NCI INSTITUTIONAL PRE-DOCTORAL RESEARCH TRAINING PARTNERSHIP AWARD RELEASE DATE: October 10, 2002 RFA: CA-03-017 National Cancer Institute (NCI) (http://www.nci.nih.gov/) LETTER OF INTENT RECEIPT DATE: February 27, 2003 APPLICATION RECEIPT DATE: March 27, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Eligible Program Directors o Eligible Mentors o Eligible Trainees o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria PURPOSE As part of a broader pilot activity of the National Institutes of Health (NIH), the Cancer Training Branch (CTB) of the National Cancer Institute (NCI) invites applications to support the development of new pre-doctoral training programs that are partnerships between extramural institutions and unique areas of research within the components of the NCI Intramural Program. The specific components of the NCI intramural program selected for these partnerships represent unique strengths of the NCI in terms of staff and resources for research and research training, and represent high priority areas for research training. The purpose of this RFA is to form partnerships between extramural institutions and the NCI in order to enhance training opportunities at these institutions for pre-doctoral students in high priority areas of cancer research. Participation in this initiative is anticipated to 1) expand opportunities for students and faculty at the respective institutions for training and the conduct of research, 2) provide greater access of trainees and researchers to unique aspects and resources- for example, databases and study cohorts- of the NCI Intramural Program; and 3) stimulate important new scientific collaborations between extramural and NCI scientists and students. RESEARCH OBJECTIVES Background While scientists at the NIH traditionally have participated in the training of graduate students on an ad hoc basis, graduate programs at universities have never been able to take full advantage of the resources available on the NIH campus to help achieve their pre- doctoral training objectives. To improve this situation, in July 2000, the NIH implemented the Graduate Partnerships Program (GPP). The GPP has the responsibility to formally link NIH intramural research with universities in the training of pre-doctoral students in the biomedical sciences and to facilitate the development, operation, and oversight of University-NIH pre-doctoral training partnerships. As a first step, the GPP created a website that comprehensively provides extramural institutions and scientists descriptions of and access to the research groups at the NIH. This website (http://gpp.nih.gov/Researchers/) facilitates the development of ad hoc and formal arrangements between extramural and intramural research groups with the GPP serving as a broker and facilitator. In addition, the GPP has expanded a prior model for University-NIH partnerships in broad areas of research training. Currently, there are nine of these partnerships: Johns Hopkins University (Biological Sciences); George Washington University (Genetics); University of Maryland (Biophysics); University of Pennsylvania (Immunology); Boston University (Bioinformatics); University of Maryland (Hearing and Communication Disorders); Oxford University, England (Biomedical and Biological Sciences); Cambridge University, England (Health Sciences Scholars Program); and the Karolinska Institute, Sweden (Neurosciences). There are currently 24 pre-doctoral students in the NCI Intramural Program participating in the GPP: 20 in the Center for Cancer Research (CRC) and 4 in the Division of Cancer Epidemiology and Genetics (DCEG). While these broad arrangements more aggressively broker connections between graduate programs and intramural research groups, they do not involve any NIH funding or formally integrate extramural and intramural scientists in a specific training program, such as those traditionally supported by institutional National Research Service Awards (NRSAs) or T32s. To explore other options for involving the NIH in graduate training, in September 2000 a focus group of approximately 20 graduate school Deans and others (mostly from the Graduate Research, Education and Training {GREAT} Group) was constituted by Dr. Mary Delong (Director of the GPP, OD, NIH) and convened at the NIH. A key recommendation of the focus group was that NIH partnerships should be created that compete for extramural training funds in a manner similar to applicants for Institutional National Research Service Awards (NRSA). The NIH decided that the best ways to pursue this new partnership concept would be to ask institutes to develop pilot programs to explore its usefulness and potential. Four ICs (i.e., NCI, NLM, NIHGR, and NIAID) are in the process of developing RFAs to pilot the TU2 program. Objectives and Scope The objectives of this RFA will be accomplished by combining the support for Ph.D. or equivalent degree (e.g., Dr.P.H., Sc.D.) candidates and the program through a new specialized cooperative training grant (TU2) guided by National Research Service Award (NRSAs) policies and through Cancer Research Training Awards (CRTAs). The TU2 will support the didactic and research training of predoctoral candidates, as well as other training related expenses of the program, at the extramural institution; and CRTAs will support candidates for their research training while in the NCI Intramural Program. Trainees will be required to meet the dissertation requirements established by their extramural home institution. In theory, the program has the flexibility to afford the trainees the opportunity to move back and forth between the extramural institution and the NCI Intramural program during the entire period of their appointment. However, in this pilot effort, it is expected that the laboratory component of the training will occur mainly at the NCI. The Division of Cancer Epidemiology and Genetics (DCEG) and the Center for Cancer Research (CCR), both of which represent the NCI Intramural Program, have selected a number of areas for possible training. Interested extramural institutions may consult with NCI coordinators in the areas described below to explore the possibility of developing a partnership training program and submitting a grant application in response to this initiative. The Division of Cancer Epidemiology and Genetics (DCEG) invites applications in the following areas of research training: o genetic and molecular epidemiology o environmental and occupational epidemiology o nutritional epidemiology o radiation epidemiology o viral and infectious disease epidemiology o biostatistics and methodologic research DCEG carries out population-based and interdisciplinary research to uncover the genetic and environmental determinants of cancer, and the means of cancer prevention. Priority is given to accelerating and broadening emergent scientific issues identified through clinical, epidemiologic, and laboratory observations, including recent discoveries in molecular genetics and cancer biology. Research projects may involve biomarkers to assess precursor states, intermediate outcomes, carcinogenic exposures, susceptibility states, and mechanisms of carcinogenesis for the entire range of cancer organ sites. The role of lifestyle factors (including diet and nutrition), environmental pollutants, occupational exposures, genetic predisposition, hormonal and other endogenous factors, infectious agents, pharmacologic compounds, and ionizing and nonionizing radiation is investigated. Particular emphasis is placed on the study of gene- environment interactions. DCEG has a firm commitment to training the next generation of cancer epidemiologists and biostatisticians, and seeks partnerships with academic institutions offering graduate education in epidemiology and related areas in order to furnish opportunities for dissertation projects at the National Cancer Institute. For the DCEG, there are approximately 6 positions available for one or a combination of the above six categories of research training. The Center for Cancer Research (CCR) invites applications in the following areas of research training: Chemistry Chemistry is a crucial component of the blend of disciplines that constitute the Center for Cancer Research (CCR) at the National Cancer Institute (NCI). Given the biomedical mission of the Institute, the research is focused on areas of chemistry that have a direct impact on that mission. While much of this research is fundamental chemistry research, not unlike that found in many academic chemistry departments, the general orientation is toward the biological sciences. As a consequence, the chemically oriented laboratories of the NCI offer a superb environment for graduate training in chemistry at the interface with biology. The Program seeks to unite the chemistry groups in the NCI into a Faculty that will provide a first class environment for the training of doctoral candidates in biologically oriented chemistry. In order to enhance the interdisciplinary nature of the Program, the Faculty will also include biological scientists whose research requires interaction with chemists. The partnership program will be a competitive graduate program to pursue research in one of the chemistry laboratories of the National Cancer Institute and is intended for individuals who wish to obtain training in chemistry at the interface of biology. Bioinformatics and Computational Biology As one of the pioneers in developing DNA sequencing, microarray transcript profiling, proteomic profiling, laser-capture microdissection, cell-based and tissue microarrays, and DNA analysis microarrays, among other technologies, the NIH offers students exposure to an unparalleled breadth and depth of expertise in the bioinformatic disciplines. Increasingly, biomedical research relies on the computer for both the exploration of existing databases and calculations focused on biological phenomena. Advances in these in silico fields are profoundly interconnected with the ongoing revolutions in genomics and proteomics. This interrelationship is clearly evident in the Human Genome Project, which has generated vast amounts of data. New software tools, however, are needed to enable researchers to better manage, correlate, analyze, and interpret such complex biological information. In the field of cancer research, such tools will not only lead to advances in basic research but also translate into the improved diagnosis, prognosis prediction, prevention, and treatment of human cancers. The NIH and the NCI's Center for Cancer Research (CCR), therefore, have increasingly focused on developing the bioinformatics needed to transform the data produced by "omic" technologies into biomedical knowledge through partnerships with applicant institutions seeking to develop better software tools for managing complex biomedical information and correlating it with diagnosis, prognosis prediction, and treatment. These endeavors are highly interdisciplinary in nature and most effectively undertaken by individuals who have a solid background not only in biology, but also in statistics, data analysis, engineering, computer science, or artificial intelligence. At present, the CCR is particularly interested in encouraging collaborative, interdisciplinary research aimed at achieving the following goals: o Developing pattern-recognition algorithms designed to analyze biological data, including artificial intelligence, support vector machines, and self-organizing maps (SOMs). o Using bioinformatics tools to identify genes that can be used to diagnose cancer patients, predict their prognosis, assess responses to therapy, and define tumor-specific therapeutic targets. o Linking critical genes identified by individual investigators to large, publicly available databases such as the protein structure database and the NCI's small molecules database. o Devising methods and web-based tools for unifying large databases and for visualizing and clustering data, including multidimensional scaling, principal component analysis, hierarchical clustering, K means, and SOMs. For the CCR, there are approximately 10 positions available, 5 for each of the 2 categories of research training. The total number of positions available (DCEG, CCR) is therefore 16. The NCI facilitators for the DCEG and the CCR are respectively Dr. Demetrius Albanes and Dr. Jonathan Wiest. Contact information for the facilitators is provided under "WHERE TO SEND INQUIRIES". After having first contacted the NCI extramural program director, potential partners will be referred to the relevant NCI facilitator to explore the possibility of submitting a grant application together. The listing of available NCI mentors for each area with a description of their research activities can be found at the following website: http://cancertraining.nci.nih.gov/TU2 MECHANISM OF SUPPORT This RFA will use the NIH TU2 cooperative agreement award mechanism. This RFA is a one-time solicitation. Since this is a pilot program, the decision to reissue this RFA in the future will be made after an interim evaluation of the success and effectiveness of the RFA. Future unsolicited, competing-continuation applications based on this initiative will compete with all investigator-initiated Institutional NRSA applications and will be reviewed according to the customary peer review procedures. The anticipated award date under this RFA is September, 2003. The NIH TU2 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award". The total project period for applications submitted in response to this RFA may not exceed five years. FUNDS AVAILABLE NCI intends to commit approximately $1,000,000 total costs in FY 2003 to fund up to 5 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $200,000 per year. Because the number of trainees on each grant and their stipends may vary, it is anticipated that the sizes of the award will also vary. Although the financial plans of NCI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS Eligible applicant institutions are domestic institutions having any of the following characteristics: o For-profit or non-profit degree-granting organizations o Not-for profit public or private institutions or academic institutions that offer the Ph.D. and or equivalent health professional degree Eligible applicant institutions must have a generally strong research program in any of the eligible area(s) proposed for research training, as evidenced by the peer-reviewed and funded research of the scientists at the institution who will serve as mentors. This pilot initiative is intended for single extramural institution partnerships and will not support a consortium of extramural institutions. ELIGIBLE PRINCIPAL INVESTIGATORS/INTRAMURAL PARTNERS The intramural and extramural leaders of the partnership must be established investigators. The extramural leader will be the PI of the grant application and the intramural leader will be the intramural partner (IP). Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs as principal investigators. ELIGIBLE PRECEPTORS Preceptors must be established investigators. Preceptors from the extramural institution must have a track record of research productivity and research support including current active research support; and must have a successful track record in mentoring predoctoral students. NCI Intramural preceptors must have a track of research productivity and in mentoring investigators early in the development of their research careers. ELIGIBLE TRAINEES Trainees must be U.S. citizens or non-citizen nationals or must be lawfully admitted for permanent residence (i.e., possession of a currently valid Alien Registration Receipt Card I-1551, or some other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Trainees must be able to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program. SPECIAL REQUIREMENTS The applicant institution (s) must be able to demonstrate how a partnership with the NCI Intramural Program will significantly compliment and enhance their research training capability in ways that otherwise would not be possible. Program Steering Committee Each Program must have a Program Steering Committee (PSC). The PSC should include as voting members the PI and the IP, and four senior core faculty (and mentors), two from the extramural institution and two from the NCI Intramural Program. The PSC can add other members as (non-voting) ad hoc participants whenever the situation requires. It would be anticipated that representatives from the dissertation committees for the individual trainees would be included on an as- needed basis among the ad hoc participants. The NCI extramural program director will serve as an ex officio with full authority to participate in all discussions and ensure that the partnership is adhering to NCI and NIH extramural policies. The PSC will be co-chaired by the PI and the IP. The PSC must meet once a year. The PSC will function to facilitate matching of predoctoral candidates previously admitted to the graduate schools of the extramural institution with appropriate extramural and intramural mentors; evaluate the progress of the program in achieving its objectives and recommend midcourse corrections as needed; approve of the extramural and intramural training plan for each candidate; evaluate the progress of each candidate's training in terms of benefiting from the unique opportunities offered by the partnership and completing the training plan within the timeline originally anticipated; ensure that each candidate in the intramural phase of the Partnership Program continues to progress towards satisfying all of the academic requirements of the extramural institution for a Ph.D. degree; define areas of potential scientific collaboration between the extramural scientists and NCI intramural scientists that will strengthen the partnership in the future; and evaluate the special marketing and recruitment efforts of the program and make recommendations for improvement. A report documenting the deliberations and decisions of the PSC must be provided annually with the Non- Competing Grant Progress Report (PHS 2590). Recruitment and Placement Plan The Training Partnership must present a recruitment and placement plan that augments and complements the extramural institution's normal procedures for recruiting predoctoral candidates, and for placing/matching candidates with mentors for their dissertation training and research. It is expected that this plan will involve special marketing efforts to inform potential candidates of this special opportunity for training, and attract the highest quality candidates possible for participation in this Partnership Program. It is also expected that this plan will provide special opportunities for the candidates to interact with potential mentors in the NCI Intramural programs prior to selection of mentor(s). A Plan for recruiting Minority Trainees must be provided and must follow current NRSA policy Guidelines (See NIH Website noted under ALLOWABLE COSTS). Special Administrative Requirements o General The NCI considers, as a condition of this NCI TU2 award, that the PI and the business officials of the extramural institution understand the official policies that govern Institutional National Research Service Awards and will take full responsibility for conforming to the reporting requirements of the NRSA program as required by Congressional legislation. This includes timely and accurate submission of Statements of Appointment (Form PHS 2271, available in an interactive format at https://grants.nih.gov/training/phs2271.pdf) for new and reappointed trainees with correct stipend levels as approved by NIH; timely and accurate submission of Termination Notices (Form PHS 416-17, available at https://grants.nih.gov/grants/funding/416/phs416-7.pdf) when trainee support is discontinued; and submission of the appropriate information confirming citizenship status of trainees at the time of appointment (The extramural institution is responsible for determining the eligibility of trainees with regard to satisfying the necessary citizenship requirements). o Budget and Related Issues Prior to developing budgets, applicants are strongly encouraged to interact with appropriate Program Staff and Grants Management Staff listed under "WHERE TO SEND INQUIRIES". Stipends: While in training, pre-doctoral candidates will receive stipend levels as determined by current NRSA policies (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-028.html) when at the extramural institution and stipend levels according to CRTA policies (http://camp.nci.nih.gov/admin/crta) when at the NCI. The stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee's institution. The extramural training institution may not alter established stipend levels. Further, stipend levels are not to be changed in the middle of an appointment period. Stipends may be adjusted only at the time of appointment or reappointment. Stipends must be based on the level established for the current fiscal year of the grant. Finally, for appointments of less than 12 months, the stipend will be based on a monthly or daily pro-ration. Student support at the extramural institution is expected to last from one to three years and in the NCI Intramural Program from two to four years. Unless there are exceptional circumstances requiring special NCI approval, total support for an individual (the combination of NRSA and CRTA support) is expected to last for no more than five years. Appointments to students are for a period of one year, and are renewable for up to five years based on adequate progress of the student. Tuition, Fees, and Health Insurance: The NRSA and CRTA mechanism will offset the combined cost of tuition and fees for the trainee at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Medical insurance will also be provided. Costs associated with tuition, fees and health insurance are allowable only if they are required for all individuals in a similar training status at the institution regardless of the source of support. A full description of the tuition policy is contained within the NIH Grants Policy Statement at: https://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm#_ Toc504812004 Training Related Expenses: Training related expenses of up to $10,000 per year per trainee may be requested to defray the costs of other research training related expenses. Typically, these costs could include staff salaries, consultant costs, equipment, research supplies, travel costs for Steering Committee Members to meet once a year at either the extramural institution or the NCI for purposes of assessing the progress of the program; and trainee travel to scientific meetings and between the extramural institution and the NCI as part of the training program. Applicant institutions should contact the NCI Extramural Program Director early in the application process to discuss this budget category. Facilities and Administrative Costs: While funded by NRSA, a facilities and administrative allowance (indirect cost allowance) based on 8 percent of the total allowable direct costs (this excludes amounts for tuition, fees, health insurance and equipment) may be requested. Stipend Supplementation: Supplementation or additional support to offset the cost of living may be provided by the extramural grantee institution during the extramural phase of the training program. Supplementation does not require any additional effort from the trainee. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal Agency. Compensation: The extramural grantee institution may provide additional funds to a trainee during the extramural phase of the training program in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting research that constitutes the research training experience. Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Concurrent Awards. An NRSA trainee may not an NRSA concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. Tax Liability: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report as gross income any monies paid on their behalf for stipends, or any course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between NRSA trainees and institutions. NRSA stipends are not considered salaries. In addition, trainees supported under the NRSA are not considered to be in an employee-employer relationship with the NIH or the awardee institution. It is therefore, inappropriate and unallowable for institutions to charge costs associated with employment (such as FICA, workman's compensation, or unemployment insurance) to the training grant. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. The NIH takes no position on the status of a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations. Special NCI Programmatic Requirements Pre-application Process. Potential applicant institutions must initially contact the NCI Extramural Program Director listed in " WHERE TO SEND INQUIRIES". This individual will clarify any issues regarding the intent and purpose of the RFA and the process for exploring potential training partnerships with NCI Intramural scientists. Applicants will be referred by the NCI Extramural Program Director to one of the NCI Intramural facilitators listed in " WHERE TO SEND INQUIRIES". The NCI Intramural facilitator will assist in initiating potential partnerships with potential IP's in either the Center for Cancer Research (CCR) or the Division of Cancer Epidemiology and Genetics (DCEG), and will assist in identifying alternative potential partnerships if the initial contact is not productive. For those situations where the initial contacts are not productive, an official statement will be developed by the facilitator and the potential IP stating the specific reason(s) for the lack of success in negotiating a partnership. This statement will be provided to the potential applicant institution and to the NCI Extramural Program Director. For those situations where the negotiations are successful, the facilitator will work with the applicant institution and the IP to develop the conditions of the co-operative agreement. o Post-award. The Partnership Program must satisfy all of the requirements of the NCI Supplemental Policy for Institutional National Service Research Awards (T32). The Supplemental policy may be found on the following website: http://deainfo.nci.nih.gov/awards/supT32guideline.htm Special NCI Administrative Policies All grantees are expected to comply with the provisions as defined in the National Research Service Award Guidelines. Institutions regularly failing to provide timely submissions of Non-Competing Grant Progress Report (PHS 2590); timely and accurate Statements of Appointment (Form PHS 2271, available in an interactive format at: https://grants.nih.gov/training/phs2271.pdf) and/or Termination Notices (Form PHS 416-7, available at the following site: https://grants.nih.gov/grants/funding/416/phs416-7.pdf); correct stipends to trainees; or not providing the correct citizenship information for trainees, will be considered by the NCI not to be in compliance with the management requirements of the award. If any of these circumstances become recurrent and serious problems, it will be the policy of the NCI to issue provisional awards for the Non-Competing Grant Progress Report (PHS 2590) until the situation(s) is fully corrected; and the level of and/or future funding of the training program could be jeopardized. Recruitment of Minority Trainees Although this is a general NIH requirement, the NCI, in order to address the effectiveness of research approaches that investigate the higher cancer incidence and mortality rates of minorities and various ethnic and underserved groups, takes a very proactive interest in the success of every grantee's recruitment efforts. Therefore, the required specific recruitment plan by NIH for each training grant will be monitored by NCI program staff for progress, and NCI staff will work with each grantee to increase the effectiveness of the plan. Allowable Costs NCI TU2 grants support all of the traditional costs outlined in the official National Research Service Award Guidelines (https://grants.nih.gov/grants/policy/nihgps_2001/). These costs are also summarized in this RFA under Special Requirements for Budget and Related Issues. Cooperative Agreement Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and will be provided to the PI as well as to the appropriate extramural institutional officials at the time of award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS and NIH policies. The administrative and funding instrument for this program will be the Cooperative Agreement (CA) grant or TU2. The cooperative agreement is an "assistance" mechanism (rather than an acquisition mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the CA, the NIH's purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and the activities in carrying out the training will be shared among the awardee(s) and the cooperating NCI Intramural Program's IP. 1. Awardee Rights and Responsibilities The Principal Investigator (PI) will have the primary responsibility for the oversight, administration and management of the NRSA-supported part of the research training program according to the conditions of this RFA. The PI will agree to accept close coordination, cooperation, and participation with the NCI Intramural research staff as well as with NCI Extramural program staff in those aspects of scientific and technical management of the project as described under the NIH Staff Responsibilities. The PI will: o Recruit graduate students for the program, with special attention to increasing the number of underrepresented minorities, and implementing the special marketing recruitment measures to ensure that high quality candidates are available. o Ensure that there are adequate faculty at the extramural institution and in the relevant NCI Intramural program with appropriate mentoring skills and research experience to participate in the training program. o Ensure that the didactic portion of the research training program is appropriately rigorous so that students are grounded in the fundamentals of the sciences appropriate to their research interests and that it involves NCI intramural participants when they can strengthen the program. o Co-chair, in collaboration with the IP, the Program Steering Committee (PSC) and ensure that it meets regularly to oversee the progress of the program, evaluate its effectiveness, make recommendations to improve its effectiveness and identify areas of extramural/intramural research collaboration. Accept and implement the recommendations of the PSC. o Ensure that the research interests of the trainees are matched with the research interests of the participating extramural and the NCI intramural faculty. o Ensure that there is a clear plan for each trainee regarding when they transition from the didactic part of the program to the research training part of the program. o Ensure that the training plan developed for each trainee will satisfy all of the requirements of the extramural institution for a Ph.D. degree. The PI will oversee all aspects of the partnership at the extramural institution and the NCI Intramural program. The PI will be responsible for reporting in the Non-Competing Grant Progress Report (PHS 2590) the progress of the partnership that occurs both at the extramural institution and the NCI Intramural Program. 2. NCI Staff Responsibilities The NCI Intramural Partner will have the following rights and responsibilities: o Primary responsibility for administering and managing the intramural research in support of the students' dissertation o Work collaboratively with the PI and the PSC to ensure that there are acceptable procedures for recruitment and selection of graduate students to participate in the intramural research component. o Work with the PI to ensure a smooth transition of the trainees from the extramural institution to the NCI Intramural Research Program o Ensure that intramural training is in compliance with the extramural institution's requirements for doctoral degrees and ensure that every graduate student selected for participation in the partnership program will pursue a research project that will result in a doctoral dissertation, will receive appropriate mentoring, and will be provided with the resources to pursue the research. o In conjunction with the PI and the PSC, develop policies for monitoring the progress of graduate students, evaluating the partnership training program and identifying areas for extramural/intramural research collaboration. o Co-chair the Program Steering Committee and accept its recommendations The IP in collaboration with the PI will oversee all activities at the NCI and be responsible for providing the information related to the NCI Intramural Program necessary for preparation of all progress reports associated with the Non-Competing Grant Progress Report (PHS 2590). The NCI Intramural facilitators will have the following rights and responsibilities: o Working with the NCI Program Director, provide oversight of the administration of the intramural component of the program. The NCI Program Director will have the following rights and responsibilities: o Provide the same program administrative oversight as for any NRSA Institutional Training Grant while trainees are at the extramural institution. o Serve as an ex officio member of the PSC. o Oversee and approve the selection of candidates for the Program to ensure that selection standards are fair and objective. o Assess annual progress towards achieving Program objectives . o Assess continued compliance of the program with intent of the RFA. o Determine acceptability of the Program for continuation in each non- competing year. 3. Collaborative Responsibilities Each Partnership Program is required to have a Program Steering Committee (PSC). The PSC should include as voting members the PI and the IP, and four senior core faculty (and mentors), two from the extramural institution and two from the NCI Intramural Program. The PSC can add other members as (non-voting) ad hoc participants whenever the situation requires. It would be anticipated that representatives from the dissertation committees for the individual trainees would be included on an as-needed basis among the ad hoc participants. The NCI extramural program director will serve as an ex officio with full authority to participate in all discussions and ensure that the partnership is adhering to NCI and NIH extramural policies. The PSC will be co-chaired by the PI and the IP. The PSC must meet once a year. The individual Program Steering Committees will have the following responsibilities: o Facilitiate the matching of predoctoral candidates previously admitted to the graduates schools of the extramural institution to appropriate extramural and intramural mentors. o Evaluate the progress of each candidate's training in terms of benefiting from the unique opportunities offered by the partnership, their career development and completing the training plan within the timeline originally anticipated. o Ensure that each candidate in the intramural phase of the Partnership Program continues to progress towards satisfying all of the academic requirements of the extramural institution for a Ph.D. degree o Approve the extramural and intramural training plan for each candidate. o Evaluate the progress of the program in achieving its objectives and recommend midcourse corrections as needed o Evaluate the special marketing and recruitment efforts of the program and make recommendations for improvement. o Define areas of potential scientific collaboration between the extramural scientists and NCI intramural scientists that will strengthen the partnership in the future. o Provide annually with the Non-Competing Grant Progress Report (PHS 2590) a report documenting the deliberations and decisions of the PSC. Mentors from the NCI Intramural Research Program will serve in an advisory capacity as ad hoc members of the mentee's dissertation committee. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between the awardee and the NCI will be brought to arbitration. The Arbitration Panel will consist of one individual from the Extramural Institution, one individual from the NCI Intramural Program, the Chief of the NCI Extramural Cancer Training Branch, and one individual agreed upon by the other 3 members of the panel. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that otherwise can be appealed in accordance with NIH regulations 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into four areas: programmatic, partnering, peer review, and financial or grants management issues: o The NCI Extramural Program Director listed below should be the initial NCI contact for all potential applicant institutions. This individual will clarify any issues you might about the intent and purpose of the RFA and the process for exploring potential training partnerships with NCI Intramural scientists. If a partnership has been agreed upon and an application will be submitted, again contact the NCI Extramural Program Director about the structure of the application and the application procedure before submitting the application: Lester S. Gorelic, Ph.D. Cancer Training Branch Office of Centers, Training and Resources National Cancer Institute 6116 Executive Blvd, Suite 7025 Bethesda, MD 20892 Phone: (301) 496-8580 Fax: (301) 402-4472 e-mail: lg2h@nih.gov o After contacting the NCI extramural Program Director above, initiate explorations of potential scientific partnerships with either the Center for Cancer Research (CCR) or the Division of Cancer Epidemiology and Genetics (DCEG) through the following intramural Facilitators: Potential Partnerships with the CCR: Dr. Jonathan Wiest Associate Director for Training and Education CCR Office of the Director Center for Cancer Research National Cancer Institute 31 Center Drive Suite 3A11 Bethesda, MD. 20852 Office: 301-451-9638 Fax: 301-496-0775 e-mail: wiestj@mail.nih.gov Potential Partnerships with DCEG: Demetrius Albanes, M.D. Chief, Office of Education Division of Cancer Epidemiology and Genetics Executive Plaza South Room 3044 Bethesda, MD 20892-7242 Phone: 301-496-1611 Fax: 302-402-3256 e-mail: albanesd@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 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: ncidearefof@mail.nih.gov o Direct your questions about financial or grants management matters to: Mr. Bill Wells Grants Administration Branch Office of Management National Cancer Institute 6120 Executive Blvd. Room EPS 243 Bethesda, MD 20892 Phone: (301) 496-8796 Fax: (301) 496-8601 e-mail: ww14j@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed Partnership Program o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institution/ NCI intramural program(s) o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Lester S. Gorelic, Ph.D. Cancer Training Branch Office of Centers, Training and Resources National Cancer Institute 6116 Executive Blvd, Bethesda, MD 20892 Phone: (301) 496-8580 Fax: (301) 402-4472 e-mail: lg2h@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS Potential applicants must interact with the NCI prior to the preparation and submission of an application in response to this RFA. Initial contact will be with the NCI extramural program director listed in WHERE TO SEND INQUIRIES. Potential applicants will then be referred to an appropriate NCI Intramural facilitator. Instructions for preparing general Institutional National Research Service Award Applications are on the NIH Website at: https://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing_NRSA_app.htm The current NRSA policy Guidelines should be consulted as a resource when preparing the application. These Guidelines are on the NIH Website at: https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_iib_4.htm#_ Toc504812031 1. Face Page (or Page 1): Complete as instructed in the PHS Form 398 (rev. 5/01). Enter RFA CA-03-017 and the title "Institutional Training Partnership Award" on line 2. 2. Page 2: Complete as instructed in the PHS Form 398. Include as Key personnel, the PI, the IP and all mentors from the extramural institution and from the NCI Intramural Program. 3. Page 3: This will be the table of contents adapted from the NRSA Substitute Page 3, PHS Form 398 (rev. 5/01) and organized as follows: Table of Contents Page Number Face Page (Form Page 1) Description and Personnel (Form Page 2) Table of Contents (NRSA Substitute Form page 3) Detailed Budget for Initial Budget Period (NRSA Substitute Form Page 4) Budget for Entire Proposed Period of Support (NRSA Substitute Form Page 5) Biographical Sketch of the PI Biographical Sketch of IP Biographical Sketches of Extramural Mentors Biographical Sketches of NCI Intramural Program Mentors Resources Research Training Program Plan (A, B and C below not to exceed 25 pages) A. Background B. Program Plan 1. Objectives of the Training Program and the Unique benefits of the Partnership 2. Training Plan - Program Direction by PI and the IP. - Proposed Training in Extramural and Intramural Environments - Experience of Mentors - Recruitment Plan – Applicant Pool - Trainee Candidates - Curriculum 3. Program Steering Committee - Membership - Responsibilities - Benchmarks C. Recruitment of Individuals from Underrepresented Racial/Ethnic Groups D. Letters of Institutional Commitment E. Responsible Conduct of Research F. Human Subjects (See NRSA substitute page 3) G. Vertebrate Animals H. Consortium/Contractual Agreements Checklist Appendix 4. Biographical sketches: Provide biosketches for the PI (not to exceed four pages), the IP (not to exceed four pages), the Extramural mentors (not to exceed two pages per mentor), and the NCI Intramural Program mentors (not to exceed two pages per mentor 5. Resources: Separately describe the resources available at the extramural institution and the NCI Intramural Program and how these resources will be integrated to create a unified partnership program that will achieve the proposed training objectives. 6. Research Training Program Plan o Objectives of the Training Program and the Unique Benefits of the Partnership: Describe how this program will uniquely complement the capability of the extramural institution and enhance the research and research agenda of the extramural institution because of potential collaborations that can be formed with the NCI Intramural Program. Include a description of the types of scientists the program will train. o Proposed Research Training in the Extramural and NCI Intramural Environments: Describe how the program is envisioned to provide research training for pre-doctoral candidates through a combination of extramural and NCI intramural mentoring . Describe how and when trainees will transition from didactic training to research training. o Experience of the Extramural and NCI Intramural Mentors in Training: For each extramural and NCI intramural mentor, describe their most recent mentoring experiences and successes in the last 5 years. For extramural mentors, focus exclusively on pre-doctoral candidates; for intramural mentors, experience may be limited to post-doctoral mentoring. Provide no more than one paragraph per mentor. o Recruitment Plan and Applicant Pool: Describe how the graduate school (s) of the extramural institution recruits candidates. Provide a qualitative and quantitative description of the typical applicant pool and the number of graduate students accepted each year. Describe any specific new steps the extramural institution will take to market and recruit graduate students if the NCI Intramural Program becomes a partner in the training of graduate students o Trainee candidates: If there are existing graduate students ready to enter the extramural institution's graduate program, identify those who could take part in this program. o Curriculum: Describe the curriculum or didactic experiences that each trainee will be expected to complete as part of this program; and, if applicable, how NCI intramural staff will enhance the didactic training. Courses offered by the NIH may be used as part of the planned didactic experiences. 7. Program Steering Committee (PSC): Provide the membership of the PSC (remember that the PI and the IP must co-chair the committee and the membership cannot exceed 6 members). Describe the role of the PSC taking into consideration the SPECIAL REQUIREMENTS AND PROGRAM CONSIDERATIONS noted above. Describe the benchmarks that the PSC will use in selecting candidates, for approving the assignment of candidates to extramural and intramural mentors, and for assessing the progress of candidates in their completion of the Ph.D. degree or equivalent. 8. Letters of Institutional Commitment: A letter should be provided with the application from an official at the extramural institution who can represent the institutions commitment to this program (e.g., Dean of the Medical School). A letter should also be provided to the Scientific Director of the NCI Intramural Program by either the NCI Director of the Division Cancer Epidemiology and Genetics or the Director of the NCI Center for Cancer Research (or their representatives) or both depending upon the nature of the training program using intramural resources. This letter(s) should describe the specific resources that will be made available to conduct the proposed partnership program. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, 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 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 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.) (https://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NCI program staff. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities (DEA) at NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA In the written comments, reviewers will be asked to discuss the following aspects of your application in order to evaluate the likelihood that the program will address the proposed research training objectives: o Merit of the objectives of the training program as a partnership that will uniquely compliment and enhance the research training capabilities of the extramural institution in ways that otherwise would not be possible, and that will result in effective scientific collaborations between the extramural institution scientists and those of the NCI Intramural Program. o Qualifications of the PI and the IP to provide administrative and scientific leadership to the partnership training program o Quality and experience of the extramural and NCI intramural preceptors to serve as mentors o Adequacy of the extramural and NCI intramural training environment to achieve the objective of the partnership program and the adequacy of the letters of commitment from the extramural institution leaders and the NCI Intramural Program leaders. o Adequacy of the membership and role of the Program Steering Committee in monitoring the training program and identifying areas for scientific collaboration. o Adequacy of the existing recruitment plans of the extramural graduate school and the specialized plans of the partnership program to ensure that the appropriate number and quality of candidates needed to conduct a successful training program. o Quality and effectiveness of the PSC and its role as proposed to evaluate the success of the partnership as a whole, monitor the progress of individual candidates and stimulate collaborations between the extramural institution and the NCI Intramural Program. o Adequacy of the Resources and Environment available at the extramural institution and the NCI Intramural Program to conduct a successful training program. ADDITIONAL REVIEW CRITERIA: In addition to the above review criteria, your application will be reviewed with respect to the following: o MINORITY RECRUITMENT AND RETENTION PLAN: The NIH remains committed to increasing the participation of individuals from underrepresented racial and ethnic groups in biomedical research. As first announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit and retain underrepresented minorities in the training program. If an application is received without a plan or without a report on the previous award period, the application will be considered incomplete and will be returned to the applicant without review. Additional information on this requirement was published in the NIH Guide to Grants and Contracts, Volume 22, Number 25, July 16, 1993 (see https://grants.nih.gov/grants/guide/notice-files/not93-188.html) Although the success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool, peer reviewers will separately evaluate the minority recruitment plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of minorities The review panel's evaluation will not be a factor in the determination of the priority score but will be included in an administrative note in the summary statement. If the minority recruitment plan is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the NCI, with guidance from the Special Review Group evaluating NCI institutional research training grant applications, will determine whether amended plans submitted after the initial review are acceptable. Revised plans will be monitored for their effectiveness each year by NCI staff. o TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH: Every predoctoral trainee supported by a TU2 institutional research training grant must receive instruction in the responsible conduct of research (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992 or see https://grants.nih.gov/grants/guide/notice-files/NOT92-236.html). Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans will be considered incomplete and may be returned to the applicant without review. Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided. o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. o INCLUSION: 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. Plans for the recruitment and retention of subjects will also be evaluated (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of intent receipt date: February 27, 2003 Application receipt date: March 27, 2003 Peer Review Date: June-July 2003 Council Review: September, 2003 Earliest Anticipated Start Date: September, 2003 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 REQUIRED FEDERAL CITATIONS 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 AMENDMENT "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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research in now available online at: http://cme.nci.nih.gov/ HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Guidance for investigators and institutional review boards regarding research involving human embryonic stem cells, germ cells, and stem cell-derived test articles can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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 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 RFA, "NCI Institutional Pre-Doctoral Research Training Partnership Award", is related to the priority area of training . Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. The NRSA Institutional Training Grants are not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. CRTA awards are made under the authority of Section 405 (b) (1) (C) of the Public Health Service Act, 42 USC 284 (b) (1) (C), as amended; and Section 413 (b) (3) of the Public Health Service Act, 42 USC 285a-2 (b) (3), as amended pertaining to the National Cancer Institute. Awards are made under authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Title 42 of the Code of Federal Regulations, Part 66. 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. https://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.

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