Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Paul Calabresi Career Development Award for Clinical Oncology (K12)
Activity Code	K12 Physician Scientist Award (Program) (PSA)
Announcement Type	Reissue of PAR-10-155
Related Notices	April 14, 2016 - This PAR has been reissued as PAR-16-189. 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. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. May 6, 2013 - See Notice NOT-CA-13-010. Notice of Correction to Application and Submission Information.
Funding Opportunity Announcement (FOA) Number	PAR-13-201
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393, 93.394, 93.395, 93.396, 93.398, 93.399
Funding Opportunity Purpose	This funding opportunity announcement (FOA) encourages applications for institutional research career development (K12) programs from applicant organizations that propose to promote the training and career development of clinical trials researchers. The purpose of the Paul Calabresi Career Development Award for Clinical Oncology (K12) is to increase the number of clinicians (M.D.s, D.O.s, Pharm.D.s, nurses with Ph.D.s or equivalent) and Ph.D. scientists who are trained to design and test clinical therapeutic research protocols (pilot/Phase I, Phase II, and Phase III clinical trials), conduct patient-oriented cancer therapeutic research in team research environments, and to support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented research.

Posted Date	April 17, 2013
Open Date (Earliest Submission Date)	May 18, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	June 18, 2013; June 18, 2014; June 18, 2015, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November 2013; October/November 2014; October/November 2015
Advisory Council Review	January 2014; January 2015; January 2016
Earliest Start Date	April 2014,; April 2015; April 2016
Expiration Date	June 19, 2015
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, 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

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

This funding opportunity announcement (FOA) encourages applications for institutional research career development (K12) programs from applicant organizations that propose to promote the training and career development of clinical trials researchers in NCI mission areas.

The purpose of the Paul Calabresi Career Development Award for Clinical Oncology (PCACO) K12 (NIH Institutional Research Career Development K12 grant mechanism) is to increase the number of clinicians (M.D.s, D.O.s, Pharm.D.s, nurses with Ph.D.s or equivalent) and Ph.D. scientists who are trained to design and test clinical therapeutic research protocols (pilot/Phase I, Phase II, and Phase III clinical trials), conduct patient-oriented cancer therapeutic research in team research environments, and to support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented research. A PCACO can support the research career development of senior fellow and/or junior faculty level clinicians (single track) or senior fellow and/or junior faculty level clinicians and postdoctoral Ph.D. scientists (dual track). Clinical and Ph.D. scientists will collaborate and interact to expedite the translation of basic science research discoveries into patient-oriented therapeutic cancer research. The PCACO is not intended to train scientists for laboratory based research.

The NCI embarked on a pilot program initiative in 1991 that prepared clinical oncologists to be effective scientific partners with basic research scientists. These well-trained clinical oncology researchers communicated, interacted, and collaborated with basic research, translational, and behavioral scientists in the design and implementation of hypothesis-driven clinical trials. The initial pilot program was highly successful and generated considerable interest in the cancer research community. This pilot program initiative was further implemented through two successive Requests for Applications, and in 1994, the Program was changed from supporting only clinician scientists to one that supports both clinician and Ph.D. scientists. Later, the program was renamed the Paul Calabresi Award in Clinical Oncology (PCACO) in honor of the late Dr. Paul Calabresi, a pioneer in the pharmacological treatment of cancer and early translational research.

This FOA encourages applications from applicant organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NCI. The NIH K12 grant mechanism (NCI PCACO) is a specialized grant program designed to foster the development of clinical researchers through creative and innovative institutional career development programs.

Unique features of PCACO include:1) a requirement for representation of at least 2 oncology specialties among the faculty and the K12 appointees (Scholars); 2) mentorship by both a basic science cancer researcher and a clinician (patient-oriented) researcher; 3) a requirement for individualized career development programs for the K12 Scholars; 4) for dual track K12 programs, the joint career development of clinicians with Ph.D.s conducting clinical science; 5) Flexibility to accommodate K12 Scholars with different levels of prior research training/experience; and 6) relevant coursework.

The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving federal support.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The total amount awarded and the number of awards will depend upon the number, quality, duration, and costs of the applications received.
Award Budget	Direct costs are limited to $50,000 in the initial year of new (Type 1) programs for curriculum planning and development, advertising and recruiting of the first class of Scholars, and development of individual Scholar's curricula. K12 scholars will begin work in the second year of the grant, where costs are limited to $750,000 annually. For renewal (Type 2) applications, the program may request up to $750,000 annually in each of the 5 years. Funds may be used only for those expenses that are directly related to and necessary for the research training and career development, and must be expended in conformance with OMB Cost Principles and the NIH Grants Policy Statement.
Award Project Period	The project award duration for this funding opportunity may not exceed 5 years.

Personnel Costs	Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds. Up to $10,000 total per annum may be allocated for all PDs/PIs of the K12 programs to partially offset their salaries and associated fringe benefit costs, depending on commitment of effort. The responsibilities of the PD/PI include program development, implementation, management, reporting, outreach and recruitment of scholars, curriculum development and evaluation. These expenses must be itemized in Section A of the R&R Budget. Salary requests for the Program Faculty/Mentors are not allowed. Additional PHS funds may not be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K12 award. However, under expanded authorities, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. For information regarding NIH policy on determining full-time professional effort for career awards, see: http://grants.nih.gov/grants/guide/notice-files/NOT-CA-09-022.html.
Scholar Travel & Scholar Costs	Scholar travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training and career development experience is an allowable scholar expense. Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget. Scholar salaries can be requested up to $100,000, in accordance with K-awardee salary guidelines, along with associated fringe benefits. The total salary requested for Scholars must be based on a full-time, 12-month staff appointment and requires scholar to devote a minimum of 9 person-months of full-time professional effort to conducting career development and health-related research with the remaining effort devoted to activities related to the development of a successful research career. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 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.
Other Program Related Expenses	If applicable and justified, the costs of a consultant, Program Administrator and/or program assistant with responsibilities directly associated with the institutional career development program can be requested, and salaries must be commensurate with institutional policy for similar positions, and specifically identified and justified. When applicable, this expense must be itemized in Section B of the R&R Budget. Other Program-Related Expenses: Travel for key persons and Advisory Committee members must be justified as specifically required by the proposed program and must not duplicate items generally available for similar programs at the applicant institution. These expenses must be itemized in Section D of the R&R Budget. Scholar Research and Development Support: Up to $30,000 per individual scholar may be provided for the following types of research related expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) tuition and fees related to required career development courses and activities; (c) travel to scientific meetings or training; and (d) statistical services including personnel and computer time. These costs must be specifically documented for each individual scholar and must be both specifically and directly related to the scholar's research activities. They cannot be pooled and used for advertising, recruiting, or other programs unrelated or indirectly related to the research activities of individual scholars. It is expected that the K12 scholars will be working in a funded research environment and that support provided by the K12 grant will augment existing research support to include the scholar. These expenses must be itemized in Section F of the R&R Budget. The size of the award is expected to stay within the annual budgetary cap: $750,000 (direct cost)/year for both single-track and dual-track programs, with the exception of the first year of new (Type 1) programs. For new program applications, the budget will total $50,000 direct costs for an initial year of curriculum planning and development, advertising and recruiting of the first class of Scholars, and development of individual Scholar's curricula. K12 scholars will begin work in the second year of the grant. The objective of this initial year is to maximize the productivity of the curriculum planning committee and advisory committee by allowing finalization of the syllabus, and for preparation for scholar training and career development in the second year of the grant. For renewal (Type 2) applications, the program may request up to $750,000 annually in each of the 5 years. Mentored career award recipients in the last 2 years of career award support may hold concurrent support from their career award and a competing NIH research grant when recognized as a PD/PI or subproject director. This policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html. Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, are not included in the direct cost limitation. See NOT-OD-05-004 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html). Candidates who have U.S. Veterans Administration (VA) appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. PD/PIs should contact the NCI prior to appointing any candidates with VA positions to discuss their eligibility.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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)

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals. Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs.

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 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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) 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 6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed Career Development Program 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The PD(s)/PI(s) are expected to have ongoing R01 and/or R01-like cancer focused grant support. (For the K12 program, R01 and/or R01-like awards are grants or contracts of at least 3 years and $150,000/year in direct costs, including those supporting clinical trials).

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 programmatically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicant institutions must also guarantee the required protected time for the scholars selected for support. The application must include a letter explaining the institutional commitment to the proposed institutional research career development program.

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the award. Mentors are expected to have independent R01 and/or R01-like cancer related research support. (For the K12 program, R01 and/or R01-like awards are grants or contracts of at least 3 years and $150,000/year in direct costs, including those supporting clinical trials).

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

Details on citizenship requirements are available in the NIH Grants Policy Statement.

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.

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.

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

The forms package associated with this FOA includes all applicable components, required 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.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following additional modification:

Substitute all references to trainees in the SF424 (R&R) Application Guide with scholars and all references to training in the SF424 (R&R) Application Guide with career development .

Other Attachments

Project Summary /Abstract. Provide an abstract of the entire application, including the long-term goals and objectives of the program. Include the rationale and design of the program, the planned duration of the program and the projected number of scholars.

Advisory Committee.The PD/PI must use an Advisory Committee (AC) to provide an oversight function and annual evaluation of the Program as a whole. The committee's responsibilities should include but are not limited to: selecting K12 Scholars, assigning preceptors, approving each scholar's career development plan, evaluating each scholar's progress, authorizing the termination of a scholar who is not performing adequately, monitoring the overall effectiveness of the program and recommending mid-course changes when needed. A detailed description of the committee's composition, function, and frequency of meetings should be provided. Plans for an annual evaluation of the program by the AC should be described.

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

• Senior/Key Person: The PD/PI (or multiple PDs/PIs) must be included here.
• Other Personnel: complete for all other personnel (including consultants, Program Administrators and program assistants) associated with the institutional career development program. Include here the salary costs proposed for the planned scholars, identifying as the Project Role Scholar .
• Equipment: Do not complete this budget category (does not apply to K12 programs).
• Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the program.
• Participant/Trainee [Scholar] Support Costs: Do not complete this budget category (does not apply to K12 programs).
• Other Direct Costs: Include the funds requested for research development costs allowed for the scholars in the program, using lines 8-10 (when necessary), and itemize as appropriate and allowed for institutional career development program.
• Indirect Costs: Indirect costs are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment) rather than on the basis of a negotiated rate agreement.
• Budget Justification: provide a detailed justification for each category for which funds are requested. For Section F, itemize each category of support costs per scholar and justify. Provide an explanation for all scholar research and development costs in the Budget Justification.

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the following additional instructions:

Particular attention must be given to the required Training Data Tables. See below ("Data Tables") for instructions.

Substitute all references to trainees in the SF424 (R&R) Application Guide with scholars and all references to training in the SF424 (R&R) Application Guide with career development .

Program Plan

Program Administration. Describe the strengths, leadership and administrative skills, and scientific expertise of the Career Development Program PD/PI. Include the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PDs/PIs, address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program.

Program Faculty. Describe in general terms the complementary expertise and experiences of the proposed mentors. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

The mentors should provide evidence of being recognized as accomplished investigators in the proposed research areas and have a track record of success in training individuals who have gone on to become independent investigators. Each mentor must provide a statement of his/her areas of scientific expertise and responsibility. Co-mentors should clearly describe how they will coordinate mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings. The application must include a statement from the co-mentors providing a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the Scholar’s scientific and professional independence will be promoted.

Proposed Career Development Activities. Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the career development program and mentored research experiences and activities. Institutions with existing training or career development programs must explain what distinguishes this program from the others, how the programs will synergize, if applicable, and justify that the faculty, pool of potential scholars, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former trainees/scholars in establishing independent productive scientific careers.

Program Evaluation. Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former trainees/scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing scholars career development and progression, including metrics such as degree completion (if applicable), publications, and subsequent positions. Specified evaluation metrics should be tied to the goals of the program. Evaluation results should be included in future renewal applications and in the Final Progress Report.

Scholar Candidates. Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and the expected career level required for the program. Do not name prospective scholars. Describe plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the evaluation criteria to be used in the selection of scholars. Provide brief summaries of career development plans that the program will employ. The application should contain a description of how career development plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences.

Institutional Environment and Commitment to the Program. The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD(s)/PI(s), other faculty and mentors, and the required protected time for scholars (9 person months, equivalent to 75%) selected for the program.

The sponsoring institution must document a strong, well-established research and career development program. Describe the sponsoring institution’s scientific environment including the resources and facilities that will be available, how the institutional research environment is particularly suited for the development of a career development program.

Recruitment and Retention Plan to Enhance Diversity

Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Additional Instructions for Program Faculty/Mentors and Research Institution

Data Tables

The application is required to include only Tables 2, 4, 5B and 6B (New Applications).

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.

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

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.

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 (SAM). 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.

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

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program 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.

Career Development Program and Environment

Does the proposed program clearly outline a plan to recruit and develop well-qualified new investigators for successful careers as biomedical or clinical researchers?

Is the career development plan likely to contribute significantly to the scientific development of the scholars?

How will implementation of the proposed program advance the objectives of this funding opportunity announcement to promote the training and career development of clinical trials researchers?

Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?

Does the career development plan seem appropriate to promote the professional development of the scholars?

Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate?

Are appropriate timelines indicated for career progression and transition to independence?

Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?

Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?

Is there evidence of appropriate collaboration among participating programs, departments, and institutions?

Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?

Are adequate plans provided for coordination and communication between multiple sites (if appropriate)? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities?

When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

Does the background information for advisory committee members indicate the relevance to the program plan for career development?

Are adequate research facilities and relevant resources being made available for the planned program?

For institutions with other K12 programs, what is the effectiveness of the plan to keep the career development activities of the proposed program distinct from that offered by the other K12 Programs?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

Do the PD(s)/PI(s) and Program Administrator (if applicable) have the experience to develop, direct and administer the proposed program?

Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?

Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track records appropriate for the proposed career development program?

Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

Mentors

Do the Mentors have expertise and experience, as well as track records of past mentoring and training?

Are the quality and extent of the Mentor's roles in providing guidance and scientific advice to the Scholars acceptable?

Are the Mentors currently engaged in relevant research?

Scholars

Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates? Are there well-defined and well justified recruitment and selection strategies? Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of career development program?

What is the quality of plans to identify, recruit, and select candidates, with a commitment to research relevant to the mission of the FOA, and the potential to develop as independent researchers?

Is there an appropriate plan for the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates?

How useful is the program plan as a vehicle for ensuring research training and career development for all Scholars as described in the career development plan?

What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?

Does the program include a plan to recruit, identify, and select candidates with a commitment to research relevant to the objectives of the FOA?

Does the program description include a plan to recruit a diverse group of scholars locally and nationally?

Does the plan for selection of the Scholars include all of the eligibility criteria stated in the FOA?

Training Record

Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?

Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training and career development?

Are the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives?

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

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

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 program.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research.

Has the career development program successfully achieved its stated objectives during the prior project period?

Has the research career development program successfully recruited a diverse pool of scholars (if

applicable)? Has the PD/PI effectively shaped the recruitment plan in response to recruitment

outcomes?

Has the program been of high quality and effective in developing new independent investigators?

Has the program been innovative in the past and does it continue to demonstrate innovation?

Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program’s evaluation?

Revisions

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.

Resource Sharing Plans

When relevant, reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm)

Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html)

Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html.

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address five Instructional Components, Format, Subject Matter, Faculty Participation, Duration and Frequency, taking into account the characteristics of institutional programs, detailed in NOT-OD-10-019. 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).

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 career development program.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, 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.

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 National Cancer Advisory 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.

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

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.

Leave of a K12 scholar to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding institute or center NCI is required. Details on the process for submission of prior approval requests can be found in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch8.htm#prior_approval_requirements).

To obtain prior approval, the award recipient must submit a letter to NCI describing the plan, countersigned by his/her mentor and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

Not Applicable

The Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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.

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the K12 program. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (Form PHS 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more.

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. Evaluation results should be included as part of the final Progress Report.

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 from databases and from participants themselves. Participants 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.

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

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 301-710-0267
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

Mark Damico, Ph.D.
Program Director, Center for Cancer Training
National Cancer Institute
Telephone: 240-276-5630
Fax: 240-276-5659
Email: damicomw@mail.nih.gov

Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
Telephone: 301-496-3428
Fax: 301-402-0275
Email: ncirefof@dea.nci.nih.gov

Barbara J. Liesenfeld
Grants Specialist
Office of Grants Administration
Telephone: 240-276-6294
Email: liesenfb@mail.nih.gov

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 Parts 74 and 92.