Part I Overview Information

Component of Participating Organization
National Cancer Institute (NCI), (http://www.nci.nih.gov/)

Title: Paul Calabresi Career Development Award For Clinical Oncology (K12)

Announcement Type
This is a reissue of PAR-04-096, which was previously released April 23, 2004.

Update: The following updates relating to this announcement have been issued:

• March 26, 2010 - This PAR has been reissued as (PAR-10-155).
• March 23, 2010 - See Notice NOT-OD-10-069 This notice terminates the Institutional Research Training and Institutional Research Career Development Programs listed below because they provide application instructions for paper submissions using the PHS 398 forms.
• July 10, 2009 - See Notice NOT-CA-09-030 The purpose of this Notice is to extend the Expiration Date.
• April 2, 2009 - Change in allowable salary levels on Career Awards supported by the National Cancer Institute (see Notice NOT-CA-09-022).
• February 9, 2009 - See Notice (NOT-CA-09-013) The National Cancer Institute (NCI) is announcing a change in allowable levels of salary support .
• May 30, 2008 - See Notice (NOT-CA-08-022) Correction of Application Receipt and Expiration Date.

Program Announcement (PA) Number: PAR-06-449

Catalog of Federal Domestic Assistance Number(s)
93.398

Key Dates
Release Date: June 7, 2006
Letters of Intent Receipt Date(s): 30 days before Application Receipt Date(s)
Application Receipt Date(s): Standard dates of Receipt/Submission Cycle II apply (please see http://grants.nih.gov/grants/funding/submissionschedule.htm)
New Application Receipt Date(s): June 1, 2007; June 12, 2008; June 12, 2009
Competing Continuation, Revised, Supplemental Application Receipt Date(s): July 1, 2007; July 12, 2008; July 12, 2009
Peer Review Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: (Now Expired March 24, 2010 per NOT-OD-10-069), New Date July 13, 2010 (per NOT-CA-09-030) Original Date: July 13, 2009

Additional Information:
NCI Cancer Training Branch Website for the K12 (go to http://www.nci.nih.gov/researchandfunding/training/K12).

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

• The goal of the Paul Calabresi Award for Clinical Oncology (PCACO) is to ensure a cadre of medical doctors and basic science researchers who can collaborate with each other to design and implement hypothesis-based translational therapeutic research.
• The purpose of the PCACO is to increase the number of medical doctors (M.D. s, D.O. s), and doctorally-degreed nurses (Ph.D.’s or equivalents) and basic research scientists (Ph.D. s, D.V.M. s, or equivalents) who are highly-motivated and trained to: 1) primarily perform clinical oncology therapeutic research that develops and tests scientific hypotheses based on fundamental and clinical research findings; 2) design and test hypothesis-based, clinical therapeutic protocols and adjunct biological analyses and for clinician candidates to administer all phases (i.e., pilot/Phase I, Phase II, and Phase III) of cancer therapeutic clinical trials, and (3) conduct cancer therapeutic research in team research settings in which basic research and clinical scientists 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 laboratory-based scientists whose research will emphasize the use of animal or other model systems.
• The PCACO application may be submitted on behalf of the program leader (principal investigator or PI) by for-profit or non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; and domestic institutions or organizations. Foreign institutions are not eligible to apply.
• A PCACO can support the research career development of clinicians only or clinicians and Ph.D. basic research scientists. If Ph.D. research scientists are included, the ratio of clinician candidates to basic research scientists must not go below 2:1.
• Each PCACO involves a program leader, clinical mentors, and candidates representing at least two clinical oncology disciplines, and an Advisory Committee to provide an oversight function and annual evaluation of the Program as a whole.
• Each PCACO includes specific didactic, clinical research and basic science research core components that an appointee must complete in order to graduate from the program; and a plan for recruitment to enhance diversity.
• The program leader is the PI. The program leader must be an established investigator in patient-oriented research and must be able to provide both administrative and scientific leadership to the Program. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Candidates for appointments to the PCACO must be citizens or non-citizen nationals of the United States (U.S.), or must have been lawfully admitted to the U.S. for permanent residence. Individuals on temporary visas are not eligible. Candidates are appointed for at least 2 years and, contingent on successful renewal, can be supported for up to 7 years. Participants must be committed to a minimum of 75 percent full-time professional effort conducting research and engaging in activities directly related to research career development, which includes all relevant didactic activities during the period of the award.
• Clinician candidates (required): All clinician candidates must currently be physicians holding M.D. or D.O. degrees, or be nurses with Ph.D. degrees; and must have completed the necessary clinical training (i.e., completed residency and are board eligible) to engage in clinical oncology research.
• Basic research science candidates (encouraged, but optional): All basic research science candidates must have doctoral-level degrees (e.g., Ph.D. s, D.V.M. s) or the equivalent, a minimum of 2 years of postdoctoral research training, and a total basic science research experience that is clearly preparatory (e.g., experience with animal models or preclinical research) for devoting a career to human therapeutic cancer research.
• Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. However, awards (renewable) for up to $750,000 annually in direct costs (clinician programs) or up to $1,050,000 annually (programs combining clinicians and Ph.D. s) are made to institutions for up to 5 years.
• Up to $75,000 per annum is provided for a candidate’s salary; and up to $30,000 per annum is provided for a candidate’s research and development support.
• The amount funded for other costs is up to $50,000. This includes up to 10 percent of the PI s/program leader’s salary plus fringe benefits, as well as for a dedicated administrator, and advertising and recruitment of candidates.
• This funding opportunity uses the NIH Mentored Clinical Scientist Development Award Program Award or K12 grant mechanism. Appointees will be considered Paul Calabresi Scholars .
• Awards issued under this funding opportunity announcement are for 5 years and are renewable. Planning, direction, and/or execution of the program will be the responsibility of the program leader/PI and the Advisory Committee on behalf of the applicant institution.
• The NIH will not accept any application in response to this funding opportunity announcement that is essentially identical to one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially identical to a previously reviewed application. This does not preclude the submission of a substantial revision of an application already reviewed, but such applications must include an Introduction addressing the previous critique.
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Review and Selection Process
2. Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The objectives of the Paul Calabresi Award for Clinical Oncology are to:

• Encourage medical doctors (e.g., M.D., D.O.) to dedicate their careers to the design and conduct of hypothesis-based clinical therapeutic research;
• Encourage basic research scientists (e.g., Ph.D., D.V.M., or equivalent) to dedicate their careers to patient-oriented, clinical therapeutic research; and
• Develop a cadre of medical doctors and basic science researchers who know how to work effectively in collaborative, team research settings.

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. Studies falling under exemption 4 for human subjects research are not included in this definition.

In 1991, the NCI recognized the need for establishing formal training programs that would prepare the next generation of clinical scientists to participate more effectively in translational research. The NCI embarked on a pilot program initiative that would prepare clinical oncologists to be effective scientific partners with basic research/behavioral scientists in the movement of discoveries in the laboratory into patient research settings or, conversely, back into a laboratory research setting. These well-trained clinical oncology researchers would be expected to communicate, interact, and collaborate with basic research /behavioral scientists in the design and implementation of clinical trials that were hypothesis driven and based on an understanding of biological mechanisms. This pilot program initiative was implemented through two successive Requests for Applications (RFAs ) in 1992 and 1997.

The initial pilot program was highly successful and generated considerable interest in the cancer research community. It therefore became clear that NCI objectives would be better served by making this grant mechanism open to investigator-initiated applications on a regular basis using a Program Announcement (PA). As a result, in 1998 the NCI established the Institutional Clinical Oncology Research Career Development Program (K12) as an ongoing PA with a once-per-year submission date. In 1999, the NCI extended eligibility for an appointment to an NCI K12 grant to include doctoral-level oncology registered nurses, in recognition of the critical role of nursing in general and oncology nursing in particular in clinical cancer research and care. Finally, in view of the continuing commitment of the NCI to increase the participation of individuals from underrepresented minority groups in biomedical and behavioral research and the critical need for more underrepresented minorities in clinical oncology research, the PA was reissued in 2003 and required that all competing applications for the Institutional Clinical Oncology Career Development Program (K12) grant include a specific plan to recruit and retain underrepresented minorities as award recipients.

The focus of this program has always been the career development of medical doctors in translational therapeutic research, with a focus on the patient rather than the laboratory-based aspect of translational research. To this end, the program specifically required that clinical candidates obtain a basic science research experience. The intent of this requirement was to enhance their ability to collaborate and communicate with basic research scientists successfully in the translational research process, not to enhance their ability to pursue a laboratory-focused career in basic science or translational research. It is now clear that translational therapeutic research of the future will require both dedicated clinician scientists and basic research scientists working in team research settings. Consequently, in 1994 the Program was changed from supporting only clinician scientists to one that supports both clinician scientists and basic research scientists as a collective in order to further enhance career development that emphasizes basic research /clinical scientific interactions and team research concepts. Additionally, the program was renamed the Paul Calabresi Award in Clinical Oncology in honor of the late Dr. Paul Calabresi, who was a pioneer in the pharmacological treatment of cancer and early translational research. This honor is in recognition of Dr. Calabresi’s humanity, dedication to his patients, mentorship of young clinical oncologists, contributions to understanding and treating cancer, tireless efforts to promote and develop the field of clinical oncology; and ceaseless service to the National Cancer Institute including his participation in the strategic development of the Nation’s War on Cancer. Most of all, this award is intended to symbolize the quality and excellence of physician scientists and the non-clinician translational researchers that NCI hopes will become critical contributors to the future elimination of death and suffering from cancer.

The NCI Paul Calabresi Award in Clinical Oncology (K12) is consistent with the objective of the NIH Roadmap Initiative to build a strong clinical research infrastructure and increase interactions between clinical and basic research scientists in translational research. Appointees to the program will be referred to as Paul Calabresi Scholars .

Individuals with clinical doctoral degrees seeking a career development experience exclusively in laboratory-based research should refer to the NIH Mentored Clinical Scientist Career Development Award or K08 at the following website: http://grants.nih.gov/grants/guide/pa-files/PA-00-003.html. Individuals with clinical degrees interested in patient-oriented research should refer to the NIH Mentored Patient-Oriented Research Career Development Award or K23 at the following website: http://grants.nih.gov/grants/guide/pa-files/PA-05-143.html. Postdoctoral individuals (e.g., Ph.D. s) trained in basic science research, who wish to change direction and focus their research careers on human cancer, should refer to the NIH Pathway To Independence (PI) Award (K99/R00): http://grants.nih.gov/grants/guide/pa-files/PA-06-133.html.

Key elements to the award in addition to the PI/program leader, Advisory Committee, faculty, mentors, and scholars are:

Environment: The research environment should be one in which there are active science/clinical research collaborations that exemplify a dynamic two-way exchange of information and ideas between research and clinical scientists.

Career Development Program for Individual Scholars: The award provides a minimum of two and up to seven consecutive 12-month appointments. At least 75 percent of the appointee’s full-time professional effort must be devoted to the program, although 100 percent effort may be requested. The remainder of the scholar’s time should be devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. The scholar is expected to develop knowledge, skills, and expertise in POR relevant to her/his career goals and the objectives of the PCACO. The program for each scholar should be tailored to their specific needs in terms of prior research/clinical experience, core requirements of the PCACO and the career goals of the scholar.

See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.


Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Mentored Clinical Scientist Development Program Award (K12) institutional award mechanism.

As an applicant, the PI will be solely responsible for planning, directing, and executing the proposed institutional career development program.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

Because the nature and scope of the proposed career development /research program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Awards are made for 5 years and are renewable. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Allowable Costs

1. Direct cost limits: An application which supports only clinician scholars must not exceed $750,000 for direct costs per year. An application which supports both clinician scholars and basic science scholars must not exceed $1,050,000 for direct costs per year.

2. Scholar Salary: The NCI will provide support for each scholar position up to $75,000 salary and associated fringe benefits per year based on a full-time professional 12-month effort commensurate with the applicant institution’s salary structure for persons of equivalent qualifications, experience, and rank.

The total salary requested must be based on a full-time, 12-month staff appointment and requires scholars to devote a minimum of 75 percent of full-time professional effort to conducting career development and health-related research with the remaining effort being devoted to activities related to the development of a successful research career. For information regarding NIH policy on determining full-time professional effort for career awards, see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.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. Candidates with VA appointments should contact the staff person in the relevant Institute prior to preparing an application to discuss their eligibility.

The proposed salary must be consistent both with the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. 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. Confirmation of salaries may be required prior to the issuance of an award.

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. 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.

Effective for all competing research grants submitted for the February 1, 2004, deadlines and beyond, 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 PI or subproject director. This new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

3. Research and Development Support: Up to $30,000 per individual scholar may be provided for the following types of 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 research 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 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.

4. Other Costs: This category is capped at $50,000, and up to 10 percent of the PI/ program leader’s salary plus fringe benefits will be provided for leadership, management, coordination, and evaluation of the program in accordance to the percent effort commitment to the program. Some partial salary plus fringe benefits may be provided for a dedicated administrator. Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally. While mentors may not receive salaries or fringe benefits on this career development award, any lab fees associated with their mentorship may be included in this other costs category.

5. Facilities and Administrative (F&A) costs will be reimbursed at 8 percent of modified total direct costs.

6. Facilities and administrative costs requested by consortium participants are included in the total cost limitation (see NOT-OD-05-004). Such costs, however, are limited to 8 percent of modified direct costs.

7. Carryover of unobligated balances: Although the K12 is subject to expanded authorities, the carryover of funds from one budget period to the next requires prior written approval by NCI.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization has any of the following characteristics:

• For-profit organization;
• Non-profit organization;
• Public or private institution, such as a university, college, hospital, and laboratory; and
• Domestic Institutions

Foreign institutions are not eligible to apply.

1.B. Eligible Principal investigators

The program leader is the PI. The program leader must be an established investigator in patient-oriented research who is able to provide both administrative and scientific leadership to the program.

1.C. Eligible Candidates For Appointments

Clinician Candidates (required): All clinician candidates must currently be physicians holding the M.D. or D.O. degrees, or be nurses with a Ph.D. degree; and must have completed the necessary clinical training (i.e., completed residency and are board eligible) to engage in clinical oncology research.

Basic Science Candidates (encouraged but optional): All basic science candidates must have doctoral-level degrees (e.g., Ph.D., D.V.M.) or the equivalent, a minimum of 2 years of postdoctoral research training, and a total basic science research experience that is clearly preparatory (e.g., experience with animal models or preclinical research) for devoting a career to human therapeutic cancer research.

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident, are eligible for an appointment to the K12 program. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Individuals who may have been or currently are a PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions of an R03 or R21 grant remain eligible for an NCI K12 appointment.

Individuals are NOT eligible for an appointment if they:

• have been or are currently PIs on an NCI or NIH individual mentored career development career, e.g., K01, K07, K08, K23 award; an NCI Transition Career Award (K22); the Pathway to Independence (K99/R00) award; or non-PHS equivalents;
• have been or are currently a PI on NIH research grants (such as R01, Program Project (P01) or Cancer Center (P50) grants or subprojects of such grants); and
• have been or are currently a PI on peer-reviewed non-NIH research grants over $100,000 in direct costs per year intended for faculty independent investigators.

Due to the emphasis of the K12 on patient-focused research, clinician scholars appointed to a K12 grant are encouraged to subsequently apply for a K23 and not a K08 if they need additional mentored career development; a K99/R00 if they need additional mentored career development (K99) and will then transition to the independent stage of their research career (R00); or for a patient-oriented NCI K22 if they need protected time to develop their independent patient-oriented research or patient-focused translational research program in their first independent research position.

Recipients of a K12 appointment may hold concurrent research support (and under certain circumstances (see Allowable Costs below) salary support) from their appointment and a competing NIH research project grant (RPG) when recognized as a PI or subproject director of the RPG (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) if they have first completed at least 2 years of training supported by the K12 grant.

Applicants are strongly encouraged to consult with the scientific/research contact person listed in Section VII of this announcement prior to the submission of an application to discuss eligibility and program requirements.

2. Cost Sharing or Matching

Cost sharing, matching, or cost participation is not required.

3. Other-Special Eligibility Criteria

All clinician and basic science Ph.D. scholars must satisfy the following additional requirements:

Special Requirements

Other training programs: Where there already exists an active Ruth L. Kirschstein (T32) National Research Service Award (NRSA) or other institutional career development program (e.g., NCI and NIH Roadmap K12, K30, General Clinical Research Core [GCRC] Scholars Program) overlap between these programs must be eliminated and/or the NCI Paul Calabresi Award for Clinical Oncology (K12) structured in a way to complement and take advantage of these other career development/training programs. This may require merging components of other programs with the NCI K12 or linking curriculum programs (e.g., K30) with the core requirements of the NCI K12.

• Institutions require NCI approval to submit an application if another NCI K12 exists at the institution.
• Institution: The institution must have substantial support for peer-reviewed basic science and clinical research and an adequate number of faculty qualified in patient-oriented therapeutic research, translational research, and basic science cancer research to serve as mentors in the proposed Program.
• Environment: The research environment should be one in which there are active basic science/clinical research collaborations that exemplify a dynamic two-way exchange of information and ideas between basic science research and clinical scientists.

Special Program Requirements

• Program Management: The 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 clinician, nurse, and basic science scholars (Note: basic science scholars are encouraged as part of these Programs but they are optional), 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, and annual written reports from the AC are required that describe the progress (e.g., success of scholars in achieving core didactic and research requirements) of the Program, evaluate its effectiveness (e.g., recruitment methods, effectiveness of mentors, effectiveness and appropriateness of curriculum), and provide recommendations for improvements. This annual report must also address the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds in the Program (see below).
• Appointees to the Program must be designated Paul Calabresi Scholars.
• The program may be completely devoted to clinician scholars. If Ph.D. basic science scholars are included (and this is encouraged), the ratio of clinician scholars to basic science scholars must not go below 2:1 at any time.
• The program must involve clinical and basic science mentors and scholars representing at least two clinical oncology disciplines such as medical oncology, surgical oncology, radiation oncology, pediatric oncology, gynecologic oncology and oncology nursing. Clinical scholars from non-oncology medical subspecialties (e.g., thoracic surgery, pulmonology) may also be represented in the Programs. However, the research career objectives of these scholars must clearly be the application of their medical training and research experience to research in clinical oncology; and the individualized career development plans developed for these scholars must be focused on clinical oncology research.
• The program may optionally involve basic science (Ph.D. degrees or equivalent) scholars. These scholars must have both clinical and basic science research mentors; and their research career focus must be on working with clinicians to translate the results of basic science laboratory findings into therapeutic cancer clinical trials.
• The program must motivate and train scholars to: 1) perform clinical oncology therapeutic research that develops and tests scientific hypotheses based on fundamental and clinical research findings; 2) design and test hypothesis-based clinical therapeutic protocols and adjunct biological analyses; 3) for clinician scholars, administer all phases (i.e., pilot/Phase I, Phase II, and Phase III) of cancer therapeutic clinical trials, and (4) conduct cancer therapeutic research in team research settings in which research and clinical scientists collaborate and interact to expedite the translation of basic science research discoveries into patient-oriented therapeutic cancer research.
• The program may be used to train scholars to conduct chemoprevention cancer clinical trials in addition to therapeutic cancer clinical trials. However, this will require prior approval of NCI Program staff; and it is expected that the scholars will be provided a hands-on experience in all facets of these trials from design to development to implementation. The conduct of chemoprevention trials cannot replace the requirement for substantive hands-on experience in the design and implementation of hypothesis-based therapeutic cancer clinical trials.
• Programs should have the flexibility to accommodate scholars with different levels of research experience and competence. (See below regarding Core Requirements. )
• A specific plan must be provided to recruit and retain individuals from underrepresented and disadvantaged groups in the Program. In addition, all future Non-competing Grant Progress Reports must include a separate section in the annual written report of the AC (see 1 above) that reports on the recruitment and retention of individuals from underrepresented and disadvantaged groups during the previous award period and makes recommendations for altering the plan, as necessary, to improve its effectiveness.
• Appointments of all scholars to the program should be for a minimum of 2 years. Contingent on successful competitive renewal of the program, individual clinician scholars can be supported for up to 7 years; basic science scholars may be supported for up to 5 years. All scholars must be able to commit a minimum of 75 percent of a full-time professional effort to the Program. The remaining 25 percent can be divided among other clinical and teaching activities only if they are consistent with the Program goals (i.e., the scholars development into effective scientists as either independent clinical investigators and/or clinician/basic science research co-leaders able to assemble and manage effective therapeutic research teams).
• The program must include specific Core Requirements that each scholar is expected to complete in order to meet the Program's training objectives. All scholars graduating from the program must complete all of these requirements either directly in this Program or through a combination of past training experience and work conducted in this Program. These requirements should include the following:
• A DIDACTIC CORE REQUIREMENT (e.g., formal courses in clinical trial design, biostatistics, informed consent, Institutional Review Boards, data safety and monitoring, lecture series, seminars, and journal clubs) based on the experience and needs of each candidate. The requirements for this core component should be the same for all scholars whether or not they have clinician or basic science research backgrounds.
  1. A CLINICAL RESEARCH CORE REQUIREMENT that provides "hands-on" experience (e.g., protocol development; preparation of IRB applications; administration of clinical trials including patient accrual, analysis of outcomes) in all aspects of Phase I, Phase II, and where possible Phase III clinical trials. Except for the administration of treatment to patients, this component should be the same for all scholars whether or not they have clinical backgrounds or basic science research backgrounds. Basic science scholars are expected to be full partners with clinicians and become equally proficient in the design and the evaluation of results from translational, therapeutic clinical trials.
  2. A BASIC SCIENCE RESEARCH CORE REQUIREMENT that provides a hands-on research experience for CLINICIAN scholars for up to 2 years that results in a peer-reviewed publication(s) and that clearly serves as a tool for ensuring that these scholars are fully prepared to communicate, coordinate and collaborate with basic research scientists in the conduct of hypothesis-driven cancer therapeutic research. Ideally, this experience should be linked to the core clinical research component.
• The expectation of the NCI is that clinician and basic research science scholars will enter the Program with different levels of experience that already satisfy many of the Didactic, Clinical Research, and Basic Science Research Core Requirements. Thus, individual scholars will need to complete only those additional didactic and research experiences that help them meet all of the core requirements of the Program and are likely to be supported by the Program for different periods of time.
• Although the submission of applications by scholars for investigator-initiated research project grants is encouraged, the core requirements cannot mandate scholars receipt of an investigator-initiated research project grant.
• All scholars who successfully complete the program are expected to receive some formal recognition from the parent institution (e.g., Masters in Clinical Research degree or special certification in clinical research).
• If basic science scholars are included in the Program, special efforts must be made to treat the clinician and basic science scholars as a COHORT with regard to sharing, presenting, and discussing their research career development and training experiences.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact GrantsInfo; Telephone: (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Applicants should follow the instructions in the PHS 398 application for Individual Research Career Development Awards (Section III)) and complete ALL the required sections with the following modifications:

SUPPLEMENTARY INSTRUCTIONS

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, follow the modified instructions below in preparing an application for an NCI Paul Calabresi Clinical Oncology Award (K12). These instructions have been adapted to accommodate the Form PHS 398 and the special needs of the K12 grant application.

1. Face Page: Use Form Page 1 of the Form PHS 398. On Line 1, include the title that best represents the nature of the career development program. On Line 2, provide the number of this Program Announcement beginning with PAR- , and the title "Paul Calabresi Clinical Oncology Award" of the Program Announcement. The Program leader will be the PI of the grant application.

2. The Description/ Performance site(s)/ Key personnel (Form Page 2 of Form PHS 398): Complete as directed in the Form PHS 398. The information provided should include the PI, Advisory Committee members, mentors, and other faculty participating in the program.

3. Table of Contents to be organized as follows:

• Section I. Basic Administrative Information:
  1. Face Page
  2. Description/Key Personnel
  3. Table of Contents
  4. Statement of Commitment
  5. Detailed Budget Page for the initial budget period
  6. Budget for Entire Proposed Period of Support
  7. Biographical Sketches (not to exceed four pages per individual)
     1. Principal investigator (PI)
     2. Advisory Committee Members
     3. Mentors, Other Faculty
     4. Scholars (if available)
  8. 8. Research Base/Resources and Facilities
• Section II. Specialized Information
  1. Career Development/Training Plan (There is no page limit, but it is suggested that applicants be as clear and brief as possible; tables should be included in the text, not as appendices.)
     1. Introduction to Revised Application (when applicable, not to exceed 3 pages)
     2. Purpose and Objectives
     3. Research Environment
     4. Description of Didactic, Clinical Research, and Basic Science Research Core Requirements
     5. Program Management
        1. Principal investigator (PI)
        2. General Recruitment Strategies
        3. Recruitment of underrepresented minorities
        4. Evaluation Plan
        5. Advisory Committee
        6. Individual Career Development Plans
        7. Progress Report (for Competing Renewal Applications)
  2. Human Subjects
  3. Vertebrate Animals
  4. Checklist
  5. Appendices

Detailed instructions for Table of Contents Section I:

Item 4. Statement of Commitment: This statement should guarantee that all scholars participating in this Program Announcement will commit a minimum of 75 percent of a full-time professional effort to research and research career development.

Item 5. Detailed Budget for the Initial Budget Period: Provide detailed budget information with regard to salary and fringe benefits, supplies, travel etc. specified for each scholar by name or by position, if there is no one available to fill the position. Note that there is an upper limit of salary of $75,000 plus fringe benefits, an upper limit for other costs of $30,000 per scholar; and a required minimum 75 percent effort.

Item 7. Biographical Sketches: Provide biographical sketches using the Biographical Sketch Format Page of the Form PHS 398. Group the biosketches into the following five sections: (1) PI; (2) K12 Advisory Committee Members; (3) Mentors; (4) Other Faculty; and (5) Scholars

(when available).

Item 8. Research Base/Resources and Facilities: Provide in a tabular format the information described below. Suggested tabular formats for this information can be found under "Summary Information on Program" as a Word document (http://www.cancer.gov/images/Documents/05e19eb1-9d9c-4168-88e8-fddc0e7bbf5f/k12table.doc or as an Acrobat file (http://www.cancer.gov/images/Documents/05e19eb1-9d9c-4168-88e8-fddc0e7bbf5f/k12table.pdf)

• Provide the current number of faculty members in each participating unit and department, as well as the total numbers of current predoctoral students and postdoctoral trainees in all ongoing programs. (Suggested Table 1)
• Provide for each participating department/ unit the names of the proposed K12 faculty, their relevant degrees, current position title, number of each type of current trainees (predoctoral, M.D. s, other postdoctoral trainees) and total number of each type of trainees (predoctoral, M.D. s, other postdoctoral trainees) for the past 10 years. For competing renewal applications, additionally whether the proposed faculty were also faculty during they have been K12 faculty. (Suggested Table 2).
• List all current and pending training support available to the participating faculty and department(s) that can support postdoctoral training. Include funding source; complete identifying number; title of the training program; name of the PI; project period; number of training positions (predoctoral and postdoctoral); and amount of the award. For each grant listed, name only those participating faculty members who are also named in this application and indicate their percent effort in those programs. Mark with an asterisk faculty from the previous award period of the grant. (Suggested Table 3).
• For each participating faculty member indicate current (active) and pending research support that will provide the context for research training experiences. Include all Federal, non-Federal, and institutional research grant and contract support. If none, state "None." Include the source of support, grant number and title, dates of the entire project period, and annual direct costs. If part of a larger project, identify the PI and provide the above data for both the parent grant and the subproject. Provide the role of the participating member on the source of support and their percent effort commitment. (Suggested Table 4)
• For each faculty member participating in this application, list all past and current students for whom the faculty member has served, or is serving, as thesis advisor or sponsor (limit to past 5 years). For each student listed, indicate: (1) the training level, either predoctoral or postdoctoral; (2) the training period; (3) the institution and degree received prior to entry into training, including date; (4) title of the research project; and (5) for past students, their current positions, and for current students, their source of support. If students were trained by proposed faculty members at sites other than the applicant organization, name these sites. For competing renewal applications, mark with an asterisk the names of those individuals who are currently training on this grant. (Suggested Table 5).
• For New competing applications only, list representative recent publications of some of the above students/trainees named in Suggested Table 5. Individuals who were trained by proposed participating faculty members at sites other than the applicant organization may be included but should be specifically identified. (Suggested Table 6)
• For each participating department/unit for each of the past 5 years, provide the characteristics of prospective candidates meeting all of the eligibility requirements for K12 candidates. (Suggested Table 7 for New and Table 6 for Renewal competing applications) Information on clinicians should be categorized by medical specialty. Include the following information:
  1. Number of individuals who have formally applied for the career development/training program;
  2. Number offered admission;
  3. Number who entered the career development/training program;
  4. Number who completed or are currently in the career development/training program; and
  5. Number who left before completion of the career development/training program.
• For programs selecting individuals exclusively from candidates who are recruited on an academic department(s) or program basis (viz. to department of hematology or interdepartmental program in cancer therapeutics), provide data for each of the participating departments/programs, including only those postdoctoral applicants who could be considered eligible scholars for the proposed career development program. For programs selecting trainees exclusively from candidates who are recruited directly to the laboratories of the proposed faculty mentors, list only those scholars who were actually in the laboratories of the faculty mentors and could be considered for the program.
• Indicate the credentials and application outcomes of the eligible scholar pool as projected for the first year of the career development program for each participating department/program. For each candidate, indicate the previous institution attended, degree(s) and year(s) awarded, and residency training/ thesis research topic with preceptor name. Also indicate whether candidates were or were not offered admission and which applicants entered the K12 program. (Suggested Table 8 for New and Table 7 for renewal competing applications)
• For New competing applications, provide recruitment statistics indicating the number of individuals from underrepresented racial and ethnic populations, individuals with disabilities, and individuals from disadvantaged backgrounds meeting the K12 eligibility requirements who applied to the participating departments/units in each of the past 5 years. Give the number of individuals from those groups offered admission and the number who entered the participating departments/units. (Suggested Table 9)
• For competing Renewal applications, provide recruitment statistics indicating the number of individuals from underrepresented racial and ethnic populations, individuals with disabilities, and individuals from disadvantaged backgrounds meeting the K12 eligibility requirements who applied to the K12 program and/or participating departments/units in each of the past 5 years:
  1. Give the number of eligible individuals from the above mentioned populations applying, the number offered admission and the number who entered the participating departments/ units and the K12 program (competing renewal applications). (Suggested Table 8)
  2. For those who entered the program during the past 5 years, for each year of the K12 program indicate anonymously (identified with an anonymous number in sequence, rather than by name, to safeguard privacy), and by participating department/unit their current status (e.g., training, graduated or completed training) and how they were supported. For those who have left the program or completed training, include information about their subsequent career development or employment. Do not include in these statistics individuals supported by CURE supplements to the K12 program. (Suggested Table 9)

1. Describe for each year of the current project period, the program's actual assignment of awarded scholar positions. Provide: (1) the total number of appointments in each year; (2) the medical subspecialties of the scholars and the number of scholars in each subspecialty; (3) the academic status of each scholar, and for individuals in fellowship training the year of their training; (4) months of support committed. Do not include individuals supported by a CURE supplement to the K12 program.
2. List all scholars who were, or are, supported by this institutional career development grant during the past 5 years. Do not include individuals supported by a CURE supplement to the K12 program. For each scholar, provide (1) the name; (2) year of initial appointment; (3) degree(s) at time of initial appointment; (4) medical specialty (subspecialty) at time of entry into the program; (5) prior institution; (6) the source of support during each year of career development/training, e.g., this career development grant, another (specify) training grant, research grant, university fellowship, individual (specify) fellowship, etc.; (7) the research topic and the research mentor; and (8) for scholars who have completed the program, their current position title and institutional affiliations. For the convenience of the reviewers, it could be useful to generate an accompanying summary table showing by medical subspecialty, the numbers of scholars going into academics, government, industry or clinical practice after leaving the K12 program (do not include in this summary trainees supported by a K12 CURE supplement).
3. Summarize the achievements of the K12 scholars during the past 5 years. Provide: (1) the name of the scholar; (2) the names of the scholars’s clinical mentor(s) and basic science research mentor(s); (3) full citations of publications resulting directly from the K12 institutional career development program; and (4) descriptive titles of clinical trials developed and/or implemented by the scholar as a direct result of the K12 program, including the trial type (Phase I, Phase, II, Phase III), and the role of the scholar in the trial (Pi, co-PI, etc.).

Detailed instructions for Table of Contents Section II.

Item 1. Part b. Purpose and Objectives: Briefly describe the background, purpose and objectives of this career development Program. This description should identify two or more clinical oncology disciplines represented in the Program and a discussion of the strategies to be used to ensure that the representation in each discipline in the mentor population and the trainee population will satisfy the intent of this NCI requirement. The description should clearly show how the purpose and objectives of the Program will meet the broader objectives and intent of the NCI to prepare clinician and where appropriate basic science scholars who can design and implement all phases of clinical trials and who can effectively work together in team research settings in patient-oriented therapeutic cancer research.

Item 1. Part c. Research Environment:

Research Base: Describe the existing funded laboratory and patient-oriented research activities and the interactive nature of the research environment that will meet and sustain needs of this Program. Include in this description the number and types of early to late phase clinical therapeutic clinical trials being conducted in the institution, the general range of activities in these trials and, wherever present, the hypothesis-based translational nature of these activities.

Resources and Facilities: Describe the research infrastructure, patient populations, facilities, etc., that are available and accessible to this Program.

Mentors: Describe the pertinent research experience and track record in training cancer clinician scientists (and, for combined clinician-basic scientist programs, translational Ph.D. cancer researchers) of each mentor participating in the Program.

Item 1. Part d. Description of Didactic, Clinical, and Basic Science Research Core Requirements:

Describe separately the core didactic, core clinical research, and core basic science research experiences that each clinician and basic science scholar must complete to satisfy the overall Core Requirements of the Program. If there are existing institutional K30 or GCRC Scholar programs, or an NIH Roadmap K12 or other NIH K12 programs, explain how the NCI K12 Program will link with and make use of these programs to meet the objectives of the NCI K12 core didactic component. Using specific, real, or hypothetical examples, describe how individualized scholar career development plans will be developed that take into account past experiences and competencies before providing new experiences and skills by the Program. Describe the official degree or certification that scholars will receive FROM THE INSTITUTION after completing the Didactic, Clinical Research, and Basic Science Research Core Requirements.

Item 1. Part e, i. Principal Investigator:

Describe the qualifications and role of the PI to provide scientific and administrative leadership and coordination of the Program.

Item 1. Part e, ii. General Recruitment Strategies:

Describe the selection criteria for clinician scholars and, where appropriate, basic science scholars recruited to this Program. Describe the various strategies that will be used to ensure that the different clinical oncology disciplines represented by the Program are included and to ensure an adequate scholar pool. Address the nature of any other competing institutional Programs that might limit the number of scholars and describe the strategies for addressing this competition.

Item 1. Part e, iii: Recruitment and Retention Plan to Enhance Diversity:

Describe strategies for recruitment of individuals from underrepresented groups and from groups that may have been disadvantaged because of disability, economic, educational or any other circumstance that has inhibited their ability to pursue a career in health-related research and how these strategies will be implemented. For the purpose of the K12, an individual is from an underrepresented group if he or she belongs to a particular ethnic and racial group that has been determined by the grantee institution to be underrepresented in cancer-related biomedical, behavioral, clinical, or social sciences research.

Item 1. Part e, iv: Evaluation Plan:

Describe the plans for ongoing evaluation of the scholars, mentors, PI, Advisory Committee (AC), and the overall program. Provide criteria that will be used for this evaluation and describe how the results of the evaluation will be used.

Item 1 Part e, v: Advisory Committee (AC):

Describe how the AC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies in the recruitment and selection of scholars; in the evaluation of special curricula and/or links to curricula developed through a K30 grant (if present); in the monitoring and evaluation of each scholar's progress with recommendations for changes in the training plan, if necessary, or termination of a scholar who is not making adequate progress; and in monitoring and evaluation of the overall effectiveness of the Program.

Item 1. Part e, vi. Individual Career Development/Training Plans:

Provide brief summaries/examples of individual career development/training plans that the Program will employ or has been able to achieve (for competing renewal applications) in preparing clinician and (if relevant) Ph.D. scholars to design, implement, and participate in patient-oriented, therapeutic research and collaborate effectively with each other in translating basic science discoveries into therapeutic clinical trials. If relevant to your K12 program, provide examples of plans for short-term (2 years) appointments.

Item 1. Part e, vii: A progress report (for competitive renewal applications) must be submitted describing:

• The progress made toward achieving the objectives of this program and the intent of NCI;
• Scholar track record; and
• Scholars from underserved/underrepresented groups recruiting and retention track record.

Item 2 Human Subjects: Follow the instructions in Form PHS 398. If an award is made, human subjects may not be involved and appointees may not participate in human subjects related research until a certification of the date of IRB approval or a designation of an exemption has been submitted to the NCI and accepted.

If a clinical trial will be involved, the PI will need to follow current NIH and NCI policies on providing information on data and safety monitoring (DSM). Refer to the following website for information on NCI policies on data and safety monitoring for training awards:

http://www.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines/page4#grants

A detailed DSM plan is not required at the time of application. The application must, however, document an existing procedure for DSM of clinical trials at the sponsoring institution. At the time an award is offered, applicants will need to contact NCI staff for specific instructions on how to fully comply with the requirements for DSM.

Item 3. Vertebrate Animals: Follow the instructions in Form PHS 398. If an award is made, vertebrate animals may not be involved until a certification of the date of the Institutional Animal Care and Use Committee (IACUC) approval has been submitted to the NCI and accepted.

3. Submission Dates and Times

3.A. Submission, Review, and Anticipated Start Dates

Letters of Intent Receipt Date(s): 30 days before Application Receipt Date(s)
Application Receipt Date(s): Standard dates of Receipt/Submission Cycle II apply (please see http://grants.nih.gov/grants/funding/submissionschedule.htm):
New Application Receipt Date(s): June 1, 2007; June 12, 2008; June 12, 2009
Competing Continuation, Revised, Supplemental Application Receipt Date(s): July 1, 2007; July 12, 2008; July 12, 2009
Peer Review Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates of Receipt/Submission Cycle II apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research;
• Name, address, and telephone number of the PI;
• Names of other key personnel;
• Participating institutions; and
• Number and title of this funding opportunity.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Dorkina Myrick, M.D., Ph.D.
Cancer Training Branch
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Blvd., Suite 7019, MSC 8346
Bethesda, MD 20892-8346 (for U.S. Postal Service express or regular mail)Express Mail: Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant and research career award (RCA) application forms found in the PHS 398 instructions. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application including the appendix material must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)

Appendices should be comprised of single-sided, unbound materials, with separators between documents.

3.C. Application Processing

Applications must be received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by NCI staff. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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 which can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Concurrent Awards: Applicants must be aware of the NIH policies associated with other federally sponsored support. An NIH policy change (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) now allows NIH mentored career development award recipients in the final two years of their award, to receive salary support from both their K award and an NIH research grant or subproject. This includes scholars selected to K12 grants. The K-award recipient (K12 scholar) must be the named PI on a competing NIH research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.). Individuals appointed as sub-project director on competing multi-component research or center grant or cooperative agreement after a competing award has been made are not eligible.

The salary requested for the PI and the K12 scholar must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department. The research development support costs allowed for this program must be carefully justified annually and must be consistent with the stage of development of the candidate and the proportion of time to be spend in research or career development activities. These costs are to be associated with each K12 scholar and are not to be regarded as a pooled resource.

Salaries for ancillary personnel support, such as mentors, secretaries, and administrative assistants, are not allowed. Partial salary for a dedicated administrator is allowable. Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally. See Other costs in Section II, 2. Funds Available.

6. Other Submission Requirements

K12 applications do not follow Modular Grant instructions.

Since the PAR states allowable direct costs per year in excess of $500,000, applicants are not required to seek prior approval from NCI programs staff for submission of a K12 application.

In addition to the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III, starting on page 44), the following information must be included in the application:

Training in the Responsible Conduct of Research

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS 398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component.

Plan for Sharing Research Data

A plan for sharing research data is not required.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025)

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the NCI.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by the National Cancer Institute in accordance with the review criteria stated below.

As part of the initial merit review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
• Will receive a written critique; and
• Will receive a second level of review by the National Cancer Advisory Board.

Applications will compete for available funds with all other approved career development award applications. The following will be considered in making funding decisions:

• Scientific merit and quality of proposed applications as determined by peer review;
• Relevance of program priorities; and
• Availability of funds.

The goal of the NCI K12 initiative is to generate a cadre of patient-oriented clinician researchers who can work with Ph.D. basic research scientists (and, optionally, basic Ph.D. research scientists who can work with clinician researchers) to develop and implement all phases (Phase I, II, III) of hypothesis-driven therapeutic clinical trials. In the written comments, reviewers will be asked to evaluate applications in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

• Principal Investigator (PI)
• Advisory committee
• Career Development Program/Core requirements
• Environment
• Mentors
• Scholars
• Institutional commitment
• Responsible Conduct of Research

• Qualifications (and track record for competing renewal applications) of the PI to provide both scientific and administrative leadership of the Program.

• Quality (and track record for competing renewal applications) of the Advisory Committee and appropriateness for performing its critical functions in recruitment of scholars, assignment of mentors, establishment and monitoring of individual career development plans, and evaluating and making mid-course corrections for the Program.
• Additionally, for competing renewal applications, adequacy of addressing any concerns expressed in the Summary Statement for the prior 5-year award.

• Overall merit of the proposed Program (and track record for competing renewal applications).
• Appropriateness and adequacy of the Didactic Core Requirements, Basic Science Research Core Requirements, and Clinical Core Requirements including the end points for completion of the K12 appointment, to train patient-oriented clinical and basic research scientists who can work effectively with each other in a translational, team research setting, in the design and conduct of all phases (e.g., Phase I, Phase II, and Phase III) of hypothesis-driven, therapeutic cancer clinical trials and adjunct biological analyses.

• Quality, sufficiency, and interactiveness of the basic science and clinical research of the institution to provide the environment necessary for the Program to meet its goals and objectives.

• Experience and quality of the mentors to ensure a successful outcome of the Program.

• Adequacy of the plans for recruiting high quality scholars, to ensure a supply of high quality trainees for the Program representing at least two oncology disciplines. Additionally, for competing renewal applications, success of these efforts.
• For K12 programs with a basic science track, adequacy of the plans for recruiting basic science scholars with prior basic science research experience that is clearly preparatory (e.g., experience with animal models or preclinical research) for devoting a career to human therapeutic cancer research. Additionally, for competing renewal applications, success of these efforts.
• Adequacy of the specific measures proposed or taken to recruit individuals from underrepresented racial and ethnic populations, individuals with disabilities, and individuals from disadvantaged backgrounds, as scholars into the Program. This does not include Continuing Umbrella of Research Experiences (CURE) supplements to the K12 program. For competing renewal applications, success

• The strength of the institution's commitment to the Program, especially with regard to ensuring that each scholar will have protected time to commit 75 percent of a full-time professional effort to research career development.

• The degree to which this program is effectively integrated with other existing training and career development programs to avoid duplication and achieve maximum complementarity.

• Appropriateness and adequacy of training in the responsible conduct of research

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

A data sharing plan is not required.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps and at http://ott.od.nih.gov/newspages/rtguide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plans with the awardee before recommending funding of an application. The final version of the resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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 NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following related administrative policies apply generally to NIH Research Career Award ( K ) programs:

A. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may begin requesting 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.

B. Other Income

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

• The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
• The funds may be used for health-related research purposes.
• The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, MD 20892. Checks must identify the relevant award account and reason for the payment.

• The current PI or the awardee institution has submitted a written request for change of PI, countersigned by the appropriate institutional business official, to the NCI Grants Administration Branch with a copy to the NCI Program Director describing the reasons for the change, the biosketch of the proposed new PI including a complete listing of active research grant support.
• The information in the request establishes that the specific aims of the original peer reviewed K12 Program to be conducted under the direction of the new PI will remain unchanged; and that the new PI has the appropriate research and administrative expertise to lead the program.
• The request is submitted far enough in advance of the requested effective date to allow the necessary time for review.

• Appropriate face page (Form Page 1) as instructed in the Form PHS 2590.
• A budget page (Form Page 2) that provides the salary and fringe benefits for each scholar by name or by position if no individual is filling the position at the time of the application. Provide all other budgetary information (e.g., supplies, travel, technical help) by scholar name or by the position broken out specifically for each scholar up to the $30,000 limit.
• A brief description of the Objectives and Goals of the Program.
• A brief summary listing by name delineating which faculty, mentors, and Advisory Committee members have left the Program and which new individuals have been added or are taking their places. Include for each person their degree and department affiliation (or equivalent).
• Biographical sketches of:
  1. New Faculty;
  2. New Mentors;
  3. New Advisory Committee (AC) Members; and
  4. New Scholars
• The biosketches for new faculty/mentors/AC members should include a listing of all active research grant support for which they are the PI or co-investigator. The biosketches for each scholar should include any Board Eligibilities or Certifications.
• Progress of Individual Scholars: For each scholar, provide the start and end dates (if the appointment ended during the reporting period) as mm/yyyy of the appointment to the Program and the cumulative number of years supported by the K12 grant; the names of the basic science and clinical research mentors; and a brief paragraph for each scholar describing progress toward satisfying the Didactic, Clinical Research, and Basic Science Research Core Requirements of the Program and the projected timetable for completing the remaining Core Requirements. The individual reports should also include: 1) A list of publications for the scholar resulting from their work in the Program; and 2) Descriptive titles of clinical trials developed and/or implemented by each scholar and resulting from their work in the program, identifying the role of the scholar in each of the trials.
• A separately attached report from the AC summarizing the actions of the AC during the last year, evaluating the performance of individual scholars and the Program as a whole in meeting its objectives and the intent of the NCI, evaluating the effectiveness of recruitment strategies and providing recommendations for improving the Program (e.g., new mentors, changes in Core Requirements, changes in recruitment strategies etc.) should be included. A special section should be devoted to evaluating the required plan for recruiting and retaining underrepresented individuals from underrepresented population groups with recommendations for changing the plan to improve its effectiveness.

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