The Trailblazer Award for New and Early Stage Investigators (R21) is a grant from the National Institutes of Health, administered by the National Institute of Biomedical Imaging and Bioengineering and partner ICs, that funds exploratory biomedical and bioengineering research led by new and early-stage investigators.

The program encourages unconventional, high-risk and high-reward approaches in imaging, bioengineering, and health informatics. Eligible applicants must be new or early-stage investigators who have not previously served as principal investigator of an NIH R01 or equivalent award. Clinical trials are permitted under this mechanism.

PA-25-169: Trailblazer Award for New and Early Stage Investigators (R21 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 ) National Eye Institute ( NEI ) Funding Opportunity Title Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional) R21 Exploratory/Developmental Research Grant Notices of Special Interest associated with this funding opportunity June 16, 2025 - Notice of Change to PA-25-169, "Trailblazer Award for New and Early-Stage Investigators (R21 Clinical Trial Optional)".

See Notice NOT-EB-25-007 . March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

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

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

Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Trailblazer Award is an opportunity for NIH-defined New and Early Stage Investigators ( https://grants. nih. gov/policy/early-investigators/index.

htm ) to pursue research programs that integrate engineering and the physical sciences with the life and/or biomedical sciences. A Trailblazer project may be exploratory, developmental, proof of concept, or high risk-high impact, and may be technology design-directed, discovery-driven, or hypothesis-driven. Importantly, applicants must propose research approaches for which there are minimal or no preliminary data.

A distinct feature for this NOFO is that no preliminary data are required, expected, or encouraged. However, if available, minimal preliminary data are allowed. Preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal.

All preliminary data should be clearly marked and limited to one-half page, which may include one figure. Applications including data more than one-half page or more than one figure will be considered noncompliant with the NOFO instructions and will not go forward to review. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Dates in bold and italics reflect changes per NOT-EB-25-007 . Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed February 16, 2026 March 16, 2026 May 07, 2026 July 2026 October 2026 December 2026 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 08, 2026 per NOT-EB-25-007 (Prior Date January 08, 2026).

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 rapid evolution and vitality of the biomedical sciences benefit from the contributions and creativity of investigators in the early stages of their careers, and a continuous infusion of new ideas, techniques, and perspectives from other fields.

This Trailblazer Award is an opportunity for New and Early Stage Investigators to pursue research programs at the interface of engineering and/or the physical sciences with the biomedical sciences. Applicants are encouraged to contact the appropriate NIBIB Program Director assigned to their specific scientific program area ( https://www. nibib.

nih. gov/research-funding ) to discuss the appropriateness of the project before submission. This Notice of Funding Opportunity (NOFO) employs an R21 Exploratory/Developmental Research Grant mechanism enhanced to provide $400,000 in direct costs over three years, allowing expanded time and resources to pursue a new or emerging research program.

All applicants to this NOFO must meet the NIH definition of New or Early Stage Investigator ( https://grants. nih. gov/policy/new_investigators/index.

htm ). The application of principles and techniques from engineering and the quantitative sciences, such as physics, mathematics, chemistry, and computer sciences, is providing innovative technologies and novel methods to accelerate the pace of biomedical research, producing new understanding of disease mechanisms and translating these new discoveries to improve human health.

The Trailblazer Award seeks to catalyze the development of transdisciplinary research approaches with the potential to open new areas of biomedical investigation. A Trailblazer project may be exploratory, developmental, proof of concept or have high risk-high impact goals. Importantly, the proposed research for this NOFO may be technology design-directed and may or may not be hypothesis-driven.

In the context of this NOFO, innovation encompasses approaches to address well-defined, unmet biomedical research needs through the development of new methods, ideas, or technologies; early steps along the path toward delivery of a new capability or method; and the integration of existing components in a previously unproven format.

High-impact projects should transform our understanding or practice by applying an innovative approach to an important biomedical challenge. For projects supported by a Trailblazer Award, successful results should provide a solid foundation for further research under other funding mechanisms, such as the R01.

Applicants will be considered ineligible for this funding opportunity if they have submitted an R01, R15 or any other R21 application, with a participating IC as the primary IC within the same review cycle. An awardee may not hold concurrent Trailblazer awards.

Trailblazer approaches are expected to differ substantially from current thinking or practice, therefore, extensive preliminary data demonstrating feasibility is an indication that the project is beyond the scope of this NOFO. Reviewers’ determinations of merit will rely instead on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge, understanding or practice.

Applicants can provide appropriate justification for the proposed work through literature citations, data from other publicly available sources, or analytical and computational models. The proposed research will likely involve considerable risk that the work may not be successful, so applicants should clearly explain the significance of the work to allow the reviewers to determine whether the potential impact justifies these risks.

Preliminary Data: Trailblazer applications are meant to be exploratory, novel, and non-incremental. We encourage the submission of high-risk, high-reward projects. A distinct feature for this FOA is that no preliminary data are required, expected, or encouraged.

However, if available, some minimal preliminary data is allowed. Preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal. Such evidence, if provided, should not represent work involving the aims of the Trailblazer application.

All preliminary data must be clearly marked and limited to one-half page, which may include one figure. Applications including data more than one-half page or more than one figure will be considered noncompliant with the NOFO instructions and not go forward to review. Figures containing published data must include citations within the figure legend.

Published data that is included in the research plan, biographical sketch or elsewhere in the application must be cited adjacent to each occurrence. Data that is published must be unambiguously identified as such within the application. References and data from widely available preprints that have a Digital Object Identifier (DOI) are considered published.

Clinical Trials: For applications submitted that propose clinical trials, this NOFO will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application.

This NOFO will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Applicants are strongly encouraged to contact the Scientific/Research contact for this NOFO for guidance in advance of submitting an application to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies ( https://grants. nih. gov/policy/clinical-trials.

htm) and consistent with the types of clinical trial projects that each IC supports. Not all research endeavors will be suitable for this NOFO. Projects from New and Early Stage Investigators that are supported by extensive preliminary data should be submitted to the Parent R01 Clinical Trial Not Allowed FOA ( https://grants.

nih. gov/grants/guide/pa-files/pa-20-185. html ) or the Parent R01 Clinical Trial Required FOA ( https://grants.

nih. gov/grants/guide/pa-files/pa-20-183. html ) or Stephen I.

Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed) ( https://grants. nih. gov/grants/guide/pa-files/PAR-21-038.

html ). Established investigators proposing exploratory and developmental projects should consider the Parent R21 Clinical Trial Not Allowed FOA ( https://grants. nih.

gov/grants/guide/pa-files/PA-20-195. html ) or the Parent R21 Clinical Trial Required FOA ( https://grants. nih.

gov/grants/guide/pa-files/PA-20-194. html ). Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields should be submitted to the Parent R03 FOA ( https://grants.

nih. gov/grants/guide/pa-files/PA-20-200. html ).

Projects that propose incremental improvements in well-established areas of investigation are not appropriate for this NOFO. Specific Research Objectives and Scope Each institute has specific areas of research interest.

National Institute of Biomedical Imaging and Bioengineering (NIBIB) NIBIB interests include the development and integration of advanced engineering, imaging, and computational technologies with life sciences for the improvement of human health and medical care.

An application is not within the NIBIB mission and will be withdrawn from consideration if its principal focus is development of technologies whose goal is to understand basic biological function or mechanisms. Additionally, NIBIB only supports projects whose technology would ultimately be applicable to a broad spectrum of disorders and diseases rather than being limited to only a single tissue, organ, or physiological condition.

However, applicants may propose research that utilizes only a single tissue, organ or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable emerging technology. An application is not within the NIBIB mission and will be withdrawn from consideration if the proposed technology or approach has limited application to a single disease, organ, or physiological condition .

For this Funding Opportunity Announcement, if an application proposes a clinical trial, 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 (see NIBIB's program areas ) 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. Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies ( https://grants. nih.

gov/policy/clinical-trials. htm ) and consistent with the types of clinical trial applications that NIBIB supports. National Eye Institute (NEI) NEI leads the federal government in conducting and supporting research in vision research.

The mission of the National Eye Institute (NEI) is to eliminate vision loss and improve quality of life through vision research. The NEI has framed its current strategic plan around this mission which addresses multiple opportunities as challenges in the vision field.

NEI will support applications that address or seek fundamental knowledge related to vision sciences, including, but not limited to: cellular and molecular neuroscience, imaging, genetics, development, basic/translational research on vision including how the visual system works from the eyes to the brain in health and disease.

The overarching goal is to reduce visual impairment and blindness and thus resulting in an improvement in the quality of life for people of all ages. In all these areas and related areas of vision sciences research, NEI encourages an emphasis on understanding and addressing health disparities that are experienced by underserved populations. For this funding opportunity, only the following trials will be supported by NEI.

Mechanistic trials defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., HOW an intervention works, but not IF it works or is safe).

Clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions will not be supported under this NOFO. Please refer to https://www. nei.

nih. gov/grants-and-training/funding-opportunities to find the appropriate NIH or NEI-specific NOFO for such clinical trials. Applications considered for funding by the NEI must fall within the areas of emphasis detailed in the NEI Strategic Plan.

( NEI Strategic Plan: Vision for the Future (PDF 22. 5 MB) To determine if your research fits within the NIBIB mission, please contact the appropriate Program Director in your scientific program area of interest ( https://www. nibib.

nih. gov/research-funding ). National Institute on Aging (NIA) NIA leads the federal government in conducting and supporting research on aging and the health and well-being of older people.

To fulfill its mission , NIA supports technologies which aim to increase the research community's understanding of the aging process, as well as diseases, conditions, and needs associated with growing older, in order to extend the healthy, active years of life.

Studies of interest to NIA include, but are not limited to, the following: Technology development for imaging modalities and visualization tools as applied to aging Applications of artificial intelligence, machine learning, or health monitoring technologies to the study of aging biology or age related diseases Bioinformatic, statistical, and computational approaches in aging biology research Novel sensors and biomarkers for monitoring age-related changes and diseases Less invasive and more ubiquitous ways of collecting biological and diagnostic data Other emerging technologies that may benefit aging research and reflect new directions, such as new imaging technologies or novel biophysical approaches Tissues-, organs- and organ systems-on-a-chip technologies Imaging of any of the pillars or hallmarks of aging which include protein homeostasis, nuclear and DNA integrity, metabolism and mitochondrial quality control, cellular senescence, autophagy and cell death, and other hallmarks as described in the literature See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. 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 may not exceed $400,000 direct costs over a maximum three-year funding period. No more than $200,000 direct costs may be requested in any single year. The scope of the proposed project should determine the project period.

The maximum project period is 3 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) 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 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 FOA targets New and Early Stage Investigators integrating engineering and physical sciences with the biomedical sciences.

Eligible individuals must be a) NIH-defined Early Stage Investigators; or b) NIH-defined New Investigators ( https://grants. nih. gov/policy/early-investigators/index.

htm ). For applications with multiple PDs/PIs, all PDs/PIs must be eligible to apply for this award. 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 ). Applicants will be considered ineligible for this funding opportunity if they have submitted an R01, R15 or any other R21 application, with a participating IC as the primary IC within the same review cycle Applicants may not hold concurrent Trailblazer awards. 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: Research Strategy: Trailblazer R21 applications only allow minimal preliminary data.

Consequently, determinations of merit and feasibility will rely instead on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.

Applicants are encouraged to provide justification for the proposed work through literature citations, data from other publicly available sources, analytical and computational models, or when available, from a limited amount of investigator-generated data.

Since Trailblazer grant applications could involve considerable risk that the proposed work may not be successful, applicants are encouraged to clearly explain the significance of the proposed work, to allow the reviewers to determine whether the potential impact outweighs these risks. Trailblazer applications are meant to be exploratory, novel, and non-incremental. We encourage the submission of high-risk, high-reward projects.

Applications for Trailblazer R21 awards should describe projects distinct from those supported through the traditional R01 mechanism, which are generally longer-term systematic investigations supported by extensive preliminary data. Projects should have well-defined goals with the potential for future development.

Applicants should explain how success in this project could lead to further development under other funding mechanisms, such as the R01. Preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal. Such evidence, if provided, should not represent work involving the aims of the Trailblazer application.

All preliminary data must be clearly marked and limited to one-half page, which may include one figure. Applications including data more than one-half page or more than one figure will be considered noncompliant with the FOA instructions and not go forward to review. Figures containing published data must include citations within the figure legend.

Published data that is included in the research plan, biographical sketch or elsewhere in the application must be cited adjacent to each occurrence. Data that is published must be unambiguously identified as such within the application. References and data from widely available preprints that have a Digital Object Identifier (DOI) are considered published.

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.

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