Interaction Between Environmental Factors and Lewy Body Dementia (R01 - Clinical Trial Not Allowed)

Interaction Between Environmental Factors and Lewy Body Dementia (R01 - Clinical Trial Not Allowed) is sponsored by National Institutes of Health (NIH). This initiative supports research establishing causal links between environmental factors and Lewy Body formation.

Expired PAR-24-249: Interaction Between Environmental Factors and Lewy Body Dementia (R01 - Clinical Trial Not Allowed) This notice has expired. 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 National Institute of Neurological Disorders and Funding Opportunity Title Interaction Between Environmental Factors and Lewy Body Dementia (R01 - Clinical Trial Not Allowed) R01 Research Project Grant 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 Many avenues of research are focused on improving our understanding of Lewy body dementia (LBD), including the disease's underlying biology and genetic risk factors.

Environmental risk factors are also considered but are understudied. This Notice of Funding Opportunity (NOFO) is to support research that establishes causal links between a range of environmental factors and Lewy body formation. These factors include exposures to environmental toxicants, light and noise, climate, and other external exposures.

This NOFO will support mechanistic, translational, and human subject studies to understand the relationship between environmental factors and LBD. It is expected that these studies will identify environmental risk factors related to the cause of LBD and its progression and their clinical relevance.

Ultimately, these studies on LBD should accelerate mechanism-focused research to identify relevant pathways with potential to lead towards better and novel therapeutic interventions and quality of life.

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.

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 Goal 1 of the National Plan to Address Alzheimer's Disease (AD) is to prevent and effectively treat AD and Alzheimer’s Disease Related Dementias (ADRD).

In the National Plan, ADRDs include Frontotemporal dementia (FTD), Vascular Contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementias (LBD) and Multiple Etiology Dementias (MED) based on similarities in clinical symptoms and brain pathologies between these and pathological AD and/or clinical AD.

Starting in 2012, the National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS) have held research summits to assess the needs and set AD/ADRD research implementation milestones. The NINDS ADRD Summit in 2022 resulted in ADRD research priorities for advancing the state-of-the-science toward meeting Goal 1 of the National Plan.

LBD is a complex brain disorder that affects more than one million Americans. Most people with LBD are older adults for whom the disorder leads to disabilities in thought and movement. The precise cause of LBD is unknown.

LBD can occur alone or along with Alzheimer's pathology or Parkinson's disease. The National Institute of Neurological Disorders and Stroke ( NINDS ) leads the NIH research programs in ADRD, including LBD. LBD is associated with abnormal deposits of a protein called alpha-synuclein in the brain.

These deposits, called Lewy bodies, affect brain cell function that, in turn, can lead to problems with thinking, movement, behavior, sleep and mood. There are two types of LBD, dementia with Lewy body disease (DLB) and Parkinson's disease with dementia (PDD). While having a family member with LBD may increase a person's risk, LBD is not normally considered a genetic disease.

At this time, no genetic test can accurately predict whether someone will develop LBD. However, some studies suggest that a healthy lifestyle, including regular exercise, mental stimulation, and a healthy diet, might reduce the chance of developing age-associated dementias.

Some researchers are looking at the disease's underlying biology and genetic risk factors, and it is thought that LBD can arise from the interaction of multiple genes and environmental factors. Environmental risk factors (ERFs) are understudied and there continues to be a need to identify the mechanistic basis for how this gene-environment interaction leads to the formation of Lewy bodies and LBD.

This NOFO focuses on the exogenous ERFs that influence LBD and is responsive to the ADRD Milestone titled “ Understanding LBD Genetic, Epigenetic, and Environmental Influences ”. Scientific Scope and Research Objectives: This NOFO will support research that firmly establishes the links between exogenous ERFs and Lewy body disease and formation.

Examples of exogenous ERFs responsive to this NOFO are the following: Air pollution: particulate matter, nitrogen oxides, sulfur dioxide, carbon monoxide, and volatile organic compounds Water and Soil Contamination : heavy metals, pathogens, pesticides, and industrial chemicals in drinking water Climate Change : extreme weather events, altered disease patterns, food and water shortages Exposure to Hazardous Chemicals : in everyday products, industrial processes, and waste sites that can pose health risks through exposure via air, water, food, and direct contact with contaminated surfaces Built Environment : Factors such as poor housing conditions, inadequate sanitation, urban sprawl, and lack of green spaces Studies will include discovery and verification of known exogenous ERFs that affect LBD.

Verification of these ERFs should include mechanistic studies on the plausibility that the risk factor(s) has an effect on LBD biology such as effects on Lewy bodies, alpha-synuclein, etc . Mechanistic, translational, and human subject studies on the relation between ERFs and LBD are all responsive to this NOFO.

In addition to mechanistic studies, the scope includes research based on clinical data, human samples, and human subjects, but it does not include NIH-defined clinical trials ( https://grants. nih. gov/policy/clinical-trials/definition.

htm ). We expect successful research proposals will draw expertise from neuroscientists that have deep expertise in basic, translational, and clinical research in LBD and scientists with expertise in exogenous ERFs that can influence the human body.

Applicants are encouraged to contact the Scientific/Research Contact listed on this NOFO to see if their chosen exogenous environmental risk factors are appropriate for this NOFO, or for any other questions about the above scientific scope, especially if human subject studies are planned. Key expectations and definitions for this NOFO: This NOFO will suppor t research on exogenous ERFs that have an effect on LBD.

This NOFO does not support research on endogenous factors (e.g., pre-existing conditions, metabolism, microbiome, xenobiotics) or behavioral factors (e.g., psychosocial effects, drug, alcohol, tobacco lifestyle, sleep, stress) unless they are associated with exogenous factors.

This NOFO will support studies on any exogenous ERFs that are implicated in LBD as evidenced by rigorous prior research based on peer-reviewed publications and/or original studies from the applicant, including preliminary data. Applicants are encouraged to use existing cohorts and databases when relevant data is available. Multi-exposure (more than one exogenous ERF) approaches are welcomed but not required.

This NOFO supports mechanistic studies with animal and other models on the mechanisms, pathways, and molecular targets of exogenous ERFs as long as there is evidence in humans that the exogenous ERFs being studied are associated with LBD and already supported by rigorous prior research based on peer-reviewed publications and/or original studies from the applicant, including preliminary data.

This NOFO supports research into areas that draw from multiple broad scientific disciplines, namely LBD and ERFs. Applicants are strongly encouraged to build integrated multidisciplinary teams who can bring their respective expertise to bear upon these areas of research. The expected outcomes of these studies include: Identification of exogenous ERFs that have an effect on LBD.

Mechanistic insight that would address the biological plausibility of these exogenous ERFs having clinical relevance to LBD. The categories of research supported under this program include but are not limited to: Epidemiological studies to identify exogenous ERF(s) associated with LBD in defined populations, e.g. cohort studies and case-control studies.

Environmental LBD risk factors studies for example with air pollution, heavy metals, pathogens, plastics, and pesticides. Preferably but not required studies with more than one of these ERFs. Occupational health studies to determine if the workplace is a risk factor for LBD and how exogenous ERFs play a role in LBD.

Ecological studies of LBD at the population level and disease patters across different regions. Mechanistic In Vivo studies with animals that validate exogenous ERFs could have an impact on LBD, including dose-response relationships and potential health outcomes. In vivo studies in animals that mimic known exogenous ERF(s) that impact LBD to define mechanisms of their effects.

Studies on how exogenous ERFs interact with genetic factors and how gene-environment interaction plays a role in LBD. Transcriptomic, metabolomic, proteomic comparisons between LBD and healthy age-matched controls living in areas where exogenous ERF(s) is more prevalent.

Leveraging other existing research resources Applications proposing to collect biospecimens are recommended to use existing NIH research resources for their studies whenever possible.

Such resources may include the NINDS BioSEND repository for banking of DNA, RNA, bioflu ids (blood, serum, plasma, CSF, urine, saliva) and other biospecimen s, or other cell and tissue repositories, such as the NINDS Human Cell and Data Repository (NHCDR) for banking of peripheral blood mononuclear cells (PBMC) and/or fibroblasts, induced pluripotent stem cell (iPSC) line derivation and genome editing.

Whenever possible, applicants should use consensus-based and/or standardized assessment approaches (e.g., the National Alzheimer’s Coordinating Center’s LBD module, the Parkinson’s Disease Biomarker Program’s LBD protocol , etc.). IMPORTANT: costs for biospecimen collection are not included as a component of the NINDS BioSEND repository award.

Therefore, most costs for the biospecimen banking are borne by the recipients utilizing this resource (see NOT-NS-15-046 ). Applicants planning projects in which biospecimens will be collected are strongly advised to consult with NINDS Biomarkers Repository staff to obtain a quote for biospecimen banking costs (email: [email protected] ).

Similarly, applicants should contact the NINDS Human Cell and Data Repository (NHCDR) for a quote to obtain support for collection of human source cells (fibroblasts, peripheral blood mononuclear cells, PBMC) and derivation of iPSC lines (email: [email protected] ). NINDS, as part of NIH, strives for rigor and transparency in all research it funds.

For this reason, NINDS explicitly emphasizes the NIH application instructions related to rigor and transparency ( https://grants. nih. gov/policy/reproducibility/guidance.

htm ) and provides additional guidance to the scientific community ( https://www. ninds. nih.

gov/funding/preparing-your-application/preparing-research-plan/rigorous-study-design-and-transparent-reporting ). For example, the biological rationale for the proposed experiments must be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner.

If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency. Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results.

Applications Not Responsive to this NOFO Studies not focused on one or more exogenous ERF(s) that affect LBD will not be considered responsive. Studies that do not include mechanistic research focused on discovering causal relationships between LBD and one or more exogenous ERF(s) will not be considered responsive. Studies including NIH-defined clinical trials will not be considered responsive.

Non-responsive applications will not be reviewed. 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 provides 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 NIH intends to commit a total budget of $3,750,000 per year to fund up to 5 awards, contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are limited to no more than $500,000 in direct costs per year and need to reflect the actual needs of the proposed project. 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 All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations 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 registration; 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.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, 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 . 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 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: 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. 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: Applicant must address the following within the Research Strategy: How the proposed project might result in at least one of the following: 1) identification of exogenous ERFs that have an effect on LBD; 2) providing mechanistic insight into the biological plausibility of these exogenous ERFs having clinical relevance to LBD; 3) identification of new therapeutic targets for treatment of LBD; 4) development of new interventional strategies based on the control of LBD-relevant exogenous ERFs.

If proposing research using animal or other model systems, applicants must justify this choice with rigorous evidence in humans that the exogenous ERFs being studied are associated with LBD. NINDS urges investigators to follow the NIH guidance for rigor and transparency in grant applications ( https://grants. nih.

gov/policy/reproducibility/guidance. htm ) and additionally recommends the research practices described at https://www. ninds.

nih. gov/funding/preparing-your-application/preparing-research-plan/rigorous-study-design-and-transparent-reporting . This will ensure that robust experiments are designed, potential experimenter biases are minimized, results and analyses are transparently reported, and results are interpreted carefully.

Proposed research practices must include, where applicable, expressing clear rationale for the chosen model(s) and primary/secondary endpoint(s), describing tools and parameters clearly, blinding, randomizing, ensuring adequate sample size, pre-specifying inclusion/exclusion criteria, appropriately handling missing data and outliers, implementing appropriate controls, preplanning analyses, and using appropriate quantitative techniques.

Applicants must indicate clearly the exploratory vs. confirmatory components of the study, consider study limitations, and plan for transparent reporting of all methods, analyses, and results so that other investigators can evaluate the quality of the work and potentially perform replications.

Investigators must indicate whether data presented or cited in the application as key support for the proposed work were collected, analyzed, and reported in a rigorous and transparent manner as indicated above. A plan to address any ambiguity, weaknesses, or limitations in the prior research must be included in the application. Proposed experiments should similarly adhere to these high standards of rigor and transparency.

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. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

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.

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 Program Officers at NINDS. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4.

1. 35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] .

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Any instructions provided here are in addition to the instructions in the policy. Section V. Application Review Information 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.

For this particular announcement, note the following: 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.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project