Part 1. Overview Information

Key Dates

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.

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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This is a career development program to foster the development of early stage, independent clinical investigators. The NIH funds research and research training at extramural institutions, as well as within the NIH Intramural Research Program (IRP) to support the development of clinical treatments for disease and to improve human health. However, these efforts can be hindered by barriers to clinical and translational research. Such barriers include limited research time for clinical investigators, increases in the length of time to independent careers, and access to hospital facilities and patient enrollments.

To address those barriers, the NIH has created the Lasker Clinical Research Scholars (Lasker Scholars) program that will offer applicants the opportunity to compete for a unique combination of intramural and extramural resources for clinical research. The program will support a small number of clinical researchers in the early stages of their independent careers to promote their development as fully independent scientists.

The program honors the contributions of Mary and Albert Lasker to the NIH and to the overall biomedical community.

The Lasker Scholars program aims to support successful candidates in two phases. Applicants will respond to this Notice of Funding Opportunity (NOFO) for an initial period of support through a position in the NIH IRP. Selected scholars who successfully complete the initial phase and internal review, and who meet the criteria described below, will be able to either remain within the IRP or receive up to 3 years of extramural grant funding in the second phase.

First Phase: The first phase will support scholars in the IRP for up to 5 years, with the possibility of an extension for an additional 2 years. NIH may grant additional extensions, as needed, on a case by case basis. Successful applicants for the Lasker Scholars Program will be appointed as independent tenure-track investigators within an NIH Institute or Center, a process that includes being hired as a full-time employee at the NIH and completing the procedures required of new Federal government employees. As Federal employees, Lasker Scholars will be subject to certain regulations and policies that will govern their relationships with outside organizations. Nonetheless, in certain cases, Lasker Scholars may be able to maintain relationships with their previous institution. The IRP will provide space, research expenses, full salary, and Federal employee benefits. Scholars will develop independent research activities over the course of their stay in the IRP and will be formally reviewed by a panel of senior extramural investigators every 2-4 years to evaluate their research progress. More information about the IRP can be found at http://irp.nih.gov/

Second Phase: Upon successfully completing the initial IRP phase of the program, the Lasker Scholar will be eligible for two options in the second phase. 

Option 1. Remain in the IRP with continued intramural funding and progression to tenured senior investigator status, if consistent with formal reviews and assessments. Retention in the IRP will be dependent on the development of a mutual agreement between the Scholar and the IRP. Tenure at the NIH requires evaluation and approval by the NIH Deputy Director for Intramural Research.

Option 2. Scholars who successfully complete at least five years in the first phase of the program will be considered for up to 3 years of support to continue their research as independent clinician scientists at an extramural institution. This support is contingent upon obtaining an appropriate full-time tenure-track or tenured extramural position at an eligible institution, and the successful NIH programmatic review of the scholar's progress during the intramural phase of the award. Scholars who choose to leave the Lasker program before completing 5 years of research in the IRP will not be eligible for the Lasker Scholars Grant but may be eligible to compete for other extramural NIH research grants as announced in the NIH Guide for Grants and Contracts.

RESEARCH AREAS OF INTEREST

Applicants are strongly encouraged to discuss their proposed research with the NIH prior to submission to ascertain that there is programmatic interest in their research area. See the Scientific/Research Contacts listed in Section VII, Agency Contacts. 

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

1. Eligible Applicants

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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government, including the NIH Intramural Research Program
• U.S. Territory or Possession

Other

• 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
• Regional Organizations

Foreign Organizations/Foreign Collaborations

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

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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. 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 applicants include physicians, dentists and nurses (including MD, MD/PhD, DO, DDS, DMD, RN/PhD, or equivalent clinical doctoral degree from an accredited domestic or foreign institution) who have a professional license to practice clinically in the U.S. The program is intended for investigators at the early stages of their independent careers. Applicants will generally have completed or be completing a post-residency clinical fellowship, and will have demonstrated sufficient patient-oriented research experience to qualify for a tenure-track level appointment. Tenured applicants are not eligible. Applicants do not have to be U.S. citizens or permanent residents, although selected Scholars must qualify for and maintain appropriate visa/residency status throughout the program. An application can be submitted on behalf of the candidate by the candidate's current institution, even if that is not the institution where the candidate would be affiliated if selected as a Lasker Scholar. Individuals not affiliated with an organization, or who want to submit an application independently of their current organization, may apply.

2. Cost Sharing

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

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

• To prevent a lapse in funding, an applicant can submit a Lasker Scholar application in which the research is similar to that in an NIH award already held by the applicant. Should the applicant be selected for and accept a Lasker Scholar award, the previous NIH award must be relinquished prior to accepting the Lasker appointment. Applicants can also submit an R01 application and a related Lasker Scholar application in parallel. Should both applications be selected for funding, the applicant will be permitted to accept only one of the 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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

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.

SF424(R&R) Cover

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.

Facilities and Other Resources: Rather than indicate the resources available, describe the resources that the proposed research will need. Also indicate the specific resources and environmental features that will be needed for research in Phase 2 of the program, should that be conducted in an extramural institution, including subject populations, collaborative arrangements, and/or equipment. 

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.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

Itemized budget information is not required at the time of application. The following instructions may be used to submit the R&R Budget.

For each budget period of the Si2 phase, usually project years 1-5:

• A $0 budget can be entered. A few required form fields must be completed to move from one budget period to the next even if the budget period requests $0.
• Select the appropriate Budget Type.
• Provide the Budget Period Start Date and End Date.
• In Section A: Senior/Key Persons provide an entry for the PD/PI, including 0.01 calendar months as the level of effort, $0 for Requested Salary and $0 for Fringe Benefits.

For each budget period of the R00 phase, usually project years 6-8, a total requested amount up to $499,000 is allowed. Itemized budget information is not required at the time of application. If awarded, the R00 applicant institution (at the time of transition to the R00 phase) will submit a detailed budget for each budget period of the R00 project period that reflects the direct and indirect costs at the R00 applicant institution.

• Provide the Budget Period Start Date and End Date.
• In Section A: Senior/Key Persons provide an entry for the PD/PI, including 0.01 person-months as the level of effort, $0 for Requested Salary and $0 for Fringe Benefits.
• In Section F: Other Direct Costs add a line item titled 'R00 Independent Phase' and provide the total request for that period (up to $499,000).
• In Section H. Indirect Costs: leave this field blank.
• Budget Justification: Applicants should indicate they are requesting no more than the allowed R00 budget.
   

R&R Subaward Budget

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.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will have on human health. List succinctly the specific objectives of the research proposed, e.g., to challenge an existing paradigm or clinical practice, create a novel design, solve a specific problem, test a stated hypothesis, address a critical barrier to progress in the field, or develop new technology.

Research Strategy:

(a) Significance – Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Explain how the proposed project will improve the field, as well as the effect on human health. Describe how the field will be changed if the proposed aims are achieved.

(b) Innovation – Explain how the application challenges and seeks to shift current clinical practice or research paradigms. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation, or intervention(s). Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.

(c) Approach – Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed and interpreted. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. Include preliminary data, if appropriate. Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. Include a prospective timeline for the project. For human subjects research, provide a brief explanation of human subjects protection and inclusion plans.

(d) Milestones - List specific "go/no-go" milestones that the applicant plans to achieve during the Phase I, intramural phase of the research. The milestones are not a reiteration of the Specific Aims, but are measurable, specific endpoints for the Phase I research that will allow NIH extramural staff to assess research progress and appropriateness for Phase 2 support. The milestones should include a timeline for achieving the goals, and may include alternative goals should the original approaches not succeed.

Vertebrate Animals: Successful scholars will submit their proposed research to review boards in the intramural research program upon being selected. Applicants need to follow the SF424 (R&R) Application Guide to complete this section for the extramural portion of the proposed work.

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): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

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.

Do not complete. Indicate that for the Si2 phase, successful scholars will submit their proposed research to review boards in the intramural research program upon being selected. Applicants proposing human subjects and or clinical trials for the extramural (R00) portion of the proposed work should create a delayed onset study record.

Delayed Onset Study

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.

Justification Attachment

Applicants proposing human subjects or clinical trials for the extramural (R00) portion of the proposed work should indicate these will not begin until after 5 years of research, and the study information is not yet available. The information will be provided in the R00 application.

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.

6. Funding Restrictions

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.

Important reminders:

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.

Letters of Reference

Letters of reference are an important component of the Lasker Clinical Research Scholar application. Applicants should arrange to have four letters of reference submitted on their behalf. Applications that are missing letters of reference will not be reviewed. Late letters will not be accepted. Applicants are responsible for monitoring the submission of letters to ensure that the letters have been submitted prior to the submission deadline. Applicants are encouraged to check the status of their letters in their eRA Commons accounts.

To submit a letter of reference, the referee will need the following information:
Notice of Funding Opportunity (NOFO) for this announcement: PAR-26-114.
The applicant's Commons Username (Note: Referees do not need to be registered in the Commons and do not need their own Commons Username – only the Commons Username of the applicant is required);
The applicant's first and last name (note – the name must match exactly the applicant's name in the Commons);
The URL to the letter submission page (https://public.era.nih.gov/commonsplus/public/reference/submitReferenceLetter.era);
The letter of reference submission dates – Deadline for receipt of letters is 5:00 p.m. (ET) on the application due date.
Letters of reference are confidential to the extent permitted by law. Email confirmations will be sent to both the applicant and the referee. Note: Since email can be unreliable, it is the applicant's responsibility to check the status of letters of reference periodically in the Commons.

Instructions for Referees:

Letters may be submitted to the Commons at (https://public.era.nih.gov/commonsplus/public/reference/submitReferenceLetter.era) beginning one month before the application due date, and must be submitted no later than 5:00 p.m. (ET) on the application due date.
Late letters will not be accepted and applications missing letters of reference may not be reviewed.
The applicant's name should be placed at the top of the letter. Although signatures are not required, the letter must include a signature block with the referee's full name, title, institution, and contact information:
In two pages or less, describe the applicant's qualities that support the applicant's claim to possess the scientific, leadership and management skills necessary to conduct successful, independent clinical research. When possible, give specific examples that illustrate these qualities.
Note: The letter submission page can be accessed without signing in to the Commons, and referees do not need to be registered in the Commons. Referees must provide the applicant's Commons User Name (User ID) and the other information below:
Referee Information (the individual providing the letter of reference):
Referee's First and Last Name (Required)
Referee's Middle Initial (MI) (Not Required)
Referee's Email Address (Required)
Referee's Institution/Affiliation (Required)
Referee's Department (Required)

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular NOFO, note the following:

The goal of the Lasker Clinical Research Scholars Program is to support a small number of exceptional clinical researchers in the early stages of their independent careers, and to promote their development to fully independent scientists. Therefore, the review will emphasize the accomplishments and potential of the applicant, as well as the research project.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

All applications will be discussed and assigned an overall impact score.

Select candidates may be invited to the NIH campus for an employment interview, based upon the results of the initial peer review, and selected by the intramural NIH Scientific Director. Applicants who are identified to progress to the interview process will be asked to provide additional information that will be used to establish the candidates' eligibility and suitability for hire. The applicant will receive a package of additional documents to complete if selected to proceed to this phase of the interview process.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Applicants are strongly encouraged to discuss their proposed research with the NIH prior to submission to ascertain that there is programmatic interest in their research area. See the Scientific/Research Contacts listed in Section VII, Agency Contacts. 

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

INTRAMURAL PHASE Selected Scholars will be notified by the Scientific Director of the host NIH Institute or Center, and will receive a formal Notice of Employment from the NIH Human Resources Office. Lasker Scholars are appointed under excepted service. These appointments will be made under time-limited Title 42 (g) or (f). Selected Scholars will be appointed as tenure-track investigators in the NIH Intramural Research Program. Tenure-track investigators receive independent resources (staff, space, and budget), and receive mentoring from their Lab or Branch Chief, and from other senior leaders in the IRP. 

TRANSITION TO THE R00 PHASE To be eligible for the extramural funding award of the program, Scholars must have:

 Successfully completed at least five years in the NIH intramural research program; Been offered, and have accepted, a full-time tenure-track or tenured position at an extramural sponsoring institution/organization.

 This support is contingent upon the successful NIH programmatic review of the scholar's progress during the intramural phase of the award. To avoid potential problems in activating the R00 phase, applicants are strongly encouraged to contact their NIH program official as soon as plans to apply for and assume a position outside the NIH Intramural Research Program. At that time, individuals should discuss plans for transition to, and application for, the R00 phase with their NIH program official. The application for the R00 phase of the award should be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase grantee organization. The R00 phase institution will submit an application on behalf of the candidate for the R00 award using the PHS 398 Application. The R00 application must include:

 A new face page signed by the R00 phase institutional representative; A new project description page (the project summary or abstract should be updated to reflect current plans for the R00 phase); Detailed budget pages for a non-modular budget; Biographical sketches for the PD/PI and any other Key Personnel;

 A new Resources page;

 A brief description of progress made during the intramural phase, including an assessment of progress toward achieving the stated milestones, that will serve as the Final Progress Report for the intramural phase; An updated research plan (the specific aims should be updated to reflect current plans for the R00 phase and the updated research plan should be briefly described in less than 5 pages); Updated Protections for Human Subjects and Inclusion of Women, Minorities and Individuals Across the Lifespan (as appropriate); Updated Vertebrate Animals (as appropriate); Updated Biohazards (as appropriate); and A new checklist. 

These materials should be sent directly to the awarding Institute or Center (IC). The original application plus one copy (preferably in PDF format) are to be mailed (or e-mailed) to the Financial or Grants Management contact person of the awarding NIH Institute or Center listed in the Notice of Award. The R00 application will be evaluated by extramural Program staff of the awarding component for completeness and appropriateness to the program.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

Not Applicable

3. Data Management and Sharing

The Data Management and Sharing Plan is not applicable SI2 phase and only applicable to the R00 phase. 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. 

4. Reporting

For the R00 phase, when multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Lasker Scholar Program Administrator
Email: Laskergrants@mail.nih.gov

NIMHD IRP Office of the Scientific Director
Email: NIMHDIRPOfficeoftheScientificDirector@nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: nichdreferral@mail.nih.gov 

National Institute on Aging (NIA)
Scientific Program Contact: 
Email: NIA-NOFO-Scientific@nih.gov

National Eye Institute (NEI)
Email: NEI_extramural@nei.gov

National Institute of Dental and Craniofacial Research (NIDCR)
Email: NIDCRintramural@nih.gov

National Institute on Deafness and Other Communication Disorders (NIDCD)
Email: NIDCD.Lasker@mail.nih.gov

NLM Intramural Research - Office of the Director
Email: NLMDIROD@mail.nih.gov

NIDDK Office of the Scientific Director
Email: NIDDKScientificDir@niddk.nih.gov

National Institute of Environmental Health Sciences (NIEHS)
Email: NOFO.information@niehs.nih.gov

National Center for Complementary and Integrative Health (NCCIH)
Division of Extramural Research (DER)
Email: NCCIHDERFunding@nih.gov

NCI Center for Cancer Research
NCICCRJobOpp@mail.nih.gov

National Heart, Lung, and Blood Institute (NHLBI)
Email: NHLBI_LaskerScholars@nih.gov
Subject: PAR-26-114

National Institute of Mental Health (NIMH)
Email: NIMHinitiatives@mail.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Office of the Scientific Director
Email: NIAAAScientificDirector@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

NIMHD Grants Management Office
Email: NIMHD-CGMO@mail.nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: nichdgrantsmanagement@mail.nih.gov

National Institute on Aging (NIA)
Grants Management Contact: 
Email: NIA-NOFO-Grants@nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)
Email: NIAIDFinancial-GrantsContact@mail.nih.gov

National Eye Institute (NEI), Grants Management
Email: NEI_extramural@nei.gov

National Institute of Dental and Craniofacial Research (NIDCR)
Email: deeranotifications@nidcr.nih.gov

National Institute on Deafness and Other Communication Disorders (NIDCD)
Email:  NIDCDGrantsMgt@nidcd.nih.gov

NLM Grants Management
Email: NLMGrants@nih.gov 

NIDDK Office of the Scientific Director
Email: NIDDKGMBManagementTeam@niddk.nih.gov

NIEHS Financial Grants Management
Email: NOFO.information@niehs.nih.gov

National Center for Complementary and Integrative Health (NCCIH)
Office of Grants Management (OGM)
Email: NCCIHDERFunding@nih.gov

NCI Office of Grants Administration
NCIFinancialContact@nih.gov

Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
Email: NHLBIOGMInbox@nhlbi.nih.gov
Subject: PAR-26-114

Chief, Grants Management Office
National Institute of Mental Health (NIMH)
Email: NIMHNOFOGrantsManagement@mail.nih.gov   

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Grants Management Contact:
Email: NIAAA-GMB@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.