NCI MENTORED CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES (K01) Release Date: November 13, 2000 (see replacement PAR-03-016) PA NUMBER: PAR-01-016 National Cancer Institute This Program Announcement (PAR) replaces PAR-98-103, which was published in the NIH Guide on September 18, 1998. PURPOSE The Comprehensive Minority Biomedical Branch (CMBB), Office of Centers, Training and Resources (OCTR), Office of the Deputy Director for Extramural Sciences (ODDES), National Cancer Institute (NCI), invites career development award applications (K01) from underrepresented minority research scientists who have been recipients of uninterrupted support from an NIH Research Supplement for Underrepresented Minority Award or any National Research Service Award (individual F31/F32 or institutional T32) or can demonstrate that they have been supported by any peer reviewed research project grant mechanism (e.g., R01, P01, ACS). This award is for candidates who seek additional support in the basic, clinical and/or population sciences in a mentored research environment with the option to continue with bridging support for their first independent research position. Successful candidates will be provided with special opportunities to enhance their knowledge and understanding of the NIH/NCI peer review system and to develop the skills required to prepare other grant applications (e.g., R01; R03; R21). This award is a novel program that is intended to support and enhance the likelihood of success for underrepresented minority investigators who have committed to basic, clinical, and prevention and population-based research careers in cancer. This PA will expire on October 2, 2002, unless reissued. NIH Grants policies apply to these awards. CAREER DEVELOPMENT OBJECTIVES Environment: The institution must have well-established basic, clinical, and/or prevention and population-based cancer research programs and qualified faculty to serve as mentors. The candidate, mentor and institutional representative must be able to propose an appropriate cancer research/career development program that will maximize the use of relevant cancer research and educational resources. Program: The NCI Mentored Career Development Award (K01) for Underrepresented Minorities can be used by postdoctoral candidates who need five full years of mentored support or by more advanced postdoctoral candidates who need additional mentored research experiences but also plan to use the award to make a transition to an independent position. Accordingly, the award provides up to five consecutive 12-month appointments with the option of involving one or two phases: A mentored phase (Phase I) for one to five years or a mentored phase of one or more years followed by a transition to an independent position (Phase II) in subsequent years. Candidates choosing to apply for Phase I or a combination of Phase I and Phase II must include the appropriate phases in their research plan. Candidates will participate in mentored research activities, which should include writing and submitting manuscripts for publication and presenting at scientific meetings. In addition, candidates will be expected to observe or participate (depending upon prior research experience and/or level of independence and without additional compensation) in the NCI/NIH peer review process, as well as to participate annually in workshops focused on preparing, writing and submitting NIH grant applications; these activities will be coordinated and/or sponsored by the CMBB. Candidate: Candidates must devote at least 75 percent of their professional effort to cancer-related research and peer review activities consistent with the objectives of this award. The candidate must develop knowledge in the basic, clinical, prevention or population-based sciences and the research skills relevant to her/his cancer research field(s). Mentor: The application must include mentoring appropriate to both Phase I and Phase II of the award; that is, mentoring in preparation to become an independent scientist and mentoring to guide the candidate in an independent position in the development of a research program competitive for peer- reviewed research support. The mentor must be a senior or mid-level faculty member with research competence and/or experience appropriate to his/her role. Where feasible, women and underrepresented minority mentors should be involved as role models. Allowable Costs: Salary: This award will provide salary up to $75,000 annually plus fringe benefits. The total salary requested must be based annually on a full-time, 12 month, staff appointment. The candidate must spend a minimum of 75 percent effort conducting cancer research studies, with the remaining effort being devoted to activities related to the development of a successful research career. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. 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 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. Because the salary amount provided by this award is based on the full-time institutional salary, no other PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K01. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. Research Development Support: During Phase I of the award, $30,000 per year will be provided for the following types of expenses: a) research expenses, such as supplies, equipment, and technical personnel; b) statistical services including personnel and computer time; c) tuition, fees, and books related to career development; d) travel to research meetings or for training, and e) travel to an annual two-day NCI awardee meeting and/or peer review related and training expenses. The amount of this support will increase to $50,000 in Phase II when the Principal Investigator moves to an independent research environment, as opposed to the environment provided by a mentor. This could be an independent research position either at the same institution or at a different institution. Ancillary Personnel Support: Salary support for mentors, secretarial and administrative assistance, etc., is not allowed. Facilities and Administration Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. Evaluation: In carrying out its stewardship of human resource-related programs, the NCI/CMBB 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. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award 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: o 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; o The funds may be used for health-related research purposes; o 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, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment; o Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided that these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The NCI will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NCI. Special Leave: Leave 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 NCI is required. To obtain prior approval, the award recipient must submit a letter to the NCI describing the plan, which must be countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution at which 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 NCI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Under unusual and pressing circumstances, an awardee may submit a written request, to the awarding component, for a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. Furthermore, the awardee must submit assurance of his or her intention to return to full-time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may discontinue an award upon determination that the purposes or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons there for the effective date, and the right to appeal the decision. Awardees planning a change of institution must submit to the NCI in advance of the change a written request for transfer, which is countersigned by the appropriate institutional business official including a statement of the reasons for the change and the new sponsor's name and biographical sketch. The awardee must establish in this request that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer reviewed research program. Additionally, the new sponsor must have the appropriate research expertise to supervise the program and sufficient research support to ensure continuation of the research program to the end of the award (initial award) period. Staff within the NCI will review this request and may require a review by an initial review group and/or the National Cancer Advisory Board. Upon approval of this request, a new career award PHS-398 application must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than for the time remaining within the existing award period. Change of Mentor: When a mentor at the grantee institution is to be replaced, the institution must submit a letter from the proposed mentor to document the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the candidate's career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. NCI staff will review the request and will notify the grantee institution of the results of the evaluation. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishing of an award in a situation involving a change of institution. MECHANISM OF SUPPORT Support for this program will be provided through the NIH K01 career development award mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. Applicants may request up to five years of support. Grants are not transferable from one principal investigator to another. Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required progress report. ELIGIBILITY REQUIREMENTS Applicants are encouraged to contact the NCI program staff listed under INQUIRIES regarding their eligibility for this award prior to the preparation of an application. Candidates must meet the following eligibility requirements: o Qualify as an underrepresented minority individual defined as belonging to a particular ethnic or racial group that has formally been determined by the applicant institution to be underrepresented in biomedical and behavioral research (e.g., African Americans, Hispanic Americans, American Indian and Alaska Natives, and Native Hawaiian and Other Pacific Islanders); o Possess a research or health professional doctoral degree (or its equivalent) that is suitable preparation for a productive research career. o Have been a recipient of uninterrupted support from either an NIH Research Supplement for Underrepresented Minorities Award, any NIH National Research Service Award (e.g., F31, F32, or T32), or any project grant equivalent to an NIH peer-reviewed research grant (e.g., R01, P01, ACS research grant). o Intended to conduct a research project highly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis and treatment that has the potential for establishing and independent research program. Former recipients of any K-series Award (e.g., K07, K08, K23), former or current principal investigators on NIH Small Grants (e.g., R03s) or Exploratory/Developmental Grants (e.g., R21s) former or current principal investigators on NIH research projects (e.g., R01s), FIRST Awards (e.g., R29s), sub-projects on Program Project Grants (e.g., P01s) or center grants (e.g., P50s) and their equivalents are NOT ELIGIBLE. Applications may be submitted on behalf of candidates by domestic, non-profit and for profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government or comparable institutions. Applications from foreign organizations are excluded from applying for this program announcement. Awards will be limited to individuals who are citizens or non-citizen alien nationals, and permanent residents of the United States. Individuals on temporary or student visas are not eligible. Women and persons with disabilities are encouraged to apply as principal investigators. INQUIRIES Written, telephone, fax, and E-mail inquiries concerning this PA are encouraged, especially during the planning phase of the application. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sanya A. Springfield, Ph.D. Chief, Comprehensive Minority Biomedical Branch National Cancer Institute 6116 Executive Boulevard, Suite 7080 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: ss165i@nih.gov Direct inquiries regarding fiscal matters to: Ms. Barbara Fisher Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-8626 FAX: (301) 496-8601 Email: bfisher@mail.nih.gov Direct inquiries regarding review matters to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Suite 8109, MSC-8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: tf12w@nih.gov APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit (October 1, February 1, and June 1). Applications should be organized using the Research Career Award, Section IV of the PHS 398, Just-In-Time procedures. Application kits are available at most institutional offices of sponsored research; from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: grantsinfo@nih.gov. The title (MENTORED CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES) and number of the PA must be typed in Section 2 on the face page of the application. The YES box must be marked. For those applicants with Internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm. Applicants must provide evidence that they received uninterrupted support as noted under ELIGIBILITY REQUIREMENTS above. Three sealed letters of recommendation addressing the candidate's potential for the research career must be included as part of the application. Submit a signed, typewritten original of the application, reference letters, current curriculum vitae with complete bibliography, 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 Rockville, MD 20817 (express/courier service) At time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Suite 8109, MSC-8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (express/courier service) The candidate must address the following issues and include the following information in the application: Candidate o Describe the candidate's commitment to a career in basic, clinical and/or population cancer research (candidates with clinical degrees (e.g., M.D.) should consider the Minorities in Clinical Oncology (K08) Award and candidates interested in patient-oriented research should consider the Mentored Patient- Oriented Research for Underrrepresented Minorities Career Development Award (K23); o Present evidence of the candidate's ability to interact and collaborate with other scientists; o Discuss prior training and how it relates to the objectives and plans of the candidate; o Discuss the innovativeness and quality of the candidate's research efforts to this point in his/her research career; o Provide letters of recommendation. Three sealed letters of recommendation in which the following issues are addressed: - The adequacy of the candidate's scientific background for the proposed research and career goals; - The quality of the candidate's scientific productivity and achievements (e.g., publications, intellectual contributions to the research environment); - The candidate's ability to work with other scientists in various interactive situations (e.g., seminars, journal clubs), on collaborative research projects, and with support staff (e.g., technicians, nurses, secretaries etc.); - Evidence of the candidate's originality and innovativeness in pursuing a research problem; - VERY IMPORTANTLY, the candidate's special potential to develop, establish and manage an independent research program. Career Development Plan o Present a systematic plan that covers Phase I (mentored, dependent) and, if appropriate, Phase II (mentored, independent) of this Program. This plan should incorporate the prior research training and experience of the candidate to provide a basis for the need for further career development to become an independent investigator focusing on research that is clearly relevant to cancer. The plan should provide a description of the research and training experiences that will occur during Phase I and Phase II of the proposed period of support, and the candidate must present a convincing case that, he/she will have a high probability of developing the research skills and ability needed to work in a collaborative environment and become a successful, independently supported investigator. The plan must include a statement regarding the proposed length of the phases; if Phase II is proposed in the application, it must begin on the anniversary award date of the second, third or fourth year of the grant. o Document prior instruction in or proposed plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. (NO AWARD CAN BE MADE IF AN APPLICATION LACKS THIS COMPONENT). Research Plan o Describe the research plan using Form PHS 398 (rev. 4/98 or subsequent revisions) following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. The candidate must consult with the mentor regarding the development of this section. The research plan must be clearly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment. It must be clear as to whether all or parts of the Research Plan will remain as activities of the candidate when the transition to an independent position is made or whether the candidate will be expected to develop an entirely new project in the independent position. Mentor's Statement o Include a signed statement from the mentor(s) with information on research qualifications and previous experience as a research supervisor. The applications must also include information to describe the mentor's research support as related to the candidate's research plan and the specific nature of the supervision and mentoring that the candidate will receive during Phase I of the proposed award period; o Provide similar information by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described; o Describe in this statement specifically whether all or parts of the research project being conducted by the candidate will remain as activities of that individual when the transition to an independent position is made or whether the candidate will be expected to develop an entirely new project in the independent position. Environment and Institutional Commitment o Describe the resources and facilities that will be available to the candidate; o Describe how the research environment of the institution is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan; o In a clear statement, provide assurances that the candidate will be able to spend a minimum of 75 percent effort in the conduct of his/her research activities, with the remaining percent effort devoted to activities related to the development of a research career. Biographical Sketch o A biographical sketch is required for the candidate and mentor(s). For the candidate, include information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project and demonstrate an uninterrupted involvement of research before submitting this application (see ELIGIBILITY REQUIREMENTS). Budget The total direct costs requested must be consistent with this K01 program announcement and the award limits of the NCI. Applications seeking information on award limits should contact the fiscal representative listed in the INQUIRIES section at the end of this announcement. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and for adherence to the ELIGIBILITY REQUIREMENTS of this program announcement by the NCI staff. Incomplete applications will be returned without further consideration. Applications that are complete and adhere to the guidelines of this PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute in accordance with standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique, and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. The following review criteria will be applied: Candidate (Principal Investigator) o Commitment of the candidate to an independent cancer research career that will be focused on problems clearly relevant to cancer; o Ability of the candidate to interact and collaborate with other scientists; o Quality and breadth of prior scientific training and experience; o Recommendations of three well-established scientists attesting to the special potential of the individual to pursue an independent career in cancer research. Career Development Plan o Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of an independent cancer research program: - Candidate's prior training and research experience; - Appropriateness of the goals and scope of the plan to complement prior training/research experience and achieve the stated training and research objectives;. o Appropriateness of the proposed durations of Phase I and, if requested, Phase II; o Appropriateness of the activities proposed during Phase I and, if requested, anticipated for Phase II for a five year award; o Adequacy of prior or proposed training in the responsible conduct of research; o Likelihood of successful planning, writing and submitting of traditional grant applications. Research Plan o Degree of relevance of the research plan to developing an independent cancer research program as it relates to the cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment; o A sound research project that is consistent with the development plan for an independent career in cancer research and commensurate with the candidate's level of research development; o Usefulness of the research project as a vehicle for enhancing existing research skills as described in the career development plan; o The originality and quality of the research hypothesis/question, design and methodology, judged in the context of the candidate's previous training and experience; o Attention to and implications of what aspects of the project will remain with the candidate as an independent investigator; o Adequacy of plans for the provisions for the protection of human and animal subjects and the safety of the research environment and conformance with the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research and Inclusion of Children Participating in Research Involving Human Subjects. Mentor/Co-Mentor o Appropriateness of the mentor's research qualifications in the area of the proposed research; o Quality and extent of the mentor's proposed role in providing guidance and advice to the candidate; o Quality and time commitment to supervising and guiding the candidate during the entire period of the award; o Previous experience in fostering and developing cancer researchers; o History of research productivity and peer reviewed support; o Adequacy of existing support for the Phase I of the proposed research project. o Adequacy and clarity of the mentor's statement describing what aspects of the Research Plan that will remain with the candidate when his/her transition is made to an independent position. Institutional Environment and Commitment o Clear commitment of the institution to ensure that a minimum of 75 percent of the candidate's effort will be devoted directly to research, with the remaining percent effort being devoted to activities related to the successful development of a research career; o Adequacy of research facilities and training opportunities; o Quality and relevance of the environment for scientific and professional development of the candidate. Budget o Justification of the requested budget in relation to career development goals and research aims and plans. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The NCI will notify the applicant of the National Cancer Advisory Board’s action shortly after its meeting. The following will be considered in making decisions: scientific and technical merit of the proposed project as determined by the initial review group, the results of the secondary review by the NCAB, availability of funds, program balance and priority. SUPPLEMENTAL GUIDELINES FOR TRANSITION TO PHASE II (INDEPENDENT) These guidelines apply only to the non-competing years in which a transition to an independent position is requested. Other non-competing applications should be completed in accordance with the guidelines for streamlined (SNAP) applications outlines in PHS form 2590. Application Procedure: The application procedure for the initial NCI Mentored Career Development Award for Underrepresented Minorities cannot be used for the transition to Phase II independent status. Therefore, follow the supplemental application guidelines below for this aspect of the Award: When the candidate is remaining in the same institution, transition applications are to be submitted on the Application for Continuation Grant Form PHS 2590 (rev. 4/98 and subsequent revisions), including the additional instructions for Research Career Award Applications starting on page IV-1. When the candidate is changing institution, the application form to use is the Form PHS 398, and it should be submitted from the new grantee institution. However, the NCI (see INQUIRIES) will provide a transfer application kit, which includes the Form PHS 398, for this purpose. Transition applications MUST be submitted two months prior to the anniversary date of the second, third or fourth year of the award. Submit a signed, typewritten original of the signed application and two signed photocopies in one package to: Records Management Center Grants Administration National Cancer Institute Executive Plaza South, Suite T-42 MSC 7107 Bethesda, MD 20892-7107 Special instructions for completion of the application: o To associate the application with a transition request, enter "NCI MENTORED CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES (K01) PHASE II" on Line 1, Form Page 1; o Provide an itemized listing with associated projected costs for all items on Form Page 2 (DETAILED BUDGET FOR NEXT BUDGET PERIOD). Also see Instructions; o Biographical Sketch (Form Page 4): Provide for all key personnel to be involved in the research project. Provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. o Progress Report Summary (Form Page 5): Follow guidelines in Instructions. Additional instructions: - This section should be as short as possible. However, because of the unique reporting requirements for the "Phase II" application, the section may exceed two pages; - Studies and Results (Item b): The information provided must clearly justify a transition to the Phase II of the award; - Plans (Item b): Follow the guidelines in the Instructions. Additional information to be provided is as follows: o Describe how the scope of the independent project initiated during Phase II will be changed in comparison with Phase I of this award. Provide detailed research plans if there is a major change in research scope of the original peer reviewed research plan; o Describe the relevance of the research plan to cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment; o Describe how the proposed research and research-related activities should contribute to the scientific development of the candidate and the development of an independently funded research program; o Describe long-term research career goals, including the timing of submission of applications for investigator-initiated research grants; o Provide a statement, from the Chairperson of the department to which the awardee has been recruited, describing the type of faculty position offered and if it is a tenure-track position (or equivalent); the responsibilities of the position; the research facilities that will be provided for exclusive use by the awardee, (and, if the transition does not involve a change of sponsoring institution, the relationship of these facilities to those of the applicant's Phase I mentor); additional non-PHS research related departmental/institutional support that will be provided for technical support staff, equipment, animals, etc; relationship of the awardee's research program to ongoing programs within the department; career plans for the awardee; o Provide a statement from the institution ensuring that a minimum of 75 percent of the candidate's effort will be devoted directly to research, with the remaining percent effort being devoted to activities related to the successful development of a research career; o If the independent position involves a change of sponsoring institution, officials from the new institution must additionally document a strong, well- established program in biomedical research related to cancer, including a high quality research environment with staff capable of productive collaboration with the candidate. (Candidates planning a change of institution must contact NCI program staff prior to submission of the Phase II application). o Provide a sealed statement from the Phase I mentor recommending the candidate for the transition. This recommendation should be based on the scientific productivity of the candidate under his/her mentorship and on the mentor's detailed evaluation that the candidate is ready to develop an innovative and independently-supported research program. This letter should be mailed directly to the NCI Program Director. Review Considerations for a "Phase II" Application: Applications received will require NCI staff approval before the transition award to an independent position is activated. Depending upon the scope of changes in the research plan as compared with the original peer reviewed grant application, the application could receive a second level of review by an IRG. Approval will be based upon the following criteria: o A statement from the mentor(s) verifying that the candidate is ready to pursue an independent research career; o The clear relevance of the new Research Plan to cancer biology, etiology, pathogenesis, prevention, control, diagnosis and treatment; o The soundness of the "Letter of Commitment" from the institution, in providing the candidate with protected time (i.e., with no less than 75 percent effort dedicated to the development of a research program and with the remaining effort to be used in research related activities) and describing arrangements with the candidate regarding a permanent, preferably tenure-track position, adequate facilities for conducting a research program, and additional resources conducive to the development of a research project and establishment of a successful research career; o The adequacy of the plans for inclusion of women, children, and minorities in any clinical or population research activities, as applicable; o The adequacy of the proposed protection of humans, animals or the environment to the extent that they may be adversely affected by the activities proposed in this application. Award Criteria for a "Phase II" Application: Funding decisions will be made by NCI program staff on the basis of successfully addressing the review considerations above. NCI program staff will notify the applicant for the Phase II to independent status of their action on the application. The transition to Phase II will take effect on the anniversary date of the grant. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided to indicate that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00- 048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to the NIH defined Phase III clinical trials and require: a) all applications or proposal and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and /or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (e.g., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998 and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications for NIH funding must be self-contained within specific page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to the view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS-led national activity for setting priority areas. This Program Announcement (PA) Mentored Career Development Award for Underrepresented Minorities, is related to the priority area of human resource development in cancer research. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATION This program is described in the catalog of Federal Domestic Assistance No. 93.398. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended by Public Law 99-158, 42 USC 241 and 284 and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American People.

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