Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)

Funding Opportunity Title

Lasker Clinical Research Scholars Program (Si2/R00 Clinical Trial Optional)

Activity Code

Si2/R00 Intramural Clinical Research Scholar Transition Award

Announcement Type

Reissue of PAR-17-254

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-18-740

Companion Funding Opportunity

none

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.279; 93.233; 93.839; 93.838; 93.837; 93.865; 93.398; 93.113; 93.867; 93.847; 93.846; 93.853; 93.242; 93.855; 93.361; 93.866; 93.121; 93.307 

Funding Opportunity Purpose

This FOA encourages applications for the Lasker Clinical Research Scholars Program for the purpose of supporting the research activities during the early stage careers of independent clinical researchers. 

The program offers the opportunity for a unique bridge between the NIH intramural and extramural research communities and contains two phases.  In the first phase, Lasker scholars will receive appointments for up to 5-7 years as tenure-track investigators within the NIH Intramural Research Program with independent research budgets.  In the second phase, successful scholars will receive up to 3 years of NIH support for their research at an extramural research facility; or, the scholar can be considered to remain as an investigator within the intramural program.

Key Dates

 

Posted Date

April 3, 2018

Open Date (Earliest Submission Date)

July 31, 2018

Letter of Intent Due Date(s)

Not applicable

Application Due Date(s)

August 31, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

October/November, 2018

Advisory Council Review

January, 2019

Earliest Start Date

February, 2019

Expiration Date

September 1, 2018  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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.

  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.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. 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. Funding Opportunity Description

    This program will address the clinical research mission of the National Institutes of Health (NIH) and will lead to better treatments for disease and to improvements in human health.  The NIH funds research and research training at extramural institutions, as well as within the NIH Intramural Research Program (IRP) to address this goal.  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.

    In an effort 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 exceptional clinical researchers in the early stages of their careers to promote their development to fully independent scientists.  The program combines a period of research experience as a tenure-track Investigator in the IRP with additional years of independent financial support, either within the IRP or at an extramural research institution. The Scholar must meet the conditions described below, including fulfilling milestones and agreement with IRP, in order to receive the additional years of funding.

    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 Funding Opportunity Announcement (FOA) 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.  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, and who have been offered, and have accepted, a full-time tenure-track or tenured position at an extramural sponsoring institution/organization, will be considered for up to 3 years of support to continue their research as independent clinician scientists. This support is contingent upon obtaining an appropriate 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 will be eligible to compete for other extramural NIH research grants as announced in the NIH Guide for Grants and Contracts. 

    The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects all of its efforts to diversify the workforce to lead to the recruitment of the most talented researchers; to improve the quality of the education and training for all researchers; to balance and broaden national perspectives in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.  The NIH encourages applications from researchers from diverse backgrounds underrepresented in biomedical research, including underrepresented racial and ethnic groups and persons with disabilities.  NIH also encourages applications from women for participation in all NIH-funded research opportunities.

    RESEARCH AREAS OF INTEREST

    Participating NIH Institutes and Centers, and their preferred areas of clinical research interest, are provided below.  Applicants are encouraged to discuss their proposed research with Scientific/Research Contact listed in Section VII, Agency Contacts.

    National Cancer Institute

    • Medical oncology, pediatric hematology-oncology, radiation oncology, surgical oncology, pathology, neuro-oncology, urology and dermatology. Specific areas within these categories include genitourinary oncology, lymphoid malignancies, neuro-oncology, immunotherapy, women's cancers, aeoro-digestive cancers, molecular diagnostics, and functional imaging. 
    • Translational and clinical epidemiology, genetics of cancer

    National Eye Institute

    • Neurodegenerative eye disease, neuro-immunology and immunometabolism

    National Heart, Lung, and Blood Institute

    • Cardiovascular, blood, and pulmonary research
    • Pediatric and developmental biology
    • Cardiovascular research: heart failure, non-surgical interventional therapeutics, cardiovascular imaging, inflammation and cardiovascular disease, pulmonary hypertension, dyslipidemias, disease discovery research.
    • Blood research: myeloproliferative disorders, benign hematology, bone marrow failure syndromes, myelodysplastic syndromes, acute and chronic leukemias and other hematological malignancies, hematopoietic stem cell transplantation, cell based therapies to treat GVHD, malignancies, viral diseases, and bone marrow failure
    • Pulmonary research: pulmonary interstitial disease, pulmonary hypertension, airway inflammation and asthma, host defense mechanisms, rare lung disease, pulmonary nontubercular mycobacterial disease. 
    • Sickle cell research, gene therapy for sickle cell disease, novel therapeutics to prevent and treat vaso-occlusive crisis.
    • Cell therapy based treatments for tumors utilizing NK cells, T-cells, hematopoietic stem cells, and iPS cells.
    • Regenerative medicine utilizing iPSCs
    • Population Sciences Research

    National Institute of Aging

    • Epidemiology of Aging

    National Institute of Allergy and Infectious Diseases

    • Clinical aspects of immunology and infectious diseases

    National Institute of Arthritis and Musculoskeletal and Skin Diseases

    • Genetics, genomics, pathophysiology, prevention, and treatment of rheumatic diseases, particularly systemic lupus erythematosus, systemic vasculitis, inflammatory arthritis, inflammatory muscle disease, ankylosing spondylitis and spondyloarthropathies, and auto-inflammatory syndromes.
    • Psoriasis and inflammatory skin diseases.

    Eunice Kennedy Shriver National Institute of Child Health and Human Development

    • Metabolic diseases
    • Bone growth and skeletal dysplasia
    • Endocrinology and molecular genetics
    • Regenerative medicine and stem cell biology
    • Reproductive and molecular medicine
    • Developmental biology and human genetics
    • Women's health

    National Institute of Dental and Craniofacial Research

    • Craniofacial anomalies, including genetics, pathophysiology, and surgical therapies
    • Craniofacial regenerative medicine, tissue engineering, stem cell biology
    • Craniofacial and dental developmental biology and human genetics
    • Metabolic bone disease

    National Institute of Diabetes and Digestive and Kidney Diseases

    • Gastroenterology
    • Nephrology
    • Endocrinology

    National Institute of Drug Abuse

    • Substance use disorders

    National Institute of Environmental Health Sciences

    • Metabolic diseases
    • Reproductive - puberty, estrogen effects, menopause
    • Women's health including bone health
    • Growth
    • Pulmonary diseases
    • Human genetics
    • Environmental exposures
    • Health disparities

    National Institute of Mental Health

    • Psychosis - underlying neurological mechanisms, pathophysiology and potential therapeutics

    National Institute on Minority Health and Health Disparities

    • Multidisciplinary studies of health disparities
    • Interactions between socioeconomic factors and race/ethnicity and their effects on health outcomes
    • Social and behavioral determinants of health disparities
    • The interaction of genetic, biological, social and behavioral factors in shaping disparities in risk factors, protective factors, and health outcomes.

    National Institute of Neurological Disorders and Stroke

    • Any area of neurology or stroke
    • Neurosurgery

    National Institute of Nursing Research

    • Symptom science/biology within a clinical context

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

    Section II. Award Information
    Funding Instrument

    Appointment (Intramural phase).

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    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

    It is anticipated that up to 5 awards will be made in FY 2018.

    Award Budget

     Award budgets are composed of salary and other program-related expenses, as described below.

    Intramural Phase (Si2)

    Allowable Costs:

    Scholars will be supported by intramural funds provided by the NIH Institute/Center in which they are conducting their research. Budget details for the intramural phase will be negotiated with the sponsoring Institute/Center. Salary will be consistent with that offered scientists in similar, intramural NIH positions.

    Extramural Phase (R00)

    Allowable Costs:

    For the extramural phase (R00) applicants can request direct costs of up to $499,000 per year. This amount includes salaries, fringe benefits, and research costs.

    Indirect Costs:

    Indirect costs will be reimbursed at the extramural sponsoring institution's indirect cost rate.

    Award Project Period

     The initial phase of research in the IRP is for 5 years with the possibility of a 2 year extension.  The extramural phase of the program is for up to 3 years 

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    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)

    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)
    • Eligible Agencies of the Federal Government
    • 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 Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – 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. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    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 careers.  At the time the application for the initial IRP phase is submitted, applicants must have completed their core residency by June 2008 or more recently.  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. 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 (specific information is available for unaffiliated candidates.) 

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    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. 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

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. 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 Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide must be followed.

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide must be followed with the following exception:

    Facilities and Other Resources: Rather than indicate the resources available, describe the resources that the proposed research will need.  Indicate how the proposed research will take advantage of the unique features of the scientific environment, subject populations, or collaborative arrangements of the NIH Intramural Research Program.  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 SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    R&R Budget

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following modifications:

    Although itemized budget information for the R00 phase is not required at time of application, applications that include itemized information will be accepted.

    The following instructions may be used to submit the R&R Budget without itemized information.

    A $0 budget can be provided for the intramural (Si2) phase, usually project years 1-5. A few required form fields must be completed to move from one budget period to the next even if the budget period requests $0.

    For each budget period of the Si2 phase:

    - 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.

    For each budget period of the R00 phase:

    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.

    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

    At the time of transition to the R00 phase, the R00 applicant institution 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.

    R&R Subaward Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    PHS 398 Research Plan

    All instructions in the SF424 (R&R) 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.

    (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 SF424 (R&R) Application Guide

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed. Do not complete. For the Si2 phase, successful scholars will submit their proposed research to review boards in the intramural research program upon being selected.

    Delayed Onset Study

    All instructions in the SF424 (R&R) Application Guide must be followed. 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 SF424 (R&R) Application Guide must be followed. 

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. 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. Overview Information 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 Policy on Late Application Submission.

    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 SF424 (R&R) 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.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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.

    In order to expedite review, applicants are requested to notify Dr. Charles Dearolf, NIH Office of Intramural Research, by email at dearolfc@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

    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:

    Funding Opportunity Number (FOA) for this announcement: PAR-18-740;

    The applicant's Commons User Name (Note: Referees do not need to be registered in the Commons and do not need their own Commons User Name – only the Commons User Name 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/commons/public/reference/submitReferenceLetter.do?mode=new);

    The letter of reference submission dates –July 31, 2018 – August 31, 2018.  Deadline for receipt of letters is 5:00 p.m. (ET).

    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/commons/public/reference/submitReferenceLetter.do?mode=new) beginning July 31, 2018, and must be submitted no later than 5:00 p.m. (ET), August 31, 2018.

    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 into 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)

    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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    For this particular announcement, 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 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.

    Overall Impact

    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).

    Scored Review Criteria

    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.

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding? 

    Investigator(s)

    Has the candidate demonstrated appropriate experience, training, and the skills to conduct innovative clinical research? Do the letters of reference indicate that the candidate has the research and leadership skills to conduct independent research? Is the clinical researcher well suited to the project?

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  

    In addition, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award? 

    Environment

     Has the applicant identified unique features of the scientific environment, subject populations, or collaborative arrangements of the NIH Intramural Research Program that will be needed to conduct the proposed Phase I research?   Assuming successful completion of the proposed milestones, has the candidate identified appropriate and sufficient institutional resources, such as subject populations, collaborations, and equipment, that will be needed for the Phase 2 portion of the research?  Are critical resources missing from the candidate's list of needed resources, for either Phase of the research? 

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    Additional Review Criteria

    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.

    Study Timeline

    Specific to applications involving clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    Not applicable

    Renewals

    Not applicable.

    Revisions

    Not applicable.

    Additional Review Considerations

    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.

    Applications from Foreign Organizations

    Not applicable.

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s). The review will be convened either by the Center for Scientific Review (CSR), or by the review division of the assigned Institute or Center, at the discretion of the assigned Institute or Center, in accordance with NIH peer review policy and procedures, 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:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Select candidates will 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.

    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.
    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 VI. Award Administration Information
    1. Award Notices

    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.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee's business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    For the R00 award, 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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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). 

    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).  For more details on the hiring process, pay scales, and benefits, see http://hr.od.nih.gov/benefits/default.htm.

    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.  Additional information concerning the philosophy and practices for IRP tenure-track investigators can be found at http://sourcebook.od.nih.gov/prof-desig/ttiphilosophy.htm and at http://sourcebook.od.nih.gov/prof-desig/investigator.

    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;

    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 of 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;
    • 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 Children (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

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    General Information:


    Charles R. Dearolf, Ph.D.
    Director, Program Development and Support
    Office of Intramural Research
    National Institutes of Health
    Telephone: 301-402-1225
    Email: LaskerScholar@nih.gov

    William Dahut (oncology)
    National Cancer Institute (NCI)
    Telephone:  301-496-4251
    Email: dahutw@mail.nih.gov

    Stephen J. Chanock (epidemiology)
    National Cancer Institute (NCI)
    Telephone: 240-276-7150
    Email: chanocks@mail.nih.gov

    David Schneeweis
    National Eye Institute (NEI)
    Telephone: 301-451-6763
    Email:  schneeweisdm@mail.nih.gov

    Robert Balaban
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone:  301-496-2116
    Email: balabanr@nhlbi.nih.gov

    Richard Childs
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-451-7128
    Email: childsr@nhlbi.nih.gov

    Luigi Ferrucci
    National Institute on Aging (NIA)
    Telephone: 410-558-8110
    Email: ferruccilu@grc.nia.nih.gov

    Myriam Gorospe
    National Institute on Aging (NIA)
    Telephone: 410-558-8443
    Email: gorospem@mail.nih.gov

    Karyl S. Barron
    National Institute of Allergy and Infectious Disease (NIAID)
    Telephone: 301-402-2208
    Email: Kbarron@nih.gov

    John O'Shea
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Telephone: 301-496-2612
    Email: osheajo@mail.nih.gov

    Sara King
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-451-7753
    Email: mullends@mail.nih.gov

    Janice Lee
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-827-1647
    Email: leejs2@mail.nih.gov

    Michael Krause
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-402-4633
    Email: michaelkr@niddk.nih.gov

    Antonello Bonci     
    National Institute on Drug Abuse (NIDA)
    Telephone: 443-740-2463
    Email: boncia@mail.nih.gov

    Janet Hall
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 919-316-4525
    Email: janet.hall@nih.gov

    Maryland Pao
    National Institute of Mental Health (NIMH)
    Telephone: 301-435-5770
    Email: paom@mail.nih.gov

    Anna María Nápoles
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: (310) 496-3348
    Email: anna.napoles@nih.gov

    Avindra Nath
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-1561
    Email: natha@mail.nih.gov

    Jessica Gill
    National Institute of Nursing Research (NINR)
    Telephone: 301-451-8452
    Email: gillj@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Not Applicable

    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.

    Authority and Regulations

    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 45 CFR Part 75.

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