New Approaches for Measuring Brain Changes Across Longer Timespans (R21 Clinical Trial Optional) is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). This NIH funding opportunity (PAR-25-279), supported by NIBIB, NICHD, and NCI, invites development of novel methods to measure brain activity, connectivity, genomics, and other neurodevelopmental parameters across the full age spectrum.

PAR-25-279: New Approaches for Measuring Brain Changes Across Longer Timespans (R01 Clinical Trial Optional) 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 National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Cancer Institute ( NCI ) Funding Opportunity Title New Approaches for Measuring Brain Changes Across Longer Timespans (R01 Clinical Trial Optional) 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 Exploratory/Developmental Grants See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 866, 93.

286, 93. 865, 93. 396 Funding Opportunity Purpose The purpose of this funding opportunity is to encourage multidisciplinary investigators to develop new approaches or apply existing approaches in novel ways to measure brain activity, connectivity, genomics, or other aspects across the age spectrum of neurodevelopment.

The overarching goal is to extend our understanding of brain development and aging, including studies of the neurodevelopmental origins of later health and disease. Research can include healthy human participants of any age; specific clinical groups such as those with cognitive, motor, or affective regulation challenges; and/or animal research on these domains of function.

The studies can focus on longitudinal neuroanatomical or functional changes at any level, including genetics/genomics, single cells, connectomics, neural population activity patterns, and others. This funding opportunity is intended to encourage technological and conceptual innovation to improve repeated measures across longer epochs of the lifespan, to better predict outcomes at later ages.

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) The following table includes NIH standard due dates marked with an asterisk.

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 The brain is a highly dynamic and consequential organ that undergoes dramatic shifts in cellular composition, connectivity, and activity patterns across the lifespan.

A key factor limiting our understanding of these changes, particularly over longer time periods, is the paucity of methods to study longer-term trajectories. Better approaches are needed to link nervous system structure and function, as well as genetic and environmental influences, across time periods and levels of temporal and spatial resolution.

This notice of funding opportunity (NOFO) encourages multidisciplinary collaborations to develop novel approaches or improve existing ones for longitudinal or cross-sectional brain measures across the lifespan.

The ultimate goal of this funding opportunity is to improve our understanding of how each stage in brain development, starting from prenatal origins, leads to the next one, and how the parameters that are set at each stage predict later brain health or disease.

Furthermore, this NOFO encourages the application of novel brain measures or tools to hypotheses regarding specific functional or anatomical trajectories across longer stretches of time during development, adulthood, or older age. The goal is to better understand the predictive value of specific genomic, connectomic, neurotransmitter, circuit-level, or other phenotypes for future brain function.

Causal interventions are encouraged, especially in experimental models, to avoid projects that are completely correlational. Applications are encouraged to address both purposes: (1) to expand the technological capacity to track or harmonize data across longer timespans, and (2) to demonstrate the relevance of this technical advance by testing a scientific hypothesis.

Expanding the technological capability for longer timespans can occur via hardware, software, or other experimental advances. Including at least one developmental or advanced age timepoint is encouraged to begin to establish a trajectory, whether in humans or animals.

The research objective of this NOFO is to develop hardware, software, biological, or other tools, or to adapt and apply existing approaches in novel ways, such that they can track functional or anatomical changes for longer stretches across the lifespan, and to then carry out a scientific demonstration project of the new technology.

Applications should include a novel technical advance that allows integrating neuroanatomical, single-cell, genomic, neural activity, or other brain-relevant data from the same individual across longer timespans than heretofore possible. Projects may include human subjects or animals.

Parallel work in animals and humans is encouraged to test the translatability of the technical advance, and strong justification would be required for any use of non-mammalian species.

Examples of research topics include, but are not limited to: Technological or analytic methods to track growing brain regions or to measure changes in structure or function Software/computational tools to harmonize repeated measurements from the same individual across the lifespan Modifications to magnetoencephalogram (MEG), electroencephalogram (EEG), magnetic resonance imaging (MRI), or other neuroimaging modalities to enable more accurate longitudinal studies across the lifespan, especially in hard-to-image populations such as those with autism, motor or sensory disorders, or others for whom current imaging technologies may be logistically challenging Tools for tracking different cell types, excitatory-inhibitory balance, or neurotransmitter systems across life stages in mammals, especially primates Computational analytic techniques to track developmental changes in information processing capabilities such as via local field potential (LFP) synchrony in specific frequency bands Tools for linking molecularly defined cell types to brain connectivity from early timepoints to older age Methods to assess the role of specific cell populations in driving neoteny in some mammalian brain regions, and the role this may play in human brain disorders Constructing and testing computational models to predict how earlier developmental parameters in cell fate specification, migration, myelination, neurotransmitter release, or neural activity patterns lead to later cognitive, affective, or social outcomes All projects must include a methods development aim and a hypothesis testing aim.

Applications are required to include at least two timepoints in each participant or animal.

Applications proposing the following will be considered non-responsive and will not be reviewed: Studies without in vivo measurements Studies that do not include a methods development aim and a hypothesis testing aim Studies without two timepoints Studies using invertebrate animal models Projects that do not include a scientific project to demonstrate how the methodology expands brain measurement capacity across the lifespan Applications that do not include annual milestones Institute-specific Areas of Interest Applicants are encouraged to discuss applications with the I/C contact listed in Section VII.

Agency Contacts. National Institute on Aging (NIA): NIA is interested in the development of novel approaches and/or innovative expansion of existing approaches to measure brain changes across longer timespans that more closely recapitulate the aging brain and diseases of brain aging.

While applications should be primarily focused on development of the approach, the circuits and brain regions of interest should be relevant to either those declining during brain aging or those resilient to the effects of brain aging. NIA is interested in all examples of approaches listed under the Research Objectives that would promote understanding of the aging brain and diseases of brain aging, particularly Alzheimer’s disease.

The scientific question should include at least one advanced age timepoint to establish a trajectory for the brain measures assessed. Although applications can include disease-relevant perturbations for model validation and testing assay utility, the focus should be on developing or improving the technology around the approach. Resources for Applicants: OutreachPro.

OutreachPro is an online recruitment materials generator that enables grantees to develop customizable and culturally appropriate materials in multiple languages to raise awareness of, and interest in, AD/ADRD clinical trials. Grantees and research teams are encouraged but not required to use this free online resource to enhance their recruitment and retention plans and related activities for their NIA-funded clinical studies.

CROMS: NIA utilizes a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects.

NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant and as described in NOT-AG-23-017 .

Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4. 1. 15.

7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website . When applicable, all NIA grantees must ensure: The study’s Informed Consent Document (ICD) lists “The National Institutes of Health (NIH) and its authorized representatives” as one of the organizations that may look at or receive copies of information in participants’ study records.

According to DHS HHS OHRP 45 CFR 46 46. 116 , all ICDs must contain “A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. ” If using the NIA informed consent template please see Section 6: Statement of Confidentiality.

An assigned NIH ClinicalTrials. gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.

gov. National Institute of Biomedical Imaging and Bioengineering (NIBIB): The mission of NIBIB is to transform through engineering the understanding of disease and its prevention, detection, diagnosis, and treatment.

Under this NOFO, NIBIB will support applications that propose to develop advanced biomedical imaging, bioengineering, sensing, and computational technologies to objectively measure neuroanatomical or functional changes across the lifespan. For applications proposing clinical trials, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005, “NIBIB Guidance for Support of Clinical Trial Applications."

Briefly, NIBIB will only support mission-focused early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early-stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): National Cancer Institute (NCI): NCI supports cancer health disparity research focused on basic, hypothesis-driven studies that explicitly address the unequal burden of cancer among racial/ethnic minorities or other underserved populations across the cancer continuum (prevention, early detection, diagnosis, treatment, and survivorship).

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. 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. Optional: Accepting applications that either propose or do not propose clinical trial(s). 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. 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. 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: NIA urges investigators to follow the NIH guidance for rigor and transparency in grant applications ( https://grants. nih.

gov/policy/reproducibility/guidance. htm ). This will ensure that robust experiments are designed, potential experimenter biases are minimized, results and analyses are transparently reported, and results are interpreted carefully.

These recommended research practices 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.

It is also strongly recommended to 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 should 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 should be included in the application. Proposed experiments should similarly adhere to these high standards of rigor and transparency.

For clinical trials, applicants must describe the rigor, robustness, and transparency of supporting data that are being used to justify the proposed trial and address any gaps identified. For all clinical trials, the rationale for the trial design, population(s) and hypotheses being tested, and control groups must be described. Potential biases and/or challenges in the study design and protocol should be identified and addressed.

For Basic Experimental Studies involving Humans (BESH), the application should describe and address how the expected effect size relates to biologically meaningful differences. Applications must include a methods development aim and a hypothesis testing aim, and applications are required to include at least two timepoints in each participant or animal.

The goal is to improve brain measures across longer time periods in the same subject beyond what is currently possible. Statistical Analysis Plan (SAP): Applicants should provide a SAP for analyses specified in the study protocol.

In addition to items requested under Section 4 - Protocol Synopsis of the PHS Human Subjects and Clinical Trials Information form, include the rationale for how missing data will be handled; plans for interim analyses for safety, efficacy, and futility; rationale for recalculation of the sample size midway through the trial (if applicable); and other measures to ensure rigor and transparency of the analysis.

Sufficient details should be provided in the SAP about any computer simulations used to investigate the operating characteristics of complex clinical trial designs (such as adaptive designs); to choose between alternative outcome measures; or to determine sample size, accounting for the impact of noncompliance, missing data, subject eligibility criteria, etc. It is particularly important to discuss the range of conditions that were considered in the simulation and why this range was considered appropriate, how robust the findings were across the range of conditions considered, and how the study will adjust for any design deficiencies (e.g., bias, loss of power) the simulations revealed.

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 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.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH.

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

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.

Applications Involving the NIH Intramural Research Program The requests by NIH intramural scientists will be limited to the incremental costs required for participation.

As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).

These costs may include salary for staff to be specifically hired under a temporary appointment