CANCER PREVENTION, CONTROL, BEHAVIORAL AND POPULATION SCIENCES CAREER DEVELOPMENT AWARD RELEASE DATE: February 03, 2004 (see extension of expiration date NOT-CA-06-024 and NOT-CA-06-009) PA NUMBER: PAR-04-055 (This PA has been reissued as PA-06-381) EXPIRATION DATE: June 1, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI/NIH) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.398 This Program Announcement (PA) replaces PAR-01-135, which was published in the NIH Guide on September 4, 2001. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism 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 Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of the Cancer Prevention, Control, Behavioral and Population Sciences Career Development Award (K07) is to support the career development of investigators who have made a commitment to focus their research endeavors on cancer prevention, control, behavioral and the population sciences. This is achieved by providing protected time through salary and research support for up to 5 years to individuals with a health professional or science doctoral degree who are 1) already proficient in GENERAL epidemiology, behavioral sciences, or other relevant disciplines, and now want to make use of these proficiencies in cancer-focused research careers in prevention, control, population and/or the behavioral sciences, or 2) already trained in cancer epidemiology, etiology, prevention, control and the behavioral and population sciences but are not yet fully independent investigators. Examples of relevant disciplines for this Program Announcement (PA) include any aspect of human cancer prevention (modifiable risk factors, new animal models and extrapolation of these models to human cancer, genetic predisposition to cancer and detection of precursor lesions, patient-oriented research focused on cancer prevention, and behavioral research and behavioral intervention trials in cancer prevention), epidemiology (biochemical, genetic, molecular), biostatistics, human cancer genetics, clinical oncology, human nutrition, behavioral and social sciences, health promotion, health services and health policy research; and medical decision analysis, survivorship and quality of life as they relate to cancer. For the purpose of this PA, cancer control research is defined as "basic and applied research in the behavioral sciences that independently or in combination with biomedical approaches, reduces cancer risk, incidence, morbidity, and mortality across the lifespan and over the entire process of carcinogenesis from primary behavioral prevention in youth, to screening, treatment, and survivorship" (Report of the NCI Cancer Control Progress Review Group, 1998). Additionally, patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials; and 4) the development of new technologies. RESEARCH OBJECTIVES Recognizing a need for training researchers in preventive oncology and the lack of multidisciplinary curricula that would be needed for this purpose, the National Cancer Institute (NCI) published in 1982 the announcement titled "Preventive Oncology Academic Award" (NIH Guide for Grants and Contracts, Vol. 11, No. 5, April 23, 1982). This award (POAA) provided support for the development of institutional preventive oncology curricula focused specifically on etiologic studies and primary prevention of cancer. In 1985, the NCI made two significant changes in the award. First, the emphasis on support for institutional curriculum development was changed to support of research and career development of individuals who wanted to make a transition to cancer prevention and control research and to individuals already trained in cancer prevention and control who were not yet fully independent investigators. Second, the original focus on cancer etiology and primary cancer prevention was expanded to include all cancer prevention and control sciences and technologies from hypothesis development through demonstration. In 1998, the National Cancer Institute completed major external reviews of its programs in cancer prevention and control sciences. The scientific experts who conducted these reviews identified the current level of support for training in cancer prevention and cancer control and the single discipline emphasis of these programs as being completely inadequate to take advantage of the new opportunities for reducing cancer incidence, morbidity and mortality. These experts recommended that the NCI increase its current level of support of education/training programs in cancer prevention and cancer control and generate new opportunities for multidisciplinary training in these disciplines of basic and clinical scientists in highly interdisciplinary and collaborative environments. Similar recommendations regarding training opportunities in cancer prevention and control have been made by other NCI advisory groups. In 1999, the NCI published a new K07 PA incorporating the recommendations made by these experts. The objective of the reissued K07 PA is to continue to provide a mechanism to support specialized didactic study and mentored research in scientific areas relevant to cancer prevention, cancer control, and behavioral and population sciences research. Individuals lacking skills in data management, statistics, epidemiology, study design, clinical trial design, hypothesis development, etc., can be provided the opportunity to participate in courses designed to overcome these deficiencies. The scope of the research and didactic training may extend from the development and experimental testing of hypotheses including chemoprevention trials, through the stage of confirming results using defined populations, to the development and demonstration of technology as applied to epidemiology, cancer prevention, cancer control, and the behavioral and population sciences as they relate to cancer. MECHANISM OF SUPPORT This PA will use the NIH Cancer Prevention, and Control Career Development (K07) Award mechanism. As an applicant, you will be solely responsible for planning, direction, and execution of the proposed program. Applicants may request from 3 to 5 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. Awards are not renewable. This PA follows the Just-In-Time initiative for Career Awards published in the NIH Guide, Volume 25, Number 10, March 29, 1996. (http://grants.nih.gov/grants/guide/notice-files/not96-081.html). Applications submitted in accordance with PHS 398 (Rev. 05/2001), Section IV (Additional Instructions for Preparing Individual Research Career Award (RCA) Applications - "K" Series (http://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing _individual_CDA_app.htm) are in compliance with the instructions provided in the 1996 Guide. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Domestic institutions/organizations o Foreign institutions are not eligible to apply INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS To be eligible for an NCI K07 award, candidates must have a Ph.D. degree, a health professional doctoral (M.D., Dr.PH., D.D.S., D.O., D.V.M., Pharm. D.) degree, or equivalent, or be a doctorally prepared oncology nurse; and must have a research or academic appointment in the sponsoring institution at the time of award. You must also be able to devote a minimum of 75 percent of full-time professional effort to the K07 Award. The remaining 25 percent effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the goals of the K07 Award, i.e., the candidate's development into an independent investigator in cancer prevention, control, and the behavioral or population sciences. Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident, are eligible for this award. Non- citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. A candidate for an NCI K07 Award may not simultaneously submit or have pending an application for any other PHS career award (e.g., K01, K08, K23), an NCI Transition Career Award (K22), a research project grant (R01, R03), or any PHS or non-Federal award that duplicates any of the provisions of the K07 award. However, K07 awardees may submit an application for an NCI Transition Career Development Award (K22), and are encouraged to actively seek independent support of their research programs through investigator-initiated grants during the term of this award. Former or current principal investigators on any NIH research grants (this does not include NIH R03 or R21 grants or their equivalents) or non-PHS peer reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center grants (P50) are NOT eligible to apply. SPECIAL REQUIREMENTS A. The sponsoring institution must have well-established research programs in basic, clinical, and/or cancer prevention/control/behavioral/population sciences. This research environment should be one in which there are active research collaborations that exemplify a dynamic two-way exchange of information and ideas between laboratory and clinical and/or population research settings. B. Allowable Costs: Salary: The K07 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 devote a minimum of 75 percent of full-time professional effort to 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. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Because the salary amount provided by this award is based on the full- time institutional salary, no other PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K07. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. Effective for all competing research grants submitted for the February 1, 2004, deadlines and beyond, mentored career award recipients in the last 2 years of career award support may hold concurrent support from their career award and a competing NIH research grant when recognized as a Principal Investigator or subproject Director. This new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html. Research Development Support: 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 of the PI; and (d) travel to research meetings or for training. The level of research development support may be negotiated downward with the acquisition of any independent grant support from any source. 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 eight percent of modified total direct costs. C. 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. 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, and fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries, stipends, 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 3 months. For longer periods, prior written approval of the NCI is required. To obtain prior approval, the award recipient must submit a letter to 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 (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, the NCI Grants Management Specialist listed on the Notice of Grant Award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided that the following conditions are met. o The awardee has submitted to the NCI a written request for a transfer, countersigned by the appropriate institutional business official, describing the reasons for the transfer and including the new sponsor's name and biosketch. o 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, and that a new sponsor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program. o The awardee should contact the NCI Program Director listed in INQUIRIES prior to submitting the request; o The NCI Program Director has recommended approval of the request and has forwarded the request for further evaluation to the Grants Management Specialist listed on the Notice of Grant Award; and o A completed transfer application has been submitted to the Grants Management Specialist listed in the Notice of Grant Award far enough in advance of the requested effective date to allow the necessary time for review, establishing that all conditions of the initial award will be met at the new institution including the presence of a qualified mentor, and that the period of support requested does not exceed the time remaining within the existing award period. G. Changes in Research Program: Individual awards are made for career development at a specific institution in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the NCI. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by NCI staff to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, NCI staff could recommend that the award be terminated. H. Termination of An Award 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. 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. Lester S. Gorelic Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7025, MSC 8346 Bethesda, MD 20892-8346 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8580 FAX: (301) 402-0181 Email: gorelicl@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. Kimery Griffin Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: 301-496-3196 FAX: 301-496-8601 Email: griffink3@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001) and instructions found in Section IV, "Research Career Award." Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the website at http://www.dunnandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 Form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants are advised that these instructions are provided under the section titled "Table of Contents" following the tables providing individual PHS Form 398 pages. For further assistance contact GrantsInfo, Telephone: (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS 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 Within the limitation of $30,000 direct costs for research development support, provide a detailed description, with justification, for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award. THE CANDIDATE o Describe the candidate's commitment to an academic career in cancer prevention, cancer control, epidemiology, or the behavioral/ population sciences as these disciplines relate to cancer prevention and control. 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 career plans of the candidate o Discuss the candidate's research efforts to this point in his/her research career. LETTERS OF RECOMMENDATION o Include three sealed letters of recommendation from well-established scientists with the application addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator in cancer research. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three recommendations. All letters should be attached to the front page of the application. CAREER DEVELOPMENT PLAN o Present a systematic plan that shows a logical progression from the candidate’s prior research and training experiences to the training and research experiences that will occur during the K07 award period to independent investigator status. This plan must provide justification of the need for further career development to become an independent investigator. The candidate should consult with the mentor in the preparation of this plan. 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. An award cannot be made if an application lacks this component. RESEARCH PLAN o Describe the research plan using Form PHS 398 (rev. 5/01 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. A sound research project that is consistent with the candidate's level of research development and objectives of their career development plan must be provided. STATEMENT(S) BY MENTOR(S)/ CONSULTANT(S)/COLLABORATOR(S) o The application must include a statement from the mentor providing: 1) information on their research qualifications and previous experience as a research supervisor; 2) a mentoring plan describing the nature of the supervision and mentoring that will occur during the proposed award period and for ensuring that the applicant will be able to create a niche for themselves in a specific area of research during the K07 award; 3) assurance that the applicant will be able to move at least a portion of their K07-supported research to their first independent research position. Information on the mentor’s active/pending research support related to the candidate’s research plan should not be included in this statement, but should be provided in the mentor’s biographical sketch . o Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. 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 and the pursuit of the proposed research plan. o In a clear statement, provide assurances that the candidate will be able to devote a minimum of seventy-five percent of his/her in the development of his/her research program, with the remaining percent effort being devoted to activities related to the development of their research career. 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. 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 and all copies of the appendix material must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Appendices should be comprised of single-sided, unbound materials, with separators between documents. 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 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 unfunded version 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 responsiveness by NCI. Incomplete and/or non-responsive applications will not be reviewed. 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 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 written critique o Receive a second level review by the National Cancer Advisory Board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate applications in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. o Candidate o Letters of reference o Career Development Plan o Research Plan o Statements by former Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s) o Environment and Institutional Commitment to the Candidate o Research Plan The application does not need to be strong in all categories to deserve a high priority score. These criteria are listed in logical order and not in order of priority. CANDIDATE o Commitment of the candidate to an academic career in cancer prevention, cancer control, epidemiology, or to the behavioral or population sciences as these disciplines relate to cancer prevention and control. 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's 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. Letters of reference submitted by mentor(s)/ co- mentor(s) will be considered independently of the three recommendations. LETTERS OF REFERENCE o Letters of reference on behalf of the candidate. CAREER DEVELOPMENT PLAN o Likelihood that the plan will contribute substantially to the scientific development of the candidate, 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 activities for the proposed award period. 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 cancer prevention, cancer control, epidemiology, or the behavioral/population sciences as they relate cancer prevention and control. 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. STATEMENTS BY MENTOR/CO-MENTOR(S) o Appropriateness of the mentor's research qualifications in the area of the proposed research. o Previous experience in fostering the development of cancer researchers. o History of research productivity and peer-reviewed support. o Adequacy of active/pending support for the proposed research project. o Strength of the mentor's statement. ENVIRONMENT AND INSTITUTIONAL COMMITMENT o Clear commitment of the institution to ensure that a minimum of seventy-five percent of the candidate's 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. 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 REVIEW CONSIDERATIONS BUDGET: The reasonableness of the requested budget in relation to career development goals and research aims and plans. 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. 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. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (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 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 is available at: http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS: NIH policy requires education on the protection of human research participants for all investigators submitting NIH proposals for research involvoing human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts, dated June 5, 2000 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS: Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as appropriate, 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.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance 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 the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm 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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