Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required)

Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required) is sponsored by National Institute of Nursing Research (NINR). Provides funding for early-stage investigators conducting basic experimental studies involving human participants.

Expired PAR-25-323: Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies .

Contact the eRA Service Desk for any submission issues. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Office of The Director, National Institutes of Health ( OD ) National Eye Institute ( NEI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Nursing Research ( NINR ) National Library of Medicine ( NLM ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers. Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Stephen I.

Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity April 06, 2026 Implementation of Changes for Basic Experimental Studies with Humans. See Notice NOT-OD-26-067 . January 29, 2026 - Basic Experimental Studies With Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH.

See Notice NOT-OD-26-032 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) 93. 867, 93. 121, 93.

361, 93. 866, 93. 846, 93.

865, 93. 393, 93. 398, 93.

273, 93. 313, 93. 242, 93.

113, 93. 879, 93. 173 Funding Opportunity Purpose The Stephen I.

Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Notice of Funding Opportunity (NOFO) must not include preliminary data. Applications must include a separate attachment describing the change in research direction.

The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This Parent Notice of Funding Opportunity is for basic science experimental studies involving humans, referred to in NIH Grants Policy Statement Section 4. 1.

3. 1 as “prospective basic science studies involving human participants. ” These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research.

Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

Studies conducted with specific applications toward processes or products in mind should submit under the appropriate ‘Clinical Trials Required’ or ‘Clinical Trial Optional’ NOFO. Funding Opportunity Goal(s) The mission of NIH is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge.

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. New Date May 25, 2026 per issuance of NOT-OD-26-067 .

(Original Expiration Date: August 26, 2028) 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 purpose of the Stephen I.

Katz Early Stage Investigator Research Project Grant is to provide a new pathway for Early Stage Investigators (ESIs) who wish to propose research projects in a new direction for which preliminary data do not exist. Named in honor of the late National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Director, Stephen I. Katz, M.

D. , Ph. D.

, this notice of funding opportunity (NOFO) is open to a broad range of scientific research relevant to the mission of the participating NIH Institutes and Centers (ICs). Proposed projects must represent a change in research direction for the ESI and should be innovative and unique. A distinct feature for this NOFO is that applications must not include preliminary data.

PD/PI's who wish to propose research projects consistent with their past work or training and/or supported by preliminary data, should apply to the Parent R01 or other NOFOs allowing for preliminary data. More information and FAQs are available on the Katz award program website .

Created in 2020, the Katz award provides a unique opportunity for early-stage investigators to take their research in a completely new direction, thereby stimulating innovation and encouraging new approaches to solving problems. This NOFO is appropriate for ESIs who wish to initiate a research project in an area different from their previous research focus and/or training experience, and therefore have not produced preliminary data.

Proposed research projects can rely on the PD/PI’s prior work and expertise as its foundation, but must not be an incremental advancement, expansion, or extension of a previous research effort. The change in research direction could involve, for example, a new approach, methodology, technique, discipline, therapeutic target, and/or new paradigm, different from the ESI’s previous research efforts.

Importantly, the proposed direction must represent a change in research direction for the PD/PI. Because a change in research direction is heavily dependent upon the area of investigation, candidates are strongly encouraged to contact a program director to discuss their proposed project.

If the application proposes multiple Principal Investigators (MPIs), all PD/PIs must be ESIs and the proposed project must be a change in research direction for all MPIs. Please note that the application must describe how the proposed new research direction is different from the ESI’s past work in a separate attachment entitled “New Research Directions” (see Section IV, SF424(R&R) Other Project Information).

For this funding opportunity, applications including preliminary data will be considered noncompliant with the NOFO instructions and will be withdrawn. Preliminary data are defined as data not yet published. Existence of preliminary data is an indication that the proposed project has advanced beyond the scope defined by this program and makes the application unsuitable for this funding opportunity.

Publication in the proposed new research direction is an indication that the proposed work may not be in a new research direction for the ESI. The logical basis and premise for the proposed work should be supported by published data or data from preprints that may have a Digital Object Identifier (DOI).

These data must be labeled and cited adjacent to each occurrence within the application and must be presented unmodified from the original published format. Figures and tables containing data must include citation(s) within the legend. The data should be unambiguously identified as published through citation that, if available, includes the DOI (see Section IV.

2). Candidates are reminded that NIH instructions do not allow URLs or hyperlinks to websites or documents that contain data in any part of the application (see NOT-OD-20-174 ). Determinations of merit and feasibility will consider the conceptual framework, level of innovation, and potential to significantly advance our knowledge and understanding.

Candidates are encouraged to justify the conceptual and technical feasibility for the proposed work through previous experience, literature citations, compelling logic, and published data and publicly available databases. Examples of sources which can be used to demonstrate feasibility (non-inclusive) include PubMed; Bookshelf; Medline Plus; Open-I; TOXNET; ClinicalTrials. gov; BLAST; Nucleotide; Genome; SNP; Gene; Protein; and PubChem.

Since applications to this NOFO could involve higher risk, candidates are encouraged to clearly explain the significance of the proposed work, to allow the reviewers to determine whether the potential impact offsets a higher risk. Candidates should clearly explain why the new knowledge to be gained is beyond incremental.

Research grant applications are assigned to participating Institutes and Centers (ICs) based on receipt and referral guidelines and applications may be assigned to multiple participating ICs with related research interests.

Candidates are encouraged to identify a participating IC that supports their area of research via the Table of IC-Specific Information, Requirements, and Staff Contacts to inquire about their interest in supporting the proposed research project. All applications submitted to this Funding Opportunity must propose basic science experimental studies involving humans, otherwise referred to in NIH Grants Policy Statement Section 4. 1.

3. 1 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information as “prospective basic science studies involving human participants,” that fall within the NIH definition of a clinical trial and also meet the definition of basic research.

NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. ” ( 32 CFR 272. 3 ).

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." ( NOT-OD-15-015 ).

Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

For the purposes of this NOFO, “specific application towards processes or products” refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.

Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena may submit under this NOFO.

Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate NOFO for the type of study.

Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention's effects on clinical outcome), and safety and efficacy studies should submit under the a 'Clinical Trials Required' or Clinical Trial Optional’ NOFO, but not under this NOFO .

Observational studies involving humans should submit under the ‘Clinical Trial Not Allowed’ NOFO - "Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed)". Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this NOFO, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements, and Staff Contacts , to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.

For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website . 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. Required:Basic Experimental Studies with Humans: Only accepting applications that propose clinical trial(s) that also meet the definition of basic research. 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 - Includes all types 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) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations 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. PD/PIs must be designated Early Stage Investigators (ESI) by NIH as defined in NOT-OD-17-101 .

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 . Please note that for multiple PD/PIs applications, all PD/PIs must be ESIs and the proposed project must represent a change in direction for each PD/PI.

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, with the following additional instructions: Bibliography & References Cited: Preprints that do not have a DOI must not be listed.

Other Attachments: Candidates must describe how the proposed research would be a change in research direction from their prior research in an attachment entitled “New Research Direction” (without the quotes). This attachment is limited to one page. If MPIs are proposed, the attachment is limited to one page per PD/PI.

Applications omitting this attachment or exceeding the page limits will be considered incomplete or noncompliant with NOFO instructions and will be withdrawn without review.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Biographical Sketch: Describe the appropriate experience, training, and skill set that the PD/PI possesses to conduct innovative new research, challenge existing paradigms and take intellectual risks, or develop novel approaches when new opportunities arise.

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: Research Strategy: Address the following factors as they pertain to the research project proposed: Significance: Explain the importance of the problem or critical barrier to progress that the proposed project addresses.

Explain how a successful outcome has the potential to transform our understanding within this field of science. Innovation: State clearly and concisely what makes your project unique and innovative. A new direction for the PD/PI(s), in and of itself, is not necessarily innovative.

If you are testing an unconventional, exceptionally novel hypothesis, describe how it challenges the standard paradigm. If no paradigm exists, explain how will your project create one. Approach: Provide enough information so that reviewers can determine what you are proposing to do.

If your methodology is standard, state what is unconventional and innovative about your approach. Given that projects supported by preliminary data are not allowed for this NOFO, justify the feasibility of the conceptual framework, premise, logical approach, and/or justification for the proposed work. Describe how your approach differs from what other investigators have attempted to do.

If the approaches entail a higher risk, explain what you will do if these approaches are unsuccessful and how the potential benefits/rewards offset the risks. Provide a timeline for the proposed research that does not overlap with section 2. 7 Study Timeline submitted on the PHS Human Subjects and Clinical Trial Information form, as applicable.

Investigator(s): If you are including collaborators on the project for aspects of the project that are not within your expertise, describe their roles and how they will contribute to the success of the project. This information should not overlap with information in the biosketches.

Published data, including from preprints that have a Digital Object Identifier (DOI), must be labeled and cited adjacent to each occurrence within the application and must be presented unmodified from the original published format. Figures and tables containing data must include citation(s) within the legend. The data should be unambiguously identified as published through citation that includes the DOI.

References and data that do not have an associated DOI are not allowed in any section of the application. Prospective candidates are reminded that NIH instructions do not allow URLs or hyperlinks to websites or documents that contain data in any part of the application (see NOT-OD-20-174 ).

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. Section 1 - Basic Information 1.

4 Clinical Trial Questionnaire Applications to this NOFO must propose a study that falls within the NIH definition of a clinical trial and also meets the definition of basic research. Consequently, applicants must answer "yes" to the four questions on 1. 4 Clinical Trial Questionnaire and complete the subsequent form fields accordingly.

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, NIH. Applications that are incomplete or non-compliant 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