From owner-sci-resources@net.bio.net Fri Jun 03 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: No NIH Guide for 7/8, 9/2, 9/9 Date: 3 Jun 1994 19:11:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 4 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2sonrt$m2@net.bio.net> NNTP-Posting-Host: net.bio.net $$MAIL BEGIN *********************************************************** There will be no NIH Guide published for July 8, September 2, and September 9. $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Sun Jun 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Newsgroups: bionet.sci-resources Subject: Symposium "Frontiers in Biosensorics" Potsdam, Germany Sep 15-16, 1994 Date: 6 Jun 1994 15:39:38 -0700 Organization: Heinrich Heine Universitaet Duesseldorf Lines: 155 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <81792.bohlen@mail.rz.uni-duesseldorf.de> Reply-To: NNTP-Posting-Host: net.bio.net *** First Announcement *** With the symposium "Frontiers in Biosensorics" a technologically important sphere of the future shall be put in the centre of interest, which is of great scientific and economic interest. Beside scientists and applicators from research and industry and representatives from the proper authorities, target audience of that event will especially be potential producers. Parallel with the symposium there will be the chance for scientists and industrial enterprises to present their projects and main fields of research and production in order to gain partners for common future projects. Thus the Symposium will be a forum for all people interested in biosensorics in general and especially in contacts with potential partners in that field. Another target group of the event are the scientists of different disciplines like e.g. immunochemistry, material research or physical technologies, which can contribute to the further development of biosensors by new results in basic research. In addition, students and young scientists of those fields, who will influence the development of that important technologically relevant sphere are invited to that symposium. In two "blocks" the following subjects will be dealt with in special lectures: o New biological identification systems for biosensors o Modified sensor surfaces and new analytical systems After the lectures the participants of the symposium can discuss the subjects with the speakers. During the coffee breaks there will an opportunity to have a look at the information stands, at which scientists and industrial enterprises will present their projects and research results. It is planned to invite especially technologically relevant industrial enterprises and thus to establish an open forum between science and economy in order to promote the research and technology transfer in the Land of Brandenburg and over and above that. The special lectures will be read by well-known speakers from science and economy not only from Germany but also from abroad. They guarantee that the symposium will be of a high quality. Parallel with that, an exhibition under the headline "Commercial Biosensors", with a main emphasis on East-German firms will show appliances, which are already available at the market. >From the list of lectures: PD Dr. Hummel, Duesseldorf - New enzymes Prof. Dr. Erdmann, FU Berlin - RNA as substrate and enzyme, "ribozymes" and biosensors Dr. Warsinke, Potsdam - Genetically and biotechnologically produced fragments of anti-bodies Prof. Dr. Hansen, TU Berlin - New biosensors for environmental analytics Prof. Dr. Brehmer, Potsdam - Thin organic layers, polymers and layer systems Prof. Dr. Spener, ICB Muenster - Binding protein - anti-body - identification systems Prof. Dr. Wulff, Duesseldorf - Chiral holes in netted polymers... Dr. Urban, Wien - Sensor surfaces for in vivo-applications Dr. Menz, Ciba Basel - Miniaturised analytical systems ... Dr. Voelker, BAYER AG Uerdingen- Ultra-thin polymer layers Dr. Hintsche, FhG Berlin - Micro-biosensors Frau Dr. Dumschat, ICB Muenster- Chip-biosensors Prof. Meyerhoff, DIFE Bergholz-Rehbruecke- Ionic channals und binding proteins Prof. Schultze, Duesseldorf - Electropolymers for biosensors... Dr. Henco, Diagen Duesseldorf - Single molecule analytics SCIENTIFIC COMMITTEE Prof. Dr. Frieder Scheller, Universitaet Potsdam Frau Dr. Jutta Fedrowitz, Wissenschaftszentrum NRW, Duesseldorf ORGANIZATION / TECHNOLOGY TRANSFER Dr. Andreas Bohlen, Potsdamer Informations- und Technologie-Transfer (PITT) The lectures take place at the University of Potsdam (Land of Brandenburg, near Berlin) on September 15, 1994 from 10 am to 5 pm and on September 16, 1994 from 9 am to 4 pm. The participation fee is DM 110,- (DM 55,- for students). Included in that fee are lunch on both days, a reception of the participants on Thursday night (Sep 15, 1994), the coffee during the breaks and the conference documents. The registration forms will be sent to you on request. Therefore it is only necessary to send a short email with the help of the "form" below to one of the following addresses: bohlen@hp.rz.uni-potsdam.de (Dr. Bohlen) OR bohlen@uni-duesseldorf.de (Dr. Bohlen) The deadline for your registration is July 31, 1994. Thank you very much in advance for your interest. With kind regards, Andreas Bohlen >>>>>>>>>>>>>>>>>>>>>>>>> E-MAIL-ANSWER >>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Please send me the registration form for the symposium "Frontiers in Biosensorics" , which will take place in Potsdam, Germany from September 15-16, 1994. Name: ........................... Surname: ........................... Academic title: ........................... Institution: ........................... Address: ........................... ........................... ........................... Phone No.: ........................... Fax No.: ........................... E-Mail ........................... [ ] I would like to participate in the symposium. [ ] I would like to exhibit [ ] a poster [ ] an appliance under the headline: ................................ [ ] Regrettably I cannot take part in the symposium but I would like to to receive some more information about: [ ] the University of Potsdam [ ] Biosensorics at the University of Potsdam [ ] the Department of Information and Technology Transfer (PITT) of the University of Potsdam Please send an extra email for each participant. ************************************************************** * Heinrich-Heine-Universitaet Duesseldorf * * Forschungs- und Technologie-Transfer * * Dr. Andreas Bohlen * * Universitaetsstr. 1 * * Gebaeude 16.11 * * D-40225 Duesseldorf * * * * Tel. (0211) 3 11-23 09 * * Fax (0211) 34 22 29 * * E-Mail hempel@uni-duesseldorf.de * ************************************************************** * * * Universitaet Potsdam * * Potsdamer Informations- und Technologie-Transfer (PITT) * * Dr. Andreas Bohlen * * Am Neuen Palais 10 * * D-14469 Potsdam * * * * Tel./Fax (0331) 9 77-11 19 * * E-Mail bohlen@hp.rz.uni-potsdam.de * ************************************************************** From owner-sci-resources@net.bio.net Mon Jun 13 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-018 - V23(22) 06/10/94 Date: 14 Jun 1994 11:50:31 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 598 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2tku5n$kne@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94018 CA-94-018 P1O1 *************************************** PROGRAM PROJECTS IN NUTRITION AND BASIC BIOLOGY RESEARCH FOR CANCER PREVENTION NIH GUIDE, Volume 23, Number 22, June 10, 1994 RFA: CA-94-018 P.T. 34; K.W. 0715035, 0710095, 0745027 National Cancer Institute Letter of Intent Receipt Date: July 25, 1994 Application Receipt Date: November 18, 1994 PURPOSE The Division of Cancer Prevention and Control and the Division of Cancer Etiology, National Cancer Institute (NCI), invite Program Project Grants for multidisciplinary nutrition and basic biology research relevant to the prevention of cancer. Specifically, they seek to encourage application of the techniques of molecular biology and molecular genetics to address questions about the fundamental role of nutrition in the initiation, promotion, progression, and prevention of cancer and the use of that knowledge to develop dietary interventions for the prevention of cancer, with a special emphasis on breast cancer, prostate cancer, and cancer in women and minorities. This Request for Applications (RFA) focuses on understanding the roles of dietary patterns, individual dietary constituents, food preparation techniques, and nutritional status in the development and prevention of cancer. The objectives of this RFA for Program Project Grants are to increase the pool of quality applications addressing nutrition and human cancer prevention using multidisciplinary approaches; to stimulate the use of modern biological approaches and techniques to elucidate the effects of nutrition on cancer initiation, promotion, progression, and prevention; and to promote the translation of knowledge of the impact of nutrition on the basic biology of cancer into dietary interventions for its prevention. Application of the tools and techniques of the basic biological sciences in research designed to increase understanding of the complex role of nutrition in cancer prevention will be enhanced significantly by a mechanism that promotes collaborations across disciplines and across institutions. Therefore, investigators are encouraged to submit Program Project Grant (P01) applications for a multidisciplinary research program with a focused theme and a minimum of three interrelated and synergistic individual component projects that comprise basic research efforts and at least one component project involving human subjects or human tissues. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Program Projects in Nutrition and Basic Biology Research for Cancer Prevention, is related to the priority areas of cancer and nutrition. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Domestic non-profit and for-profit organizations and institutions, public and private, are eligible to apply. Applications may be submitted from a single institution or may include arrangements with multiple institutions if appropriate. Applications from or involving minority institutions and from minority and women investigators are encouraged. Foreign institutions are not eligible. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Program Project Grant (P01). Applicants will be responsible for the planning, direction, and execution of the proposed projects. The total project period for an application submitted in response to this RFA must not exceed four years. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the amount of the direct cost awards will vary from $700,000 to $1,000,000. This is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Up to $4 million in total costs per year for up to four years will be committed specifically to fund applications that are submitted in response to this RFA. It is anticipated that three to four awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background Associations of dietary patterns and constituents with mortality and incidence have been suggested for a variety of cancers, including breast, prostate, lung, colon, stomach, esophagus, and cervix. Among these, breast and prostate cancer are of particular significance because of the large numbers of persons affected in the United States. The state of current knowledge of the role of nutrition, in terms of the effects of dietary patterns, types and levels of individual dietary constituents, and nutritional status, on the development and prevention of breast, prostate, and other cancers is still rudimentary. It has been subject to the inherent methodological limitations and inadequacies of the epidemiologic studies and animal models upon which it is largely based. Nonetheless, the available evidence has been sufficient to permit the provision of general dietary guidance that may help reduce risk of cancer and to justify the conduct of clinical trials to test the efficacy of dietary modification or supplementation with nutrients in the primary and secondary prevention of various cancers. Further significant advances in understanding the role of nutrition in cancer prevention require answers to questions about the fundamental mechanism(s) of action of dietary patterns and dietary constituents in the initiation, promotion, progression, and prevention of cancer, in the context of nutrient-gene-environmental interactions. Information is needed regarding nutrient and dietary non-nutrient microconstituent interactions with and effects on cellular metabolism, genomic stability, intracellular signal transduction, the net expression of growth-promoting and growth-inhibiting genes, and other modulators of gene expression and carcinogenesis. More information is also needed about the transport of nutrients to target tissues and about individual variability in susceptibility and response to nutrient effects. Such knowledge of the basic mechanisms of action of dietary components in cancer development is needed to provide informed recommendations about the optimal range of intake of specific dietary constituents and to refine and individualize dietary guidance for prevention of cancer. Studies that provide the necessary information fall within the province of bionutrition and encompass research on nutrients at the cellular level and the metabolic and behavioral consequences of food or nutrients in living organisms including humans. With the increasing recognition of the invaluable contributions of the techniques of molecular biology and molecular genetics to all facets of biomedical research, it is appropriate that their use in addressing important questions about nutrition and cancer prevention be encouraged. The potential for these new technologies to revolutionize many aspects of the science of nutrition, by increasing understanding of the nutrient-cell interactions that affect transition from healthy to diseased cells and permitting more reliable determination of the nutrient requirements for optimal health and functional capacity, was given explicit recognition in the trans-NIH Bionutrition Initiative. Although bionutrition rests firmly on the foundation of the modern biological sciences, it has been conceptualized as encompassing a broad range of activities from basic research through translational research to practical applications. Accordingly, this RFA encourages the submission of multidisciplinary research project applications in the form of Program Project Grants (P01). This type of award is intended to support a broadly based multidisciplinary program that has a well-defined central research focus or objective and may include support for common supporting resources (cores) required for the conduct of the component research projects. The central research focus of a Program Project Grant involves several disciplines or several aspects of one discipline and may involve multiple institutions. The individual projects must be interrelated and synergistic; hence, they result in a greater contribution to program goals than if each project were pursued separately. Individual investigators may apply their specialized research capabilities to basic research projects, clinical research projects, cancer prevention and control research projects, or combinations of such projects as they relate to the focused central theme of the overall Program Project. Applications are encouraged especially from investigative teams with members trained in molecular, biological and genetic techniques and nutritional science who have an interest in applying those techniques and knowledge to address questions regarding nutrition and cancer prevention. Program Projects responsive to this RFA must comprise basic research efforts and at least one component project involving studies of human subjects or human tissues. Applicants are encouraged to structure Program Projects that are no larger than necessary to achieve an effective collaborative effort among the participating basic biology and nutrition investigators. B. Research Areas of Interest The studies encouraged by this RFA will employ innovative approaches to examine fundamental effects of nutrients and other food constituents on initiation, promotion, progression, and prevention of cancer, as well as individual variability in response, to develop more effective nutrition interventions for prevention of cancer, especially breast and prostate cancer and other cancers affecting women and minorities. A wide variety of potential Program Projects, comprising individual projects ranging from basic to translational research and practical applications, may be considered for support; however, all applications must delineate clearly the relevance of each proposed individual research project, especially those with a basic biology focus, for the prevention of human cancer. Illustrative, but not exhaustive, examples of research areas relevant to nutrition and basic biology research for the prevention of cancer are as follows: o Evaluate nutrient-genome interactions in carcinogenesis and anticarcinogenesis, e.g., nutrient effects on DNA repair or modulation of gene expression. o Examine the potential for nutrients or other dietary constituents to influence the activation of oncogenes or inactivation of tumor suppressor genes. o Study nutrient influences on differentiation and on signals induced by physiological or chemical differentiation in various tissues. o Evaluate nutrient effects on growth factors for cellular transformation, including the ability to block or prevent the interaction of growth factors with receptors. o Examine nutrient-carcinogen-promoter interactions, including cellular defense mechanisms against environmental carcinogens/promoters that may be regulated by dietary factors. o Elucidate mechanisms and controls of nutrient transport to target sites in various tissues. o Quantify dose-response relationships for nutrients, nutrient derivatives, and other bioactive dietary constituents as part of the evaluation of their absorption, metabolism, and distribution in target tissues and their effects on molecular and cellular events. o Identify biomarkers indicative of early cellular transformation that may be monitored in nutrition epidemiologic studies and modulated in dietary intervention trials. o Identify biomarkers that will provide improved assessment of dietary intake and/or nutritional status for use in nutrition epidemiologic studies and dietary intervention trials. o Characterize the nature, extent, and causes of individual variability in cancer risk and in responses to dietary constituents. o Develop dietary intervention strategies to modulate expression of genetically determined cancer risk, including risk resulting from loss of response to natural regulators of proliferation and/or risk resulting from blocked expression of differentiation (maturation) programs. o Conduct small-scale clinical/metabolic intervention studies to test dietary modifications with potential for cancer prevention developed on the basis of knowledge of nutrient-genomic interactions. SPECIAL REQUIREMENTS The Program Project Grant is intended solely for the support of a multidisciplinary or multifaceted research program that has a focused theme. This unique grant mechanism builds on the leadership of the principal investigator and the interaction of the participating investigators to integrate the individual projects in a way that accelerates the acquisition of knowledge beyond that expected from the same projects conducted separately, without combined leadership or a common theme. A project within a Program Project is similar to the traditional research grant application in the sense that each is reviewed for scientific merit. However, a component project additionally is evaluated within the context of the special collaborative interrelationships required for a Program Project. In order to be responsive to this RFA, a Program Project must include basic research efforts and at least one component project involving studies of human subjects or human tissues. The relevance of each component project, especially those projects with a basic biology focus, to the prevention of human cancer must be clearly delineated. A Program Project Grant may contain one or more core component(s), each with a separate budget, for administrative or research support services that are required for and shared solely within this particular Program Project. Each core must provide essential facilities or services for two or more projects judged to have substantial merit. There is no allowance for unspecified developmental research funds (seed money) in Program Project Grants. A Program Project should include a sufficient number of scientifically meritorious projects to promote an effective collaborative effort among the participating investigators. For this RFA, Program Projects should be no larger than necessary to achieve the desired collaboration among basic biology and nutrition investigators. To be eligible for an award, a Program Project must consist of a minimum of three scientifically meritorious projects. There is no limit for the maximum number of projects to be included in a Program Project; however, the Program Project should not be so large that it exceeds the scientific and administrative leadership capability of the principal investigator, or that it loses a tight focus. In the peer review process, components not recommended for further consideration are considered in the peer review evaluation of the principal investigator's scientific judgment and program administration skills. The principal investigator of the Program Project Grant must be an established scientist with a strong record of accomplishment, who is substantially committed to and capable of exercising the responsibility for the scientific leadership, integration and administration of the entire Program Project. Also, the component projects should be directed by investigators who are experienced in the conduct of independent research and whose backgrounds and interests relate sufficiently to one another to allow for integrated group pursuit of the proposed Program Project goals and objectives. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact persons listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by July 25, 1994 a letter of intent that includes the names of the principal investigator and principal collaborators; a descriptive title of the potential application and a list of titles for the anticipated components of the P01; identification of the organization(s) involved; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed and to allow NCI staff to avoid conflict of interest. The letter of intent is to be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Telephone: (301) 496-3428 FAX: (301) 402-0275 APPLICATION PROCEDURES The regular research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892; and from the NCI program administrators named under INQUIRIES. General instructions for the preparation of the Program Project Grant application are contained in the application form PHS 398 (rev. 9/91). Instructions provided in the PHS 398 application kit are designed primarily for traditional research project (R01) applications. Program Project applications require additional information and a special format as described in the publication, "Program Project Grant of the National Cancer Institute: Guidelines 1993." Applicants may request a copy of this publication from the NCI Referral Officer listed under LETTER OF INTENT. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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 title of the RFA, "Program Projects in Nutrition and Basic Biology Research for Cancer Prevention," and the RFA number, CA-94-018, must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear, and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional complete copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 (if using overnight mail services) Bethesda, MD 20892 (if using U.S. mail) Applications must be received by November 18, 1994. If an application is received after that date, it will be returned to the applicant without review. Also, the DRG will not accept any application in response to this RFA that is the same as a P01 application currently being considered by any other NIH review group or awarding unit. The DRG 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. Applicants from institutions that 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. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned 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 NCI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The second level of review by the National Cancer Advisory Board considers the special needs of the NCI and the priorities of the National Cancer Program. Peer review for scientific and technical merit of each Program Project application submitted in response to this RFA will emphasize two major aspects: (1) review of the program as an integrated research effort focused on a central theme and (2) review of the merit of individual research projects and core components. Review criteria for the program as an integrated effort include: o Scientific merit of the overall program. o Significance and importance of the Program Project objectives. o Coordination, interrelationships and synergism among the meritorious research projects and core components as related to the common theme of the Program Project. o Advantages of conducting the proposed research as a Program Project rather than through separate research efforts. o Qualifications of the principal investigator to serve as both the scientific and administrative leader of the entire Program Project. o Adequacy of the commitment (percent effort) of the principal investigator to the Program Project. o Ability of the principal investigator to select individual projects for both scientific excellence and relatedness to the theme of the Program Project and actively promote interactions and collaborations. o Presence of an organizational and administrative structure appropriate for effective attainment of the Program Project objectives. o Mechanisms for internal quality control of the research. o Mechanisms for regular communication and coordination among investigators. o Institutional environment in which the research is conducted, including the availability of space, equipment, and patients or subjects, as well as the physical proximity of program participants. o Appropriateness of the size of the Program Project. Review criteria for individual projects include: o Scientific merit of the individual project in the context of the proposed program, considering the following factors: --Specific scientific objectives of the project that benefit significantly from, depend upon, or contribute to collaborative interactions with other projects in the program. --Qualifications, experience and commitment (percent effort) of the project leader and investigators responsible for the individual research project. --Adequacy of the proposed means for protecting against or minimizing potential adverse effects upon humans, animals, or the environment. --Adequacy of adherence to guidelines for including gender and minority representation in any study population. --Appropriateness of the budget. o Intrinsic scientific merit of the proposed project. Review criteria for core(s) include: o Utility of the core to the Program Project. o Quality of the facilities or services provided by this core (including procedures, techniques, and criteria for prioritization). o Qualifications, experience, and commitment of the personnel involved in this core. o Appropriateness of the budget and accountability for distribution of costs to projects. AWARD CRITERIA The anticipated date of award is July 1, 1995. Scientific merit, as reflected by the priority score; availability of funds; and programmatic priorities will be considered in making awards pursuant to this RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Susan M. Pilch, Ph.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Suite 212 Bethesda, MD 20892 Telephone: (301) 496-8573 FAX: (301) 402-0553 Carl E. Smith, Ph.D. Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 700 Bethesda, MD 20892 Telephone: (301) 496-5471 FAX: (301) 496-1040 Direct inquiries regarding fiscal matters to: Robert E. Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 213 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control. Awards will be made under the authority of the Public Health Services Act, Title IV, Section 301 (Public Law 78-410, 42 USC 241 and Section 412, as amended by Public Law 99-518, 42 USC 285a-1) and administered under Federal regulations 42 CFR Part 52 and PHS grant policies 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12732 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Jun 13 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-94-018 - V23(22) 06/10/94 Date: 14 Jun 1994 11:50:26 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 937 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2tku5i$kn4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DK94018 DK-94-018 P1O1 *************************************** MEDICAL THERAPY IN BENIGN PROSTATIC HYPERPLASIA: FULL-SCALE TRIAL NIH GUIDE, Volume 23, Number 22, June 10, 1994 RFA: DK-94-018 P.T. 34; K.W. 0755015, 0715105, 0705075 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: August 2, 1994 Application Receipt Date: August 30, 1994 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites cooperative agreement applications from investigators to serve as a Clinical Center, and/or the Data Coordinating Center and/or the Diagnostic Center for the full-scale phase of the "Trial of Medical Therapy in Benign Prostatic Hyperplasia (BPH)." The BPH Trial is a prospective, multicenter, randomized, placebo-controlled, double-masked clinical trial to determine if medical therapy (finasteride and/or doxazosin) delays or prevents the progression of benign prostatic hyperplasia (BPH). Patients will be randomly assigned to receive either finasteride, doxazosin, a combination of finasteride and doxazosin, or placebo. The primary outcome of the trial is time to progression of BPH as defined in the pilot study protocol. A sample of full-scale study participants will have prostate biopsies performed. The protocol for the ongoing BPH Pilot Study provides details on inclusion and exclusion criteria, baseline and follow-up procedures for participants, and overall organization of the trial. The protocol and sample size requirements were developed by awardees under a cooperative agreement mechanism with NIDDK assistance. It is recommended that applicants obtain a copy of the protocol, available upon request from DKUHD, to assist them in preparing their response to this RFA. Successful applicants for Clinical Centers will be eligible to apply for a second Request for Applications, "Basic Research Studies of Benign Prostatic Hyperplasia," which will be issued by February 28, 1995. Funding for this solicitation will be by means of supplements to cooperative agreements (U01). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), "Medical Therapy of Benign Prostatic Hypertrophy: Full-Scale Trial" is related to the priority areas of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Only U.S. organizations are eligible to apply. Domestic applications may not include international components. Applications may be submitted by for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority and women investigators, minority institutions and institutions that may contribute substantial minority representation in the trial are encouraged. The expertise appropriate for this research program for a Clinical Center includes a knowledge of the clinical and epidemiological aspects of urologic diseases as well as experience in the design and conduct of collaborative clinical trials and/or clinical investigations. Experience in recruitment and follow-up of a large number of patients with urologic diseases in clinical trials as well as clinical experience with a large number of patients with benign prostatic hyperplasia is especially useful for Clinical Centers. Skills in management of multicenter clinical trials, establishing and maintaining a large data base, and analysis of complex data sets are appropriate for the Data Coordinating Center. For the Diagnostic Center, experience in collection, storage and pathologic diagnosis of prostate biopsy specimens is important. The Diagnostic Center must also have the capabilities to measure prostate-specific antigen and the hormones noted in the protocol. An institution may apply to serve as a Clinical Center, the Data Coordinating Center, and the Diagnostic Center. However, a specific plan on how the independent operation (i.e., confidentiality of study-wide data) of each unit will be maintained is required. A separate application for each type of center will be required from an institution applying to serve as a Clinical Center, and/or the Data Coordinating Center and/or the Diagnostic Center. Applicants from institutions that 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. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator could be included with the application. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), which is an assistance mechanism rather than an acquisition mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH 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. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is approximately $6.9 million. It is anticipated that one award for a Data Coordinating Center for approximately $650,000 (including direct and indirect costs) per year and one award for a Diagnostic Center for approximately $650,000 (direct and indirect costs). Fourteen awards will be made for Clinical Centers. Funding for any one Clinical Center will be no more than $400,000 in total costs (direct and indirect costs) for each year. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, awards in response to this RFA are contingent on the availability of funds for this purpose. The total project period for applications submitted in response to the present RFA will be seven years. The anticipated award date is April 1, 1995. RESEARCH OBJECTIVES Background Benign prostatic hyperplasia (BPH) is an abnormal, localized enlargement of the prostate gland of adult men. This enlargement is known to occur in early adulthood but it remains asymptomatic for many decades. The age of onset of symptoms is variable. The symptoms vary from those characteristic of bladder outlet obstruction (e.g. decreased force of urinary stream, hesitancy in initiating the stream, and significant dribbling after completion of urination) to those characteristic of bladder irritation (e.g. increased daytime and nighttime frequency of urination, and urgency in the need to urinate). There is frequently a combination of both types of symptoms. Although enlargement of the prostate gland may be detected through routine physical examination, there is, at the present time, no way to determine: 1. who will develop symptomatic BPH, 2. at what rate the prostate is enlarging, 3. which constellation of symptoms will occur, 4. the relationship between prostate size and the development of symptoms, and 5. the interrelationship between chronic abacterial prostatitis and prostate cancer, although BPH frequently occurs concurrently with these diseases. The current standard for management of BPH is by means of surgical intervention to relieve the obstruction of the enlarged portion of the prostate. Costs for this surgical intervention exceed five billion dollars annually and are increasing. The costs for this procedure, the complications of surgical intervention, and an increased understanding into the biology of prostate growth, have prompted the development of pharmacological methods for the treatment of the symptoms of BPH. Currently, there are two categories of drugs that have been developed for the treatment of the symptoms of BPH; one blocks the alpha-1 adrenoreceptors, the other inhibits the enzyme 5-alpha reductase. Each drug category treats different, unique aspects of BPH symptoms. There are many unanswered questions about the pharmacologic treatment of BPH as noted below. 1. At what stage of prostate growth or symptoms is it best to intervene to prevent progression or to initiate regression and cessation of symptoms? 2. What is the relationship between the reduction in prostate size and the regression of specific types of symptoms? 3. Can objective diagnostic and pathological tests determine which symptomatic patients are candidates for the various pharmacologic therapies and which patients will not respond to medical therapy and thus are solely candidates for surgical intervention? 4. Does pharmacologic therapy affect the other two frequently concurrent diseases of the prostate, chronic prostatitis and cancer? BPH Pilot Study In 1992 the NIDDK issued the RFA, "Treatment of Benign Prostatic Hyperplasia: Pilot Study." Six Clinical Centers, one Data Coordinating Center, and one Diagnostic Center were selected to develop the study protocol and carry out a pilot study. The Pilot Study protocol was developed from October 1992 through October 1993. Recruitment, treatment and follow-up of approximately 150 patients began in December 1993 and will continue through November 1994. It is anticipated that the full-scale trial will begin April 1, 1995. Goal of the Activity The primary goal of this RFA is to initiate a collaborative full-scale trial to test whether medical therapy (finasteride and/or doxazosin) delays or prevents the progression of symptoms of BPH or if it relieves these symptoms, and the duration of these effects. The primary outcome will be the time to progression of BPH. Clinical progression is defined as the occurrence of the following in the Pilot Study protocol; (1) acute urinary retention, (2) renal insufficiency due to BPH, as indicated by a 50 percent increase from baseline in serum creatinine, (3) recurrent urinary tract infections, (4) incontinence, and (5) an increase from baseline in the American Urological Association (AUA) symptom score index of four or more points. Scope of the Activity It is estimated that 2,800 study participants, recruited by 14 clinical centers, will be required for the full-scale trial. Thus each Clinical Research Center is expected to randomize at least 200 study participants during an 24- month initial period of recruitment. The full-scale study will consist of three phases: (1) a 24-month period of recruitment, (2) a 48-month period of intervention and follow-up, and (3) 12 months for data analysis, close-out of the Clinical Centers, and reporting of results. Unless otherwise noted in this RFA, applicants should prepare their applications using patient eligibility criteria set forth in the BPH Pilot Study protocol. Major entry and exclusion characteristics are briefly described as follows. The study participants in this trial will be males of all races at least 50 years of age who have a peak urinary flow rate at least 4 ml/second, but not greater than 15 ml/second, and the voided volume is at least 125 ml. In addition, the AUA symptom severity score should be greater than or equal to eight. Selected exclusion criteria include any prior medical or surgical intervention for BPH, prior experimental intervention for prostate disease, significant renal or hepatic impairment, orthostatic hypertension, among others. Study Outline Investigators should develop their applications for the full-scale trial based on the inclusion and exclusion criteria and the general design of the pilot study as outlined in this RFA and the Pilot Study Protocol. However, contrary to the Pilot Study Protocol, urodynamic studies will not be conducted during the full-scale trial. It is expected that investigators will carry out the already developed protocol, however, modifications to this protocol beyond that noted above are expected. Study Components 1. Clinical Centers A Clinical Center is an institution that is actively involved in the recruitment, evaluation, treatment, and follow-up of study participants. It should consist of an interdisciplinary team of clinical investigators and appropriate personnel, such as a research coordinator, and clerical staff. An application for a Clinical Center should provide evidence that the investigators are capable of randomizing at least 200 participants into the study during the 24-month period of recruitment. Of the 200 randomized participants at each Clinical Center, 40 (20%) will have prostate biopsies performed. Applicants for Clinical Centers should describe the target population from which they expect to randomize the required number of study participants. Clinical Centers will be required to submit protocol data expeditiously. Clinical Centers must work in concert with the Data Coordinating Center to implement procedures for data audits and other data quality control procedures as established by the study protocol. The Principal Investigator and Co-Investigators in each Clinical Center should be skilled in collaborative clinical investigation. There should be evidence of strong institutional support for the Clinical Center, including adequate space in which to conduct clinic activities and office space for staff. An organizational structure for the Clinical Center should be set forth in the application delineating lines of authority and responsibility for dealing with problems in all general areas as well as stated willingness to follow the stated common protocol. The applicant should include a succinct discussion of previous relevant investigational efforts. The applicant also should discuss in detail the recruitment strategies to procure the expected number of randomized participants, approaches to attain high levels of adherence to the intervention, and high rates of follow-up. In order to attain the required number of randomized study participants it is anticipated that Clinical Centers will have to rely on referrals from individual physicians and recruit from health maintenance organizations, physician group practices, and other sources. Clinical Centers may wish to consider the establishment of procedures to follow-up study participants recruited from "satellite" clinics and/or the sites of recruitment noted above. However, the technical feasibility and cost of such an approach should be clearly described in the application. 2. Central Functions The Data Coordinating Center will have primary responsibility for collecting, editing, storing, and analyzing data generated by the Clinical Centers. It should be prepared to assume a key role in overseeing implementation and adherence to the protocol, and assuring quality control of the data collected. The Data Coordinating Center will be expected to provide appropriate biostatistical, data management, and coordination expertise. The Data Coordinating Center also will be expected to provide appropriate detailed reports to the Steering Committee and to the External Advisory Committee at regular intervals and will be responsible for the logistics and planning of meetings of these committees and their subcommittees. Applicants for the Data Coordinating Center should provide a detailed description of prior experience in multicenter studies. The Diagnostic Center will have primary responsibility for collecting, storing and analyzing serum samples and pathological tissue, including prostate biopsy specimens, provided by the Clinical Centers. The Diagnostic Center will also be responsible for interpreting radiological studies of the prostate carried out by the Clinical Centers. The Principal Investigator of the Diagnostic Center should be skilled in pathology or urology. The results of all of these studies will be reported to the Data Coordinating Center. The results of selected studies may be transmitted directly to the Clinical Centers for patient management. For any component of the Diagnostic Center supported by a subcontract, all NIH policies and procedures governing consortium grants must be followed. 3. Steering Committee The primary governing body of the study will be the Steering Committee comprised of each of the Principal Investigators of the Clinical Centers, the Data Coordinating Center, and the Diagnostic Center, the Chairperson of the Steering Committee, the NIDDK Urology Program Director and the NIDDK Project Coordinator (described in detail under Terms and Conditions). 4. External Advisory Committee An independent committee supported by the NIDDK and composed of experts in urology, pathology, biostatistics, clinical trials, and bioethics who are not otherwise involved in the study will be established to review periodically the progress of the study (described in detail under Terms and Conditions). This Committee will also be responsible for reviewing the acceptability of initial data quality monitoring plans established by the Steering Committee and the subsequent monitoring of data quality by means of reports prepared by the Data Coordinating Center. 5. Project Coordinator The Clinical Trial Program Director, Division of Kidney, Urologic and Hematologic Diseases will be the Project Coordinator for the full-scale trial. The Project Coordinator will assist the Steering Committee and External Advisory Committee in carrying out the study (described in detail under Terms and Conditions). Study Phases The randomized full-scale clinical trial will include 14 Clinical Centers, one Data Coordinating Center and one Diagnostic Center for a period of 84 months. It will have the following three phases: 1. Participant Recruitment: 24 months 2. Intervention and Follow-up: 48 months 3. Study Close-Out and Data Analysis: 12 months It is expected that each Clinical Center will randomize at least 200 study participants during an initial 24-month period. Follow-up procedures will be carried out over a period of 48-months. It is important to note, however, that as participants are randomized, intervention and follow-up will begin immediately. A 12-month period is planned for close-out of Clinical Centers, data analysis, and reporting of results. It is expected that all data will be submitted centrally and that access to data and publications will be by the mechanism(s) defined in the protocol. The External Advisory Committee, appointed by the Institute, will review progress at least semi-annually and provide advice to the Institute. Guidelines for Budget Preparation by Study Phases Each applicant for a Clinical Center, the Data Coordinating Center or the Diagnostic Center should submit an adequately justified yearly budget for the entire anticipated project period of 84 months. The budgets for each budget period of the study should be clearly delineated. The following information is provided to assist applicants in the preparation of budgets. Detailed budgets will vary according to policies of the applicant and specific needs identified in the response to this announcement. Budget Period Time Period Activity* 1 4/1/95 through 3/31/96 Recruitment, Intervention and Follow-Up 2 4/1/96 through 3/31/97 Recruitment, Intervention and Follow-Up 3 4/1/97 through 3/31/98 Intervention & Follow-Up 4 4/1/98 through 3/31/99 Intervention & Follow-Up 5 4/1/99 through 3/31/2000 Intervention & Follow-Up 6 4/1/2000 through 3/31/2001 Intervention & Follow-Up 7 4/1/2001 through 3/31/2002 Close-Out of Clinical Centers/Data Analysis and Reporting of Results *An initial recruitment period of 24 months is delineated to obtain a sample size of 2,800 among 14 Clinical Centers. However, intervention and follow-up will begin immediately after randomization. For a Clinical Center, the budget should request support for the minimum number of full-and/or part-time staff to successfully carry out the trial. A Clinical Center could include a Principal Investigator, Co-Investigator, study coordinator, and data entry clerk. Support for travel for two key investigators to attend quarterly meetings of the Steering Committee should also be included within the budget. Steering Committee meetings will be held in the Washington, DC area. Travel for centralized training of the study coordinator and data entry clerk must also be budgeted (assume central training to be held in the Washington, DC area annually during years 1 through 6). For applications for the Data Coordinating Center, the budget should also include the time and effort of key personnel needed to conduct the trial and the required number and cost of computers to be used at the Clinical Centers for distributed data entry. Travel to the Washington, DC area for External Advisory Committee meetings (two per year), Steering Committee meetings (three per year), site visits (seven trips annually for years 1 through 5 of the project period) is also to be included in the budget. The Data Coordinating Center should also budget for travel for the Chairperson of the Steering and Planning Committee (three meetings per year). Staff for the Diagnostic Center could include a Principal Investigator, Co-investigator, laboratory technologist and support staff to process specimens. Travel to the Steering Committee meetings and centralized training as noted above should also be budgeted. Terms and Conditions of Award The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the Institute Project Coordinator. These special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74, and other HHS, PHS, and NIH grant administration policy statements. 1. Awardee Activities The tasks or activities in which awardees will have substantial and lead responsibilities include protocol revision, patient recruitment and follow-up, data collection, data quality control, final data analysis and interpretation, and preparation of publications. The awardee agrees to follow the common protocol and manual of operations developed for the Pilot Study and as amended. The awardees also agree to transmit all study data to a central Data Coordinating Center for combination and analysis. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 2. NIDDK Activities The function of the NIDDK Project Coordinator and the Urology Program Director, Division of Kidney, Urologic and Hematologic Diseases will be to assist the Steering Committee and External Advisory Committee in carrying out the trial. The NIDDK Project Coordinator will assist in quality control, interim data analysis, safety monitoring, and final data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The Urology Program Director will assist in clarification of specific clinical and scientific problems and concerns. The NIDDK Urology Program Director and NIDDK Project Coordinator will have voting membership (one vote between them) on the Steering Committee, and as appropriate, its subcommittees. The NIDDK reserves the right to terminate or curtail the study (or an individual award) in the event of a substantial shortfall in participant recruitment, follow-up, data reporting, quality control or other major breach in the program. Early termination may also occur due to adverse effects of the interventions and reaching study endpoints. If the NIDDK does not agree with the protocol approved by the Steering Committee, the arbitration process described elsewhere should be used to resolve the differences between the parties. 3. Cooperative Activities A Steering Committee, composed of the Principal Investigator of each Clinical Center, the principal investigator of the Data Coordinating Center, the NIDDK Project Coordinator, the NIDDK Urology Program Director and the Chairperson of the Steering Committee will be the main governing board of the study and will have primary responsibility for facilitating the conduct, monitoring interim measures of trial progress, and reporting trial results. The Steering Committee, or one of its subcommittees, will have primary responsibility for the ongoing monitoring of the quality of study-wide data provided by the Clinical Centers. The chairperson, who will be someone other than the NIDDK staff members, will be selected by the Steering Committee from among their members, or alternatively, from among experts in the fields of urology or clinical trials who are not participating directly in the trial. Subcommittees will be established by the Steering Committee, as it deems appropriate; the NIDDK Project Coordinator and Urology Program Director will serve on subcommittees as he/she deems appropriate. Any changes to the collaborative protocol will be developed by the Steering Committee. Data will be submitted centrally to the Data Coordinating Center. Protocols will define rules regarding access to data and publications. It is anticipated that awardees will have lead responsibilities in all joint tasks and activities. Awardees will be required to accept and implement the common protocol and procedures approved by the Steering Committee. 4. Governance The primary governing body of the study will be the Steering Committee. Each member of the Steering Committee will have one vote. However, the NIDDK Urology Program Director and the NIDDK Program Director will have one vote between them. It is anticipated that the Steering Committee will meet on a quarterly basis during the course of the trial, or more often if deemed necessary. Subcommittees of the Steering Committee may be established as necessary and will meet as necessary. The NIDDK Project Coordinator or the Urology Program Director and the Data Coordinating Center will be represented on each subcommittee. An independent External Advisory Committee supported by the NIDDK and composed of experts in relevant medical, statistical and bioethical fields who are not otherwise involved in the study will be established to review periodically the progress of the study. The committee will oversee participant safety, evaluate results, monitor data quality, and provide operational and policy advice to the Steering Committee and the NIDDK regarding the status of the study. The Principal Investigator of the Data Coordinating Center, the NIDDK Project Coordinator, the NIDDK Urology Program Director and the Director of the Division of Kidney, Urologic and Hematologic Diseases may participate as ex-officio, non-voting members of this Committee. Committee members will be appointed by the NIDDK in consultation with members of the Steering Committee. 5. Arbitration Any disagreement that may arise in scientific-programmatic matters between award recipients and NIDDK may be brought to arbitration. An arbitration panel will be composed of three members--one selected by the Steering Committee (with NIDDK member not voting) or by the individual awardees in the event of an individual disagreement, a second member selected by NIDDK and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardees' right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, Subpart D. The special terms of award (1-5) described above are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR parts 74 and 92, and other HHS, PHS, and NIH grant policy statements. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. Since only men have prostate glands, discussion of issues related to recruitment of women need not be included in the application. LETTER OF INTENT Prospective applicants are asked to submit, by August 2, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIDDK staff to estimate the potential review workload and to avoid conflict of interest in the review. A letter of intent is to be sent to: Dr. Robert D. Hammond Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 APPLICATIONS PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these awards. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NIH program administrators listed under INQUIRIES. Use the conventional format for research project grant applications and ensure that the points identified in the "Review Criteria" section below are fulfilled. To identify the application as a response to the RFA, Check "YES" on item 2a of page 1 of the application and enter the title "Medical Therapy of Benign Prostatic Hypertrophy: Full Scale Trial" and enter the RFA number DK-94-018 in the space provided. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the original completed application form. Failure to use the label could result in delayed processing of the application such that it may not reach the review committee in time for review. Send or deliver the completed, signed application and three complete photocopies to the following office, making sure that the original application with the RFA label attached is on top to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to Dr. Hammond at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants, otherwise the NIDDK cannot guarantee that the application will be reviewed in competition for the RFA. Applications must be received by August 30, 1994. An application not received by this date will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants and for responsiveness by the NIDDK. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIDDK staff will return the application to the applicant. 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, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria The Initial Review Group evaluates the merit of each grant application on the meeting agenda according to specific criteria. The principal criteria for the initial review of all research applications, as required in the PHS Scientific Peer Review Regulations, include: 1. scientific, technical, or medical significance and originality of the proposed research; 2. appropriateness and adequacy of the experimental approach and methodology to be used; 3. qualifications of the principal investigator and staff in the area of the research; 4. the principal investigator's experience and record in previous research activity; 5. reasonable availability of resources; 6. reasonableness and adequacy of justification of the proposed budget and duration of support; and 7. adequacy of the proposed means for protecting against adverse effects upon humans, vertebrate animals, or the environment. The evaluation of applications for Clinical Centers, the Data Coordinating Center and the Diagnostic Center will be based primarily on the scientific merit of the proposed study. Specific criteria for review of applications will be as follows: For Clinical Centers: 1. Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the operation of a Clinical Center in the proposed Clinical Trial. Evaluation will include the following: familiarity with and experience in recruiting participants in a randomized trial; handling laboratory specimens; working in collaboration with other investigators under a common protocol; ability to implement study procedures, and meticulous and expeditious handling of study data. 2. Documentation of access to patient population(s) from which a substantial number of trial participants can be recruited in sufficient numbers to meet the goals specified in the RFA. 3. Ability to recruit representative minority populations. 4. Understanding and awareness of the scientific, ethical, and practical issues underlying the proposed trial and appropriateness of plans to deal with them. 5. Responsible budgeting and staffing and distribution of available resources appropriate for the work proposed. 6. Adequacy of the proposed facility and space. 7. Evidence of the degree of institutional commitment and support for the proposed program, including the relative position of the proposed project staff within the applicant's organizational structure. 8. Willingness to work cooperatively with other centers in the manner summarized in the RFA. 9. Willingness to carry out a developed study protocol. 10. Adequacy of plans to ensure accurate collection and timely transmission of study data. For the Data Coordinating Center: 1. Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the operation of a Data Coordinating Center for a collaborative clinical trial, as well as availability of the medical consultation of a qualified urologist, and the time these professionals will devote to the project. Prior experience in similar studies, in the collection of data and patient specimens from multiple clinical sites, as well as experience in monitoring the quality and timeliness of such data, must be demonstrated. 2. A knowledge of the potential problems associated with the conduct of this study and possible solutions must be demonstrated. 3. Suitability of proposed data management and data analysis plans. 4. Ability to design, implement and maintain a distributed data entry system for the Clinical Centers. 5. The approach to and likelihood of soliciting cooperation from the participating Clinical Centers and exercising appropriate leadership in matters of study design and protocol revision, and data acquisition, management, and analysis. Specific plans for ensuring quality control of data collection across all study sites (Clinical Centers and Diagnostic Center) are required. 6. Appropriateness of the budget for the work proposed. 7. The adequacy of the proposed facility, technical hardware, and space. 8. The organizational and administrative structure of the proposed program. 9. Evidence of the degree of commitment and support of the organization/institution for the proposed program, including the relative position of the proposed project staff within the applicant's organizational structure. For the Diagnostic Center: 1. Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the operation of a Diagnostic Center for a collaborative clinical trial as defined in the Pilot Study protocol. 2. Suitability of proposed plans for collection and testing of patient samples and evaluation of diagnostic tests carried out by the Clinical Centers. 3. Appropriateness of a plan to correlate results of testing patient samples with the major endpoints of the trial. 4. Acceptability of a sampling and analysis scheme for prostate biopsies in a subset of study participants. 5. Appropriateness of the budget for the proposed work. 6. The adequacy of the proposed facility, technical hardware and space. 7. Evidence of the degree of commitment and support of the organization/institution for the proposed program, including the relative position of the proposed project staff within the applicant's organizational structure. 8. Evidence of willingness to work cooperatively with other centers in the manner summarized in the RFA and Pilot Study protocol. 9. Plans for internal quality control and quality control for specimen collection by the Clinical Centers. AWARD CRITERIA Applications recommended by the National Diabetes and Digestive and Kidney Diseases Advisory Council will be considered for award based upon (a) scientific and technical merit; (b) program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; (c) availability of funds; (d) appropriate minority representation in the trial; and (e) geographic balance among clinical centers. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are encouraged to request a copy of the pilot study protocol. Direct inquiries regarding programmatic issues to: John W. Kusek, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A04 Bethesda, MD 20892 Telephone: (301) 594-7522 FAX: (301) 594-7501 Inquiries regarding fiscal matters may be directed to: Trude H. McCain Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 653 Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 Schedule The timetable for receipt, peer review, and funding of this RFA is as follows: Letter of Intent Receipt Date: August 2, 1994 Application Receipt Date: August 30, 1994 Initial Review: November/December 1994 Review by Council: February 1995 Anticipated Award Date: April 1, 1995 Request for Applications for Basic Research in BPH As noted previously, a separate RFA, "Basic Research Studies in Benign Prostatic Hyperplasia" may be issued no later than February 28, 1995. Those institutions selected as Clinical Centers for the full-scale will be eligible to apply for supplements to the cooperative agreements (U01). It is anticipated that patient material and data acquired by the Clinical Centers during the full-scale trial will be available for use in the studies proposed in response to this RFA, contingent upon agreement by the Steering Committee. AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance No. 93.849-Kidney, Urologic and Hematologic Diseases Research. Awards are made under the authority of the Public Health Service Act, Title IV Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Jun 13 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-94-008 - V23(22) 06/10/94 Date: 14 Jun 1994 11:50:19 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 846 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2tku5b$kmn@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AA94008 AA-94-008 P1O1 *************************************** ALCOHOL RESEARCH CENTER GRANTS NIH GUIDE, Volume 23, Number 22, June 10, 1994 RFA: AA-94-008 P.T. 04; K.W. 0404003, 0710030 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: December 1, 1994 Application Receipt Date: January 19, 1995 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides grant support for Alcohol Research Centers to conduct interdisciplinary research on alcoholism and alcohol abuse. The Center grants program is interrelated with and complementary to all other research support mechanisms and scientific activities that comprise the NIAAA programs of research on the nature, causes, and consequences of alcohol abuse and alcoholism, including diagnosis, treatment, prevention, and health services research related to prevention and treatment of alcoholism. The NIAAA currently supports 14 Centers and anticipates that the level of support for this program will not expand during this competition. Support for four of the current five-year Center grant awards will expire in late 1995. Research within each of these four Centers is organized around a central theme, respectively, adolescent alcohol abuse, alcoholism treatment, epidemiology of alcohol problems, and pathologic effects of alcohol. Applications for new Centers in these and other research areas will be accepted with applications from currently funded Centers seeking renewal support. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Alcohol Research Center Grants, is related to the priority area of alcohol abuse and alcoholism reduction. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-783-3238). ELIGIBILITY Any domestic public (non-Federal) or private non-profit or for-profit institution may apply for a Center grant. However, the proposed Center must be affiliated with an institution, such as a university, medical center, or research center, that has the resources to sustain a long-term, coordinated research program. An applicant institution must demonstrate the ability to attract high-quality scientists from biomedical, behavioral, and/or social science disciplines who are willing to make a long-term commitment to research. An application must also have a detailed five-year plan for a proposed research program. In addition, the applicant must assure that research training opportunities will be available. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The Alcohol Research Centers Grant program is designed to complement the regular research project grants program of the NIAAA by providing long-term (typically, for five years) support for interdisciplinary research programs with a distinct focus on a particular theme relating to alcoholism, alcohol abuse, and other alcohol-related problems. The program is intended to encourage outstanding scientists from biomedical, behavioral, social science, and other relevant disciplines to bring a full range of expertise, approaches, and advanced technologies to the study of problems related to alcohol abuse and alcoholism. Center grants help to provide a stable environment for investigators to engage in alcohol research in a coordinated and integrated effort. A Center is expected to be a source of scientific excellence and, through sustained excellence, to become a significant regional or national research resource. In addition, the applicant institution is expected to afford opportunities for research training to persons from various disciplines and professions. A specialized Center (P50) is a comprehensive, broad-based multidisciplinary, multi-investigator, long-term program of combined research and research support activity planned around a specific major research objective or research theme. In addition to providing support for shared resources, this type of Center supports a full range of basic, developmental, clinical, and/or applied research components; allows for growth and development through pilot projects; and is intended to provide state-of-the-art leadership in the alcohol field. FUNDS AVAILABLE It is estimated that approximately $6 to 7 million will be available in FY 1996 to fund approximately four Centers. The total cost for a Center may not exceed $1.7 million per year. Continuation support in the future years is anticipated. RESEARCH OBJECTIVES All proposed research to be conducted within a Center must be clearly directed toward one or more of the following goals: prevalence, etiology, diagnosis, prediction, clinical course, management or treatment of alcohol abuse, alcoholism, or alcohol-related health problems; health services research; consequences of alcoholism or alcohol abuse; and factors that relate to prevention of alcohol abuse, alcoholism, or other problems associated with alcohol consumption. For example, research to improve knowledge of the impact of alcohol use on related health problems, such as liver and gastrointestinal disorders; nicotine and other drug abuse; neurological impairment; and mental disorders that co-occur with alcohol abuse disorders, is also encouraged. The Alcohol Research Center grant provides a mechanism for fostering interdisciplinary cooperation in a group of established investigators conducting high-quality alcohol research. Therefore, existence of a strong research capability is fundamental to the establishment of a new Center or the continuation of an existing Center. A Center should be an identifiable organizational unit within an institutional or organizational structure such as a university, medical center, or a consortium of affiliated cooperating institutions. Center Components The following paragraphs describe the specific components of a Center application: Administrative Core Component A Center should promote synergistic interaction of broad and diverse elements that require clearly specified lines of authority and accountability by appropriate institutional officials. The purpose of the administrative core component is to provide the organizational framework for the management, direction, and coordination of the Center. The administrative core component must be managed by the Center Director or Scientific Director and may include funds for scientific enrichment activities such as special lectures, visiting scientists, symposia, seminars, workshops etc.; and for education and research dissemination activities for the public. Scientific Core Components Core components for this RFA are defined as shared research resources that enhance productivity or in other ways benefit a group of investigators working in alcohol-related research to accomplish the stated goals of the Center. A core component is a laboratory, facility, service, or other resource that interacts synergistically with research projects of the Center. Research projects that use the core may be funded primarily from the Center grant award (Specialized Research Center), from other support mechanisms such as Research Project Grants, Program Projects, or a combination thereof, that have relevance to the NIAAA mission. Core components should provide investigators with some technique, instrumentation, service, or resource in a way that will enhance research progress and contribute to effectiveness. Each core component is directed by an investigator with established expertise relative to the support or service to be provided, usually a faculty-level individual. Some examples of research support that core components typically provide are: (1) technology that implements automation or large batch preparation; (2) tissue and/or cell culture facilities; (3) complex instrumentation, e.g., electron microscopy, mass spectrometry, electrophysiology; (4) animal care and preparation; (5) service and training; (6) patient coordination; and (7) information processing, data management, and statistical services. Research Components Research components are individual scientific research projects, interrelated within the overall Center program so that the components contribute collectively to the goals of the Center program to a greater extent than if each project were pursued separately. Each research component must be a highly focussed project under the direction of a component director. The component director should be an established researcher of independent and scientifically recognized standing who is responsible for the scientific direction and conduct of the individual research component. A Center Director or Scientific Director may also serve as a component director. Pilot Project Component The purpose of pilot projects is to provide the Center with a flexible means to develop and explore new research activities or directions, and unique scientific opportunities that could evolve into independently funded research projects. These funds are not intended to supplement ongoing research projects. Pilot projects must be in a separate pilot project component that incorporates all of the pilot studies of the proposed Center grant. SPECIAL REQUIREMENTS The following paragraphs describe the general requirements for a Center application. Details for preparing the application are provided in the "Supplemental Instructions," which are available from the program staff listed under INQUIRIES. Center grant applications should be organized into discrete components that comprise a proposed program of research. Each component is either a research component or a core component for which a separate detailed budget is included in the application. The application must include an administrative core and at least three research components; it may also include shared resource cores and/or a pilot project component. The minimum acceptable combined number of research components and core components is four (an administrative core and three research components). The maximum combined number of research components and core components, including a pilot project component, is 10 for the total project period. More than a total of 10 components is not acceptable even if some components are in operation for less than the five-year period. The research plan for each core component and each research component is limited to 25 pages. Pages not used for one component may not be used to extend the page limit of other components/cores. These page limits do not apply to pilot projects. For pilot project requirements, see section entitled "Pilot Project Component," (below). Administrative Core Component The administrative core component plays a key role in the coordination and operation of the Center. This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. An important function of this core is the administration of the budget. Through this component, the Center Director provides substantive leadership and manages the administrative core component. This component may also include the costs of scientific enrichment, education, and information dissemination activities. The administrative core should also provide for integration of Center functions. Scientific Core Components Each shared resource component should be clearly described in terms of the services/resources to be provided to investigators. The description should include a discussion of the core's contributions to the research objectives of the Center. Relevant aspects of cost effectiveness, time-saving, and increased efficiency attributable to the existence of the cores should also be addressed. A core component may support Center grant research components and separately funded research project grants that are related to the Center's theme. Each separately funded research project associated with the Center and utilizing core facilities should have a brief description that includes its research objectives and how the Center's core facility will impact upon it. The minimum number of research components/projects supported by a core component is two. A core component director who has documented experience and scientific expertise relative to the purpose of the core must be designated for each core. This person should be an established scientist in his or her field. The description of the organization and mode of operation of the shared resource core should include discussion of quality control for the service or resource, and the procedures for evaluating and selecting projects eligible for use of the facility. Training in complex techniques and methods should be described if they are functions in proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives. Research support or evaluation activity is appropriate for a core when it is directly related to improving operation, resources, quality, or utility of the core. In renewal applications, ongoing or completed core activity that has enhanced or facilitated research should be described. Past performance and accomplishments of cores should be described, as should the effect of services provided by cores on investigators' productivity. Research Components For each proposed research component, a clear description of the major goals, objectives, and its integration with the other components in relation to the overall Center program should be provided. o The question(s) to be addressed and the hypotheses to be tested by the proposed research should be highly focused and fully explained. o A discussion of the design and procedures should describe the strategies proposed to accomplish the specific aims of the project and highlight innovative aspects of the approach. o A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention devoted to a description of necessary resources, subjects, clinical populations, tissue resources, etc., which will be involved in proposed studies. All proposed research components need not be ongoing at any one time, but may be phased in at different time points during the life of the proposed Center grant. At least 3 research components must be ongoing at all times, and no more than 10 research and/or core components may be proposed over the entire project period. This aspect should receive careful attention in the application and individual component preparation. Pilot Project Component Pilot projects should be adequately, though concisely described. For every year that funds are requested for pilot projects, the application must provide descriptions of the project to be supported. While the specific number of pilot projects to be proposed is at the discretion of the applicant, requested funding for pilot studies may not exceed $100,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any one year. All proposed pilot projects need not be ongoing at any one time, but may be phased in at different points during the life of the proposed Center grant. It is also recognized that the relative priority or need for specific pilot projects may change over the course of time. While the Center's framework for management of pilot funds and the mechanism for operating the program are left to the discretion of the Center, the application must provide specific information to enable adequate scientific evaluation by a peer review committee. The application should include: o A full description of the management of the pilot project component, including a description of the process to be followed by the Center Director in selecting new pilot projects should a need arise to replace any of the pilots contained in the application. o A full description of each proposed pilot study including its rationale, objectives, approach, investigators, and significance for the Center. The research description of any individual pilot project may not exceed eight pages; the entire narrative for this Pilot Project Component may not exceed 50 pages irrespective of the number of pilot projects proposed. o For competing renewal applications, information should be provided on the past experience of the Center in utilizing pilot funds to further the goals. The narrative should include an assessment of the overall benefits derived from the availability of pilot resources. A budget should be submitted for the pilot project component as a whole. In addition, budget information should be provided for each individual pilot project. See "Supplemental Instructions" for further information on pilot project description requirements. Renewal Applications A comprehensive progress report is required for competing continuation (renewal) applications. A statement must be included in the application regarding the progress made by the Center as a whole in its development as a national or regional research resource. In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal. More specific details are provided in the special instructions appended to this announcement. Facilities and Environment Applicants must demonstrate the availability of adequate laboratory, clinical, and office facilities needed to carry out the objectives of the proposed Center program. Although not required, it is desirable for all Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Reference facilities affording access to the relevant literature must be readily available. It is expected that such reference facilities will be the primary repository of additional reference materials that may be obtained through Center funding. Relevant support services, including adequate data processing facilities, must also be readily accessible within or through the institution. Assurances of such support must be included with the proposal. Organization and Administration A Center must be an identifiable organizational unit with an administrative structure and clear lines of authority which will facilitate coordination among Center personnel to assure maximum accountability and efficiency in Center operations. An applicant must designate an institutional official to serve as principal investigator for the Center grant and as Director of the Center. The institutional appointment of this person must provide sufficient authority to allocate space, personnel, and other resources essential to the Center. This individual must demonstrate the ability to organize, administer, and direct the Center. The Director of the Center will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center. Overall program management, coordination, communication, progress assessment, and quality control are typically responsibilities of the Director and are facilitated through the administrative core. The administrative core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core. The applicant may also designate a Scientific Director who will be responsible to the Center Director and provide direct supervision of the scientific and operational aspects of the research program. Such a person should be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the research program. The Scientific Director will be responsible for assuring interaction and collaboration among scientists conducting research within the Center to facilitate a concerted approach to the research goals of the Center. The Scientific Director also will be responsible for the direct monitoring of ongoing research and for identifying (with the assistance of colleagues) research activities to be expanded or decreased and needs for additional resources or reallocation of resources. If the Center Director also serves as the Scientific Director, his or her functions as Scientific Director should also be described. Key professional staff, such as directors of individual research components and core components of the Center, should have the necessary training/experience to assure that the objectives and goals of the proposed studies will be achieved. Such persons must be established investigators with proven track records. A Program Advisory Committee shall be established and chaired by the Center Director. Its membership, selected by the Center Director from individuals outside the Center, should be composed of at least five members who should be identified in the application. Members should be persons of recognized scientific standing who are generally familiar with the Center's activities and represent a cross-section of disciplines that are relevant to the work of the proposed Center. It shall be the responsibility of this Committee to review and make recommendations to the Center Director on the conduct of all activities of the Center, including the conduct of pilot projects. Training While the primary function of each Center is the conduct of high-quality interdisciplinary research, an important component related to the Center and its research efforts is the training of research and clinical personnel. The applicant institution must therefore demonstrate or give reasonable assurances that it has: (a) the capacity to train predoctoral and/or postdoctoral students for careers in alcohol research; and (b) the capacity to conduct programs of continuing education in the Center's designated research theme in the medical, behavioral, and health service fields. While the Center need not necessarily have formal training programs of its own, there must be specific provision for coordination between the Center and the training programs of the applicant institution and/or affiliated institutions. Center grant funds may not be used to pay stipends or other trainee costs; however, Center staff may participate in the development of training programs, and Center resources may be made available for use of trainees. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. Terms and Conditions of Support Center grant funds may be requested for support of core components and individual research components associated with the Center program. Administrative core resources may include, for example, salaries of personnel responsible for management of the Center, program enrichment activities such as special lectures, visiting scientists, symposia, seminars, workshops, etc., and costs related to dissemination of research information to the scientific community and lay public. Funds may be requested for costs associated with individual research components which are part of the Center program. Examples of such costs include: research staff salaries, supplies, travel, special consultation, research patient costs, publication costs, and the like. Funds also may be requested for the allowable indirect costs of the applicant organization. In addition, costs of advisory committees, steering committees, and consultants may be included in the administrative core. Consultants for specific research components should be included in the budgets for those components. If committees other than the Program Advisory Committee are included, specific plans as to how the committees will be selected and how they will function should be presented in the application. Alcohol Research Center grant funds may be used only for costs that are necessary to carry out the research and research support activities of the Center program, and must be in conformance with HHS cost principles (encompassed in 45 CFR Part 74) and the Public Health Service Grants Policy Statement (rev. 4/94). This publication should be available from your office of sponsored research. Funds provided under this program may not be used for the purchase of land; nor for the purchase, construction, preservation, or repair of any building. However, costs of alteration and renovation of existing facilities necessary to accomplish the objectives of the grant may be allowed subject to PHS grants policy limitations. Funds provided through Center grants may not be used for support of trainee stipends, fees, or other expenses directly relating to training activities. Support will be provided for a period of up to five years (renewable for subsequent periods) subject to continued availability of funds and scientific progress. Applicants may request up to $1.7 million total cost (including direct and indirect costs combined) per year. The actual amount of support awarded will depend upon consideration of factors listed under AWARD CRITERIA. The Center grant is neither expected nor intended to cover all costs of running a successful Alcohol Research Center program. Research and training activities associated with the Center may receive additional funding from Federal sources as well as from State and local sources. NIAAA expects and encourages the institution and scientists attracted to such Centers to seek and compete actively for such funding. Research staff in funded Centers may submit applications for independent research project grants for support of research projects that do not overlap with their Center project. Centers will be required to submit detailed annual progress reports including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modifications in long-term research plans. Also required are reporting of inventions, reports of expenditures, final reports, and other reports in accordance with PHS policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 1, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAAA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ernestine Vanderveen, Ph.D. Centers Program National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grant Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone 301-594-7248; and from the NIAAA program administrator named below under INQUIRIES. Applications must be received by January 19, 1995. The RFA label available in the PHS (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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 2a of the face page of the application form and the YES box must be marked. Page limits and limits on size of type are strictly enforced. Page limitations, including those for appendices, are specified in the Supplemental Instructions for Preparing an Alcohol Research Center Grant application. Non-conforming applications will be returned without being reviewed. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH Division of Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included in the application material. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mark Green, Ph.D. Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 REVIEW CONSIDERATIONS The Division of Research Grants (DRG), NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If NIAAA staff find that the application is not responsive to the RFA, it will be returned 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 NIAAA in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Review Criteria The initial review for scientific and technical merit of applications will emphasize two major aspects: (1) review of the Center as an integrated research effort focused on a central theme, including the administrative core; and (2) the review of each research component and all other core components. The review will also include an assessment of the academic and physical environment and special considerations, e.g., compliance with human subject and animal welfare requirements, and compliance with policies concerning inclusion of women and minorities in clinical research study populations. 1. The Center as an Integrated Effort o The significance of the overall research goals and development of a well-defined central research theme. o Multidisciplinary scope of the Center. o Center cohesiveness, coordination, and interrelation; and the synergistic potential among the Center components and core units. o The qualifications, experience, and administrative competence of the Center Director; and his or her commitment and ability to devote substantial time and effort to the Center. o The scientific ability of the Scientific Director and his or her professional experience and leadership. o The justification of the core components in terms of accomplishing the Center objectives, and their usefulness to the research components and/or independently supported investigators who utilize the core services or facilities. o The justification of individual research components in terms of the overall research goals and the central research theme of the Center and their relation to other research components. o The scientific qualifications and ability of the directors of the research project components and/or the core components, the extent to which each of the directors will contribute to overall Center goals, and their commitment to the Center. o Administrative arrangements and organizational structure of the administrative core to facilitate and monitor attainment of Center objectives and maintain quality control of ongoing projects. These factors include: - plans for communication and cooperation among investigators involved in the Center; - mechanisms for allocation of funds and core resources and selecting meritorious replacement pilot projects if this becomes necessary; - quality control, oversight; - day-to-day management, long-term planning, and periodic evaluation; - contractual and consortium arrangements; and - procedures for replacement of key persons, if necessary. o Appropriateness of the overall budget for the work proposed in the Center. o Potential of the Center to become or maintain itself as a regional and national resource, including capacity to provide quality research training, opportunities for independent research career development, and plans for research information dissemination and education activities. o In addition, applications for renewal support will be evaluated in terms of the degree to which the Center has achieved stated goals with special attention to: - the scientific merit of completed research; - recruitment of new scientists into alcohol research; - development of a multidisciplinary research team; and - coalescence of the Center staff into an effective team. 2. Individual Research Components and Core Components, including the Pilot Project Component o The scientific and technical merit of each research component and each core component. o The significance of each research and core component and its relation to the central theme of the Center. o Evidence of quality control of proposed core component's services, resources, facilities. o The qualifications, experience, and commitment of the component director responsible for the research component and/or core component, including his or her ability to devote adequate time and effort to the Center. o The appropriateness of the budget request for each of the proposed research project components and/or core components, administrative core, and any pilot project core component. o For pilot projects, the potential of the proposed study as a building block in the development of future research. 3. Resources and Environment In addition to the scientific components, e.g., research project and core components, the initial review group will also evaluate: o The academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects and materials, and the potential for interaction with scientists from other departments and other institutions. o The institutional strength, stability, commitment to research and support for the Center, including fiscal responsibility and management capability to assist the Center Director and staff in complying with HHS, PHS, and NIH policies. o Opportunities for research training and education for persons from various disciplines and professions. 4. Other Considerations o When an application proposes research or research-related activity that involves potential risks to human subjects, animals, and/or the environment, the adequacy of the proposed means for protecting against such risks must be demonstrated for each component. o Specific statements addressing compliance with NIH policies on inclusion of women and minorities in studies involving human subjects. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall merit of the application, as well as such considerations as program balance, relevance to the mission and goals of NIAAA, research program priorities, equitable geographic distribution, continuity of support, and availability of funds. Awards will be made for up to five-year project periods with separate fiscal awards made annually. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ernestine Vanderveen, Ph.D. Centers Program National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Direct inquiries regarding fiscal matters to: Edward Ellis Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Relationship to NIAAA In view of the special significance of this program, close coordination and communication between the NIAAA staff and staff of the Alcohol Research Centers is intended. The NIAAA program official will have responsibility for maintaining liaison with appropriate Center leadership, serving as resource consultant to the Center program, and keeping NIAAA staff informed on progress and accomplishments of the Centers. In addition, the program official with other NIAAA staff and consultants will, from time to time, make on-site visits for purposes of program coordination and exchange of information. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.891. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464J, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 549, "Grants for National Alcohol Research Centers;" Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Jun 13 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-94-073 - V23(22) 06/10/94 Date: 14 Jun 1994 11:50:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 464 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2tku53$km9@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR94073 PAR-94-073 P1O1 ************************************* CENTERS FOR RESEARCH ON SERVICES FOR PEOPLE WITH MENTAL HEALTH DISORDERS NIH GUIDE, Volume 23, Number 22, June 10, 1994 PA NUMBER: PAR-94-073 P.T. 04; K.W. 0730057, 0710030 National Institute of Mental Health Application Receipt Date: October 1 PURPOSE The National Institute of Mental Health (NIMH) announces the availability of support for multidisciplinary Centers for Research on Services for People with Mental Disorders. The purpose of these Centers is to promote, develop, and conduct multidisciplinary research that can help to improve the organization, financing, delivery, quality, effectiveness, and outcomes of services for persons of all ages with mental disorders. Support is available for research centers focused in whole or in part on mental health services for children and adolescents, adults, elderly persons including those with Alzheimer's disease and other dementia, and persons with mental disorders who are involved with or at risk of becoming involved with the legal system. Support is also available for centers focused in whole or in part on mental health economics and on methodological issues in mental health services research. Centers are encouraged to include minorities and women in all facets of their research program; however, centers focused entirely on services for minority populations should apply for support under Program Announcement 92-122, "Minority Mental Health Research Centers." This program announcement (PA) addresses one of the major recommendations set forth in Caring for People with Severe Mental Disorders: A National Plan of Research to Improve Services. It complements the NIMH report, "Implementation of Caring for People with Severe Mental Disorders: A National Plan of Research to Improve Services," which invites applications for research project grants, research demonstrations, and career development applications in support of this National Plan. This PA also addresses recommendations for services research contained in the National Plan for Research on Child and Adolescent Mental Disorders and in the NIMH announcement, "Implementation of The National Plan for Research on Child and Adolescent Mental Disorders." This PA supersedes and replaces NIMH program announcements PA-92-94, "Centers for Research on Services for People with Severe Mental Disorders," and PA-92-20, "Centers for Research on Mental Health Services for Children and Adolescents." Its scope is broader than these two earlier program announcements, because discussions of health care reform have emphasized the need for the NIMH to develop a center program that covers the entire mental health service system, including services provided in general medical settings and other agency, institutional, and community contexts. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Centers for Research on Services for People with Mental Disorders, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic organizations and by public and private institutions, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Specialized Center (P50) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this PA may not exceed five years. The funding cap for a Center for Research on Services for People with Mental Disorders is $600,000 in direct costs for the initial project year, with annual increases of four percent thereafter, plus negotiated institutional indirect costs. Applications that request direct costs in excess of this amount will be returned to the applicant without review. RESEARCH OBJECTIVES Examples of the types of services research issues that might be addressed by a Center are listed below. The list is illustrative, rather than comprehensive. It is expected that additional relevant and important research topics will be identified by investigators who respond to this program announcement. o Studies of the prevalence of mental disorders (including co-occurring substance abuse disorders) and associated disability in various types of service settings o Studies of access to needed mental health services and barriers to care o Research on clinical and related services provided to persons with mental disorders by mental health professionals, general health care personnel, and other providers in different types of service settings, including accuracy of diagnoses, appropriateness, quality, and effectiveness of care, and short- and long-term outcomes for patients and their families o Research on rehabilitation services for persons with mental disorders o Research on the organization and financing of services for persons with mental disorders, including services provided and paid for by State and local governments and the private sector o Studies of costs and cost-effectiveness of services for persons with mental disorders in various settings, including new and alternative types of services and case management o Research on cost-containment strategies in mental health care (e.g., managed care, capitated care, contracted care) o Studies of effects of major changes and innovations in the structure, financing and delivery of mental health services at various levels of government and in the private sector o Research on the interface between mental health services and other types of services needed to maintain people with mental disorders in the community, including research on models of coordinated and consolidated care o Studies of self-help programs, groups, and organizations for persons with mental disorders o Research on the role of families in caring for persons with mental disorders, including assessment of appropriateness and effectiveness of family education programs and family support programs o Studies of the impact of various mental health laws, civil rights legislation, and administrative regulations on delivery and effectiveness of mental health services o Research to test the validity and reliability of measurement instruments for use in services research (e.g., outcome measures) o Research on development of methodology for mental health services research Program specifications. A Center should be planned and organized for the purpose of addressing major gaps in scientific knowledge in the field of mental health services research on people with mental disorders. Centers must be multidisciplinary, including investigators from disciplines such as psychiatry, general internal medicine, family medicine, pediatrics, geriatric medicine, pharmacology, psychology, social work, nursing, epidemiology, biostatistics, economics, sociology, public health, law, and political science. The Principal Investigator will serve as Director of the Center and provide scientific and administrative leadership by devoting at least 50 percent of his/her time to the Center, including time spent on Center research projects that are clearly related to and supportive of the overall Center plan for research on services for people with sev