This PAR will expire on October 2, 2003 unless reissued. CANCER PREVENTION, CONTROL, BEHAVIORAL AND POPULATION SCIENCES CAREER DEVELOPMENT AWARD Release Date: September 4, 2001 PAR NUMBER: PAR-01-135 (see replacement PAR-04-055) National Cancer Institute This program announcement replaces PAR-99-108, which was published in the NIH Guide on June 3, 1999. PURPOSE 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 mechanism provides support for three to five years of specialized didactic study and mentored research for individuals with a health professional or science doctoral degree who are not fully established investigators and who want to pursue research careers in the cancer prevention, control, population and/or behavioral sciences. 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, chemoprevention trials in human populations, 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 PAR, 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). RESEARCH OBJECTIVES Background Recognizing a need for training researchers in preventive oncology and the lack of multidisciplinary curricula that would be needed for this purpose, in 1982 the National Cancer Institute (NCI) published 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 focusing 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 wanting to make a transition to cancer prevention and control research and to individuals already trained in cancer prevention and control who are 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 conducting 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 increasing the current level of NCI support of education/training programs in cancer prevention and cancer control and generating 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 program announcement incorporating the recommendations made by these experts. Goals and Scope The award provides support for up to five consecutive 12-month periods. A minimum of 75 percent effort must be devoted to the program. The remaining 25 percent can be divided among other clinical and teaching activities and coursework only if these activities are consistent with the program goals, i.e. the candidate"s development into an independent investigator. Both the didactic and the research phases of the award are expected to develop necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate in cancer prevention, cancer control, and behavioral and population sciences research. Candidates 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 Cancer Prevention, Control, Behavioral and Population Sciences Career Development Award provides a career development opportunity for: 1) individuals already proficient in general epidemiology, the behavioral sciences, or other relevant disciplines, and 2) individuals already trained in cancer epidemiology, etiology, prevention, control and the behavioral and population sciences to become fully independent investigators. The scope of the research/didactic training may extend from the development and experimental testing of hypotheses, 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. The recipient must receive appropriate mentoring throughout the duration of the program. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors and serve as role models. Candidates must name a primary mentor who, together with the applicant, is responsible for the planning, direction, and execution of the program. The primary mentor should have sufficient independent research support to provide for any research costs of the candidate"s research program in excess of the research support provided by this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. Allowable Costs Salary: The K07 award can provide salary up to $75,000 plus fringe benefits. The total salary requested must be based on a full-time, 12-month appointment requiring the candidate to devote a minimum of 75 percent 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. Research Development Support: Up to $30,000 per year can 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. 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. Evaluation In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. Other Income Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: 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 benefits payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. 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 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. Special Leave Leave to another institution, including a foreign laboratory, with award support may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NCI is required. To obtain prior approval, the award recipient must submit a letter to the Grants Management Specialist listed on the Notice of Grant Award, countersigned by his or her department head and the appropriate institutional official, describing the reason for leave, and the accommodations that will be made at the new institution to ensure that the didactic training and research objectives at the new institution remain within the scope of the award. THE AWARD RECIPIENT SHOULD CONTACT THE NCI PROGRAM DIRECTOR LISTED IN INQUIRIES BEFORE SUBMITTING THE LETTER. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NCI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the grantee institution. 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: 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. 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. 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, 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. 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, the award could be terminated. 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. 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. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) K07 award mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. The total project period for an application submitted in response to this PA may not exceed 5 years. Awards made for a five-year project period, or recommended by peer review for a shorter project period, are not renewable. ELIGIBILITY REQUIREMENTS The candidate must have a Ph.D. degree, a health professional doctoral degree (M.D., Dr.PH., D.D.S., D.O., D.V.M., Pharm. D.) 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. The candidate must be able to devote a minimum of 75 percent full-time professional effort conducting research and research career development activities during the period of the award. 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 noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen 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. Current and former principal investigators on NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) are eligible. However, current and former principal investigators on NIH research project (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible. A candidate for the K07 may not simultaneously submit or have pending an application for another career award (K01, K08, K23), a research project grant (R01, R03), or any other PHS award that duplicates the provisions of this award. 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. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Brian W. Kimes Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7001, MSC 8345 Bethesda, MD 20892-8346 Telephone: (301) 496-8537 FAX: (301) 402-0181 E-mail: bk34t@nih.gov Direct inquiries regarding fiscal matters to: Ms. Catherine Blount Grants Administration Branch 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 8109, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: tf12w@nih.gov APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/2001) (http://grants.nih.gov/grants/funding/phs398/phs398.html) and should use the instructions in Section IV of the application kit. The application will be accepted at the standard application deadlines for other K-awards as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. The title and number of the program announcement must be typed in Section 2 of the face page of the application. The YES box must be marked. For those applicants with Internet access, the 398 kit may be found at: http://grants.nih.gov/grants/funding/phs398/phs398.html All clinical trials supported or performed by NCI require some form of monitoring. 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 to 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 of the NCI for Data 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. Finally, for details on the essential elements of a data and safety monitoring plan for clinical trials funded by the National Cancer Institute and for how the NIH/NCI policies on data safety and monitoring apply to NCI K-awards, see: http://nci.nih.gov/clinicaltrials/conducting/dsm-guidelines. Submit a signed, typewritten original of the application, including the checklist, and three signed exact, single-sided photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8329 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8329 The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. The information summarized below must be provided in the application: 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, o Letters of recommendation. 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, 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. 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. Mentor"s Statement o The application must include a statement from the mentor providing information on their research qualifications and previous experience as a research supervisor. 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 biosketch. 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. 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 devote a minimum of 75 percent of his/her full-time professional effort 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. Biographical Sketch A biographical sketch is required for the applicant and 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 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. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for completeness by the Center for Scientific Review and for adherence to guidelines by the National Cancer Institute. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the Division of Extramural Activities of 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 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. 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. 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. Environment and Institutional Commitment o Clear commitment of the institution to ensure that a minimum of 75 percent of the candidate"s full-time professional 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 Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. The NCI will notify the applicant of the National Cancer Advisory Board"s (NCAB) action. 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 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 research involving human subjects should read the UPDATED "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (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. Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: 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 now available online at http://cme.nci.nih.gov/. 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. 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 a 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. 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). REQUIREMENTS FOR SHARING RESEARCH RESOURCES NIH policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community when they have been published. All investigators should read the Guidelines available at the following url address: http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm. See also: NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2001/) and Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts: Final Notice, December 1999 (http://www.nih.gov/od/ott/RTguide_final.htm). It is expected that biomaterials and other patentable research resources (examples could be, but are not limited to, vectors, embryonic cell lines, mutant mice, etc.) produced in projects funded by this initiative will be made available and distributed to the broader scientific community. 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, Cancer Prevention, Control, Behavioral and Population Sciences Career Development Award , is related to the priority area of human resource development. 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 Number 93.398, Cancer Research Manpower. 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 administered under NIH grants policies and Federal Regulations 42 CFR Part 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 Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of 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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