Consortium for Neuroscience AD/ADRD in Low- and Middle-Income Countries (U01 Clinical Trial Not Allowed) (RFA-AG-25-032)

Consortium for Neuroscience AD/ADRD in Low- and Middle-Income Countries (U01 Clinical Trial Not Allowed) (RFA-AG-25-032) is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired RFA-AG-25-032: Consortium for Neuroscience AD/ADRD in Low- and Middle-Income Countries (U01 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Funding Opportunity Title Consortium for Neuroscience AD/ADRD in Low- and Middle-Income Countries (U01 Clinical Trial Not Allowed) U01 Research Project – Cooperative Agreements May 9, 2025 - Notice to Applicants That the Simplified Review Framework Will be Applied to All Relevant Applications for August/October 2025 Councils.

See Notice NOT-OD-25-116 . September 11, 2024 - Coordinating Center to Support Consortium for Neuroscience Alzheimers Disease and AD-Related Dementias (ADRD) Research in Low- and Middle-Income Countries (LMICs) (U24 Clinical Trial Not Allowed). See Notice RFA-AG-25-014 .

April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity Resource-Related Research Project (Cooperative Agreements) See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) aims to promote collaborative research programs by inviting applications to support innovative and sustainable Alzheimer's disease (AD) and AD-related dementias (ADRD) (including frontotemporal dementia (FTD), Lewy body dementia (LBD), vascular cognitive impairment/dementia (VCID), and mixed etiology dementias (MEDs)) neuroscience research for experienced investigators in low- and middle-income countries (LMICs).

These collaborative research programs are expected to contribute to the long-term goals of building sustainable AD/ADRD neuroscience capacity and research, ultimately leading to prevention and mitigation strategies for AD/ADRD in LMICs. This NOFO supports applications submitted from LMIC institutions as defined by the World Bank . LMIC scientists are expected to collaborate with scientists from the United States.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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). Required Application Instructions 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 1. Overview Information 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 The rationale for pursuing global AD/ADRD research in LMICs is compelling. 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 are 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.

Diversity in AD/ADRD research participants and global research are crucial in ensuring research findings are generalizable. Moreover, global AD/ADRD research and cross-country comparisons may assist in improving our understanding of the multifactorial 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 underrepresented 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.

Through this NOFO, the National Institute on Aging (NIA) seeks to support Cooperative Agreement (U01) projects that propose to achieve the following objectives: Enable the formation of transformative collaborations between institutions/scientists in the U.S. and LMICs. Support experienced LMIC scientists to perform innovative and sustainable AD/ADRD neuroscience research within their LMIC environment.

These research programs are expected to contribute to the long-term goals of building sustainable AD/ADRD neuroscience research capacity and research, ultimately leading to prevention and mitigation strategies for AD/ADRD in LMICs.

To achieve this goal, the proposed projects are expected to include the following types of activities: The formation and/or solidification of collaborations/partnerships between scientists/institutions in the U.S. and LMICs using a Multiple Principal Investigators(MPI) approach. MPIs should consist of at least one scientist working in an institution based in an LMIC and at least one U.S. scientist.

Scientist(s) from LMIC institutions must have prior experience conducting neuroscience AD/ADRD research and may demonstrate experience either through proof of leading a scientific endeavor or through receipt of funding from a local funding agency. The U.S.-based scientist(s) must have documented experience conducting research within LMIC settings, as well as experience conducting NIH-supported research.

To enable succession planning, LMIC institutions are encouraged to include at least one early-stage investigator in the research team and to include them in the development and planning aspects of the research award. Applicants must present an MPI plan that clearly delineates roles and responsibilities.

Applicants are encouraged to involve multiple U.S. and LMIC partner institutions in the proposed research project, as scientifically appropriate and justified. Partnerships with appropriate LMIC governmental organizations, non-governmental organizations (NGOs), and academic institutions are encouraged.

Initial inclusion of more than three LMICs in the overall partnership structure for new applications is likely to be very challenging and should only be undertaken if there is strong justification, including how the partnership will be managed and how the support and responsibilities will be distributed.

The formation of an External Advisory Board with subject matter expertise in order to supplement or complement the areas of expertise of the research team members. The proposed External Advisory Board is required to provide guidance and feedback on conducting the research project and develop a sustainability plan.

The composition of this committee depends on the nature and scope of the project, and the committee may include, as appropriate to the project, individuals employed by the Program Director/Principal Investigator's (PD/PI) institution.

The application should identify the types of expertise appropriate for the External Advisory Board, the number of members, and the operations and frequency of meetings, but it must NOT recommend individuals by name nor provide biographical sketches of proposed members. Membership can be negotiated with program staff at the time of award.

Conducting AD/ADRD neuroscience research within LMICs, that addresses significant issues unique to LMICs and that are also relevant to the U.S.. Applicants must demonstrate relevance to their LMIC as well as how their proposed research can inform preventative or therapeutic strategies for the U.S. Specific Areas of Interest Investigators should propose studies that advance understanding of AD/ADRD neuroscience in LMICs.

Although study designs will depend upon the specific goals of the project, all applications must clearly define the population(s) or sub-population(s) of interest and describe how investigators will ensure representation appropriate for future research goals. All studies must have a neuroscience focus.

Research areas include, but are not limited to, the following: Descriptive epidemiology and trends (i.e., incidence, prevalence, morbidity, mortality) in diverse populations. Longitudinal cohort and other epidemiological studies that investigate risk and preventive factors associated with mild cognitive impairment (MCI),AD/ADRD, and/or neuropathological outcomes in diverse populations.

Risk factors include those that are genetic, environmental, modifiable, and co-morbidities. Novel genetic variants that may have a strong genetic contribution to AD/ADRD biology. Examination of the association between highly prevalent co-morbidities (e.g., cardiovascular risk factors, diabetes, dyslipidemia, peripheral arterial disease), cognitive impairment and AD/ADRD phenotypes.

The role of early life co-morbidities, such as childhood infections and diseases prevalent in LMICs. The impact of the exposome (e.g., environmental exposures including environmental toxicants, air pollution, and diet) on brain health, AD/ADRD risk, and cognitive reserve/resilience. The role of infectious agents, including COVID-19, in cognitive impairment and AD/ADRD.

Etiology of age-related AD/ADRD subtypes. Genetic and other -omics data (e.g., APOE status, genome-wide association study or whole sequencing, epigenetics, transcriptomics, metabolomics, and proteomics).

Neurobiological and Neuropathological neuroimaging endpoints, including, but not limited to, the use of novel positron emission tomography (PET) ligands; cerebrospinal fluid, or blood-based biomarkers such as beta-amyloid, tau, and neurofilament; and autopsy tissue when possible.

Physiology and other co-morbidities including, but not limited to, obesity, diabetes, hypertension, and other vascular contributions to cognitive impairment (VCID); brain stress measures (e.g., autonomic, cortisol, EEG, fNIRS); role of inflammation or immune systems; and mental health history. Identification of underlying mechanisms of cognitive reserve/resilience (e.g., protective genotypes of cognitive reserve).

Development of accessible, low-cost tools for the diagnosis of AD/ADRD. Population-based research for the discovery or expansion of predictive pre-clinical biomarkers (e.g., blood, fluid, neuroimaging, language) associated with vascular or neurological changes in different populations. Annual Investigator Meeting Investigators are expected to participate in an annual (virtual or in-person) PD/PI meeting.

The first meeting will be held after the first Notice of Awards are issued. The meeting is expected to last up to two days. The annual meeting will provide a forum for investigators to discuss research updates, identify opportunities for synergy and collaboration across projects (e.g., data harmonization, protocol optimization), and identify pertinent research challenges and solutions.

The consortium coordinating center will organize annual meetings in coordination with NIA Program Officials and Project Scientists and investigators and develop the agenda with input from the funded research teams. Applicants should include funds to support travel to the meeting in their yearly budget.

Non-responsiveness Criteria The following types of applications will be considered non-responsive and will be withdrawn prior to review: Applications that include non-human animals. Applications that include populations not from LMICs. Applications that do not propose research related to AD/ADRD neuroscience.

Applications from high-income countries , as defined by the World Bank. Applications not from an established LMIC investigator. Applications which do not include a U.S. collaborator.

Applications that do not include a U.S.-LMIC collaborative MPI plan. Frequently Asked Questions Responses to frequently asked questions about this NOFO will be posted here .

Applicants are encouraged to leverage existing NIH and NIA-supported infrastructure, such as the following: Human, Health and Hereditary in Africa (H3Africa) Harnessing Data Science of Health Discovery and Innovation in Africa (DSI-Africa) Global Environmental and Occupational Health program (GEOHealth) Health and Retirement Study: International Family of Studies Harmonized Cognitive Assessment Protocol (HCAP) Network Alzheimer’s Disease Research Centers Alzheimer’s Disease Sequencing Project NIA’s Genetics of Alzheimer's Disease Data See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI. 2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIA intends to commit $2. 16M in FY 2025 and FY 2026 to fund 5 awards.

Application budgets are limited to $400,000 in direct cost per year. The project period is limited to 5 years. 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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations 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. Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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 .

The PDs/PIs must be established, experienced investigators in the scientific area on which the application is focused and capable of providing both administrative and scientific leadership on the development and implementation of the proposed program. The U.S. PDs/PIs should have experience conducting research in LMICs.

Non-U.S.-based high-income countries (HIC) investigators are NOT eligible as PD/PIs but may be included as consultants, especially if they present special opportunities for furthering research programs, present special opportunities and/or unusual talent for furthering research programs, or provide resources relevant to the proposed project that either are not readily available in the eligible LMIC or the U.S. institution or which augment existing resources.

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 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. 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: National Institute on Aging (NIA) All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission 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. 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 PDs/PIs should be established investigators in the scientific area on which the application is focused and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The U.S. PDs/PIs should have experience conducting research in the LMICs. All instructions in the How to Apply - Application Guide must be followed.

The budget should include costs for PDs/PIs and selected key personnel to travel to attend meetings of their research group at least once annually. The budget should also include costs for the PDs/PIs and selected key personnel to travel to attend the annual network meeting of all funded awards. 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. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Research Strategy: Applicants must organize the research strategy into subsections as indicated below. Applicants may include other sections as needed.

Sub-section A. Background and Significance Provide an overview of relevant scientific literature. Identify the scientific gap(s) fulfilled by the proposed projects, its relevance to the LMIC and how the proposed research will address the scientific gap.

Describe how the design and data collected will advance the understanding of AD/ADRD in LMIC(s). Explain how the findings of the project will inform future AD/ADRD preventative, therapeutic or intervention strategies, or public health guidelines to decrease the burden of AD/ADRD in LMIC(s). Describe how the research could inform AD/ADRD preventative, therapeutic, or intervention strategies in the U.S. or globally.

Justify and explain the rationale for selection of the study population/geographic regions. Sub-section B. Multi-disciplinary Team Applicants must present an MPI plan that clearly delineates roles and responsibilities.

MPIs must consist of at least one U.S. scientist and at least one scientist working in an institution based in an LMIC. The U.S. scientist(s) must have documented experience conducting research activities within LMIC settings. Describe the scientific expertise of the members of the U.S.-LMIC MPI team.

Provide a rationale and a justification for choosing the scientific team. In the justification, outline the individual team members' areas of expertise and ways in which team members complement each other for the benefit of the project. Describe the experience/expertise of the lead U.S. investigator(s) in performing research in a LMIC setting.

Describe how this experience will be used to successfully implement the proposed aims of the project. Explain how the expertise of the research team is appropriate for the types of data to be collected/included and/or the tools/techniques needed to establish or expand the infrastructure proposed (e.g., genetic or environmental, epidemiology, exposure assessment, cell/molecular sciences, engineering/database management).

If the project focuses on a particular population, explain how the expertise and experience of the research team is appropriate to support engaging with those populations and relevant community partners. Provide an overview of the governance and organizational structure of the team, including the process for making decisions on scientific direction and allocating funds and resources.

Provide a summary of prior or new collaboration(s) with community partners, including, but not limited to, the following: Community-based organizations Professional organizations Describe how the team will engage with relevant stakeholders, how the relationship will draw upon the respective strengths of the team and the stakeholders over the course of the study, and how this relationship will be sustained. Sub-section C.

Innovation and Preliminary Data Describe how the project is innovative, and how data collected, or new research infrastructure created, will allow for novel and/or expanded investigations of AD/ADRD in LMICs.

Summarize preliminary data that demonstrates the feasibility of the proposed research, methods to recruit the selected population of interest, collection and use of high-quality data, collaboration within a multidisciplinary team, and productive interactions with community stakeholders. Summarize preliminary data on the proposed assessments as valid and reproducible. Provide an overview of the study population selected.

If new recruitment is planned, provide a description of how the participants of the study will be recruited and retained in the study. Describe any potential challenges in recruitment, retention, and how these challenges will be addressed. Describe methods that will be used to accomplish specific aims.

Describe the information or types of data to be collected in the study and how the activities and research proposed will advance AD/ADRD research for the study population. Describe the development and/or testing of new measures, tools and/or methods for recruitment, retention, and data collection from well-defined populations.

Describe the analytic plan, including calculations for expected effect sizes, sample size, and power analyses for all aims. Include a description of community engagement activities and explain how these activities will be sustained over the period of the study and/or beyond.

Describe how the infrastructure created and/or data collected will support a precision medicine approach for future preventative or therapeutic intervention strategies development. Describe plans for sustainability and future research. Propose an External Advisory Board.

The application should identify the types of expertise appropriate for the External Advisory Board, the number of members, and operations and frequency of meetings but must NOT recommend individuals by name nor provide biographical sketches of proposed members. Letters of Support: Applicants should include letters of support from collaborating entities that are essential to the mission of the work proposed.

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 .

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.

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.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply Application Guide. 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