Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimer's Disease and Related Dementias (R01 Clinical Trial Not Allowed)

Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimer's Disease and Related Dementias (R01 Clinical Trial Not Allowed) is sponsored by NIH. This opportunity supports mission-aligned projects and measurable outcomes.

PAR-25-374: Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimers Disease and Related Dementias (R01 Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

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 Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimer’s Disease and Related Dementias (R01 Clinical Trial Not Allowed) R01 Research Project Grant March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 See Section III. 3.

Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) invites applications that combine computational and experimental approaches to enable rigorous preclinical testing of drugs or drug combinations currently used for other conditions, as well as investigational drugs at various stages of clinical development, predicted to be efficacious in Alzheimer's Disease (AD) and AD-related dementias (ADRD).

This initiative will also support preclinical testing of repurposable or investigational drug candidates in combination with non-pharmacologic interventions leading to robust translational outcomes.

The central goal of this NOFO is to establish robust proof of concept in mouse models or cell-based models of AD/ADRD that will enable rational drug repositioning and the development of precision combination therapies for the treatment and prevention of AD/ADRD.

Funding Opportunity Goal(s) To encourage biomedical, social, and behavioral research and research training directed toward greater understanding of the aging process and the diseases, special problems, and needs of people as they age.

Open Date (Earliest Submission Date) 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.

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 Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. 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 Drug repurposing has several advantages over the development of new drugs including, shorter development times, lesser cost of development, and higher success rates.

This has been done successfully for several disease conditions, however, despite multiple attempts at drug repurposing for Alzheimer's disease (AD) or AD-related dementias (ADRD) treatment, these have been without success.

As we learn about the enormous complexity of AD pathophysiology and associated co-morbid conditions, it is becoming apparent that efficacious treatment for an individual patient will need to target multiple aspects of the disease and be directed towards several pathogenic processes and, as a result, require development of combination therapies.

The promise and challenges to successful drug repurposing and combination therapy development for AD were one of the major topics of discussion at the NIH AD Research Summits of 2012 , 2015, and 2018 and 2021 .

A series of recommendations were generated from the summit discussions that called for establishing new research programs that will promote the use of systems-based, data-driven approaches to create the biomedical knowledge base, tools, and resources needed for successful drug repurposing and repositioning and combination therapy development for AD/ADRD.

In 2017, NIA launched the funding initiative PAR-17-032 “ Translational Bioinformatics Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimer’s Disease” , (reissued in 2020 as PAR-20-156 ). The projects funded through this initiative led to the establishment of NIA's Advancing Combination Therapy and Drug Repurposing for Alzheimer’s Disease (ACTDRx AD) program.

ACTDRx AD is a cross-disciplinary program using translational bioinformatics approaches to formulate hypotheses and identify drug candidates (individually or in combination) that may be efficacious for the treatment of AD/ADRD. The program has brought investigators working on other chronic disorders with deep expertise in data science and multiscale modeling into AD/ADRD research.

Cutting edge computational methods, including artificial intelligence and machine learning approaches, have facilitated the identification of hundreds of potentially repurposable drugs.

However, there remains a need to prioritize the most promising drug candidates through additional computational approaches and through rigorous and reproducible preclinical testing in mouse models or cell-based models to evaluate their PK/PD properties and efficacy against multiple AD/ADRD outcomes (molecular, biochemical, neuropathologic, functional).

This new iteration of the program will build on NIA’s investment in data-driven approaches to AD drug repurposing and combination therapy development.

This initiative is envisioned to expand current efforts with a focus on prioritization of drug candidates for repurposing and repositioning (as individual treatment or in combination with other drug candidates or non-pharmacologic interventions) and on rigorous, reproducible preclinical proof-of-concept studies in mouse models or cell-based models of AD/ADRD.

The overarching goal of this Notice of Funding Opportunity (NOFO) is to support rigorous preclinical testing of drug candidates that have been identified through data-driven approaches for repositioning, repurposing, and combination therapy for t reatment and prevention of AD/ADRD.

This NOFO solicits R01 applications that will conduct rigorous proof-of-concept studies using mouse models of AD/ADRD or cell-based models (such as iPSCs and organodis), to prioritize and test drugs or drug combinations predicted to be efficacious in AD/ADRD treatment and/or prevention .

This initiative will also support preclinical testing of repurposable or investigational drug candidates in combination with non-pharmacologic interventions leading to robust translational outcomes.

Drugs to be tested could be FDA-approved drugs being currently used for other indications and investigational drugs that are at various stages of clinical development (for AD/ADRD or other conditions), including candidate drugs from failed Phase II/Phase III clinical trials, that have been predicted to be efficacious for the treatment and prevention of AD/ADRD.

Of particular interest is robust preclinical testing of prioritized drug candidates that have been identified through NIA’s ACTDRx AD program in response to funding initiatives PAR-17-032 and PAR-20-156 .

Additionally, o f specific interest are projects that leverage the network concept of drug targets to advance rational drug repurposing based on the ability of single or multiple therapeutic agents to perturb entire molecular networks away from disease states in animal models and/or cell-based models (e.g., iPSCs, organoids etc.) .

A cademic/industry partnerships are encouraged where industry partners provide failed Phase II/III compounds and biosamples from legacy trials to enable drug repositioning and combination therapy analyses. Additionally, applicants are strongly encouraged to partner with academic and/or industry researchers with prior experience in preclinical drug development for neurodegenerative diseases.

Applications in the following categories are particularly invited, although these do not exhaust the possible approaches to drug repositioning and combination therapy development for AD/ ADRD: Conducting preclinical studies to establish evidence of efficacy, synergy, toxicity, target engagement, mechanism of action, route of administration, dose range, schedule of administration for repurposed drug/drug combination in relevant mouse-model systems or cell-based model systems.

Testing individual drugs or drug combinations to evaluate efficacy and toxicity, including combining current disease treatment with a repurposed treatment or combining multiple repurposed therapies. Testing candidate drugs in blood brain barrier (BBB) permeability studies. Testing potential synergies and/or adverse events of individual drugs or drug combinations in relevant disease models.

Assessment of PK/PD properties through the generation of multi-omic molecular data (i.e., transcriptional, epigenomic, proteomic and metabolomic) that will enable systems-level analyses to determine mechanism of action of putative drugs/drug combinations; and provide evidence that the drugs modulate disease relevant pathways/networks in preclinical/ mouse models and / or cell-based models.

Development of quantitative, mechanistic methods that can assess the synergy or additivity of candidate therapeutics, including synergy between candidate drugs and non-pharmacological perturbations (i.e. exercise, diet, sleep, cognitive training).

Applications should propose a streamlined preclinical testing strategy with go/no-go decision points that allow critical and unbiased assessment of therapeutic agents leading to robust translational outcomes.

Projects should bring together relevant technologies and a multidisciplinary team of scientists with necessary expertise including in animal models of AD, network biology, disease biology, biostatistics, PK/PD modeling, pharmacology, and clinical research to design assays and develop tools and methods that enable prioritization and rigorous testing of candidate drugs.

All preclinical efficacy testing studies should be conducted and reported in compliance with NIH guidance on rigor and reproducibility . Particularly, the preclinical efficacy studies are expected to follow the general ARRIVE guidelines for animal research and the best practice guidelines for AD preclinical efficacy studies .

Applicants are strongly encouraged to use the mouse models of Late Onset Alzheimer's Disease (LOAD) developed and made available via NIA’s MODEL-AD Translational Centers. The list of available mouse models can be accessed via the AD Knowledge Portal and the Model-AD explorer . Applications to this NOFO should follow open-science, open-source principles and maximize the appropriate sharing of scientific data.

Studies should adhere to NIH guidelines for rigorous study design and transparent reporting to maximize the reproducibility and translatability of their findings. All data and analytical outputs will be shared rapidly and broadly via the NIA-supported AD Knowledge Portal .

Applicants must describe and justify any applicable factors or data use limitations related to concerns of intellectual property, patents, IND filing, licensing limits, or 3 rd party contracts that will affect access, distribution, or reuse of scientific data generated from the project. Exceptions to data sharing due to these claims will be considered on an individual basis.

Applicants are strongly encouraged to contact NIA Scientific/Research staff listed in Section VII: Agency Contacts early in the pre-submission process to ensure that their application is responsive to the programmatic goals of this NOFO.

Non-responsive Applications The following types of applications will be considered non-responsive to this NOFO and will be withdrawn prior to scientific peer review: Studies that propose only bioinformatics and computational approaches to discovery, prioritization or testing of drug candidates for repurposing and/or combination therapy development. Studies that propose research on basic mechanisms of disease.

Studies that propose development and testing of new therapeutic agents for AD. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. 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 The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NIA intends to commit $6 million in FY 2026 to fund 4 - 5 awards. Application budgets are capped at $1 million in direct costs per year.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 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 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 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 the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility 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 Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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 PD(s)/PI(s) should have demonstrated accomplishment in effectively leading multidisciplinary teams.

If the application is multi-PD/PI, investigators should have complementary and integrated expertise and skills in order to provide an appropriate leadership approach, governance, plans for conflict resolution, and organizational structure applicable to the study. The applicant(s) should have experience overseeing selection and management of sub awards, if needed.

Projects should bring together a multidisciplinary team of scientists with necessary expertise including in mouse models and/or cell-based models of AD, network biology, disease biology, biostatistics, PK/PD modeling, pharmacology, and clinical research to design assays and develop tools and methods that enable prioritization and rigorous testing of candidate drugs.

All instructions in the How to Apply- Application Guide must be followed. 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: Applications should propose a streamlined preclinical testing strategy with go/no-go decision points that allow critical and unbiased assessment of therapeutic agents leading to robust translational outcomes.

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.

In keeping with NIA’s strategic goal to enable and promote open science practices and to increase research rigor and reproducibility, recipients must make all resources (e.g. analytical methods and pipelines, network models, research tools, cell lines and animal models) developed through funded projects available to the broad scientific community via the NIA-supported AD Knowledge Portal , or through other NIH-designated repositories, and/or open-source/open-access platforms.

In keeping with the open science aspect of this funding initiative, the following will be expected from the recipients: All analytical methodologies, tools and pipelines, network models will be made fully reproducible and transparent so that results can be vetted and existing analysis techniques can be quickly applied to new application areas.

All models of biological systems and networks will be openly available to users such that theoretical predictions can be rapidly validated experimentally. All disease models (cell lines and animal models) generated during the project will be made freely available to qualified investigators to accelerate their characterization, validation, and translational utility.

All biological samples used to generate data with this award will be made available to all recipients of this initiative and to other qualified investigators. Award recipients will be expected to have all resources (e.g. analytical methods and pipelines, network models, research tools, cell lines and animal models) deposited in the AD Knowledge Portal and/or other NIH-designated repositories.

Awardees are expected to make all resources available after they have undergone quality control (no later than 6 months after resource generation). There will be no embargo imposed on the use of such resources after they have been made available through these repositories. Program staff may negotiate modifications to the plan prior to funding.

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.

In keeping with NIA’s strategic goal to enable and promote open science practices and Findable, Accessible, Interoperable, and Reusable (FAIR) data practices, and the NIA/NIH goal to enhance transparent reporting and increase research rigor and reproducibility, recipients must make all data available to the broad scientific community via the NIA-supported AD Knowledge Portal , or through other NIH-designated data repositories, and/or open-source/open-access platforms adopting the FAIR principles.

In keeping with the open science aspect of this funding initiative, all data sets used/generated on the project (such as data about phenotypes and high-dimensional omic data, including genomic, proteomic, and metabolomic data generated from cell-based and animal models) will be made accessible and reusable by qualified individuals other than the original data generators to enable multiple parallel approaches to data analysis and interpretation.

As part of a complete Data Management and Sharing plan, applications must provide a plan and timeline for data generation, reporting and deposition. Applicants should include appropriate support for annotation and curation of the molecular and phenotype data used and/or generated on the project to maximize the usability of the data by the broader research community. Program staff may negotiate modifications to the plan prior to funding.

All data and results generated from animal model studies, including both negative and positive findings, are expected to be incorporated in NIA's Alzheimer's Disease Preclinical Efficacy Database Portal (AlzPED) no later than 9 months after study completion or at the time of first manuscript publication, whichever comes first.

Published studies will be incorporated in AlzPED as a curated record; unpublished studies will be incorporated in AlzPED as a citable pre-print. Recipients will be expected to have all data and analytical results deposited in the AD Knowledge Portal and/or other NIH-designated data repositories after they have undergone basic quality control (within 3 months of data generation completion).

Data shared via the AD Knowledge Portal will be made broadly available twice a year and no later than 6 months after deposition. There will be no publication embargo imposed on the use of data after they have been made available through the AD Knowledge Portal or other data repositories. 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 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. 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. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

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

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. In order to expedite review, applicants are requested to notify the NIA Referral Office by email at [email protected] when the application has been submitted.

Please include the FON and title, PD/PI name, and title of the application.

Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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