EXPIRED
THE HOWARD TEMIN AWARD Release Date: February 22, 2000 (see replacement PAR-03-104) PA NUMBER: PAR-00-066 National Cancer Institute This program announcement (PA) replaces PAR-99-063, which was published in the NIH Guide on February 12, 1999 PURPOSE 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 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 develop knowledge in the basic sciences and research skills relevant to the candidate's career goals, with up to three of the initial years (at least one year required) in a mentored environment followed by a transition to an unmentored independent investigator phase for the remaining time on the award. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, "The Howard Temin Award", is related to the priority area of cancer and human resource development. Potential applicants may obtain a copy of "Healthy People 2000" at (http://odphp.osophs.dhhs.gov/pubs/hp2000). 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. The candidate must have a research or a health professional doctorate 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 the potential for establishing an independent research program in the period after the doctorate. Recipients of an NCI Preventive Oncology/Population Sciences Career Development (K07) Award, a Mentored Clinical Research Scientist Career Development (K08) Award or a Mentored Patient-Oriented Research Career Development (K23) Award who are in their last two years of support are also eligible to apply. The career development award will be terminated upon acceptance of a Howard Temin Award. Candidates must be able to identify an individual who can serve as a mentor for some portion of the initial mentored phase of this award. Former or current principal investigators on NIH Small Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s) remain ELIGIBLE to apply. However, former or current principal investigators on NIH research projects (i.e., R01s), FIRST Awards (i.e., R29s), sub-projects on Program Project Grants (i.e., P01s) or center grants (i.e., P50s) and their equivalents are NOT ELIGIBLE. Applications may be submitted, on behalf of candidates, by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence by the time of award. 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 for this award. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) K01 mechanism. The total project period for an application submitted in response to this PA may not exceed 5 years. The actual length of the awarded project period will depend upon the number of years of prior research experience and the need for additional experiences to achieve independence. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. Awards are not renewable. FUNDS AVAILABLE The Howard Temin award is a highly competitive award, with the intent of providing support to outstanding junior scientists during their transition to an independent investigator status. RESEARCH OBJECTIVES A. Purpose: The National Cancer Institute is interested in encouraging basic scientists to become more interested in research problems of high relevance to human biology particularly as they relate 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 interested 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. Well-trained basic scientists who focus their research on human biology and human disease will be an essential component of the translational research enterprise. The Howard Temin Award not only offers continuing encouragement to clinicians for training in basic research, but additionally represents a complementary new effort to encourage scientists trained in the basic sciences to focus on problems of direct high relevance to the clinical sciences or the prevention, control and population sciences as they relate to cancer. Specifically, the Howard Temin Award provides an opportunity for medically trained individuals and basic scientists to initially work under a mentor in an institutional environment that will enable them to transition to an independent research position and acquire research support focused on issues and problems directly relevant to human cancer. B. Environment: The institution must have a well-established basic research and/or clinical career development program(s) and qualified faculty to serve as mentors. The candidate, mentor and institution must be able to describe a multi-disciplinary career development program in basic research that will maximize the use of relevant research and educational resources. C. 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 program and the remainder devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. The candidate must develop knowledge in the basic sciences and research skills relevant to his or her career goals. The candidate may find it appropriate to include relevant didactic and laboratory or field research experiences. D. Mentor(s): The recipient must receive appropriate mentoring during some fraction of the first three years of the initial phase of the award. The candidate may move to an unmentored research environment 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. The transition must take place no later than the end of the third year. The transition application Where feasible, women and minority mentors should be involved as role models. E. Allowable Costs: 1. 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 effort conducting cancer research 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. 2. Research Development Support: During the mentored phase 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; and (d) travel to research meetings or for training. The amount of this support will increase to $50,000 when the principal investigator transitions to an independent research position either at the same institution or at a different institution. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc. is not allowed. 4. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. F. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified, that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. G. 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. H. 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 NIH funding component is required. To obtain prior approval, the award recipient must submit a letter to the NIH funding component describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component 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 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. Further, 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. I. 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 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 therefor, the effective date, and the right to appeal the decision. Awardees planning a change of institution, must submit to the funding NIH component in advance of the change a written request for transfer, countersigned by the appropriate institutional business official, describing the reasons for the change and including the new sponsor's name and biosketch. 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). Staff within the NIH funding component will review this request and may require a review by an initial review group and/or the appropriate National Advisory Council or Board. Upon approval of this request, a new career award 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 the time remaining within the existing award period. J. 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 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. Staff within the NIH funding component 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 relinquishment of an award in a change of institution situation. 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 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 research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which has been published in the Federal Register of March 20, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994 available electronically at http://grants.nih.gov/grants/guide/notice-files/not94-100.html. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by NIH, unless there are clear and compelling 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and should use the instructions in Section IV of the application kit. Applications will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email: grantsinfo@nih.gov. The title and number of the PA must be typed in Section 2 on the face page of the application form and the YES box must be marked. Application kits are also available on the world wide web at: http://grants.nih.gov/grants/funding/phs398/forms_toc.html. 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 Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html). The completed original application and three legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW 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: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8062 MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) The application must address the following issues and include the following information: Candidate o Describe the candidate's commitment to a career in basic biomedical research directly relevant to human biology and cancer (candidates interested in patient-oriented research should consider the Mentored, Patient-Oriented Research 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 Letters of recommendation. Three sealed letters of recommendation addressing the following issues: - 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 the mentored and unmentored phases 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 cancer research that is directly relevant to human biology and human disease. The plan should provide a description of the research and training experiences that will occur during the mentored and unmentored phases; and 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 independently supported investigator. 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 propose 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 should consult with the mentor regarding the development of this section. The research plan must be directly relevant to human biology and human cancer disease. It must be clear whether all or parts of the Research Plan 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 in the independent position. Mentor's Statement o The application must include a signed statement from the mentor(s) including information on research qualifications and previous experience as a research supervisor. The applications must also include information to describe the mentor's research support related to the candidate's research plan and nature of the supervision that will occur during the mentored phase of the proposed award period; o Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described. o This statement should also 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 and 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 development of his/her research program, with the remaining percent effort spent on activities related to the development of their research career. Biographical Sketch o Biographical Sketch A biographical sketch is required for all key personnel. Provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. Budget Applicants using a PHS 398 Form bearing the revision date 4/98 must follow the instructions in the form. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Center for Scientific Review and for adherence to the guidelines of this PA by the National Cancer Institute. Incomplete applications 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 National Cancer Institute in accordance with the 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 o Commitment of the candidate to a career in basic cancer research that will be focused on problems directly relevant to human biology and human cancer disease; o Ability of the candidate to interact and collaborate with other scientists; o Quality of the 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 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 research program directly relevant to human biology and human cancer disease, based on: - 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 the mentored and unmentored phases; o Appropriateness of the proposed activities during the mentored and unmentored phases for a five year award; o Adequacy of prior or proposed training in the responsible conduct of research. Research Plan o Degree of relevance of the research plan to developing an independent research program focused on human biology and human disease as they relate to the etiology, pathogenesis, prevention, diagnosis, and/or treatment of human cancer; o A sound research project that is consistent with the development plan for an independent career in cancer research and the candidate's level of research development must be provided (All applicants for this award will have had previous postdoctoral research experience and in some cases may have been Principal Investigators on small research grants); o Usefulness of the research plan 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 Plan will go with the candidate at the time of the transition to an independent position. o Adequacy of the Plans attention to children, gender, and minority issues when human subjects are involved. 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)'s proposed role in providing guidance and advice to the candidate. o Previous experience in fostering the development of cancer researchers; o History of research productivity and peer reviewed support; o Adequacy of existing support for the mentored phase of the proposed research project. o Adequacy and clarity of the mentor(s)'s statement describing what aspects of the Research Plan will go with the candidate when the 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 The NCI will notify the applicant of the National Cancer Advisory Board's (NCAB) action shortly after its meeting. Funding decisions will be made based on the scientific merit of the application as evaluated by the initial review group, the results of the secondary review by the NCAB, the need for research personnel in specific program areas, and the availability of funds. SUPPLEMENTAL GUIDELINES FOR TRANSITION TO THE UNMENTORED PHASE These guidelines apply only to the non-competing year in which the transition 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 Howard Temin Award cannot be used for the transition to an unmentored 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 obtained from the 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 for support 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 HOWARD TEMIN AWARD (K01) TRANSITION" 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 include: - 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; - Studies and Results (Item b): The information provided must clearly justify a transition to the unmentored phase 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 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, 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; 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 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 mentor (if the transition does not involve a change of sponsoring institution); 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 transition involves a change of sponsoring institution, 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 TRANSITION APPLICATION. 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. Review Considerations for a "Transition" 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 direct relevance of the new Research Plan to human biology and human disease as they relate to cancer etiology, pathogenesis, prevention, control, diagnosis and treatment; o The soundness of the "Letter of Commitment" from the institution, to provide the candidate with protected time (no less than 75 percent effort dedicated to the development of a research program with the remaining effort to be used in research related activities) and describing arrangements with the candidate providing 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 "Transition" Application: Funding decisions will be made by NCI program staff based on satisfying the review considerations above. NCI program staff will notify the applicant for the transition to unmentored status of their action on the application. The transition to the unmentored phase will take effect on the anniversary date of the grant. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Depending upon whether your inquiry involves application strategies and scientific issues, budget or fiscal issues or review issues, contact the appropriate individual noted below: Direct inquiries regarding programmatic issues to: Dr. Andrew Vargosko Office of Centers, Training and Resources National Cancer Institute 6116 Executive Blvd., Suite 7011 MSC/8346 Bethesda, MD 20892-8346 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: av8b@nih.gov Inquiries regarding fiscal matters may be directed to: Ms. Catherine Blount Office of Administrative Management National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-3179 FAX: (301) 496-8601 Email: cb136g@nih.gov Direct inquiries regarding review matters to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8062 MSC/8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: tf12w@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.398 Cancer Research Manpower. Awards are made under authorization of the Public Health Service Act as amended by Sections 301 and 405 of the (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 and contract 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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