NCI TRANSITION CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES Release Date: March 27, 2001 (see replacement PAR-03-101) PA NUMBER: PAR-01-074 National Cancer Institute PURPOSE The Comprehensive Minority Biomedical Branch (CMBB), Office of Centers, Training and Resources (OCTR), Office of the Deputy Director for Extramural Sciences (ODDES), National Cancer Institute (NCI), invites transition career development award applications from recipients of the NCI Mentored Career Development Award for Underrepresented Minorities or from underrepresented minority individuals who are advanced postdoctoral and/or newly independent research scientists who have been in an independent position for less than two years at the time of the application. The purpose of the NCI Transition Career Development Award for Underrepresented Minorities (K22) is to provide "protected time" to develop and receive support for their initial cancer research program. This award is intended to facilitate the transition of a minority postdoctoral research scientist from the mentored to the independent stage of their careers in cancer research. The unique feature of this award is that the individuals may apply without a sponsoring institution while they are still in a mentored position. Successful candidates will be provided with special opportunities to enhance their knowledge and understanding of the NIH/NCI peer review system and to develop the skills required for preparing competitive research project grants. This award is a novel program that is intended to support and enhance the likelihood of success for underrepresented minority postdoctoral and newly independent investigators who have committed to basic, clinical, and prevention and population-based research careers in cancer. Awardees must apply for an R01 research grant or equivalent prior to the end of the second year of the award. RESEARCH OBJECTIVES Environment: The sponsoring institution, once identified, must have well- established basic, clinical, and/or prevention and population-based cancer research programs. The candidate's proposed cancer research program should benefit from the relevant cancer research and educational resources that are available. The sponsoring institution must also demonstrate a commitment to the development of junior faculty as productive, independent investigators. Program: The NCI Transition Career Development Award (K22) for Underrepresented Minorities can be used by more advanced postdoctoral and newly independent minority candidates who need protected time to establish their initial cancer research program. Accordingly, the award provides up to three consecutive 12-month appointments to recipients who must devote a minimum of 75 percent effort to the proposed basic, clinical or population science research program. The remaining 25 percent can be divided among other activities only if they are consistent with the program goals, i.e. the candidate's development into an independent investigator. Candidate: Candidates must devote at least 75 percent of their professional effort to cancer-related research and peer review activities consistent with the objectives of this award. The candidate must develop advanced knowledge in the basic, clinical, prevention or population-based sciences and the advanced research skills relevant to her/his cancer research field(s). Allowable Costs: Salary: The NCI Transition Career Development Award for Underrepresented Minorities (K22) will provide salary up to $75,000 annually plus fringe benefits. The total salary requested must be based annually on a full-time, 12 month staff appointment 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. The institution may supplement the NCI 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 K22. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. Research Development Support: Up to $50,000 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 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 8 percent of modified total direct costs. Evaluation: In carrying out its stewardship of human resource related programs, the NCI may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: o The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution; o The funds may be used for health-related research purposes; o The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment; o Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided 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. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NCI is required. To obtain prior approval, the award recipient must submit a letter to the NCI describing the plan, 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 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 a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. Furthermore, the awardee must submit assurance of his or her intention to return to full-time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NCI 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 NCI shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. Awardees planning a change of institution must submit to the NCI in advance of the change a written request for transfer, countersigned by the appropriate institutional business official, describing the reasons for the change. 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. Staff within the NCI will review this request and may require and upon approval of this request, a new career award PHS 398 application must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than the time remaining within the existing award period. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. MECHANISM OF SUPPORT Support for this program will be provided through the NIH K22 award mechanism. The total project period for an application submitted in response to this PA may not exceed 3 years. Planning, direction, and execution of the program will be the responsibility of the candidate on behalf of the applicant institution. Grants are not transferable from one principal investigator to another. Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required progress report. Awards are not renewable. 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. Recipients of the NCI Mentored Career Development Award for Underrepresented Minorities and/or candidates who meet the following requirements are eligible to apply: o Qualify as an underrepresented minority individual defined as belonging to a particular ethnic or racial group that has formally been determined by the applicant institution to be underrepresented in biomedical and behavioral research (e.g., African Americans, Hispanic Americans, American Indian and Alaska Natives, and Native Hawaiian and Other Pacific Islanders). o Possess a research or health professional doctoral degree (or its equivalent) that is suitable preparation for a productive research career. o Have been in or currently in a "mentored" research postdoctoral position and have completed two years or more of research in this capacity at the time of the application, or be in a suitable independent position for less than two years with continuous previous postdoctoral research training at the time of the application. Exceptions to this condition will require explicit written permission from the NCI. o Intend to conduct a research project highly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis and treatment that has the potential for establishing an independent research program. Although applications may be submitted for peer-review without institutional representation, if approved for funding applications must be submitted on behalf of candidates by domestic, for profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government or comparable institutions (see section on AWARD CRITERIA AND PROCEDURES). Applications from foreign organizations are excluded from applying to this program announcement. Awards will be limited to individuals who are citizens or non-citizen alien nationals, or permanent residents of the United States. Individuals on temporary or student visas are not eligible. Women and persons with disabilities are encouraged to apply as principal investigators. SPECIAL REQUIREMENTS Recipients of an NCI Transition Career Development Award for Underrepresented Minorities (K22) must submit a competitive research grant application to the NIH/NCI, or an R01 equivalent research grant application to an equivalent funding organization (for example, an American Cancer Society Research Project Grant) for peer review and funding consideration prior to the end of the second year of support. INQUIRIES Written, telephone, fax, and E-mail inquiries concerning this PA are encouraged, especially during the planning phase of the application. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sanya A. Springfield, Ph.D. Chief, Comprehensive Minority Biomedical Branch National Cancer Institute 6116 Executive Boulevard Suite 7018A Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: ss165I@nih.gov Direct inquiries regarding fiscal matters to: Ms. Barbara Fisher Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: (301) 846-1015 FAX: (301) 846-5720 Email: bf18m@nih.gov Direct inquiries regarding review matters to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Suite 8109, MSC-8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: tf12w@nih.gov APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Applications should be organized using the Research Career Award, Section IV of the PHS 398, Just-In-Time procedures. Applications for which the candidate already has a position must be completed as directed. Postdoctoral candidates with no sponsoring institution may leave out all information that is the grantee institution's responsibility to provide; this information must be provided at a later time if the candidate is selected for funding (see section on AWARD CRITERIA AND PROCEDURES). Application kits are available at most institutional offices of sponsored research; from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: The title (NCI TRANSITION CAREER DEVELOPMENT AWARD FOR UNDERREPRESENTED MINORITIES) and number of the PA must be typed in Section 2 on the face page of the application. The YES box must be marked. For those applicants with Internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm. Applicants must provide evidence that they received uninterrupted support as noted under ELIGIBILITY REQUIREMENTS above. Submit a signed, typewritten original of the application and current curriculum vitae with complete bibliography, including the checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Rockville, MD 20817 (express/courier service) At time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Suite 8109, MSC-8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (express/courier service) The Center for Scientific Review (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 submission of 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. 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 Coordinator 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/. 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. The candidate must address the following issues and include the following information in the application: Candidate For applicants already in an independent position: o Describe immediate and long-term career goals, explaining how the award will contribute to their attainment; o Describe the current position in terms of its ability to enable the candidate to pursue an independent career in cancer research; All Applicants: o Describe immediate and long-term career goals, explaining how the award will contribute to their attainment; o Describe all activities during the "mentored" period (postdoctoral, previous K-award, etc.) of cancer research training. Include all research experiences and mentors, any pertinent didactic experiences and any other experiences designed to acquire critical skills, techniques and scientific perspectives for pursuing an independent career in the chosen area of cancer research (e.g., basic research, clinical or patient-oriented research, and prevention, control and population research); o Describe scientific productivity during the mentored period of career development; o Establish the potential to manage an independent research program; o Establish the ability to become an independent investigator during the three year term of the award; o Describe the ability to interact and collaborate with other scientists; o Establish the ability to make a commitment of at least 75 percent effort to the objectives of this award; o Submit three letters of recommendation from established scientists familiar with the candidate's potential and capability to become a successful independent investigator in which the following issues are addressed: - the adequacy of the candidate's scientific background for the proposed research and career goals; - the quality of the candidate's scientific productivity and achievements (e.g., publications, intellectual contributions to the research environment); - the candidate's ability to work with other scientists in various interactive situations (e.g., seminars, journal clubs), on collaborative research projects, and with support staff (e.g., technicians, nurses, secretaries etc.); - evidence of the candidate's originality and innovativeness in pursuing a research problem; - VERY IMPORTANTLY, the candidate's special potential to develop, establish and manage an independent research program. 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 research plan must be clearly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment; o Describe how the proposed research extends the mentored research training that has been completed into new concepts and ideas; o Describe the equipment, specialized facilities and personnel resources that will be needed to conduct the proposed research; o Describe the plans for inclusion of women, minorities and children in any clinical or population research activities; o Describe the plans for protection of humans, animals or the environment to the extent they may be adversely affected by activities proposed in the application. Previous Mentor's Statement o Include a signed statement from the previous mentor(s) with information on potential and capability of the candidate to become a successful independent investigator in which the following issues are addressed: - The adequacy of the candidate's scientific background for the proposed research and career goals; - The quality of the candidate's scientific productivity and achievements (e.g., publications, intellectual contributions to the research environment); - The candidate's ability to work with other scientists in various interactive situations (e.g., seminars, journal clubs), on collaborative research projects, and with support staff (e.g., technicians, nurses, secretaries etc.); research qualifications and previous experience as a postdoctoral researcher. The application must also include information to describe the previous mentor's research support as related to the candidate's research plan. Environment and Institutional Commitment o Describe the resources and facilities available to the candidate; o Describe how the research environment of the institution is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan; o In a clear statement, provide assurances that the candidate will be able to spend a minimum of 75 percent effort in the conduct of his/her research activities, with the remaining percent effort devoted to activities related to the development of a research career. Biographical Sketch o A biographical sketch is required for the candidate, including information on research projects completed and/or research grants participated in during the postdoctoral or mentored phase that are relevant to the proposed project. Budget The total direct costs requested must be consistent with this K22 program announcement and the award limits of the NCI. Applicants seeking information on award limits should contact the fiscal representative listed in the INQUIRIES section of this announcement. o Provide a detailed description, with justification, for all equipment, supplies and personnel that are required to achieve the research objectives of this award. Non-Competing Renewals o In addition to the information requested in the Application for Continuation Grant form PHS 2590 (Rev. 4/98), documentation must be provided with the Progress Report for the third year of the award showing that the awardee has submitted a competitive research grant (or equivalent) for funding. This documentation should minimally be a copy of the face page of the application with all required institutional signatures. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and adherence to the guidelines of this PA by NCI staff. Incomplete or non- responsive applications will be returned without further consideration. Applications that are complete and adhere to the guidelines of this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the National Cancer Institute in accordance with review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. The following review criteria will be applied: Candidate (Principal Investigator) For candidates already in an independent position: o Suitability of the position for the candidate to pursue an independent research career; For all Candidates: o Quality of the mentored period of cancer research training in terms of research experience(s), didactic experiences and other experiences (e.g., special skills, perspectives, techniques) that will enhance the candidate's ability to pursue an independent cancer research career in the chosen area of research (e.g., basic research; clinical or patient oriented research; or prevention, control and population research); o Scientific productivity during the mentored period of cancer research training; o Commitment of the candidate to an independent cancer research career that will be focused on problems clearly relevant to cancer; o Potential ability to successfully manage an independent research project; o Ability of the candidate to interact and collaborate with other scientists; o Recommendations of three well-established scientists attesting to the special potential of the individual to pursue an independent career in cancer research. Research Plan o Adequacy of the proposed research plan for developing an independent cancer research program as it relates to the basic, clinical or patient-oriented and/or prevention control and population cancer research and commensurate with the candidate’s level of research development; 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 Adequacy of plans for the protection of human and animal subjects and the safety of the research environment and conformance with the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research and Inclusion of Children Participating in Research Involving Human Subjects. Previous Mentor/ Co-Mentor o Adequacy and clarity of the previous mentor's statement describing the potential and capability of the candidate to become a successful independent investigator. 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 independent 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; o Adequacy of the proposed budget items for the achievement of the career development and research objectives of the award. Non-Competing Renewals o Adequacy of 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 Adequacy of the long-term research career goals, including the timing of submission of applications for competitive research grants. AWARD CRITERIA AND PROCEDURES Applications will compete for available funds with all other recommended applications. The NCI staff will notify the applicant of the National Cancer Advisory Board's action shortly after its meeting. The following will be considered in making decisions: scientific and technical merit of the proposed project as determined by the initial review group, the results of the secondary review by the NCAB, availability of funds, program balance and priority. The NCI will notify the candidates who have competed successfully for funding with a "Letter of Intent to Commit Funds." Candidates in a postdoctoral position will then have one-year from the date of the letter to find an institution that offers a position, preferably tenure-track, suitable for enhancing a research career. For candidates who already have a position in a sponsoring institution, negotiation with the institution will begin without delay. Negotiations will be initiated by asking the candidate's institution to submit a "Statement of Environment and Institutional Commitment" to the NCI. This statement will be evaluated by NCI staff using the following criteria: o Documentation of a strong, well-established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate; o Agreement of the institution's statement of commitment of equipment, physical and personnel resources with the peer-reviewed recommendation of needs; o Adequacy of the arrangements with the candidate to provide 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. For postdoctoral candidates, if the NCI approves the "Statement of Environment and Institutional Commitment" offered by the institution, the institution will be asked to submit a completed PHS Form 398 application. For candidates who already have a position in a sponsoring institution, the NCI only needs to approve the Statement. After NCI approval and subject to the availability of funds, the institution will receive an award. At the time of the award to the grantee institution in support of the K22, any current award held or other support provided for the mentored training of the candidate will be terminated. An award can be terminated prior to the end of the third year by the NCI if the candidate does not submit an R01 type grant application or equivalent for peer review before the end of the second year (See SPECIAL REQUIREMENTS). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided to indicate that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED " NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to the NIH defined Phase III clinical trials and require: a) all applications or proposal and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and /or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (e.g., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998 and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.: Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications for NIH funding must be self-contained within specific page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS-led national activity for setting priority areas. This Program Announcement (PA) NCI Transition Development Award for Underrepresented Minorities, is related to the priority area of human resource development in cancer research. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATION This program is described in the catalog of Federal Domestic Assistance No. 93.398. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended by Public Law 99-158, 42 USC 241 and 284 and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American People.


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