From owner-sci-resources@net.bio.net Fri Feb 04 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 4, 28 January 1994 Date: 4 Feb 1994 21:09:56 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 726 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2iv9n4$cms@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940128 V23N04 P1O1 ************************************ No RFAs present NIH GUIDE - Vol. 23, No. 4 - January 28, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** IMMUNE RESPONSES TO LYME DISEASE INFECTION AND VACCINATION (AI-94-008) National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** SYNTHESIS OF CONGENERS AND PRODRUGS (RFP NCI-CM-47012-20) National Cancer Institute INDEX: CANCER $$INDEX R2 ********************************************************** PHYSICAL ACTIVITY INTERVENTION IN HEALTH-CARE SETTINGS FOR HIGH-RISK SEDENTARY ADULTS - COORDINATING CENTER (RFP NHLBI-HC-94-07) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 ********************************************************** SURFACE MODIFICATION FOR BIOCOMPATIBILITY (RFP NIH-NINDS-94-04) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** RESEARCH ON ORAL WOUND HEALING AND TISSUE REGENERATION (PA-94-031) National Institute of Dental Research INDEX: DENTAL RESEARCH This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** IMMUNE RESPONSES TO LYME DISEASE INFECTION AND VACCINATION NIH GUIDE, Volume 23, Number 4, January 28, 1994 RFA: AI-94-008 P.T. National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: February 7, 1994 Application Receipt Date: March 18, 1994 The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) will join with the National Institute of Allergy and Infectious Diseases (NIAID) to co-sponsor the Request for Application (RFA) AI-94-008 entitled "Immune Responses to Lyme Disease Infection and Vaccination," published in the NIH Guide for Grants and Contracts Vol. 23, No. 1, January 7, 1994. The NIAMS has a continuing interest in the support of research on Lyme disease, particular its chronic and arthritic manifestations. Applications received in response to this RFA that focus on issues relating to chronic Lyme disease, particularly arthritis, will be considered for funding by both the NIAID and NIAMS. INQUIRIES Interested investigators are encouraged to contact Program Staff to discuss potential applications and to obtain the full text of the amended RFA. Inquiries may be addressed to: Dr. Susana A. Serrate-Sztein Rheumatic Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 594-5593 FAX: (301) 480-7881 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NCI-CM-47012-20 ****************************************** SYNTHESIS OF CONGENERS AND PRODRUGS NIH GUIDE, Volume 23, Number 4, January 28, 1994 RFP AVAILABLE: NCI-CM-47012-20 P.T. National Cancer Institute The Drug Synthesis and Chemistry Branch (DS&CB) of the Developmental Therapeutics Program (DTP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) is seeking contractors with expertise in chemical synthesis and drug design to synthesize a variety of compounds for evaluation as potential anti-AIDS or anti-cancer agents. The assigned objectives of this project are to design and synthesize the following: (a) congeners of lead compounds having confirmed activity to enhance activity or potency; (b) prodrugs with structural modifications that may provide altered pharmacokinetics, altered drug transport, improved bio-availability through increased water solubility, or increased chemical stability; (c) other altered structures that possess elements of both congeners and prodrugs; and (d) compounds related to natural products, e.g., alkaloids, heterocycles, nucleosides, and peptides. Each contractor should have available a fully operational facility, including all necessary equipment and instrumentation for all aspects of the contract. The nature of this project requires that the following restriction be applied: "The NCI signs legally binding agreements with certain suppliers (often pharmaceutical or chemical companies) that state that all information on compounds submitted by the supplier will be held confidential. The successful offeror will be expected to synthetically modify such commercially confidential (discreet) materials. Thus, pharmaceutical or chemical companies could obtain valuable data on new lead compounds. Therefore, in order to honor the confidentiality agreement with the original supplier, the NCI believes that the compounds cannot be sent to potential competitors of the supplier, and thus pharmaceutical and chemical companies must be excluded from the competition." For purposes of this restriction, a pharmaceutical or chemical company is defined as an organization that sells drugs and chemicals to the general public for profit. The Standard Industrial Classification (SIC) number is 8731. This is a recompetition of contracts currently held by the Georgia Tech Research Corporation (Georgia Institute of Technology), Purdue Research Foundation, and the University of Tennessee. It is anticipated that two cost-reimbursement contracts will be awarded for a period of two years beginning on or about September 30, 1994. INQUIRIES Request for Proposals (RFP) No. NCI-CM-47012-20 will be issued on or about January 31, 1994 and proposals will be due approximately 30 days thereafter. Copies of the RFP may be obtained by sending a written request to: Charles Lerner Research Contracts Branch, TCS National Cancer Institute Executive Plaza South, Room 603 Bethesda, MD 20892 Telephone: (301) 496-8603 $$R1 END ************************************************************ $$R2 BEGIN NHLBI-HC-94-07 ****************************************** PHYSICAL ACTIVITY INTERVENTION IN HEALTH-CARE SETTINGS FOR HIGH-RISK SEDENTARY ADULTS - COORDINATING CENTER NIH GUIDE, Volume 23, Number 4, January 28, 1994 RFP AVAILABLE: NHLBI-HC-94-07 P.T. National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) is soliciting proposals for a Coordinating Center to participate in a multicenter clinical trial designed to develop and evaluate the effectiveness of various intervention approaches delivered in health-care settings in increasing and maintaining physical activity and cardiorespiratory fitness among sedentary men and women at elevated risk of coronary heart disease (CHD) by blood pressure (BP) or lipoprotein criteria. The study will also examine the cost-effectiveness of the various intervention approaches as well as the magnitude of effects on BP, lipoproteins, and weight and the long-term maintenance of those effects. In addition to one Coordinating Center to be awarded under RFP No. NHLBI-HC-94-07, an estimated total of three clinical center contracts will be awarded under a separate RFP. The Coordinating Center will have responsibility for the overall coordination, monitoring, and central management of all activities, including data entry and management, quality control, data analysis, and collaborative development of the study protocol, manual of operations, interventions, and data collection procedures. The Coordinating Center will also be charged with the responsibility of competitively selecting a Central Blood Laboratory to perform as a subcontract to the Coordinating Center after contract award. A planned total of 810 adult subjects will be randomized into three intervention groups and one comparison group. This will be a five year study with a projected award date of September 30, 1994. The primary study outcomes will be cardiorespiratory fitness (i.e., maximum oxygen uptake) and physical activity (frequency, intensity, duration, and estimated caloric expenditure). Because of the need for scientifically comparable data in a defined population and relevance to the U.S. health care system, offerors other than U.S. institutions will not be considered. This procurement will be a new award and is open to all offerors who meet the determination of responsibility as defined by FAR 9.104. INQUIRIES Request for Proposals (RFP) No. NHLBI-HC-94-07 is now available. Letters of Intent will be due two weeks after the release date of the RFP. Proposals will be due on March 21, 1994. All requests for this RFP must be submitted in writing, verbal requests will not be accepted. Written requests must reference RFP No. NHLBI-HC-94-07, include three self-addressed mailing labels, and be addressed to: John C. Taylor Contracting Office National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue Federal Building, Room 200 Bethesda, MD 20892 Telephone: (301) 496-9655 $$R2 END ************************************************************ $$R3 BEGIN NIH-NINDS-94-04 ****************************************** SURFACE MODIFICATION FOR BIOCOMPATIBILITY NIH GUIDE, Volume 23, Number 4, January 28, 1994 RFP AVAILABLE: NIH-NINDS-94-04 P.T. National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, is seeking a contract to create surfaces on implantable silicon microstructures for the purpose of controlling the interaction of neurons, glia, and related cells and their protein products with the microstructure. Biomaterials that penetrate into the central nervous system as the microscopic electrode shafts of the neural prostheses interact with neural and other tissues on a cellular and molecular level. In order to achieve tight coupling between these implanted microelectrodes and the target neural substrate, this interaction must be understood and controlled. This contract supported research will study these interactions with a long-term goal of rationally designing microelectrode surfaces to promote specific tissue interactions. The efficiency of these microelectrodes depends on the micro environment around stimulating sites. The surface of the microelectrodes and the proteins that adsorb to this surface have a major impact on the way in which different cell populations react to the implant. Neural growth cones are sent out from many neurons around a microelectrode following implantation. With appropriate surfaces it may be possible to get selected neurons to send processes directly to the microelectrodes. This study will investigate cellular and molecular responses to specific surface modifications of silicon microelectrodes. Personnel with established expertise in cell biology and surface science are needed. It is anticipated that one award will be made for a period of three years. Award is anticipated for September 1994. INQUIRIES This is not a Request for Proposals (RFP). RFP NIH-NINDS-94-04 will be issued on or about February 1, 1994 with proposals due on April 4, 1994. To receive a copy of the RFP, submit a written request along with two self-addressed mailing labels to: Laurie Leonard Contracts Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 ATTN: RFP NIH-NINDS-94-04 All responsible sources shall be considered by the agency. $$R3 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-031 ************************************************ RESEARCH ON ORAL WOUND HEALING AND TISSUE REGENERATION NIH GUIDE, Volume 23, Number 4, January 28, 1994 PA NUMBER: PA-94-031 P.T. National Institute of Dental Research PURPOSE The National Institute of Dental Research (NIDR) invites investigator-initiated grant applications to conduct multidisciplinary basic and clinical research on wound healing and tissue regeneration associated with the orofacial region. Applications that address the healing, regeneration and repair of oral tissues following periodontal diseases, trauma, and surgical treatment of birth defects such as cleft lip and palate and cancer are sought through this Program Announcement (PA). 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, Oral Wound Healing and Tissue Regeneration, is related to the priority area of oral health. 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 domestic and foreign, non-profit and for-profit, public and private organizations, such as dental or medical schools, universities and research institutions. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) Award (R29). Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms available for the support of research in response to this PA include the traditional research project grant (R01), FIRST (R29) Award, small grant (R03), and Interactive Research Project Grants. Responsibility for the planning, direction, and execution of the projects will be solely that of the applicants. RESEARCH OBJECTIVES Background Wound healing is a complex process in which a variety of cellular and matrix components act in concert to reestablish the integrity of injured tissue. The complexity of this process may be simplified into four broad categories of the healing response that coincide with the temporal sequence of normal healing: hemostasis; inflammation; cell proliferation (repair); and tissue remodelling. The problems of repair and regeneration of orally related tissues, however, have certain unique features. For example, materials used in osseous reconstruction of the jaw must withstand extreme physical stresses. Moreover, the presence of teeth in the wound area can expose the underlying tissues of the oral environment and thus complicate the healing process. In addition, microorganisms and the host response to microorganisms in the oral cavity can prevent or significantly prolong healing of damaged tissues. The purpose of this PA is to further both basic and clinical research relevant to wound healing and tissue regeneration following periodontal diseases as well as various types of orofacial trauma, such as surgical treatment of cleft lip and palate, ablation and reconstructive treatment for cancer of the orofacial area, and regeneration of functional salivary glands following chemotherapy and radiation. A brief description of the relevant portions of the three major NIDR program areas covered by this PA follows. Craniofacial Injuries and Disorders The craniofacial region is especially susceptible to injuries and wounds resulting from motor vehicle crashes, motorcycle and bicycle related accidents, injuries associated with sports and recreation, and interpersonal violence. Additional sources of trauma include surgical correction of congenital craniofacial deformities. Successful management of injuries and wounds of the craniofacial structures presents unique challenges. The diversity of tissues and structures in close proximity to each other and the variety of functions in which they participate, including speech, hearing, breathing, mastication and swallowing, compound the problem of treating orofacial trauma. Wound healing following reconstructive surgery must often accommodate tissue deficits, such as large bony defects, thus compounding problems of the wound healing process. Oral Cancer The management of cancer of the orofacial complex similarly presents a unique challenge to the health care profession. Cancer therapy may involve surgery, chemotherapy, radiation therapy, or any combination of the three. The variety of tissues that comprise the orofacial complex (e.g., glandular secretory tissues, connective and mucosal tissues) respond in select fashion to ablative and reconstructive treatment of tumors of the head and neck. Restoration of optimal function and normal appearance is a principal goal of the care and management of tumors of the head and neck. Because of the recurring nature of many types of cancers, therapy frequently must be repeated, often complicating the healing process. A serious side effect of therapy, especially that involving radiation or chemotherapy, is damage to the salivary glands and the immune system, which can in turn lead to a general impairment of healing, repair, and regeneration of the oral tissues. Periodontal Diseases Periodontal diseases comprise a group of related microbial- induced chronic inflammatory disorders that destroy the tissues supporting the teeth. These diseases can result in loss of substantial bone and soft tissue around the affected teeth, which challenges the clinician's efforts to restore full structure and supporting function to the periodontium. Periodontal healing is complicated by microbial recolonization of the subgingival sulcus, systemic diseases (e.g., diabetes), conditions in which there is direct bone contact with the root cementum (ankylosis), and the downward migration of epithelial cells, which prevents the reattachment of the fibrous periodontal ligaments to the cementum and alveolar bone. Major goals of periodontal therapy are, therefore, to inhibit microbial recolonization, prevent epithelial interference with proper integration of the soft and hard tissues, accelerate complete reformation of the lost alveolar bone without ankylosis or root resorption, reestablish a complete periodontal ligament network, and restore healthy gingival soft tissues. Major gaps exist in our understanding of the mechanisms by which healing of the periodontium can be accelerated and or enhanced by the clinician. Guided tissue regeneration of the periodontium, for example, while no longer considered experimental, remains an evolving technology requiring further research. Scope A selection of research topics appropriate for this PA is identified below. This list is illustrative and not exclusive, restrictive or in priority order. Investigators are encouraged to submit scientifically meritorious applications in any area of research responsive to the overall research objectives of this PA. Projects should be founded on a strong hypothesis as evidenced by preliminary data. Prior experience of the investigative team is an important element in demonstrating the likely success of the research proposed. o Molecular and Cellular Basis of Healthy Tissues Investigations that address the molecular and cellular characteristics of healthy oral tissues and their mechanisms for regeneration are central to understanding the goals of successful wound healing therapy. These studies include the role of cell adhesion molecules, isolation and characterization of tissue progenitor cells, normal gene expression in oral tissues, and molecular basis of homeostatic tissue cell replacement. In addition, studies of the influence of anatomical features, such as tooth root furcations, on proper healing of the oral tissues are needed. Investigations that identify cell lineages (e.g., cementoblasts) associated with periodontal wound healing are also appropriate. Also, studies that would advance an understanding of the molecular and cellular basis of periodontal guided tissue regeneration, as well as improve the methodology involved, are strongly encouraged. o Cytokines, Growth Factors, and Biological Response Modifiers Cytokines and polypeptide growth factors, including angiogenic growth factors and bone morphogenetic proteins, have been shown to regulate many of the processes involved in wound healing both in vitro and in animal models. The precise role of these factors in wound healing in the orofacial area requires further delineation. As some growth factors affect specific stages of healing and cell types in a temporal manner, it may be necessary to combine certain growth factors for complex wounds and to determine the optimal time for delivery of the factors. Furthermore, biological response modifiers that can control the activities of cytokines and growth factors need to be identified and characterized. The use of genetic therapies to deliver the genes for these proteins to the injured or defective sites represents an exciting contemporary approach for enhancing orofacial wound healing. o Biomaterials Development of new bone-derived, metallic, and synthetic materials for osseous reconstruction is central to the advancement of repair and regeneration of craniofacial and periodontal tissues. Moreover, the use of bone-inductive techniques with appropriate biodegradable and non-biodegradable scaffolding materials appears to offer new modalities for the treatment of congenital or acquired bone defects. Also, studies are needed to develop methods to evaluate the long-term performance of biomaterials, such as hydroxyapatite, ceramic, and coral implants, which are used in the repair of orofacial bone defects. Recent advances in the use of modified collagen matrices for the reconstruction of oral soft tissue, including the mucosal surfaces of the mouth, promise improved materials for soft tissue regeneration. Resorbable barrier materials, such as those used in guided tissue regeneration, are needed to prevent migration of tissues that interfere with structural and functional repair of the oral tissues. o Nutrition Wound healing is affected by a wide variety of metabolic and nutritional factors. Their effects on reparative and defense mechanisms are complex, additive and often synergistic. Studies are needed to determine the effects of nutritional factors on the regenerative process of oral tissues. Since metabolic and nutritional deficiencies can increase oral tissue susceptibility to injury and prolong the healing process, studies that will identify and establish effective treatment plans to prevent or correct the deficiencies are needed. o Aging, Systemic and Behavioral Conditions Studies are needed to clarify the mechanisms through which aging, systemic diseases (e.g., diabetes, Paget's disease), and behavioral practices (e.g., alcohol consumption, smoking) influence oral wound healing. Studies are also needed to develop improved means for promoting oral wound healing under such adverse conditions. o Radiation and Chemotherapy Radiation and chemotherapy have profound effects on the immune system, cell proliferation and tissue growth. These treatments appear to influence the healing process. Studies are therefore needed to define the effects of radiation and chemotherapy on, for example, production of cytokines and growth factors by oral tissues, the stability and integration of reconstructive biomaterials, and the molecular mechanisms involved in oral tissue damage. o Models of Oral Wounds The investigation of oral wound healing has been hampered by a lack of in vitro and suitable animal models. Furthermore, sensitive methods to quantify the histological, immunological, and biochemical events in the wound are needed. Models are needed in which it would be possible to study the effect of, for example, chronic inflammation, cytokines and growth factors, biomaterials, free radicals, aging, diabetes, or tobacco smoke on orofacial wound healing. The use of transgenic and gene knockout animals might provide important models for studying oral wound healing. o Technology Transfer and Clinical Application of Basic Science This PA encourages collaborative research efforts among clinicians, materials scientists, and basic scientists to transfer the knowledge gained in the laboratory to the clinical arena. Cooperative efforts between universities and for-profit as well as not-for-profit private organizations are encouraged in order to develop commercial applications that promote oral wound healing. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample site appropriate for the scientific objectives of the study. This information should be included in form PHS 398 (rev. 9/91) in items l-4 of the Research Plan and summarized in item 5, Human Subjects. Applicants are urged to carefully assess the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all such projects to include representation of the full array of United States racial, ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed or the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS-398 (rev. 9/91), which may be obtained 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 institution's office of sponsored research. To identify the application as a response to this PA, check "YES" on item 2a on the face page of the application and enter PA-94-031, "Wound Healing and Tissue Regeneration." Applications will be accepted at the standard application deadlines indicated in the application kits. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. A signed, typewritten original of the application, and five signed photocopies, in one package must be submitted to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by initial review groups of the Division of Research Grants, NIH, or by the review group of the relevant Institute in accordance with the standard NIH peer review procedures. Following scientific-technical review, applications will receive a second level review by the appropriate national advisory council or board. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that institute, center or division. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Mohandas Bhat, M.D.S, Dr.P.H. Director, Craniofacial Development and Disorders Program Telephone: (301) 594-7648 Matthew A. Kinnard, Ph.D. Director, Oral Soft Tissue Diseases and AIDS Program Telephone: (301) 594-7641 Dennis F. Mangan, Ph.D. Director, Periodontal Diseases Program Telephone: (301) 594-7641 Extramural Program National Institute of Dental Research Westwood Building Room 509 Bethesda, MD 20892 Direct inquiries regarding fiscal matters to: Ms. Theresa Ringler Grants Management Office National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization 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. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, MD 20816 From owner-sci-resources@net.bio.net Mon Feb 07 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 30 January 1994 Date: 4 Feb 1994 21:03:29 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 104 Approved: biosci-moderator@net.bio.net Message-ID: <2iv9b1$c1u@net.bio.net> This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF Bulletin December 1993, Volume 21, No. 4 File size (bytes): 37798 STIS Filename: bul9312 Document Type: General Publication Title: N S F RELOCATION IS FINALIZED File size (bytes): 832 STIS Filename: ldasltr Document Type: Program Guideline Title: Management of Technological Innovation 1993 Focus on Management of Innovation for Environmentally Conscious Manufacturing File size (bytes): 17344 STIS Filename: nsf9363 Title: NSF 94-5 - Networking Infrastructure for Education Supplements, New Projects and Planning Grants File size (bytes): 24405 STIS Filename: nsf945 Title: NSF Institute for Science Education File size (bytes): 15655 STIS Filename: nsf946 Document Type: Recruit Title: Staff Associate for the Inter-American Institute for Global Change Research File size (bytes): 5984 STIS Filename: iaistaff Document Type: Report Title: NSF 93-173 - The Multinational Coordinated Arabidopsis thaliana Genome Research Project - Progress Report- Year Three File size (bytes): 201032 STIS Filename: nsf93173 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 114004 STIS Filename: phnalpha Document Type: SRS Data Brief Title: DB 93-324 Academic R&D Spending Increased in FY 1992 File size (bytes): 316 STIS Filename: db93324 Also available: db93324.ps ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve db93324, the text of your message should be as follows: get db93324 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve db93324, you would enter: ftp> get db93324 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Fri Feb 11 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 6 February 1994 Date: 11 Feb 1994 23:23:53 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 113 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ji069$leh@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF February Bulletin Vol 21; No. 6 File size (bytes): 32051 STIS Filename: bul9402 Document Type: General Publication Title: NSF 94-10 Stis Users Guide File size (bytes): 58232 STIS Filename: nsf9410 Title: NSF 94-4 STIS Flyer File size (bytes): 4038 STIS Filename: nsf944 Also available: nsf944.ps Document Type: Letter Title: Current List of REU Sites File size (bytes): 49889 STIS Filename: reulist Document Type: Program Guideline Title: NSF 94-11-Cise Educational Infrastructure Program File size (bytes): 18172 STIS Filename: nsf9411 Title: NSF 94-9 - Graduate Research Traineeships, FY 1994 File size (bytes): 29004 STIS Filename: nsf949 Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 26789 STIS Filename: sesvac Title: Science Education Administrator (Associate Program Director) File size (bytes): 5232 STIS Filename: vex9410 Title: Program Assistant (Office Automation) File size (bytes): 5168 STIS Filename: vgs9433 Title: Senior Legislative Policy Analyst File size (bytes): 6383 STIS Filename: vgs9434 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 858 STIS Filename: cmpublic Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113768 STIS Filename: phnalpha ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnalpha, the text of your message should be as follows: get phnalpha Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnalpha, you would enter: ftp> get phnalpha WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Fri Feb 11 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 6, 11 Februrary 1994 Date: 11 Feb 1994 23:38:54 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1764 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ji12e$lt5@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940211 V23N06 P1O2 ************************************ X-comment: RFAs described: MH-94-007, DK-94-016, AI-94-012, AI-94-011 NIH GUIDE - Vol. 23, No. 6 - February 11, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FUNDING STRATEGIES FOR FY 94 National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** EARTHQUAKE DISASTER RELIEF National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** EXTRAMURAL ASSOCIATES DEVELOPMENT AWARD (RFA OD-94-002) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** NATIONAL MULTIPURPOSE RESEARCH AND TRAINING CENTERS National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, COMMUNICATIONS DISORDERS $$INDEX N5 ********************************************************** SUPPORT FOR MENTORED CAREER AWARDS (K20, K21) AND EXPEDITED REVIEW National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N6 ********************************************************** TIME-LABELED FETAL PRIMATE TISSUES AVAILABLE National Center for Research Resources INDEX: RESEARCH RESOURCES NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** CENTRAL LABORATORY FOR VIRAL ACTIVATION TRANSFUSION STUDY (RFP NHLBI- HB-94-11) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 ********************************************************** CLINICAL CENTERS FOR VIRAL ACTIVATION TRANSFUSION STUDY (RFP NHLBI-HB-94-12) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 05/06/94 ************************************************* RESEARCH TRANSITION GRANT PROGRAM IN CLINICAL MENTAL HEALTH SERVICES (RFA MH-94-007) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R4 05/20/94 ************************************************* RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM (RFA DK-94-016) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R5 06/21/94 ************************************************* AFFECTING GRAFT SURVIVAL WITH DONOR IMMUNE TISSUE (RFA AI-94-012) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R6 07/13/94 ************************************************* BASIC BIOLOGY OF IMMUNE RESPONSES FOR VACCINE RESEARCH (RFA AI-94-011) National Institute of Allergy and Infectious Diseases National Institute on Aging INDEX: ALLERGY, INFECTIOUS DISEASES; AGING ERRATA $$INDEX E1 ********************************************************** MINORITY DISSERTATION RESEARCH GRANTS IN AGING (RFA AG-94-004) National Institute on Aging INDEX: AGING $$INDEX E2 ********************************************************** PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS (RFA GM-94-004) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX E3 ********************************************************** APPLIED RESEARCH RELEVANT TO AN ELECTRONIC MEDICAL RECORD (RFA LM-94-002) National Library of Medicine Agency for Health Care Policy and Research INDEX: NATIONAL LIBRARY OF MEDICINE; HEALTH CARE POLICY $$INDEX E4 ********************************************************** OPERATION AND MAINTENANCE OF THE BIOLOGICAL DATA PROCESSING SYSTEM (RFP NCI-CM-57198-12) National Cancer Institute INDEX: CANCER This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ******************************************************** NOTICES $$N1 BEGIN ********************************************************** FUNDING STRATEGIES FOR FY 94 NIH GUIDE, Volume 23, Number 6, February 11, 1994 P.T. National Institutes of Health The information indicated below will guide the Institutes and Centers in their funding decisions on Research Project Grants (RPGs) in FY 94. Although these principles remain essentially the same as those for FY 1993, there are some changes. The changes include the fact that this year there is a distinction between principles and funding strategies. Section I, core principles, includes three statements that will be applicable for more than FY 94. On the other hand, funding strategies, which are detailed in Section II, may be changed from year to year depending on the appropriation level and associated Congressional directives. I. Core Principles 1. Grants will be awarded on the basis of reasonable and allowable costs, consonant with the principles of sound cost management and in consideration of Institute or Center (I/C) priorities, constraints on the growth of average grant costs, and the availability of funds. 2. The award of noncompeting research project grants at committed levels continues to be the cornerstone of the NIH Financial Management Plan and is the basis of the plan's credibility with the scientific community and Congress. 3. Determination of commitments for future years must take into consideration stability of support for investigators, optimum portfolio balance, and opportunities to address emerging problems. II. Fiscal Year 1994 Funding Strategies 1. For FY 1994 competing grants, the average increment for the subsequent noncompeting award may not exceed the direct cost level of the previous budget period by more than four percent. NIH staff may make exceptions for specifically justified programmatic requirements and one-time, non-recurring costs such as equipment. 2. Every effort will be made to accommodate shifts in the NIH fiscal situation. If conditions are such that funding at the committed levels is not possible, the I/Cs will consult with the Deputy Director for Extramural Research, NIH, to determine an appropriate resolution. 3. The average total cost of competing grants in the FY 1994 cohort will not increase by more than the Biomedical Research and Development Price Index (BRDPI) (4.19 percent) over the cohort of competing grants in FY 1993 (including special initiative small business grants - Small Business Innovative Research (SBIR)/Small Business Technology Transfer (STTR)). Given specific appropriation levels, some I/Cs may not be able to provide an increase consonant with the BRDPI. 4. When necessary, budgetary reductions from the requested level will be achieved through implementing a combination of initial review and Council/Board recommendations, staff review for cost allocability, allowability, and reasonableness, and programmatic adjustments to arrive at an appropriate funding level. 5. Based on adjustments to the project, I/C staff, in consultation with the principal investigator, will decide whether or not a new statement of specific aims is required. When reductions are 25 percent or more below the IRG recommended level, staff will obtain a revised statement of specific aims, a revised budget, and/or a revised timetable, as appropriate, for the project, which must be approved and countersigned by the institution and approved by program and grants management staff. To ensure initial review group understanding of the modified scope of a funded project, the approved statement of revised aims should be submitted by the investigator in competing continuation grant applications. 6. For competing continuation grants, one factor in arriving at the award amount will be the level of support in prior years and the extent to which the I/C can permit growth within the existing constraints on average costs. 7. The average length of research project grants will not exceed four years (excluding special initiative small business grants - SBIR/STTR). 8. In making funding decisions, I/Cs should factor in the total costs of a grant, especially at the margin of the funding plan. INQUIRIES For further information, contact the Grants Management Specialist or Health Scientist Administrator responsible for the grant. The names and telephone numbers are indicated on the Notice of Grant Award. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** EARTHQUAKE DISASTER RELIEF NIH GUIDE, Volume 23, Number 6, February 11, 1994 P.T. National Institutes of Health The National Institutes of Health wishes to inform grantees in the Los Angeles area who suffered recent earthquake damage or destruction of facilities, equipment, and/or supplies of the procedure to follow to seek public assistance to repair the damage. The Federal Emergency Management Agency (FEMA), Office of Emergency Services (OES) will accept such requests from public or private non-profit institutions and organizations. Requests must be submitted by institutional officials --- not by individual investigators --- following the instructions that will be provided by the OES. INQUIRIES Institutional Officials may contact: Mr. Charles Lilly Office of Emergency Services Federal Emergency Management Agency 150 East Colorado Boulevard Pasadena, CA 91101 Telephone: (818) 583-7747 Individuals who have already notified NIH staff of their damages are urged to make sure their institutional officials have initiated contact with the Federal Emergency Management Agency. For further clarification, contact: Dr. James F. O'Donnell Director, Office of Extramural Programs National Institutes of Health Building 31, Room 5B32 Bethesda, MD 20892 Telephone: (301) 402-0854 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** EXTRAMURAL ASSOCIATES DEVELOPMENT AWARD NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA: OD-94-002 P.T. National Institutes of Health Application Receipt Date: April 19, 1994 PURPOSE The Extramural Associates Program (EAP) is initiating a program to provide support to Extramural Associate (EA) Institutions with Extramural Associates who have participated in the NIH EA Program since 1991. The award will enable these institutions to establish or enhance an office of sponsored research and to provide for other research infrastructure needs. ELIGIBILITY Eligibility is limited to those domestic academic institutions that have a significant enrollment comprised of minorities (i.e., African Americans, Hispanics, Asians, Native Americans), or are women's colleges, and have a faculty member who participated in the NIH Extramural Associates Program since 1991. INQUIRIES Further information may be obtained from: Mr. Theodore W. Blakeney, Jr. Office of Extramural Programs National Institutes of Health Building 31, Room 5B38 Bethesda, MD 20892 Telephone: (301) 496-9728 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL MULTIPURPOSE RESEARCH AND TRAINING CENTERS NIH GUIDE, Volume 23, Number 6, February 11, 1994 P.T. National Institute on Deafness and Other Communication Disorders The National Institute on Deafness and Other Communication Disorders plans to issue a Request for Applications (RFA) for National Multipurpose Research and Training Centers (RTCs). These Centers are Congressionally mandated to include research, training, continuing education, and information dissemination in communication sciences and disorders. Both new and competing renewal applications are encouraged. The RFA will be issued within the next few months with a due date in October, 1994. INQUIRIES For further information, contact: Dr. Judith A. Cooper, Deputy Director National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite 400C Rockville, MD 20892 Telephone: (301) 496-5061 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** SUPPORT FOR MENTORED CAREER AWARDS (K20, K21) AND EXPEDITED REVIEW NIH GUIDE, Volume 23, Number 6, February 11, 1994 P.T. National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is interested in expanding the number of qualified researchers, especially clinicians, engaged in biomedical and behavioral drug abuse and addiction research. To this end, NIDA has set aside an additional $1.7 million for mentored career awards (K20, K21) in Fiscal Year 1994. These programs give promising, new investigators the opportunity to work with established researchers for a period of up to five years. To enhance the number of applications that will be considered during this fiscal year, all non-AIDS K20 and K21 application received by the June 1, 1994 deadline and assigned to the NIDA will be reviewed through an expedited initial review process. AIDS K20 and K21 applications received by the May 1, 1994 deadline will be reviewed on their normal schedule. In order to facilitate the expedited initial review of these non-AIDS applications, in addition to the copies sent to the Division of Research Grants, a copy of each application must be sent directly to: Ms. Eleanor Friedenberg Office of External Program Review National Institute on Drug Abuse 5600 Fisher's Lane, Room 10-42 Rockville, MD 20857 Both AIDS and non-AIDS K20 and K21 applications will be reviewed in order to permit the selection of applications for funding by the National Advisory Council on Drug Abuse in September and funding of applications by September 30, 1994. INQUIRIES For further information, contact: Timothy P. Condon, Ph.D. Office of Science Policy, Education, and Legislation National Institute on Drug Abuse 5600 Fisher's Lane, Room 10A55 Rockville, MD 20857 Telephone: (301) 443-6071 $$N5 END ************************************************************ $$N6 BEGIN ********************************************************** TIME-LABELED FETAL PRIMATE TISSUES AVAILABLE NIH GUIDE, Volume 23, Number 6, February 11, 1994 P.T. National Center for Research Resources A series of nonhuman primate fetuses (logtailed macaque, Macaca fascicularis) will be made available in the coming year allowing interested investigators to track cohorts of cells labeled on specific days of gestation through the full course of fetal development. Fetuses labeled with tritiated thymidine on days 42, 55, 70, and 90 of gestation will be taken at four or five intervals ranging from one week to six months after labeling. Other fetal age cohorts may be available in the future. INQUIRIES Investigators interested in receiving specimens or more information may contact: Dr. Anita Hendrickson University of Washington SM-20 Seattle, WA 98195 FAX: (206) 543-1524 e-mail: anitah@u.washington.edu This project is partially supported by NCRR/NIH through the Regional Primate Research Center at the University of Washington. $$N6 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NHLBI-HB-94-11 ******************************************* CENTRAL LABORATORY FOR VIRAL ACTIVATION TRANSFUSION STUDY NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFP AVAILABLE: NHLBI-HB-94-11 P.T. National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute issued Request for Proposals (RFP) NHLBI-HB-94-11, on January 28, 1994, and proposal will be due approximately eight weeks thereafter. It is anticipated that a three-year contract will be awarded on or about September 30, 1994. The contractor will serve as the Central Laboratory for a multicenter clinical trial designed to determine if viral activation in HIV-1 infected individuals is associated with blood transfusion. It is anticipated that approximately 330 patients will be tested and followed over a period of two years. The Principal Investigator must be on-site and have expertise in clinical pathology or transfusion medicine. Responsibilities of the central laboratory will include, but are not limited to, the following: (1) participate as a member of the Steering Committee in finalizing the details of the protocol and in completing the manual of operations; (2) develop procedures for the collection of blood samples and their processing, temporary storage and delivery to the Central Laboratory; (3) perform tests using the polymerase chain reaction (PCR) technology to quantitate the amount of CMV and HIV-1 present in peripheral blood mononuclear cells, quantitative culture of CMV and HIV-1 and other tests such as lymphocyte subsets and p24 relating to viral activation; (4) develop and implement collection procedures for the laboratory data; (5) utilize a computerized system to enter and edit the results from the blood tests and blind duplicates on a regular basis and transmit test results electronically to the Coordinating Center in an acceptable format; (6) assure standardization of all blood tests within the Central Laboratory and have an ongoing quality control program to assess and control within run and between run variability, accuracy, precision, and limits for each analyte; (7) store aliquots from each participating clinical center for the purpose of case-control or other special studies under conditions appropriate to prevent analyte degradation; and (8) contribute to the analysis and reporting of trial data. INQUIRIES Requests for copies of the RFP must include three self-addressed mailing labels and are to be directed to: Lynda A. Bindseil BDR Contracts Section National, Heart, Lung, and Blood Institute 7550 Wisconsin Avenue Federal Building, Room 610 Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN NHLBI-HB-94-12 ******************************************* CLINICAL CENTERS FOR VIRAL ACTIVATION TRANSFUSION STUDY NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFP AVAILABLE: NHLBI-HB-94-12 P.T. National Heart, Lung, and Blood Institute This study will determine if viral activation occurs following blood transfusion and if leukocyte depletion or irradiation can prevent it. It also will evaluate the role of donor leukocytes producing this activation by examining the effects of removing leukocytes by filtration or abolishing their ability to proliferate by gamma irradiation. Finally, the study will examine the persistence of donor lymphocytes after transfusion. The project will require a total of at least 330 HIV-1 infected patients with CD4 counts below 250 cells/mm3 prior to their transfusion. Each clinical center will be expected to recruit and follow at least 33 patients in accordance with protocol requirements. Responsibilities will include, but are not limited to, the following: (1) participate as a member of the Steering Committee in finalizing details of the protocol and in completing the manual of operations; (2) coordinate with a blood bank, the preparation and transfusion of blood products for the patients; (3) collect clinical data on each patient and perform regular physical exams on the patients; (4) collect blood samples from patients for testing by a centralized laboratory; (5) transmit scientific data to a medical coordinating center; (6) participate in all committee and any subcommittee meetings; and (7) participate in developing and writing scientific presentations and manuscripts for publication. It is anticipated that several awards will be made from this solicitation and that awards will be made on or about September 30, 1994. It is anticipated that the awards will be multiple-year cost reimbursement completion contracts with a term of three years. INQUIRIES RFP No. NHLBI-HB-94-12 was released on January 26, 1994. Requests for copies of the RFP must include three self-addressed mailing labels and are to be directed to: Lynda A. Bindseil BDR Contracts Section National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue Federal Building, Room 610 Bethesda, MD 20892 $$R2 END ************************************************************ $$R3 BEGIN MH-94-007 FULL-TEXT ************************************** RESEARCH TRANSITION GRANT PROGRAM IN CLINICAL MENTAL HEALTH SERVICES NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA AVAILABLE: MH-94-007 P.T. National Institute of Mental Health Application Receipt Date: May 6, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The purpose of this RFA is to stimulate the development of programs of clinical mental health services research at institutions that currently have strong programs in mental health clinical research, but are not engaged in extensive clinical mental health services research. A second goal of this RFA is to bring the expertise of mental health clinical researchers and general health services researchers into the clinical mental health services research field and to promote their collaborations with each other and with clinical mental health services researchers. The development of programs focusing on the special mental health services issues of the following populations are strongly encouraged: minorities; persons who are homeless; persons who live in rural areas; or persons with AIDS, who are HIV positive, or at risk of contracting the AIDS virus. 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, Research Transition Grant Program in Clinical Mental Health Services, is related to priority areas of alcohol and other drugs, mental health and mental disorders, and violent and abusive behaviors. 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 domestic public and private non- profit and for-profit organizations, including universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government except for those institutions with extensive, ongoing collaborations between clinical mental health investigators and mental health services researchers. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the resource-related research project (R24). The R24 mechanism is used to support research projects that will enhance the capability of resources to serve biomedical research. The Research Transition Grant Program (RTGP) will be used by the National Institute of Mental Health (NIMH) to enhance research capability and clinical mental health services research program. Each award will be limited to five years of funding and is nonrenewable. This RFA is a one-time solicitation. FUNDS AVAILABLE It is anticipated that at least $2.5 million in total costs will be made available so that a minimum of five awards can be made. Each award will have a maximum yearly total cost amount of $500,000. RESEARCH OBJECTIVES Background. The RTGP in Clinical Mental Health Services is part of an integrated NIMH approach to institutional infrastructure development made up of several types of grants including: NIMH Developing Clinical Research Centers, Research Infrastructure Support Program (RISP) grants, Child and Adolescent Mental Health Services Research Centers, and Social Work Research Development Center grants. Together these provide a continuum of research infrastructure support for institutions with varying levels and types of mental health research activity. The RTGP grants are designed to enable institutions with current programs in clinical mental health research to develop into major clinical mental health services research settings, thus increasing the number of investigators obtaining extramural funding for work in the services research field. Expansion of the nation's clinical mental health services research infrastructure is a major priority for NIMH because it is essential for improving the care received by adults (including the elderly), adolescents, and children who suffer from mental and emotional disorders, particularly the most severe disorders. Mental Health Services Research. The field of mental health services research examines the impact of the organization, financing, management, and delivery of mental health services on the quality, cost, access to, and outcomes of care. There are two major components of services research: service systems research and clinical services research. Service systems research focuses on questions related to the organization, financing, and integration of mental health services. Clinical mental health services research focuses on the process and quality of care and the effectiveness in community settings of clinical interventions whose efficacy has been demonstrated in controlled clinical research environments. This RFA seeks to enhance the clinical mental health services component of services research. SPECIAL REQUIREMENTS A central philosophical principle underlying this program is that different institutions will require different types and amounts of development in clinical services research. Therefore, this RFA does not prescribe in any detail the nature of the activities to be applied for or supported. The following types of support may be requested under this program: o Partial salary support for clinical mental health services research faculty, particularly women and minorities o Training expenses in clinical mental health services research, such as tuition remission or course fees, for junior clinical faculty o Research patient recruitment, diagnosis, assessment, and follow-up o Consultation from clinical mental health services research investigators o Biostatistical and data-base management o Small equipment and research instruments o Research technicians and assistants o Developmental, feasibility, and/or pilot studies STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). 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 Grants Management Branch, National Institute of Mental Health, 5600 Fishers Lane, Room 7C-05, Rockville, MD 20857, telephone 301/443-4414. The RFA number (MH-94-007) and the title, Research Transition Grant Program in Clinical Mental Health Services, must be typed in item 2a on the face page of the PHS 398 application form and the "YES" box must also be marked. Applicants must specify that the R24 mechanism is being used. Applicant institutions will need to demonstrate that they: (1) have a strong base of ongoing clinical mental health research activities; (2) need additional support to establish and maintain collaborative working relationships between clinical and services researchers; and (3) have the potential for building a mental health services research program that will equip them to compete effectively in future years for clinical mental health services research grants. The RFA label available in the PHS 398 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. All applications must be received by May 6, 1994 and will be reviewed in July. Applications received after the receipt date will be returned to the applicant without review. Submit, in one package, a signed original of the application, including the Checklist, and three signed copies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of the submission, two additional copies of the application must also be sent to: Wright Williamson, M.S.W. Division of Extramural Activities National Institute of Mental Health 5600 Fishers Lane, Room 9C-14 Rockville, MD 20857 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by an initial review group (IRG) convened by the NIMH and composed primarily of non-Federal scientific experts. Final review is by the appropriate National Advisory Council; review by Council may be based on policy considerations as well as scientific merit. By law, only applications recommended for consideration for funding by the Council may be supported. Summaries of IRG recommendations are sent to applicants as soon as possible following IRG review. Criteria to be considered in evaluating applications for scientific/technical merit are listed in the RFA. AWARD CRITERIA Awards will be made on or before September 30, 1994. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Ann A. Hohmann, Ph.D., M.P.H. Services Research Branch National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 For further information on grants management issues, applicants may contact: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants. Awards are made under authorization 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. This RFA is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100. $$R3 END ************************************************************ $$R4 BEGIN DK-94-016 FULL-TEXT ************************************** RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA AVAILABLE: DK-94-016 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: April 20, 1994 Application Receipt Date: May 20, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE This initiative invites grant applications for biomedical and health services research, using the United States Renal Data System (USRDS) database. 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, Research Using the United States Renal Data System, is related to the priority area 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 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 domestic and foreign organizations, both public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the investigator initiated research project grant (R01) mechanism. Each grant award will be capped at $100,000 total cost (including direct and indirect cost) per year for a maximum of two years. The responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The earliest possible award date will be April 1, 1995. FUNDS AVAILABLE For FY 1995, a total of $500,000 dollars has been committed to fund applications submitted in response to this RFA. Awarded funds will be used to obtain a data file from the USRDS Coordinating Center, and to support the independent analysis of the data file by the investigator. It is anticipated that approximately five awards will be made; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the award of grants pursuant to this RFA is also contingent upon the availability of funds designated for this purpose. RESEARCH OBJECTIVES The USRDS database contains information on 462,000 Medicare patients who have been treated for end stage renal disease (ESRD) therapy since 1976. For each patient, the database includes information on basic demographics, the primary medical diagnosis which led to renal failure, dialysis records, hospital records, and transplantation information. Applications proposing to investigate issues which impact on the morbidity, mortality, well being, or cost of treatment for treated ESRD patients will be considered responsive to this RFA. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by April 20, 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. The letter of intent is to be sent to the Chief, Review Branch, Division of Extramural Activities at the address listed under INQUIRIES. 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 is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91), available in the office of sponsored research at most academic or research institutions and 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. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Detailed instructions on submission procedures are described the RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIDDK in accordance with the usual NIH peer review procedures. Following review, the applications will be given a secondary review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant or held until the next regular receipt date and reviewed by the Division of Research Grants. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Camille A. Jones, M.D., M.P.H. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-06 Bethesda, MD 20892 Telephone: (301) 594-7586 FAX: (301) 594-7501 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 594-7543 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization 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. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN AI-94-012 FULL-TEXT ************************************** AFFECTING GRAFT SURVIVAL WITH DONOR IMMUNE TISSUE NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA AVAILABLE: AI-94-012 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 15, 1994 Application Receipt Date: June 21, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES" BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for basic, preclinical and clinical studies to increase knowledge of the interaction between donor and recipient immunocompetent cells. These studies have the potential to help develop protocols for enhancing solid organ graft survival by infusion of donor cells prior to or after transplantation. Information from these studies could lead to the use of donor tissue to manipulate the recipient's immune system in a controlled and specific fashion, thereby increasing graft survival and improving the management of autoimmune diseases. 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, Affecting Graft Survival With Donor Immune Tissue, is related to the priority areas of diabetes and chronic disabling diseases, and to immunization and infectious diseases. 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 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply for First Independent Research Support and Transition (FIRST) Awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and the FIRST Award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years; foreign awards may not exceed three years. FUNDS AVAILABLE The estimated funds available for the total (direct and indirect) first year costs of all awards made under this RFA will be $1,500,000. In Fiscal Year 1994, the NIAID plans to fund approximately seven R01s/R29s. Applications may not request more than four percent annual inflationary increases for future years. 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 NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Successful transplantation relies on the ability to transplant a solid organ without rejection while maintaining a normal immune response to infectious agents. With the exception of transplants between identical twins, the only way to accomplish this is to induce a specific non-responsive (tolerant) state, whereby the grafted tissue is ultimately not recognized as foreign. Donor specific transplant tolerance has been achieved for solid organ transplantation in animal models via induction regimens using donor immunocompetent tissue, e.g., bone marrow and peripheral blood. The application of those induction regimens to humans would be served best by understanding fully the basic immunological mechanisms involved and the role of the donor immune tissue in inducing and maintaining this tolerant state. Research Objectives and Scope The objective of this RFA is to support innovative new research to characterize the immunocompetent cells responsible for and the mechanisms by which donor immune tissue or cells enhance graft survival. This RFA will support basic, preclinical, and clinical studies aimed at characterizing the interaction between donor and recipient immunocompetent cells. These studies have the potential to help develop protocols for enhancing graft survival by using an infusion of donor lymphoid or dendritic cells prior to or after solid organ transplantation, either alone or in combination with other agents, to make the recipient non-responsive to the donor. Information from these studies could lead to the use of donor tissue to manipulate the recipient's immune system in a controlled and specific fashion. Applications should focus on identifying the donor and recipient cells involved in and the mechanisms responsible for induction and maintenance of donor-specific non-responsiveness in the transplant setting. Areas of particular interest to the NIAID are listed in the RFA. Animal models must be used in a way that is applicable to human transplants. Therefore, although studies using just the infusion of donor immunocompetent cells may be proposed, this type of study must be focused on understanding the basic mechanisms of transplant tolerance induction and maintenance. Knowledge generated by this research project must be applicable to human transplantation where an underlying immunosuppressive regimen is used. Therefore, studies proposing to use a monotherapy must also show that currently accepted standard immunosuppressive regimen is or is not deleterious to the induction of the tolerant state. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical research, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by April 15, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator (Program Director), and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID 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 Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). These application forms may be obtained from the institution's office for sponsored research or its equivalent, or 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. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "AFFECTING GRAFT SURVIVAL WITH DONOR IMMUNE TISSUE" must be typed in. Applications must be received by June 21, 1994. REVIEW CRITERIA The general criteria for applications are the review criteria used for traditional research project grant applications. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the RFA, as well as inquiries regarding programmatic issues, may be directed to: Stephen M. Rose, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A14 Bethesda, MD 20892 Telephone: (301) 496-5598 FAX: (301) 402-2571 Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and the five sets of appendices to: Olivia Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C19 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Barbara Huffman Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C26 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: April 15, 1994 Application Receipt Date: June 21, 1994 Scientific Review Date: October 1994 Advisory Council Date: February 1995 Earliest Award Date: April 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R5 END ************************************************************ $$R6 BEGIN AI-94-011 FULL-TEXT ************************************** BASIC BIOLOGY OF IMMUNE RESPONSES FOR VACCINE RESEARCH NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA AVAILABLE: AI-94-011 P.T. National Institute of Allergy and Infectious Diseases National Institute on Aging Letter of Intent Receipt Date: April 15, 1994 Application Receipt Date: July 13, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRES" BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) and the Biology of Aging Program (BAP) of the National Institute on Aging (NIA) invite applications for basic studies designed to elucidate key processes underlying immune responsiveness that will facilitate new and improved approaches to vaccination for infectious diseases other than AIDS. There is increasing need to develop methods for achieving protective immunity that depend on manipulating elements of the immune system (e.g., the order, concentrations, and delivery of cytokines). There are numerous examples of potential vaccines that are ineffective because of weak immunogenicity that could become effective vaccines if properly presented to a prepared or modulated immune system. This RFA is intended to spur the acquisition of knowledge necessary to efficaciously and safely modulate elements of the immune system leading to protective immunization against infectious diseases. 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, Basic Biology of Immune Responses for Vaccine Research, is related to the priority areas of diabetes and chronic disabling diseases, and to immunization and infectious diseases. 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 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanism of support will be the Program Project (P01) grant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for first year of support for all awards made under this RFA will be $3,000,000. In Fiscal Year 1995, the NIAID and the NIA plan to fund approximately four P01 awards. Applications may not request more than four percent annual inflationary increases for future years. Applications may not request budgets in excess of $750,000 total costs (direct and indirect) in the first year. An application with a first year requested amount in excess of the above will require written approval by senior NIAID and NIA officials via the program officers for acceptance of the application for processing. The usual PHS policies governing grants administration and management will apply. 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 NIAID and the NIA, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background The most effective procedure for managing human infectious diseases is preventive immunization (vaccination). Despite the remarkable successes of vaccination in eradicating smallpox and soon, poliomyelitis, and preventing illness and death of many millions of children, there remain many infectious diseases that have not yielded to vigorous attempts to develop vaccines. Furthermore, it is increasingly evident that successful vaccination of elderly humans is a special problem that needs to be addressed due to the declining competence of the immune system with age. The generation of protective immunity depends upon a responsive immune system. During the last 10 years, there has been a flood of new information in the field of immunology. Much has been learned about the mechanisms of defined, protein antigen processing and presentation of key epitopes in a manner that engenders effective immune responses. Yet, very little is known about the antigens of pathogenic microorganisms and how they could be presented to drive desired types of immune responses. Similarly, a great deal is known about subsets of T lymphocytes and the spectrum of cytokines each subset produces, as well as about B lymphocytes and their responses to cytokines. Yet, relatively little is known about the characteristics and generation of memory T and B cells, which are essential for long-lasting protective immunity. Moreover, the mechanisms responsible for the generation of cytotoxic T cells that are efficient in attacking and neutralizing cells in the body that are infected with viruses, bacteria and protozoa remain uncertain. Research Objectives and Scope The goal of this initiative is to further increase knowledge about the basic structures and functions of the immune system that lead to protective immunization against infectious diseases. HIV infection and its sequelae are not within the scope of this RFA. Examples of relevant research topics are provided below. However, the list of examples is neither complete nor restrictive: o Elucidation of the events and factors that lead to selective expression/expansion of morphologically and/or functionally distinguishable T cell subsets; o Studies on the phenotypic and functional stability of T cell subsets and control of the selective expression of cytokine genes by subsets of T cells; o The morphological and/or functional characteristics of memory B and T cells and clarification of mechanisms for generating specific memory cells; o Analysis of the roles played by different types and functional states of antigen processing/presenting cells and the cytokines they secrete in determining the major type of immune response, the effector mechanism expressed and/or isotypes of antibodies produced; and o Studies on the basic mechanisms that are affected by immunological adjuvants and examination of the immuno-enhancing properties of adjuvants All of the preceding examples represent central features of immune responses to antigens in general. However, they are particularly important, at present, in devising new approaches to vaccination against infectious, pathogenic organisms. Applications submitted in response to this RFA should focus on elucidating basic mechanisms that qualitatively and/or quantitatively enhance immune responses, both humoral and cell-mediated. Improved understanding of approaches to enhancing immune responses will be important not only to immunization of healthy, young adults but the elderly as well. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical research, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by April 15, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Program Director, the number and title of this RFA, and a list of the key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID 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 Dr. Mark Rohrbaugh at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 09/91). These application forms may be obtained from the institution's office for sponsored research or its equivalent and 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. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "Basic Biology of Immune Response for Vaccine Research" must be typed in. Applications must be received by July 13, 1994. REVIEW CRITERIA The general criteria for P01 applications are those review criteria used for traditional research project grant applications. For P01 grant applications, additional review criteria are used, which are outlined in the NIAID information brochure on Program Project Grants and Multiproject Cooperative Agreements. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct requests for the RFA and the information brochure, as well as inquires regarding programmatic issues to: M. Michele Hogan, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A22 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7551 FAX: (301) 402-2571 Anna M. McCormick, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and the five sets of appendices to: Mark Rohrbaugh, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C22 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8424 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Jeffrey Carow Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 6003 Executive Boulevard Bethesda, MD 20892 $$XID NIHGUIDE 19940211 V23N06 P2O2 ************************************ Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: April 15, 1994 Application Receipt Date: July 13, 1994 Scientific Review Date: October 1994 Advisory Council Date: February 1995 Earliest Award Date: April 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research and No. 93.866 - Aging Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R6 END ************************************************************ ERRATA $$E1 BEGIN R3 19940114 APPEND RFA AG-94-004 BOTH *********************** MINORITY DISSERTATION RESEARCH GRANTS IN AGING NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA: AG-94-004 P.T. 34, FF; K.W. 0710010, 0710030 National Institute on Aging Application Receipt Date: March 18, 1994 The following correction is issued for RFA AG-94-004, which was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 2, January 14, 1994. ELIGIBILITY The applicant investigator applying for a dissertation research grant must be a member of an ethnic or racial minority group enrolled in an accredited doctoral degree program in the biomedical, social, or behavioral sciences and must have approval of the dissertation topic by a named dissertation committee or other formal group for that purpose. The student must also be conducting or intending to conduct dissertation research on aging or problems related to aging. Research topics should fit within one or more of the areas described below for each individual program (see INQUIRIES). $$E1 END ************************************************************ $$E2 BEGIN R13 19940107 APPEND RFA GM-94-004 FULL ********************** PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA: GM-94-004 P.T. 22, FF; K.W. 0720005 National Institute of General Medical Sciences Application Receipt Date: April 27, 1994 The January 7, 1994 issue of the NIH Guide for Grants and Contracts (Vol. 23, No. 1) published a Request for Applications for Predoctoral Fellowship Awards for Minority Students (RFA GM-94-004). Reference was made in that publication to a suggested format for institutional certification to be found at the end of the text. The following is that suggested format. SUGGESTED FORMAT FOR INSTITUTIONAL CERTIFICATION: PREDOCTORAL FELLOWSHIP AWARDS FOR MINORITY STUDENTS INSTITUTIONAL CERTIFICATION This is to certify that (FILL IN APPLICANT NAME) who submitted an application for an NIH Predoctoral Fellowship Award for Minority Students is: (1) currently enrolled in a Ph.D. or combined M.D./Ph.D. (or other combined professional doctorate/research Ph.D.) degree program in the biomedical sciences at this institution, or has been accepted by and agreed to enroll in such a program during the 1994-95 academic year; (2) an underrepresented minority student, i.e., belonging to a particular ethnic or racial group that has been determined by our institution to be underrepresented in biomedical or behavioral research in the U.S. OPTIONAL. This individual is a member of the (PLEASE CIRCLE ONE) Black, Hispanic, Native American, Pacific Islander, or other racial/ethnic group. (3) a U.S. citizen, non-citizen national, or permanent resident. Signature and Title of the Graduate Program Director. Signature and Title of the Authorized University Official. $$E2 END ************************************************************ $$E3 BEGIN R3 19940204 APPEND RFA LM-94-002 BOTH *********************** APPLIED RESEARCH RELEVANT TO AN ELECTRONIC MEDICAL RECORD NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA: LM-94-002 P.T. 34; K.W. 0710078, 0730045 National Library of Medicine Agency for Health Care Policy and Research Letter of Intent Receipt Date: March 28, 1994 Application Receipt Date: April 27, 1994 The Applied Research Relevant to an Electronic Medical Record RFA (LM-94-002), published in the NIH Guide for Grants and Contracts, Volume 23, Number 5, February 4, 1994, invited applications for cooperative agreements for applied research and development projects relevant to the development of an electronic medical record system (EMRS). The purpose of this amendment is to revise the Notice of Availability of the RFA and the RFA as follows: In the Notice of Availability, the following areas are revised: In the heading section at the top of the Notice, insert "Agency for Health Care Policy and Research" under the National Library of Medicine because AHCPR is a co-sponsor of the RFA. Under APPLICATION PROCEDURES, the first sentence of the sixth paragraph is revised to read: "Applications must be received by April 27, 1994." Under REVIEW CONSIDERATIONS, the third bullet in the third paragraph listing factors to be used in judging applications is revised to read: "compliance with the requirements noted in the SPECIAL REQUIREMENTS section of this RFA". In the RFA, the following areas are revised: In the heading section at the top of the Notice, insert "Agency for Health Care Policy and Research" under the National Library of Medicine because AHCPR is a co-sponsor of the RFA. Under RESEARCH OBJECTIVES, the third paragraph under Objectives and Scope on AHCPR areas of interest in applications is revised to read: "The AHCPR has particular interest in applications that address improvements in delivery of health services through the use of an EMRS. Such topics include, but are not limited to: o incorporation of guidelines, decision aids, expert systems, and reminder systems o use of EMRS data for multiple purposes including patient care, payment, research, utilization review, assessment of quality of care, outcome analysis, and planning o database development o security/confidentiality/privacy issues o behavioral, interface, and other issues related to user acceptance o accessing data and information sources o multi-media options o storage, transmission, and retrieval of images o cost/benefit evaluations o shareability and standards, including content, data-exchange, and vocabulary issues o transmission of EMRS data among institutions to improve patient care". Under APPLICATION PROCEDURES, the first sentence of the sixth paragraph is revised to read: "Applications must be received by April 27, 1994." Under REVIEW CONSIDERATIONS, the third bullet in the fourth paragraph listing factors to be used in judging applications is revised to read: "compliance with the requirements noted in the SPECIAL REQUIREMENTS section of this RFA". Under AWARD CRITERIA, the third paragraph is revised to read: "Applicants should be aware that in addition to scientific/technical merit, consideration will be given to program priorities, program balance, and total cost of the proposal when staff, the Board of Regents of NLM, and the National Advisory Council of AHCPR make their funding recommendations." INQUIRIES For further information regarding these revisions and for copies of the corrected RFA, direct inquiries to: Milton Corn, M.D. Division of Extramural Programs National Library of Medicine Building 38A, Room 5N505 Bethesda, MD 20894 Telephone: (301) 496-4621 FAX: (301) 402-0421 E-mail: corn@lhc.nlm.nih.gov James McAllister, M.P.H. Center for General Health Service Extramural Research Agency for Health Care Policy and Research 2101 E. Jefferson Street, Suite 501 Rockville, MD 20852 Telephone: (301) 594-1439 FAX: (301) 594-2155 E-mail: jmcallis@po3.ahcpr.gov $$E3 END ************************************************************ $$E4 BEGIN R3 19940121 APPEND RFA NCI-CM-57198-12 BOTH ***************** OPERATION AND MAINTENANCE OF THE BIOLOGICAL DATA PROCESSING SYSTEM NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFP AVAILABLE: NCI-CM-57198-12 P.T. National Cancer Institute This is an amendment to the synopsis published in the daily CBD on January 5, 1994 and the NIH Guide for Grants and Contracts Vol. 23, No. 3, January 21, 1994. Offerors should note that this solicitation is a total small business set-aside under the Standard Industrial Classification (SIC) code 7379. The small business size standard is $14.5M. See Note (s):1. RFP No. NCI-CM-57198 will be issued on or about February 4, 1994 and proposals will be due approximately March 21, 1994. Copies of the RFP may be obtained by sending a written request to: Joyce A. Crooke Research Contracts Branch, TCS National Cancer Institute Executive Plaza South, Room 603 Bethesda, MD 20892 Telephone: (301) 496-8620 No collect calls will be accepted. $$E4 END ************************************************************ From owner-sci-resources@net.bio.net Fri Feb 11 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-94-016 - V23(06) 02/11/94 Date: 11 Feb 1994 23:39:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 427 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ji12k$ltc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DK94016 DK-94-016 P1O1 *************************************** RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA: DK-94-016 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: April 20, 1994 Application Receipt Date: May 20, 1994 PURPOSE The purpose of this initiative is to invite grant applications for biomedical research questions that can be answered using the United States Renal Data System (USRDS) database. Awarded funds will be used to generate a tailored data file through the USRDS Coordinating Center, and to support the independent analysis of the data file by the investigator. 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), Research Using the United States Renal Data System, is related to the priority area 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 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 domestic and foreign organizations, both public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the investigator initiated research project grant (R01) mechanism. Each grant award will be capped at $100,000 total cost (including direct and indirect cost) per year for a maximum of two years. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. The earliest possible award date will be April 1, 1995. FUNDS AVAILABLE It is anticipated that approximately five awards will be made; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the award of grants pursuant to this RFA is also contingent upon the availability of funds designated for this purpose. A total of $500,000 dollars have been set aside for this RFA in FY 1995. RESEARCH OBJECTIVES The number of patients being treated for End-stage renal disease (ESRD) in the United States has increased steadily since 1977. The total number of U.S. patients with treated ESRD was over 210,000 in 1990. End-stage renal disease treatment is costly. The 1990 estimated federal Medicare payments for ESRD patients averaged $36,600 per patient. The estimated total 1990 direct medical payments for ESRD by public and private payers was $7.26 billion. ESRD is a very serious condition, with high hospitalization rates and death rates. Thus, research to decrease the morbidity and mortality due to ESRD is urgently needed. The USRDS is a database with information on treated end stage renal disease patients and their treatment facilities in the United States. It is designed to serve as a resource to the academic and clinical medicine communities. The database contains information on approximately 462,000 Medicare patients who have had ESRD therapy at any time since 1976, including basic demographics, the primary medical diagnosis that led to renal failure, dialysis records, hospital records, and transplant information. For patients included in any of the USRDS special data collection studies, the specially collected information can be linked with their master file. In addition to patient-specific information, the database contains details on the 2,646 institutions that provide ESRD treatment services. Limited information is also available on non-Medicare funded ESRD patients who are being treated by the Department of Veterans Affairs. The USRDS database is supplemented by data from the U.S. Census Bureau. All release of data will be in compliance with the U.S. Privacy Act of 1974, and other relevant legislation. This information on patients may be supplied in encrypted form, so that identification of individuals is precluded. In addition, investigators seeking to use the data must supply written assurances that they will not use the data to attempt to identify individuals. Since 1989, the USRDS Coordinating Center has produced an annual data report which contains descriptive and analytic epidemiologic data on ESRD patients. The USRDS database has been very successful in providing data on several important issues in the biomedical research and clinical nephrology community. However, there are many other important questions that could be posed, and there is a multitude of data that can be analyzed. The purpose of this RFA is to solicit applications from investigators to pose and answer important biomedical and health research questions relevant to ESRD in the United States. Specific questions that would be considered responsive to this RFA include, but are not limited to, the following examples: o the relative incidence, prevalence, mortality, morbidity, and survival associated with various co-morbid conditions, causes of ESRD, modes of ESRD treatment, or subgroups of the treated ESRD population in the United States; o examination of the relative burden of disease in various minority groups; o ecologic analyses that relate prevalence of predisposing diseases to incidence and prevalence of treated and untreated ESRD in various subgroups of the population. o Analyses combining a biomedical research question and a health services research question. Creativity in using the data to develop descriptive, analytic, and hypothesis generating studies is encouraged. Applications proposing to investigate issues with a large impact on the health, well being, morbidity and mortality of treated ESRD patients will be considered responsive to this RFA. Investigators are urged to become familiar with the structure and data elements currently contained in the USRDS database, including data elements from relevant special studies. This information (including data dictionary, structure of the database, special studies data collection instruments) can be obtained from the Director, Epidemiology Program, Division of Kidney, Urologic and Hematologic Diseases, NIDDK, (301) 594-7586 (see INQUIRIES Section below). In addition, copies of the USRDS Annual Data Reports may be useful. The United States Renal Data System Annual Data Reports may usually be found in dialysis units, nephrology department libraries, and medical libraries; a copy of the 1993 Annual Data Report can be ordered through the National Technical Information Service (703) 487-4600, order number PB 93 202 786, for $77. The USRDS data release policy includes the following provisions: The sole purpose of providing the data is the conduct of legitimate biomedical and health services research by the Principal Investigator (PI). The investigator will not use the data to identify individual persons or institutions represented on the file. The investigator will not combine or link the data provided with any other collection or source of information that may contain information specific to individuals on the file, unless specific, written authorization has been obtained through the approval process. The investigator will not use the data for purposes that are not related to biomedical or health services research. The investigator will not publish or otherwise disclose the data in the file to any person unless the data have been aggregated (that is, combined into groupings of data such that the data are no longer specific to any individual within each grouping) and no cells (aggregates of data) contain information on fewer than 10 individuals. A copy of any aggregation of data intended for publication will be submitted to the USRDS Project Officer for review prior to publication; if the publication is not in conformity with the Privacy Act, it will not be published until revised to adhere to the Privacy Act provisions. Appropriate administrative, technical, procedural, and physical safeguards shall be established by the investigator to protect the confidentiality of the data and to prevent unauthorized access to it. The safeguards will provide a level of security outlined in OMB Circular No. A-130, Appendix III-- "Security of Federal Automated Information Systems," which sets forth guidelines for security plans for automated information systems in Federal agencies. The investigator is encouraged to contact Dr. Camille Jones (301-594-7586) or the USRDS Project Officer, Dr. Lawrence Agodoa (301-594-7553) to discuss the data request and to request a copy of the USRDS Data Release Policy and the USRDS Agreement for Data Release Form. Both may be reached via mail at the following address: KUH/NIDDK, Westwood Building, Room 3A-06, 5333 Westbard Avenue, Bethesda, MD 20892. The USRDS database Coordinating Center may also be contacted for information about the database (313-998-6610). The official request to the USRDS for USRDS data can be submitted at any time and must be done separately from submitting an application to the NIH in response to this RFA. If the only way that the investigator will be able to do the analysis is with funding from this RFA, the investigator should submit the request for USRDS data after the application has been approved. The USRDS process of reviewing a written request for data and generating and releasing the data takes approximately three months. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations; i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention and preventive strategies, diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned without review. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by April 20, 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. The letter of intent is to be sent to the Chief, Review Branch, Division of Extramural Activities at the address listed under INQUIRIES. 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 is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The form is available from most institutional offices of sponsored research and 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. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. 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 check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact 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 copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by May 20, 1994. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 and as a component project of a program project. 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 previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. If the application is not responsive to the RFA, NIDDK staff will return it to the applicant. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further review if they are not competitive for the award. The NIDDK will notify the