GEORGE M. O"BRIEN UROLOGY RESEARCH CENTERS RELEASE DATE: May 8, 2002 RFA: DK-02-032 (Reissued as RFA-DK-07-004) PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Diabetes and Digestive and Kidney Diseases ( National Cancer Institute ( LETTER OF INTENT RECEIPT DATE: October 17, 2002 APPLICATION RECEIPT DATE: November 19, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) 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 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 This Request for Applications (RFA) invites investigators to submit research applications for the George M. O"Brien Urology Research Centers Program. The emphases for this program are fourfold (1) to continue to attract new scientific expertise into the study of the basic mechanisms of urological diseases and disorders, (2) to encourage multidisciplinary research focused on the causes of these diseases, 3) explore new basic areas that may have clinical research application, and 4) generate *Developmental Research (DR)/Pilot and Feasibility (P&F) studies of two years duration, which are anticipated will lead to new and innovative approaches to study urological disease, and the eventual submission of competitive investigator-initiated R01 research grant applications. The mounting complexities associated with the studies of disease processes will likely require investigators who have training and expertise in disciplines such as cell and molecular biology, biochemistry, physiology, genomics and proteomics, developmental biology, tissue engineering, epidemiology, immunology and pathology. In addition, appropriate expertise will likely include a focus into topical areas, such as factors influencing the development and progression of benign prostate growth, understanding bladder urothelium responses to infections, effects of diabetes on lower urinary tract, immunobiology and neurobiology of the lower urinary tract and relationship to urological disease, factors influencing the development of urolithiasis, genetics of urological diseases, factors influencing normal and abnormal bladder urothelial biology, etc. The major emphasis of these projects should be on understanding the normal growth and development processes of the urinary tract and the development of non-malignant disorders, e.g. benign prostatic hyperplasia, prostatitis, urinary incontinence and dysfunctional voiding, urinary tract infections, interstitial cystitis, pediatric bladder and developmental urological disorders, erectile function, urinary tract stone disease, chronic pelvic pain of bladder origin, as well as the urological malignancies. Individual institutions with both basic and clinical research capabilities are eligible to apply. Inter-institutional collaborative research arrangements are also appropriate and encouraged. Coordination for such arrangements must be evident and clearly meaningful and appropriate for the research proposed. *Generally DR/P&F proposals are expected to have limited preliminary data and are reviewed based on the clear development of hypotheses and supporting literature. RESEARCH OBJECTIVES Background The application of human genomic information to improve clinical outcome is a major challenge facing biomedical researchers today. Nevertheless, with the elucidation of the human genome, there has been an explosion of new methods and technologies that should allow for the routine discovery of new genes and the identification of their biological relevancy. However, the understanding of normal cellular processes and the development and progression of urological diseases will require more than the delineation of an array of complex protein-protein interacting pathways. These pathways are aberrantly modified in disease states and reflected in the subtle protein changes in the cell. Such changes in protein expression are likely to be translated into changes in cell growth, differentiation, and/or apoptosis. In addition, because of the complexity and heterogeneity of many of the urological diseases there is an ever increasing need for the to utilize these new molecular approaches to well characterized experimental animal models for the study the physiology and neurophysiology of lower urinary tract function. Prospective applicants are urged to consult the research priorities web pages of both the NIDDK and NCI for additional urological research areas of interest to the institutes: and The O"Brien Research Center must be an identifiable unit within a single university medical center, or within a consortium of cooperating institutions with a university affiliation. The original intent of the O"Brien Research Centers was to bring together investigators from relevant disciplines in a manner that would enhance and extend the effectiveness of research related to the urological disease and its complications. More recently the overall goal of the O"Brien Urology Research Center has been expanded to bring together, in a cooperative, multidisciplinary and integrative manner, basic science and clinical investigators to enrich the effectiveness of research into causes, treatment and cure of the many urological diseases which fall within the purview of the NIDDK. For this purpose the center director should clearly define criteria that is used to select an investigator as a center grant participant. The O"Brien Urology Research Center must also address the scientific information base and provide focal points for sustaining and maintaining state-of-the-art research that will contribute to improved detection, diagnosis, treatment and prevention of the urological diseases and disorders. These centers are expected to conduct a wide spectrum of research activities that will contribute significantly to the development of specialized research resources, the development of improved research model systems and the expansion of the research base through collaborative research with scientists and clinicians in other institutions locally and nationwide. Interrelated, basic research subprojects, each with high scientific merit and clear research objectives have been the hallmarks of the O"Brien Urology Research Centers program. In the aggregate, the subprojects should continue to be directed to the development of fundamental knowledge leading to the understanding of urological disease processes and the design of curative or preventive strategies. However, a new dimension to the centers program is the requirement to include Research Development/Pilot and Feasibility (P&F) project(s) as integral components of the centers concept (described below). Core facilities that will benefit the overall centers program are likely components of a center (described below). Core Facilities Core facilities in an O"Brien Urology Research Center are shared resources that enhance productivity or in other ways benefit a group of investigators working to accomplish the stated goals of the center. Cores should be designed to furnish a group of investigators with a specific technique, service, determination, or instrumentation in a manner that will enhance the research in progress, consolidate manpower effort, and contribute to cost- effectiveness by providing a service at lower cost and possibly higher quality than if each investigator were to attempt the same activity individually. Cores may be proposed in relation to any acceptable research activity of the center, but usually fall into one of four categories: (l) provision of a technology that lends itself to automation or preparation in large batches (e.g., radioimmunoassay and tissue culture), (2) complex instrumentation (e.g., electron microscopy or mass spectrometry), (3) animal preparation and care, and (4) technical assistance and training (e.g., molecular biology). Examples of possible core resources that would be considered within the scope of this request for applications include the following: o Molecular biology core to supply oligonucleotides and provide automated DNA sequencing capability, o Animal models core to develop, breed, and maintain animal models for diseases of interest, which can be used to improve understanding of the human forms of the disease, o Tissue culture core for the harvest, cultivation, and handling of large numbers of cells, o Other cores needed to characterize gene transfer systems. These cores are not listed in any particular order, nor should they be construed to represent a comprehensive list of cores that could be fostered under this program. The establishment of and continued support for biomedical research cores within an O"Brien Urology Research Center must be justified on the basis of use by Center investigators. The minimum requirement is significant usage by two or more principal investigators each with a Center project. A director must be named for each core. The organization and proposed mode of operation of each core should be described, with a plan for prioritizing investigator use of the core as well as the criteria for determining core users or potential users. Each core must have in place a procedure to evaluate efficiency and to maintain appropriate quality control. Limited developmental research is an additional appropriate function of a core facility, so long as the research is related directly to enhancing the function or utility of the core and is not an undertaking that should be funded through other mechanisms. Teaching the investigators and/or their staff members" new techniques and methodologies is also an important function of the cores. The cores are not intended to supplant investigator capabilities, rather, they are intended to enhance the opportunities of investigators to learn and become proficient in the technologies available through the core. Developmental Research (DR)/Pilot and Feasibility (P&F) Projects The DR/P&F program should provide modest support for innovative initiatives with the potential to advance progress in understanding cellular and molecular mechanisms that initiate or are involved in the progression of specific urological diseases. This program is directed toward both new/young and established investigators who wish to explore the feasibility of a novel approach to a problem in this area. Investigators eligible for DR/P&F funding fall into three general categories: (1) new investigators without current or past NIH support as a principal investigator, and whose current or previous support from other sources have been modest, (2) established investigators with limited previous Urology research experience who wish to apply their expertise to a problem in this area, and (3) established urological investigators who propose testing innovative ideas that represent a clear departure from their ongoing research directions. It is anticipated that the majority of the recipients of DR/P&F funding will be from the first category. Each DR/P&F study award is intended to provide a modest amount of support, not to exceed $60,000 direct costs/year, for duration not to exceed two years, which will allow an investigator the opportunity to develop sufficient preliminary data to provide the basis for an application for independent research support. DR/P&F study support is not intended for large projects by established investigators, which otherwise would be submitted as separate research grant applications. DR/P&F funds also are not intended to support or supplement ongoing funded research of an investigator. Each DR/P&F study proposal should state clearly the justification for eligibility of the investigator under one of the above three criteria. A proposed DR/P&F study should present a testable hypothesis and clearly delineate the question being asked, detail the procedures to be followed, and discuss how the data will be analyzed. The DR/P&F studies should be submitted for review generally in the format of NIH research project applications (R01), but with a 15-page limitation for the entire application. The Administrative Core oversees the handling and implementation of any DR/P&F program. Within this structure, each applicant institution must also establish a mechanism to oversee the ongoing use of funds for the proposed DR/P&F program. This mechanism must include the use of appropriate consultants (described below) for review from the scientific community external to the center. These same consultants may, if desired, review and assess other activities of the center and may constitute the external advisory group to the center. The external advisory committee need not be named in advance of the application submission, only the mechanism for use of the proposed DR/P&F program. The projects selected to receive these funds are to be described by the Director in the DR/P&F section of the application. Enrichment and Educational Program The O"Brien Urology Research Center grant may budget for and provide limited support for an optional enrichment program, whose description and budget may also be included within the administrative core of the centers application. It may provide support for visiting scientists, seminars, and research forums. Limited travel support is allowable for center investigators to travel to present scientific findings, learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange. In all cases, the enrichment program should further the overall aims and objectives of the center as well as of the scientific cores. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) P50 Specialized Center award mechanism. This mechanism supports the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary approach on a specific urological disease process or biomedical problem. These grants differ from traditional program project (P01) grants in that they are more complex and flexible in terms of the activities that can be supported. In addition to support for multidisciplinary research projects, support is also provided for pilot research projects, specialized resources, and shared core facilities. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five (5) years. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. Applicants from institutions which have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. This RFA is a one-time solicitation. The earliest anticipated award date is July 1, 2003. FUNDS AVAILABLE The NIDDK and NCI intend to provide sufficient funds in FY 2003 to fund five(5) new and/or competing continuation center grants in response to this RFA. New or competing renewal O"Brien Urology Research Center applications may request maximum annual direct costs of $750,000 (not to exceed $3.5 million for five years). For renewal applications, budgets requested for research subprojects and core facilities are limited to 20% budget growth over the most recent non-competing budget. Both new and renewal applications must include budgets of $120,000 annually for Developmental Research/Pilot and Feasibility (P&F) projects. The direct cost cap of $750,000, however, can be exceeded by the Facilities and Administrative (F&A) Costs (previously referred to as "indirect costs") on consortia subcontracts to other participating institutions. The budgets of these consortia subcontracts may include the regular cost-of-living increases (currently 3% per year). Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDDK and NCI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds in FY 2003 and the receipt of a sufficient number of applications of outstanding scientific and technical merit. 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 To be considered eligible, applicant organizations must have: (1) a statement of institutional commitment that addresses how the institution will incorporate the O"Brien Urology Research Center high within its institutional priorities, (2) research subprojects, representing a balance and diversity of research approaches, (3) a qualified principal investigator who is a scientific leader in the field, (4) developmental/Pilot & Feasibility programs and (5) appropriate shared resources to support the proposed research of the O"Brien Urology Research Center. Although an application must be submitted by a single applicant institution, subcontracted collaborative scientific arrangements with scientists from other institutions may be included if these arrangements are clearly delineated, and formally and officially confirmed by signed statements from the responsible officials of each institution. However, a full institutional commitment must come from the applicant institution. Support will not be provided for applications with research activities focused exclusively on basic research, or clinical research or trials, or epidemiological research, or malignant diseases of the urinary tract. NIDDK program staff listed under INQUIRIES should be consulted if there are questions regarding any of the above eligibility requirements for exclusion. 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 Annual O"Brien Urology Research Center Workshop O"Brien Urology Research Center investigators will likely be expected to participate in an annual or biennial workshop, organized and convened by the DKUHD-NIDDK, to share research experiences with other O"Brien Urology Research Centers, assess progress, identify new research opportunities, share materials, establish interactions and research priorities and collaborations that will maximize the impact of the research on reducing incidence and mortality, and improving survival of ESRD patients. Travel funds for the Principal Investigator and selected O"Brien Urology Research Center investigators and collaborators are to be budgeted for this purpose. 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: Leroy M. Nyberg, Jr., Ph.D.,M.D. Director, Urology Programs Division of Kidney, Urology, and Hematology National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Blvd, Room 627 Bethesda, MD 20892-5458 Telephone: (301) 594-7717 FAX: (301)480-3510 E-mail: o Direct your questions about peer review issues to: Francisco O Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 Telephone: (301) 594-8897 FAX: (301)480-3505 E-mail: o Direct your questions about financial or grants management matters to: Ms. Helen Ling Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Blvd, Room 732 Bethesda, MD 20892-5456 Telephone: (301) 594-8857 FAX: (301) 480-4237 E-mail: 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 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 IC 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: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Division of Extramural Activities 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) 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 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 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: 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: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Division of Extramural Activities 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) 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 responsiveness by the NIDDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 (IC) 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 Diabetes and Digestive and Kidney Diseases Advisory Council. 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 discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that 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 carry out important work that by its nature is not innovative but is essential to move a field forward. Support will not be provided for applications with research activities focused exclusively on basic research, or clinical research or trials, or epidemiological research, or malignant diseases of the urinary tract. Specific criteria to be used in the evaluation of grant applications are listed below. a. Individual Research Subprojects: Within the O"Brien Urology Research Center concept of research to be performed, reviewers will evaluate each research subproject using the five criteria listed below. Each criterion will be addressed and considered by the reviewers in assigning the overall score project merit: a.1. Significance: The importance of the research objective to human urological diseases and its likelihood of completion within the project period. Do these studies address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? a.2. Approach: The adequacy of the experimental design and methods to achieve the research objectives. Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the subproject? Does the applicant acknowledge potential problem areas and consider alternative tactics? a.3. Innovation: Originality and novelty of the experimental design as it relates to the proposed research subproject. Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the research subproject challenge existing paradigms or develop new methodologies or technologies? a.4. Investigators: The qualifications of the investigators to conduct the proposed research and the appropriateness of the time commitments of each investigator to the conduct of the subproject. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? a.5. Environment: The scientific environment in which the research work will be done, and the unique features, if any, of the environment to support the proposed work. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The scientific review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. b. Shared Resources (Cores) b.1. adequacy of the proposed plan and/or track record to develop and maintain appropriate cores and potential for the distribution of reagents, tissues, transgenic animals within and outside the O"Brien Urology Research Centers, b.2. degree to which plans and/or track record indicate that shared resources effectively and efficiently support (or will support) the research of the O"Brien Urology Research Center in a manner that cannot be supported through available national resources, b.3. adequacy of the justification for each specialized resource relative to its essential need for the conduct of O"Brien Urology Research Centers subproject research or pilot projects and O"Brien collaborative subprojects, b.4. adequacy of qualifications and performance (if applicable) of managers of resources, b.5. appropriateness of the requested budgets to conduct each resource operation. c. Developmental Research Program/Pilot & Feasibility (P&F) Projects c.1. adequacy of the process for attracting new ideas for pilot studies within and outside of the O"Brien Urology Research Center institution. c.2. adequacy of the proposed process record for continuously reviewing and funding a spectrum of pilot projects (e.g., research, technology development, resources) for their quality and importance to research that will have an impact on human urological diseases. c.3. general quality of the pilot projects provided by the O"Brien Urology Research Center to demonstrate the effectiveness of the process of funding pilot projects, c.4. established mechanism within the institution to solicit DR/P&F applications and to oversee the use of funds for the proposed DR/P&F program. c.5. appropriateness of the budget relative to the needs and demonstrated capabilities of the O"Brien Urology Research Center. d. Overall Program Organization and Capability: d.1. scientific qualifications and involvement of the O"Brien Urology Research Centers Principal Investigator, as well as his/her demonstrated scientific and administrative leadership capabilities, adequacy of the time commitment of the Principal Investigator, d.2. adequacy of the planning and evaluation process to include: determining research productivity of existing projects and resources, discontinuing activities of low productivity, initiating new activities in response to important research opportunities, establishing collaborations, and the use of external advisors, d.3. adequacy of access to patients and populations for conducting current and projected therapeutic, prevention, detection and control research, d.4. degree to which the organization and leadership of the O"Brien Urology Research Center promote and facilitate scientific interactions between subprojects, pilot projects, etc., and effective use of the O"Brien Urology Research Center infrastructure (e.g., shared resources) in the conduct of research, d.5. effectiveness of and/or plans for promoting interdisciplinary scientific interaction, d.6. effectiveness of and/or plans for integrating O"Brien Center subproject research and resources with existing O"Brien Urology Research Center programs, d.7. adequacy of tangible institutional commitments that will enable and facilitate the research objectives of the O"Brien Urology Research Center (e.g., special facilities, recruitments, discretionary resources such as dollars and space), d.8. written assurance that O"Brien Urology Research Center interactions with commercial entities will uphold the principles of academic freedom, including the ability of the participating investigators to collaborate freely, and to send and receive biomedical research materials without restriction to other scientific researchers. e. Interactions with other O"Brien Urology Research Centers e.1. adequacy of plans (new application) or progress (competing renewal applications) to promote and maintain communication and integration of scientific subprojects of mutual interest with other O"Brien Urology Research Centers, e.2. willingness to interact with other O"Brien Urology Research Centers and with the NIDDK in sharing information, in assessing scientific progress, in identifying new research opportunities and in establishing scientific priorities. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the subproject and P&F research 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: October 17, 2002 Application Receipt Date: November 19, 2002 Peer Review Date: March 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 1, 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 (, a complete copy of the updated Guidelines are available at 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 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 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 Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.849 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and administered under NIH grants policies described at and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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