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

Key Definitions for This NOFO

• AITC Program: A collective consisting of individual P30 “Collaboratories” and a single U24 Coordinating Center. The program is comprised of the following types of Centers that operate independently, and in cooperation with all the other Centers:
  • AITC: P30 Center(s) that focus on implementation of AI and technology approaches for aging and AD/ADRD research. The Center(s) is/are funded through RFA-AG-26-006. Hereafter, the Centers will also be referred to as “Collaboratory(ies)” or "AITC(s)."
  • AITC Coordinating Center (AITCC): A center that provides leadership and coordination for the AITC Program through a cooperative agreement with NIA. The AITCC is funded through this NOFO, RFA-AG-26-007, using the U24 (Resource-Related Research Projects – Cooperative Agreements) activity code. Hereafter, the AITC Coordinating Center will also be referred to as “AITCC” or "Coordinating Center (CC)."
  • AD/ADRD: ADRD include, but are not limited to, Frontotemporal dementia (FTD), Vascular Contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementias (LBD), and Multiple Etiology Dementias (MED).

Background

The AITC Coordinating Center (hereafter “AITCC”) will serve as a bridge between the AITCs to facilitate and coordinate activities across the AITC Program. The AITC Program promotes the development and implementation of AI approaches and technology through research projects for aging and AD/ADRD research. AI and other emerging technologies have the potential to address pressing issues in aging and AD/ADRD. The AITC Program supports innovative cross-disciplinary collaborative teams, with investigators from academia, non-profit, and healthcare sectors across a wide range of disciplines working to advance priorities in aging and AD/ADRD research. 

Goals of the overall AITC Program are as follows:

1. Serve as a national resource to promote development and implementation of innovative AI and technology approaches to advance aging and AD/ADRD priorities;
2. Support nationwide research projects to develop and implement AI and technology approaches and respond rapidly to emerging priorities in the shifting artificial intelligence and technology landscape; and
3. Collaborate with a wide range of stakeholders in addressing algorithmic fairness and how to incorporate AI and technology approaches in the special circumstances of individuals experiencing cognitive decline/impairment.

In achieving these goals, it is expected that the AITCC will interact with the AITCs. The AITCC will serve as a hub for the AITC Program and will facilitate and coordinate activities across Collaboratories.

Functions and Activities

The central functions of the AITCC are to (1) serve as a hub for the AITC Program and facilitate and coordinate activities across the AITC Program, (2) centralize and lead stakeholder engagement activities across the AITC Program, and (3) enhance the scientific impact and reach of the AITC Program by actively disseminating information about the program and attracting new researchers from across the country to participate in program activities and resources.

The AITCC will include the following four teams:

Administrative Team. This team will financially and logistically support an annual AITC Symposium, and will support communications for the overall AITC Program through the following activities:

• Coordinating with AITC PIs to develop the theme, agenda, and logistics for an annual AITC Symposium to highlight AITC Program and research recipient progress.
• Fostering communication and cooperative arrangements between AITCs and other NIA research centers or consortia (e.g., Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging, Centers on the Demography and Economics of Aging, Resource Centers for Minority Aging Research (RCMARs), Alzheimer's Disease Research Centers (ADRCs), Nathan Shock Centers, Claude D. Pepper Centers, Alzheimer’s Disease Sequencing Project AI and Machine Learning Consortium).
• Highlighting AITC research and commercial advances in research areas relevant to NIA, including those identified by the Program Officer, the National Advisory Council on Aging, the AD/ADRD Research Implementation Milestones, etc.
• Maintaining an active AITC Program website with links to each AITC site and resources generated by NIA and each AITC. The website will serve as the source of information for scientific and lay audiences and will be accessible and readily identifiable.

Commercialization Team. This team will coordinate and provide avenues for increasing business development knowledge and access to commercialization paths for research project recipients. Team activities may include the following:

• Partnering with business schools to provide knowledge sharing opportunities for commercialization of research projects. Partnerships may include providing opportunities for business students to participate on innovation teams (e.g., drafting business development plans).
• Collaborate with NIA’s Office of Strategic Extramural Programs (OSEP) to engage with organizations in AgeTech and venture capital space, and other commercial stakeholders to create business and professional development opportunities for research project recipients.
• Engaging with NIA OSEP to provide training opportunities for ‘pre-SBIR’ recipients to facilitate the SBIR pipeline.
• Collate entrepreneurial and business development training programs and accelerators available to research project recipients that could provide resources and education on how to bring AI and technology concepts to market. Programs may include national programs, NIH-run programs, and programs available at AITC institutions and their business schools.

Research and Consulting Team. This team will support the solicitation, acceptance, and centralized review process for the national research project competitions, in close coordination with the AITCs. Team activities may include the following:

• Developing and maintaining processes and infrastructure for soliciting and accepting research project applications from the national competitions held by each AITC.
• Facilitating a centralized external review  of research project applications from the annual national competitions held by each AITC.
• Coordinating with AITC PIs to develop and facilitate challenge prize competitions.
• Maintaining a centralized database through which the AITCs can track research project/preliminary study progress, including recruitment and retention.
• Collecting and tracking appropriate demographic information from research project recipients and work collaboratively with the AITC PIs to track outcome metrics to be collected from each research project recipient at the end of the project period. Common metrics and processes for tracking may include the following:
  • Number and characteristics of research projects awarded each cycle;
  • Representation of states and U.S. territories of applicants and recipients;
  • Distribution of recipients across academia, industry, etc.;
  • Number of research project recipients that go on to submit R01 or small business innovation research (SBIR) applications (or other outcomes of research project awards such as commercialization or business development);
  • Distribution of project focus areas across NIA’s scientific portfolio;
  • Innovation of research projects (e.g., are the research projects similar to the current NIA portfolio or do they stand out as different/innovative?);
  • Number and nature of collaborations with AITCs;
  • Products resulting from collaborations with other Collaboratories;
  • Number and nature of collaborations with other NIA or NIH funded projects;
  • Products resulting from collaborations with other NIA or NIH funded projects;
  • Number and nature of collaborations with organizations outside NIH; and
  • Products resulting from collaborations with organizations outside NIH.

Stakeholder Engagement Team. The AITCC will facilitate a centralized cross-AITC/AITCC stakeholder engagement team. The objective of this team is to ensure that AI approaches and technologies developed by the AITC will be maximally adoptable by and accessible to their end users by soliciting stakeholder input throughout all phases of the development cycle. Cross-AITC/AITCC team activities may include the following:

• Identifying and engaging with stakeholder groups, which may include midlife and older adults with and without AD/ADRD and their caregivers.
• Develop resources, best-practice guidelines, focus groups, and community-based participatory research strategies.

External Advisory Panel (EAP)

An External Advisory Panel (EAP) for the AITC Program will be established, in conjunction with the AITCC, to review the progress of all components of the Program and provide recommendations to the AITC and AITCC Project Directors and/or Principle Investigator (PD(s)/PI(s)).

EAP Membership: Membership may include study investigators, representatives from relevant federal agencies (cannot include NIA or NIH representatives), and independent scientific experts in areas appropriate to the multidisciplinary content of the Collaboratory. The EAP is expected to have 5-7 permanent members; however, membership may expand permanently or on an ad hoc basis as needed. The AITCC is expected to propose suitable EAP members to NIA for final approval.

EAP Meeting Logistics: The EAP will meet twice a year to evaluate and comment on the progress of the AITC Program. The meetings will alternate between virtual and in-person formats. The in-person meeting should be planned in conjunction with the annual AITC Symposium to be held at an NIA-approved location in Bethesda, MD.

EAP Meeting Content: During the EAP meeting, AITC and AITCC PIs are expected to present annual accomplishments and future directions. The EAP will make recommendations, in writing, regarding progress of the AITC Program, including changes, if any, that would benefit the program.

Staff in the Office of Planning, Analysis, and Evaluation (OPAE) at NIA may evaluate the AITC Program and make recommendations regarding progress of the AITC Program, including changes, if any, that would benefit the program.

Non-Responsiveness Criteria

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

• Applications that do not clearly articulate relevance of the CC activities to promote AI and technology approaches in aging and AD/ADRD.
• Applications that do not propose administration, commercialization, consulting, and stakeholder engagement activities.

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 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 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

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).

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.

Page Limitations

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

With the following exceptions or additional requirements: 

For this specific NOFO, the Research Strategy section is limited to 30 pages. 

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 applicant must propose PD(s)/PI(s) and other personnel well suited to implement the activities of the CC. Specifically, the PD(s)/PI(s) must have the following experience:

• Demonstrated experience in management and coordination of large teams
• Experience bringing together multiple stakeholders to translate an idea into a product

The proposed team and its structure must have the appropriate breadth of expertise, which may include, but is not limited to, the following:

• Demonstrated expertise in AI and technology applications
• Demonstrated experience in engaging relevant stakeholders, which may include older adults, individuals living with dementia and their caregivers, venture capital firms, researchers, research participants, and clinicians
• Knowledge of regulatory requirements for AI and technology 
• Knowledge of industry and commercialization considerations in AI and technology

R&R Budget

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

Applicants should budget for the Annual AITC Symposium and in-person EAP meeting. The Symposium and EAP meeting must be held at an NIA-approved federal or non-federal location. The in-person EAP meeting budget should include travel costs for EAP members. 

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 AITCC with respect to oversight and coordination of the AITC Program.

Research Strategy:

In a section labeled “Administrative Plan”, describe plans for addressing the following:

• Administrative and organizational structure of the AITCC Administrative and Leadership Team (AITCC Admin Team). Include the unique features of the organizational structure that serve to facilitate accomplishment of the stated goals and objectives.
• Describe how communications will be planned, implemented, and provided to AITCs, collaborators, and outside researchers. Specifically address how the AITCC Admin Team will communicate with AITCs and NIA to ensure coordination and collaboration across the AITC Program, such as arranging and hosting regular PD/PI conference calls.
• Highlight how the proposed staffing plan incorporates and leverages scientific and administrative expertise and experience to fulfill the stated goals and objectives.
• Describe proposed makeup of the EAP roster (i.e., required expertise of EAP members) and plans for operating and utilizing the EAP (see Section I. NOFO Description, EAP for additional details). (NOTE: Potential EAP members should not be named in the application or contacted prior to review.)
• Describe plans for convening two EAP meetings per year (one virtual and one in-person at an NIA-approved federal or non-federal location, as described in Section I. NOFO Description, EAP).
• Describe plans for providing logistical support for an annual AITC Symposium to highlight AITC and research project recipient progress. The Symposium must be planned in conjunction with the in-person EAP meeting at an NIA-approved federal or non-federal location.
• Describe plans for engaging with AITC PIs to collaborate on developing the theme, agenda, and logistics for the annual AITC Symposium and maintaining an active AITC website with links to NIA and each AITC site.
• Establish a mechanism for disseminating scientific and commercial advances of AITC projects.

In a section labeled “Commercialization Plan”, describe plans for addressing the following:

• Describe how proposed partnerships and collaborations will provide knowledge sharing and professional development opportunities relevant to commercialization of research projects.
• Assisting research project recipients with scaling, dissemination, and commercialization of AI and technology products derived from AITCs.
• Provide assistance through preparation of background instructions and submission templates to ensure compliance with laws and FDA regulations associated with AI and technology.

In a section labeled “Research and Consulting Plan”, describe plans for addressing the following:

• 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 AITC community.
• Describe a plan for collecting and tracking appropriate demographic information from research project grant recipients across AITCs.
• Describe plans for developing and maintaining a database for collecting information from AITC activities.
• Describe plans for ensuring broad participation of the annual research award competition to attract applicants from across the country and from varied academic and industry backgrounds.
• Describe plans for facilitating the research award competition, including solicitation, receipt, and centralized review of applications, including plans for engaging with the AITCs in this process. The review of research project applications will be centrally organized by the AITCC with input and collaboration from the AITCs.

In a section labeled “Stakeholder Engagement Plan”, describe plans for addressing the following:

• Highlight how the proposed staffing plan incorporates and leverages stakeholder engagement experience.
• Describe plans for collaborative and meaningful engagement with the AITCs on stakeholder engagement activities.
• Describe plans for developing resources and best practices for engaging with relevant stakeholders to ensure that AI and technology approaches developed by the AITCs are maximally adoptable by, and accessible to, their end users.

Evaluation Plan:

Applications must include a clear description of objectives and plans for evaluating the AITCC, including all activities supported by the AITCC, in line with broader AITC Program goals. The application must specify clearly defined milestones with metrics to gauge the short- or long-term success of the AITCC in achieving its objectives. Where appropriate, applicants should seek feedback from participants to help identify weaknesses and areas for improvement. The AITCC evaluation plan should focus on the activities of the AITCC, not the entire AITC Program. The AITC Program and its constituent parts will be evaluated by NIA on the extent to which the overall goals of the program are met. NIA may use information from its review to determine whether to continue the program as currently configured, continue with modifications, or discontinue the program.

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 non-responsive 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 the Center for Scientific Review (CSR), 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.

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 following:

• The PI/PD will have primary responsibility for the design, development, coordination, and implementation of the objectives. 
• The AITCC is expected to propose EAP members to NIA for final approval. Membership may include study investigators, representatives from relevant federal agencies (cannot include NIA or NIH representatives), and independent scientific experts in areas appropriate to the multidisciplinary content of the Collaboratory. The AITCC is expected to regularly host EAP meetings.
• Developing the maintaining the AITC website and making it discoverable within the six months of award. 
• Establishing metrics and timelines for accomplishing the activities and achieving the objectives of the AITCC.
• Planning and participating in outreach and dissemination activities, including developing, hosting, and maintaining a public website; hosting and attending meetings to discuss the project's progress; and other coordination, outreach, and dissemination activities. 
• Responding promptly and cooperatively to requests for information or input from NIH. 
• Participating in ongoing conference calls with Project Scientist(s) and/or other NIH program staff, as scheduled and agreed upon.
• 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 will assign a Project Scientist(s) as the point of contact to work with the PD(s)/Pl(s).
• The NIA/NIH Project Scientist will interact scientifically with the research team and provide input, expert advice, and suggestions on the design, development, coordination, and implementation of the objectives. 
• The NIA/NIH Project Scientist will facilitate interaction with other NIH-supported activities or programs to allow exchange of relevant tools and data, to facilitate resource compatibility, and to avoid unnecessary duplication of effort.
• Additionally, an agency program official (PO) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The PO will interact with the PD(s)/Pl(s) on a regular basis to monitor progress and facilitate cooperation. Monitoring may include regular communication with the PD(s)/Pl(s) and his/her staff. 
• Additional NIA/NIH staff (e.g., additional projects scientists) may participate in all work groups, implementation teams, and committees as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program. 

Areas of Joint Responsibility include the following:

• Coordinating and facilitating the interactions between participants under this cooperative agreement and other NIA grant recipients. 
• Attend the EAP meetings and consider any recommendations from the EAP for modifying the AITCC's focus to accommodate new opportunities and directions. 
• Sharing and reviewing annual progress among components of the program and with external stakeholders.  

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 recipient, 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.

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]

Rebecca Krupenevich, Ph.D.
National Institute on Aging (NIA)
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Megan Hancock
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]

Section VIII. Other Information

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

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