ADRC Program, on the contributions of collaborations within the Program, and on the progress and effectiveness of the Program as a whole. 

Dispute Resolution:

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

3. Data Management and Sharing

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 (Coordinating Center, ADRCs and others as determined). Participants may be contacted during and after the completion of this award for periodic updates on publications, new collaborations, support from research grants or contracts, and other information helpful in evaluating the impact of the program. NIH and its ICs will use this information to determine overall success in building a data resource of ADRC data, functioning as the central hub for organizing and enabling communication within and outside the ADRC program and facilitating future AD/ADRD research. 

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]

Cerise Elliott, Ph.D.
National Institute on Aging (NIA) 
Division of Neuroscience (DN)
Telephone: 301-496-9350
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Robin Laney
National Institute on Aging (NIA)
Telephone: 301-496-1473
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.