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.

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

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: regenerative medicine, pediatric and developmental biology
• Cardiovascular research: heart failure, cardio-oncology, interventional therapeutics
• Blood research: chronic myeloproliferative disorders, benign hematology, bone marrow failure syndromes, myelodysplastic syndromes, hematological malignancies, and hematopoietic stem cell transplantation
• Pulmonary research: pulmonary interstitial disease, pulmonary hypertension, airway inflammation, host defense mechanisms, rare lung disease, pulmonary mycobacterial disease
• Sickle cell research
• Tumor immunology and immunotherapy

National Institute of Allergy and Infectious Diseases

• Vector biology and antimicrobial resistance

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 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.

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

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

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.

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.

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.

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 2007 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.

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.)

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

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.

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.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

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.

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

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

SF424(R&R) Other Project InformationAll 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) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed

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

A $0 budget can be provided for the intramural (Si2) phase. 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.

• A total requested amount up to $499,000 is allowed for each budget period of the R00 phase. 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

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

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

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.

Protections for Human Subjects: 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.

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:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

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.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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, Asst. Director for Intramural Research, by email at [email protected] 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-17-254;

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 25, 2017 August 25, 2017. 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 25, 2017, and must be submitted no later than 5:00 p.m. (ET), August 25, 2017.

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)

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

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

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.

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?

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?

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?

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?

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?

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.

Protections for Human Subjects for Phase 1 will be evaluated after an appointment is made, and as with all research involving human subjects conducted within the IRP, will be subject to 45 CFR Part 46. Reviewers should describe any concerns at the time of review. For Phase 2 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 will be evaluated for Phase 1 after an appointment is made. Reviewers should describe any concerns at the time of review. When the proposed Phase 2 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 will be evaluated for Phase 1 after an appointment is made. Reviewers should describe any concerns at the time of review. The committee will evaluate the involvement of live vertebrate animals for Phase 2 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 will be evaluated for Phase 1 after an appointment is made. Reviewers should describe any concerns at the time of review. Reviewers will assess whether materials or procedures proposed for Phase 2 are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not applicable

Not applicable

Not applicable

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.

No applicable.

Select Agent Research will be evaluated for the intramural research after an appointment is made. Reviewers should describe any concerns at the time of review. 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 will be evaluated for Phase 1 after an appointment is made. Reviewers should describe any concerns at the time of review. 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).

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.

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

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.

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.

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

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.

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, including assessment of progress toward achieving the stated milestones to determine appropriateness for extramural funding.

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

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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

During the Intramural Research Program phase, scholars will submit an annual research report for each supported project, according to the standard procedures for IRP Investigators (described at http://sourcebook.od.nih.gov/sci-prgms/annualZ01.htm).

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 progress report, 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.

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 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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

General Information
Charles R. Dearolf, Ph.D.
Assistant Director for Intramural Research
National Institutes of Health
Telephone: 301-402-1225
Email: [email protected]

William Dahut (oncology)
National Cancer Institute (NCI)
Telephone: 301-496-4251
Email: [email protected]

Stephen J. Chanock (epidemiology)
National Cancer Institute (NCI)
Telephone: 240-276-7150
Email: [email protected]

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: [email protected]

Richard Childs
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-451-7128
Email: [email protected]

Karyl S. Barron
National Institute of Allergy and Infectious Disease (NIAID)
Telephone: 301-402-2208
Email: [email protected]

John O'Shea
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-496-2612
Email: [email protected]

Sara King
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-7753
Email: [email protected]

Bob Angerer
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-1483
Email: [email protected]

Michael Krause
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-4633
Email: [email protected]

Antonello Bonci
National Institute on Drug Abuse (NIDA)
Telephone: 443-740-2463
Email: [email protected]

Janet Hall
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4525
Email: [email protected]

Maryland Pao
National Institute of Mental Health (NIMH)
Telephone: 301-435-5770
Email: [email protected]

Avindra Nath
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1561
Email: [email protected]

Jessica Gill
National Institute of Nursing Research (NINR)
Telephone: 301-451-8452
Email: [email protected]

Eugene Carstea
Center for Scientific Review (CSR)
Telephone: 301-408-9756
Email: [email protected]

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 45 CFR Part 75.