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.

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The rationale for pursuing global Alzheimer's dementia (AD) and AD-related dementias (ADRD) research in LMICs is compelling. According to World Health Organization, approximately 60% of all people living with AD/ADRD live in LMICs, and this percentage is expected to increase to 71% by 2050. Moreover, the number of people living with AD/ADRD in LMICs is expected to experience a greater increase compared to the number of people with AD/ADRD in high-income countries by 2050 due to increases in life expectancy alongside a greater burden of risk factors. Furthermore, these projections might be confounded by temporal changes due to shorter survival after dementia, lack of education and awareness, inadequate diagnostic assessment, and variability in costs of care for the elderly with AD/ADRD, all of which could lead to under-accounting of the AD/ ADRD burden. Although most people living with AD/ADRD live in LMICs, research on AD/ADRD in these regions is limited and under-resourced. Most research data on AD/ADRD and evidence for AD/ADRD risk factors come from high-income countries (HICs) and research and data on the impact of risk factors on AD/ADRD in LMICs is lacking. AD/ADRD risk and protective factors in HICs might be different from those in LMICs, and modification in interventions might be required for people from different regions and cultures. The inclusion of participants of all sexes/genders, races, ethnicities and ages in AD/ADRD research participants and global research is crucial in ensuring research findings are generalizable. Moreover, global AD/ADRD research and cross-country comparisons may assist in improving our understanding of the multi-factorial and complex nature of AD/ADRD. The wide variety of dietary, lifestyle and environmental exposures, as well as genetic variation of respective populations, can provide valuable insights on factors that contribute to, or protect against, developing AD/ADRD in different populations.    

A dearth of AD/ADRD research in LMICs has created limitations in knowledge of AD/ADRD epidemiology, which warrants the need for sustainable AD/ADRD research programs in LMICs. Supporting AD/ADRD research, research infrastructure, and AD/ADRD scientists in LMICs will provide the opportunity to study populations that are currently understudied in AD/ADRD research and ultimately lead to more evidence-based prevention, detection, intervention, and treatment strategies for those populations. Evidence-based AD/ADRD prevention, detection and intervention strategies that are practical for populations living in LMICs could contribute greatly to reducing the global burden of the disease due to the higher prevalence of modifiable risk factors in LMICs compared to HICs, and the subsequent higher potential for AD/ADRD prevention in LMIC regions.  

Access to AD/ADRD research funding continues to be a concern for scientists, both junior and established faculty, in LMICs. Most LMIC scientists obtain funding support through research collaborations with partners from HICs within Europe or North America, where the funding environment is substantially better. However, this may diminish the ability of LMIC scientists to lead and perform sustainable research, while building collaborative research networks relevant to them.  Longer term funding programs that support independent and innovative investigator-initiated research for LMIC scientists will be of great importance for the sustainability of research in those regions. 

Purpose

This NOFO will support one award to a U.S. institution. The Coordination Center applicant should demonstrate expertise in coordination of large research projects in LMIC settings and is expected to include senior members who have considerable leadership skills and experience in productive collaborations with large research teams and/or multi-stakeholder groups (e.g., research or other health consortia, community-based organizations) in a wide range of settings (e.g., rural, urban). The Coordination Center application must also demonstrate the following:  

• Experience with data management using applicable tools. 
• Experience with stakeholder engagement and outreach activities, including, but not limited to, participants, researchers, federal, and community-based organizations. 
• Successful partnerships with multiple study teams across LMIC and a wide range of other settings in the design, implementation, and completion of large research studies. 
• Effective communications across scientific teams, community engagement stakeholders, and NIH ICs. 
• Website development, file management, organization, and maintenance. 
• Organization of scientific meetings. 
• Meeting travel planning. 
• Knowledge of NIH data sharing policies, FAIR principles,and experience with deposition of data to NIH repositories. 

Research Objectives

Administration and Coordination. The administration and coordination functions will focus on providing administrative and logistical support for activities for LMIC investigators funded under RFA-AG-25-031 and RFA-AG-25-032, in collaboration with NIA program staff and fostering synergy across the consortia. Specific responsibilities will include, but not be limited to, the following:

• Provide leadership and expertise in administration, reporting, coordination, engagement, outreach and dissemination activities. 
• Identify and track consortia metrics to assess progress and success.
• Prepare and submit timely reports including publications, data submission, and other documentation as required by NIA. Distribute reports and data summaries to consortia members and NIA Program Staff on progress, publications, presentations, and innovations across the consortia.
• Coordinate with NIA program staff to plan, facilitate, and manage consortia (e.g., working groups) and annual program meetings (in-person or virtual) as appropriate.
• Provide administrative support to the LMIC investigators to address specific scientific challenges, share best practices, and promote the integration of cross-disciplinary ideas and methodologies.
• Provide opportunities for training LMIC investigators with a focus on promoting diversity in the research workforce.

Collaboration and Communication. The collaboration and communication function will serve as a unifying force that brings together  expertise and fosters a culture of cooperation, transparency, and innovation within the consortia and with the research community globally. Specific responsibilities will include, but are not limited to, the following:

• Act as a central point of contact for the consortia members, NIA program staff, and external stakeholders. Facilitate communication and collaboration among all parties. Ensure that information flows smoothly and that all stakeholders are kept informed of consortium activities, decisions, and progress.
• Promote synergy and coordination across the various components of the consortia. Organize workshops and symposia that bring together consortia members, fostering interdisciplinary collaboration and knowledge exchange.
• Facilitate interactions within the consortium through support of workshops, tutorials, and tracking of consortium activities. These may include protocol and methodology development, cross-consortium activities such as joint projects and analyses, manuscript preparation, and publications.
• Identify collaborative opportunities and foster such partnerships with NIH and NIA funded programs and the global research community.

Data Sharing and Resource Dissemination. The Data Sharing and Resource Dissemination function will focus on the coordination of data sharing according to NIH data sharing policies and FAIR principles.It will also focus on developing and disseminating resources generated from the consortia through a website that is intuitive and readily accessible by the broader research community. This central hub facilitates information dissemination, collaboration, and outreach; and fosters engagement with the consortia members and the scientific community. Specific responsibilities will include, but are not limited to, the following:

• Coordinate with NIA- or NIH-supported funded resources and repositories, including the National Alzheimer's Coordinating Center (NACC), National Cell Repository for Alzheimer's Disease (NCRAD), and other NIH-supported funded repositories created for the sharing of biospecimen samples, deposition of data, and facilitation of easy discovery and access of data by the broader scientific community.
• Develop or work with existing databases to organize and house raw and processed data and metadata, protocols, methodologies software, tools, analyses, and other products of the consortium consistent with the FAIR Principles.
• Develop and maintain an organized and up-to-date external website for public engagement to boost the consortia visibility and impact.
• Develop and maintain an internal website tailored for use by consortia members and NIA program staff. This website will serve as a centralized resource hub, containing essential information for consortium member (e.g., standard operating procedures for biospecimen collection and processing, other experimental methodologies, examples of consents, sharing of best practices).
• Develop and maintain a comprehensive catalog detailing population-based/cohort studies and their associated grant information. This catalog must encompass comprehensive descriptions of the cohorts, including information on the racial and ethnic groups involved, the status and progress of specimen collection, and other relevant specifics. Ensure that this information is regularly updated and readily accessible to the broader scientific community. 

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference 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. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Notice of NIH's Interest in Diversity, NOT-OD-20-031, and Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

The U.S. PDs/PIs should have experience conducting research in LMICs. 

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.

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:

Damali Martin, Ph.D., MPH
Division of Neuroscience
National Institute on Aging (NIA)
Phone: 301-402-8310
Email: martinda@mail.nih.gov
 

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Investigators should describe their expertise/experience in coordination large research projects within a LMIC setting.

R&R Budget

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

The budget should also include costs for the PDs/PIs and selected key personnel to travel to attend the annual network meeting for LMIC consortia.

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:

Applicants must describe the following under the Approach section:

• Experience with data management using applicable tools. 
• Experience with stakeholder engagement and outreach activities, including, but not limited to, participants, researchers, federal, and community-based organizations. 
• Successful partnerships with multiple study teams across LMIC and other settings in the design, implementation, and completion of large research studies. 
• Effective communications across scientific teams, community engagement stakeholders, and NIH ICs. 
• Website development, file management, organization, and maintenance. 
• Organization of scientific meetings. 
• Meeting travel planning. 
• Knowledge of NIH data sharing policies, FAIR Principles, and experience with deposition of data to NIH repositories. 

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 components of participating organizations, NIA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the National Institute on Aging Referral Office by email at ramesh.vemuri@nih.gov when the application has been submitted. Please include the FON and title, PD/PI name, and title of the application.

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

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

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 NIA, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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:

• 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.
• Developing objectives, approaches, and measures to be included in the U24 project.
• Designing protocols, proposing milestones, and overseeing conduct of analyses and experiments.
• Overseeing and coordinating the effort of the multidisciplinary team and participating institutions and ensuring their optimal interactions and integration in the conduct of research activities.
• Complying with Federal regulatory requirements, including, but not limited to, those relating to human subject protections, informed consent, and reporting of adverse events.
• Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined below in Section VII: Agency Contacts. The PD/PI(s) will be expected to maintain close communications with the NIH Project Scientist(s) and, where appropriate, the Program Officer(s). The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
• Cooperating in the reporting of the study progress and findings. Where warranted by appropriate participation, plans for joint publication with NIH of the results and conclusions are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIH staff will apply in all cases. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.
• Overseeing the overall budget, activities, and performance of the cooperative agreement.
• Accepting the participatory and cooperative nature of the collaborative research process and complying with the policies and practices of NIH.
• Participating in teleconferences with NIH program staff, as needed; and in an annual Program Director/Principal Investigator (PD/PI) meeting.
• Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved DMS Plan for tis award and NIH sharing policies.
• Designating investigators to serve as members of an External Advisory Committee. Organizing and attending annual (or as needed) External Advisory Committee meetings.

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 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 study objectives. They may present experimental findings to the research team from published sources or from other relevant sources, participate in the analysis of results, and advise on management and technical performance.
• The NIA 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.
• NIH will assign a Program Officer(s) who will be responsible for retaining overall programmatic stewardship of the award. 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 their staff.
• NIH may designate additional staff to provide advice to the recipient on specific scientific and/or analytic issues. Such staff may include another Project Scientist(s) or analyst(s), who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study, or who may assist in the coordination of activities across multiple sites. NIH will clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
• NIH staff will make recommendations for the future years of funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research; and/or c) maintenance of a high quality of research, which will allow improvements in future studies of minority health and health disparities.
• NIH reserves the right to terminate or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting. 
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Agreeing upon and formalizing yearly project-specific milestones to be met prior to receiving the next year of funding .
• Ensuring that sites and investigators, as well as NIH and other research partners, fully comply with Federal regulatory requirements. This includes, but is not limited to, those relating to human subjects protections, informed consent, and reporting of adverse events.
• Establishment of a Research Governing Body:
  • The Steering Committee will serve as the research governing body for the U01 project, consisting of the leadership of the U01 project and NIA staff that will serve in an non-voting capacity.  The project scientist will serve as a voting member).
  • The Steering Committee will be chaired by one of the U01 PDs/PIs.
  • The Steering Committee members will meet regularly to review and monitor progress, plan and design research activities, and establish priorities. Meetings may occur as regularly scheduled teleconferences and include at least one in-person meeting each year over the course of the U01 project period.
• The PI(s)/PD(s) will be responsible for scheduling teleconferences and in-person meetings, as well as preparing concise minutes from teleconferences and in-person meetings. The meeting minutes will be distributed to the NIA Program Officer(s) and to research team members within one week of the meeting. 

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 (Coordination Center investigators, LMIC investigators, U.S. collaborators and others as determined). Participants may be contacted during and after the completion of this award for periodic updates on information helpful in evaluating the impact of the program. NIH and its ICs will use this information to determine overall success in building sustainable, independently resourced AD and/or ADRD neuroscience research programs at the LMIC institution.

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: GrantsInfo@nih.gov (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: support@grants.gov

Damali Martin, Ph.D., MPH 
Division of Neuroscience 
National Institute on Aging (NIA)
Email: martinda@mail.nih.gov 

Maryam Ghaleh, Ph.D.
Division of Neuroscience 
National Institute on Aging (NIA)
Email: maryam.ghaleh@nih.gov 

Dallas Anderson, Ph.D.
Division of Neuroscience 
National Institute on Aging (NIA)
Email: andersda@nia.nih.gov  

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

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

Jeni Smits 
National Institute on Aging (NIA)
Phone: 301-827-4020 
Email: Jeni.smits@nih.gov 

Section VIII. Other Information

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

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.