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)

Funding Opportunity Title

NCI Mentored Patient-Oriented Research Career Development Award to Promote Diversity (K23)

Activity Code

K23 Mentored Patient-Oriented Research Career Development Award

Announcement Type

Reissue of PAR-09-051

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
  • May 31, 2012 - See Notice NOT-OD-12-113. This Notice clarifies instructions under Section III. Eligibility Information.

Funding Opportunity Announcement (FOA) Number

PAR-12-052

Companion FOA

PAR-12-051, K08 Mentored Clinical Scientist Research Career Development Award to Promoted Diversity

Number of Applications

Applicants may only have one individual Career Development Award Application pending peer review at any time. See Section III. 3. Additional Information on Eligibility

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

93.398

FOA Purpose

The purpose of the NIH Mentored Patient-Oriented Research Career Development Award (K23) is to support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented cancer research[POR]. The NCI's Diversity Training Branch (DTB) and the Center to Reduce Cancer Health Disparities (CRCHD) announce the availability of the "Mentored Patient-Oriented Research Award to Promote Diversity" for career development of individuals with a health professional doctoral degree from groups currently underrepresented on a national level in the biomedical, clinical, behavioral, and social sciences. The NCI recognizes a unique and compelling need to promote diversity in the patient-oriented research workforce.

Key Dates
Posted Date

December 15, 2011

Open Date (Earliest Submission Date)

January 12, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply , by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

January 8, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series)  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.


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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

 The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists are available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.  More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

1. Research Career Objectives

The Diversity Training Branch (DTB) of the NCI's Center to Reduce Cancer Health Disparities (CRCHD) expects efforts to diversify cancer research workforce to lead to the recruitment of the most talented researchers from all groups, thereby capitalizing on the discoveries of new technologies being developed for the diagnosis/treatment of cancers and the predictions of cancer risk.

The overall objective of the NCI Research Career Development Award program is to prepare qualified individuals for careers that have a significant impact on the health-related research workforce needs of theNational Cancer Institute.

The objective of the NCI Mentored Patient-Oriented Research Career Development Award (K23) program is to ensure a future cadre of well-trained scientists working in Patient Oriented Research (POR) areas who will become competitive for NIH research project (R01) grant support. The specific objectives of the Mentored POR-Career Development Award are to:

The goal of the NCI DTB K23 is to diversify the pool of clinical researchers who are available to conduct cancer focused patient-oriented studies, capitalizing on the discoveries of biomedical research and translating them to clinical settings. This award forms an important part of the NCI initiative to recruit the most talented researchers from all groups and to promote diversity in the patient-oriented research workforce.

Related Funding Opportunity: Clinically trained professionals or individuals with a clinical degree who are representative of groups underrepresented in biomedical research and are interested in further career development in laboratory- or field-based research that is not patient-oriented should consider the NCI Mentored Clinical Scientist Career Development (K08) Award which can be found at (PAR-12-051).

Background

Substantial national and local efforts are directed toward a reduction in cancer morbidity and mortality in the general population. However, in spite of these efforts, the American Cancer Society estimates that approximately 1.6 million men and women will be diagnosed with cancer, and approximately 0.5 million of deaths from cancer are projected to occur in the United States in 2011. Past patterns of cancer incidence and mortality predict that the disproportionate increase in U.S. cancer incidence and mortality will be experienced by both minority and underserved populations.

Cultural Barriers to Cancer Treatment. Contributing to the cancer mortality of U.S. minorities is their limited access to treatment by culturally competent physicians. This factor is largely due to the small numbers of U.S. patient-oriented clinical oncologists from diverse backgrounds. A reduction in the overall cancer mortality rate in minority and underserved populations would substantially impact known cancer statistics. Cultural barriers to cancer diagnosis/treatment and to advice regarding preventive health care will take on added importance as the techniques of molecular epidemiology are increasingly applied to identify minority individuals and family members at high risk for cancer. As a result of this new technology, physicians will increasingly be called upon to deal with culturally sensitive issues such as prophylactic surgery for family members and/or major changes in lifestyle, possibly even including childbearing.

Need for Diversity among Clinician Scientists. There is abundant evidence that not only patients, but the biomedical enterprise will directly benefit from broader inclusion. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings.

It is therefore imperative that a sufficient number of clinical scientists in oncology from diverse backgrounds be trained and available so that access to care is not limited by the number of clinical scientists in oncology who are sensitive to cultural issues. Additionally, the clinical scientist in oncology must have an understanding of the new technologies being developed that will assist in the diagnosis/treatment of cancers and the predictions of cancer risk. This understanding can best be provided by a research and career development experience in the development and/or application of these technologies.

Specific Research Objectives

This FOA has been part of an important NCI initiative to attract talented individuals from diverse backgrounds underrepresented in biomedical science on a national level. The Diversity Training Branch, CRCHD will provide successful candidates with special opportunities to enhance their knowledge and understanding of the NIH/NCI peer review system and to develop the skills required for preparing competitive research project grants. The NCI is especially interested in increasing the number of clinicians from diverse groups, trained to conduct high-quality, patient-oriented clinical research. The K23 provides the awardee, through multidisciplinary didactic training, the opportunity to obtain both the knowledge and the research skills necessary to compete for independent support in patient-oriented research. The purposes of this award are to:

Patient-oriented Clinical Research. For the purposes of this award, and in agreement with the recommendations of the NIH Director's Panel on Clinical Research, (http://www.nih.gov/news/crp/97report/index.htm ), patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena for which an investigator directly interacts with human subjects). This area of research includes: (1) mechanisms of human disease; (2) therapeutic interventions; (3) clinical trials; and (4) the development of new technologies.

The objective of the NIH Mentored Patient-Oriented Research Career Development Award (K23) program is to provide salary and research support for a sustained period of “protected time” (3-5 years) to ensure a future cadre of well-trained scientists from diverse backgrounds working in Patient-Oriented Research (POR). The K23 award is expected to help research-oriented clinicians to develop research skills and gain experience in advanced methods and experimental approaches needed to become an independent investigator conducting POR.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, the submission of a sufficient number of meritorious applications and the availability of funds.

Award Budget

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

Award Project Period

The total project period may not exceed 5 years.

Other Award Budget Information
Salary

NIH will contribute up to $100,000 per year toward the salary of the career award recipient.  

The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Other Program-Related Expenses

NIH will contribute $30,000  per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status)

The overarching goal of this FOA is to diversify and expand the pool of independent and talented cancer research investigators:

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NCI expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective 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.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as:  individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.  The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A.    Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.    Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.    Individuals from disadvantaged backgrounds who are defined as:

1.    Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.    Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. 

Disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

Information must be submitted by the applicant Institution in a letter certifying that the applicant belongs to one of the above groups. The letter should be inserted in the application immediately before the Checklist as a PDF file. Application processing may be delayed or the application may be returned if it does not comply with this requirement.

Candidates for this award should have broad clinical training, must demonstrate competence in clinical activities, must document a serious intent for a research career in patient-oriented clinical oncology, and must document sensitivity to cultural issues impinging upon the practice of medicine among the major U.S. ethnic populations.

Nomination: The candidate must be nominated by institutions on the basis of qualifications, interests, accomplishments, and motivation, and based upon the candidate's intent to conduct a research project highly relevant to cancer biology, cancer health disparities, etiology, pathogenesis, prevention, diagnosis, and/or treatment that has the potential for establishing an independent research program. Accordingly, the NCI continues to encourage institutions to diversify their student and faculty populations and to identify candidates who will increase diversity on a national basis.

Level of Effort: Candidates must be able to commit a minimum of 9 person-months (75% of full-time professional effort) conducting research career development activities associated with this award. The remaining 3 person-months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K23 Award, i.e., the candidates development into an independent investigator in POR. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056.

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in NCI prior to preparing an application to discuss their eligibility.

Former principal investigators on NIH research project (R01), program project (P01), center grants, FIRST Awards (R29), sub-projects of program project (P01) or center grants, other career development awards (K–awards), or the equivalent are not eligible. Former principal investigators of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Awards (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

Candidates for this award must have a health-professional doctoral degree. Such degrees include but are not limited to the MD, DO, DD.S, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice. Candidates with PhD degrees are eligible for this award if the degree is in a clinical field and they usually perform clinical duties. Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the PhD in a non-clinical discipline but who are certified to perform clinical duties should contact the appropriate Institute concerning their eligibility for a K23 award. Candidates also must have completed their clinical training, including specialty and, if applicable, subspecialty training prior to receiving an award. However, candidates may submit an application prior to the completion of clinical training.

Career Stage: The intent of the K23 program is to support clinical scientists in their early career stages (i.e. postdoctoral positions or early stage of faculty positions such as Assistant professors with = 2 yrs of appointments).

Clinicians (including those with MD, DDS. DVM, and other licensed health professionals) in clinical faculty position that denotes independence in clinical responsibilities but not in research are also eligible for the K23 award.

It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent positions. Candidates in such positions are strongly encouraged to contact the NCI program official for confirmation of their eligibility before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that the position he/she is in complies with the intent of this eligibility requirement.

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.

NIH will not accept any application that is essentially the same as one already reviewed. An individual may not have two or more competing NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

A candidate for an NIH K23 award may not simultaneously submit or have an application pending for any other NIH career award (e.g., K01, K07, K08, K22, K23, K25), a research project grant (R01), or any PHS award that duplicates any of the provisions of the K23 award. Ineligible individuals include current and former principal investigators on NIH research project grants, comparable individual career development awards (e.g., K01, K07, K08, K23, K25) equivalent non-PHS peer-reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants. Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions of the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

Level of Effort

At the time of award, the candidate must have a “full-time” appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036

Mentor

Candidates must have at least two mentors. The candidate must name a primary sponsor/mentor, who, together with the applicant is responsible for the planning, direction, and execution of the clinical program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators in patient-oriented research. A second basic research mentor in the proposed research area should have a proven record of success in training independent investigators. The mentors should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. Where feasible, women, individuals from diverse race and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models. Appropriate mentors include, but are not limited to, NIH-supported investigators involved in POR. The mentor(s) should also be sensitive to the individual needs of the candidate, have a proven record of success in training independent investigators, demonstrate a strong, continuous commitment to the candidate throughout the period of training and should have sufficient independent research support to absorb the costs of the proposed research project in excess of the allowable costs of this award.  

Institutional Environment

The applicant institution must have a strong, well-established record of career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.  The institution must demonstrate a commitment to the development of the candidate as a productive investigator and be willing to allow the protected time needed by the candidate.  The candidate, mentor(s), and institution must describe a career development program that will maximize the use of this environment, including available facilities and resources.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Career Development Award Supplemental Form

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

Candidate’s Background (Component of Candidate Information)

Career Goals and Objectives (Component of Candidate Information)

Describe a systematic plan that:

Career Development/Training Activities During Award Period (Component of Candidate Information)

Training in the Responsible Conduct of Research (Component of Candidate Information)

Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

Research Strategy (Component of Research Plan)

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.

Letters of Reference

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the appropriate required reference letters will not be reviewed (more details in the Notice). This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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.

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 SF 424(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.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the NCI Referral Office by email at ncirefof@dea.nci.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Cover Letter: The PHS398 cover letter must include the list of referees (including name, department affiliation, and institution.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Overall Impact

Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.

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.

Candidate

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

Research Plan

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Environment & Institutional Commitment to the Candidate

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/priority score, but will not give separate scores for these items.

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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/priority score.

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions: Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, and laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years?  Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

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) Genome Wide Association Studies (GWAS).

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) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

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

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Within ten years of making awards under this program, NCI will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program.  Upon the completion of this evaluation, NCI will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program. 

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

John O. Ojeifo, M.D., Ph.D., M.B.A.
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: 240-276-6186
E-mail: ojeifojo@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)

Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
Telephone: 240-276-6390
E-mail: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Barbara J. Liesenfeld 
Office of Grants Administration 
National Cancer Institute (NCI)
Telephone: 240-276-6294
E-mail: liesenfeld@nih.gov

Section VIII. Other Information

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

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 Parts 74 and 92.  


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