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TREC COORDINATION CENTER RELEASE DATE: July 8, 2004 RFA Number: RFA-CA-05-011 Update: The following update relating to this announcement has been issued: December 3, 2009 - This RFA has been reissued as (RFA-CA-10-501). (see NOT-CA-04-010) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399 LETTER OF INTENT RECEIPT DATE: October 15, 2004 APPLICATION RECEIPT DATE: November 16, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Pre-Application Meeting o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Division of Cancer Control and Population Sciences (DCCPS), National Cancer Institute (NCI), invites applications for cooperative agreements (U01 mechanism) to support the establishment of a Transdisciplinary Research on Energetics* and Cancer (TREC) Coordination Center. This Coordination Center will support the TREC Centers, which focus upon the research areas of nutrition, energetics*, energy balance, and physical activity. The primary mission of the Coordination Center is to foster collaborations among transdisciplinary teams of scientists, to facilitate data analyses, to examine common research questions across sites, to coordinate and facilitate semi-annual meetings of the TREC Centers, to develop training modules, and to evaluate progress, with the goal of accelerating progress toward reducing cancer incidence, morbidity, and mortality associated with obesity, low levels of physical activity, and poor diet. This RFA is occurring in tandem with RFA CA-05-010 entitled, Transdisciplinary Research on Energetics and Cancer (TREC) Centers, which utilize the U54 cooperative agreement funding mechanism to establish up to five TREC Centers. *Energetics -- The study of the flow and transformation of energy through living systems The American Heritage Dictionary, 2000. The TREC Centers will encompass projects that range from the biology and genetics of energy balance to the behavioral, socio-cultural, and environmental influences on nutrition, physical activity, weight, energy balance, and energetics. The mission of the TREC Centers will focus on two great challenges in the area of energetics/energy balance and cancer: 1) Enhancing our understanding of the mechanisms underlying the association between energy balance and carcinogenesis across the cancer continuum from causation and prevention though survival, and 2) Developing effective innovative approaches with broad population impact at the social-environmental and policy levels for prevention of obesity, focusing on children and critical time periods during adulthood where weight gain is likely to occur, such as with smoking cessation, cancer treatment, and major life transitions involving work or family. (Refer to Figure 1: TREC Conceptual Model at http://cancercontrol.cancer.gov/TREC/.) Because of the central requirement for interactions across TREC Centers, a TREC Coordinating Center will be established under a cooperative agreement mechanism (U01) to facilitate the required interactions. This facilitation will include: (1) working with NCI program staff and Principal Investigators (PIs) to organize the biannual meetings of the TREC Centers; (2) identifying commonalities in research questions being explored across sites; (3) compiling state-of-the-art instruments for diet, weight, and physical activity assessments in use across sites; (4) identifying of common data elements in research across sites that could be compared or combined to examine more detailed questions in specific populations; (5) bringing together special working groups on key scientific topics; (6) providing state of the art cross-site communication and a project web site; (7)and/or developing training modules in diverse disciplines, such as genetics and proteomics; or developing advances in self report and technologies for assessment of diet and physical activity to support transfer of knowledge across disciplines. TREC Centers are encouraged to form partnerships with industry, public health agencies, and other organizations that have strong ties to minority communities with high rates of obesity and cancer. Background Existing research indicates that weight, physical activity, and nutrition alter cancer risk and carcinogenesis for many cancers, and evidence is building on the effects of these health factors on cancer prognosis and quality of life among cancer survivors. National health surveillance data provide evidence of progress related to these factors in several areas that may reduce cancer risk, incidence, and mortality. For example, specific changes in diet that may reduce risk and improve prognosis include reductions in total and saturated fat and increases in fruit and vegetable intake. Modest reductions in saturated fat intake and increases in fruit and vegetable consumption have occurred in the past decade. Some evidence also suggests that leisure time physical activity may be increasing in some population groups, despite the fact that results from several surveys indicate that over 25 to 28 percent of adults in the United States report no leisure-time physical activity. It also seems likely that overall levels of physical activity are declining due to more sedentary occupations, decreased transportation- related physical activity, and increasing automation. Furthermore, the marked increase in the epidemic of overweight and obesity suggests that levels of energy expenditure from overall physical activity are still too low to adequately balance energy expenditure with current levels of energy intake within the U.S. population. As suggested by the 2002 International Agency for Research on Cancer (IARC) report, the combination of efforts to improve diet, physical activity, and body weight may have significant effects. Yet, research has typically examined single cancer prevention-related factors, such as nutrition, in depth, and few studies have used a multidisciplinary approach to assess these factors simultaneously and integrate their effects on health (IARC, 2002). Given that these factors are often closely inter-related in human populations, it is even more surprising that so little research has focused on the intersection of diet, physical activity, and weight. Although research studies of diet and cancer risk and prognosis have examined potential mechanisms in some detail, cancer research in the areas of weight and physical activity has largely been focused on defining the existence and extent of the association of these factors with cancer outcomes. Very few research studies have explored the combined effects of body weight, body composition, physical activity, and diet on the many physiologic systems that are affected by these factors individually, and virtually none have examined the combined influence of these factors on mechanisms related to carcinogenesis. These mechanistic pathways are likely to involve the steroid hormones, insulin-like growth factors, insulin resistance, lipid metabolism, immune functions, and inflammatory factors, such as cytokines and prostaglandins. The identification of which changes lead to cancer and adverse health outcomes among specific groups of people is fundamental to the development of global public health initiatives and to personalized strategies for intervention. Genomics and post-translational (i.e., proteomics) technological advances have the potential to assist in deciphering the molecular basis by which these health factors influence the cancer process and may also assist in identifying intervention targets based on personalized risk assessment. A second major gap limiting progress in advancing evidence-based interventions to prevent obesity and support weight control at the population level is the lack of research evidence on which social- environmental, policy, or structural-level changes can most effectively facilitate cost-effective approaches for prevention and weight control. The state of this field is similar to that of tobacco control in the 1980s before NCI and other organizations supported research on innovative initiatives to advance tobacco control beyond the level of the individual. Research innovations in this area identified changes in work- and school- based policies and practices, pricing of tobacco products, and other legislation that supported progress in tobacco control. Similarly, in the area of cancer screening, major gains were made in use of cancer screening, with efforts focused not solely on the individual patient or provider, but also on the health care delivery system at the organizational level. In the areas of weight control, diet, and physical activity, policies related to school food and physical activity practices, urban planning, and health insurance may have important roles in changing health behaviors at the population level. However, the effectiveness of these efforts has not been adequately tested. At present, in the United States, insurance coverage for treatment of obesity is allowed only if an individual has a secondary co-morbid condition, such as hypertension, hyperlipidemia, or diabetes mellitus. There is currently no coverage for obesity prevention, or for the treatment of existing obesity to prevent the development of other diseases in the future. Controversy exists regarding the level of physical activity that should be recommended for different elements of overall health. Current studies suggest that the physical activity dose needed to prevent weight gain versus that needed to reduce weight and prevent weight regain do not appear to be the same (Jakicic, 2002; McCaffree, 2003). This hypothesis has not been studied in a randomized, controlled clinical trial. It has also been suggested that increasing energy expenditure or reducing energy intake by 100 kcal/day would prevent weight gain; however, this has not been empirically tested (Hill et al., 2003). Finally, what type of physical activity (i.e., moderate intensity versus vigorous) is needed to prevent weight gain has not been identified (Jakicic, 2002). Despite the epidemiological evidence linking cancer to obesity and to lack of physical activity, even less is known about the appropriate level and type of physical activity required to aid in cancer prevention and control (IARC, 2002). Current evidence indicates that obesity prevention efforts should focus on children to avoid the difficulty of treating obesity once established (Jakicic, 2002; Hill et al., 2003; Mercer et al., 2003). Weight gain is more likely during life transitions, such as with physical injury, marriage, and parenting, and with some types of treatment, such as with smoking cessation or treatment for depression and some types of cancer (Muller et al., 2001). Therefore, key target populations for prevention strategies should include children as well as adults undergoing high-risk events for weight gain, such as smoking cessation, injuries, or cancer treatment. Tobacco research has demonstrated that individual-based or single modality interventions have little impact on preventing the initiation of smoking or on increasing smoking cessation (Mercer et al., 2003), and preliminary research suggests similar effects may be observed for physical activity and nutrition. Unlike in the area of tobacco control, comprehensive population-wide strategies that have specifically addressed obesity have not been evaluated (Muller et al., 2001) despite several comprehensive population-wide interventions that have included physical activity and nutrition for cardiovascular risk reduction. Significant advances are required to integrate our current and future understanding of these pathways into a population perspective that will allow use of such knowledge for cancer prevention and control. Such advances depend critically on programs that bring together researchers with diverse perspectives and give them the support needed to facilitate collaboration. The TREC Coordination Center will partner with the TREC Centers to establish a cohesive foundation on which to explore how these factors interrelate in transdisciplinary, integrative approaches that span the cancer continuum and range from basic and clinical metabolic studies to behavioral and population based studies. Objectives and Scope The Coordinating Center (U01) will provide the scientific and organizational leadership necessary to facilitate the interactive and integrative functions essential to foster transdisciplinary interaction across the TREC Centers. The primary mission of the TREC Coordination Center is to foster collaboration and communication among transdisciplinary teams of scientists with the goal of accelerating progress toward reducing cancer incidence, morbidity, and mortality associated with obesity, low levels of physical activity, and poor diet. The second mission of the TREC Coordination Center is to coordinate training opportunities for new and established scientists to carry out integrative research on energetics, energy balance, and its consequences. Finally, the TREC Coordination Center, under the leadership of NCI, will have an integral role in the overall evaluation process. The successful applicant will facilitate transdisciplinary research and training through scientific leadership and organizational support in the areas of communication, coordination, and collaboration across multiple research institutions, as well as consultation and oversight from the NCI program director and other NCI professional staff. Significant research resources in genetics, bioinformatics, dietary assessment, and animal models have been developed by the NCI for use by the research community. The center will provide close interaction with NCI staff; facilitate utilization of any identified common resources; and enhance interactions across research centers in diverse areas such as assisting research centers in identifying and developing scientific working groups, providing cross disciplinary training opportunities, and facilitating the use and development of common and new measures of exposure. These relationships can be best supported by the cooperative agreement mechanism (U01). Because of the central requirement for interaction across TREC Centers, the TREC Coordinating Center will facilitate activities such as the biannual meetings of the TREC Centers and the development and maintenance of a web site for shared communications. Under the leadership of the Steering Committee, the TREC Coordination Center will support the process to identify and develop commonalities in methodologically-based research questions being explored across sites, compile state-of-the-art instruments for diet, weight, and physical activity assessments in use across sites, identify common data elements in research across sites that could be compared or combined to examine more detailed questions in specific populations, bring together special working groups on key scientific topics, or develop training modules in diverse disciplines, such as genetics and proteomics or advances in self-report and technologies for assessment of diet and physical activity to support transfer of knowledge across disciplines. The TREC Coordinating Center will work under the guidance of the Steering Committee and NCI Program Director to develop an evaluation system that will be integrated into the TREC Centers design and operations. This system will make it possible for each TREC Center to collect relevant data on identified performance variables and for NCI to compare site performance to that of other TREC Centers, as well as enable evaluation of the initiative as a whole. The aim of this requirement is to enhance the processes of communication and collaboration among the TREC Centers and ensure that those processes contribute to the achievement of the goals of the TREC initiative. The TREC Center, in partnership with the TREC Coordinating Center, must provide career development opportunities for new and established investigators who wish to pursue active, transdisciplinary research careers in nutrition, physical activity, weight, and energy balance; and provide developmental funds for innovative developmental projects. An essential part of this initiative is interactions among TREC Centers (e.g., research collaborations, exchange of scientists on a visiting basis, special issue working groups, resource sharing, and other innovative mechanisms). Under the direction of the TREC Coordinating Center, Principal Investigators from all TREC Centers will be required to participate in biannual meetings, and must budget accordingly. The TREC Coordination Center Staff will work with NCI and Steering Committee Staff to plan and coordinate each meeting. The purpose’s of these meetings are to share scientific information, to assess scientific progress in the field, to identify new research opportunities and developmental projects, to promote inter-TREC collaborations in order to foster discovery, and to resolve areas of controversy. The TREC Coordination Center will be used to archive data for common use and to support common resources that can be shared across each TREC Center. Where pertinent, TREC Centers will be encouraged to use common measures that allow pooling of data. These efforts should be informed by an awareness of initiatives coordinated by the NCI’s Center for Bioinformatics (http://cabig.nci.nih.gov/). Related cores relevant to the support of cross-site developmental projects will be identified and selected by the Steering Committee. Developmental projects will have a transdisciplinary focus. Each TREC Center application should include, within its budget proposal, resources to support these cross-collaborative efforts. The Steering Committee, TREC Centers, and TREC Coordination Center application should work together to maximize shared resources toward these efforts. The successful applicant for the TREC Coordinating Center (U01) will demonstrate the capacity to collaborate with the TREC Centers and NCI Program Staff to develop an evaluation system that will be integrated into the Coordination Center’s design and operations. This system will make it possible to track each TREC Center’s performance and compare its performance to that of other TREC Centers, and will enable NCI to monitor the evaluation of the initiative as a whole. For example, this component includes evaluating the quality and innovativeness of the science conducted by the TREC Centers as well as assessing critical intermediate indicators of success such as infrastructure development and capacity building, career development, linkages and resource sharing arrangements within and among the TREC Centers, and the interdisciplinary and multilevel nature of the research. Evaluation variables may include items such as: peer-reviewed publications, developed web sites, theoretical- based models within new initiatives, evidence-based diffusion or dissemination strategies, or new collaborations and partnerships. Objective criteria for the evaluation component will include the extent to which: (1) the overall capacity to study the mechanisms underlying the association between energy balance and carcinogenesis across the cancer continuum, from causation and prevention through survival, in the TREC Centers has increased as a result of the new funding; (2) the capacity to study the relationship between nutrition, physical activity, and energetics, as they relate to the goal of reducing cancer incidence, morbidity, and mortality associated with obesity, has been enhanced through the sharing of resources within and among TREC Centers; (3) collaborative relationships within and among TREC Centers have been established; (4) training and career development opportunities exist for new and established investigators; (5) a transdisciplinary research culture has been engendered which takes into account the perspectives of multiple disciplines and multiple levels of analysis; and (6) TREC Center investigators abilities to compete for future R01 grants and participate in other research mechanisms have been enhanced. The evaluation will also examine intermediate markers of the importance and potential impact of the science conducted by the TREC Centers in addressing the relationship between energy balance and obesity based on the integration of social, behavioral, and biological sciences into more comprehensive study design. Possible metrics include the development of: (1) new theories or conceptual models ranging from genetics, psychology, molecular biology, and anthropology, to urban planning, informatics, social sciences, health behavior, and communication; (2) new measures of dietary, physical activity, and anthropometric assessment or psychometric and statistical methodology for coding self-reported data; (3) new biological markers of genetics, molecular biology, and physiology of obesity; and (4) new treatments or interventions that address the individual-level determinants of behavior to the effective population- level interventions in prevention of obesity and the social-environmental or policy level across diverse at risk populations. These markers will be identified from the conceptual framework presented earlier and from other theoretical models and empirical evidence in the literature. MECHANISMS OF SUPPORT This RFA will use the NIH cooperative agreement (U01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary NIH peer review procedures. The anticipated award date is September 1, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the non-modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Follow the instructions for non-modular budget research grants applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. The NIH U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant roles 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. FUNDS AVAILABLE NCI intends to commit approximately $1 million in FY 2005 to fund one new grant in response to this RFA. An applicant may request a project period of up to 5 years and may request a maximum annual direct cost of $600,000. Of that, $100,000 per year should be budgeted as a set-aside for Core Funds that will be used to support cross-site developmental projects. The cross-site developmental projects will be identified and selected by the Steering Committee. Facilities and administrative costs (F&A) for third parties (e.g., subcontractors or consortium partners) are not included within the $600,000 direct cost cap. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of the award will also vary. Although the financial plans of the 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 You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations; o Public or private institutions, such as universities, colleges, hospitals, and laboratories; o Units of State and local governments; o Eligible agencies of the Federal government; o Domestic institutions/organizations; o Foreign institutions are not eligible to apply -- however, domestic applications with foreign components are permitted; and o Faith-based or community-based organizations. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Applicants are permitted to apply for consideration to become a TREC Center under RFA-CA-05-010 and the TREC Coordination Center under RFA-CA-05-011. The Coordination Center, which is required for facilitating important interactions, will be responsible for: o Working with NCI program staff and PIs to identify commonalities in research questions being explored across sites, to compile state-of-the- art instruments for diet, weight, and physical activity assessment in use across sites; to identify common data elements in research across sites that could be compared or combined to examine more detailed questions in specific populations; to bring together special working groups on key scientific topics, or the development of training modules in diverse disciplines, such as genetics, proteomics, advances in self reporting and technologies for assessment of diet and physical activity; and to support transfer of knowledge across disciplines. o Facilitating communications, coordination, and collaborations across multiple research institutions including but not limited to the TREC Centers, as well as consultation and oversight from the NCI program director and other NCI professional staff. This is managed by a communications core, that will support all cross-site communications efforts among the TREC Centers, NCI Program Staff, and Steering Committee members, develop and maintain the TREC project web site and group email lists, and facilitate group meetings. o Facilitating the utilization of the significant research resources in genetics, bioinformatics, dietary and behavioral assessments, and animal models that have been developed by the NCI for use by the research community. o Building the capacity of current resources to provide core for all TREC Centers. Shared core services and resources used to support cross-site developmental projects will be identified, selected, and monitored by the Steering Committee. For example, genomic and proteomic analyses, the capacity for collection of survey data, and the centralized measurement and analysis of physiological data such as serum hormone levels, analysis of body composition from imaging techniques, or diverse rodent phenotyping services could be offered efficiently from a Coordinating Center. Such centralized services could contribute to collaboration and data standardization. Core Funds for the TREC Coordination Center Core Funds will be available to the Chair of the Steering Committee (SC), with budget recommendations provided by the members of the SC. Applicants responding to this RFA should not apply for the Core Funds in their U01 applications. Core Funds are reserved for post-award collaborative research and for a variety of other functions; the allocation of core funds must be approved by the NCI program director prior to dissemination. 1. Core Funds are used to expand participation within the TREC Centers through the provision of funds to an investigator who may have content expertise that is not part of the existing TREC Centers but is relevant to developmental projects. However, receipt of these Core Funds does not, in and of itself, imply membership on the SC. 2. Core Funds can also be used to support cross-site developmental projects, evaluate common measures, or develop new methodologies which can be validated at multiple centers and in larger populations. However, Core Funds should not be used to pay for activities that have been supported under the TREC Centers. A set-aside in the Coordination Center’s budget allowance of $100,000 per year for cross-site developmental projects should be included in the budget plans. Supplements from the Core Funds may provide direct costs and appropriate facilities and administrative costs up to 20 percent indirect cost. The following example illustrates the functions of the TREC Centers and the support that it offers for moving basic research findings into practice. Example: An investigator within the TREC Centers identifies a possible dietary or other related biomarker through original laboratory research. Based on pilot data, the dietary or biological marker, related to steroid hormones, insulin-like growth factors, insulin resistance, lipid metabolism, and immune or inflammatory factors seems to be useful as a potential mechanism to evaluate the effects of energy balance and cancer outcomes. The investigator can then approach the SC to support evaluation of the marker and possible further testing as part of a cross-site collaboration among TREC Centers. The SC then has the responsibility to review the data on the potential marker using its standing formal criteria as a guide. The SC can consult the NCI to obtain information on the requirements and need for additional research on the marker. If necessary, scientific resources from other Centers can be pooled to conduct studies. o Planning and implementation of semi-annual meetings for the duration of the RFA. Potential models for these semi-annual meetings could include the successful Gordon Summer conferences or the Centers for Disease Control and Prevention (CDC) at the University of North Carolina (UNC) summer course on Physical Activity and Public Health. o Organizing sessions at relevant national meetings such as American Association for Cancer Research (AACR), North American Association for the Study of Obesity (NAASO), Society for Behavioral Medicine (SBM), and American Association for the Advancement of Science (AAAS). These sessions could be designed to include representatives from several TREC Centers as well as other experts. o Coordination of efforts by the TREC Steering Committee in the performance and evaluation component of the TREC Centers in achieving the goals of the RFA. o Providing scientific leadership and institutional commitment, with prior experience in coordinating multi-center initiatives, meetings, and career development training. o Providing complementary scientific expertise to the TREC Centers and providing core resources. o Developing a comprehensive budget proposal that includes all leadership activities, meetings, common core resources, and cross-site activates. Cooperative Agreement Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable U.S. Gov t Office of Management and Budget (OMB) administrative guidelines, DHHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other DHHS, PHS, and NIH Grants Administration policy statements. (Part 92 applies when state and local governments are eligible to apply as a "domestic organization.") The administrative and funding instrument used for this program is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NCI scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI 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 for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Project Coordinator. 1. Awardee Rights and Responsibilities The Awardee (i.e, the Principal Investigator) has primary authority and responsibility to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program in accordance with the terms and conditions of the award. The Awardee will facilitate the establishment of the TREC Steering Committee for this initiative. The Awardees and Principal Investigator from each of the TREC Centers (RFA CA-05-010) are voting members of the Steering Committee and are required to attend the twice-yearly Steering Committee meetings. The TREC Centers and the Coordination Center each have one vote, as does the NCI Program Coordinator. The Awardee will be responsible for accepting and implementing the goals, priorities, procedures, and policies agreed upon by the Steering Committee. The Awardee will be responsible for close coordination and cooperation with the Principal Investigators from the U54 TREC Centers RFA and with NCI staff for all components of the TREC initiative, e.g., research collaborations, exchange of scientists on a visiting basis, special issue working groups, resource sharing, and other innovative mechanisms for data sharing and inter-TREC collaborations. Awardees will retain custody of, and have primary rights to, the data developed under these awards, subject to Government rights of access consistent with what are the current Department of Health and Human Services (DHHS), Public Health Service (PHS), and NIH policies throughout the length of awards under the auspices of this RFA. Awardees will be responsible for implementing the approved data-sharing plan for their project. Awardees will be required to accept and implement the common processes and procedures approved by the Steering Committee. The NCI anticipates that awardees under the auspices of this RFA will develop unique research resources. The policy of the NIH is to make the results and accomplishments of the activities that it funds available to the public. Awardees will be responsible for implementing the approved research resource sharing plan and intellectual property plan for their project. The Awardee will ensure that there are appropriate core services for the integration of data emerging from the TREC Centers. Any activities funded on the individual U54 grants will be required to be coordinated with the activities of the TREC Coordinating Center. 2. NCI Staff Responsibilities The NCI Project Coordinator will have the following roles and responsibilities. o The NCI Project Coordinator will have substantial scientific- programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination beyond normal program stewardship for grants. The Project Coordinator will be the primary agent responsible to identify and provide relevant content expertise to this project from NCI’s staff scientists. o The NCI Project Coordinator will work in cooperation with the PI to support the development of and to facilitate the TREC programs (e.g., training and evaluation), will attend and participate as a voting member in all meetings of the TREC Steering Committee, and will provide liaison between the Steering Committee, the TREC Centers, and the NCI. o The NCI Project Coordinator will assist the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action. An NCI Program Director will be responsible for the normal stewardship of the awards, as described below. o The NCI Program Director will review the scientific progress of award and its components as well as for compliance with the operating policies developed by the Steering Committee. o The NCI Program Director may recommend withholding of support, suspension, or termination of a U01 award for lack of scientific progress or failure to adhere to policies established by the Steering Committee. o The NCI Program Director will notify, as warranted, the appropriate NIH offices concerning failure of the TREC Centers or Coordinating Center to adhere to policies established by the Steering Committee. o The NCI Program Director will have access to all data generated under collaborative studies conducted under this award, consistent with current DHHS, PHS, and NIH policies. The Program Director, or designee, will review periodically data management and analysis procedures approved by the Steering Committee. On-site program review will be conducted as necessary. o The NCI Program Director may also serve as the NCI Project Coordinator. 3. Collaborative Responsibilities Steering Committee o The NCI Project Coordinator and the Principal Investigators will be responsible for forming a Steering Committee, the main governing board of the TREC Centers Program, as defined below. An arbitration system, which is detailed below in the next subsection, will be available to resolve disagreements between the NCI Project Coordinator and the members of the Steering Committee. o The Steering Committee will be composed of the Principal Investigator from the U01 Coordination Center; a Primary Investigator from each U54 Research Center, and the NCI Project Coordinator; each representative will have one vote. The Steering Committee may also include one non-voting representative from each extramural NCI Program Division (Division of Cancer Control and Population Sciences; Division of Cancer Prevention; and Division of Cancer Biology. o The Steering Committee chairperson(s) may not be an NCI staff member(s). The Steering Committee may establish subcommittees, as it deems appropriate; the NCI Project Coordinator will serve on subcommittees, as s/he deems appropriate. The Steering Committee members will provide scientific, statistical, and technical input into discussions of pooled and collaborative research projects where relevant. o The Steering Committee may, when it deems it to be necessary, invite additional, non-voting scientific advisors to the meetings. The NCI reserves the right to augment the scientific or consumer expertise of the Steering Committee when necessary. o The Steering Committee will meet twice every year, separately from the TREC Center biannual meetings, at locations selected by the Steering Committee in consultation with the NCI. The Awardee of the U01 Coordination Center, the PI, and a senior investigator from each U54 Center must attend every Steering Committee meeting. TREC Centers may budget travel support for up to five project co-investigators to attend the biannual meetings. The Steering Committee has the final authority to approve the attendance of any non-voting participants at the biannual meeting. o The Steering Committee will evaluate the merit of all proposed cross- site developmental projects and identify common resources to support such efforts. In addition, the Steering Committee, in partnership with NCI Program Staff, will monitor the progress of these projects, facilitate common data sharing, evaluation, and group publications. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee (with the NCI member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NCI, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and DHHS 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 three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Linda Nebeling, Ph.D., M.P.H., R.D. Chief, Health Promotion Research Branch Division of Cancer Control and Population Sciences National Cancer Institute 6120 Executive Boulevard, EPN Room 4080, MSC 7335 Bethesda, MD 20892-7335 Rockville, MD 20852 (for express/courier service) TEL: (301) 451-9530 FAX: (301) 480-2087 Email: nebelinl@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: ncirefof@dea.nci.nih.gov o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: Crystal.Wolfrey@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 research; o Name, address, and telephone number of the Principal Investigator; o Names of other key personnel; o Participating institutions; and 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: Linda Nebeling, Ph.D., M.P.H., R.D. Chief, Health Promotion Research Branch Division of Cancer Control and Population Sciences National Cancer Institute 6120 Executive Boulevard, EPN Room 4080, MSC 7335 Bethesda, MD 20892-7335 Rockville, MD 20852 (for express/courier service) TEL: (301) 451-9530 FAX: (301) 480-2087 Email: nebelinl@mail.nih.gov PRE-APPLICATION Conference The NCI will hold a pre-application telephone conference to which all prospective applicants are invited (see http://www.scgcorp.com/trec-call2004/ ). Program staff and staff from the NCI Division of Extramural Activities (DEA) will make brief presentations that review the goals and objectives for the Transdisciplinary Research on Energetics and Cancer (TREC) Centers and answer questions from the attendees. Prospective applicants are urged to monitor the NIH Guide Notice for date and time of the meeting at NOT-CA-04-010 (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-04-010.html.) SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact Grants Info, Telephone: (301) 710-0267; Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: BUDGET: The budget(s) should be presented in logical, discrete units for each section of the application using the standard PHS-398 form pages 4-5. The budgets to be submitted should include: a) A detailed composite budget for the entire TREC Coordinating Center; b) A separate budget for Administrative, Communications, Evaluation, Training, and Organizational Core activities; A recommended budget allocation per year is provided for each activity: - Administration: $100,000 - Communications: $150,000 - Evaluation and Data Sharing: $200,000 - Training: $50,000 - Organizational Developmental Projects: $100,000 Within these core activities, the budget should include support for: o Fostering communication networks and information exchange. Serving as the communications hub for project-related activities, including: arranging conference calls and biannual steering group meetings, and any additional steering committee meetings; developing and maintaining a Web site with interactive features for exchanging information, resources, instruments and strategies. o Disseminating results and lessons learned including research accomplishments and challenges. Providing technical assistance for enhancing the maintenance, sustainability, and translation of the projects. o Establishing commonalities in questions, methods and measurement. Identifying site-specific research questions, measures, and methods that are shared across the funded projects (e.g., What research questions do funded sites bring to the table? How can being part of the collaborative group provide a forum for asking questions that go beyond what can be learned in one study?). o Serving as a catalyst for identifying subgroups of investigators who will come together to work on common approaches. Assessing the potential for common measures. Working with the Steering Committee to establish a small core of common processes and outcomes. o Providing technical assistance and expert advice on cross-cutting themes, frameworks, and evaluation. o Facilitating a process for data sharing among the TREC Centers and others. Establishing a study-wide presentation and publication policy for utilizing shared data and advising on cross-cutting rules and regulations regarding shared data. o Designing a feasible infrastructure and database for shared data sets to be used in the study period and a method for public access of data within two years after then end of the initial award period. o Supplemental funding opportunities will be considered by the Steering Committee as a way of supporting collaborative developmental projects. Since the Coordinating Center funding runs concurrently with TREC Centers funding, post-funding tasks would need to be planned for, but may not be supported in this initial award. o Establishing a mentorship program between more experiences investigators and those less experienced investigators (or established investigators moving into new directions) involved in research or practice at the TREC Centers. Mentorship opportunities are encourages across all TREC Centers. Training opportunities should be coordinated with the biannual Steering Committee meetings. o Incorporating activities to evaluate the performance of the TREC Centers RFA. Additional pages for budget justification are to be used when necessary. 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 http://grants.nih.gov/grants/funding/phs398/labels.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 and all five copies of the appendices must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041, MSC-8329 Bethesda MD 20892-8329 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 (for express/courier service) Appendices should be comprised of unbound materials, with separators between documents APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e., FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html). This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or nonresponsive applications will not be reviewed. 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 of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to attack a highly significant research problem for which some of the details of approach have not been established through preliminary data. SIGNIFICANCE: Does this Coordination Center provide appropriate technical expertise and leadership? If the aims of the application are achieved, how will scientific knowledge be advanced? Will the TREC Coordination Center enhance the TREC Centers proposed concepts or methods that drive the field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics needed to make a coordination center of this kind an effective infrastructure? INNOVATION: Does the Coordination Center employ state-of-the-art resources, approaches, and methods? Are the aims original and justifiable for each of the activities: administrative, communication, evaluation, training and organization? INVESTIGATOR: Is the primary investigator appropriately trained and well suited to lead this coordination center and oversee this work? Is the leadership and management structure proposed appropriate? Does the leadership team of the Coordination Center provide the experience needed to manage an efficient operation? ENVIRONMENT: Does the scientific environment and resources in which the work will be done contribute to the probability of success? Does the proposed Coordination Center take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. 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: October 15, 2004 Application Receipt Date: November 16, 2004 Peer Review Date: February 2005 Council Review: June 2005 Earliest Anticipated Start Date: September 1, 2005 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; and o Programmatic priorities. REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); and efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (See NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-084.html.) Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. For additional information, see NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available at http://www.cancer.gov/clinical_trials/. SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: (a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and (b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is 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 http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information, the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES IARC WORKING GROUP. Vanio H, Bianchini F (eds). IARC Working Group on the Evaluation of Cancer-Preventive Strategies. IARC Handbooks of Cancer Prevention, vol. 6. Weight control and physical activity. 1-315. 2002. Lyon, France, IARC Press. Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity and mortality from cancer in a prospectively studied cohort of U.S. adults. NEJM 2003 348: 1625-38. Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA 2002 288:1723-1727. Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA 2002 288:1728-1732. Fulfilling the Potential of Cancer Prevention and Early Detection; Susan J. Curry, Tim Byers, and Maria Hewitt, Editors; National Research Council; 2003; 1-564. Blair, SN, LaMonte, MJ, Nichaman MZ. The evolution of physical activity recommendations: how much is enough? Am J Clin Nutr. 2004 May;79(5):913S- 920S. Review. Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the environment: Where do we go from here. Science 2003 299(5608), 853-855. Jakicic JM. The role of physical activity in the prevention and treatment of body weight gain in adults. J Nutrition 2002 132, S3826-S3829. M sse LC, Dassa C, Gauvin L, Gilles-Corti B, Motl R. Emerging measurement and statistical methods in physical activity research. Amer J Prev Med 2002 23(2), S44-S55. McCaffree J. Physical activity: How much is enough? J Amer Dietetic Association 2003 103(2), 153-154. Mercer SL, Green LW, Rosenthal AC, Husten CG, Kanh LK Dietz WH. Possible lessons from the tobacco experience for obesity control. 2003 77(4), S1073-S1082. Muller MJ, Mast M, Asbeck I, Langnase K, Grund A. Prevention of obesity is it possible? The International Association for the Study of Obesity reviews 2001 2, 15-28. WHO CONSULTATION ON OBESITY (2000). Obesity: Preventing and Managing the Global Epidemic. Report of a WHO Consultation WHO Technical Reports Series, No. 894. Geneva, Switzerland, World Health Organization.
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