NHLBI Emerging Investigator Award (EIA) (R35 Clinical Trial Optional)

NHLBI Emerging Investigator Award (EIA) (R35 Clinical Trial Optional) is sponsored by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health. This award promotes scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PDs/PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards and whose outstanding reco…

RFA-HL-26-003: NHLBI Emerging Investigator Award (EIA) (R35 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 Heart, Lung, and Blood Institute ( NHLBI ) Funding Opportunity Title NHLBI Emerging Investigator Award (EIA) (R35 Clinical Trial Optional) R35 Outstanding Investigator Award April 06, 2026 - Implementation of Changes for Basic Experimental Studies with Humans. See Notice NOT-OD-26-067 .

January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs. See Notice NOT-OD-26-029 . 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 04, 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 Outstanding Investigator Award See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93. 837, 93. 233, 93.

839, 93. 840, 93.

838 Funding Opportunity Purpose The purpose of the NHLBI Emerging Investigator Award (EIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PDs/PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards (of which one must be an NHLBI-funded NIH Early Stage Investigator (ESI) award) and whose outstanding record of research demonstrate their ability to make major contributions to the heart, lung, blood and sleep (HLBS) research.

The EIA is intended to support an investigator's research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding on individual grant awards. The EIA will support the research program of NHLBI-funded investigators for up to seven years and will provide increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions.

It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer time frame. Research supported by the EIA must be within the scope of the NHLBI mission .

It is anticipated that the EIA will: Provide a stable funding environment, thereby improving productivity and facilitating ambitious and creative research; Accelerate scientific innovation by enabling flexibility in pursuing new research directions as they arise, since PD/PIs will not be bound to specific aims proposed in advance of the studies; Reduce the time researchers spend writing grant applications and managing multiple grant awards, thereby allowing more time to be devoted to conducting research; Facilitate the commitment of the PDs/PIs to research through increased stability of funding; and Enable PDs/PIs to devote more time and energy to mentoring students and junior scientists and providing scientific service.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced.

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

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 NHLBI Emerging Investigator Award (EIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PDs/PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards, of which one must be an NHLBI-funded NIH Early Stage Investigator R01 award, and whose outstanding record of research demonstrate their ability to make major contributions to the heart, lung, blood and sleep (HLBS) research.

The EIA is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding. The EIA will support the research program of NHLBI-funded investigators for up to seven years and will provide increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions.

It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer time frame. Research supported by the EIA must be within the scope of the NHLBI mission . Applicants are strongly encouraged to review the NHLBI R35 Program Frequently Asked Questions (FAQs) and consult with the appropriate scientific research contacts.

This Notice of Funding Opportunity (NOFO) is intended for investigators who have the potential to conduct outstanding, innovative research. For this reason, eligibility is limited. Please refer to Section III.

Eligibility Information for specific details.

It is anticipated that the NHLBI EIA will: Provide a stable funding environment, thereby improving productivity and facilitating ambitious and creative research; Accelerate scientific innovation by enabling flexibility in pursuing new research directions as they arise, since PDs/PIs will not be bound to specific aims proposed in advance of the studies; Reduce the time researchers spend writing grant applications and managing multiple grant awards, thereby allowing more time to be devoted to conducting research; Facilitate the commitment of the PDs/PIs to research through increased stability of funding; and Enable PDs/PIs to devote more time and energy to mentoring junior scientists and providing scientific service.

An EIA is intended to be the primary, and in most cases, sole support for all the NHLBI-related research conducted by an investigator. Research supported through the EIA must be related to HLBS research areas as described within the scope of the NHLBI mission . Within these bounds, investigators will have the freedom to explore new avenues of inquiry that arise during the course of their research.

Work involving the addition of human subjects, vertebrate animals, stem cells, select agents, or a new foreign component requires prior approval of NHLBI according to existing policies and procedures. It is expected that the EIA will replace current NHLBI funding on other NHLBI individual research grants, as described below. Research involving human subjects is permitted under this NOFO.

Specifically, mechanistic trials are permitted. NIH defines a mechanistic study as a study “designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention".

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 or of observable facts without specific applications towards processes or products in mind". However, Phase I, II, III, and T4 non-mechanistic clinical trials are not permitted under this NOFO.

The funding levels of an EIA will be determined by NHLBI, based on the recommendations of the Scientific Peer Review Committee, the National Heart, Lung, and Blood Advisory Council (NHLBAC), evaluation of the needs, expected productivity, current funding levels, and availability of funds. NHLBI will continue to implement NOT-OD-12-140 , "Notice of NIH Special Council Review of Research Applications from PDs/PIs with More than $1.

0 Million Direct Costs in Annual NIH Support" in considering all sources of investigator support.

Investigators should consider the following features of the EIA award when deciding to apply: EIAs will be for up to seven years; Existing Research Project grants will be relinquished; The EIA is not tied to predefined scope or specific aims and thus provides flexibility to pursue new ideas and new research directions as the scientific opportunities arise; and A reduction in administrative burden associated with writing multiple grant applications and managing multiple grant awards.

PDs/PIs can submit R01 application(s) and an EIA application in parallel. Should both R01 and EIA applications be selected for funding, the PD/PI will be permitted to accept either the EIA or the R01 award, but not both. The EIA is intended to provide the primary, and most likely sole source of NHLBI funding on individual grant awards.

The EIA does not eliminate the eligibility of the PD/PI for the following separate sources of NHLBI funding: Grants supporting research resources (e.g., P30, R24, or U24 awards) Grants supporting training (K01, K08, K12, K22, K23, K25, K99, R25, T32, T35) Grants supporting workforce development Clinical trials that are not permitted under this NOFO (see above for allowable clinical trials) NHLBI program project or center grants NHLBI Catalyze Program Grants The NHLBI will not consider funding future individual PD/PI research grants from an EIA recipient during the EIA except when the existing EIA is within the last few months of the project period or in No Cost Extension (NCE).

Alternatively, a recipient may receive R01 funding at any point during the EIA period if the EIA is bilaterally terminated. Note that in this scenario, the PI cannot receive both R01 and EIA funding in the same Fiscal Year unless the R01 is reduced by the amount expended on EIA. For more information regarding R01 submission during recipient's 6th year to prevent a lapse of funding at the conclusion of the R35 award, please see FAQs .

Applications Not Responsive to this NOFO : The following types of projects are not responsive to this NOFO and will not proceed to review: Research outside the scope of the NHLBI mission ; and Research that includes Phase I, II, III, or T4 non-mechanistic clinical trials (see NOT-OD-15-015 for the NIH definition of a clinical trial and NOT-HL-18-611 for NHLBI's Policy Regarding Submission of Clinical Trial Applications) Please see https://www.

nhlbi. nih. gov/grants-and-training/funding-opportunities-and-contacts for a list of all available NOFOs in which NHLBI participates, including those that support clinical trials.

Applications missing Letters of Support will be considered not responsive and will not proceed to review. 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. The NHLBI intends to commit up to $20 million per year in total costs for new awards in Fiscal Years 2026, 2027, and 2028, across this NOFO and the companion NOFO listed ( RFA-HL-23-002 ).

The NHLBI intends to fund up to 20 new R35 awards per year in Fiscal Years 2026, 2027, and 2028. Applications may request up to $700,000 direct costs per year. Investigators are encouraged to request what is well-justified for their research program.

The award amount will be determined by the NHLBI and commensurate with current NHLBI support of the PD/PI. Applications may request a maximum project period of up to seven (7) 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications for additional information System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.

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

gov 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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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 (PD/PI) is invited to work with their organization to develop an application for support. Only single PD/PI applications are allowed. Applications with multiple PDs/PIs will not be accepted.

Applications that do not meet eligibility requirements will not be reviewed. Eligibility is determined by NHLBI after the receipt of applications on the intended application due date. Eligibility to apply to this NOFO is limited to PDs/PIs who meet all of the following criteria: Are currently PD/PI on at least two NHLBI R01-equivalent (defined here as R01, DP1, or DP2) awards.

At least one of the R01-equivalent awards must meet all the following requirements : Be a single-PD/PI award, AND Not be in a no-cost extension (NCE), AND Not be an NIH-defined clinical trial, unless that clinical trial meets the definition of a mechanistic clinical trial as defined in Section I of this NOFO. The additional qualifying R01-equivalent(s) can be multiple-PD/PI, and/or in a first NCE, and/or an NIH-defined clinical trial.

One of the awards must be an NHLBI-funded NIH Early Stage Investigator (ESI) R01. The PD/PI must commit a minimum of six person months (i.e., the equivalent of 50% effort on a full-year appointment, 66. 67% on a 9-month appointment, or 100% on a 6-month appointment) throughout the duration of the EIA.

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement 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 ). It is anticipated that the EIA will be highly competitive.

To prevent a lapse in funding, a PD/PI can submit an R01 application and an EIA application in parallel. Should both R01 and EIA applications be selected for funding, the PD/PI will be permitted to accept either the EIA or the R01 award but not both. Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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. Biographical Sketch : The NHLBI EIA is intended for investigators with track records of creativity, consistent productivity, and significant scientific impact.

The PD/PI must, in the Biographical Sketch, address these considerations and demonstrate a history of conducting rigorous and reproducible research and reporting it in a transparent fashion. In addition, the PD/PI must demonstrate their suitability for funding through the NHLBI EIA, including flexibility and adaptability to new research opportunities.

Explicitly address intellectual and technical contributions to any publications with former mentors and highlight contributions since becoming an independent investigator. Include experience as a mentor of undergraduate and graduate students, postdoctoral or clinical fellows, medical students or junior faculty.

Current & Pending Support : Use the SF424 R&R Current and Pending Support instructions and attach this information to the Senior/Key Personnel Form. List NHLBI grants first, followed by other NIH grants, followed by other sources of support.

Provide a list of all current and pending support for the PD/PI (even if they receive no salary support from the project(s)) for ongoing projects and pending applications, regardless of source of support (e.g., Federal, private, non-profit). Show the total award amount for the entire award period (including indirect costs) as well as the number of person months per year to be devoted to the project by the senior/key person.

Provide current and pending research support information at time of application using the format typically used for Just-in-Time information. Be sure to distinguish the direct costs per year that support research in the investigator's laboratory from support that goes to other investigators.

Concurrent submission of an application to other organizations that are not components of NIH or the Public Health Service will not prejudice its review. All instructions in the How to Apply - Application Guide must be followed. While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 7 years of support.

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: Specific Aims : Do not use.

Specific Aims are not required and should not be submitted. Research Strategy : The Research Strategy should include the following information: 1. Background regarding the area(s) of research proposed and key gaps in our understanding or challenges that need to be addressed relevant to HLBS research.

Describe the potential for the identified area(s) of research to be groundbreaking or paradigm-shifting. Describe future impact on HLBS research. 2.

The overall vision, conceptual framework, and general strategies for furthering and sustaining the proposed research program, including plans for building on prior accomplishments to formulate a highly innovative program for advancing and transforming the research field. 3. The importance of the research question and how the research could impact the current understanding of the problem being addressed and/or advance the field of study.

Describe how the research program could evolve as the work is being performed and how the risks and challenges will be addressed.

Explain how the proposed research program is in an area that will continue to be important and generate significant new discoveries within the mission of the NHLBI (e.g., describe how the research program will result in new opportunities, explore new areas of scientific inquiry, and develop new systems and strategies, if applicable).

The proposed research can be either a continuation of the previous or current work of the PD/PI, or involve a new line of investigation. If the planned research diverges significantly from past/current work, explain the rationale for the changes and describe the ability of the PD/PI to undertake this new direction. A detailed experimental plan is not expected.

Preliminary data are not required, but limited information may be included if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which the PD/PI has not yet published.

Although the proposed direction of the research program will be considered in review, if new opportunities or directions arise during the course of the research, the PD/PI will have the flexibility to change course and pursue them. Explain how the proposed research program will benefit from the flexibility, level of effort, and the longer-term funding offered by the EIA.

Letters of Support: The application must include a Letter of Support from the institution’s Authorized Organization Representative (AOR). Applications that are missing a Letter of Support will not be reviewed. The Letter of Support must not exceed 2 pages in length.

In two pages or less, the Letter of Support must include: A statement that, if chosen to receive the EIA, the PD/PI will commit a minimum of six person months(i.e.,&nbnbsp;the equivalent of 50% effort on a full-year appointment, 66. 67% on a 9-month appointment, or 100% on a 6-month appointment) throughout the duration of the EIA.

Effort expended toward teaching, administrative, and/or clinical duties should not be included in the research effort calculation; however, a statement describing the PD's/PI's overall level of professional effort devoted to research duties versus teaching, administrative, and/or clinical duties is requested; A statement identifying the two current NHLBI R01-equivalent (defined here as R01, DP1, or DP2) awards that render the PD/PI eligible for the EIA, of which one must be an NHLBI-funded NIH Early Stage Investigator (ESI) award; Evidence of a clear and substantial institutional commitment to the PD/PI (e.g., 20% salary support, access to resources, protected time, space, etc.) for the duration of the award; and Awareness of and acceptance by the AOR that most NHLBI research awards must be relinquished as a condition of receiving an EIA, as described in this NOFO.

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 . Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format.

Where the DMS Plan Format Page requires a Yes or No response, no additional narrative is allowed. 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