THE HOWARD TEMIN AWARD RELEASE DATE: April 14, 2003 PA NUMBER: PAR-03-104 EXPIRATION DATE: July 2, 2006, (Expiration date has been extended, see NOT-CA-05-023) National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.398 This Program Announcement (PAR) replaces PAR-00-066, which was published in the NIH Guide on February 22, 2000. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The goal of the National Cancer Institute's (NCI) Howard Temin Award is to bridge the transition from a mentored research environment to an independent basic cancer research career for scientists who have demonstrated unusually high potential during their initial stages of training and development. This special award is aimed at fostering the research careers of outstanding junior scientists in basic research who are committed to developing research programs directly relevant to the understanding of human biology and human disease as it relates to the etiology, pathogenesis, prevention, diagnosis, and treatment of human cancer. The major objective of the award is to sustain and advance the early research careers of the most promising M.D.s and Ph.D.s while they consolidate and focus their independent research programs and obtain their own research grant support. To achieve this objective, the Howard Temin Award offers candidates up to five years to gain additional skills and knowledge in human cancer research during a period of one to three years in a mentored environment, followed by transition to the equivalent of a junior faculty position to develop an independent research program. RESEARCH OBJECTIVES The National Cancer Institute is interested in encouraging basic scientists to become involved in research related to the etiology, pathogenesis, prevention, diagnosis, control and treatment of human cancer. In the past, the major effort of the NCI has been to encourage medically trained individuals to become involved in basic research problems at the most fundamental biological levels, but there has been no effort to encourage scientists trained in the basic sciences to focus on problems of direct relevance to the clinical sciences or the prevention, control and population sciences. The continued success of future cancer research will depend upon the increased ability of the cancer biomedical research community to effectively translate observations in the laboratory into patient and population research settings. Basic scientists who focus their research on human biology and human disease and who are well trained to work with more applied scientists (clinical researchers, prevention researchers) will be an essential component of the translational research enterprise. The Howard Temin Award also encourages postdoctoral individuals exclusively trained in the basic sciences to refocus their research careers on problems of direct relevance to human cancer prevention, detection, diagnosis, and treatment. Specifically, the Howard Temin Award provides an opportunity for basic scientists to train under a mentor experienced in human cancer research, transition to an independent research position and acquire research support focused on issues and problems directly relevant to human cancer. MECHANISM OF SUPPORT This PA will use the NIH K01 award mechanism. Planning, direction, and/or execution of the program will be the responsibility of the applicant and his/her mentor. Applicants may request up to five years of support. The actual length of the awarded project period will depend upon the number of years of prior research experience and the need for additional experience to achieve independence. Each award is non-renewable and non-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 (refer to "Non-Competing Renewals"). NIH Grant policies apply to these awards. This PA follows the Just-In-Time initiative for Career Awards published in the NIH Guide, Volume 25, Number 10, March 29, 1996. Applications submitted in accordance with PHS 398 (Rev. 05/2001), Section IV (Additional Instructions for Preparing Individual Research Career Award (RCA) Applications - "K" Series, are in compliance with the instructions provided in the 1996 Guide Notice. ELIGIBLE INSTITUTIONS Applications may be submitted on behalf of candidates by domestic, non- Federal organizations with any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the appropriate degree(s) and the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The candidate must have a research or a health professional doctoral degree or its equivalent, must have completed at least three years of postdoctoral research at the time of award, and must have demonstrated highly productive research activity and high potential for establishing an independent research program in the period after the doctorate. Candidates must be able to identify an individual with extensive experience in human cancer research who can serve as a mentor for the initial mentored phase of this award. The candidate's research proposal must DIRECTLY relate to etiology, pathogenesis, prevention, diagnosis, control and treatment of HUMAN cancer. Work developing or refining model systems will be supported only if the proposed research objectives actively test the relevance of the model to human cancer. Candidates who are not U.S. citizens, non-citizen nationals, or permanent residents MAY APPLY for this award. However, candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence, in order for the actual grant award to be made. Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. 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 to receive this award. ELIGIBLE individuals include former or current principal investigators on NIH Small Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s). Current recipients of an NCI Preventive Oncology/Population Sciences Career Development (K07) Award, or a Mentored Clinical Research Scientist Career Development (K08) Award who are engaged in basic research may apply during the last two years of the career development award budget period. The career development award will be terminated upon acceptance of a Howard Temin Award. INELIGIBLE individuals include former or current principal investigators on NIH research projects (i.e., R01s), FIRST Awards (i.e., R29s), Mentored Patient-Oriented Research Career Development (K23) Award, NCI Transition Career Development Award (K22), sub-projects on Program Project Grants (i.e., P01s) or Center Grants (i.e., P30s, P50s) and their equivalents. SPECIAL REQUIREMENTS A. Program The award provides up to five consecutive 12-month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the career development plan/research proposed in the Temin application and the remainder devoted to activities related to the development of a successful research career focused on human cancer research. The candidate may find it appropriate to include didactic experiences as part of the career development plan. Environment: The institution must have a well-established track record of conducting research directly relevant to human cancer and faculty who are highly experienced in human cancer research and can serve as mentors. The candidate, mentor and institution must be able to describe a career development program that takes maximum advantage of the research and educational resources relevant to the candidate's career development. Mentor(s): The mentor must be an individual with extensive direct experience in human cancer research. Women and minority mentors should be involved as role models whenever feasible. The recipient must receive appropriate mentoring for at least the first year of the grant and for no more than the first three years. The candidate may move to the unmentored (independent) research phase only on the award anniversary dates of the second, third and fourth year of support. See the SUPPLEMENTAL GUIDELINES FOR TRANSITION TO THE UNMENTORED STATE below. B. Allowable Costs: Salary: The Temin award will provide salary up to $75,000, plus fringe benefits. The total salary requested must be based on a full-time, 12-month, staff appointment requiring the candidate to spend a minimum of 75 percent professional effort on the career development plan/research proposed in the Temin application. The remaining percent effort must be 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. Research Development Support: During the mentored phase of the award, up to $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; and (d) travel to research meetings or for training. The amount of this support will increase to a maximum of $50,000 per year when the principal investigator transitions to the unmentored (independent) research phase, either at the same institution or at a different institution. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc. is not allowed. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. C. Evaluation: In carrying out its stewardship of human resource related programs, NIH may need to obtain information essential to an assessment of the effectiveness of this program. Recipients are hereby notified that they may be contacted 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. D. 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, Office 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 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 awarding component 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 NIH awarding component. E. 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 three months. For longer periods, prior written approval of the NCI is required. To obtain prior approval, the award recipient must submit a letter to NCI describing the plan, countersigned by his/her mentor and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of 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 requesting 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 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. In addition, the awardee must submit assurance of his/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. F. Termination or Change of Institution When a grantee institution plans to terminate an award, NCI 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 purpose 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 therefore, the effective date, and the right to appeal the decision. Awardees planning a change of institution are urged to contact the NCI Program Director (name listed in Notice of Grant Award) to discuss the transfer and obtain instructions. The required paperwork must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested at the new institution must be no more than the time remaining within the existing award period. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. G. Change of Mentor: When a mentor at the grantee institution is to be replaced, the institution must submit a letter from the proposed mentor documenting the need for substitution, the new mentor's qualifications for supervising the program, and the new mentor's research support that will provide a funded research environment appropriate for the candidate's 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. H. Reporting Requirements: If the application is funded, additional reporting requirements for continuation of this project are listed in the section titled "NON-COMPETING RENEWALS". WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Cynthia Pond Program Director, Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7011 Bethesda, MD 20892-8346 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-8580 FAX: 301-402-4472 Email: pondc@mail.nih.gov o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: ncirefof@dea.nci.nih.gov o Direct your questions about financial or grants management matters to: Ms. Catherine Blount Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: 301-496-3179 FAX: 301-496-8601 Email: blountc@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001 or subsequent revisions) and instructions found in Section IV. "Research Career Award". The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. ADDITIONAL REQUIREMENTS In addition to the required information listed in the instructions for Research Career Awards in the PHS 398, all applications MUST include the following information in the respective sections: BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT o Provide only total direct costs on Form Page 5 (Budget for Entire Proposed Period of Support) o Under justification (Form Page 5), provide (in narrative format) detailed information and justification for all items included in the budget, such as tuition, fees, books, travel, and research development support. BIOGRAPHICAL SKETCH o Provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. LETTERS OF REFERENCE Three letters of reference must be provided with the application that include the following: o Description of the adequacy of the candidate's scientific background for the proposed research and career goals. o Description of the quality of the candidate's scientific productivity and achievements (e.g. publications, intellectual contributions to the research environment). o Discussion of 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.). o Evidence of the candidate's originality and innovativeness in pursuing a research problem. o Description of the candidate's special potential to develop and manage an independent research program. THE CANDIDATE o Describe the candidate's commitment to a career in basic research directly relevant to human biology and cancer; 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 Present a systematic plan that covers the mentored and unmentored phases of this Program. This plan must incorporate the prior research training and experience of the candidate, and provide an explanation for the need for further career development. The plan must provide a description of the research and training experiences that will occur during the mentored and unmentored phases. The plan must present a convincing case that, as a result of these experiences, the candidate will have a high probability of developing the research skills and ability needed to work in a collaborative environment and become a successful independent cancer researcher. The plan must include a statement regarding the proposed length of the mentored and unmentored phases; the unmentored phase 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. STATEMENT(S) BY MENTOR, CO-MENTOR(S), CONSULTANT(S), AND COLLABORATOR(S) o Mentor/Co-mentor(s): The application must include signed statement(s) from the primary mentor and any co-mentor(s), if proposed, providing information on their research qualifications and previous experience as research supervisor(s). This information should demonstrate how these qualifications and existing research support will be used to assist the candidate to achieve the objectives of his/her career development and research plans. This information should clearly establish that the mentor has extensive direct experience in human cancer research. Co-mentors, if proposed, must specifically address the nature of their role in the career development plan and how the responsibility for the candidate's development is shared and coordinated with the primary mentor. The statement of the primary mentor should specifically describe whether all or parts of the research project being conducted by the candidate will go with the candidate when the transition to an independent position is made or whether the candidate will be expected to develop an entirely new project during the independent phase of the award. Specific information (e.g. grants) on the active/pending research support of the mentor(s) related to the candidate's research plan should not be included in this statement, but should be provided in the corresponding biosketches. o Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biosketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE 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 in human cancer research, as proposed in the research plan of the application. This should include a brief discussion (one paragraph) of the depth and breadth of human cancer research being conducted at the institution. o In a clear statement, provide assurance that the candidate will be able to spend a minimum of 75 percent of total professional effort on the career development plan/research proposed in the Temin application, with the remaining percent effort devoted to activities related to the development of a successful research career. RESEARCH PLAN o Describe the research plan, clearly explaining the direct relevance of the research to human biology and human cancer disease. Work developing or refining model systems will be supported only if the proposed research objectives actively test the relevance of the model to human cancer. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, three original sealed letters of reference, and three signed photocopies in one package to: Center for Scientific Review (CSR) National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice- files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for adherence to the guidelines of this PA by the NCI program staff. Applications not adhering to the guidelines of this PA, and those applications that are incomplete as determined by CSR or by NCI program staff, will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA, will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 o Receive a second level review by the National Cancer Advisory Board REVIEW CRITERIA In the written comments, reviewers will be asked to evaluate the following aspects of the application: o Candidate o Statements by Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s) o Environment and Institutional Commitment to the Candidate o Research Plan 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. The application does not need to be strong in all categories to deserve a high priority score. CANDIDATE o Strength of the candidate's statement regarding his/her commitment to a basic cancer research career focused on problems directly relevant to human biology and human cancer disease. o Strength of the evidence presented by the candidate of interaction and collaboration with other scientists. o Quality and breadth of prior scientific training and experience, including publications, that establish the innovativeness of the candidate in research and a high potential for an independent research career. o Strength of the recommendations of three well-established scientists attesting to the special potential of the individual to become an independent investigator. o Likelihood that the career development plan will contribute substantially to the scientific development of the candidate and the achievement of scientific independence in a field directly relevant to human biology and human cancer disease. o Adequacy of prior or proposed training in the responsible conduct of research. o Appropriateness of the proposed durations of the mentored and unmentored phases. o Appropriateness of the proposed activities during the mentored and unmentored phases for a five year award. STATEMENTS BY MENTOR, CO-MENTOR(S), CONSULTANT(S), AND COLLABORATOR(S) o Appropriateness of the qualifications of the mentor(s) in the area of the proposed research and of the mentor(s) as someone who has extensive, direct experience in human cancer research. o Quality, nature and extent of the previous experience of the mentor(s), especially as it relates to training successful cancer researchers. o Quality, nature and extent of the supervision that will occur during the mentored phase of the proposed award period. o Adequacy of existing peer-reviewed research of the mentor(s) to provide an appropriately funded environment for the mentored phase of the candidate's career development. o Adequacy and clarity of the statement of the mentor(s) describing what aspects of the Research Plan will remain with and facilitate the transition of the candidate to an independent position. o Adequacy and clarity of similar information provided by any co-mentor, as well as description of respective areas of expertise and responsibility. ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE o Quality of the environment for scientific and professional development. o Adequacy of research facilities. o Adequacy of the track record of the institution in the conduct of human cancer research. o Adequacy and clarity of the applicant institution's assurance that the investigator will spend a minimum of 75 percent professional effort on the career development plan/research proposed in the Temin application, with the remaining percent effort devoted to activities related to the development of a successful research career. RESEARCH PLAN o Degree of relevance of the research plan to understanding the etiology, pathogenesis, prevention, detection, diagnosis, and/or treatment of human cancer. o Originality and quality of the research hypothesis/question, design and methodology, judged in the context of the candidate's previous training and experience. o Usefulness of the research plan as a vehicle for enhancing existing research skills. o Potential of the research plan to help the candidate develop into an independent career directly relevant to human cancer research. o Adequacy of the application's attention to children, gender, and minority issues when human subjects are involved. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will 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 criteria included in the section on Federal Citations, below). 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 Inclusion Criteria in the sections on Federal Citations, below). 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 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the career development plan and proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities NON-COMPETING GRANT PROGRESS REPORTS Funding beyond the first year of the award is contingent upon satisfactory progress during the preceding year. Progress is documented on form PHS 2590 (rev. 5/2001 or subsequent revisions) and instructions found in Section IV. "Additional Instructions for Preparing Continuation Research Career Award (RCA) Progress Reports". The PHS 2590 is available at http://grants.nih.gov/grants/funding/2590/2590.htm. GUIDELINES FOR TRANSITION TO INDEPENDENT (UNMENTORED) PHASE These guidelines apply only to the non-competing years in which a transition to an independent position is requested. The unmentored phase of career development must begin on the anniversary date of the second, third or fourth year of the award. The annual progress report for this year, called a transition application, must include additional material related to the transition. Transition applications require approval by NCI program staff before transition to the independent phase can occur. Additional peer review may also be necessary if changes in the research plan are proposed. Different instructions apply when the candidate is changing institutions at the time of transition to independence (see below). To ensure that the transition occurs smoothly, it is strongly suggested that candidates planning a change of institution contact NCI program staff prior to submission of the transition application. TRANSITIONING TO INDEPENDENCE AT THE SAME INSTITUTION When the candidate is remaining in the same institution, transition applications are to be submitted on form PHS 2590. Follow the instructions for "Non-competing Grant Progress Reports" with these ADDITIONAL special instructions: FACE PAGE o To associate the application with a transition request, enter "NCI HOWARD TEMIN AWARD (K01) TRANSITION" on Line 1. DETAILED BUDGET FOR NEXT BUDGET PERIOD o Provide an itemized listing with associated projected costs for all items on Form Page 2. BIOGRAPHICAL SKETCH o Provide a biosketch 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. PROGRESS REPORT SUMMARY This section should be keep as short as possible. However, due to the unique reporting requirements for the transition application, the section may exceed two pages. Items a-j: as directed in PHS 2590 with the following additional material: Item b. Studies and Results o Provide detailed information that clearly justifies a transition to the unmentored phase of the award. Item d. Plans o Describe how the scope of the project initiated during the unmentored phase will be changed in response to the increased level of research support provided in the mentored phase 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 DIRECT relevance of the research plan to the etiology, pathogenesis, detection, prevention, diagnosis, and/or treatment of human cancer. 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. Item j. Mentor's Report o Provide a sealed statement from the 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 FOR THE CANDIDATE'S HOWARD TEMIN AWARD. ENVIRONMENT AND INSTITUTIONAL COMMITMENT - TRANSITION o Provide a signed statement from the Chairperson of the Department to which the awardee has been recruited describing the type of faculty position offered and whether it is a tenure-track position (or equivalent); the responsibilities of the position; the laboratory facilities that will be provided for exclusive use by the awardee and the relationship of these facilities to the laboratories of the applicant's former mentor; additional non-PHS research related departmental/institutional support that will be provided (i.e. technical support staff, equipment, animals); the relationship of the awardee's research program to ongoing programs within the institution; and career plans for the awardee. o Provide a statement from the institution ensuring that a minimum of 75 percent of the candidate's professional effort will be devoted directly to the career development plan/research proposed in the Temin application, with the remaining percent effort being devoted to activities related to the development of a successful research career. Submit a signed, typewritten original of the signed application and two signed photocopies in one package to: Records Management Center Grants Administration Branch National Cancer Institute Executive Plaza South, Suite T-42 MSC 7107 Bethesda, MD 20892-7107 (Express mail, use Rockville, MD 20852) TRANSITIONING TO INDEPENDENCE WITH CHANGE OF INSTITUTION When the candidate is changing institution, transition applications are to be submitted on form PHS 398 (rev. 5/2001 or subsequent revisions) and instructions found in Section IV. "Additional Instructions for Preparing Individual Research Career (RCA) Applications "K"Series". The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html In addition, candidates must provide a progress report. 1. PHS 398 as directed in PHS 398 with the following special instructions: FACE PAGE o To associate the application with a transition request, enter "NCI HOWARD TEMIN AWARD (K01) TRANSITION" on Line 1. DETAILED BUDGET FOR NEXT BUDGET PERIOD o Provide an itemized listing with associated projected costs for all items on Form Page 2. BIOGRAPHICAL SKETCH o Provide a biosketch for all key personnel involved in the project. OTHER SUPPORT o Provide Other Support Format Page 7-GG for all key personnel. 2. PROGRESS REPORT There is no set format for the progress report. Candidates may use Item 4 "Progress Report Summary" found in Section IV. "Additional Instructions for Preparing Continuation Research Career Award (RCA) Progress Reports" of form PHS 2590 as a template. The PHS 2590 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Use of the Progress Report Summary, with the additional items below, will provide all the necessary information. Items a-j: as directed in PHS 2590 with the following additions: Item b. Studies and Results o Provide detailed information that clearly justifies a transition to the unmentored phase of the award. Item d. Plans o Describe how the scope of the project initiated during the unmentored phase will be changed in response to the increased level of research support provided in the mentored phase 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 DIRECT relevance of the research plan to the etiology, pathogenesis, detection, prevention, diagnosis, and/or treatment of human cancer. 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. Item j. Mentor's Report o Provide a sealed statement from the 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 FOR THE CANDIDATE'S HOWARD TEMIN AWARD. ENVIRONMENT AND INSTITUTIONAL COMMITMENT - TRANSITION o Provide a signed statement from the Chairperson of the Department to which the awardee has been recruited describing the type of faculty position offered and whether it is a tenure-track position (or equivalent); the responsibilities of the position; the laboratory facilities that will be provided for exclusive use by the awardee; additional non-PHS research related departmental/institutional support that will be provided (i.e. technical support staff, equipment, animals); the relationship of the awardee's research program to ongoing programs within the institution; and career plans for the awardee. o Provide a statement from the institution ensuring that a minimum of 75 percent of the candidate's professional effort will be devoted directly to the career development plan/research proposed in the Temin application, with the remaining percent effort being devoted to activities related to the development of a successful research career. o Provide documentation of a strong, well-established institutional program in biomedical research related to cancer, including a high quality research environment with scientists capable of productive collaboration with the candidate and the furtherance of the candidate's goals to establish an independent research program directly relevant to human cancer. Submit a signed, typewritten original of the signed application and two signed photocopies in one package, to the grants specialist whose name appears on the Notice of Grant Award, at: Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) REVIEW CRITERIA FOR A "TRANSITION" APPLICATION o Adequacy of candidate's progress toward meeting the career development goals and research aims of the original application as they relate to a research career directly relevant to human cancer. o Adequacy of the mentor(s)' statement regarding the candidate's scientific productivity. o Strength of mentor(s)' recommendation for transition to independence. o Soundness of the commitment from the institution to provide the candidate with the following: protected time (minimum 75 percent effort); a permanent (preferably tenure- track) position; adequate facilities for conducting the proposed research program; and additional resources conducive to the development of a research project and establishment of a successful research career in human cancer. 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 the application. o If the transition involves a change of sponsoring institution, the adequacy of research facilities and training opportunities at the new institution, the strength of the institution's cancer research program, and the availability of staff capable of productive collaboration with the candidate and the furtherance of candidate's goals to establish an independent research program directly relevant to human cancer. AWARD CRITERIA FOR A "TRANSITION" APPLICATION Funding decisions will be made by NCI staff based on satisfaction of the review criteria above. NCI staff will notify the candidate regarding action taken on the transition application. If the transition to the independent phase is not recommended for approval, program staff may determine that the mentored phase be continued, funding be withheld until suitable arrangements are made, or the award terminated. The transition to the unmentored phase will take effect on the anniversary date of the grant. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_ 2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is available online at: http://cme.nci.nih.gov/ HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified 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 view the Internet sites. Furthermore, we caution reviewers 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.398 at http://www.cfda.gov/, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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