From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-098 - V26(29) 08/29/97 Date: 2 Sep 1997 14:39:35 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 413 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui12n$kqu@net.bio.net> NNTP-Posting-Host: net.bio.net AUTOIMMUNITY: GENETICS, MECHANISMS, AND SIGNALING NIH Guide, Volume 26, Number 29, August 29, 1997 PA NUMBER: PA-97-098 P.T. National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis, Musculoskeletal and Skin Diseases National Institute on Aging Office of Research on Women's Health, NIH PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA), and the Office of Research on Women's Health, National Institutes of Health (NIH) invite applications for new and innovative investigator-initiated basic and preclinical research into the immune responses underlying autoimmune disease and its regulation for preventive or therapeutic purposes. Three specific areas of emphasis are highlighted: 1) genetic susceptibility for autoimmune disease, including the MHC and other genetic loci; 2) role and regulation of co-stimulation of T cells in autoimmunity; and 3) signal transduction in the autoreactive response. 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, "AUTOIMMUNITY: GENETICS, MECHANISMS, AND SIGNALING" related to the priority area of Diabetes and Chronic Disabling Diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by for profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Domestic and foreign institutions are eligible to apply for R01 grants. Foreign institutions are not eligible for FIRST awards (R29). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISMS OF SUPPORT Traditional research project grant (R01) AND FIRST award (R29) applications may be submitted in response to this announcement. Applications for R01 grants may request up to five (5) years of support; applications for R29 grants must request five years of support. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES Background Autoimmune diseases result when the immune response is directed at the body's own tissues. Autoreactive immune responses may be initiated in response to either exogenous (from outside the body, such as a pathogen) or endogenous (from inside the body) antigens in the context of a genetic background susceptible to autoimmunity. Antigen is processed and presented to the T cell, whose response can be affected by the availability of co-stimulatory ligand-receptor interaction(s). The interaction of antigen with the T cell in the context of co-stimulatory signals results in activation of various signal transduction pathways (see below). In addition, the environment of this interaction, including cytokines present, amount and character of antigen present and co-stimulatory molecules, can affect the type of response and its intensity. Autoimmune diseases are more common in families. More than one gene is thought to underlie this genetic susceptibility with one of the important genetic loci being the Major Histocompatibility Complex locus. Marked progress in mapping areas of genetic susceptibility has been made for some diseases, including insulin dependent diabetes mellitus and systemic lupus erythematosus. For these two diseases, several of the susceptibility genes map to overlapping regions of the chromosome suggesting that the same or similar genes may be involved in the development of these different diseases. The fine mapping and identification of the genes should allow the evaluation of the functional consequences of their gene products. Evaluation of the interaction of multiple genes and the environment in the development of the autoimmune phenotype can follow. Further understanding of this process in the development of autoreactive responses could lead to novel approaches for the prevention or therapy of autoimmune diseases. Increasingly, basic research has emphasized the importance of more than one signal for the activation of T cells. The antigen-T cell receptor complex is primary, but equally, the presence or absence of other signals, called co-stimulation, can direct the interaction to the development of tolerance rather than activation. Blockade of the co-stimulatory signal has prevented the development of disease in animal models of multiple sclerosis, insulin dependent diabetes mellitus, and systemic lupus erythematosus. Recently, investigation of this path in ongoing autoimmune disease suggests that these molecules may be important in the perpetuation of the autoreactive response. The number of these co-stimulatory signals which have been identified is growing rapidly, initially including the B-7 family, and now expanded to include the CD40-CD40L family. With further understanding of the mechanisms, these molecules could be exploited to modulate the initiation or progression of autoimmune disease. Finally, much progress has been made in defining the intracellular and extracellular signaling pathways that mediate the consequences of the immune response after interaction of antigen and the immune system. These include the secretion of cytokines, production of cytotoxic T cells, activation of phosphoprotein signaling cascades, activation or repression of transcription factors, activation of cell death pathways, including apoptosis, and inflammatory cascades. The final common pathways of damage include release of proteases, nitric oxide and superoxide production, antigen-antibody complexes, and cytokines. Further understanding of these pathways in the development and regulation of the response to autoantigens and in mediating autoimmune disease may allow development of effective and innovative therapies for autoimmune disease. NIA has responsibility for supporting basic research and training in fundamental studies of immunology that relate to aging. Research Objectives and Scope The objective of this PA is to encourage the application of advances in basic immunology to understanding the pathogenesis and regulation of the immune response to self antigens, focusing specifically on genetic susceptibility, including the interaction of genes, role of co-stimulation of immune cells, mechanism of induction, perpetuation, and tissue injury in the autoreactive response. Further understanding of the pathogenic and regulatory processes of the autoreactive immune response should lead to new approaches for the prevention or treatment of autoimmune diseases. Examples of topics of research interest include, but are not limited to: o characterization of loci of genetic susceptibility to autoimmune disease, including overlapping loci for multiple diseases; characterization of the genes in these loci and their products, including the functional role of these genes; o mechanisms and interactions by which genes influence the susceptibility to development of autoimmune disease; o characterization of the role of co-stimulatory molecules in the response to self antigens; o identification of regulators (agonists and antagonists) of co- stimulatory molecules in the autoreactive response; o the role of apoptosis in the pathogenesis of autoimmunity and autoimmune disease; o the role of STAT proteins in the autoreactive immune response; potential for regulation of this response; and o characterization of cytokine expression and regulation in response to self antigens INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". The PA number and the PA title must also be typed in section 2. The completed, signed original and five (5) legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) R29 applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic (research scope and eligibility) issues may be directed to: Elaine Collier, M.D. Division of Allergy, Immunology, and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A20 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: ec5x@nih.gov Joan T. Harmon, Ph.D. Chief, Diabetes Research Section National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8808 FAX: (301) 480-3503 Email: JOAN_HARMON@NIH.GOV Susana Serrate-Sztein, M.D. Arthritis Branch National Institute of Arthritis, Musculoskeletal and Skin Diseases Natcher Bldg. Rm 5AS37G Telephone (301) 594-5032 FAX: (301) 480-4543 Internet: szteins@ep.niams.nih.gov Anna M. McCormick, Ph.D. Chief, Biology Branch Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Internet: am38k@nih.gov Direct inquiries regarding fiscal matters to: Mrs. Pam Fleming Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B30 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: pf49e@nih.gov Linda Stecklein Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6As-49J Bethesda, MD 20892-6600 Telephone: (301) 594-8847 FAX: (301)480-3504 Email: steckleinl@ep.niddk.nih.gov Ms. Carol Fitzpatrick Grants Management Branch NIAMS, NIH Natcher Bldg. Rm 5AS43K Telephone: (301) 594-3506 FAX: (301) 480-4543 Internet: fitzpatric@ep.niams.nih.gov Mr. Joseph Ellis Grants Management Officer Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Internet: je14j@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citations are No. 93.855 - Immunology, Allergy, and Transplantation Research, No. 93.847 - Diabetes, Endocrinology, and Metabolic Diseases, No. 93.846 - Arthritis, Musculoskeletal and Skin Diseases, and No. 93.366 - Aging Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourage all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the EPA and PHS missions to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-103 - V26(29) 08/29/97 Date: 2 Sep 1997 14:40:50 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 276 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui152$l2a@net.bio.net> NNTP-Posting-Host: net.bio.net PILOT CLINICAL TRIAL GRANT FOR NEUROLOGICAL DISEASE NIH Guide, Volume 26, Number 29, August 29, 1997 PA NUMBER: PAR-97-103 P.T. National Institute of Neurological Disorders and Stroke PURPOSE The NINDS is committed to identifying effective treatments for neurological disorders by supporting well-executed clinical trials. Before proceeding to a full-scale clinical trial, pilot clinical studies are often required. The NINDS announces its interest in supporting pilot studies required to obtain necessary information to clearly establish the clinical basis for proceeding to a full-scale trial. The purpose of NINDS Pilot Clinical Trial Grant For Neurological Disease is to obtain preliminary data and conduct studies to support the rationale for a subsequent full-scale clinical trial of an intervention to treat or prevent neurological disease. 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, NINDS PILOT CLINICAL TRIAL GRANT FOR NEUROLOGICAL DISEASE, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202- 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanism of support for the NINDS Pilot Clinical Trial Grant is the research project grant (R01). It is expected that most grants will not exceed $350,000 per year in direct costs for 3 years. RESEARCH OBJECTIVES The research project should directly address how the Pilot Grant will advance the design of a subsequent full-scale clinical trial. The application should also address the intrinsic scientific merit of the study conducted under the Pilot Grant, whether or not a full-scale trial is performed. The NINDS Pilot Clinical Trial Grant may include: -Studies to refine the intervention strategy (dosage, duration, delivery system) -Studies to define and refine the target population -Collection of preliminary data for establishing measures of efficacy and safety In preparing for the definitive clinical trial, a pilot study will address questions that are formulated to optimize the design of the eventual trial rather than address the clinical question with lower power. The objective of the NINDS Pilot Clinical Trial Grant is to increase the quality of clinical research to evaluate interventions for the treatment or prevention of neurological disease. To meet this objective the proposed pilot study must successfully incorporate creative and realistic solutions to difficult problems in clinical neurological research for the particular intervention being evaluated. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 28, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. As with most applications to NIH, the research plan is limited to 25 pages. All information for review of the NINDS Clinical Trial Planning Grant application must be included in the body of the application; appendices will not be considered during the review for this mechanism. The completed original application and four legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892 BETHESDA, MD 20817 (for express/courier service) In order to facilitate the review of applications assigned to the NINDS, the applicant should, at the same time, mail or deliver one copy of the application to: Dr. Lillian Pubols Chief, Scientific Review Branch NINDS, NIH Federal Building, Room 9C10 7550 Wisconsin Avenue Bethesda, Maryland 20892-9175 EMAIL: lp28e@nih.gov REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. For applications given primary assignment to the National Institute of Neurological Disorders and Stroke, the initial peer review group will be convened by the Institute. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria for research grant applications: The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score. (1) Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? In addition, the following must be addressed: - The state of equipoise in the medical and patient communities - The scientific basis for the proposed intervention including discussion of current practice and alternative interventions - Impact of the proposed intervention on health care and quality of life (2) Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? The following should be addressed: (a) Study Design and Procedures. - Sequence of clinical studies, including the proposed pilot study, that will produce a definitive clinical trial - Translation of the clinical question into statistical hypotheses - Selection of outcome measure(s) - Inclusion and exclusion criteria - Secondary questions (including capacity for post hoc analyses) - Detailed protocol with standardized procedures that will be used for this pilot study - Ethical and safety issues, and quality control procedures - Necessity for randomization and masking (b)Data Analysis - Specific methods to be used for data analysis - The sample size for the pilot study may not be adequate to detect any but the largest treatment differences; however, the data from this study should provide a basis for providing sample size estimates for future trials. - Population and demographics of the clinical condition (3) Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? The following should be addressed: - Training and expertise in the clinical problem and the proposed intervention - Training and expertise in clinical trials (5) Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research will be reviewed. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that IC. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Joseph S. Drage, M.D. Training and Special Programs Officer, National Institute of Neurological Disorders and Stroke Telephone: (301) 496-4188 FAX: 301-402-0302 Email: jd66x@nih.gov Direct inquiries regarding fiscal matters to: Ms. Angeline Wilson Grants Management Branch National Institute of Neurological Disorders and Stroke Telephone: (301) 496-9231 FAX: 301-402-0219 Email: aw45j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.853. 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-102 - V26(29) 08/29/97 Date: 2 Sep 1997 14:40:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 248 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui14l$l1a@net.bio.net> NNTP-Posting-Host: net.bio.net NINDS CLINICAL TRIAL PLANNING GRANT NIH Guide, Volume 26, Number 29, August 29, 1997 PA NUMBER: PAR-97-102 P.T. National Institute of Neurological Disorders and Stroke PURPOSE The NINDS seeks to fund high quality clinical trials to evaluate treatments for neurological disorders. The NINDS Clinical Trial Planning Grant allows for early peer review of the rationale and design for clinical trials of treatments for neurological disorders and provides support for the development of a detailed clinical trial research plan, including a complete manual of operations and procedures. 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, THE NINDS CLINICAL TRIAL PLANNING GRANT, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202- 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanism of support will be the Developmental Planning Grant (R21), which will provide up to $150,000 in direct costs for a single year. The award cannot be renewed. RESEARCH OBJECTIVES The NINDS encourages clinical research to evaluate interventions to treat and prevent neurological disease. The NINDS has established the Clinical Trial Planning Grant because extensive efforts are required to develop a detailed study protocol and to organize an effective research group. After the basic design and rationale for a neurological treatment trial has been reviewed, the NINDS Clinical Trial Planning Grant supports the development of specific elements which will be essential to conducting a successful full-scale clinical trial, including adequate plans for recruitment of patients, experimental design and protocols, data management, analytical techniques, facilities, administrative procedures, and collaborative arrangements. Detailed information regarding the rationale of the clinical trial, based on adequate, preclinical science and preliminary clinical research, must be developed prior to submission and included in the application for a Clinical Trial Planning Grant. The purpose of the planning grant is not to obtain preliminary data or to conduct studies to support the rationale for the clinical trial. The expected product of the planning grant is a detailed clinical trial research plan including a complete manual of operations and procedures. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 28, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. As with most applications to NIH, the research plan is limited to 25 pages. All information for review of the NINDS Clinical Trial Planning Grant application must be included in the body of the application; appendices will not be considered during the review for this mechanism. The completed original application and four legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892 BETHESDA, MD 20817 (for express/courier service) In order to facilitate the review of applications assigned to the NINDS, the applicant should, at the same time, mail or deliver one copy of the application to: Dr. Lillian Pubols Chief, Scientific Review Branch NINDS, NIH Federal Building, Room 9C10 7550 Wisconsin Avenue Bethesda, Maryland 20892-9175 EMAIL: lp28e@nih.gov REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria: All applications will be reviewed using the criteria below: (1) Rationale. The background and significance of the application must address the rationale for a future, full-scale, randomized clinical trial (RCT) including: - reasons for selection of intervention and mode of delivery including specific details such as dose or a particular procedure; - the biological mechanisms and clinical data that support conducting an RCT; - information adequate to determine the significance and need to perform an RCT; - compelling need to proceed with an RCT as soon as possible; impact on health care; - competitive therapies--advantages and disadvantages; - ethical issues surrounding an RCT and the disease under study; - a clear statement of the question that an RCT would address. (2) Experimental Design. The application for a planning grant will include a full description of the experimental design of the future RCT, including: - translation of the clinical question into a statistical hypothesis; - sample size and duration of the RCT; - endpoint(s) and data to be collected; - randomization, masking, and inclusion/exclusion criteria; - the strengths and weaknesses of the proposed methods, and possible alternatives; - ancillary therapies - capability to develop methods for standardization of procedures for data management and quality control. (3) Plans to Address Patient Recruitment/Retention. The application must address the following items: - plans for documenting the availability of the requisite eligible- patient pool; - plans for including women and minority individuals as trial participants - and plans for recruitment outreach, as appropriate; follow-up procedures to ensure collection of data at stated intervals. (4) Investigators. The application must include a clear statement of the leadership and proposed organization of the RCT, including: - identification of a principal investigator, and for multi-center trials, a core of potential center investigators; - professional training and experience of the RCT organizers in such areas as the clinical problem under study, administration of complex projects, and study design. - inclusion of statisticians, data managers and study coordinators; - plans to add or drop centers; essential committee structure, i.e., Planning, Steering, Executive. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that IC. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Joseph S. Drage, M.D. Training and Special Programs Officer, National Institute of Neurological Disorders and Stroke Telephone: (301) 496-4188 FAX: 301-402-0302 Email: jd66x@nih.gov Direct inquiries regarding fiscal matters to: Ms. Angeline Wilson Grants Management Branch National Institute of Neurological Disorders and Stroke Telephone: (301) 496-9231 FAX: 301-402-0219 Email: aw45j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.853. 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA ES-97-004 - V26(29) 08/29/97 Date: 2 Sep 1997 14:39:22 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 871 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui12a$kpm@net.bio.net> NNTP-Posting-Host: net.bio.net CENTERS FOR CHILDREN'S ENVIRONMENTAL HEALTH AND DISEASE PREVENTION RESEARCH NIH Guide, Volume 26, Number 29, August 29, 1997 RFA: ES-97-004 P.T. National Institute of Environmental Health Sciences U.S. Environmental Protection Agency, National Center for Environmental Research and Quality Assurance Letter of Intent Receipt Date: September 30, 1997 Application Receipt Date: January 21, 1998 PURPOSE The National Institute of Environmental Health Sciences (NIEHS), the Environmental Protection Agency (EPA) and the National Center for Environmental Health, Centers for Disease Control and Prevention (CDC), share the common objective of fostering research that will ultimately reduce the extent of adverse human health effects occurring as a consequence of exposure to hazardous environmental agents. The agencies recognize that these health impacts can be particularly detrimental for children due to pronounced differences in nature and extent of environmental exposure as well as in functional development when compared to adults. A Federal Executive Order of April 21, 1997, "Protection of Children from Environmental Health Risks and Safety Risks," charges agencies to consider special environmental risks to children in their activities. Accordingly, NIEHS and EPA invite grant applications for Centers that will develop multidisciplinary basic and applied research in combination with community-based prevention research projects to support studies on the causes and mechanisms of children's disorders having an environmental etiology, identify relevant environmental exposures, intervene to reduce hazardous exposures and their adverse health effects, and eventually decrease the prevalence, morbidity, and mortality of environmentally related childhood diseases. The purpose of awards in this program of Centers for Children's Environmental Health and Disease Prevention Research is to: Provide for multidisciplinary interactions among basic, clinical, and behavioral scientists interested in establishing outstanding, state- of-the-art research programs addressing environmental contributions to children's health and disease. Support a coordinated program of research/prevention Centers pursuing high quality research in environmental aspects of children's disease, with the ultimate goal of facilitating and accelerating translation of basic science knowledge into clinical applications or intervention strategies that can be used to reduce the incidence of environmentally related childhood disease. Develop fully coordinated programs that incorporate exposure assessment and health effects research with development and validation of risk management and health prevention strategies. Establish a national network that fosters communication, innovation, and research excellence with the ultimate goal of reducing the burden of morbidity among children as a result of exposure to harmful environmental agents. The long-range goal of this program is to promote translation of basic research findings into applied intervention and prevention methods, thereby enhancing awareness among children, their families, and health care practitioners regarding detection, treatment, and prevention of environmentally related diseases and health conditions. Each application is to be designed around a central scientific theme, specifically examining the role of environmental agents in one of the following research foci: (1) children's respiratory disease; (2) childhood learning; (3) growth and development (see Research Scope below). A minimum of two (2) basic biomedical research projects and one (1) community-based intervention research component must be proposed within each Center (see Description of a Center below). 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), "Centers for Children's Environmental Health and Disease Prevention Research," is related to the priority area of Environmental Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). THE EPA CHILDREN'S ENVIRONMENTAL HEALTH INITIATIVE The EPA recognizes that children's environmental health issues are a top priority and must become a central focus of the agency's efforts. This RFA is a component of the agency's overall initiative that, together with the efforts of partner agencies, will ensure that children receive the protection they need and deserve and help our nation fulfill its obligation to protect future generations. Potential applicants may obtain a copy of the EPA's national agenda to protect children's health from environmental threats (EPA 175- F-96-001) from the EPA program contact listed under INQUIRIES. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit organizations, public and private, that meet the requirements stated in this RFA. Minority individuals, persons with disabilities, and women are encouraged to apply as Principal Investigators. The need for communication and interaction among awarded sites dictates that only domestic institutions in the United States will be eligible for these Center grant awards. MECHANISM OF SUPPORT The funding mechanisms to be used to assist the scientific community in participating in this grant program will be those of: 1) the National Institutes of Health (NIH) Specialized Center (P50); or 2) the Environmental Protection Agency's Office of Research and Development, administered in accordance with 40 CFR Part 30 and 40. Policies that govern grant award programs of each agency will prevail for respective sources of support. Support of grants pursuant to this RFA is contingent upon receipt of a sufficient number of applications of high scientific merit and of appropriated funds for this purpose. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will also vary within the funding limits available (see Description of a Center). The maximum award will be $1 million in direct costs in the first and all subsequent years. Funding in subsequent years is contingent upon satisfactory progress during the preceding year and availability of funds. The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is August, 1998. FUNDS AVAILABLE Although this solicitation is included in fiscal plans of EPA and NIEHS for FY 1998, support for these Center grants is contingent upon availability of funds for this purpose. It is anticipated that an estimated total of $10 million, including direct and indirect costs, will be available for the first year of the program, which will support up to six Centers in FY 1998. It is expected that NIEHS and EPA may solicit additional new Specialized Center applications through subsequent issuance of a similar RFA addressing children's environmental health. RESEARCH OBJECTIVES Background Establishment by NIEHS and EPA of Centers for Children's Environmental Health and Disease Prevention Research recognizes the unique vulnerability of children to hazardous environmental exposures. The greater susceptibility of children to such exposures is likely related to changes in organ system growth as well as developmental and metabolic capacities that adjust during childhood. For example, lung surface area increases tenfold and gas exchange areas increases more than twenty-fold from birth to adulthood. Since many xenobiotics are absorbed through the alveolar epithelium, the lung represents a particularly sensitive organ. Moreover, the diets of children and their unique behavioral patterns such as crawling and hand-to-mouth activities augment the probability of certain exposures. In the past, standards regulating exposure to environmental health threats have been, in some cases, based on research and assessment of risks to adults. Often, the knowledge base to ensure that standards are protective of infants and children has not been adequate. Because children have very different metabolic, physiologic, and developmental processes, diets, and exposure patterns than adults, their health outcomes can differ drastically. There is a clear need for additional research that can more fully incorporate children's unique traits into risk assessment paradigms. Environmentally related childhood diseases represent an enormous public health problem. For example, asthma, the most common chronic childhood illness, afflicts nearly five million children and is the leading cause of children's emergency room use, hospital admission, and school absences. From 1982 to 1993, the prevalence, morbidity, and age-adjusted mortality rates for asthma increased significantly despite improvements in asthma diagnosis and management and improved understanding of the biology and immunology of the disease. The mortality rate attributed to asthma for children five to fourteen years of age has doubled since 1980 and is highest among African- American children, who are three times more likely than Caucasian children to die of this illness. Chronic asthma in children is highly associated with chronic respiratory disease in adulthood and has a huge health, societal, and economic impact. Approximately 20% of the 76.7 million children in the United States live in poverty. Children who live in these impoverished communities are exposed to multiple indoor and outdoor environmental pollutants at disproportionately high levels. Preambulatory and crawling children spend significant time indoors and are subjected to high levels of allergens found in carpeting, bedding, upholstered furniture, and house dust. Indoor pollution levels may also depend on heating sources, use of household chemicals, parental smoking habits, and the presence of nearby industrial or waste facilities, which may result in increased amounts of polycyclic aromatic hydrocarbons, volatile organic compounds, and particulates. In addition, it is estimated that 20-60% of children between one and five years of age are exposed to unsafe levels of organophosphate pesticides. Exposure to such agents may occur in both indoor living space and outdoor play areas. There is thus a particular need to address environmental health problems of children living in socioeconomically disadvantaged or medically underserved communities. The current initiative is intended to foster advancement in children's health through enhancing our understanding of basic disease mechanisms and promoting community-based prevention activities related to children's respiratory disorders, childhood learning, and growth and development. Collaborative, multidisciplinary research approaches are required to explore the dynamic interaction of children with their environment. This Center program therefore emphasizes integration of basic laboratory science with applied intervention strategies. Because the latter are also research projects, it is important to note that each intervention research project should include appropriate methodology for assessing its effectiveness (see 'Description of a Center' below). Centers are expected to have fully coordinated programs that incorporate exposure assessment and health effects research with development and validation of risk management and health prevention strategies. Moreover, involvement of the affected community in planning, implementing, and evaluating an intervention effort is essential. Community-based prevention/intervention research not only expands our understanding of the causes and remedies of environmentally related disorders, but also enhances the capacity of communities to participate in processes that shape research and intervention approaches. By bridging gaps between basic and applied researchers and between institutional researchers and community members, this program aims to improve our knowledge regarding detection, treatment, and prevention of environmentally related diseases in children. Research Scope and Objectives Centers for Children's Environmental Health and Disease Prevention Research are research-based Center grants designed to support interactive groups of research projects and core service facilities. Research activities included in these Center grants must comprise, by definition, a multidisciplinary approach to biomedical problems addressing one or more of the specific research topic areas announced in this RFA (see below). A Center should identify a central theme or focus of its research effort so that the subprojects involved are responsive to one or more of the specific research areas of children's environmental health supported by this grant program. Furthermore, the translational objective of this program requires that one of the subprojects consist of a community-based intervention. The following is the list of specific research topics that will be considered to be responsive, for purposes of the current RFA, to the research mission areas of EPA and NIEHS. These topics identify areas where research at the basic/applied interface is essential to potential development of new approaches that can be used for detection, prevention, treatment, and effective management of environmentally related childhood disorders. Respiratory Diseases Particulate and gaseous pollutants and volatile organic compounds, when inspired, can lead to inflammation of the airways and development of a spectrum of respiratory and systemic disturbances and diseases. This is especially true in the case of environmental agents, or their metabolic products, which have the capacity to access alveolar spaces and to diffuse or be transported into the blood stream. Such compounds may then exert adverse health effects at systemic target organs. The principal objective of research in this focus area is to understand the mechanisms of respiratory disease in children, including asthma, chronic obstructive pulmonary diseases, and allergy associated with chemical and biological environmental exposures. Additional research is needed to examine mechanisms of tissue damage, including that produced by reactive oxygen species generated as a result of exposure to environmental oxidants. These oxidants include ozone, nitrogen dioxide, and particulate matter. By virtue of their greater physical activity out-of-doors when pollution levels may be high, children may experience higher exposures to these hazards than adults. In response to such pollutant exposure, epithelial cells in the lung synthesize and release a variety of potent mediators that can contribute to a local inflammatory reaction and play a role in pathogenesis of respiratory disturbances. It is important to understand the basic mechanisms by which pollutants alter the inflammatory response in airways, resulting in airway hyperactivity, IgE antibody production, and asthma. It is equally important to address other mechanisms of lung dysfunction, including compromise of immunologic responsiveness and modulations of receptor signaling pathways. Childhood Learning Exposure to a number of common environmental contaminants, such as lead, polychlorinated biphenyls (PCBs), and mercury, may inhibit intellectual development in children and ultimately result in behavioral problems. For example, PCBs and their heat degradation products have long half-lives, cross the placenta, and are excreted in breast milk. Prenatal exposure to PCBs can cause significant developmental toxicities in animals. Children are more susceptible to PCB-induced toxic effects than adults, and these effects are more severe and influence more organ systems in children than in adults. These effects may persist throughout a child's lifespan, while in an adult only a portion of the lifespan may be affected. Continued research on toxic effects associated with low level developmental exposure to these contaminants is needed. Enhancing our understanding of the pathways by which these contaminants exert their toxic action may result in development of more effective interventions. Effects of intrauterine exposure to environmental hazards are of interest, including changes that occur in maternal biokinetics during pregnancy and determinants of placental transport and fetal accumulation of toxicants. Additional effort should also be focused on defining how such contaminants modify intellectual and behavioral development, especially in areas such as hyperactivity and learning disabilities. Alterations in cognitive and behavioral function due to exposure to such agents as metals, solvents, and pesticides have to date received little systematic attention. For the purposes of this RFA, research focusing exclusively on lead poisoning in children will be considered nonresponsive. Growth and Development In utero or postnatal exposure to a variety of environmental agents can have a profound influence on initial growth and development. One such area that merits research attention in both basic and applied science is sexual development. Endocrine-disrupting chemicals may affect a number of physiological processes, including onset of menses and puberty. Moreover, exposures during early windows of vulnerability may carry risks for later onset of adult diseases. For example, children susceptible to effects of air pollution have reduced lung development, leading to smaller lung capacity in adulthood; this difference may in turn have important ramifications for adult respiratory morbidity and mortality. It is also important to expand our understanding of the potential role of environmental factors in the etiology of birth defects. Parental exposure to organic solvents, agricultural chemicals, or heavy metals may increase the risk of having a child with a neural tube defect. For all of these research areas, attention should be given to mechanistic studies of toxicity. It is also desirable that exposure assessment research be included, where appropriate. Furthermore, it is important to evaluate the contribution of genetic heterogeneity to the disease process. Information on individual variability with respect to chemical sensitivity and metabolism of xenobiotic agents has a significant role in defining disease onset and progression. Asthma susceptibility, for example, is known to run in families. Identification of asthma susceptibility genes, which might interact with environmental factors to contribute to the rising incidence of this disease, would hold significant promise for designing new prevention and treatment approaches. Prospective applicants are strongly encouraged to discuss potential program relevancy issues as well as application preparation with the program staff contact cited under INQUIRIES in this RFA. Applicants should note that the research scope of this RFA does not include any long-term (longer than five years) studies. Description of a Center A Specialized Center provides the opportunity for investigators to engage in interdisciplinary and collaborative research directed toward a specific focus in children's environmental health. It is required that each Center include community-based intervention research as well as basic studies clearly related to a disease or dysfunction. The foundation of the intervention should be strongly linked to the basic science research. The basic science studies should be driven by the needs of the intervention project. Thus, a Center should have a central theme to which all research projects pertain. In addition, a Center may include core units to provide services to the various research projects and to support the organizational and administrative aspects of the program. Applications that include only basic or only intervention/ prevention research will not be responsive to this RFA. The minimal requirements for a Specialized Center of Research in Children's Environmental Health are as follows: Each Center will propose an overall research mission and plan that are responsive to the objectives of the Specialized Center Program set forth in the RFA (see Research Objectives above). Each Center will support at least two basic research projects that thematically address one or more research areas listed under Research Scope. Potential basic research projects should include mechanistic studies of environmental agents which contribute to adverse health outcomes in children. These may include: basic cellular and molecular mechanisms of toxicity; pathophysiology; epidemiology; and individual susceptibility. These basic research projects should be linked to the intervention research project described below. Interactions between investigators responsible for basic research and intervention research projects are expected to strengthen the research, enhance transfer of fundamental findings to an applied setting, and identify new research directions. [It is anticipated that a Center will devote 30-45% of its budget to basic research projects.] Each Center will support one project that develops, implements, and evaluates a community-based intervention/prevention program. Activities conducted under this RFA should be consistent with Federal Executive Order No. 12988 entitled, "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations." To the extent practicable and permitted by law, grantees shall make achieving environmental justice part of their project's mission by identifying and addressing, as appropriate, disproportionately high and adverse human health effects of environmental contaminants on minority, low-income, and medically underserved children, including African, Hispanic, Asian, and Native Americans. It is strongly encouraged that basic science projects be in a similar scientific area as the intervention research project in order to facilitate transfer of information from laboratory to the community. This project may take the form of a primary, secondary, or tertiary prevention. It is important to note that this project must specifically address all of the following parameters: (a) scientific basis of the proposed research and the hypothesis to be tested; (b) sample size needed, power considerations, procedures for sample selection, and recruitment and retention of a study population; (c) detailed description of a research design for the proposed intervention; (d) measurement instruments and their reliability and validity, considering both process and outcome evaluation; (e) data management and analysis methods; (f) identification and description of target community and known environmental health hazards; (g) means of establishing effective interaction and collaboration with community members. Because this project is intended to be community-based, the application must demonstrate a specific, existing linkage to a community-based organization and specific involvement of community members in development, conduct, and interpretation of the intervention. NIEHS, EPA, and CDC recognize that local health departments often play an important role in delivering public health services to the community. Therefore, applicants are also encouraged to consider including local, county, or state health departments in the proposed intervention research project. However, involvement of a local health department will not substitute for the required community- based organization. Applications lacking a demonstrable linkage to a community-based organization will be considered nonresponsive. [It is anticipated that a Center will devote 20-30% of its budget to one community-based intervention research project.] Each Center may support facility cores that provide a technique, service, or instrumentation that will enhance ongoing research efforts. Examples of such facilities are animal resources, cell/tissue culture, pathology, biostatistics, molecular biology, analytical chemistry, exposure assessment, etc. Budgeted Center projects as well as research projects external to the Center may have access to facility cores. The application should provide a total operational budget for each facility core together with the percentage of support requested from the Center grant. In addition, the Center must have in place and adequately described in the application management policies which ensure that budgeted Center projects are given highest priority in receiving services provided by the facility core. The application should explain the organization and proposed mode of operation of each core, including a plan for usage, priority setting, allocation of resources, and any applicable chargeback system. [It is anticipated that a Center will devote 10-20% of its budget to facility cores.] An administrative core unit which provides overall oversight, coordination, and integration of Center activities. An External Advisory Committee to the Center Director must be established. This group should consist of a group of three (3) to five (5) scientists, having expertise appropriate for the Center's research focus, plus one (1) representative from a community-based organization involved in community-based intervention research. Representation from a state or local health department is also encouraged. At least 67% of Committee members should be from outside the grantee institution. The membership of the advisory committee must be approved by the funding agency. The function of this Committee is to assist in evaluating the merit, value, and contribution of research projects; the relevance and importance of individual organizational elements to accomplishing the overall goals of the Center; and the effectiveness of the newly recruited Center scientist program. [It is anticipated that a Center will devote 10-15% of its budget to an administrative core.] To attract new investigators into children's environmental health research, each Center is encouraged to partially support up to two (2) newly recruited Center scientists. Up to $70,000 per year, direct cost, may be used for each newly recruited Center scientist to provide up to 75% salary support, technical support, equipment, and supplies. The duration of support as a newly recruited scientist is limited to two (2) years. Following termination of support as a newly recruited Center scientist, such an individual may, if appropriate, become or continue to be a part of a basic or community- based intervention research project and make use of Center facilities. Recruitment of women and underrepresented minority scientists is specifically encouraged. To the extent possible, the types of individuals sought and their expected roles should be described in the application if specific individuals have not been identified. [It is anticipated that a Center will devote no more than 14% of its budget to recruitment of new scientists.] SPECIAL REQUIREMENTS Annual meetings, to be held in Washington, DC or Research Triangle Park, NC, are planned for the exchange of information among investigators. Applicants must budget travel costs associated with these meetings in their applications. In addition, since these Centers include a community-based intervention, applicants are expected to maximize opportunities for information exchange between institutional researchers and community members. As part of this program, applicants must generate a report that describes community input, program implementation, and relevant findings. This report must be produced at least annually and distributed among community members in such a way that it can be easily comprehended by the public. Applicants must budget for production and dissemination of such reports. This requirement is intended to establish a minimal level of communication among project participants; additional, more frequent dissemination efforts may be appropriate. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS The NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) requires that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. Grantees, regardless of funding source, will be expected to adhere to this policy. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy >From the program staff listed under INQUIRIES. Program staff may also provide further discussion concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 30, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows EPA and NIEHS staff to estimate potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ethel Jackson, DDS, Chief, Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-24 Research Triangle Park, NC 27709 APPLICATION PROCEDURES Content of Applications A response to this RFA should consist of an application that includes a detailed description of a Specialized Center of Research in Children's Environmental Health consisting of at least two individual basic research projects, a community-based intervention research project, an administrative core, up to two newly recruited Center scientists, and, if applicable, one or more facility cores. The proposed research plan should present the applicant's perception of the Center's organization and component functions. This plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment in organizing a multiproject research infrastructure for conducting basic and applied studies in children's environmental health sciences. The research plan for the Center and all component projects must address the "Research Scope" described earlier. The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these awards. Application kits are available at most institutional offices of sponsored research or may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. For individual projects or cores, page limits stated in the PHS 398 instructions must be followed. The overall Center application must also use the PHS 398 format to provide at the beginning of the application an overall summary of the Center's organization and cumulative aggregate budgeting for various research subprojects and cores. All information essential for evaluation of the application must appear in the body of the application rather than in an appendix. If IRB or IACUC review is unavoidably delayed beyond submission of the application, a follow-up IRB certification and/or IACUC verification from an official signing for the applicant organization must be sent to and received by the Scientific Review Administrator of the Special Emphasis Panel by March 2, 1998. If IRB certification and/or IACUC verification is not received by March 2, 1998, the application will be considered incomplete and returned to the applicant. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title, Centers for Children's Environmental Health and Disease Prevention Research, and number, RFA ES-97-004, must be typed on line 2 of the face page of the application form and the YES box must be checked. To simplify administration of this joint NIEHS/EPA initiative, submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ethel Jackson, DDS Chief, Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-24 111 T.W. Alexander Drive, EC-24 Research Triangle Park, NC 27709 Research Triangle Park, NC 27709 (for express/courier service) Applications must be received by January 21, 1998. Schedule The following is the schedule planned for this initiative. It should be noted that this schedule may be changed without notification due to factors that were unanticipated at the time of announcement. Please contact the program official listed below regarding any changes in the schedule. Letter of Intent Receipt Date: September 30, 1997 Application Receipt Date: January 21, 1998 Initial Review Group Peer Review: March 1998 NAEHS Council/NCERQA Review: May 1998 Earliest Award Date: August 1, 1998 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness to the RFA by NIEHS and EPA Staff. Incomplete applications will be returned to the applicant without further consideration. Any application that does not meet the minimum requirements as set forth in the 'Description of a Center' section of this RFA will be considered unresponsive to the RFA and returned to the applicant. This includes, but is not limited to, an evaluation by EPA and NIEHS Staff of the program relevancy of the proposed basic research and intervention research subprojects. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS and the EPA. This initial review group will function according to PHS policy, utilizing the review criteria stated below. As part of the initial merit review, a triage process may be used in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to this RFA. Applications determined to be noncompetitive by the review committee will be withdrawn from further consideration, and the principal investigator will receive a summary statement reflecting the reviewers' evaluation. Applications judged to be competitive will be further discussed and assigned a priority score. Applications recommended for funding will then receive a second level review by both EPA's National Center for Environmental Research and Quality Assurance (NCERQA) and NIEHS's National Advisory Environmental Health Sciences Council (NAEHSC). Review Criteria Evaluation of applications will be based upon the following: 1. Research Plan Scientific and technical merit of each proposed basic research project, including originality, feasibility, innovation, and adequacy of experimental design. Scientific and technical merit of the proposed intervention research study, including the extent of community sanction, interaction, and participation. Extent to which the design demonstrates sensitivity to cultural and socioeconomic factors in the community. Demonstration of effective communication channels between institutional researchers and community members. Plans for useful and practical dissemination of findings within the affected community. Adequacy of statistical and analytical methods, data management, and process and outcome evaluation measures. Integration of basic and intervention research into a coherent enterprise with adequate plans for interaction and communication of information and concepts among investigators. Cohesiveness and multidisciplinary scope of the Center as a whole. Degree of interrelationships, collaboration, and synergism of research that might be expected to derive from Center support. Coordination and interdependence of individual projects and their capacity to result in a greater contribution to the overall goals of the Center than if each were pursued independently. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for recruitment and retention of subjects will also be evaluated. (See INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS.) Appropriateness of policies to ensure the protection of human subjects and the humane care and use of laboratory animals. 2. Personnel Scientific, administrative, and leadership abilities of the Principal Investigator and other key participants, particularly, but not exclusively, in the area of the proposed research. The Principal Investigator should be an established research scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the Center. A minimum time commitment of 25% is expected for this individual. Documented commitment of time by key personnel for the proposed studies. Procedures established for recruitment and evaluation of new Center scientists. Evidence of efforts to develop novel mechanisms for recruiting candidates among women and underrepresented minority investigators. Potential of new Center Scientists to become independent investigators in clinical, basic, or intervention research in children's environmental health. 3. Facilities and Management Adequacy of administrative and technical capabilities to conduct the research proposed. Scientific and organizational structure of the Center, including adequacy of arrangements for external review. Nature and quality of facility cores. Technical merit, justification, cost effectiveness, qualifications of staff, utility to investigators, and arrangements for internal quality control, allocation of resources, priority of usage, and day-to-day management. Adequacy of animal facilities and appropriateness of animal care management where animal work is proposed. Adequacy of clinical facilities and appropriateness of patient care management where clinical work is proposed. As appropriate, access to inpatient and outpatient children's health care units providing adequate numbers of patients for intervention research projects that require patient participation. [Applications from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting proposed research. In such a case, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application.] Institutional assurance to provide support to the Center in such areas as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting. 4. Budgeting Appropriateness of the proposed budget and duration in relation to proposed research. AWARD CRITERIA The anticipated date of award is August, 1998. Approved applications will be considered for award based on scientific and technical merit; program balance; and availability of funds. Funding will be provided to each Center by a single award from either EPA or NIEHS or a combination of two separate awards. Administrative and budgetary policies of EPA and NIEHS will apply to these awards. In order to receive funding, an individual domestic institution's application for a Specialized Center grant must have three or more related, interactive, and high quality research subprojects that provide a multidisciplinary, yet thematic, approach to the problems to be investigated. At least one of the subprojects must be a community-based intervention. Awards will not be made for applications with research activities focused exclusively on intervention research or exclusively on basic research or for applications or components thereof proposing long-term epidemiological or large-scale clinical trial research. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Allen Dearry, Ph.D. Chemical Exposures and Molecular Biology Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-21 Research Triangle Park, NC 27709 Telephone: 919/541-4500 FAX: 919/541-2843 Email: dearry@niehs.nih.gov Christopher Saint, Ph.D. Assistant Center Director National Center for Environmental Research and Quality Assurance U.S. Environmental Protection Agency 401 M Street, SW (8723R) Washington, DC 20460 Telephone: 202/564-6909 FAX: 202/565-2448 Email: saint.chris@epamail.epa.gov Direct inquiries regarding fiscal matters to: Mr. David Mineo Chief, Grants Management Branch Division of Extramural Research and Training National Institute of Environmental Health Science P.O. Box 12233, EC-22 Research Triangle Park, NC 27709 Telephone: 919/541-1373 FAX: 919/541-2860 Email: mineo@niehs.nih.gov Mr. Jack Puzak Deputy Director National Center for Environmental Research and Quality Assurance U.S. Environmental Protection Agency 401 M Street, SW (8701R) Washington, DC 20460 Telephone: 202/564-6825 FAX: 202/565-2444 Email: puzak.jack@epamail.epa.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 66.500, 93.113, 93.114 and 93.115. Awards by NIEHS are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 100-607) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. EPA awards are made under the authority of 40 CFR Part 30 and 40. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS and EPA strongly encourage all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the EPA and PHS missions to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-97-003 - V26(29) 08/29/97 Date: 2 Sep 1997 14:39:06 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 833 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui11q$kkh@net.bio.net> NNTP-Posting-Host: net.bio.net ADOLESCENTS AND STD COOPERATIVE RESEARCH CENTER NIH Guide, Volume 26, Number 29, August 29, 1997 RFA: AI-97-003 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: October 15, 1997 Application Receipt Date: January 8, 1998 PURPOSE The purpose of this Request for Applications (RFA) is to stimulate multi-disciplinary, collaborative research to further understanding of sexually transmitted diseases (STDs) in adolescent populations and to develop and evaluate effective approaches to their prevention and control. The Sexually Transmitted Diseases Branch of the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites grant applications for an Adolescents and Sexually Transmitted Diseases Cooperative Research Center (STD CRC). The STD CRC will provide a multi- disciplinary approach to STD research by bridging biomedical, clinical, behavioral, and epidemiological research; will foster interaction among STD investigators; and will facilitate intervention-oriented research. 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, Adolescents and Sexually Transmitted Diseases Cooperative Research Center (STD CRC), is related to the priority areas of STDs and AIDS. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications will be limited to domestic institutions but may include an international component. Applications may be submitted by domestic for-profit and non-profit research institutions; public and private organizations, such as universities, colleges, hospitals, laboratories, units of State or local governments; and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U19), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total requested project period for applications submitted in response to this RFA may not exceed 5 years. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. The anticipated award date is August 1, 1998. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $1.2 million. In Fiscal Year 1998, the NIAID plans to fund one Adolescents and STD CRC. The final number of awards to be made is dependent upon the availability of funds. The initial year's total costs, including direct and indirect costs, should not exceed $1.2 million for each award. 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, 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 In 1995, an estimated 14 million cases of STDs occurred in the United States. Approximately 65% occurred in people under 24 years of age; three million occurred in teenagers. Associated health care costs exceeded $ 8 billion. Because of infections acquired during adolescence, women and their infants bear a disproportionate share of disease burden and long term sequelae of STDs, including infertility, ectopic pregnancy, cervical cancer , fetal wastage, low birth weight, and congenital/perinatal infection. Additionally, STDs disproportionately impact the health of some minority populations. Both the incidence of STDs and their long-term and potentially fatal sequelae are consistently higher among African and Hispanic Americans than among white Americans. o Chlamydial infection is the most prevalent bacterial STD in the U.S. and a major cause of pelvic inflammatory disease (PID); over four million cases are diagnosed annually. In virtually all studies, adolescents appear to have greater risk for infection compared to older women. Cross-sectional studies and data collected from adolescent and family planning clinics have documented that adolescents 15-19 years have the highest rates of infection irrespective of socioeconomic status. Due to delays in diagnosis or inadequate therapy, 10 to 40 percent of these young women with chlamydial cervicitis develop PID. o Gonorrhea, the other major cause of PID, occurs at an annual rate of approximately 0.5 million new cases, 25 percent of which occur in teenagers. Although rates of infection have been steadily decreasing in the last decade, gonorrhea rates have declined slowly in adolescent populations compared to older age groups. o During the 1980s, the rate of syphilis increased in African- American adolescent males and females. Congenital syphilis rates were particularly high among pregnant adolescent women because perinatal care is less frequent in younger women. o Trichomoniasis affects over three million American women; in the US and throughout the world, it is not uncommon to find 25% of these infections in adolescents. o In the U.S., as many as 40 million people are believed to be infected with human papillomavirus (HPV). High-risk HPV types are causally associated with cervical cancer. Globally, cervical cancer is the most common cause of cancer-related death in women. In one study, the incidence rate for HPV infection in college-aged women during their first year of sexual activity with a single partner was 25%. Another study of female college students found a 50% prevalence of the young women had HPV infection. o Approximately 65 million Americans are afflicted with genital herpes, caused by herpes simplex viruses 1 & 2 (HSV). Genital herpes is a painful, recurrent, incurable disease with annual costs estimated to exceed $96 million. Serological evidence of genital herpes infection suggests that rates increase rapidly during adolescence. Estimated annual cases of genital herpes in teenagers and young adults in the U.S. increased from 15,000 yearly visits in 1966 to about 100,000 by 1995. o Both ulcerative and non-ulcerative STDs increase the risk of human immunodeficiency virus (HIV) transmission approximately 3-5 fold, independent of the effect of sexual behavior; and HIV infection, which decreases immune function, may alter the natural history and increase the prevalence of some STDs. One in five cases of AIDS is diagnosed in young people 20-29 years of age; given the length of the incubation period between HIV infection and onset of AIDS, virtually all of these people became infected as teenagers. Objectives and Scope In spite of decades of STD prevention and control programs and STD research, rates of infection continue to grow. The alarming dimensions of STDs and related health problems described above point to the need for more effective research that will lead to essential tools for preventing and controlling STDs, especially in adolescent populations. The 1996 report of the Institute of Medicine, "The Hidden Epidemic - Confronting Sexually Transmitted Diseases" identified adolescents as an underserved population that requires special emphasis in both STD research and STD service delivery. The report encourages efforts in prevention that are dependent upon the development of new biomedical tools (vaccines, topical microbicides and diagnostic tests), interventions and paradigms that are likely to be more effective for prevention and control of STDs in adolescent populations. The STD CRCs have been developed as multi-disciplinary research efforts that integrate clinical observations into basic biomedical research; apply the findings of basic research to the development of improved diagnostics, therapeutics, vaccines and topical microbicides; and integrate behavioral and epidemiological research needed to ensure the optimal utilization of these tools. The purpose of this RFA is to stimulate multi-disciplinary, collaborative research to further understanding of STDs in adolescent populations and to develop and evaluate effective approaches to STD prevention and control. The scientific complexity of the STD problems is such that coordinated, multi-disciplinary research is required to solve these problems. This will be accomplished through collaborations among scientists from various disciplines working in the scientific areas of biomedical, clinical, behavioral, and epidemiological research. In this RFA, the term scientific area refers to the four broad categories of investigation: (1) biomedical, (2) clinical, (3) behavioral, and (4) epidemiological research. The term discipline refers to investigators' specialized areas of expertise or training. Some examples of disciplines associated with the four scientific areas include but are not limited to (1) reproductive endocrinology, immunology, virology, and molecular biology; (2) gynecology, infectious diseases, and adolescent medicine; (3) psychology, sociology, and anthropology; (4) epidemiology, biostatistics, and computer modeling. Research on HIV infection is supported by the Division of Acquired Immunodeficiency Syndrome (DAIDS) and is not included in the scope of this RFA except in studies where it is directly linked to research on STDs as risk factors for HIV transmission or in alteration of the natural history of STDs. Applications must include: o at least three research projects: one should be in behavioral or epidemiological research in adolescent populations (of particular interest is research on social networks; and two or more projects that link disciplines within a single scientific area and at least one project that links disciplines in two different areas (disciplines and scientific areas are defined above); o research on two or more STD pathogens or syndromes selected from Diseases, Syndromes, and Areas of Interest listed below; o a strong clinical capability in adolescent medicine (described below) with accessible adolescent populations to participate in the clinical and behavioral/epidemiological research projects; and o provisions for the Principal Investigator of each CRC (also known as the CRC Director) to attend meetings with NIAID staff twice each year and for all CRC Project Leaders to attend CRC workshops twice during the program period. Diseases, Syndromes, and Areas of Interest Applicants are encouraged, but not limited, to consider research projects in the following areas: o Pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, Haemophilus ducreyi, Treponema pallidum, Trichomonas vaginalis, herpes simplex viruses 1 and 2, and human papillomavirus. In designing specific projects, use of human material to address basic research questions is highly recommended. o Adverse Outcomes of Pregnancy: Research is needed to define the epidemiology, pathogenesis, and immunology of STD-related adverse outcomes of pregnancy in adolescent populations. o Human Papillomavirus Infection: The NIAID's priorities in HPV include research on the epidemiology, natural history, pathogenesis, and immunology of infection , diagnosis and treatment in adolescent populations. o Pelvic Inflammatory Disease (PID): Additional research is needed in a number of areas, including diagnosis, epidemiology, pathogenesis, treatment, and long term sequelae. Of particular interest are age-related host factors that influence disease progression including tubal scarring. o Inter-Relatedness of Sexually Transmitted Infections: Because of the HIV epidemic, it is now recognized that infection with one sexually transmitted infection can alter susceptibility to and natural history of other STDs. Understanding the molecular bases of these interactions is needed, especially those that are age-related. For example, research is needed to examine the role of classical STDs in the acquisition and progression of HIV infection and on the role of HIV in alterations of the natural history, diagnosis, or response to treatment of STDs. One project on HIV infection may be included. o Reproductive Endocrinology: The role of reproductive hormonal changes, both endogenous (puberty) and exogenous, on the biology of susceptibility and resistance to infection is a high priority. o Immunology: Basic immunological research related to vaccine development for any of the pathogens or syndromes listed above is of interest. In order to make critical advances in this area vis a vis adolescent populations, functional collaborations between immunologists and microbiologists focused on the immune response in adolescent populations will be extremely important. Work on non- specific defense mechanisms including the role of defensins, normal flora (lactobacilli), mucus and pH is encouraged, especially in the context of changes associated with puberty and the use of hormonal contraceptives . o Behavioral/Epidemiological Research: Behavioral research is needed to decrease risk-associated behaviors and to increase health behaviors, specifically those related to seeking early diagnosis, treatment, and immunization. Also of interest is research on social networks; special attention should be paid to methods and evaluation outcomes that would be useful in characterizing social networks and in designing interventions for social networks. STD CRCs, because of their multi-disciplinary approach, are in a unique position to assess behavioral measures and evaluate interventions. o Topical Microbicides: Basic biomedical and clinical research leading to topical microbicide development to prevent sexually transmitted infections is needed. Topical microbicides are products for intravaginal use that are microbicidal (virucidal and/or bactericidal) but not necessarily spermicidal; they are used by women to prevent sexually transmitted infections (HIV and other STDs). Examples of such research include, but are not limited to, identifying early events in the infectious process, characterizing vaginal physiology and normal flora in adolescent populations, developing methods to measure and assess clinical significance of vaginal/cervical inflammation and comparing changes induced by microbicides in adolescent versus adult women. Clinical Capability As stated earlier, applications must have a strong clinical capability in adolescent medicine and access to adolescent populations to serve the clinical and behavioral and/or epidemiological research projects. In describing the clinical and laboratory facilities, the application should include specific information on the institution's present patient load, projections for patient involvement in future clinical investigations, history of recruitment of subjects, and disease prevalence as well as on the availability of appropriate biohazard facilities and safety procedures. Optional Developmental Component Applications may include a Developmental Fund Core to provide support for new investigators or pilot projects. Eligible investigators are individuals in the early or mid stages of their career who have NOT held an NIH grant including an R29, RO1, PO1, UO1, any research career or training grant (K or T awards), or any other type of grant or contract with annual direct costs in excess of $37,500 for research in STDs. Potential awardees and specific research projects to be pursued need not be identified in the CRC application. However, the application should include a one page description of the kind of project that might be funded under this mechanism and how it interdigitates with CRC research projects. Approval of the developmental funds portion of the application does not in any way commit the investigators to the execution of the sample project. In addition, the application must provide a description of review process and selection criteria for proposed projects. Budget Issues Budget requests within each project may include research-related costs for supplies, patient involvement and medical care, funds for limited investigator travel, and costs of publication. Proposals for studies that do not receive the majority of funding through the CRC will not be counted as a project. There must be concordance between the science proposed and the budget requested. Furthermore, if additional sources of funding have been identified for a project, then letters documenting a funding commitment must be included in the application. STD CRC award funds may be utilized to support the following research-related activities: o PI Level of Effort: The applicant Principal Investigator (STD CRC Director) must allot 15% of time to the administration of the CRC. If less effort is indicated, justification must be provided, including a written plan explaining how they will be able to successfully and fully meet the responsibilities demanded by these endeavors. Effort on scientific projects would be additional. o Shared Research Resources (Cores): The STD CRC may include funds for equipment, supplies, and services to expand and/or maintain clinical, laboratory, biostatistical, or behavioral facilities shared by research staff from at least two research projects. o Advisory group activities: The STD CRC funds may be used to support activities related to acquiring scientific advise from experts in the field. These advisory groups should be constituted after the grant award has been made and should not be named in the application. o Developmental Funds Core for New Investigators: This optional core sets aside and restricts funds solely to cover salaries and research costs for new investigator or pilot projects. There is no ceiling on the total dollar amount of the developmental funds pool, but once identified as developmental funds these monies constitute a restricted portion of the total CRC budget and will not be available for other CRC activities. The annual total amount for each developmental award may not exceed $40,000 and may be used for salary, technical support, laboratory supplies, and equipment. Supplies and equipment expenditures for each award may not exceed $20,000 annually. Projects and investigators funded under the developmental core may not receive subsequent awards from this pool. The duration of support is limited to three years. If the investigator achieves independent funding through a traditional research grant (R01) or a FIRST (R29) award prior to the end of the developmental award, the award must be terminated, and unexpended funds must be returned to the developmental funds pool. In general, the CRC should try to advance learning experiences in STD research and to make medical students, house staff and postdoctoral candidates more aware of STD research opportunities in the clinical, biomedical, and behavioral sciences. It is permissible for projects to include post-residency personnel who spend a maximum of one third of their time in clinical activities related to the research focus of the project. Formal training programs in clinical or basic sciences that include stipends for these students are supported by other funding mechanisms at the NIH, such as the National Research Service Awards (T-32s) and do not, therefore, fall within the purview of this request. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. SPECIAL REQUIREMENTS Collaborative Organization The application should include a plan to maintain close collaboration and communication among members this STD CRC (and potentially among of the seven other STD CRCs) and an organizational chart showing the name, the organization and the scientific discipline of the Principal Investigator, the Project Leaders, and the key personnel for the projects and cores. The application must also include a signed letter of agreement from each collaborator and/or consultant to the program indicating willingness to participate in the program and a description of the exact nature of the participation. Terms and Condition of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Awards will be made to an institution on behalf of a Principal Investigator who will be responsible for the coordination of STD CRC scientific and administrative activities. Support of all CRC activities will be coordinated through a Central Operations Office located within the applicant organization. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the details for the project within the guidelines of the RFA and for performing the scientific activity, and agree to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific and technical management of the project described in 2. below. Specifically, awardees have primary responsibilities as described below. Under the Cooperative Agreement, a partnership relationship exists between the recipient of the award and NIAID in which successful applicants are responsive to the guidelines and conditions set forth in the RFA. At the same time, investigators are expected to define research objectives and approaches in accord with their own interests and perceptions of novel and exploitable approaches to the research which ultimately is likely to result in improved prevention and control of STDs. It is the primary responsibility of the Principal Investigator to clearly state the objectives and approaches of the research, to plan and conduct the research stipulated in the proposal, and to ensure that the results obtained are analyzed and published in a timely manner. NIAID may periodically review and generate internal reports >From data and progress reports developed under this cooperative agreement. Awardees will retain custody of and have primary rights to the data developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The multi-disciplinary and collaborative nature of the STD CRCs creates an extraordinary opportunity for information exchange and scientific advancement in STD research. Principal Investigators are expected to take advantage of this opportunity by participation in both formal events established expressly for this purpose and informal investigator-initiated dialogues. 2. NIAID Staff Responsibilities The NIAID will have substantial scientific/programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The NIAID will work closely with the Principal Investigators and shall be represented by a Scientific Coordinator (Program Officer). The Scientific Coordinator will be a program officer in the STD Branch of NIAID. During the award period, the NIAID Scientific Coordinator may provide appropriate assistance, advice, and guidance in: design of research activities; coordination and facilitation of information, technology, and reagent exchange between STD CRCs; data collection and analysis; assistance in review and selection of developmental fund applicants; and technical and administrative activities of CRCs. However, it is again emphasized that the role of NIAID will be to facilitate and not to direct the activities of the STD CRC. It is anticipated that decisions in all activities outlined within this RFA will be reached by consensus of the investigators and that the NIAID Scientific Coordinator will be given the opportunity to offer input to this process. 3. Collaborative Responsibilities The CRC Principal Investigator of the Adolescents and STDs CRC and the other seven STD CRCs and NIAID Scientific Coordinator will meet twice a year to review progress of the CRCs at the NIH in Bethesda, Maryland (or at a site designated by NIAID). The first such meeting will be a Post Award Meeting. In addition, two workshops for the Principal Investigators and CRC Project Leaders will be convened during the project period to share STD research advances, and to discuss STD research needs and opportunities, to develop collaborations. It is likely that workshops will be convened in Year 1 and Year 3 of the project period at the NIH in Bethesda, Maryland (or at a site designated by NIAID). Applicants should be aware that there are no additional travel monies available. Funds for travel to all meetings must be included in applicant's budget. A critical element of the STD CRCs' success is the degree of communication among its members. Therefore, additional informal meetings among participants from other STD CRCs as well as regular telephone and written communication will be encouraged. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Principal Investigator, a second member selected by the NIAID, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR part 50, subpart D, and HHS regulation at 45 CFR part 16. In the event that research supported by the Cooperative Agreement results in development of a therapeutic or other medical intervention, NIAID will retain the option to cross-file or independently file an application for investigational clinical trial (i.e., an Investigational New Drug Application [IND]) to the United States Food and Drug Administration. Reports of data generated by the CRC or any of its members which are required for inclusion in INDs and Clinical Brochures and for cross-filing purposes will be submitted by the Principal Investigator to the Scientific Coordinator upon request. Such reports will be in final draft form and include background information, methods, results, and conclusion. They will be subject to approval and revision by NIAID and may be augmented with test results from other Government sponsored projects prior to submission to the appropriate regulatory agency. STUDY POPULATIONS A strong emphasis is placed on studying STDs in adolescent populations that are disproportionately affected. These populations include women and minorities. Subjects may be recruited or specimens obtained from domestic sites or through collaborations with foreign institutions in developing countries if the collaboration is beneficial to the foreign country and offers the potential for collection of STD data that are pertinent to U.S. populations and could not be generated as effectively in the United States. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 15, 1997, a letter of intent that includes a descriptive title of the overall proposed research; the name, address, and telephone number of the Principal Investigator; a list of the key investigators and their institution(s), and the number and title of the RFA in response to which the application may be submitted. 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. Madelon Halula at the address listed under INQUIRIES. APPLICATION PROCEDURES Before preparing an application, the applicant should carefully read the new information brochure accompanying the RFA, "NIAID Program Project Grants and Multiproject Cooperative Agreements". Instructions for formatting the application as outlined in the brochure should be followed carefully. Failure to follow the instructions may result in unnecessary delays in the review process. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Application forms are available at most institutional offices of sponsored research and >From the Division of Extramural Outreach Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov. Applications from multi-component consortia must contain a single face page, an overall budget page, and separate budget pages for each institution involved. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package, to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and five sets of appendix material must also be sent to: Dr. Madelon Halula Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C-16 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Applications must be received by the January 8, 1998. All components, subparts and sections of the application must be collated into the application, and the packages sent to the DRG and to the NIAID must each be complete in themselves. Applications that do not conform to the instructions contained in PHS 398 (rev. 5/95) application kit will be judged nonresponsive and will be returned to the applicant. Current NIH policy permits a component research project of a multiproject grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multiproject application and the R01 application are found to be in the fundable range, the investigator must relinquish the R0l and will not have the option to withdraw from the multiproject grant. This is an NIH policy intended to preserve the scientific integrity of a multiproject grant, which may be seriously compromised if a strong component project(s) is removed >From the program. Investigators wishing to participate in a multiproject grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. REVIEW CONSIDERATIONS Review Method Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and for responsiveness by NIAID staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration or review. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. The NIAID will remove from competition those applications judged to be non-competitive for award and will notify the Principal Investigators and institutional business officials. For applications found non-competitive, summary reports will be very brief and will only highlight the major reason(s) for the non- competitive rating. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The review criteria are stated in the NIAID Program Project Grants and Multiproject Cooperative Agreements brochure which accompanies the RFA. In addition, applicants are expected to address research priorities, objectives, and other requirements stated in this RFA as well as the following: o the scientific and technical significance, merit, and originality of the research projects and anticipated contributions to the prevention and control of STDs; o the scientific expertise and experience of the Principal Investigator, the Project Leaders and key project and core personnel; o documentation of a strong capability in adolescent medicine, adequate and appropriate patient populations, disease prevalence, and historical success of recruitment and retention of subjects; o inclusion of populations that are not currently represented in existing STD CRCs; o documentation of the sponsoring institution's commitment to the cooperative program and willingness to accept the participation and assistance of NIAID staff; o adequacy of proposed plan for coordination and communication within the applicant STD CRC and with NIAID and other STD CRCs; and o adequacy of review plan and selection criteria for new investigators making application to the optional Developmental Funds. In addition, applications from existing STD CRCs must include a comprehensive progress report (as stated above under Objectives and Scope) and demonstrate successful collaborative activities supported through their CRC. Applicants who have not had an STD CRC should explain how they will establish successful collaborative efforts. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities and balance, and availability of funds. Program balance takes into account pathogen(s) proposed for study, the potential impact on health of women, minorities and adolescents, as well as geographic distribution of the existing CRCs (of particular interest is access to populations that are currently not being studied in other STD CRCs). INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Penelope J. Hitchcock Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A-24 Bethesda, MD 20892 Bethesda, MD 20852 (for express/courier service Telephone: (301) 402-0443 Email: ph22k@nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dr. Madelon Halula Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C-16 Bethesda, MD 20892 Bethesda, MD 20852 (for express/courier service Telephone: (301) 402-2636 FAX: (301) 402-2638 Email: mh30x@nih.gov Direct inquiries regarding fiscal matters to: Ms. Sharie Bernard Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B-33 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: October 15, 1997 Application Receipt date: January 8, 1998 Scientific Review Date: April 1998 Advisory Council Date: June 1998 Earliest Award Date: August 1998 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 Immunology, Allergic and Immunological Diseases Research and 93.856 Microbiology and Infectious Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. The PHS and EPA strongly encourage all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the EPA and PHS missions to protect and advance the physical and mental health of the American people. ADDENDUM STD CRCs can serve as important resources to increase awareness of the prevention, diagnosis, and treatment of STDs in the public health, the lay and the local medical communities. The NIAID has been involved with the Centers for Disease Control's (CDC) Accelerated Research Program in STDs. Several proposed projects for this CDC program involve collaborations between the existing STD CRCs and state and local health departments. Applicants with interest in this area should contact the Division of STDs/HIV, National Center for Prevention Services, CDC for information on support of outreach projects. From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-099 - V26(29) 08/29/97 Date: 2 Sep 1997 14:39:50 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 359 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui136$ks1@net.bio.net> NNTP-Posting-Host: net.bio.net GENES AND MECHANISMS UNDERLYING PRIMARY IMMUNODEFICIENCY NIH Guide, Volume 26, Number 29, August 29, 1997 PA NUMBER: PA-97-099 P.T. National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), invite applications for research studies to: identify and characterize genes that cause primary immunodeficiency diseases; characterize the molecular mechanisms involved in primary immunodeficiency diseases which are not the result of a single defective gene; identify the immunologic role of defective gene products and their normal counterparts; and, based on this knowledge, develop more effective approaches for the diagnosis, treatment, and prevention of these disorders. 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 Program Announcement, "GENES AND MECHANISMS UNDERLYING PRIMARY IMMUNODEFICIENCY", is related to the priority areas of Maternal and Infant Health and Diabetes and Chronic Disabling Diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by for profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Domestic and foreign institutions are eligible to apply for R01 grants. Domestic institutions are eligible for First Independent Research Support and Transition Award (FIRST)(R29) grants. Foreign institutions are not eligible for FIRST award (R29) grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISMS OF SUPPORT Mechanisms supported by NIAID and NICHD in this PA are the traditional research project grant (R01) and the FIRST award (R29) grant. Applications for R01 grants may request up to five (5) years of support, however, foreign application may not request more than 3 years of support; applications for R29 grants must request five years of support. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES Background Primary immunodeficiency diseases are a heterogeneous group of diseases all of which are characterized by an immune system dysfunction that is responsible for clinical features such as increased susceptibility to infection and abnormal inflammatory responses. There are more than 70 such diseases (e.g., Wiskott- Aldrich Syndrome, Ataxia-telangiectasia, Bare Lymphocyte Syndrome). Although many are rare it has been estimated that as many as 500,000 individuals in the United States are affected, of whom 5,000-10,000 (many of them children) are severely affected. The causative genes and pathogenic mechanisms for many of these diseases have not been identified. Morbidity, mortality, medical and social costs for severely affected individuals and their families are extremely high. Remarkable progress has been made in the identification and cloning of genes which cause primary immunodeficiency diseases. These include: 1) X-linked Agammaglobulinemia, an antibody deficiency disease in which all classes of antibody are low or absent; the defective gene encodes Btk, an enzyme found in the cytoplasm of B lymphocytes; 2) X-linked Severe Combined Immunodeficiency, an immunodeficiency in which both cellular and humoral immunity are deficient; the defective gene encodes the common gamma chain of many of the cytokine receptors on T lymphocytes; 3) X-linked Hyper-IgM Syndrome in which IgM antibodies are normal or elevated but IgG and IgA are low or absent; the defective gene encodes a protein expressed on activated T lymphocytes called CD40 ligand; 4) Wiskott-Aldrich Syndrome, an immunodeficiency involving T and B lymphocytes and platelets; the defective gene encodes a previously unknown protein whose function is not yet known; and 5) Chronic Granulomatous Disease in which patients suffer from defective neutrophil function; the defective genes encode proteins which are important for the production of microbicidal oxidants. Research Objectives and Scope The research objectives of this PA are to: identify and characterize genes that cause primary immunodeficiency diseases; characterize the molecular mechanisms involved in primary immunodeficiency diseases which are not the result of a single defective gene, identify the immunologic role of defective gene products and their normal counterparts; and, based on this knowledge, develop more effective approaches for the diagnosis, treatment, and prevention of these disorders. The identification of the genes described in the background section provides the opportunity for detailed evaluation of the roles that the products of these genes play in normal immune system function. Progress in genome mapping and the application of positional cloning techniques provide the opportunity to identify and characterize the genetic defects in additional disorders. For disorders which are not caused by a single genetic defect, advances in the understanding of the molecular mechanisms of immunity provide opportunities for characterization of the pathogenic mechanisms. Research topics of interest include, but are not limited to, the following: Identification of previously unidentified defective single genes which cause primary immunodeficiency e.g., X-linked Lymphoproliferative Syndrome, Chediak- Higashi Syndrome) Characterization of the molecular mechanisms involved in the pathogenesis of immunodeficiency diseases which are not the result of a single defective gene (e.g., Common Variable Immunodeficiency) Characterization of the immunologic role of genes whose defects cause primary immunodeficiency, including cellular expression, ligands, signaling pathways and molecular interactions Delineation of the mechanisms for associated clinical abnormalities not apparently explained by the known genetic defect (e.g. neutropenia in Hyper IgM Syndrome) Identification of genetic and other factors which result in different levels of severity by exacerbating or compensating for the mutations in these genes Characterization of the transcriptional regulation of the defective genes Characterization of the defective genes in mouse models of immunodeficiency INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". The PA number and the PA title must also be typed in section 2. The completed, signed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) R29 applications must include at least three (3) sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic (research scope and eligibility) issues may be directed to: Howard B. Dickler, M.D. Chief, Clinical Immunology Branch Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A-19 6003 Executive Blvd. Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 EMAIL: hd7e@nih.gov Allan Lock, D.V.M. Health Science Administrator Developmental Biology, Genetics and Teratology Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development Building 61E, Room 4B01B 6100 Executive Boulevard Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 402-4083 EMAIL: LockA@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Maryellen Connell Grants Management Branch Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-28 6003 Executive Blvd. Bethesda, MD 20892-7610 Telephone: (301-402-5576) Fax: (301-480-3780) Email: mc40u@nih.gov or Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development Building 61E, Room 8A17 MSC-7510 6100 Executive Boulevard Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 EMAIL: ShawverD@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citations are No. 93.855 - Immunology, Allergy, and Transplantation Research and No. 93.865 - Research for Mothers and Children. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 29, pt. 1of1, 29 August 1997 Date: 2 Sep 1997 14:38:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 768 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui10q$kiq@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 29 - August 29, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** CHANGE IN RECEIPT DATES FOR NIDA RESEARCH CENTERS GRANT PROGRAM National Institute on Drug Abuse INDEX: DRUG ABUSE NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 01/08/98 ************************************************* ADOLESCENTS AND STDS COOPERATIVE RESEARCH CENTER (RFA AI-97-003) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 01/21/98 ************************************************* CENTERS FOR CHILDREN'S ENVIRONMENTAL HEALTH AND DISEASE PREVENTION RESEARCH (RFA ES-97-004) National Institute of Environmental Health Sciences U.S. Environmental Protection Agency, National Center for Environmental Research and Quality Assurance INDEX: ENVIRONMENTAL HEALTH SCIENCES; ENVIRONMENTAL PROTECTION AGENCY $$INDEX P1 ********************************************************** AUTOIMMUNITY: GENETICS, MECHANISMS, AND SIGNALING (PA-97-098) National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis, Musculoskeletal and Skin Diseases National Institute on Aging Office of Research on Women's Health INDEX: ALLERGY, INFECTIOUS DISEASES; DIABETES, DIGESTIVE, KIDNEY DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; AGING; WOMEN'S HEALTH $$INDEX P2 ********************************************************** GENES AND MECHANISMS UNDERLYING PRIMARY IMMUNODEFICIENCY (PA-97-099) National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development INDEX: ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P3 ********************************************************** REGULATION OF THE IMMUNE RESPONSE (PA-97-100) National Institute of Allergy and Infectious Diseases National Institute on Aging National Institute of Diabetes and Digestive Diseases and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ALLERGY, INFECTIOUS DISEASES; AGING; DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX P4 ********************************************************** BASIC MECHANISMS OF VACCINE EFFICACY (PA-97-101) National Institute of Allergy and Infectious Diseases National Institute of Dental Research National Institute on Aging National Institute of Child Health and Human Development INDEX: ALLERGY, INFECTIOUS DISEASES; DENTAL RESEARCH; AGING; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P5 ********************************************************** NINDS CLINICAL TRIAL PLANNING GRANT (PAR-97-102) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX P6 ********************************************************** PILOT CLINICAL TRIAL GRANT FOR NEUROLOGICAL DISEASE (PAR-97-103) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX P7 ********************************************************** CENTERS FOR BEHAVIORAL SCIENCE RESEARCH IN MENTAL HEALTH (PAR-97-104) National Institute of Mental Health INDEX: MENTAL HEALTH The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the NIH gopher (gopher.nih.gov) and the NIH website (http://www.nih.gov). Alternative access is through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing grant applications submitted to the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact aid which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAs, AND RFAs IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** CHANGE IN RECEIPT DATES FOR NIDA RESEARCH CENTERS GRANT PROGRAM NIH Guide, Volume 26, Number 29, August 29, 1997 P.T. National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) wishes to give notice of a change in the receipt dates for Center grant applications submitted under NIDA's Research Center Grant Program Guidelines, December 1995. The previous receipt dates were June 1 and October 1 annually. Effective immediately, NIDA will accept applications under the NIDA Research Center Grant Program using the three standard receipt dates of February 1, June 1, and October 1 (annually). INQUIRIES Inquiries regarding this notice may be directed to: Jacqueline R. Porter Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 Email: jp86z@nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN AI-97-003 FULL-TEXT ************************************** ADOLESCENTS AND STDS COOPERATIVE RESEARCH CENTER NIH Guide, Volume 26, Number 29, August 29, 1997 RFA AVAILABLE: AI-97-003 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: October 15, 1997 Application Receipt Date: January 8, 1998 PURPOSE The purpose of this Request for Applications (RFA) is to stimulate multi-disciplinary, collaborative research to further understanding of sexually transmitted diseases (STDs) in adolescent populations and to develop and evaluate effective approaches to their prevention and control. The Sexually Transmitted Diseases Branch of the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites grant applications for an Adolescents and Sexually Transmitted Diseases Cooperative Research Center (STD CRC). The Institute recognizes that adolescents >From all segments of society are at extremely high risk for STDs. Furthermore there are unique biomedical and behavioral factors that underlie the risk of STD acquisition and transmission in adolescents. Therefore, a research program that specifically focuses on STDs in this young, at-risk population is likely to be highly productive. The STD CRC will provide a multi-disciplinary approach to STD research by bridging biomedical, clinical, behavioral, and epidemiological research; will foster interaction among STD investigators; and will facilitate intervention-oriented research. The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $1.2 million. In Fiscal Year 1998, the NIAID plans to fund one Adolescents and STD CRC. 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, Adolescents and Sexually Transmitted Diseases Cooperative research Center (STD CRC), is related to the priority areas of STDs & AIDS. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Penelope J. Hitchcock Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A24 Bethesda, MD 20892 Telephone: (301) 402-0443 FAX: (301) 402-1456 Email: ph22k@nih.gov $$R1 END ************************************************************ $$R2 BEGIN ES-97-004 FULL-TEXT ************************************** CENTERS FOR CHILDREN'S ENVIRONMENTAL HEALTH AND DISEASE PREVENTION RESEARCH NIH Guide, Volume 26, Number 29, August 29, 1997 RFA AVAILABLE: ES-97-004 P.T. National Institute of Environmental Health Sciences U.S. Environmental Protection Agency, National Center for Environmental Research and Quality Assurance Letter of Intent Receipt Date: September 30, 1997 Application Receipt Date: January 21, 1998 PURPOSE Establish research/prevention programs addressing environmental contributions to children's health; facilitate translation into clinical applications and intervention strategies to reduce the incidence of environmentally related childhood disease; establish a network that fosters communication, innovation, and research excellence with the goal of reducing morbidity among children as a result of exposure to harmful environmental agents. 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), Specialized Centers in Children's Environmental Health, is related to the priority area of Environmental Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Allen Dearry, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-21 Research Triangle Park, NC 27709 Telephone: (919) 541-4500 FAX: (919) 541-4937 Email: dearry@niehs.nih.gov Christopher Saint, Ph.D. National Center for Environmental Research and Quality Assurance U.S. Environmental Protection Agency 401 M Street, SW (8723R) Washington, DC 20460 Telephone: (202) 564-6909 FAX: (202) 565-2448 Email: saint.chris@epamail.epa.gov $$R2 END ************************************************************ $$P1 BEGIN PA-97-098 FULL-TEXT ************************************** AUTOIMMUNITY: GENETICS, MECHANISMS, AND SIGNALING NIH Guide, Volume 26, Number 29, August 29, 1997 PA AVAILABLE: PA-97-098 P.T. National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis, Musculoskeletal and Skin Diseases National Institute on Aging Office of Research on Women's Health PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA), and the Office of Research on Women's Health, National Institutes of Health (NIH) invite applications for new and innovative investigator-initiated basic and preclinical research into the immune responses underlying autoimmune disease and its regulation for preventive or therapeutic purposes. Three specific areas of emphasis are highlighted: 1) genetic susceptibility for autoimmune disease, including the MHC and other genetic loci; 2) role and regulation of co-stimulation of T cells in autoimmunity; and 3) signal transduction in the autoreactive response. The funding mechanisms to be used to support research under this PA are research project grants (R01) and First Independent Research Support and Transition (FIRST) (R29) awards. 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, Autoimmunity: Genetics, Mechanisms, and Signaling, related to the priority area of Diabetes and Chronic Disabling Diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES This PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221, the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov)), and by mail and email from the program contact listed below. Elaine Collier, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A20 - MSC 7640 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: ec5x@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-97-099 FULL-TEXT ************************************** GENES AND MECHANISMS UNDERLYING PRIMARY IMMUNODEFICIENCY NIH Guide, Volume 26, Number 29, August 29, 1997 PA AVAILABLE: PA-97-099 P.T. National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), invite applications for research studies to: identify and characterize genes that cause primary immunodeficiency diseases; characterize the molecular mechanisms involved in primary immunodeficiency diseases which are not the result of a single defective gene; identify the immunologic role of defective gene products and their normal counterparts; and, based on this knowledge, develop more effective approaches for the diagnosis, treatment, and prevention of these disorders. The funding mechanisms to be used to support research under this PA are R01s and R29s. 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 Program Announcement, "GENES AND MECHANISMS UNDERLYING PRIMARY IMMUNODEFICIENCY", is related to the priority areas of Maternal and Infant Health and Diabetes and Chronic Disabling Diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES This PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221, the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov)), and by mail and email from the program contact listed below. Howard B. Dickler, M.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A-19 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: hd7e@nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-100 FULL-TEXT ************************************** REGULATION OF THE IMMUNE RESPONSE NIH Guide, Volume 26, Number 29, August 29, 1997 PA AVAILABLE: PA-97-100 P.T. National Institute of Allergy and Infectious Diseases National Institute on Aging National Institute of Diabetes and Digestive Diseases and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Aging (NIA), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), invite applications to enhance our knowledge of the broad range of mechanisms that control the immune response and age-related changes in the regulation of immune responses and the underlying mechanisms responsible for these changes. Enhanced knowledge in these areas is critical for understanding the generation and control of immune responses to antigenic challenges and in the development of new strategies to treat and prevent immunologically based diseases. Support will be provided for basic and pre-clinical studies using molecular and cellular approaches to dissect the immune response. The funding mechanisms to be used to support research under this Program Announcement (PA) are R01s and R29s. 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, "REGULATION OF THE IMMUNE RESPONSE", is related to the priority areas of Immunization and Infectious Diseases and Diabetes and Chronic Disabling Disease. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Stephen M. Rose, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A14 Bethesda, MD 20892-7640 Telephone: (301) 496-5598 FAX: (301) 402-2571 Email: sr8j@nih.gov $$P3 END ************************************************************ $$P4 BEGIN PA-97-101 FULL-TEXT ************************************** BASIC MECHANISMS OF VACCINE EFFICACY NIH Guide, Volume 26, Number 29, August 29, 1997 PA AVAILABLE: PA-97-101 P.T. National Institute of Allergy and Infectious Diseases National Institute of Dental Research National Institute on Aging National Institute of Child Health and Human Development PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Dental Research (NIDR), the National Institute on Aging (NIA), and the National Institute of Child Health and Human Development, National Institutes of Health (NIH), invite applications that utilize basic knowledge of antigen presentation pathways, lymphocyte activation and immunoregulation to define fundamental principles of vaccine efficacy. Innovative studies are sought to develop vaccination strategies applicable for broad classes of pathogens or to define approaches to direct specific immune responses in order to enhance vaccine effectiveness for infectious pathogens. 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 Program Announcement (PA), BASIC MECHANISMS OF VACCINE EFFICACY, is related to the priority areas of Immunization and Infectious Diseases, HIV Infection and Maternal and Infant Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line, (data line 301-402-2221) and the NIH Gopher (gopher@nih.gov) and the NIH Website (Http://www.nih.gov) and by mail and Email from the program contacts listed below. Charles Hackett, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A23 Bethesda, MD 20892-7640 Telephone: (301) 496-7551 FAX: (301) 402-2571 Email: ch187q@nih.gov Dennis F. Mangan, Ph.D. Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN-32F Bethesda, MD 20892-6402 Telephone: (301) 594-2421 FAX: (301)480-8318 Email: Dennis.Mangan@nih.gov Anna 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 Email: am38k@nih.gov Allen Lock, D.V.M. Center for Research for Mothers and Children National Institute for Child Health and Human Development 6100 Executive Boulevard, Room 4B01 - MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: locka@hd01.nichd.nih.gov $$P4 END ************************************************************ $$P5 BEGIN PAR-97-102 FULL-TEXT ************************************* NINDS CLINICAL TRIAL PLANNING GRANT NIH Guide, Volume 26, Number 29, August 29, 1997 PA AVAILABLE: PAR-97-102 P.T. National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS) seeks to fund high quality clinical trials to evaluate treatments for neurological disorders. The NINDS Clinical Trial Planning Grant allows for early peer review of the rationale and design for clinical trials of treatments for neurological disorders and provides support for the development of a detailed clinical trial research plan, including a complete manual of operations and procedures. The mechanism of support will be a Developmental Planning Grant (R21), which will provide up to $150,000 in direct costs for a single year. The award cannot be renewed. 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, Title of PA, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Joseph S. Drage, M.D. Training and Special Programs Officer, National Institute of Neurological Disorders and Stroke Telephone: (301) 496-4188 FAX: 301-402-0302 Email: jd66x@nih.gov $$P5 END ************************************************************ $$P6 BEGIN PAR-97-103 FULL-TEXT ************************************* PILOT CLINICAL TRIAL GRANT FOR NEUROLOGICAL DISEASE NIH Guide, Volume 26, Number 29, August 29, 1997 PA AVAILABLE: PAR-97-103 P.T. National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS) is committed to identifying effective treatments for neurological disorders by supporting well-executed clinical trials. Before proceeding to a full-scale clinical trial, pilot clinical studies are often required. The NINDS announces its interest in supporting pilot studies required to obtain necessary information to clearly establish the clinical basis for proceeding to a full-scale trial. The purpose of the NINDS Pilot Clinical Trial Grant For Neurological Disease is to obtain preliminary data and conduct studies to support the rationale for a subsequent full-scale clinical trial of an intervention to treat or prevent neurological disease. The mechanism of support for the NINDS Pilot Clinical Trial Grant is the research project grant (R01). It is expected that most grants will not exceed $350,000 per year in direct costs for three years. 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, Title of PA, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202- 512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Joseph S. Drage, M.D. Training and Special Programs Officer, National Institute of Neurological Disorders and Stroke Telephone: (301) 496-4188 FAX: 301-402-0302 Email: jd66x@nih.gov $$P6 END ************************************************************ $$P7 BEGIN PAR-97-104 FULL-TEXT ************************************* CENTERS FOR BEHAVIORAL SCIENCE RESEARCH IN MENTAL HEALTH NIH Guide, Volume 26, Number 29, August 29, 1997 PA AVAILABLE: PAR-97-104 P.T. National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) invites centers grant (P50) applications for Centers for Behavioral Science Research in Mental Health (CBSR). The purpose of these Centers is to provide integrated multidisciplinary research environments in which to pursue focused questions in basic behavioral science related to mental health and mental disorder. This mechanism is intended to encourage investigators from a variety of disciplines and approaches to contribute the full range of expertise and advanced technologies available in basic behavioral science toward the understanding of mechanisms underlying mental health and mental illness, and to begin the translation of basic behavioral findings and techniques to relevant clinical issues. 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 Program Announcement (PA), Centers for Behavioral Science Research in Mental Health, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Home Page (www.nih.gov) and by mail and E-mail from the program contact listed below. Mary Ellen Oliveri, Ph.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 5600 Fishers Lane, Room 18C-26 Rockville, MD 20857 Telephone: (301) 443-3942 FAX: (301) 443-4822 Email: MOLIVERI@NIH.GOV $$P7 END ************************************************************ From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-101 - V26(29) 08/29/97 Date: 2 Sep 1997 14:40:24 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 395 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui148$kvs@net.bio.net> NNTP-Posting-Host: net.bio.net BASIC MECHANISMS OF VACCINE EFFICACY NIH Guide, Volume 26, Number 29, August 29, 1997 PA NUMBER: PA-97-101 P.T. National Institute of Allergy and Infectious Diseases National Institute of Dental Research National Institute on Aging National Institute of Child Health and Human Development PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Dental Research (NIDR), the National Institute on Aging (NIA), and the National Institute of Child Health and Human Development, National Institutes of Health (NIH), invite applications that utilize basic knowledge of antigen presentation pathways, lymphocyte activation and immunoregulation to define fundamental principles of vaccine efficacy. Innovative studies are sought to develop vaccination strategies applicable for broad classes of pathogens or to define approaches to direct specific immune responses in order to enhance vaccine effectiveness for infectious pathogens. Applications submitted in response to Program Announcements are assigned according to established PHS referral guidelines. When the subject of an application is of interest to more than one component of NIH, dual assignments are made. 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 Program Announcement (PA), BASIC MECHANISMS OF VACCINE EFFICACY, is related to the priority areas of Immunization and Infectious Diseases, HIV Infection and Maternal and Infant Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by for profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Domestic and foreign institutions are eligible to apply for R01 grants. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISMS OF SUPPORT Traditional research project grant (R01) and FIRST award (R29) applications may be submitted in response to this announcement. Applications for R01 grants may request up to five (5) years of support; applications for R29 grants must request five years of support. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES Background Vaccination has proved to be enormously successful in combating a number of infectious diseases, yet attempts to produce effective vaccines for certain pathogenic viruses, bacteria, fungi, or parasites have been unsuccessful. The specific nature of the pathogen determines the type of immune response required for successful elimination and prevention of disease. Many currently used vaccines elicit antibody responses that provide effective protection. However, antibodies are not effective against certain microorganisms, such as tuberculosis, malaria, hepatitis C or the human immunodeficiency virus (HIV), and T cell-dependent cytotoxic responses may be required to prevent disease. Recent advances in basic immunology have demonstrated that different antigen presentation pathways are utilized for the stimulation of CD4 and CD8 T cell subsets, which then mediate different functional activities. Furthermore, the types of cytokines produced by activated T cells determine the types of immune responses that will result. The cytokine profile that is induced depends on the local cytokine milieu, on the antigen concentration and on the types of costimulatory signals provided by the antigen-presenting cells. A dominance of type-2 cytokines, such as IL-4 or IL-10, results in strong antibody responses of certain isotypes, whereas type-1 dominance, characterized by IFN-gamma or TNF-alpha, results primarily in cell-mediated cytotoxicity. This diversity in immune functional responses is essential for natural protection against a broad spectrum of pathogenic agents and offers the potential for manipulating the immune system to induce more effective immunity to particular pathogens. In conjunction with the recently enhanced ability to identify immunogenic epitopes by molecular and biochemical techniques, application of the basic principles of antigen presentation, lymphocyte activation, cytokine regulation and mechanisms of cytotoxicity should provide novel and predictable approaches for the development of more effective vaccines. Research Objectives and Scope Innovative research applications are sought that use the current wealth of knowledge of the immune system to define basic and general principles of vaccine efficacy. This PA is NOT intended to support the identification of specific pathogen antigens or descriptive studies on protection against particular pathogens. Rather, the emphasis is focused on studies to elucidate basic mechanisms of immune protection by vaccination protocols that may be applied to a variety of antigen systems. Projects should address key issues at the basis of vaccine function; accordingly, employment of relevant microbial systems and utilization of models that will facilitate application of principles to eventual clinical studies in humans are especially encouraged. Examples of research topics of interest include, but are not limited to, the following: o The mechanistic basis of adjuvant activity, and the design of novel adjuvants based upon functional principles; o Elucidation of the basic causes of vaccine failure, such as T cell receptor antagonism and age-related deficiencies in responses; and novel approaches to counteract these problems; o Immunological memory related to vaccine composition, form, and delivery; for example, memory responses to different microbial polysaccharides; o Basic mechanisms of epitope dominance and their impact on vaccine design; o Methodologies to target immunogens to specific antigen presenting cells and antigen-processing pathways for enhancement of protective responses; o Genetic basis for variability in immune responsiveness to vaccines; o Mechanisms of unique antigenic and immunogenic properties of novel vaccine vectors, including nucleic acid, viral or microbial vectors; and o Design of effective vaccination approaches for non-peptide immunogens, including lipids, carbohydrates, and other types of antigens not readily addressable by genetic vectors. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". The PA number and the PA title, "BASIC MECHANISMS OF VACCINE EFFICACY," must also be typed in section 2. The completed, signed original and five (5) legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) R29 APPLICANTS ONLY. R29 applications must include at least three (3) sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. GCRC INSTITUTIONS Applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. R01 and R29 applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score and weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts of methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review will also examine: the appropriateness of proposed budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic (research scope and eligibility) issues may be directed to: Charles Hackett, Ph.D. Chief, Molecular and Structural Immunology Section Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A23 6003 Executive Blvd. Bethesda, MD 20892-7640 Telephone: (301) 496-7551 FAX: (301) 402-2571 EMAIL: ch187q@nih.gov Dennis F. Mangan, Ph.D. Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN-32F Bethesda, MD 20892-6402 Telephone: (301) 594-2421 FAX: (301)480-8318 Email: Dennis.Mangan@nih.gov Anna McCormick, Ph.D. Chief, Biology Branch Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: am38k@nih.gov Allen Lock, D.V.M. Center for Research for Mothers and Children National Institute for Child Health and Human Development 6100 Executive Boulevard, Room 4B01 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: locka@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Celeste Kerner Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B26 6003 Executive Blvd. Bethesda, MD 20892-7610 Telephone: (301) 402-6213 FAX: (301) 480-3780 Email: ckerner@mercury.niaid.nih.gov Mr. Martin Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44A Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: Martin.Rubinstein@nih.gov Mr. Joseph Ellis Grants Management Officer Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: je14j@nih.gov E. Douglas Shawver Grants Management Branch National Institute for Child Health and Human Development 6100 Executive Boulevard, Room 8A17 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: shawverd@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is No. 93.855 - Immunology, Allergy, and Transplantation Research, No. 93.121- Oral Diseases and Disorders Research Awards, No. 93.366 - Aging Research, and No. 93.865 - Research for Mothers and Children. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-100 - V26(29) 08/29/97 Date: 2 Sep 1997 14:40:10 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 393 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui13q$kto@net.bio.net> NNTP-Posting-Host: net.bio.net REGULATION OF THE IMMUNE RESPONSE NIH Guide, Volume 26, Number 29, August 29, 1997 PA NUMBER: PA-97-100 P.T. National Institute of Allergy and Infectious Diseases National Institute on Aging National Institute of Diabetes and Digestive Diseases and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Aging (NIA), the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), invite applications to enhance our knowledge of mechanisms that control the immune response, age- related changes in the regulation of immune responses, and the underlying mechanisms responsible for these changes. Enhanced knowledge in these areas is needed for the generation and control of immune responses to antigenic challenges and for the development of new strategies to treat and prevent immunologically based diseases. Support will be provided for basic and pre-clinical studies using molecular and cellular approaches to dissect the immune response. 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 Program Announcement (PA), "REGULATION OF THE IMMUNE RESPONSE", is related to the priority areas of Immunization and Infectious Diseases and Diabetes and Chronic Disabling Disease. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by for profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Domestic and foreign institutions are eligible to apply for R01 grants. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISMS OF SUPPORT Traditional research project grant (R01) and FIRST (R29) applications may be submitted in response to this PA. Applications for R01 grants may request up to five (5) years of support; applications for R29 grants must request five years of support. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES Background Investigation is needed to enhance understanding of the activation of signaling pathways in immune system cells, the development of effector cell specificity, phenotype and function, and processes involved in the overall regulation of immune responses. For example, the molecular control of immunoglobulin gene expression and gene recombination has progressed significantly with the identification of enhancer elements, switch recombination sequences and immunoglobulin germline heavy chain transcription from cryptic promoters. The finding that the same molecular machinery used for immunoglobulin gene recombination is also used for the T-cell receptor gene recombination shows economy of the system. However, it has been demonstrated that the intracellular and external regulatory signals that trigger and control the recombination processes in the two systems are different. While many components of immune cell regulation have been discovered, including pathways of antigen processing and subsequent Major Histocompatibility Complex (MHC) association as well as the activities of cytokines, chemokines and growth factors, the complexity of the emerging picture suggests that many regulatory processes are still unknown. One example is how signals from the surface of immune cells are differentially interpreted to lead to either stimulation or suppression of immune function. Little is known about how the immune system is influenced by and interacts with other systems, including the endocrine and nervous systems. It is expected that continued support of immunological research will ensure further progress leading to a better understanding of the immune system. Research Objectives and Scope The major objective of this PA is to continue support for research to elucidate the molecular machinery and control of the immune response at all levels. This includes support for molecular biological studies on gene expression, gene recombination and interactions among different parts of the immune system to control the overall response to a stimulus. The scope of research to be supported under this PA includes, but is not limited to, the following broad areas of interest and specific examples of investigations. o definition of pathways that regulate gene activation and intra- or extra-cellular signals that control gene rearrangements in the immune system; o elucidation of the control of the immune system antigen receptor repertoire to prevent autoimmune reactivity; o further definition of interactions of immune system molecules to initiate and maintain an effective immune response; o continued mapping of genes activated in cells of the immune system; o further definition of the processes that control immune cell differentiation and development; o determination, at the cellular and molecular levels, of the central nervous system modulation of the immune response; o determination of the role of bidirectional signaling between T cells, B cells, antigen presenting cells and other immune system cells in normal and abnormal immune responses; o elucidation of the function of antigen processing, presentation and costimulation in establishing the local microenvironment necessary for activation and establishment of effector functions; and o elucidation of the cellular and molecular bases of age-related changes in immune regulation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". The PA number and the PA title must also be typed in section 2. The completed, signed original and five (5) legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) R29 applications must include at least three (3) sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic (research scope and eligibility) issues may be directed to: Stephen M. Rose, Ph.D. Chief, Genetics and Transplantation Branch Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A14 6003 Executive Blvd. Bethesda, MD 20892-7640 Telephone: (301) 496-5598 FAX: (301) 402-2571 EMAIL: sr8j@nih.gov Anna M. McCormick, Ph.D. Chief, Biology Branch Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Internet: am38k@nih.gov Walter S. Stolz, Ph.D. Director, Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Natcher Building, Room 6As-25C Bethesda, MD 20892-6600 Telephone: (301) 594-8834 FAX: (301) 480-3505 Email: stolzw@ep.niddk.nih.gov Susana Serrate-Sztein, M.D. Chief, Arthritis Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS37G Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: szteins@ep.niams.nih.gov Direct inquiries regarding fiscal matters to: Laura Eisenman Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B23 6003 Executive Blvd. Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: le55d@nih.gov Mr. Joseph Ellis Grants Management Officer Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Internet: je14j@nih.gov Nancy Dixon Grants Management Officer Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6An-44C National Institutes of Health Bethesda, MD 20892-6600 Telephone: (301) 594-8854 FAX: (301) 480-3504 email: dixonn@ep.niddk.nih.gov Ms. Carol Fitzpatrick Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS43K Telephone: (301) 594-3506 FAX: (301) 480-4543 Email: fitzpatric@ep.niams.nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is No. 93.855 - Immunology, Allergy, and Transplantation Research, No. 93.366 -Aging Research, No. 93.847 - Digestive Diseases and Nutrition, No. 93.848 - Diabetes, Endocrinology and Metabolic Diseases, No. 93.849 -Kidney, Urologic and Hematologic Diseases, and No. 93.846 -Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be administered under PHS grants policies and Federal Regulations 24 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Sep 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-104 - V26(29) 08/29/97 Date: 2 Sep 1997 14:38:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 590 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ui11b$kjb@net.bio.net> NNTP-Posting-Host: net.bio.net CENTERS FOR BEHAVIORAL SCIENCE RESEARCH IN MENTAL HEALTH NIH GUIDE, Volume 26, Number 29, August 29, 1997 PA NUMBER: PAR-97-104 P.T. National Institute of Mental Health Application Receipt Dates: March 23, 1998; March 23, 1999 PURPOSE The National Institute of Mental Health (NIMH) invites applications for Centers for Behavioral Science Research in Mental Health (CBSR). The purpose of these Centers is to provide integrated multidisciplinary research environments in which to pursue focused questions in basic behavioral science related to mental health and mental disorder. This mechanism is intended to encourage investigators from a variety of disciplines and approaches to contribute the full range of expertise and advanced technologies available in basic behavioral science toward the understanding of mechanisms underlying mental health and mental illness, and to begin the translation of basic behavioral findings and techniques to relevant clinical issues. 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 Program Announcement (PA), "Centers for Behavioral Science Research in Mental Health," is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic public and private organizations, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Racial/ethnic minorities, women, and persons with disabilities are encouraged to apply as Center Directors and/or Principal Investigators. MECHANISM OF SUPPORT A CBSR will be supported by the Center grant mechanism (P50), which provides funding for multidisciplinary and multi-investigator approaches to the investigation of specific and complex research problems requiring the application of diverse expertise and methodologies. FUNDS AVAILABLE It is estimated that up to $3.25 million total costs will be available across fiscal years 1998 and 1999 to support up to five new or competing centers, with an anticipated average annual total cost (including indirect costs) of approximately $650,000 per award. A maximum of three new or competing centers will be funded in either year. The exact amount of funding available will depend on appropriated funds, the quality of applications, and program priorities at the time of award. No plans exist currently for funding any new or competing centers after 1999. Support under this Program Announcement may be requested for a project period of up to 5 years. Previously supported NIMH Centers for Behavioral Science Research may submit competing renewal applications in response to this Program Announcement. Individual centers will be limited to a maximum of ten years of total support. RESEARCH OBJECTIVES Background The basic behavioral sciences are comprised of a number of fields, including psychology, sociology, anthropology, and linguistics; each of these fields encompasses a number of sub-fields that, in turn, are associated with a broad range of conceptual and methodological strategies. There also are a number of different levels of analysis for addressing research questions in behavioral science, including social experience and behavior (e.g., culture, interpersonal and group interaction), individual psychological processes and characteristics (e.g., cognition, emotion, personality), and biological processes that influence and are influenced by behavioral phenomena (e.g., brain function, autonomic and hormonal systems, genetics). Available methods and technologies also cover a wide range, including performance measures, subjective report, behavioral observation, and detailed psychophysiological assessments. There are two goals of the CBSR. The first goal is to foster integration among the various basic behavioral science approaches in order to provide a fuller understanding of mental health. In so doing, this program aims to promote the scientific advances and opportunities that are made possible by cross-disciplinary collaboration and the cross-fertilization of approaches. The second goal is to begin the process of translating basic behavioral findings and techniques from the laboratory or the field to more applied mental health arenas by including in each Center some examination of relevant clinical, preventive, or services issues related to mental health and disorder. The components of a Center that address these issues of clinical translation are expected to be limited in scope and to enhance (but not to eclipse) the overall basic-science thrust of the Center. NIMH also will be interested in the separate submission of more clinically-relevant R01-type applications that may emerge from a CBSR's beginning efforts at translation. Center Characteristics A CBSR is expected to address critical questions in basic behavioral science research through multidisciplinary, integrative, and highly focused research programs. A CBSR is characterized as follows: The Center should be conceptualized and organized according to a broad multidisciplinary framework. In the design and execution of the research program, expertise and technological support must be available to address social, psychological, and biobehavioral levels of analysis. It is not necessary for each constituent research project to involve all three levels, but they all must be represented in the Center as a whole, and the overarching Center goal must be to foster their integration. Research questions addressed must concern basic behavioral processes and mechanisms that are important to understanding mental health. A limited set of research questions must be directed towards beginning translational research. Such questions may involve the linkage of basic behavioral science knowledge and methods to issues relevant to prevention, treatment, or mental health services. Research on basic behavioral processes that utilizes populations characterized by specific risk factors or clinical diagnoses also may be relevant. The research must propose novel approaches and must not duplicate work that is currently grant supported. The CBSR Director must have a demonstrated capability to organize, administer, and direct the Center. This individual should be the scientific leader of the Center and thus must also be the Principal Investigator on at least one of the projects and have a minimum time commitment of 30 percent to the Center grant. A CBSR must provide research apprenticeship opportunities for junior investigators who have the potential for independent research careers to become skilled in the strategies, approaches, and techniques of modern behavioral science research. At least two Research Apprenticeships must be made available each year. In addition, there should be close coordination between the Center and relevant predoctoral and/or postdoctoral research training programs of the institution. A CBSR should be conceptualized and defined by its integrative, multidisciplinary nature and need not be limited by geographical or departmental boundaries. A research team may consist of investigators or institutions that are geographically distant, to the extent that the research design requires and accommodates such arrangements. Research Areas The following are examples of broad basic behavioral science research areas related to the NIMH research mission that could be supported by this program. The list is not comprehensive. Attitudes, persuasion, stereotyping Emotion and mood Group identity and behavior, including multi-ethnic and minority issues Interpersonal interactions and processes Language and communication Learning and memory Marital and family relationships Motor control and skill Personality/individual differences; gender differences Reasoning; problem-solving; decision-making; planning Sensation and perception Sexual and reproductive behavior Societal and cultural influences on behavior Stress, coping, and adaptation Sleep and circadian rhythms In keeping with the integrative, multidisciplinary emphasis of the CBSR, it is very important that attention be given to connections across these various domains and processes, e.g., links between emotion and learning or memory, between interpersonal interactions and physiological reactivity, or between group identity and decision- making. Developmental approaches to understanding these domains and processes also are of interest. In addition to human studies, animal models are appropriate. Also appropriate are theoretical and mathematical modeling approaches. Activities Supported To provide a suitable structure for achieving objectives of this program, a Center may request funds for the following: Individual Research Projects: Funds must be requested to support three or more individual research projects. Each project should have the characteristics of a traditional research grant (R01) as well as demonstrating a significant integrative contribution to the CBSR. Cores: Funds may be requested for "core" support. Each Core must provide essential services to two or more approved Individual Research Projects. Possible Cores include those focused on administrative, subject recruitment, measurement, or data management/analysis issues. Core support may involve salaries, research resources to be shared across projects, equipment needed to conduct the proposed research, and incidental alteration and renovation of facilities consistent with Public Health Service policy. Depending upon the geographical and administrative boundaries of the Center components, there may be one or more Cores. Research Apprenticeships: Funds must be requested to support the supervised research activities of junior faculty, postdoctoral staff, and/or advanced graduate students. These individuals should have high potential for a research career but require further supervised research experience. Salary support, tuition, travel, and research support may be provided. At least two research apprenticeships must be made available each year. Essential Scientific Expertise: To provide the most effective combination of scientific knowledge and skills, applicants may request funds to support scientists to augment or strengthen the skills, expertise, and capabilities of existing staff. Although recruitment of such scientists may take place after the award has been made, the expertise required, the role in Center activities, and the time to be devoted to the Center should be provided in the application. It should be emphasized, however, that after the award is made, such individuals may not serve as a substitute for a Project Principal Investigator. SPECIAL REQUIREMENTS A major requirement for a CBSR is the conduct of multidisciplinary, integrative basic behavioral science research on focused questions related to mental health and mental illness; the nature of these relationships must be stated clearly in the application. The application must describe the hypotheses to be tested and the goals and approaches for the CBSR. In addition, the proposal should clearly articulate the reasons a Center approach is needed for the proposed work as well as the unique benefits that will accrue from a Center. The application should include the following components, in the designated order. Budget: A summary "detailed budget page for the initial budget period" and "budgets for the entire project period" should be included for the proposed CBSR as a whole. In addition, an individual "detailed budget page for the initial budget period" and "budgets for the entire project period" should be included for EACH component (Core(s) plus Individual Research Projects). General Description of the Center (Not to exceed 10 pages): An overview should be provided of the entire proposed Center describing the central theme and goals, and how the Center will achieve its major objectives. The proposed contribution of each of the Individual Research Projects and Core(s) in achieving the objectives of the Center should be explained. Plans for the Research Apprenticeships should be described as well as the methods for selecting qualified individuals. Furthermore, the administrative arrangements and support necessary to effect the research should be carefully described. In particular, when more than one institutional site is involved, a detailed statement and supporting documentation for the cooperative administrative arrangements are required and should be submitted with the application. In addition, detailed information should be provided on collaborations, recruitment, facilities, and resources as well as any expenses anticipated from grant funds for sites with such an arrangement. Cores (Not to exceed 5 pages for any one Core): The applicant should describe how the Core will contribute to the overall goals of the Center as well as how each specific project will draw upon a particular Core. The description of each Core should clearly indicate the facilities, resources, services, and professional skills that the facility will provide. Individual Research Projects (Not to exceed 10 pages for any one project): The major research objectives and goals of each project, its integration with the other projects, and its relationships to the overall Center should be described. In addition, detailed descriptions should be provided on the following: a. Research Plan: The questions to be addressed and the hypotheses to be tested by the proposed research should be highly focused and fully explained. Full discussion is required on the status of current research efforts (both within the Center and elsewhere) addressing this issue, the limitations of existing approaches, and why the research necessitates a multidisciplinary, integrative approach. b. Method: The description of the design, methodology, and data management and analysis plan should outline the strategies proposed to accomplish the specific aims of the project, and should include a discussion of the innovative aspects of the approach. The experimental procedures need not be spelled out in great detail if those procedures have already been extensively published and widely accepted by the scientific community. In contrast, any new methodology and its advantage over existing methodologies should be fully described. Furthermore, the feasibility of the proposed studies, the potential pitfalls, relevant alternative approaches should changes become necessary, and their relevance to the goals of the Center should be fully discussed. The methods to be used should be cited and referenced. It should be emphasized that this necessitates the inclusion of investigators that are considered to be leaders in their fields and whose studies are widely published and accepted by the scientific community. c. Operational Plan: A description of the resources and working arrangements required to implement the research plan should be fully elaborated. A detailed description should be given of all research components. A distinction must be made between those resources that already are in place (including staff) and those resources that must be added to complete the proposed research. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are encouraged to submit, by January 5, a letter of intent. that includes a descriptive title of the proposed Center, the name, address, and telephone number of the Center Director, the identities of other key personnel and participating institutions and the number and title of the PA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIMH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Mary Ellen Oliveri at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone (301) 435-0714; fax (301) 480-0525; Email: ASKNIH@ODROCKM1.OD.NIH.GOV. The PA title and number, "PAR-97-104; CENTERS FOR BEHAVIORAL SCIENCE RESEARCH IN MENTAL HEALTH," must be typed in section 2 of the face page of the application form and the YES box must be marked. Applicants responding to this Program Announcement are advised that they must contact the program director (Dr. Oliveri at the address listed under INQUIRIES) prior to submitting an application, if they will be requesting direct costs in excess of $500,000 in any year. If agreement from NIMH is obtained to accept the application for consideration for award, the applicant must indicate this in a cover letter sent with the application, citing the Program Announcement number, the Institute (NIMH), and the NIMH staff contact (Dr. Oliveri, address below). An application subject to this policy that does not contain the required information in the cover letter sent with the application will be returned to the applicant without review. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight mail service) At the time of submission, two additional copies of the application must be sent to: Mary Ellen Oliveri, Ph.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 5600 Fishers Lane, Room 18C-26 Rockville, MD 20857 Telephone: (301) 443-3942 FAX: (301) 443-4822 E-mail: MOLIVERI@NIH.GOV Applications must be received by the March 23, 1998 and March 23, 1999. If an application is received after the date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Schedule Fiscal Year 1998 Letter of Intent Receipt Date: January 5, 1998 Application Receipt Date: March 23, 1998 Administrative review: March-April 1998 IRG review: May-June 1998 Advisory Council Review: September 1998 Anticipated Start Date: September 30, 1998 Fiscal Year 1999 Letter of Intent Receipt Date: January 5, 1999 Application Receipt Date: March 23, 1999 Administrative Review: March-April 1999 IRG review: May-June 1999 Advisory Council Review: September 1999 Anticipated Start Date: September 30, 1999 REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness, and by the NIMH to determine if they satisfy the objectives and requirements of a CBSR as outlined in this program announcement Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. Review Criteria Criteria for review of CBSR applications will include the following: Intrinsic merit: The overall quality, scientific merit, relevance to mental health/illness, and innovation of the research to be done; the likelihood that the work will lead to fundamental advances within the field, to new discoveries, and/or to new technological developments. In addition, the research conducted must center around a highly focused and well-defined research problem. Appropriateness of the Center approach: The need for and suitability of the Center approach; whether a Center approach will add significantly to what could be accomplished through other modes of research support. In this respect, the integration of component projects is of utmost significance and should be described explicitly. Research competence: The qualifications and scientific credentials of the Center Director and constituent project directors will be considered. It is expected that these individuals will be regarded by their peers as leaders in their respective fields. Center Director credentials: Ability of the Center Director to organize, direct, and administer the Center and, in addition, be the principal investigator on at least one of the proposed projects. It is expected that this individual will devote a minimum of 30 percent time to the Center grant. Thus, the Director must by necessity be the scientific leader of the Center. Institutional commitment: The nature and level of resource commitments and resources available from the home institution and >From other participant institutions; and plans for interactions with the rest of the sponsoring institution. Appropriateness of management plans and arrangements: The feasibility and adequacy of the organizational and administrative plans; the appropriateness of the budget; and the mechanisms to evaluate the Center's progress. Quality of plans for Research Apprenticeships: The effectiveness of approaches used to attract and involve junior investigators and students who show potential for significant contributions and independent research careers. Quality of linkages between the proposed Center and ongoing training programs in the institutional environment. Human and animal subjects: Adequacy of the Center's plans for the protection of human and animal subjects. Gender and minority concerns: Adequacy of the Center's plans to address gender and minority issues in the proposed research. AWARD CRITERIA Potential to advance the field Scientific merit of the research program as determined by peer review Responsiveness to the purposes and objectives outlined in this PA Availability of research funds and the competing demands of other research funding requirements The P50 grant supporting a Center for Behavioral Science Research in Mental Health is not transferable to another institution. INQUIRIES Inquiries from potential applicants are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct and inquiries regarding programmatic issues and address the letter of intent to: Mary Ellen Oliveri, Ph.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 5600 Fishers Lane, Room 18C-26 Rockville, MD 20857 Telephone: (301) 443-3942 FAX: (301) 443-4822 Email: MOLIVERI@NIH.GOV Direct inquiries regarding fiscal matters to: Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 Email: Diana_Trunnell@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. 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. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Sep 04 23:00:00 1997 Path: biosci!biosci!not-for-mail From: "Josef P. Magyar" Newsgroups: bionet.sci-resources Subject: mouse-human fusion cell lines Date: 5 Sep 1997 11:22:08 -0700 Organization: Institute of cell Biology, Swiss Federal Institute of Technology Lines: 18 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <340BDD31.590F2759@cell.biol.ethz.ch> NNTP-Posting-Host: net.bio.net We are looking for a cell fusion library containig characterised human chromosomes e.g. chromosome 1 or 2 etc. Could anybody provide this, or give a source for it ? Please reply to the eMail address indicated below (I will post it afterwards to the discussion group) -- ********************************************* * Silvio Hemmi, PhD * Molecular Biology I * University of Zuerich * ETH-Hoenggerberg, HPM D5 * CH-8093 Zurich, Switzerland * Tel +41/1/633 24 93 * eMail hemmi@molbiol.unizh.ch ********************************************* From owner-sci-resources@net.bio.net Fri Sep 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 30, pt. 1of1, 5 September 1997 Date: 5 Sep 1997 18:56:15 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 685 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5uqd7v$bbd@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 30 - September 5, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** IMMIGRANT ELIGIBILITY PROVISIONS OF THE PERSONAL RESPONSIBILITY AND WORK OPPORTUNITY RECONCILIATION ACT OF 1996 (PRWORA), P.L. 103-193 National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NOTICE OF LEGISLATIVE AND ADMINISTRATIVE CHANGES National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** MUCOSAL IMMUNITY IN PATHOGENESIS/PREVENTION OF HUMAN DISEASE (PA-97-073) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 11/25/97 ************************************************* CANCER RESEARCH NETWORK ACROSS HEALTH CARE SYSTEMS (RFA CA-97-017) National Cancer Institute INDEX: CANCER $$INDEX R2 11/25/97 ************************************************* LONG-TERM CANCER SURVIVORS: RESEARCH INITIATIVES (RFA CA-97-018) National Cancer Institute INDEX: CANCER $$INDEX P1 ********************************************************** HIV PATHOGENESIS IN WOMEN'S INTERAGENCY HIV STUDY (WIHS) (PA-97-105) National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Cancer Institute National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Neurological Disorders and Stroke Office of Research Women's Health INDEX: ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; DRUG ABUSE; CANCER; DENTAL RESEARCH; DIABETES, DIGESTIVE, KIDNEY DISEASES; NEUROLOGICAL DISORDERS, STROKE; WOMEN'S HEALTH The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the NIH gopher (gopher.nih.gov) and the NIH website (http://www.nih.gov). Alternative access is through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing grant applications submitted to the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact aid which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAs, AND RFAs IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 26, Number 30, September 5, 1997 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made a final finding of scientific misconduct in the following cases: Jill A. London, Ph.D., University of Connecticut Health Center: Based upon a report from the University of Connecticut Health Center as well as information obtained by the Office of Research Integrity (ORI) during its oversight review, ORI found that Dr. London, former Assistant Professor, Department of Biostructure and Function, School of Dental Medicine, University of Connecticut Health Center, engaged in scientific misconduct by intentionally falsifying data in conjunction with applying for and reporting research supported by the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH). Specifically, ORI found that Dr. London~s grant applications and articles contained numerous falsifications, including (1) Figures 6, 7, and 8 in a paper (London, J.A. & Cohen, L.B. ~High time resolution, multi-site optical measurement of vertebrate somatosensory cortex during epileptiform discharges and vertebrate gustatory cortex.~ Optical Methods in Neurobiology, pp. 61-78, 1988.) prepared for the 11th Annual Meeting of the European Neuroscience Association (hereafter referred to as the European Neuroscience paper) that cited support by NINDS, NIH grants R01 NS08437 and P01 NS16993; (2) Figure 1A in a paper (London, J.A., ~Optical recording of activity in the hamster gustatory cortex elicited by electrical stimulation of the tongue.~ Chemical Senses 15:137-143, 1990.) that cited support by NINDS, NIH grants R01 NS08437 and P01 NS16993; Figure 1A was found to be very similar or identical to Figure 7 of the European Neuroscience paper in #1 above; (3) Figures 10 to 13 in grant application 2 P50 DC00168-14, ~Connecticut Chemosensory Clinical Research Center,~ submitted to NIDCD, NIH on January 28, 1994; these figures also appear as Figures 4 to 7 in grant application 2 P50 DC00168-14A1, submitted to NIDCD, NIH on September 28, 1994; (4) Figures 2, 8, and 9 in grant application 1 R01 DC01752-01, ~Optical recording of hamster gustatory cortex activity,~ submitted to NIDCD, NIH on January 29, 1992; these figures were the same as Figures 11, 12, and 13, respectively, in grant application 2 P50 DC00168-14 (see #3 above); (5) figures supplied for Figures 1 and 3 in grant application 1 F32 NS09601-01, ~Modular response patterns in hamster gustatory cortex,~ submitted to NINDS, NIH on August 3, 1993; these figures were the same as Figures 10 and 11, respectively, in grant application 2 P50 DC00168-14 (see #3 above); (6) Figure 3 of a handout that Dr. London provided during an NIH site visit on April 25, 1994, conducted in conjunction with the review of grant application 2 P50 DC00168-14; the top and bottom portions of Figure 3 of the site visit handout were very similar or identical to Figures 6 and 7, respectively, of the European Neuroscience paper (see #1 above), and approximately 115 of the 125 traces appearing in each of the figures showed identities, with one or two ~active~ traces being identical; (7) Figures 1, 2, and 3 in a paper (London, J.A. & Wehby, R.G. ~Classification of inhibitory responses of hamster gustatory cortex.~ Brain Research 666:270-274, 1994.) that cited support by NIDCD, NIH grants P50 DC00168 and T32 DC00025; and (8) nine figures included in a manuscript (London, J.A. & Wehby, R.G. ~Excitatory neural responses in the hamster gustatory cortex.~ Submitted to Brain Research, 1996.) that cited support by NIDCD, NIH grants P50 DC00168 and T32 DC00025. Dr. London has accepted the ORI finding and has entered into a Voluntary Exclusion Agreement with ORI in which she has voluntarily agreed, for a period of five (5) years, beginning August 8, 1997: (1) to exclude herself from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government as defined in 45 C.F.R. Part 76 (Debarment Regulations); and (2) to exclude herself from serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. Dr. London is required to submit a letter to o Chemical Senses requesting a retraction of the following article: London, J.A. ~Optical recording of activity in the hamster gustatory cortex elicited by electrical stimulation of the tongue.~ Chemical Senses 15:137-143, 1990; o Brain Research requesting a retraction of the following article: London, J.A., & Wehby, R.G. ~Classification of inhibitory responses of the hamster gustatory cortex.~ Brain Research 666:270-274, 1994; and o Optical Methods in Neurobiology requesting a retraction of Section V, Results -- Hamster of the following article: London, J.A., & Cohen, L.B. ~High time resolution, multi-site optical measurement of vertebrate somatosensory cortex during epileptiform discharges and vertebrate gustatory cortex.~ Optical Methods in Neurobiology, pp. 61-78, 1988, prepared for the 11th Annual Meeting of the European Neuroscience Association. Shoushu Jiao, M.D., University of Wisconsin: Based upon reports from the University of Wisconsin as well as information obtained by the Office of Research Integrity (ORI) during its oversight review, ORI found that Dr. Jiao, former Research Associate, Department of Pediatrics, University of Wisconsin, engaged in scientific misconduct by falsifying and creating laboratory records while conducting biomedical research. The data in these records were reported in a National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) grant application to support a request for Public Health Service (PHS) funding. Based on the factual findings in the reports, the following article has been retracted: Jiao, S., Gurevich, V., & Wolff, J.A. ~Long-term correction of rat model of Parkinson~s disease by gene therapy.~ Nature 362:450-453, 1993. Dr. Jiao has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed: (1) to exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of four (4) years, beginning on August 8, 1997. (2) to exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government as defined in 45 C.F.R. Part 76 (Debarment Regulations) for a period of three (3) years, beginning on August 8, 1997; and (3) that any institution that submits an application for PHS support for a research project on which Dr. Jiao~s participation is proposed, uses him in any capacity on PHS supported research, or submits a report of PHS-funded research in which he is involved must concurrently submit a plan for supervision of his duties to the funding agency for approval for a period of one (1) year following the three (3) year exclusion. The supervisory plan must be designed to ensure the scientific integrity of Dr. Jiao~s research contribution. The institution also must submit a copy of the supervisory plan to ORI. INQUIRIES For further information contact: Acting Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** IMMIGRANT ELIGIBILITY PROVISIONS OF THE PERSONAL RESPONSIBILITY AND WORK OPPORTUNITY RECONCILIATION ACT of 1996 (PRWORA), P.L. 103-193 NIH GUIDE, Volume 26, Number 30, September 5, 1997 P.T. 34; K.W. 1004006 National Institutes of Health This notice provides information on the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), P.L. 104-193, which restricts the access of certain categories of immigrants to specified Federal benefits. Since this Act affects some benefits administered by the Department of Health and Human Services (HHS), HHS has issued guidance on certain immigrant eligibility provisions of the PRWORA. Effective August 26, 1997, HHS has adopted an interpretation on Section 403 of the PRWORA. Section 403 of PRWORA bars most qualified aliens who enter the U.S. on or after the enactment (August 22, 1996) from being eligible for ~Federal means-tested public benefits~ for five years. Under HHS interpretation, ~Federal means- tested public benefits~ include only those benefits provided under the means-tested, mandatory spending programs. The only HHS programs meeting this definition include Medicaid and Temporary Assistance for Needy Families (TANF) Block Grants (the successor to the AFDC program). No NIH programs meet the ~Federal means-tested public benefits~ criterion for purposes of PRWORA. Therefore, all qualified aliens, regardless of when they entered the U.S., may continue to be eligible to participate in programs supported by the National Institutes of Health if they meet other program requirements. Guidance on other immigration-related issues is still under consideration. HHS is currently analyzing these complex provisions to determine their impact on numerous programs and services. Further information will be provided as issues are resolved. For detailed information concerning this notice, please refer to The Federal Register, Volume 62, Number 165, Pages 45,256 - 45,258, August 26, 1997. If additional questions remain, please contact your awarding grants or contracts management office in the NIH Institutes and Centers. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NOTICE OF LEGISLATIVE AND ADMINISTRATIVE CHANGES NIH GUIDE, Volume 26, Number 30, September 5, 1997 P.T. 34; K.W. 1014006 National Institutes of Health The purpose of this Notice is to provide information on recent legislative changes, administrative requirements and Executive Orders that impact NIH grantees. There are no additional reporting requirements required by these changes. 1. Military Recruiting and Reserve Officer Training Corps Program Access to Institutions of Higher Education Effective March 29, 1997, the Department of Defense adopted an interim rule to implement Section 514 of the Omnibus Consolidated Appropriations Act of 1997 (see ~NOTICE OF LEGISLATIVE MANDATES CONTAINED IN THE OMNIBUS CONSOLIDATED FISCAL YEAR 1997 APPROPRIATIONS ACT, P.L. 104-208, SIGNED SEPTEMBER 30, 1996", NIH GUIDE, Volume 26, Number 4, February 7, 1997). The rule prohibits NIH from providing funds to educational institutions that have a policy or practice (regardless of when implemented) that either prohibits, or in effect prevents (1) the maintaining, establishing, or operation of a unit of the Senior Reserve Officer Training Corps at the covered education entity; or (2) a student at the covered educational entity from enrolling in a unit of the Senior Reserve Officer Training Corps at another institution of higher education. Under the same rule, NIH is prohibited from providing funds to educational institutions that have a policy or practice that prohibits or prevents (1) entry to campuses, or access to students (who are 17 years of age or older) on campuses, for purposes of Federal military recruiting; or (2) access by military recruiters for purposes of Federal military recruiting to information pertaining to students (who are 17 years of age or older) enrolled at the covered educational entity. The adopted rule implements the law, and is effective March 29, 1997. Additional information on this topic can be found at gopher://gopher.legislate.com:70/11/regs/590/590178. 2. Implementation of the President~s Welfare-to-Work Initiative for Federal Grant Employees On March 8, 1997, the President issued a memorandum to the heads of the executive departments and agencies entitled "Government Employment for Welfare Recipients." This memorandum directs all Federal agencies to hire people off the welfare rolls into available job positions in the Government. To supplement this initiative, Federal agencies have been asked to encourage all grantees and their subrecipients to hire welfare recipients and to provide additional training and/or mentoring to hired welfare recipients. Additional information on the Welfare-to-Work initiative and hiring of welfare recipients, including the allowability of training costs, available Federal tax credits, and examples of successful private sector initiatives, can be found at http://www.whitehouse.gov/WH/EOP/OMB/html/fedreg/omb-not.html. 3. Seat Belt Use by Grantees - Executive Order 13043 On April 16, 1997, the President issued Executive Order 13043, "Increasing Seat Belt Use in the United States." In support of this Order, the NIH encourages all grantees to adopt and enforce on-the- job seat belt policies and programs for their employees when operating company-owned, rented, or personally owned vehicles. The text of the notice, and additional details on this issue can be found at: gopher://gopher.legislate.com:70/11/regs/591/591354. Appropriate links to related regulations and policies have been provided with the copy of this notice published on the NIH Homepage. If additional questions remain, please contact your awarding grants or contracts management office in the NIH Institutes and Centers. $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** MUCOSAL IMMUNITY IN PATHOGENESIS/PREVENTION OF HUMAN DISEASE NIH GUIDE, Volume 26, Number 30, September 5, 1997 PA NUMBER: PA-97-073 P.T. National Institutes of Health This notice is an addendum to Program Announcement PA-97-073, MUCOSAL IMMUNITY IN PATHOGENESIS/PREVENTION OF HUMAN DISEASE, which was published in the NIH Guide for Grants and Contracts, Vol. 26, No. 23, July 18, 1997. The National Institute of Child Health and Human Development (NICHD) is also a sponsor of this program announcement. The NICHD was inadvertently omitted from the PA. The NICHD staff contact for electronic and telephone is listed below and inquiries regarding programmatic (research scope and eligibility) issues are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. National Institute of Child Health and Human Development Allan Lock, D.V.M. Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: LockA@hd01.nichd.nih.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN CA-97-017 FULL-TEXT ************************************** CANCER RESEARCH NETWORK ACROSS HEALTH CARE SYSTEMS NIH GUIDE, Volume 26, Number 30, September 5, 1997 RFA AVAILABLE: CA-97-017 P.T. National Cancer Institute Letter of Intent Receipt Date: October 17, 1997 Application Receipt Date: November 25, 1997 PURPOSE A Request for Applications is available to encourage the expansion of collaborative cancer research among health care provider organizations that are oriented to community care, have access to large, stable and diverse patient populations and are able to take advantage of existing integrated data-bases that can provide patient-level information relevant to research studies on cancer control and cancer-related population studies. Health care provider organizations range from traditional staff model health maintenance organizations (HMO) to extended health care networks associated with academic medical centers. A CRN would consist of a research network of such health care provider organizations that possess in-house clinical research capacity, that collaborate with other provider organizations with such capacity, or with clinical researchers affiliated with academic health centers. A CRN should consist of diverse members drawn from a number of financially autonomous and managerially distinct organizations. Up to two awards are anticipated. A total of $16.8 million is set aside to fund applications submitted in response to this solicitation (first year funding is $4 million). 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, CANCER RESEARCH NETWORK ACROSS HEALTH CARE SYSTEMS, is related to multiply priority areas, including cancer surveillance and data systems. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), and the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and E-mail from the program contact listed below. Martin Brown, Ph.D. Applied Research Branch National Cancer Institute 6130 Executive Boulevard, Room 313 Bethesda, MD 20892-7344 Telephone: (301) 496-5716 FAX: (301) 435-3710 Email: mb53o@nih.gov $$R1 END ************************************************************ $$R2 BEGIN CA-97-018 FULL-TEXT ************************************** LONG-TERM CANCER SURVIVORS: RESEARCH INITIATIVES NIH GUIDE, Volume 26, Number 30, September 5, 1997 RFA AVAILABLE: CA-97-018 P.T. National Cancer Institute Letter of Intent Receipt Date: October 24, 1997 Application Receipt Date: November 25, 1997 PURPOSE The National Cancer Institute invites research grant applications to identify important areas that have an impact on long term survivors of cancer. The purpose of this RFA is to support research that will lead to a decrease in the physiologic and psychological morbidity associated with long term (more than 5 years) survival after cancer treatment. Questions related to the experience of the cancer survivor encompassing both physiologic and psychological variables are to be explored and interventions to promote positive outcomes evaluated where appropriate. This RFA is not intended to address questions that explore differences between survivors and non-survivors that may be linked to mechanisms of disease progression or genetic predisposition. The estimated funds (total costs) available for the first year of support for awards under the RFA will be $3,000,000. Pending receipt of a sufficient number of applications of high scientific merit, the NCI intends to fund a total of approximately 12 to 15 awards in response to the RFA in FY98. This RFA will use the National Institutes of Health (NIH) Research Project Grant (R01), the Small Grant (R03) and the FIRST (R29) award. The total project period for an application submitted in response to this RFA may not exceed 5 years. The small grant (R03) is limited to 2 years. 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, Long-Term Cancer Survivors: Research Initiatives, is related to the priority area of long term and late effects of cancer and its treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), and the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and E-mail from the program contact listed below. Claudette G. Varricchio DSN, RN, FAAN Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Room 300 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: varriccc@dcpcepn.nci.nih.gov $$R2 END ************************************************************ $$P1 BEGIN PA-97-105 FULL-TEXT ************************************** HIV PATHOGENESIS IN WOMEN'S INTERAGENCY HIV STUDY (WIHS) NIH GUIDE, Volume 26, Number 30, September 5, 1997 PA AVAILABLE: PA-97-105 P.T. National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Cancer Institute National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Neurological Disorders and Stroke Office of Research Women's Health PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Cancer Institute (NCI), the National Institute of Dental Research (NIDR), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Neurological Disorders and Stroke (NINDS) and the Office of Research on Women's Health (ORWH) invite applications for studies on HIV Pathogenesis in the Women's Interagency HIV Study (WIHS). 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 Program Announcement (PA), "HIV PATHOGENESIS IN WOMEN'S INTERAGENCY HIV STUDY (WIHS)", is related to the priority area(s) of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contacts listed below. NIAID: Paolo G. Miotti, M.D., M.P.H. Telephone: (301) 496-9176 FAX: (301) 402-3211 Email: pm122m@nih.gov NICHD: David Burns, M.D., M.P.H. Telephone: (301) 496-7339 FAX: (301) 496-8678 Email: db98d@nih.gov NIDA: Katherine Davenny, Ph.D. Telephone: (301) 443-1801 FAX: (301) 443-2317 Email: kd25h@nih.gov NCI: Sandra Melnick, Dr.P.H. Telephone: (301) 435-4914 FAX: (301) 402-4279 Email: sm33k@nih.gov NIDR: Maryann Redford, D.D.S., M.P.H. Telephone: (301) 544-5588 FAX: (301) 480-8254 Email: mr48a@nih.gov NIDDK: Judith Fradkin, M.D. Telephone: (301) 594-8814 FAX: (301) 480-3503 Email: jf58s@nih.gov NINDS: A.P. Kerza-Kwiatecki, Ph.D. Telephone: (301) 496-1431 FAX: (301) 402-2060 Email: ak45w@nih.gov ORWH: Joyce Rudick Telephone: (301) 402-1770 FAX: (301) 402-1798 Email: jr27q@nih.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Fri Sep 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-017 - V26(30) 09/05/97 Date: 5 Sep 1997 18:56:32 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1061 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5uqd8g$bc5@net.bio.net> NNTP-Posting-Host: net.bio.net CANCER RESEARCH NETWORK ACROSS HEALTH CARE SYSTEMS NIH GUIDE, Volume 26, Number 30, September 5, 1997 RFA: CA-97-017 P.T. National Cancer Institute Letter of Intent Receipt Date: October 17, 1997 Application Receipt Date: November 25, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to encourage the expansion of collaborative cancer research among health care provider organizations that are oriented to community care, have access to large, stable and diverse patient populations and are able to take advantage of existing integrated data-bases that can provide patient-level information relevant to research studies on cancer control and cancer-related population studies. Health care provider organizations range from traditional staff model health maintenance organizations (HMO) to extended health care networks associated with academic medical centers. A CRN would consist of a research network of such health care provider organizations that possess in-house clinical research capacity, that collaborate with other provider organizations with such capacity, or with clinical researchers affiliated with academic health centers. A CRN should consist of diverse members drawn from a number of financially autonomous and managerially distinct organizations. In this RFA, organizations which affiliate for research purposes as components of the Cancer Research Network will be referred to as CRN members. The Division of Cancer Control and Population Studies (DCCPS), National Cancer Institute, invites applications for cooperative agreements to develop and support a cancer research infrastructure, consisting of 1 or more networks, composed of health care provider organization researchers who will be capable of conducting studies of cancer epidemiology, treatment, and prevention and control. The central objective of this RFA is to encourage cancer research uniquely well-suited to the research interests and strengths of researchers affiliated with health care provider organizations as well as of high priority to NCI. The RFA is also intended to encourage collaboration between researchers based as health care provider organizations and researchers affiliated with academic medical centers. 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), Cancer Research Networks Across Health Care Systems, is related to multiple priority areas, but centrally related to cancer surveillance and data systems. 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 202-512-1800). ELIGIBILITY REQUIREMENTS The CRN will be led by a Principal Investigator, a researcher affiliated with one of the CRN members, who will coordinate of overall activities of the CRN. Each CRN member will also be represented by a co-Principal Investigator, who may also be designated as lead researcher on one or more of the specific research projects of the CRN. The organizational entity with which the CRN Principal Investigator is affiliated will be the awardee institution for this RFA and the lead institution for the CRN. The application must name the CRN Principal Investigator, co-Principal Investigators and the respective CRN organizational members. Applications may be submitted by domestic for-profit and non-profit health care provider organizations (network members) acting jointly as a U.S. research network. A domestic application may not include an international component. Networks must include a sufficient number of health care provider organization members, such that total patient enrollment is at least 2 million adults (ages 18 and over). Also, network covered populations must include diverse populations with respect to gender, race/ethnicity and, to the extent that is it practical, rural/urban and geographic location. Applicants must demonstrate a shared commitment among all participating network members to working together on proposed research studies. Applicants must show evidence of ability to access and organize data collection from all participating network members. Applicants are encouraged to demonstrate the capability of data linkages with local centralized tumor registries, pathology and radiologic facilities, and state vital records. If these capabilities do not currently reside within one or more of the network members, the applicant may assemble a group with plans to develop the necessary expertise across all network members. Each network member must have access to a resource unit that supports research data management locally or centrally. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. (The U19 is a program project cooperative agreement. Therefore, the NCI Program Project Guidelines must be used in the preparation of applications in response to this RFA [vide infra]). Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed 4 years. The anticipated award dates will be Summer 1998. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is included in the financial plans of the National Cancer Institute, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time, the National Cancer Institute has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this program is $4 million. It is anticipated that 1 or 2 applicants will receive awards. RESEARCH OBJECTIVES The purpose of this RFA is to enhance research on cancer epidemiology, prevention, early detection and control in the context of health care delivery systems. To accomplish this, the initiative will support the development of research capabilities across multiple healthcare provider organizations for the conduct of cancer research projects. The CRN will accomplish two major objectives: - Formulate and implement a joint CRN research agenda resulting in the conduct of three or more specified research projects in selected areas of cancer control and population studies. - Develop standardized data collection instruments, surveys and analytical methods to promote the development of consistent and uniform data bases, and other research materials that can be shared across member institutions and utilized in joint research projects using uniform protocols when appropriate. Meeting these research objectives will be facilitated by ongoing meetings and communication. These meetings would be structured to foster collaboration between clinical practice and research personnel within individual CRN organizations, between researchers at different CRN organizations and between CRN researchers, researchers affiliated with academic medical centers and NCI. In accomplishing these objectives NCI anticipates the development of increased cancer research capacity through increased sharing of specific expertise, thereby raising research competence of all CRN members. This would enable more CRN based researchers to participate more fully in existing NCI-sponsored research mechanisms, such as CCOPs and Cooperative Groups and to collaborate with NCI-sponsored cancer centers. Background The National Cancer Institute has long supported a program of research in cancer control that is designed to identify promising innovations in cancer prevention, detection, treatment and rehabilitation and to demonstrate, through controlled studies, which interventions are efficacious. As cancer control research matures there is a growing need to identify existing patient care settings and existing data resources that will facilitate the conduct of cancer control translational research. Once efficacy for specific interventions has been demonstrated in selected populations, research on effectiveness in larger, more diverse populations found in representative community settings is essential to ensure the full benefit of the intervention is realized. Efficacy, which denotes how well the intended objectives of a procedure or treatment are realized in ideal settings, such as a research trial, is a necessary but not sufficient prerequisite of effectiveness. Effectiveness implies that an efficacious intervention is also feasible and can be replicated in diverse settings at reasonable economic cost. Settings that capture large, diverse care populations also constitute a valuable resource for conducting studies of primary prevention interventions, novel methods of early detection and interventions designed to increase the quality-of-life and reduce the risk of recurrent disease in cancer survivors. In order to conduct studies of effectiveness at the national level, it is necessary to capture a large and diverse patient population with adequate representations of individuals by age, gender, income, education, minority status and urban/rural and geographical locations. Sample size requirements will vary from study to study, but many studies may require a CRN population of a few million persons. This would be true of many studies that require cancer incidence, stage-at-diagnosis, survival, or cancer patterns of care as study endpoints. For example, a health care provider organization with a membership of one million individuals over the age of 18 would expect about 750 newly diagnosed breast cancer cases each year and about 133 deaths from breast cancer. Much smaller numbers of cases would be expected for specific sub-populations that may be of interest or for the less common cancer sites. Effectiveness research often requires large and diverse populations because the effectiveness of an intervention may vary as a function of such individual characteristics as education, income, age, gender and minority status as well as by health care system characteristics. Effectiveness research is greatly facilitated when pre-existing database systems can be used to track, retrospectively or prospectively, longitudinal patterns of health services resource use and clinical outcomes at the individual patient level. While historically less research oriented than academic medical centers, some large health care provider organizations have substantial records of conducting clinical research supported by R01 grants as well as internal funds. There is currently growing interest on the part of provider organizations in participating in clinical research, and there has been rapid development and standardization, among these organizations, of integrated epidemiological-clinical-financial databases that would greatly facilitate the conduct of cancer control research on a large population-based scale. In addition, many academic health centers have developed extensive primary care networks that provide formal links between primary care delivery systems and the research capabilities of traditional academic centers. There is a great diversity in the operation and structure of health care provider organizations. However, certain provider organizations possess characteristics that make them particularly well suited for population-based medical research. This is especially true of provider organizations that have: - Patient populations enrolled in the provider organization over an extended period that are roughly representative of the general population, and that receive most or all of their medical care services through those organizations. - Research resources including qualified and experienced clinical research personnel with institutional access to research-oriented primary care and specialty physicians. - A history and/or willingness to establish collaborative research relationships with clinical research personnel affiliated with academic medical centers. - Practice settings with an emphasis on prevention, detection and treatment of early stage disease. - The capability to track individual patients longitudinally and, by record linkage from diverse sources, to integrate information on patient clinical characteristics with information on behavior, knowledge and attitudes, health status, and medical care use, cost and cancer outcomes. - An organizational structure that facilitates the collection of study specific data on organization members, recruitment of members into intervention trials and demonstration projects, and the linkage of these data with existing patient-specific clinical data. - An emphasis on the practice of evidence-based medicine, with a priority on the public health and welfare of organization members. Objectives and Scope The ultimate purpose of the type of research funded by this RFA is to reduce the burden of cancer morbidity and mortality. Therefore, it is appropriate that studies funded by this RFA focus on cancer sites that are responsible for substantial components of cancer morbidity and mortality. Research funded by this RFA might address any of the diverse areas noted below. The following broad areas are of particular interest: - Studies which address the distribution of preventable cancer risk factors and the burden of disease in the covered population of the CRN; - Studies which evaluate how innovative cancer prevention and control programs, based on rigorous intervention research, can be effectively disseminated throughout and implemented in the context of health care provider systems; - Studies of the relationship between health care delivery system organizational structure and patterns of cancer prevention and control service delivery associated with access to care and favorable outcomes. In addition, research funded by this RFA should be designed to take advantage of the large patient populations and diverse patient care settings, the integrated data systems and the other complimentary research resources made available by the CRN to achieve research objectives that would otherwise be infeasible or prohibitively expensive. Areas of research that would be particularly enhanced by this mechanism include, but are not limited to: Epidemiological Studies - Epidemiological studies in which longitudinal medical records are particularly useful in identifying cancer risk factors, including the potential risks associated with pharmaceuticals, medical devices, and other forms of non- cancer treatment. - Studies of the long-term risk of second cancers or other late effects of cancer treatment. Behavioral Cancer Prevention and Control - Studies of the feasibility, cost-effectiveness and dissemination of efficacious bio-behavioral cancer prevention and control interventions. - Studies of innovative behavioral cancer prevention and control interventions targeted to specific populations in different organization settings, e.g., physician practice, ancillary health personnel, or public education. - Studies of delivery systems for counseling and other approaches used for genetic testing, monitoring for cancer occurrence and preventive interventions.. Evaluation and Methodological Studies Related to Clinical Trials - Research on the costs and benefits to patient enrollees and health care provider institutions that result from participation in NCI or other trials. One purpose of this research is to identify strategies for increasing accrual to NCI trials. - Methodological research on the incorporation of quality- of-life, patient satisfaction and economic endpoints in NCI trials through direct clinical trial data collection or by other methods such as using modeling or other extrapolation methods to make it possible to use retrospective data to supplement the analysis of within-trial data. Survivorship Issues - Studies of indirect costs, quality-of-life, complications and recurrence as a function of treatment approach, care setting and referral patterns. - Studies of interventions to prevent morbidity associated with cancer and its treatment Cancer Control Surveillance and Outcomes Research - Studies of existing patterns of care for cancer prevention, screening, treatment, and rehabilitation in relationship to existing evidence of efficacy, cost-effectiveness, clinical recommendations and practice guidelines. - Studies of the effectiveness of preventive medicine and evidence-based medical practice. - Studies of the diffusion of state-of-the-art cancer prevention, screening, treatment, care and rehabilitation. - Studies of the formulation and implementation of organizational policy regarding the dissemination of innovative technology, e.g., counseling, screening for genetic predisposition to cancer and newly approved advanced diagnostic imaging tools. Clinical Informatic Studies - Studies of the feasibility, effectiveness and cost of using clinical informatic systems to identify, recruit and track organization members for targeted cancer prevention and screening interventions. - Studies of the feasibility, effectiveness and cost of using clinical informatic systems to aid patient/physician decision making for cancer prevention, screening and treatment. - Studies of the feasibility, effectiveness and cost of using clinical informatic systems as an aid to multi-disciplinary management of cancer care. SPECIAL REQUIREMENTS Applications in response to this RFA are required to describe four components: the CRN research agenda component, a research study component consisting of three or more specific research studies, an infrastructure component and an evaluation component. The research agenda component should discuss the theme of the CRN research agenda and the rational for this them. The research study component should describe the specific collaborative studies that the CRN proposes to conduct. The infrastructure component would describe the proposed means by which the CRN would build the collaborative cancer research capacity of the network to support the proposed studies. The evaluation component should describe an evaluation study designed to determine how successful the development of the CRN has been in meeting the goals of this RFA. The following issues should also be addressed in the infrastructure component of the application: CRN Member Characteristics - The nature of health care provider organization patient enrollment for each of the CRN members must be documented. The following characteristics of the enrollment are relevant to the application: - size of enrollment; - geographical location of enrollment; - sociodemographic characteristics of membership (age, gender, race/ethnicity, socioeconomic status, health status); - length and continuity of enrollment (for enrollees with and without a history of cancer); - benefit coverage; - longevity and stability of health care provider organization; - size and composition (practice specialty) of medical staff; - structure (staff model, IPA, point-of-service, etc.); - type and/or proportion of services offered "within plan" and "contracted-out." - The nature of CRN member data systems must be documented. What type of systems are available for the acquisition, storage and analysis of epidemiological, clinical and resource use and cost data? Are data systems automated? How much retrospective data is available? Do capacities exist to link data across CRN members? What planned centralized data coordination or management is in place? What type of data elements can be shared for research purposes? What mechanisms and procedures exist to protect the confidentiality of research subjects. Data Linkage - Linkage to cancer registry. The feasibility and willingness of CRN members to link data to a SEER cancer registry or other population-based (e.g., state cancer registries) or hospital-based tumor registries should be described. Existing linkage to cancer registries should be documented in the application. - Linkage to other data resources. The feasibility and willingness of CRN members to link to other types of data resources, such as registries related to cancer surveillance or genetics, health related survey data, radiology and pathology facilities data, demographic and socioeconomic data, data on use of out-of-plan services, and state vital records should be described. Through letters of intent, or other documentation, the application should demonstrate that the CRN has identified appropriate data resources of value to the overall research goals of the CRN and initiated efforts to implement data linkage with these resources. Research Capacity Development - Research capacity and experience. The institutional research capacity and experience of each member of the CRN must be documented, including the number and qualifications of in-house research staff. All research capacity and experience related to cancer research must be documented, including collaboration with or membership in existing NCI cancer centers, cooperative groups, CCOP research bases, or consortia. Emphasis should be placed on the research capacity and experience which is expected to be most relevant to the activities of the proposed CRN. Individual members of the CRN must demonstrate a capacity and willingness to facilitate professional interaction between research and clinical care staff of the health care provider organization. - The applicant must describe how the activities of the CRN will result in the increased capacity of individual members of the CRN or the CRN as a whole to conduct research under existing NCI mechanisms. Administrative Procedures - The applicant CRN must specify a set of criteria and a process to be used to consider adding new (organizational) members to the CRN, in the event that this warranted by the research needs of the project. Addition of new members would require the consultation and approval of the NCI Program Director. - The applicant must specify a set of criteria and a process to be used to consider extending or modifying research studies initially proposed in the application and approved for funding, and initiating new or related research studies within the scope of the approved award, in the event that such extensions, modifications or initiations are warranted by scientific considerations and can be accommodated by the time schedule and funding of the project (or through various mechanisms that might become available to extend time and/or funding). The proposed process should take the interactive nature of the funding mechanism into account and provide a consultative role for the NCI Program Director and the NCI Review Committee.. It is recommended that the infrastructure component of the study comprise approximately one-third of the (total 4 year) budget of the CRN. The infrastructure component should be designed to meet two goals: support of the specific research studies proposed and development of the general research capacity of the CRN and its affiliated network members. The infrastructure component may include, but is not necessarily limited to, meetings of researchers to share research expertise and engage in joint planning, development of research support personnel, development of standardized data acquisition and processing systems, development of central data coordination centers, and development of communications systems for facilitating interaction between researchers. In the research component of the application the applicant CRN must describe at least three specific research studies planned for the funding period. It is recommended that the research component of the study comprise approximately two-thirds of the (total 4 year) budget of the CRN. The application must include proposals for specific research studies along the lines suggested in the section on Objectives and Scope. All or some sub-group of all CRN network members should be involved in each of the proposed studies. Descriptions for each proposed study should include all the elements that would be included in a standard R01 grant application for a research study, including budget. It is recommended that the evaluation component comprise between 2-5% of the budget of the CRN. The purpose of the evaluation component is to evaluate how well the CRN, and especially the infrastructure component, performs to meet the goals of this RFA. The evaluation component should describe objective criteria and methods for evaluation, including a baseline assessment of the research strengths and weakness of the CRN and individual network members at the beginning of the project and identify existing barriers to network members participation in cancer research activities as well as opportunities for overcoming these barriers through the CRN mechanism. Specific criteria that should be considered in the evaluation are: the extent to which the overall cancer research capacity of the CRN has increased as a result of the funded project, the extent to which cancer research capacity of the network members has been enhanced through the complementary sharing of resources across network members and through collaboration with academic medical center affiliated researchers, the extent to which network members ability to compete for R01 grants and participate in other research mechanisms has been enhanced, the extent to which "research culture" has been engendered and enhanced in the clinical care setting of network members, and the extent to which enduring research-oriented data systems, research methods and collaborative relationships have been established and institutionalized. The evaluation budget should be carefully described and justified for each budget period. To promote the orderly development of a CRN, a number of issues must be addressed in the application. The applicant must describe or propose an organizational structure consisting of a network of health care provider organizations with documented institutional commitment from each member of the proposed CRN to participate in the proposed activities of the CRN. The CRN need not have a centralized physical location, but it must have an identifiable Steering Committee which will work with an NCI Program Director in the context of a Cooperative Agreement. Membership of the Steering Committee shall consist of the CRN Principal Investigator, the co-Principal Investigators of the CRN, and the NCI Program Director. The Steering Committee will convene Working Groups for planning and supervising the specific research activities of the CRN. Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Director, with consultation from other NCI scientists as appropriate.. The inability of an awardee to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in adjustment of funding, withholding of support, suspension or termination of award. 1. Awardee Rights and Responsibilities Awardees will have primary and lead responsibilities for the development and formation of a Cancer Research Network with a central objective to conduct approved research projects and develop standardized data collection instruments, surveys and methods. The Principal Investigator and Co-Principal Investigators associated with each CRN member institution and/or major research project will meet at the initiation of the award with the NCI Program Director to discuss scientific and technical direction and strategies relating to the conduct of specific studies proposed by each Network. CRN members will agree to follow common protocols approved by the Steering Committee. In the event that more than 1 CRN award is made, representatives from all CRNs will meet annually to jointly discuss ongoing research plans and progress. The award recipients are encouraged to provide information to NCI of progress on other funded projects external to the collaborative activities but relating to the activities funded under this RFA. While joint research projects are strongly encouraged under this RFA, research projects conducted at individual CRN member institutions under the supervision of a single Co-Principal Investigator, that otherwise contribute to meeting the goals and objectives of this RFA , are allowed. Co- Principal Investigators of such single institution studies will have equivalent status with all other Co-Principal Investigators in regard to participation on the CRN Steering Committees and other CRN committees. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. All awardees and NCI will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions involved in CRN research projects. No identifying information of individual patients or providers should be available through pooled CRN research databases. Encrypted study identification numbers will be used for all pooled CRN studies. 2. NCI Staff Responsibilities The NCI Program Director will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. a. Establishment of NCI /CRN Review Committee NCI oversight of the CRN will be the responsibility of the NCI Program Director, with the advice of a CRN Review Committee composed of NCI professional staff drawn from relevant NCI Divisions and Programs. The NCI Program Director, or a designated NCI staff person from the NCI CRN Review Committee, will have voting membership on the CRN Steering Committee(s), and, as determined by those committee(s), their subcommittees. The NCI Program Director, with assistance of NCI staff from the Review Committee, will have scientific-programmatic involvement in the conduct of the proposed research studies. The dominant role and prime responsibility for the studies resides with the awardee for the studies as a whole, although specific tasks and activities in carrying out particular studies may be shared among awardees and NCI staff. The NCI Program Director will provide assistance and guidance as needed on an ad hoc basis, in developing shared study protocols among CRN members, selecting data elements, obtaining cooperation from the CRN members, linking databases, and analyzing pooled data. b. Strategy Sessions The NCI Program Director or designee, in cooperation with the CRN, will sponsor strategy sessions (to be held in conjunction with selected biannual meetings of the CRN Steering Committee), attended by CRN co-Principal Investigators and other appropriate staff from the CRN and appropriate NCI staff. c. Data Management Each awardee will retain custody of and primary rights to their own data and is responsible for statistical analysis, computer processing and statistical interpretations. The NCI Program Director will have access to all data generated under this award and will periodically review the data management and analysis procedures. d. Monitoring and Program Review In addition to normally prescribed duties of program and grants staff, an on-site program review will occur as early as 10 months but no later than 18 months after award. The program review will be conducted to evaluate progress of the CRN in meeting the goals and objectives of this RFA. The inability of a participating CRN member to meet the performance requirements set forth in the Terms and Conditions of Award, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. e. Rights Reserved to NCI The NCI reserves the right to terminate or curtail the study (or an individual award) in the event of shortfalls in participant recruitment, follow-up, data reporting, quality control, or other major breach of study protocols, reaching a major study endpoint substantially before schedule with persuasive statistical significance, or human subject ethical issues that may dictate a premature termination. 3. Collaborative Responsibilities The CRN Steering Committee will be the main governing board of the CRN and will have primary responsibility for overall policies and procedures of the CRN and for decisions about and approval of specific research protocols and pooled data analysis. The CRN Principal Investigator, named in the CRN application, will serve as the Chairperson of the Steering Committee. The CRN Steering Committee will convene as needed to discuss collaborative study progress and address scientific-technical aspects of implementation. The voting membership of the Steering Committee shall consist of the CRN Principal Investigator, all CRN Co-Principal Investigators and the NCI Program Director. The Steering Committee should plan on at least 2 meetings per year, with at least the co-P.I. representing each participating CRN member in attendance. When deemed necessary at least one data manager as well as one co-P.I. from each CRN member will attend such meetings. Subcommittees will be established by the Steering Committee, as it deems appropriate. In the event that more than one CRN is funded, the respective CRN steering committees, in consultation with the NCI Program Director, will determine the need for joint activities across the CRNs. 4. Arbitration Process The Terms and Conditions of Award require that the NCI Program Director make post-award decisions related to program performance and programmatic decisions on scientific-technical matters. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the NCI Program Director. An arbitration panel (with appropriate expertise) composed of one member selected by the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, NCI. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by October 17, 1997, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NCI 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: Martin Brown, Ph.D. Applied Research Branch National Cancer Institute Executive Plaza North, Room 313 6130 Executive Blvd. Bethesda, MD 20892-7344 Telephone: (301) 496-5716 FAX: (301) 435-3710 Rockville, MD 20852 (if express/courier service) APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Suite 6095, MSC 7910, Bethesda, MD 20892- 7910, telephone 301/435-0714, E-mail: ASKNIH@odrockm1.od.nih.gov. In addition since the U19 mechanism is being used, applicants must use the instructions for NCI Program Project Grant Applications. These are available from the NCI Referral Officer (301) 496-3428. The RFA label available in the PHS 398 (rev.5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed exact photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard Executive Plaza North, Room 636 Bethesda, MD 20892 Rockville, MD 20852 (if using express/courier service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with the other applications received on or before the designated receipt date. Applications must be received by November 25, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. Application Preparation All applications must be submitted on the form PHS 398 (rev. 5/95). The rationale an theme of the proposed CRN research agenda should be discussed in an introductory section. Separate research plans should be prepared for the infrastructure component, each proposed research study, and the evaluation component. Maximum page limitations for each section are: introductory section - 5 pages, research agenda component - 10 pages, infrastructure component - 25 pages, each proposed research study - 25 pages, evaluation component - 10 pages. Regardless of the number of proposed research studies, the maximum page limitation for the entire research plan is 200 pages. Each application must contain a detailed budget for the first 12-month period and a budget for the entire proposed project period for direct costs. Separate budgets should be submitted for each component of the CRN: the infrastructure component, each proposed research study, and the evaluation component. Budgets for each CRN member organization other than the lead CRN institution must be submitted as sub-contracts the lead institution (or consultant contracts to the lead institution may be used when only the professional services of specified individuals are involved). Additional instructions are in the NCI Program Project Grant Guidelines. REVIEW CONSIDERATIONS General Considerations All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the scientific merit of the proposed research is important, it will not be the sole criterion for evaluation of a study. Other considerations, such as the importance and timeliness of the proposed studies, access to patients, and multi disciplinary nature of the studies, will be part of the evaluation criteria. Review Method Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness to the RFA by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned and receive no further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process by which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria Applicants are encouraged to submit and describe their own ideas about how best to meet the general research and infrastructure goals outlined in this RFA, and are expected to address issues identified under SPECIAL REQUIREMENTS of the RFA. Four general areas will be considered in review of applications: research agenda; the feasibility of the infrastructure component of the proposal and the likelihood that this component will effectively contribute to meeting the goals of the RFA; the importance and scientific merits of the proposed research studies to be conducted by the CRN; the objectivity and methodological soundness of the evaluation component. The following review criteria will be used: - Research Agenda How well does the research agenda meet the goals and priorities of the RFA? How successful is the research agenda in providing a coherent basis for the integration of the separate CRN research projects? Does the proposed research agenda address an important set of problems? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? - Infrastructure Component Is the infrastructure proposal realistic and feasible given the resources allocated to it and the characteristics of CRN members? How well does the infrastructure component serve to support the overall goals and priorities of the proposed research agenda and the conduct of specific proposed research studies? How well does the infrastructure component serve to increase the cancer research capabilities of the CRN as a whole and individual CRN members by facilitating the development of shared resources, knowledge and information? - Evaluation Component Are objective criteria and methods of evaluation proposed? Are appropriate resources and expertise proposed to ensure an adequate evaluation study? Is the statistical design of the evaluations study sound? - Research Studies Specific CRN research studies will be reviewed using the current criteria that is applied to R01 grants (NIH GUIDE, Volume 26, Number 22, June 27, 1997), as follows: (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigators: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: * The adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. * The reasonableness of the proposed budget and duration in relation to the proposed research * The adequacy of the proposed protection for humans and animals, and the safety of the research environment. In addition to the above criteria, CRN proposals will be reviewed with regard to commitment to conduct pooled analyses of combined data across CRN members for research objectives that require pooled analyses of data and adequate plans for central data coordination centers when necessary to support pooled analyses. Such commitment may be demonstrated by the identification of specific central data coordination centers in the application, identification of data managers for each CRN member and description of mechanisms for ensuring data quality and comparability. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; and (c) availability of funds. Letter of Intent Receipt Date: October 17, 1997 Application Receipt Date: November 25, 1997 Review by NCI Advisory Board: May 11-13, 1998 Anticipated Award Date: August 1, 1998 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Martin Brown, Ph.D. Applied Research Branch National Cancer Institute Executive Plaza North, Room 313 6130 Executive Boulevard Bethesda, MD 20892-7344 Telephone: (301) 496-5716 Email: mb53o@nih.gov Direct inquiries regarding fiscal matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20892-7150 Telephone: (301) 496-7800 x213 Email: wolfreyc@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3 . . . [use appropriate program number]. 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 Parts 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities ( or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Sep 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-018 - V26(30) 09/05/97 Date: 5 Sep 1997 18:56:55 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 482 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5uqd97$bdd@net.bio.net> NNTP-Posting-Host: net.bio.net LONG-TERM CANCER SURVIVORS: RESEARCH INITIATIVES NIH GUIDE, Volume 26, Number 30, September 5, 1997 RFA: CA-97-018 P.T. National Cancer Institute Letter of Intent Receipt Date: October 24, 1997 Application Receipt Date: November 25, 1997 PURPOSE The National Cancer Institute invites research grant applications to identify important areas that have an impact on long term survivors of cancer. The purpose of this RFA is to support research that will lead to a decrease in the physiologic and psychological morbidity associated with long term (more than 5 years) survival after cancer treatment by addressing specific areas that affect cancer survivors to a greater extent than members of the population at large. Questions related to the experiences of the cancer survivor encompassing both physiologic and psychological variables are to be explored and interventions to promote positive outcomes evaluated where appropriate. This initiative is expected to provide information about the incidence and scope of the effects of cancer and its treatment on survivors, the relationship of treatment to late effects and to yield new insights about measures that are appropriate to the potential problems and needs of long term survivors. This RFA is not intended to address questions that explore differences between survivors and non-survivors that may be linked to mechanisms of disease progression or genetic predisposition. 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), Long-Term Cancer Survivors: Research Initiatives, is related to the priority areas of long term and late effects of cancer and its treatment. 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Teams of applicants representing a multi-disciplinary approach to the problem identified are encouraged. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible to apply for First Independent Research Support and Transition (FIRST) awards. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Research Project Grant (R01), the Small Grant (R03) and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years. The small grant (R03) is limited to 2 years. The anticipated award date is July, 1998. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health services Grant Policy Statement, DHHS Publication No. (OASH) 94-50,000 (REV.) April 1, 1994. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for awards under this RFA will be $3,000,000. Pending receipt of a sufficient number of applications of high scientific merit, the NCI intends to fund a total of approximately 12 to 15 awards in response to this RFA in FY98. Usual PHS policies governing grants administration and management related to the three mechanisms (R01, R03 and R29) will apply. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the continuing 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 the availability of funds. RESEARCH OBJECTIVES Background There are now approximately 10 million cancer survivors in the United States, 7 million of whom have survived for at least 5 years. SEER ( Surveillance , Epidemiology and End Results) data demonstrate improvements in the 5 year relative survival rates for melanoma, breast, uterine, prostate, testicular and bladder cancer, and for Hodgkin's Disease and non-Hodgkin's lymphoma, from 1974 - 76 to 1981 - 87 . There has been a decline in cancer mortality in the US from 1990 to 1995. Problems facing cancer survivors are multifaceted. They include physical, emotional and social stresses arising as a result of the effects of treatment, changes in lifestyle, disruption of home and family roles, and the fear of recurrence. Physical morbidity is an issue for the cancer survivor, as are psychologic and social morbidity. Cancer survivors often live with compromise, and face potential challenges arising as a result of changes in their strength and endurance, reproductive capacity, sexuality and body image . Cancer is a disease with both physical and psychosocial sequelae. Survivors have indicated that their concerns shift over time from illness related problems and towards societal and interpersonal issues. There is currently no consensus as to the defined needs of cancer survivors, or the long term physiologic and/or psychologic sequelae of the disease. Research into these areas is essential to delineate the long term health outcomes of cancer survivors. It is anticipated that new collaborative teams will be formed to address the issues that range from the biological/physiologic level to the psychosocial realm. The nature of the issues suggests a multi- disciplinary approach that will generate focused methods of assessment, provide impetus for research on quality of life, explore outcomes of different approaches to follow-up and surveillance of survivors as well as inquiries into the impact on family life, insurance and employment. Many late physiologic effects have been documented for survivors of childhood cancer. These include late effects from chemotherapy and irradiation, and the effects of multi-modal treatment including new primary cancers, impairment of cognitive, pulmonary, cardiac, hepatic, and gonadal function , and cosmetic changes. Reviews of the existing body of literature point to an increasing number of such physiologic effects. Areas that continue to be of particular importance to cancer survivors include: issues of quality of life and psychosocial adjustment beyond the acute period of treatment; reproduction and offspring; surveillance for the adverse sequelae of treatment and the development of new cancers; and the risk of recurrence. Knowledge of the human toll of having had, and being treated for, cancer measured in terms of quality of life, social outcomes related to jobs, insurance, social interactions is needed before interventions to lessen the negative impact or support the positive adjustment in an individual are proposed. RESEARCH GOALS The scope of this RFA is limited to long term survivors, defined here as at least five years from completion of primary cancer therapy and currently free of disease. This RFA requests applications that will provide the information about incidence and scope of effects of cancer and its treatment on survivors, their relationship to treatment, and where appropriate, proposals to test interventions, and the timing of interventions, to reduce the late morbidity of cancer and cancer therapy and to promote as normal a life as possible for the survivor. To achieve these purposes, a descriptive phase may be included to generate hypotheses about the intervention to be tested. It is suggested that the proposals will represent multi-disciplinary approaches and multiple end points where appropriate. SCOPE OF RESEARCH This initiative focuses on expanding our understanding of the physiologic and psychological issues related to cancer survivorship. Examples of some pertinent areas and research topics are listed below. This list is intended to be illustrative, not exhaustive. Topics are not presented in a priority order: o Prevalence and longitudinal incidence studies of physiologic late effects, e.g. cardiac toxicities and events, pulmonary compromise, late effects of limb sparing, minimal breast surgery and reconstructive surgery, ovarian failure, renal failure, and neurologic defects. o Prevalence and longitudinal incidence studies of psychosocial late effects, e.g. job and insurance discrimination, sexuality, quality of life, depression, cognitive function and mentation. o Prevalence and longitudinal studies of second cancers, including investigation of risk factors. o Reproductive function, e.g. fertility and health of offspring. o Economic impact, e.g. evaluation of effectiveness and cost of psychosocial and other interventions that will impact on survivorship outcomes. o Evaluation of the effectiveness of prevention interventions to prevent sequelae, e.g. cardioprotective agents, prevention of second cancers, maintenance of fertility, early interventions during treatment to lessen negative impact of sequelae. o Exploration of the impact of survivorship related to insurance and employment discrimination, including that related to the identification of high risk status, including genetic susceptibility. o Studies in offspring, e.g. birth defects, delayed developmental milestones and malformation rates. o Development and testing of diverse methodologic approaches specific to cancer survivors, e.g. instrument development, adaptation and validation of existing measures for use in special populations including culturally and ethnically diverse groups and the elderly. o Targeted prevalence studies of specific cancer related effects on survivors to determine the need for large scale studies. REQUIREMENTS In order for the purposes of the RFA to be accomplished, several requirements must be addressed: o The focus must be on long term survivors of cancer. This is not limited to persons who were diagnosed and treated as adults. Studies of long term survivors of childhood cancer are encouraged, as are studies of elderly survivors. o Attention must be paid to the use of appropriately valid and reliable measures of both physiologic and psychosocial variables. A short period of time at the start of the award can be dedicated to additional validation studies if needed. o The creations of a data base of the cohort that could be used to facilitate future studies should be considered. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (concerning the inclusion of women in study populations, and concerning the inclusion of minorities in study populations) which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies.. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 24, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Claudette G. Varricchio DSN, RN, FAAN Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Room 300 Bethesda, MD 20892- 7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 e-mail: varriccc@dcpcepn.nci.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Suite 6095, MSC 7910, Bethesda, MD 20892- 7910, telephone 301/435-0714, E-mail: ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier services) At the time of submission, two additional copies of the application must be sent to: Mrs. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express/ courier service) Applications must be received by November 25, 1997. If an application is received after that date, it will be returned to the applicant without review. 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. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the National Cancer Institute. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. REVIEW CRITERIA The five criteria to be used in the evaluation of grant applications are listed below. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications found to have significant and substantial merit will be considered for funding by the following: o priority score o availability of funds o programmatic priorities SCHEDULE Letter of Intent Receipt Date: October 24, 1997 Application Receipt Date: November 25, 1997 Review by National Cancer Advisory Board: May 1998 Anticipated Date of Award: July 1998 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Claudette G. Varricchio DSN, RN, FAAN Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300 Bethesda, MD 20892- 7340 Telephone: (301) 496-8541 FAX: (301) 496 8667 E-mail: varriccc@dcpcepn.nci.nih.gov Direct inquiries regarding fiscal matters to: Joy L. McCauley Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 253 FAX: (301) 496-8601 E-mail: mccaulej@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, CANCER control. 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 Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non- use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Sep 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-105 - V26(30) 09/05/97 Date: 5 Sep 1997 18:57:32 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 485 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5uqdac$bf1@net.bio.net> NNTP-Posting-Host: net.bio.net HIV PATHOGENESIS IN WOMEN'S INTERAGENCY HIV STUDY (WIHS) NIH GUIDE, Volume 26, Number 30, September 5, 1997 PA NUMBER: PA-97-105 P.T. National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Cancer Institute National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Neurological Disorders and Stroke Office of Research on Women's Health PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Cancer Institute (NCI), the National Institute of Dental Research (NIDR), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),the National Institute of Neurological Disorders and Stroke (NINDS) and the Office of Research on Women's Health (ORWH) invite applications for highly focused basic research integrated with the WOMEN'S INTERAGENCY HIV STUDY (WIHS) scope and structure. Applications are expected to utilize the WIHS study population, a large cohort of HIV-infected women in the U.S., to formulate specific hypotheses concerning HIV/AIDS pathogenesis in women. The WIHS cohort is followed in five large metropolitan areas (New York, Washington DC, Chicago, Los Angeles and San Francisco). 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 Program Announcement (PA), "HIV PATHOGENESIS IN WOMEN'S INTERAGENCY HIV STUDY (WIHS)" is related to the priority area of "HIV Infection" (SAI: Natural history, transmission, behavior, women, in-vivo pathogenesis). Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-10473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or Local Government, and eligible agencies of the Federal Government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Traditional research project grant (R01) and FIRST award (R29) applications may be submitted in response to this program announcement. Applications for R01 grants may request up to five years of support; applications for R29 grants must request five years of support. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES A. Background 1. HIV IN WOMEN. HIV in women is increasing worldwide. In the U.S., the epidemic began expanding among women in the late 1980s and the full extent of the epidemic in this population has yet to be clearly defined. As of December 1996, the Centers for Disease Control and Prevention (CDC) estimated that the cumulative number of AIDS cases in adult and adolescent women in the U.S. was 85,500, with 20,302 in 1996 alone. Women now comprise approximately 15% (85,500/581,429) of the total adult and adolescent AIDS cases, the highest proportion yet reported. The impact of AIDS is particularly severe in minority populations in the U.S. Blacks and Hispanics combined constitute 48% of AIDS cases among men, but 76% among women. In the U.S., the proportion of women acquiring HIV infection through sexual contact with HIV-infected men is increasing. In 1996, 40% of women with AIDS reported acquiring HIV infection through sexual contact with a man with or at risk for HIV infection, and 34% reported injecting-drug use as their main exposure category. AIDS is now the third leading cause of death for women aged 25 to 44 after cancer and cardiovascular disease and the leading cause of death for African-American women in this age group. The increasing mortality rate for women also affects children: the estimated 80,000 HIV-infected women of childbearing age who were alive in 1992 will leave about 125,000-150,000 orphans during the 1990s. At the current stage of the HIV/AIDS epidemic, new paradigms have emerged that will influence the direction of future research on HIV/AIDS. Some of these paradigms will increasingly apply to women, as women become a progressively larger fraction of persons with HIV/AIDS in industrialized countries. Research areas that are likely to draw more attention in the near future will include the study of pathogenicity and transmissibility of different HIV subtypes or recombinant forms and their interaction with variably susceptible individuals; the change in the scope of HIV natural history studies in the era of combination antiretroviral therapy; and the contribution of such studies to the design of a wide spectrum of prevention modalities (e.g. prevention of HIV and prevention of opportunistic infections). In addition, studies of natural history of HIV-related malignancies and active surveillance of malignancies in HIV infected and high-risk uninfected women may lead to new screening and prevention modalities in high-risk populations of women. Studies of HIV/AIDS in women can play a unique role in testing new biological or socio-behavioral hypotheses at the population level and in linking basic science findings and laboratory methods to epidemiologically well defined populations and communities. 2. WIHS. The Women's Interagency HIV Study (WIHS), a multicenter, prospective study, was established in August, 1993 to carry out comprehensive investigations of the impact of HIV infection in women. This study has been conducted by NIH in tandem with a similar study coordinated by the U.S. Centers for Disease Control and Prevention (CDC), the HIV Epidemiology Research Study (HERS). In addition to NIAID, several other NIH institutes currently fund different components of the WIHS. These Institutes include: the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Cancer Institute (NCI) and the National Institute of Dental Research (NIDR). The WIHS has interacted with the community from the outset, by soliciting the community's input to better identify problems and pursue research opportunities. Community involvement through the individual WIHS sites and the Community Advisory Board (CAB) is encouraged to foster women's participation and understanding of research scope and results. The rationale for establishing the WIHS in 1993 was to investigate the clinical, laboratory and psychosocial aspects of HIV infection in women, in a multi-site, prospective fashion. The significant investment needed to develop a complex infrastructure such as exists in the WIHS requires a period of several years of collaborative research and cohort follow-up for maximum scientific benefit to accrue. In addition, changes should be monitored in the natural history of HIV and associated conditions occurring as a result of treatment advances and longer survival. The follow-up phase began at completion of participants' recruitment in November, 1995. A total of 2,641 women (2066 HIV positive and 575 negative), 80% of minority background, were enrolled. During the course of the study, progress in HIV/AIDS research will continue to require flexibility in modifying goals and adjusting the infrastructure to reflect new knowledge and new, state-of-the-art methodology. The achievement of this goal will be facilitated by the fact that clinical care and research activities are carried out at the same health facility. This allows for real-time clinical observation and laboratory testing. The rapid implementation of new protocols will be especially dependent on the presence of the following project-wide characteristics: adequate infrastructure and coordination within the individual consortia, effective linkage between the study sites, real-time coordination of activities by the Data Center, and efficient use of the biological specimens. B. Research Objective and Scope Applications are invited to conduct studies focused on basic mechanisms of HIV infection and progression in women. Applications in response to this Program Announcement may include expansion of ongoing studies and new studies. In addition, studies may involve all WIHS sites or may be limited to defined subsets of the WIHS population, when special requirements exist, such as the need for more frequent participant visits. Studies may address, in detail, biological aspects of HIV infection and how such aspects affect women's health. Proposed studies should emphasize investigations predicated upon specific hypotheses. Applications may focus on investigations in the specific areas of interest of the collaborating NIH Institutes, as outlined below. HIV/AIDS in women is a high priority for research for ORWH. ORWH will be pleased to provide cofunding through the participating institutes in support of meritorious grant applications, contingent upon the availability of funds. Important areas of investigation include, but are not limited to, the following subjects: NIAID: grant applications in the area of molecular basis of HIV infection and disease progression in women, including the interplay of host and viral characteristics; characterization of HIV in cervico-vaginal mucosa and its relationship with HIV in blood; virologic and immunologic factors and their relationship with endocrinologic factors in HIV infected women; cellular and molecular bases for higher susceptibility of women to HIV transmission via the mucosal route as compared to men. NICHD: grant applications in the areas of endocrinologic factors (including both endogenous and common exogenous hormonal exposures), HIV expression, and disease progression; interactions between pregnancy and HIV infection; and fertility-related behaviors among HIV-seropositive women. NIDA: grant applications investigating direct and indirect effect of drug use and associated co-morbidity; viral and immune factors influencing the course of HIV-related disease, including correlations between systemic and genital changes and the role of the female genital tract as a reservoir of HIV infection. NCI: grant applications in the areas of surveillance of the prevalence, incidence, and secular trends of all cancers occurring in the WIHS cohort; the natural history of AIDS-related cancers; the role of human papillomavirus, Epstein-Barr virus, and Human Herpes Virus 8 in the etiology of AIDS-associated cancers; and the effects of viral strain variation, co-infections with multiple viruses, host genetics, immune perturbations, hormonal changes, and anti-retroviral treatment on the pathogenesis and clinical epidemiology of AIDS-related pre-cancerous changes and cancers. NIDR: grant applications investigating the in vivo role and mechanism of action of oral antiviral factors (salivary and mucosal); the influence of oral co-infections on HIV infection and disease pathogenesis; the role of the oral pharyngeal region as a reservoir of HIV infection; oral diagnostics and therapeutics; the role of host response in candida infections; characterization of salivary molecules exhibiting anti-candida activities; and identification of anti-candida epitopes and construction of bioactive synthetic peptides. NIDDK: grant applications to elucidate the pathogenesis of AIDS wasting syndrome (AWS), including the effects of HIV on endocrine and gastrointestinal function, metabolism, appetite and diet, physical activity, and body composition; studies of intercurrent illnesses in the pathogenesis and natural history of AWS; studies of the pathogenesis and natural history of endocrine, gastrointestinal and renal dysfunction in HIV-positive women, including mechanisms of drug-induced diabetes and hepatic and renal toxicity. NINDS: grant applications investigating the pathogenesis of central and peripheral nervous system abnormalities caused directly or indirectly by HIV infection in HIV-positive women. Such research could include the role of genetic factors, immune status, and hormonal function in women at risk for AIDS-related neurological disorders. ORWH: co-sponsor of this program announcement. As such, ORWH will be providing partial funding to selected grants awarded by the Institutes identified above contingent upon the availability of funds. In addition to addressing the aspects described above in the main study population (approximately 2000 HIV seropositive women), focused studies may be conducted in the approximately 500 HIV seronegative women who are currently under active follow-up. Using the WIHS infrastructure and through the rapid identification and enrollment of recent seroconverters, such studies may investigate events during early HIV infection in women and may address questions such as the genetic basis for HIV exposure without infection and its relationship with high-risk behavior (sexual or drug-related). By investigating the dynamics of initial HIV infection, these studies may provide critical background knowledge for the design of clinical trials in patients with primary HIV disease. HIV uninfected women may also be enrolled in studies investigating the role of hormonal factors and contraceptive use on susceptibility to HIV infection. C. Research Structure. BIOLOGICAL SPECIMENS. Scientific questions addressed by studies submitted under this Program Announcement may utilize biological specimens already collected and banked or specimens to be prospectively collected. Stringent monitoring of specimen utilization will occur throughout the study duration to permit specimen use by a broad number of investigators. Use of WIHS specimens will be restricted to the use stated in the grant. To address any peer review's concerns regarding specimen access, applicants are advised to provide documentation of the establishment of a collaboration with the WIHS investigators. Inquiries on this matter should be directed to the Program staff of the participating NIH Institutes. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 9, 1994 (FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the Program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard deadlines for AIDS applications as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive MSC 7910, Bethesda, MD 20892-7910, telephone (301)435-0714, e-mail: asknih@odrockm1.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". The PA number and the PA title must also be typed in section 2. The completed original application and five legible, single-sided copies of the application must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from Institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applications will be assigned on the basis of the established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants, NIH. Incomplete applications will be returned to the applicant without further consideration. R01 and R29 applications will be reviewed for scientific and technical merit by the Division of Research Grants, NIH in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there a comprehensive use of the WIHS cohort of women, the WIHS database and the WIHS-originated specimen bank? Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Investigator: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Is there an optimal level of integration with the current WIHS activities and investigators? Budget: Is the requested budget and estimation of time to completion of the project appropriate for the proposed research? The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA. Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, and availability of funds. INQUIRIES. Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic (research scope, eligibility and responsiveness) issues may be directed to: NIAID: Paolo Miotti, M.D., M.P.H. Telephone: (301) 496-9176 FAX: (301) 402-3211 e-mail: pm122m@nih.gov NICHD: David Burns, M.D., M.P.H. Telephone: (301) 496-7339 FAX: (301) 496-8678 e-mail: db98d@nih.gov NIDA: Katherine Davenny, Ph.D. Telephone: (301) 443-1801 FAX: (301) 443-2317 e-mail: kd25h@nih.gov NCI: Sandra Melnick, Dr.P.H. Telephone: (301) 435-4914 FAX: (301) 402-4279 e-mail: sm33k@nih.gov NIDR: Maryann Redford, D.D.S., M.P.H. Telephone: (301) 544-5588 FAX:(301) 480-8254 e-mail: mr48a@nih.gov NIDDK: Judith Fradkin, M.D. Telephone: (301) 594-8814 FAX: (301) 480-3503 e-mail: jf58s@nih.gov NINDS: A.P. Kerza-Kwiatecki, PhD. Telephone: (301) 496-1431 FAX: (301) 402-2060 e-mail: ak45w@nih.gov ORWH: Joyce Rudick Telephone: (301) 402-1770 FAX: (301) 402-1798 e-mail: jr27q@nih.gov Direct inquiries regarding fiscal matters to: Ms. Ann Devine Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C23 6003 Executive Blvd. Bethesda, MD 20892 Telephone: (301) 402-5601 AUTHORITY AND REGULATIONS. This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citations are No. 93.855 - Immunology, Allergy, and Transplantation Research and No. 93.856 - Microbiology and Infectious Disease Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Sep 09 23:00:00 1997 Path: biosci!biosci!not-for-mail From: ltest@rte9-sun_5.5.1 (news_check.py) Newsgroups: bionet.sci-resources Subject: Re: Elementary teachers as Mentors Date: 10 Sep 1997 09:44:37 -0700 Organization: AT&T WorldNet Load Test Lines: 40 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5v69je$6kf@lztnsc06.att.com> NNTP-Posting-Host: net.bio.net In article <5uf771$182@net.bio.net> Nishi Mary Mathew wrote: > Hello All science educators and elementary science teachers, > > I would like to have the preservice elementary teachers in my class Hello All science educators and elementary science teachers, I would like to have the preservice elementary teachers in my class interact with elementary level (K-6) teachers before they start teaching in schools (student teaching) and also while they are student teaching via a ListServe/distribution list that I set up. I am interested in science teaching and would like for the student teachers to have a flavor of what it (science teaching) entails, so that they are not turned off from teaching science because of their personal experiences. I would like to enlist the help of elementary grade teachers who are interested in teaching science and do so often, to interact with these preservice teachers. this will mainly be in the form of answering their questions and giving them pointers on how to be successful and what to avoid, to teach science effectively *based on your personal experiences and ideas*. I hope there will be various interesting discussions that ensue. Science content experts (University level teachers) are also welcome to join this group to help with science content. I wold like to get started as soon as possible. If you are interested please respond to my e-mail address at: nishi@ccwf.cc.utexas.edu Thank you, Nishi Matthew, Science Education Center The University of Texas at Austin, Austin, Texas. From owner-sci-resources@net.bio.net Fri Sep 19 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 20 Sep 1997 14:42:22 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 234 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199709200900.CAA17110@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. From owner-sci-resources@net.bio.net Sun Sep 21 23:00:00 1997 Path: biosci!biosci!not-for-mail From: "Mikala St. Germain" Newsgroups: bionet.sci-resources Subject: Information Needed Date: 22 Sep 1997 11:41:09 -0700 Organization: All USENET -- http://www.Supernews.com Lines: 14 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <3424B386.716FF5C8@usa.net> NNTP-Posting-Host: net.bio.net Greetings: I am writing a career oriented book on 3d animation in the fields of architecture, manufacturing, all areas of science, medicine, forensics and education. I wish to inform the reader of the various employment opportunities in these fields for 3d animators, and I hope to omit nothing, including any required background in the various fields that would assist in locating employment. I am also interested in places prospective employers would go to find talent in this area. If you have any information you would like to share, please email me at mikala_st.germain@usa.net. Thanks. From owner-sci-resources@net.bio.net Fri Sep 26 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 31, pt. 1of1, 19 September 1997 Date: 27 Sep 1997 14:04:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 846 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <60jsdf$dnh@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 31 - September 19, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** REMINDER - MODIFICATIONS TO THE NIH GUIDE FOR GRANTS AND CONTRACTS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** INCREASE IN TOTAL COSTS FOR PROGRAM PROJECTS National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX N3 ********************************************************** DEMOGRAPHIC RESEARCH ON SEXUAL BEHAVIORS RELATED TO HIV (PAS-97-093) National Institute of Child Health and Human Development National Institute of Dental Research National Institute of Mental Health INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; DENTAL RESEARCH; MENTAL HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 01/06/98 ************************************************* QUALITY OF CARE UNDER VARYING FEATURES OF MANAGED CARE ORGANIZATIONS (RFA HS-98-005) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX R2 02/18/98 ************************************************* NUTRITION ACADEMIC AWARD (RFA HL-97-011) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 02/18/98 ************************************************* AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAM (RFA TW-98-002) Fogarty International Center INDEX: FOGARTY INTERNATIONAL CENTER $$INDEX P1 ********************************************************** FELINE IMMUNODEFICIENCY VIRUS: A POTENTIAL MODEL OF AIDS (PA-97-106) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P2 ********************************************************** PREVENTION OF RECURRENT DISEASE AFTER LIVER TRANSPLANTATION (PA-97- 107) National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; ALCOHOL ABUSE, ALCOHOLISM; ALLERGY, INFECTIOUS DISEASES $$INDEX P3 ********************************************************** STUDIES OF MOLECULAR MECHANISMS OF RENAL INJURY AND RECOVERY (PA-97- 108) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the NIH gopher (gopher.nih.gov) and the NIH website (http://www.nih.gov). Alternative access is through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing grant applications submitted to the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact aid which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAs, AND RFAs IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** REMINDER - MODIFICATIONS TO THE NIH GUIDE FOR GRANTS AND CONTRACTS NIH GUIDE, Volume 26, Number 31, September 19, 1997 P.T. National Institutes of Health This is a reminder that after September 26, 1997, printed copies of the NIH Guide for Grants and Contracts will no longer be available. As described in the June 27 issue of the NIH Guide, the print and LISTSERV versions of the NIH Guide will be terminated. The full text of all Requests for Applications (RFAs), Program Announcements (PAs), and Notices will be available on the Office of Extramural Research (OER) Homepage (http:www.nih.gov/grants/oer.htm). The NIHTOC-L, which contains only the Table of Contents of each weeks NIH Guide will continue. To subscribe to the NIHTOC-L, send mail to: LISTSERV@LIST.NIH.GOV. The text of the mail should read ONLY: SUBSCRIBE NIHTOC-L First-name Last-name e.g., SUBSCRIBE NIHTOC-L John Smith Anyone currently subscribed to the NIHGDE-L that would like to receive the Table of Contents list (NIHTOC-L) should subscribe using the above procedures. INQUIRIES Inquiries or comments regarding these procedures may be directed to: James O'Donnell, Ph.D. Office of Extramural Programs National Institutes of Health 6701 Rockledge Drive, Room 6182 - MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-2768 Email: odonnelj@od.nih.gov Myra Brockett Office of Extramural Programs National Institutes of Health 6701 Rockledge Drive, Room 6202 - MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-2694 Email: mb36t@nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** INCREASE IN TOTAL COSTS FOR PROGRAM PROJECTS NIH GUIDE, Volume 26, Number 31, September 19, 1997 P.T. National Institute of Dental Research The National Institute of Dental Research (NIDR) announces a change in policy regarding program project grants (P01). Currently, in order for a grant to be funded as a P01 it must consist of a minimum of three research projects, not including cores, and the first year direct costs may not exceed $500,000. Grants that include consortium arrangements may exceed the cap by the amount of the indirect costs associated with the consortium. This policy has been in effect for approximately the past five years. During this time the average first year direct costs for investigator-initiated individual research grants (R01) has surpassed, by nearly twenty-five percent, the average costs for a single project which is part of a P01, thus leading to the situation whereby research supported by the P01 mechanism may be at a fiscal disadvantage to that supported by the R01 mechanism. Also, for fiscal planning purposes, the Institute finds it more effective to place limits on maximum levels of funding in terms of total (i.e., direct plus indirect) costs rather than direct costs alone. Therefore, effective immediately, the NIDR modifies its policy and will accept applications for all new (Type 1) and competitively renewed (Type 2) program projects whose total first year costs (i.e., direct plus indirect costs) do not exceed $1.125 million. This represents an increase of approximately one-third and brings the average direct cost of an individual project included in a P01 more in line with the current average direct costs for an R01 funded by the NIDR. While the minimum number of fundable research projects required for a P01 still remains at three, applicants are strongly encouraged to plan research supported through P01s to include a minimum of four fundable projects of high scientific merit. Potential applicants are reminded of the National Institutes of Health (NIH) policy (NIH Guide for Grants and Contracts, Volume 25, Number 14, May 3, 1996) that requires that all applicants receive prior written approval before submitting a formal investigator- initiated Type 1 application whose first year direct costs equal or exceed $500,000. Prior to submitting a P01 or any other grant application with first year direct costs above $500,000, applicants must telephone the extramural scientific program director responsible for the administration of the scientific subject matter of the proposed research. A full listing is available through the NIDR Home Page (http://www.nidr.nih.gov) and applicants are encouraged to review the information about extramural scientific program interests and priorities listed there. For projects of this size, applicants should be prepared to provide the following information to NIDR staff: o Overall objectives and goals of the P01 as a whole. o Specific aims of each research project as it relates to the objectives and goals of the P01. o Overall and individual project/core budgets including any consortium costs. o Names and institutions/departments of affiliation of key personnel. Following review by Institute staff, a written response indicating whether or not the application falls within the programmatic interests of the NIDR will be forwarded to the applicant within 15 working days. INQUIRIES Additional information regarding these policies can be obtained from extramural scientific program directors within the Division of Extramural Research or from Dr. Norman S. Braveman, Assistant Director for Program Development, Division of Extramural Research, National Institute of Dental Research (Telephone: (301) 594-2089; Email: BravemanN@de45.nidr.nih.gov). $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** DEMOGRAPHIC RESEARCH ON SEXUAL BEHAVIORS RELATED TO HIV NIH GUIDE, Volume 26, Number 31, September 19, 1997 PA NUMBER: PAS-97-093 P.T. National Institute of Child Health and Human Development National Institute of Dental Research National Institute of Mental Health Application Receipt dates: May 1, September 1, January 1 The following notice is issued for PAS-97-093, which was published in the NIH Guide, Vol. 26, No. 27, August 15, 1997. The sponsoring Institutes have committed funds for applications that are received by the Sept. 1, 1998 deadline. Applications in response to the PA topic, Demographic Research on Sexual Behaviors Related to HIV, will continue to be of interest to the sponsoring institutes and will continue to be considered under normal funding plans. INQUIRIES Inquiries regarding this program announcement may be directed to: Susan F. Newcomer, Ph.D. Demographic and Behavioral Science Branch National Institute for Child Health and Human Development 6100 Executive Boulevard, Room 8B13 Bethesda, MD 20892 Telephone: (301) 496-1174 FAX: (301) 496-0962 Email: NewcomeS@hd01.nichd.nih.gov Patricia Bryant, Ph.D. Director, Behavior, Health Promotion and Environment National Institute of Dental Research Natcher Building, Room 4AN 18A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2095 FAX: (301) 480-8318 Email: BryantP@de45.nidr.nih.gov Willo Pequegnat, Ph.D. Office on AIDS National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: wpequegn@nih.gov $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HS-98-005 FULL-TEXT ************************************** QUALITY OF CARE UNDER VARYING FEATURES OF MANAGED CARE ORGANIZATIONS NIH GUIDE, Volume 26, Number 31, September 19, 1997 RFA AVAILABLE: HS-98-005 P.T. Agency for Health Care Policy and Research Letter of Intent Receipt Date: October 31, 1997 Application Receipt Date: January 6, 1998 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for cooperative agreements that will assess the association between features of managed care organizations, health outcomes, and quality of care for patients with chronic diseases. These cooperative agreements will be co-sponsored by the American Association of Health Plans Foundation (AAHPF) under a partnership agreement with AHCPR. Studies should focus on one or more conditions meeting the following criteria: high prevalence, association of outcomes with quality of care, ease of severity assessment with inexpensive measures, some outcomes measurable within a two-year time frame, and adequate patient numbers across the severity spectrum. Aggregations of conditions might be selected for study if the data are adequate and methodologies are sound, particularly if these conditions apply to special populations such as children, women, minority populations or the elderly populations. AHCPR expects to award up to $1.5 million and AAHPF a comparable amount in fiscal year 1998 to support the first year of approximately 4 to 7 projects under this RFA. AAHPF and AHCPR will each contribute half of each project's funding. Applicants are asked for written permission to share with AAHPF applications that AHCPR intends to fund under this RFA, along with a summary of the results of peer review of those applications. 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. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. INQUIRIES This RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), the AHCPR Website http://www.ahcpr.gov), and by mail and fax from Global Exchange at the address listed below. Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 $$R1 END ************************************************************ $$R2 BEGIN HL-97-011 FULL-TEXT ************************************** NUTRITION ACADEMIC AWARD NIH GUIDE, Volume 26, Number 31, September 19, 1997 RFA AVAILABLE: HL-97-011 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 1, 1997 Application Receipt Date: February 18, 1998 THIS RFA USES "JUST-IN-TIME" PROCEDURES. THE RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE FOLLOWED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The primary objective of this initiative is to encourage the development or enhancement of medical school curricula to increase opportunities for students, house staff, faculty, and practicing physicians to learn nutrition principles and clinical practice skills with an emphasis on preventing cardiovascular diseases (CVD). A second objective is to provide training modules for dissemination to other medical schools as well as other health care professional schools. This RFA is part of the Academic Award Program (KO7) of the National Heart, Lung, and Blood Institute. It is anticipated that in fiscal year 1998, support will be available for total costs of approximately $750,000 and that approximately five grants will be awarded under this program. 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, Nutrition Academic Award, is related to the priority areas of nutrition, heart disease and stroke, obesity, physical activity, diabetes, chronic disabling conditions, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Elaine J. Stone, Ph.D., M.P.H. Division of Epidemiology and Clinical Applications National Heart, Lung, Blood Institute 6701 Rockledge Drive, Room 8134, MSC-7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0382 FAX: (301) 480-1669 Email: Stonee@gwgate.nhlbi.nih.gov $$R2 END ************************************************************ $$R3 BEGIN TW-98-002 FULL-TEXT ************************************** AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAM NIH GUIDE, Volume 26, Number 31, September 19, 1997 RFA AVAILABLE: TW-98-002 P.T. Fogarty International Center Letter of Intent Receipt Date: October 15, 1997 Application Receipt Date: February 18, 1998 PURPOSE The Fogarty International Center (FIC), National Institutes of Health (NIH), invites applications from non-profit private or public U.S. institutions with interest in working with foreign colleagues to build global HIV/AIDS research capacity and thereby help to prevent HIV transmission through development of HIV/AIDS international training and research programs for foreign health scientists, clinicians, and allied health workers in collaboration with U.S scientists in developing countries, including emerging democracies in Eastern Europe and Latin America. This announcement is for the third five-year funding cycle for the AIDS International Training and Research Program (AITRP). Both new and competing renewal applications for this D43 program are welcome. Prevention, through biomedical or behavioral approaches, is critical to stop the global spread of HIV/AIDS. International collaboration can greatly enhance HIV/AIDS prevention efforts, but to be fully effective, prevention research in other countries must involve scientists and health professionals from these countries who are familiar with the unique local and cultural factors contributing to the epidemic in their countries, and should also be fully endorsed by their governments. A major goal of this program is to train developing country scientists to address more effectively the AIDS epidemic through research. This training program will help to: (1) establish critical biomedical and behavioral science expertise in developing countries affected by HIV/AIDS; (2) facilitate new prevention research efforts which supplement or complement NIH and other U.S. AIDS research; (3) establish long-term cooperative relationships between U.S. and foreign research groups; and (4) support cooperation between U.S. academic research centers and foreign scientists. Collaborations supported through this effort will help to facilitate the conduct of scientifically valid and ethically sound HIV/AIDS prevention, technology testing and research. Funds will be awarded to provide training in the various scientific disciplines required to conduct HIV/AIDS research in accordance with the stated objectives for the program. Applicants are strongly encouraged to relate training to ongoing prevention research efforts in developing countries supported by NIH and other organizations. In October, 1996, the FIC convened a panel of scientists to conduct a comprehensive review of the AITRP program. The present announcement reflects most of the recommendations of the panel as described in their report. In addition, the recommendations from the NIH AIDS Research Program Evaluation Task Force, contained in the "Levine" Report, contributed to this Request for Applications (RFA). For example, the need to develop a coordinated and comprehensive Prevention Science Agenda that includes and combines biomedical, behavioral, and social interventions was underscored. Applicants are encouraged to request copies of both of these documents from the FIC. This RFA also reflects guidance of other NIH components, including the Office of AIDS Research (OAR), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), the National Cancer Institute (NCI), the National Institute of Dental Research (NIDR), the National Institute on Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH). The FY 1999 NIH Plan for HIV-Related Research, available from the FIC, describes the range of prevention research encompassed within the "Levine" report and emphasizes the importance of international cooperation and multidisciplinary prevention research to combat the global spread of HIV/AIDS. The FIC AITRP program review noted that the program has become an important component of global research on AIDS and related diseases and that, by integrating research and research training, and by its inherent flexibility, the AITRP is adding significant value to the human resource capability for research and disease prevention in developing countries. This RFA refocuses AITRP from an emphasis on epidemiology to prevention research involving multiple disciplines, which will require a broader research perspective. Accordingly, the overall focus of prevention research training in the new FIC AITRP should be multidisciplinary. Based upon the review of the AIDS International Training and Research Programs (AITRP), the FIC has adopted the following mission and goal statement for the next funding cycle of the AITRP. "The mission of the AITRP is to train international health professionals in research on prevention of HIV infection." The interpretation of this mission statement, in the context of the overall AITRP review, is broad, encompassing not only prevention of HIV transmission and infection, but also prevention of progression of HIV infection to AIDS, which may reduce the likelihood of HIV transmission by infected individuals. AITRP, by strengthening research and public health capacity in developing countries, will help to: o prevent HIV-uninfected persons from becoming HIV-infected; o prevent HIV-infected persons from transmitting HIV to uninfected persons (including prevention of mother-to-child transmission); and o prevent HIV disease progression in infected individuals which, as noted above, may also help to further reduce the spread of HIV. Five specific goals are to: o Encourage development of genuine collaboration and equal partnerships between investigators in different countries; o Assist developing countries achieve independent capacity to conduct their own research and training; o Encourage independent local research on HIV prevention; o Assist NIH institutes to conduct their research missions related to HIV; and o Stimulate multidisciplinary cooperation. Applicants are strongly encouraged to propose multidisciplinary training in one or more areas in each of the two broad fields of biomedical and behavioral research, in addition to a core component of data management and analysis. Biomedical research areas may include basic science, clinical science, epidemiology (as a subset of prevention research), behavioral change, and vaccine research. Behavioral research areas may include the social sciences, behavioral change, economics, policy issues, etc. Data management and analysis includes protocol development, biostatistics, data collection procedures, and quality control. The research focus of the AITRP will remain HIV/AIDS. This includes specific HIV-related co-factors, namely opportunistic infections, STDs, TB, and HIV-associated reproductive health issues but only insofar as they specifically relate to HIV/AIDS. This program will continue to emphasize support for trainees from, and training activities in, the developing countries of Africa, Latin America and the Caribbean, Asia and the Pacific region. The program will also accommodate trainees from, and training activities in, countries of Central and Eastern Europe and the former Soviet Union. However, AITRP is not expected to necessarily be active in all countries with significant HIV incidence or prevalence. Rather, the demonstrated capacity and/or potential to achieve sustained research and training efforts within a country will be the priority. In this regard, research capacity is built in large part by participation in research and thus AITRP programs are strongly encouraged to link training with NIH-supported and other research programs in common countries in such a manner that training and research mutually reinforce each other. The emphasis in AITRP will be depth, not breadth; that is, programs which focus on a relatively few sites or countries would have a greater impact than those which dilute their resources across many countries. 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, "AIDS International Training and Research Program (AITRP)," is related to the priority of HIV infections. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 Summary Report: Stock No. 017-001-0473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Kenneth Bridbord, M.D. Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C32 - MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-2516 FAX: (301) 402-2056 Email: bridbord@nih.gov $$R3 END ************************************************************ $$P1 BEGIN PA-97-106 FULL-TEXT ************************************** FELINE IMMUNODEFICIENCY VIRUS: A POTENTIAL MODEL OF AIDS NIH GUIDE, Volume 26, Number 31, September 19, 1997 PA AVAILABLE: PA-97-106 P.T. National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to Program Announcements (PAs). These PAs identify areas of ongoing research emphasis for the NIAID. The Division of AIDS, NIAID, solicits applications on the molecular biology, immunology, and host factors involved in feline immunodeficiency virus (FIV) infection of cats. The overall goal of these studies is to advance the understanding of the virus/host infection process in this model and to determine the potential use and/or validate the application of the FIV/cat model for testing potential therapeutics, topical microbicides, and novel mucosal-targeted vaccine designs against HIV. Applicants proposing studies focusing solely on FIV pathogenesis are encouraged to apply under PA-96-072 "Mechanisms of AIDS Pathogenesis". Traditional research project grants (R01), small grants (R03), and First Independent Research Support and Transition (FIRST) awards (R29) may be submitted in response to this program announcement. 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, Feline Immunodeficiency Virus: A Potential Model of AIDS, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail or e-mail from the program officer, listed below. Roger H. Miller, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2C36A Bethesda, MD 20892-7620 Telephone: (301) 496-8197 FAX: (301) 402-3211 Email: rm42i@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-97-107 FULL-TEXT ************************************** PREVENTION OF RECURRENT DISEASE AFTER LIVER TRANSPLANTATION NIH GUIDE, Volume 26, Number 31, September 19, 1997 PA AVAILABLE: PA-97-107 P.T. National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: December 9, 1997 Application Receipt Date: January 9, 1998 PURPOSE To encourage experienced and new investigators to submit small grants (R03s) to plan multicenter clinical trials or to submit research project grants (R01s) to conduct full-scale multicenter clinical trials on methods for preventing the recurrence of disease after liver transplantation. Of major relevance are studies on preventing the recurrence of alcoholic liver disease, and preventing the recurrence of hepatitis B and C virus infection after liver transplantation. Specific interventions should be compared. It is of interest to learn about the natural history of these diseases in patients undergoing standard therapy. 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 program announcement (PA), Prevention of Recurrent Disease after Liver Transplantation, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), and by mail or email from the program official contact listed below. Tommie Sue Tralka Division of Digestive Diseases & Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8879 FAX: (301) 480-8300 Email: tralkat@ep.niddk.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-108 FULL-TEXT ************************************** STUDIES OF MOLECULAR MECHANISMS OF RENAL INJURY AND RECOVERY NIH GUIDE, Volume 26, Number 31, September 19, 1997 PA AVAILABLE: PA-97-108 P.T. National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and kidney Diseases announce a continuing interest in receiving research project applications on the above subject. The need for this initiative was recognized, in part, as a result of the recommendations emanating from the conference held at the NIH in May 1996, organized and sponsored by the DKUHD, titled "Acute Renal Failure in the 21st Century." A report from the meeting summarized recommendations from the participants, which included a set of published recommendations for patient management and outcomes assessment (AJKD, Vol. 29, # 5, 793-799, 1997). Also advocated was the development and establishment of a multi-center database as one mechanism to facilitate cooperative multi-center studies. It was further recommended that research initiatives be undertaken to enhance the transfer of new body of knowledge derived from basic studies and laboratory investigation (including cellular and molecular aspects of tissue injury, changes in cell differentiation, cell repair mechanisms, cell death and organ recovery) to the clinical management of ARF. With a more complete understanding of these fundamental aspects of the pathophysiological response by the kidney to ARF, it is anticipated that new therapies and potentially novel uses of replacement therapies may emerge. Additional insight in this field will likely emerge from another conference convened by the American Society of Nephrology, with support from the NIDDK ("Mechanisms of Tissue Injury and Repair") that will be convened November 1997. 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. Potential applicants may obtain a copy of "Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. M. James Scherbenske, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS.19E 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-7719 FAX: (301) 480-3510 Email: scherbensk@extra.niddk.nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Fri Sep 26 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA TW-98-002 - V26(31) 09/19/97 Date: 27 Sep 1997 14:05:33 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1048 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <60jset$dqk@net.bio.net> NNTP-Posting-Host: net.bio.net AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAM NIH GUIDE, Volume 26, Number 31, September 19, 1997 RFA: TW-98-002 P.T. Fogarty International Center Letter of Intent Receipt Date: October 15, 1997 Application Receipt Date: February 18, 1998 PURPOSE The Fogarty International Center (FIC), National Institutes of Health (NIH), invites applications from non-profit private or public U.S. institutions with interest in working with foreign colleagues to build global HIV/AIDS research capacity and thereby help to prevent HIV transmission through development of HIV/AIDS international training and research programs for foreign health scientists, clinicians, and allied health workers in collaboration with U.S scientists in developing countries, including emerging democracies in Eastern Europe and Latin America. This announcement is for the third five-year funding cycle for the AIDS International Training and Research Program (AITRP). Both new and competing renewal applications for this D43 program are welcome. Prevention, through biomedical or behavioral approaches, is critical to stop the global spread of HIV/AIDS. International collaboration can greatly enhance HIV/AIDS prevention efforts, but to be fully effective, prevention research in other countries must involve scientists and health professionals from these countries who are familiar with the unique local and cultural factors contributing to the epidemic in their countries, and should also be fully endorsed by their governments. A major goal of this program is to train developing country scientists to address more effectively the AIDS epidemic through research. This training program will help to: (1) establish critical biomedical and behavioral science expertise in developing countries affected by HIV/AIDS; (2) facilitate new prevention research efforts which supplement or complement NIH and other U.S. AIDS research; (3) establish long-term cooperative relationships between U.S. and foreign research groups; and (4) support cooperation between U.S. academic research centers and foreign scientists. Collaborations supported through this effort will help to facilitate the conduct of scientifically valid and ethically sound HIV/AIDS prevention, technology testing and research. Funds will be awarded to provide training in the various scientific disciplines required to conduct HIV/AIDS research in accordance with the stated objectives for the program. Applicants are strongly encouraged to relate training to ongoing prevention research efforts in developing countries supported by NIH and other organizations. In October, 1996, the FIC convened a panel of scientists to conduct a comprehensive review of the AITRP program. The present announcement reflects most of the recommendations of the panel as described in their report. In addition, the recommendations from the NIH AIDS Research Program Evaluation Task Force, contained in the "Levine" Report, contributed to this Request for Applications (RFA). For example, the need to develop a coordinated and comprehensive Prevention Science Agenda that includes and combines biomedical, behavioral, and social interventions was underscored. Applicants are encouraged to request copies of both of these documents from the FIC. This RFA also reflects guidance of other NIH components, including the Office of AIDS Research (OAR), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), the National Cancer Institute (NCI), the National Institute of Dental Research (NIDR), the National Institute on Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH). The FY 1999 NIH Plan for HIV-Related Research, available from the FIC, describes the range of prevention research encompassed within the "Levine" report and emphasizes the importance of international cooperation and multidisciplinary prevention research to combat the global spread of HIV/AIDS. The FIC AITRP program review noted that the program has become an important component of global research on AIDS and related diseases and that, by integrating research and research training, and by its inherent flexibility, the AITRP is adding significant value to the human resource capability for research and disease prevention in developing countries. This RFA refocuses AITRP from an emphasis on epidemiology to prevention research involving multiple disciplines, which will require a broader research perspective. Accordingly, the overall focus of prevention research training in the new FIC AITRP should be multidisciplinary. Based upon the review of the AIDS International Training and Research Programs (AITRP), the FIC has adopted the following mission and goal statement for the next funding cycle of the AITRP. "The mission of the AITRP is to train international health professionals in research on prevention of HIV infection." The interpretation of this mission statement, in the context of the overall AITRP review, is broad, encompassing not only prevention of HIV transmission and infection, but also prevention of progression of HIV infection to AIDS, which may reduce the likelihood of HIV transmission by infected individuals. AITRP, by strengthening research and public health capacity in developing countries, will help to: o prevent HIV-uninfected persons from becoming HIV- infected; o prevent HIV-infected persons from transmitting HIV to uninfected persons (including prevention of mother-to-child transmission); and o prevent HIV disease progression in infected individuals which, as noted above, may also help to further reduce the spread of HIV. Five specific goals are to: o Encourage development of genuine collaboration and equal partnerships between investigators in different countries; o Assist developing countries achieve independent capacity to conduct their own research and training; o Encourage independent local research on HIV prevention; o Assist NIH institutes to conduct their research missions related to HIV; and o Stimulate multidisciplinary cooperation. Applicants are strongly encouraged to propose multidisciplinary training in one or more areas in each of the two broad fields of biomedical and behavioral research, in addition to a core component of data management and analysis. Biomedical research areas may include basic science, clinical science, epidemiology (as a subset of prevention research), behavioral change, and vaccine research. Behavioral research areas may include the social sciences, behavioral change, economics, policy issues, etc. Data management and analysis includes protocol development, biostatistics, data collection procedures, and quality control. The research focus of the AITRP will remain HIV/AIDS. This includes specific HIV-related co-factors, namely opportunistic infections, STDs, TB, and HIV-associated reproductive health issues but only insofar as they specifically relate to HIV/AIDS. This program will continue to emphasize support for trainees from, and training activities in, the developing countries of Africa, Latin America and the Caribbean, Asia and the Pacific region. The program will also accommodate trainees from, and training activities in, countries of Central and Eastern Europe and the former Soviet Union. However, AITRP is not expected to necessarily be active in all countries with significant HIV incidence or prevalence. Rather, the demonstrated capacity and/or potential to achieve sustained research and training efforts within a country will be the priority. In this regard, research capacity is built in large part by participation in research and thus AITRP programs are strongly encouraged to link training with NIH-supported and other research programs in common countries in such a manner that training and research mutually reinforce each other. The emphasis in AITRP will be depth, not breadth; that is, programs which focus on a relatively few sites or countries would have a greater impact than those which dilute their resources across many countries. 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, "AIDS International Training and Research Program (AITRP)," is related to the priority of HIV infections. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 Summary Report: Stock No. 017-001-0473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS The grantee institution must be a U.S., nonprofit private or public institution capable of meeting the objectives in this RFA. The previous FIC epidemiology (D43) and postdoctoral (T22) training programs related to AIDS have now been combined into this new D43 program with an emphasis on prevention. However, only one D43 application will be allowed under this program from each U.S. institution. Thus, existing postdoctoral programs are not eligible to apply as free-standing postdoctoral programs, but will be provided two-year phaseout funding. Postdoctoral training, however, can be included as part of the new AITRP. The three newly awarded epidemiology (D43) programs initiated during the second funding cycle (1993) can apply for this competition, but have the option of a two-year administrative extension in which case they can reapply during a recompetition planned two-years later for another five-year funding cycle. Any programs which opt for this two-year extension must provide a revised workplan indicating how they are refocusing their program to achieve the multidisciplinary prevention research goals of this RFA. This revised workplan should be submitted in lieu of a letter of intent by October 15, 1997. These modifications are being made to establish a staggered AITRP funding cycle in order to achieve greater flexibility as recommended in the AITRP program review. MECHANISM OF SUPPORT Grants will be made as D43 awards for a total project period of five years. Continued support during this period depends on satisfactory performance as judged by annual progress reports; site visits and meetings of program directors; indicators such as career progress of trainees (e.g., positions occupied, first author publications, presentations, research undertaken and research awards received); and impact on developing national capacity for research and prevention. FUNDS AVAILABLE Approximately $6,500,000 (total costs) will be allocated to this program in FY 1998, availability of funds permitting, resulting in an estimated twelve awards, depending upon the quality of approved applications. The development of new programs is a time consuming process. As a result, while the total (direct and indirect) cost per grant for the first year must not exceed $600,000 (base award) for continuing programs, new programs must not exceed $400,000 for base awards. Up to $200,000 additional (total funds) may be requested only by continuing programs for expanded activities in one or more special areas as described below. An additional $100,000 may be requested by both continuing and new programs for collaborative activities with non-AITRP funded U.S. or foreign (developed country) institutions, for collaboration with other AITRP programs for in- country activities in common countries, and for training new and minority U.S health science students. It is recognized that these limitations in budget requests could result in a substantial reduction in funding for some continuing programs, particularly since the highest priority for funding will be to award the most meritorious proposals up to the justified level of base budget requests before making awards for expanded activities in special areas as described below under award criteria. RESEARCH OBJECTIVES Applicants are strongly encouraged to include both biomedical and behavioral sciences prevention research, as well as training in data management and analysis. This program is intended to complement ongoing AIDS research efforts of the NIH and, to the extent possible, of other government, non- government and international organizations. The underpinning of any research training program is one that has ongoing research activity. A strong research infrastructure results in a good training experience and programs are thus encouraged to develop human resources in those developing countries that currently are or are likely to be sites of HIV/AIDS-related research field trials of HIV vaccines, anti-HIV drugs, and other interventions, including but not limited to those supported by the NIH. Specifically, the program is designed to: o Increase expertise of scientists in developing countries on AIDS- related biomedical and behavioral prevention research primarily through long-term training at U.S. institutions which may lead to M.S. and/or Ph.D. degrees as well as targeted short-term training at U.S. institutions in any relevant research field, with the goal to increase HIV/AIDS prevention research capacity in collaborating countries; o Increase research collaboration and capacities in foreign countries that are engaged in HIV/AIDS-related prevention research through targeted in-country, short-term, didactic and technical training; and o Expand ongoing collaborative training in HIV/AIDS prevention research between U.S. and foreign scientists. Training Plan Emphasis should be given to U.S.-based, long-term (usually a minimum of two years) training either leading to an advanced degree or to provide postdoctoral training. Long-term training could include degrees in any relevant HIV prevention research field. The new AITRP places an even greater emphasis on U.S.-based long-term training than in the past. Short-term courses or workshops that are only for the purpose of general orientation to HIV/AIDS and networking are strongly discouraged and will receive much lower priority for funding. The RFA will allow short-term training targeted toward specific needs such as learning laboratory techniques required to conduct a research study or designing behavioral interventions and initial activities to establish relationships in countries where none currently exist. Types of Training 1. Training in biomedical and behavioral HIV/AIDS-related prevention research disciplines as well as data management and analysis in support of that research which may lead to an M.S. or Ph.D. degree for individuals with previous field research experience. The duration of training is estimated to range from about two to four years. Academic courses will be taken in the U.S. Field studies and research could be conducted in the U.S., but to the extent possible, is encouraged to take place in the trainees' home country. Active involvement in on-going research projects is vital for a successful research training experience. Innovative ways to involve trainees in research projects conducted in their home countries is especially encouraged. 2. Training in biomedical and behavioral HIV/AIDS-related prevention research disciplines which may lead to an M.S. degree for individuals without prior field research experience. Academic courses will be taken in the U.S.; field studies would ordinarily be conducted in the trainees' home country. The duration of training is estimated to be about two years. 3. Postdoctoral research experiences (generally of two years duration) for foreign health scientists (in the U.S.) and for U.S. health scientists overseas. 4. Training (about three to six months duration) conducted in the U.S. in laboratory procedures and research techniques in support of specific HIV/AIDS prevention research (for example, development of pilot biomedical and behavioral studies); for individuals with M.S. and Ph.D. degrees. 5. In-country, practical and applied short-term training (up to three weeks) targeted to specific needs in support of HIV/AIDS prevention research for professionals, technicians and allied health professionals, including training necessary to support local participation in institutional review boards, data and safety monitoring boards and community advisory boards necessary to support future clinical trials of interventions. 6. Advanced research training (generally of one to two years duration) for current and/or former trainees, including re-entry grants to enable them to continue this advanced training in their home country and to participate in in-country prevention research projects such as interventions to prevent the further spread of HIV/AIDS. 7. Support to enable U.S. faculty to be involved in advanced research training activities conducted in-country. 8. Support to enable new and minority U.S. health science students (including medical students and residents) to receive overseas health research experiences (generally of three to twelve months duration) in collaboration with foreign trainees upon return to their home countries. Trainees Trainees shall be individuals who are involved in or are expected to be involved in HIV/AIDS prevention research activities in their home country. The following categories of individuals are eligible for training: 1. Foreign health professionals (M.D., D.D.S./D.M.D., Ph.D., or equivalent); 2. Foreign professionals with a bachelors or masters degree in a basic or health science; 3. Medical technicians and health care workers; 4. Allied health professionals such as behavioral scientists, nurses and social workers; 5. Current or former AITRP trainees involved in advanced research training in their home countries; and 6. U.S. health science students, medical residents and postdoctoral researchers. SPECIAL REQUIREMENTS The primary effort of the program should be directed toward research and research capacity building in developing countries and selected other countries that have, or are likely to have, population groups with a significant incidence of HIV/AIDS. Countries in Central and Eastern Europe and the former Soviet Union are eligible to participate, as are countries in Africa, the Americas, Asia and the Pacific Region. It is not expected that the AITRP necessarily be active in all countries with significant HIV incidence or prevalence. Any expansion to additional countries will be predicated on scientific opportunities and the likelihood of sustained success and any additional funding will be provided on a competitive peer review basis. Any extension of AITRP efforts from an established country program to neighboring countries must be carefully planned. Though exceptional efforts to establish formal regional networks among programs is discouraged, regional cooperation and collaboration is encouraged. Trainees from developed countries may be allowed into the program only under special, well-justified circumstances and with prior approval by the FIC as a reprogramming request to meet special training needs. Potential applicants are strongly encouraged to form consortia where appropriate to provide a full complement of training opportunities of the best possible scientific quality across the prevention research disciplines: biomedical and clinical research, behavioral and social sciences research and data management and analysis. Training and research activities will relate to HIV/AIDS prevention and other interventions, opportunistic infections and other diseases strongly associated with AIDS (e.g., STDs and tuberculosis). Applicants are required to include training in responsible conduct of research as a part of the program. An award will not be made unless a description of such training is included. Before any funds can be expended from this award, the grantee institution must show evidence of approval for collaborative research between the U.S. and foreign countries and institutions included in the program through an endorsement from the Minister of Health or other appropriate government officials as well as from the collaborating institutions. In this regard, existing programs are expected to update their prior agreements. The applicant institution must include a plan describing the recruitment and selection procedures for trainees, for the peer review of training-related and advanced in-country research (re-entry grants) as well as plans for continued collaboration with former trainees. The AITRP grant applications should clarify and completely specify: (a) criteria and procedures for the selection of trainees as, for example, by a committee composed of U.S. and foreign investigators at participating institution(s) in the program; and (b) a mechanism for internal peer review of applications to support relevant in-country research projects with budgets generally not exceeding $25,000. Projects exceeding this limit require preapproval >From the FIC. The criteria and mechanisms for review and selection of trainees and research projects will be reviewed at the NIH at the time the grant applications are reviewed competitively. After funding, these criteria and mechanisms must be instituted as described and no further outside review carried out at the FIC or elsewhere at the NIH will be required during the funding period of the grant, except for the usual and customary duties of project management at the NIH. As part of their obligations under this program, awardees are required to design and implement a system to fully track and document the long-term impact of this training program on: (1) the careers of current and former AITRP trainees; (2) research capacity in the home countries of trainees; and (3) the contributions to future NIH- supported international HIV/AIDS research efforts. Examples of such impact include how training received under the program allowed participants to assume more responsible positions upon returning home, how continuing collaborations with former trainees resulted in the funding of collaborative research projects for which trainees were either principal or co-principal investigators, and publications in which trainees were first authors and which were based upon support under this program. This tracking system, to follow trainees at least ten years after completion of their training, should be described in the application. It is imperative that coordination and collaboration should occur between the participating AITRP programs and institutions, especially when operating within the same country (e.g., Brazil, Thailand, etc.). The organization and coordination of activities among sites will be facilitated by the FIC. Joint meetings should be held during international and regional meetings. Programs are strongly encouraged to include plans for coordination and if possible, collaboration with other AITRP and non-AITRP programs when working in common countries and/or regions. FIC will also facilitate coordination and collaboration with other government agencies [e.g., the Centers for Disease Control and Prevention (CDC), the United States Agency for International Development (USAID)] and with bilateral and multilateral international organizations, including collaborations with in-country projects funded by NIAID, NICHD, NCI, NIDR, NIDA and NIMH. Inclusion of the latter two is particularly important given the recommended increased emphasis on multidisciplinary biomedical and behavioral research. Collaboration and coordination is strongly encouraged with international organizations and NGOs [e.g. United Nations Programme on AIDS (UNAIDS), the Pan American Health Organization (PAHO), the Rockefeller INCLEN program, the International Union Against Tuberculosis and Lung Disease (IUATLD), and the International Union Against Venereal Diseases and Treponematoses]. Within allowable limits, research collaborations can include other industrialized nations in addition to the U.S. when the purpose of that collaboration is to facilitate and/or support activities in a common developing country. Support for travel and subsistence of U.S. or foreign investigator(s), and the exchange of data, materials and supplies will be allowed for this purpose, not to exceed 10 percent of direct costs of this award unless prior approval is secured from the FIC. As a condition of this special expenditure, the applicant must indicate some form of cost-sharing by the counterpart institution in an industrialized nation.Communication FIC AITRP programs should endeavor to ensure that research results are accessible and to facilitate translation of results into practice by: (a) exchanging newsletters among grantees; (b) sponsoring in- country meetings for all trainees in a country; and (c) establishing a World Wide Web site for dissemination of new information and for less formal exchange of information among sites. In addition, grantees are required to: (a) provide for in-country dissemination of research results; and (b) develop mechanisms to facilitate access of their foreign collaborators to current published literature. The AITRP grant applications should include specific plans for in-country dissemination of research results for local prevention of HIV infection, and these efforts should be part of regular progress reports. Up to 10 percent of budgets can be utilized for these purposes and additional funds can be requested to support this activity. FIC will establish an AITRP web site linking all of the individual program web sites and will circulate individual newsletters among all programs. Protection of Human Subjects and Laboratory Animals Recognizing that in many cases the required assurances will be in place as a result of previous funding by HHS components, applicable provisions for the protection of human research subjects and laboratory animals in research and training activities must be met in both domestic and foreign settings. Title 45 CFR, Part 46, provides guidelines concerning Department of Health and Human Services regulations for the protection of human subjects. The requirements for using animals are detailed in the Public Health Service Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks (OPRR), National Institutes of Health, 6100 Executive Boulevard, MSC 7508, Rockville, Maryland 20852-7508. In this regard, applicants must be sure to meet the requirements of obtaining single project assurances from OPRR for all projects involving human subjects at foreign sites unless otherwise covered by a multiple project assurance. Applicants must also be sure to obtain the necessary assurances including review at both U.S. and foreign sites for research in which they are actively engaged by virtue of consultancy (for example, resulting in co- authorship) or for research conducted on biological samples obtained >From scientific colleagues in collaborating countries, if the samples are individually identifiable to any of the scientists. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. In this regard, the frame of reference for inclusion of minorities in research is whether the participants would be considered to be minorities in the U.S. population and most of the foreign populations under study would be considered minorities in the U.S. On a related matter, programs are encouraged to include representation of women in selecting foreign trainees and to include adequate representation of women and minorities in selecting U.S. trainees under this program. LETTER OF INTENT Prospective applicants are asked to submit, by October 15, 1997, a letter of intent that includes a descriptive title of the proposed training and research programs, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions in collaborating countries, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent should be sent to: Kenneth Bridbord, M.D. Director Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C32 31 CENTER DR MSC 2220 BETHESDA, MD 20892-2220 Telephone: (301) 496-2516 FAX: (301) 402-2056 Email: bridbord@nih.gov The letter of intent also will be used to communicate any additional information that may be developed to prospective applicants, including the location and time of any meetings that may be convened to answer questions from prospective applicants. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and five copies of any appendices must be sent to: Hortencia Hornbeak, Ph.D. National Institute of Allergy and Infectious Diseases National Institutes of Health Solar Building, Room 4C19-MSC 7610 6003 Executive Blvd. Rockville, MD 20852-7610 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: hh7g@nih.gov Applications must be received (not postmarked) by February 18, 1998. If an application is received after that date, it will be returned to the applicant without review. 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. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the FIC. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned to the applicant without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, all applications will be discussed, assigned a priority score and receive a written critique as well as receive a second level review by the FIC Advisory Board. Timetable Letter of Intent Receipt Date: October 15, 1997 Application Receipt Date: February 18, 1998 Review for Scientific Merit: June 1998 Review by the FIC Advisory Board: September 1998 Anticipated Award (Start) Date: September 30, 1998 Review Criteria The following criteria apply to new applicant institutions as well as those seeking a competing renewal. Factors to be considered in the scientific evaluation of each application include: In general, the success of the programs to date (for competing renewals) and/or the likelihood that the applicant institution can meet the goals and objectives stated in this RFA and specifically considering the following: (1) Significance o The expected public health and scientific contributions of the proposed activity; o The demonstrated capacity and/or potential to achieve sustained research and training efforts within a country; o Strength of the academic program; and o Previous success in training AIDS-related scientists and in maintaining collaboration with former trainees including assisting former trainees in obtaining support for their research upon return to their home countries. (2) Approach o Balance in the proposed training program to provide breadth of training opportunities in the fields of 1) biomedical and clinical prevention research; 2) social and behavioral research; and 3) data management and analysis; o The appropriate mix of long- and short-term training to achieve the goals of this RFA; o Opportunities for trainees to become involved in research projects conducted in their home countries; o Adequacy of proposed procedures and criteria for 1) recruitment, review and selection of trainees and 2) peer review of research projects; o Demonstrated capacity and/or potential to collaborate with other institutions and to coordinate program activities with related efforts of other FIC and NIH programs, other federal agencies (e.g., CDC and USAID), international organizations (e.g., UNAIDS and PAHO), and NGOs [e.g., the International Union Against Tuberculosis and Lung Disease (IUATLD), the International Union Against Venereal Diseases and Treponematoses and the Rockefeller INCLEN program]; o Demonstrated capacity and/or potential to provide overseas research experience for U.S. health science students and medical residents, including new and minority U.S. health scientists from AITRP and non-AITRP institutions, such as HBCUs, as well as plans to include an adequate representation of women among foreign and U.S trainees; and o Systems for documenting the long-term impact of the program on research capacity in the home countries of trainees including the impact of the program on the careers of current and former AITRP trainees. (3) Innovation o Overall creativity and cost-effectiveness of the training and research plan; o Plans for trainees to become involved in research projects conducted in their home countries; and o Adequacy and creativity of plans to use modern information technology to facilitate access to scientific information, distance learning, as well as coordination and research collaboration. (4) Investigator(s) o Qualifications of the program director to lead and the named faculty to participate in the proposed training and research program; o Documentation of previous international collaboration with developing country scientists and institutions included in the proposed program; o Depth of the program director's and faculty's experience in the fields of 1) prevention; 2) biomedical, social and behavioral research; and 3) data management and analysis; o Active research support of program director and participating faculty; and o Career accomplishments of former trainees including extent of former trainees' involvement in the proposed program. (5) Environment o Demonstration of continued or of future support for the program >From governments and institutions and other non-governmental organizations from collaborating countries; o Demonstrated support for domestic and international AIDS-related research and training as evidenced by support from the NIH or other sources. Examples include research support by NIAID, NICHD, NCI, NIDR, NIDA and NIMH; o The strength of resources and training environment in-country as evidenced by 1) the quality of teaching and research facilities and other resources in-country; 2) the availability of high-quality candidates; and 3) past history of success in former trainees returning to their home countries and their continued involvement in the program, for example, in advanced in-country research and/or as faculty and mentors for new trainees; and o Training environment in the U.S. including the institutional commitment, the caliber of preceptors, the quality of teaching and research facilities and resources. The initial review group will also examine the adequacy of the process for providing for the protection of human and animal subjects and the safety of the research environment, as well as plans to include training in responsible conduct of research and training in the operations of IRBs, data and safety monitoring boards and community advisory boards as a part of the program. In this regard, IRBs in the home countries of trainees will be responsible for determining the adequacy of inclusion of women and minorities in research involving human subjects in their countries. Allowable Costs U.S. investigators may request funds (including re-entry grants) to support research projects in the trainees' home country that emanate >From the M.S. and Ph.D. training program. The research supported (1) must be one of the requirements in fulfillment of an M.S. or Ph.D. degree or part of advanced research training; (2) be relevant to an AIDS problem in the trainee's country; and (3) may form the basis for a long-term collaboration funded by future research grant support. The following cost categories are allowable for reimbursement under this program. It should be noted that the following stipends and allowances are maximums and applicant institutions are encouraged to design the most cost-effective programs, generally at lesser amounts: Stipend and Salary o Living allowance (stipend) comparable to trainee's professional level, but not to exceed $45,000 per annum while undergoing training in the U.S.; o Living allowance (stipend) while conducting in-country dissertation research or in-country advanced research training (re- entry grants) at a level comparable to that received by similar professionals in-country, but also not to exceed $45,000 per annum; o Stipend support (not to exceed $45,000 per year) for foreign and U.S. postdoctoral researchers; o Support (pro-rated salary, up to 25 percent of annual salary or $25,000, whichever is less), to enable U.S. faculty to be involved in advanced research training activities conducted in-country; o Program director's salary (up to 25 percent of annual salary or $25,000, whichever is smaller); and o Salary for clerical and administrative support staff (up to 2.0 FTE, but not more than 10 percent of direct costs). Tuition o Tuition, not to exceed 20 percent of total direct costs. Exceptions to this policy require prior approval from the FIC. Travel o Round trip economy class air fare between the U.S. and home country (two trips for M.S./Ph.D. candidates and advanced research trainees, one for all others); o Travel and per diem for the program director and faculty colleagues to provide guidance to students conducting dissertation- related field studies and/or advanced research training in their home countries; and o Travel and per diem for faculty presenting short-term, in-country courses. Training Related Expenses o Allowance for the grantee institution of up to $600 monthly per student to cover health insurance, scientific meetings, and incidental research expenses; o Support of up to $15,000 for in-country field research in partial fulfillment of the M.S./Ph.D training program; and o Research support of up to $25,000 per trainee to facilitate the conduct of advanced research training (re-entry grants) in the home country conducted by current and/or former trainees; the program director is expected to have projects submitted for this funding peer reviewed by the U.S. institution in accordance with plans outlined in the grant application. Other o Up to 10 percent of allowable direct costs may be used to cover collaboration with other developed countries when the object of that collaboration involves work in a common developing country; o Up to 10 percent of allowable direct costs may be used to establish or enhance an international component within an existing CFAR or P30 program, with the goal to support developmental research by foreign collaborators which would lead to newly funded research awards; o Up to 10 percent of allowable direct costs may be utilized to support coordination and communications activities, including attendance at meetings for this purpose; o Up to $200,000 additional (total funds) may be requested for expanded activities in special areas as outlined below (competing renewals only); and o Up to $100,000 additional (total funds) may be requested (by both competing renewals and new programs), to support initiatives for collaboration with other non-AITRP institutions or collaboration with AITRP institutions for work in common countries, for telecommunications distance learning including expanded access to the internet, and to support training for new and minority U.S. health science students. o In keeping with the intent to maintain a flexible program, requests for administrative supplemental budget increases of up to 20 percent of funded levels in a given budget year for the expansion of prior approved activities will be allowed to meet special needs and take advantage of unusual opportunities. Such requests, which will be reviewed by program staff, also may be subjected to external peer review and support will depend upon availability of funds. In addition, in response to compelling needs and/or research opportunities, programs may be requested to take on additional responsibilities within the general scope of the award, on mutually agreeable terms and conditions. Expanded Activities As noted above, if additional funds are available, competing renewals may request up to $200,000 for expanded activities in special areas which must be linked to one or more existing NIH-funded research efforts in those areas. Examples include special training, training- related research and overall capacity building efforts to support HIV/AIDS vaccine trials including training to increase laboratory capacity in-country; prevention of mother-to-child HIV transmission; behavioral interventions to prevent HIV transmission; as well as research and training/capacity building related to HIV and opportunistic infections in general; TB; STDs; microbicides; nutritional interventions; drug abuse; risk factors, pathogenesis, prevention and management of oral HIV-related diseases; and clinical trials methodologies. Apart from the $200,000 for expanded activities, another $100,000 per year can be requested (by both competing renewals and new programs), raising the total allowable request to $900,000 for competing renewals and $500,000 for new programs for the purpose of including another U.S. institution as a collaborating partner if that institution was not otherwise an applicant or participant in the AITRP program, or to collaborate with another AITRP institution for work in a common country, for telecommunications/distance learning and to support training for new and minority U.S. health science students. The $200,000 category for expanded activities must link efforts to specifically identified and currently active (18 months at time of application) research grants and/or contracts supported by other ICDs, e.g., NIAID, NICHD, NCI, NIDR, NIDA, and NIMH. Grantee institutions may request an indirect cost allowance based on 8 percent of the total allowable direct costs exclusive of tuition and related fees and expenditures for equipment. The total allowable cost (direct and indirect) per grant for the first year of this five year award must not exceed $600,000 (base funds) for continuing programs and $400,000 for new starts. Applicants should assume a budget increase of 2 percent per year for each succeeding year. While applicants may develop programs at or close to these limits, they are strongly encouraged to pursue the most cost-effective approaches for implementing these programs. The intent is to award an estimated twelve grants, depending upon the quality of the approved grant applications and the availability of funds. As noted above, before any funds can be expended from this award, the grantee institution must show evidence of approval for collaborative research between the U.S. and foreign countries and institutions included in the program through an endorsement from the Minister of Health or other appropriate government official as well as from the collaborating institutions. The anticipated date of award is on or before September 30, 1998. AWARD CRITERIA The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o the extent and effectiveness of efforts made by applicants in developing multidisciplinary biomedical and behavioral research training programs necessary to support prevention research efforts in the home countries of trainees; o cost-effectiveness of programs; o efforts made to collaborate with other AITRP programs and institutions and with other organizations; o the extent to which proposed training programs support and complement other NIH-funded international HIV research efforts; o availability of funds (with the first priority given to funding the most meritorious programs to the level requested in their base budgets, not including the special requests); o program balance among critical research training areas of emphasis such as, but not limited to, preparation for future prevention research efforts including trials of HIV vaccines, anti-HIV drugs, and other interventions (e.g., microbicides, behavioral interventions, nutritional supplementation); and o geographic distribution among countries included in applications under consideration, including the need for a given program to work in a specific country (such as linkage with another NIH-supported research project in that country). INQUIRIES Prospective applicants are strongly encouraged to discuss their applications, including proposed collaborating countries and institutions with FIC program staff (see below) before submitting formal applications. All programmatic and scientific inquiries, including any requests for further instructions to prepare applications, should be directed to: Kenneth Bridbord, M.D. Director Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C32 31CENTER DR MSC 2220 BETHESDA, MD 20892-2220 Phone: (301) 496-2516 FAX: (301) 402-2056 Email: bridbord@nih.gov Inquiries related to the review of these applications may be directed to: Hortensia Hornbeak, Ph.D. National Institute of Allergy and Infectious Diseases National Institutes of Health Solar Building, Room 4C19-MSC 7610 6003 Executive Blvd. Rockville, MD 20852-7610 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: hh7g@nih.gov Inquiries regarding fiscal matters may be addressed to: Mrs. Silvia Mandes Grants Management Officer Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 31 Center Dr MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 E-mail: mandess@ficod.fic.nih.gov AUTHORITY AND REGULATIONS Awards are made under authorization of the Public Health Service Act, Title III and Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241, 242l and 287b) 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 to Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Sep 26 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-011 - V26(31) 09/19/97 Date: 27 Sep 1997 14:05:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 711 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <60jseh$dq1@net.bio.net> NNTP-Posting-Host: net.bio.net NUTRITION ACADEMIC AWARD NIH GUIDE, Volume 26, Number 31, September 19, 1997 RFA: HL-97-011 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 1, 1997 Application Receipt Date: February 18, 1998 THIS RFA USES "JUST-IN-TIME" PROCEDURES. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE FOLLOWED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The primary objective of this initiative is to encourage the development or enhancement of medical school curricula to increase opportunities for students, house staff, faculty, and practicing physicians to learn nutrition principles and clinical practice skills with an emphasis on preventing cardiovascular diseases (CVD). A second objective is to provide training modules for dissemination to other medical schools as well as other health care professional schools. 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, Nutrition Academic Award, is related to the priority areas of nutrition, heart disease and stroke, obesity, physical activity, diabetes, chronic disabling conditions, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Institution An application may be submitted by any domestic institution with a school of medicine. Eligible institutions may submit only one application in each competition and receive only one award. Principal Investigator A Principal Investigator for the Nutrition Academic Award must have the following credentials: o doctoral degree o sufficient graduate or post graduate training and experience in nutrition research, medical or nutrition clinical practice, and/or medical education to develop and implement a high quality medical curriculum in nutrition, emphasizing cardiovascular disease prevention, and to provide leadership for a multidisciplinary team; o knowledge and skills and a demonstrated commitment to medical education for students, house staff, physicians and other health care professionals; o permanent appointment (not adjunct) at the rank of Associate or Full Professor on the faculty of an accredited school of medicine in the United States, its territories, or its possessions; o demonstrated support from the Dean and educational leadership of the institution and; o be a citizen or non-citizen national of the United States or have been lawfully admitted for permanent residence at the time of application. Individuals who have or have had another NIH career development award (K series) or a regular research grant (R01) are eligible for this award if the individual meets the requirements of the Nutrition Academic Award program. Applications from women and individuals from diverse racial/ethnic backgrounds are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (KO7) of the National Heart, Lung, and Blood Institute. 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 and is non-renewable. Awards will be limited to a maximum of $50,000 for the salary of the Principal Investigator, plus applicable fringe benefits, and a maximum of $150,000 for the total cost of the award for the first year (including indirect costs). A three percent escalation is allowed per year in subsequent years. The salary cap may not be exceeded in any year. Facilities and Administrative costs may not exceed 8 percent. It is anticipated that support for this program will begin September 30, 1998. Application instructions have been modified to reflect "just-in-time" streamlining efforts at the NIH. The just-in-time concept requires applicants to submit certain materials only when there is the possibility of an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and NHLBI staff. For this RFA, only limited budgetary information is required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and key personnel must be included in the research plan. Instructions for completing the Biographical Sketch have been modified. In addition, the Other Support information and application "Checklist" page are not required as part of the initial application. If the possibility of an award exists following the initial review, the Budget, Other Support, and Checklist information will be requested by NHLBI staff. The APPLICATION PROCEDURES section of this RFA provides specific details of these modifications to the standard PHS 398 application kit. FUNDS AVAILABLE It is anticipated that in fiscal year 1998, support will be available for total costs of approximately $750,000 and that approximately five grants will be awarded under this program. An additional competition will be held in fiscal years 1999 and 2000. The actual number of awards each year will depend upon the merit and scope of the applications received and the availability of funds. OBJECTIVES Background Diet has been associated with eight of the ten leading causes of death in the United States (USDHHS, 1988). A number of national committees, panels, and agencies have made recommendations for the nation to modify and improve dietary intake as a major step toward preventing premature morbidity and mortality from cardiovascular and other chronic diseases (National Research Council, 1989; USDHHS, 1991; Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, 1993; National High Blood Pressure Education Program, 1993; US Department of Agriculture, 1995; Krauss et al, 1996). Currently, health care providers and health care organizations are paying increasing attention on risk factor management as a key part of optimal care of patients to prevent CVD, and emphasis is being placed on strategies to prevent nutrition-related diseases (Pearson et al, 1996). More recognition is being given to the importance of nutrition training for health care providers from several disciplines, since they play a key role in meeting this need with patients and the general public. Over the years, physician and patient surveys have shown repeatedly a need to increase physicians' skills and efforts in nutrition. For example, Schucker et al (1991) in a survey on cholesterol awareness showed only 9% of the public reported that their physicians gave them advice to follow cholesterol-lowering diets, although one in four reported a diagnosis of elevated cholesterol. For over 30 years, inclusion of nutrition in medical school curricula has been advocated by nutrition societies and expert committees (Zimmermann et al, 1993; USDHHS 1991; NHLBI, 1994; US Preventive Services, 1996). The Committee on Nutrition in Medical Education (1985) recommended that nutrition be a required course in medical schools, a minimum of 25 hours be provided to teach the basic material, nutrition questions be included in medical licensing examinations, and a separate nutrition department be instituted in medical schools. At the time of the 1985 report, only 25% of medical schools had required nutrition courses, only a few medical schools provided 25 hours or more of nutrition content, fewer than 3% of questions on the National Boards related to nutrition, and only one or two medical schools had a separate nutrition department (Winick, 1993). Nearly a decade later there was little, if any, improvement in this situation (Winick, 1993). In 1997, Hark et al reported that medical licensing examinations contained 11% to 12% nutrition content, as identified by nutrition professionals. Many of the items were related to vitamin deficiencies, and little coverage was given to nutrition-related screening and preventive counseling (Hark et al, 1997). A national consensus on the essentials of nutrition education in medical schools has recently been developed (American Medical Student Association, 1996). Thus, although numerous reports contain major recommendations for the inclusion of nutrition in medical education and physician training, implementation has been limited (USDHHS, 1991; Pearson et al, 1996; Tobin, 1997). Prevention of CVD through nutrition cuts across several medical and other health care specialties (e.g., cardiology, internal medicine, preventive medicine, family practice, pediatrics, obstetrics and gynecology, geriatrics, nursing, dietetics, physician assistants), and a multidisciplinary approach is required to integrate nutrition training in these specialties. In addition to training in nutrition principles and counseling techniques, physicians need training on how to set up an office practice system that is supportive of a team approach to CVD prevention. Training mechanisms for faculty in medical schools with strong backgrounds in nutrition science, research, and prevention to expand nutrition training of physicians as well as other health professionals could help meet some of these needs (Bruer et al, 1994; Hunt et al, 1995; Pearson et al, 1996; Ockene et al, 1996; Morrison et al, 1996). The aim of this academic award program is to stimulate the development and enhancement of medical school education programs so that physicians may learn nutrition principles and clinical practice skills for the prevention of CVD risks and improved nutritional management of their patients. A second aim is to provide training modules for dissemination to other medical and other health professional schools. Awardees should propose objectives and plans for incorporating nutrition into medical school programs. Preference will be given to applicants who also include training opportunities for other health care providers. The plans should include mechanisms to: o Encourage the development of high quality curricula in schools of medicine that will significantly increase the knowledge and skills of students, house staff, and others, including faculty and practicing physicians, to apply state-of-the-art nutrition principles, practice, and counseling with an emphasis on prevention of CVD. o Evaluate the impact of the proposed program. o Promote professional development of the awardee so he/she can serve as a focal point for multidisciplinary interactions promoting effectiveness in teaching, research, and clinical care in the field of nutrition, including training of other health care professionals. o Develop or enhance an infrastructure at the Institution to continue educational and training programs in nutrition and CVD prevention when the award is concluded. o Promote communication among specialists in primary care and other specialties to ensure coordinated nutritional prevention and treatment strategies. o Develop coordinated clinical and educational approaches to address nutritional needs of patients of various ages and ethnic groups, and populations with special needs. o Engage in an interchange of teaching modules and strategies among other awardees and their institutions. o Develop curricula and training modules in collaboration with other awardees that can be adapted and used by other academic training units and institutions. o Promote research studies in nutrition and CVD prevention at the Institution, funded by other support. SPECIAL REQUIREMENTS Applicants should develop a comprehensive program that effectively addresses their needs related to the objectives of this RFA. The primary focus must be on plans to improve the quality of nutrition medical school education for students and physicians. Plans and educational materials for curricular improvements must be of a design that facilitates dissemination and adoption at other institutions. All applications must include plans to evaluate the outcome of the educational initiatives. The responsibilities of the Principal Investigator and key personnel must be described in the budget justification section. The minority and gender composition of students to be trained should be described. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994, (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies of the policy from these sources or >From the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. Although the Nutrition Academic Award is not primarily a mechanism to support research, medical students and residents are considered human subjects and it is likely that human subjects will be involved. Therefore, protection of human subjects must be addressed, and the approximate percent of women and each minority group that you expect in the total population must be included. LETTER OF INTENT Prospective applicants are asked to submit, by December 1, 1997, a letter of intent, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel, participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be faxed or sent to Dr. Louise Corman, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). These forms are available at most institutional offices of sponsored research and from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email: asknih@odrockm1.od.nih.gov. 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. In addition, to identify the application as a response to this RFA, check "YES" in item 2 of application page 1 and enter the title "Nutrition Academic Award NIH HL-97-011". Use the following modifications in completing the standard PHS 398 application instructions: o BUDGET INFORMATION - No current/future year budgets or justifications (form pages 4 and 5) are required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and all key personnel must be specifically stated at the beginning of the research plan. Necessary budget information will be requested by NHLBI staff if there is a possibility for an award. o BIOGRAPHICAL SKETCH - In addition to the standard information requested on Form Page 6, the applicant should provide the title and source of any sponsored support relevant to the proposed workscope. o OTHER SUPPORT - No other support information is required on the "Other Support" page (Form Page 7). Selected other support information relevant to the proposed application may be included in the Biographical Sketch as indicated above. Complete other support information will be requested by NHLBI staff if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NHLBI staff if there is a possibility for an award. o FACE PAGE - Currently, the Division of Research Grants requires that requested costs be reflected on the face page for computer system tracking purposes. Because no budgetary information is required as part of the "streamlined" application, we are requesting that the following amounts be entered on the face page: 7a. Direct Costs for Initial Budget Period - $139,000; 7b. Total Costs for Initial Budget Period - $150,000; 8a. Direct Costs for Proposed Period of Support - $695,000 and; 8b. Total Costs for Proposed Period of Support - $750,000. IT IS UNDERSTOOD THAT THESE LEVELS ARE STRICTLY FOR ADMINISTRATIVE PURPOSES AND THAT ACTUAL AWARD LEVELS ARE SUBJECT TO NEGOTIATION, PRIOR TO AWARD. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW. Submit a signed, typewritten original of the application and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express courier service) At the time of submission, two additional copies of the application must be sent to Dr. Louise Corman, at the address listed under INQUIRIES. Applications must be received by February 18, 1998. If an application is received after this date, it will be returned to the applicant without review. 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. The DRG will also not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. If an application is determined to be unresponsive to the RFA, the principal investigator will be notified and the application returned. The following sections are specific cost guidelines that will apply to those applications selected for award consideration. 1. Principal Investigator's Salary The salary for the Principal Investigator (or any other investigator on the team) must not exceed the actual institutional salary rates for the effort being devoted to the Academic Award. In addition, salary rates must not exceed an annual salary level of $125,000 plus fringe benefits (a maximum of $50,000 plus fringe benefits for 40 percent effort). A candidate must devote at least 20 percent effort and no greater than 40 percent effort to this award. The combined efforts of any individual, Principal Investigator or key personnel, on the Nutrition Academic Award with any other non-NIH or NIH-supported grant(s) or contract(s) must not exceed 100 percent. 2. Program Support o the applicant should include some percentage of effort for a multidisciplinary team with sufficient training and experience in medical education and nutrition needed to develop, implement, and evaluate high quality curricula. The team might include health professionals such as physicians, nutritionists, behavioral scientists, exercise scientists, or nurses. The mix of expertise will be determined by the applicant; o consumable supplies essential to the proposed program and education materials are allowable. Office equipment or furniture costs are not allowable; o funds for the Principal Investigator to travel and meet with other investigators and NHLBI staff to exchange ideas and to develop collaborative projects must be included. Investigators may be requested to meet as a group up to three times a year; $1,000 per trip should be budgeted for this purpose. One other member of the team also may be budgeted to attend the meeting if needed; o funds for educational development to enable the awardee to develop relevant skills can be included; 3. Facilities and Administrative Costs Awards will be provided for the reimbursement of actual Facilities and Administrative costs at eight percent of the total direct costs of each award. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases, it may be necessary for the applicant to be relieved of some responsibilities for the five years of the grant award in order to implement the proposed plan. An institution is expected to apply on behalf of a named individual meeting the Principal Investigator criteria for this award. Only one application may be submitted from each eligible institution in each competition. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a noncompetitive basis depending upon progress in meeting the program's objectives. An annual report that summarizes curriculum development at the institution and other elements of the program plan, and outlines future plans will be required. This report will serve as the basis for renewal of the grant. Awards may not be transferred from one institution to another. If a Principal Investigator moves to another institution, the award will continue at the original institution only upon acceptance by the National Heart, Lung and Blood Institute of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to this RFA by NHLBI. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, NHLBI. As part of the initial merit review, all applications will receive a written critique and undergo a review in which only those applications deemed to have the highest scientific merit of the applications under review (usually two to three times the number of applications that the NHLBI and participating Institutes anticipate funding under the program) will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria Applications for this Nutrition Academic Award will be evaluated in terms of the following criteria: o qualifications and experience of the Principal Investigator candidate who must hold an academic position in a medical school at the Associate or Full Professor rank and key personnel, including pertinent experience in teaching, curriculum development, program evaluation, clinical practice, administration, and conducting research studies; o plans to develop, improve, and integrate an interdepartmental curriculum in nutrition with existing institutional training programs for medical students, graduates, and post-graduates at the institution and which also could be used at other appropriate health professional schools; o plans to evaluate the proposed educational components and overall program; o plans for communication and interdepartmental collaboration between medical specialists in appropriate disciplines to ensure the development, implementation, and evaluation of optimal educational programs; o plans and ability to work cooperatively with other Awardees to develop innovative and portable curricular materials and modules in nutrition for adoption at other medical schools and other interested health professional schools; o description of the need for this program including the potential impact of the program on nutrition medical training at the institution and on medical education in general with a focus on preventing cardiovascular diseases; o the magnitude of current programs, curricula and nutrition related research that exist at the applicant's Institution. This award is designed to enhance Institutions that have a base of research and training in nutrition as well as develop such activities in Institutions that do not have existing nutrition education programs. Each applicant should provide a description or table of what currently exists in curricular activities, nutrition research, interdepartmental collaborative efforts, and mechanisms to provide training to other health care professionals; o institutional commitment to implement the proposed curricular activities and infrastructure to maintain a program in nutrition education after the termination of the award. AWARD CRITERIA The anticipated date of award is September 30, 1998. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program, as evidenced by the priority score, and the availability of funds. Subject to the availability of necessary funds and consistent with the objectives of the Nutrition Academic Award, the NHLBI will provide funds for a project period up to five years. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify issues or answer questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Elaine J. Stone, Ph.D., M.P.H. Division of Epidemiology and Clinical Applications National Heart, Lung, Blood Institute 6701 Rockledge Drive, Room 8134, MSC-7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0382 FAX: (301) 480-1669 Email: Stonee@gwgate.nhlbi.nih.gov Eva Obarzanek, Ph.D., M.P.H., R.D. Division of Epidemiology and Clinical Applications National Heart, Lung, Blood Institute 6701 Rockledge Drive, Room 8136, MSC-7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0383 FAX: (301) 480-1669 Email: ObarzanE@gwgate.nhlbi.nih.gov Direct inquiries regarding review matters to: Louise Corman, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7180, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0270 FAX: (301) 480-3541 Email: CormanL@gwgate.nhlbi.nih.gov Direct inquiries regarding fiscal matters to: William W. Darby Chief, Heart and Vascular Diseases Grants Management Section National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7140, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0177 FAX: (301) 480-3310 Email: DarbyW@gwgate.nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 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 to a review by a Health Systems Agency. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES American Medical Student Association, Nutrition Curriculum Project. Essentials of nutrition education in medical schools: a national consensus. Acad Med 1996;71(9):969-971. Bruer RA, Schmidt RE, David H. Commentary: nutrition counseling-- Should physicians guide their patients? Am J Prev Med 1994;10(5):308-311. Committee on Nutrition in Medical Education, National Research Council. Nutrition education in U.S. medical schools. Washington, DC: National Academy Press, 1985. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA 1993;269:3015-3023. Hark LA, Iwamoto C, Melnick DE, Young EA, Morgan SL, Kushner R, Hensrud DD. Nutrition coverage on medical licensing examinations in the United States. Am J Clin Nutr 1997;65:568-571. Hunt JR, Kristal AR, White E, Lynch JC, Fries E. Physician recommendations for dietary change: their prevalence and impact in a population-based sample. Am J Public Health 1995;85:722-726. Krauss RM, Deckelbaum RJ, Ernst N, Fisher E, Howard BV, Knopp RH, Kotchen T, Lichtenstein AH, McGill HC, Pearson TA, Prewitt TE, Stone NJ, Van Horn L, Weinberg R. Dietary guidelines for healthy American adults. A statement for health professionals from the Nutrition Committee, American Heart Association. Circulation 1996;94:1795-1800. Morrison G, Hark L. Medical Nutrition and Disease. Blackwell Science: Philadelphia 1996. National Heart, Lung, and Blood Institute. Report of the Task Force on Research in Epidemiology and Prevention of Cardiovascular Diseases. Washington, DC: USDHHS, NIH, NHLBI 1994. National High Blood Pressure Education Program. Working Group Report on Primary Prevention of Hypertension. National Heart, Lung, and Blood Institute, National Institutes of Health. USDHHS, NIH Publication No. 93-2669, 1993. National Research Council. Diet and Health: Implications for Reducing Chronic Disease Risk, National Academy Press: Washington, DC, 1989. Ockene IS, Herbert JR, Ockene JK, Merriam PA, Hurley TG, Gordon MS. Effect of training and a structured office practice on physician- delivered nutrition counseling: The Worcester-Area Trial for Counseling in Hyperlipidemia (WATCH). Am J Prev Med 1996;12(4):252-258. Pearson TA, McBride PE, Miller NH, Smith SC. Organization of preventive cardiology services: Task Force 8 Bethesda Conference Report. JACC 1996;27(5):1039-1047. Schucker B, Wittes JT, Santanello NC, Weber SJ, McGoldrick D, Donato K, Levy A, Rifkind BM. Change in cholesterol awareness and action. Results from national physician and public surveys. Arch Intern Med 1991;151:666-673. Tobin BW. Nutrition in the basic medical sciences curriculum. Nutrition Today 1997;32(2):54-62. US Department of Health and Human Services. Surgeon General's Report on Nutrition and Health. USDHHS, Public Health Service, DHHS (PHS) Publication No. 88-50210, Washington, DC, 1988, p. 4. US Department of Agriculture and US Department of Health and Human Services. Nutrition and Your Health: Dietary Guidelines for Americans. Home and Garden Bulletin No. 232, 1995. US Department of Health and Human Services. Healthy People 2000: National health promotion and disease prevention objectives. Washington, DC: US GPO, DHHS Pub. No. 93-1332, 1991. US Preventive Services Task Force. Guide to clinical preventive services, 2nd ed. Baltimore: Williams and Wilkins, 1996. Winick M. Nutrition education in medical schools. Am J Clin Nutr 1993;58:825-827. Zimmermann M, Kretchmer N. Isn't it time to teach nutrition to medical students? Am J Clin Nutr 1993;58:828-829. From owner-sci-resources@net.bio.net Fri Sep 26 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-98-005 - V26(31) 09/19/97 Date: 27 Sep 1997 14:05:04 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 768 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <60jse0$dpb@net.bio.net> NNTP-Posting-Host: net.bio.net QUALITY OF CARE UNDER VARYING FEATURES OF MANAGED CARE ORGANIZATIONS NIH GUIDE, Volume 26, Number 31, September 19, 1997 RFA: HS-98-005 P.T. Agency for Health Care Policy and Research Letter of Intent Receipt Date: October 31, 1997 Application Receipt Date: January 6, 1998 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for cooperative agreements that will assess the association between features of managed care organizations, health outcomes, and quality of care for patients with chronic diseases. These cooperative agreements will be co-sponsored by the American Association of Health Plans Foundation (AAHPF) under a partnership agreement with AHCPR. Studies should focus on one or more conditions meeting the following criteria: high prevalence, association of outcomes with quality of care, ease of severity assessment with inexpensive measures, some outcomes measurable within a two-year time frame, and adequate patient numbers across the severity spectrum. Aggregations of conditions might be selected for study if the data are adequate and methodologies are sound, particularly if these conditions apply to special populations such as children, women, minority populations, or the elderly. The AAHPF and AHCPR will each contribute half of each project's funding. Applicants are asked for written permission to share with AAHPF applications that AHCPR intends to fund, along with a summary of the results of peer review of those applications. 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. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign, public or private non-profit organizations, including universities, clinics, units of State and local governments, and other non-profit organizations and foundations. For-profit organizations are not eligible as applicants, but may participate as members of consortia or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible to receive grant/cooperative agreement awards. AHCPR encourages women, members of minority groups, and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT The RFA mechanism of support is the cooperative agreement, U01, in which there will be substantial scientific and programmatic involvement by AHCPR and AAHPF. The total project period for applications submitted in response to this RFA may not exceed 3 years. The earliest anticipated award date is April 1, 1998. FUNDS AVAILABLE Dependent upon the availability of funds, AHCPR expects to award up to $1.5 million (direct plus indirect costs) and AAHPF a comparable amount in fiscal year 1998 to support the first year of approximately four to seven projects under this RFA. The number of awards is dependent on the number of high quality applications and their individual budget requirements; it is not the intent of AHCPR/AAHPF that the awards be equal in size. Funding beyond the initial budget period will depend upon annual progress reviews and the continued availability of funds. The expectation is that AHCPR and AAHPF will each contribute up to $3.5 million over a three-year period for these projects. Indirect costs awarded by AHCPR will be in accord with federally established indirect cost rates. Indirect costs awarded by AAHPF will be in accord with AAHPF's nine (9) percent limit. RESEARCH OBJECTIVES Background Managed Care Organizations (MCOs) include health plans with enrolled populations, integrated delivery systems or networks that provide comprehensive services to regular users even if users are not enrolled in a single health plan, and employer-based groups where the employer exercises essential features of managed care such as selection of preferred providers and financial incentives for cost effective treatment. Only limited research has compared quality of care and health outcomes for patients with chronic disease conditions in relation to changing structures and operations within MCOs. Information from such studies would be helpful for: (a) plans and providers to improve quality of care; (b) consumers to consider when making health care decisions; and (c) employers, certifying agencies, and public programs in making decisions about how to design and encourage development of financing and delivery systems that result in high quality of care. The quality of medical care, whether managed or not, has been criticized in many studies. Some studies have shown that practitioners frequently fail to assess patients' understanding of their illness (Cohen MZ, et al., 1994) or their ability to function (Rubenstein LV, et al., 1989; Wasson J, et al., 1992). In addition, surveys and audits regularly reveal failures to comply with well-established guidelines of care for patients with chronic conditions (see e.g., Cassell EJ, 1991; Stockwell, et al., 1994). Differences in quality of care may occur as the result of differences in innovative programs, practice patterns, organizational features, and tactics (see e.g., Wagner EH, et al. 1996). Some past research has focused on quality and outcomes of managed care vs. fee-for-service or between staff and group practice models vs. other managed care plans. In general, few differences in quality and outcomes are consistently reported (see e.g., Greenfield S, et al., 1995; Horwitz SM and Stein REK, 1990; Retchin SM, et. al., 1992). Ware et al., 1996, also found that outcomes did not differ for the average patient enrolled in HMOs compared to traditional insurance in three cities from 1986-1990. However, elderly and poor persons with chronic illness fared better with traditional coverage. In contrast to those results, Udvarhelyi, et al., 1991, found that patients with high blood pressure treated in four group practices during 1985- 1987 had more physician visits and better outcomes when covered by an HMO rather than traditional insurance. Brook, et al., studied patients with chronic illness randomly assigned to enroll in an HMO from 1974 to 1982. That study found similar health outcomes as those assigned to traditional coverage. One reason for the lack of consistent findings of differences in outcomes may be that past research has not been sufficiently sensitive to variations in quality or outcomes that may result from more specific features of MCOs such as composition of provider networks, variation in provider payment arrangements, degree of clinical integration, use of specialists, and consumer cost- sharing mechanisms. These features vary substantially within broadly defined types of health plans or MCOs. Objectives and Scope This RFA seeks applications for studies that assess the associations between MCO features and clinical performance and patient outcomes for chronic conditions. Methods o Chronic disease conditions should be selected on the basis of high prevalence, association of outcomes with quality of care, ease of severity assessment with inexpensive measures, some widely recognized outcomes measurable within a two-year time frame, and adequate patient numbers across the severity spectrum. Aggregations of conditions might be selected for study if the data are adequate and methodologies are sound, particularly if they represent problem areas for special populations such as children, women, minority populations, or the elderly. Comorbidities should be carefully considered in any study design. Patients with co-morbidities are of particular interest as subjects for study under this RFA. o Features of MCOs that may affect performance can be selected from among the range of features that generate much interest in the professional literature as well as the popular press and policy debates. Such features might include, for example: - demand management with self-care, nurse call lines, and wellness education; - staffing patterns and responsibilities, e.g., types of providers involved in primary care; - methods of establishing provider networks; - availability of specialists and sub-specialists; - methods for influencing provider practice, including risk- sharing; - clinical oversight and use of guidelines or other evidence-based tools; - utilization review protocols, e.g., for hospital emergency visits; - disease management programs. o Processes of care include preventive measures, diagnostic tests, treatments, and other patient care activities. Assessing processes of care involves measuring adherence to practice guidelines, protocols, or standards. For example, the National Heart, Lung, and Blood Institute has developed guidelines for asthma, and the Foundation for Accountability has developed preliminary measures for breast cancer, although the latter have not yet been rigorously tested. The American Diabetes Association commissioned a multidisciplinary committee to develop and test a number of standards for diabetes care. AHCPR has sponsored guidelines for several chronic diseases. One example is the treatment of heart failure. Guidelines in that area are: Unstable Angina: Diagnosis and Management, Clinical Practice Guideline, Number 10, Publication No. 94-0602, 1994; Heart Failure: Evaluation and Care of Patients With Left- Ventricular Systolic Dysfunction, Clinical Practice Guideline, Number 11, Publication No. 94-0612, 1994; and Cardiac Rehabilitation, Clinical Practice Guideline, Number 17, Publication No. 96-0672, 1995. AHCPR-sponsored guidelines are available from the AHCPR Publications Clearinghouse (see "INQUIRIES" below). Applicants should also consider the National Committee for Quality Assurance recommendations for process and outcomes indicators. Investigators should select and refine the final performance measures on the basis of a published meta-analysis or review of existing literature, consensus groups of experts, and/or judgments of advisory panels. Regardless, applicants must rigorously address validity, acceptability, and generalizability of the selected measures. o Outcome measures should include clinical and physiologic measures as well as patient self-reported measures, and should include general functional status as well as disease specific measures. To the extent possible, patient self- reports should include functioning level, disability days, time lost from work, understanding of the problems, perceived outcomes of care, and satisfaction with access to care and with interpersonal communication with providers. Selected outcome measures also must be defended with respect to validity, acceptability, and generalizability. Applicants are encouraged to use existing measures and should consider using quality measures and patient assessment questions organized or developed by AHCPR programs, but not to the exclusion of other existing measures that may be highly valuable. AHCPR does not wish to duplicate efforts already completed or underway in the development of new measures under the programs, Q-Span (Expansion of Quality Measures) or CAHPS (Consumer Assessment of Health Plans Study). For two compendia of relevant measures, see the searchable CONQUEST database now available with an introductory publication (AHCPR Pub. No. 96-0042), and CAHPS measures of consumer and patient self report assessments of health plans and satisfaction. For additional information on these programs, see "INQUIRIES" below. o A number of variables should be tested for their contribution to patient outcomes within a multivariate analysis. Patient characteristics may be important covariates with plan features in affecting quality and outcomes. Patient variables might include severity of the study condition, presence of comorbid conditions, and other factors determining compliance with treatment regimens and reporting of functional status. o The features of each MCO as well as information about the patient's illness and quality of treatment could be measured retrospectively for 6-12 months prior to the beginning of a study. After the study begins, outcomes can be assessed for approximately two years. This approach is not meant to preclude evaluating new or recently implemented clinical interventions. Any substantial change in the features of the MCO during the course of observation should be noted and examined for its independent contribution to the outcomes. Attrition from the sample should be examined for any connection with quality of care. o Generalizability of findings for each disease is highly desirable. Applicants should assess the generalizability resulting from their choice of plans, geographic or market areas, and providers and patients for study. Applicants should consider how they might maximize the generalizability of their findings across organizational forms (e.g., group or staff model Health Maintenance Organizations, preferred provider plans, etc.) and/or across all chronic conditions. Two examples of ways to advance this goal would be (a) research consortia, and (b) studies that focus on two or more chronic conditions. In addition, after award of the cooperative agreements, investigators will be expected to participate in collaborative work with other awardees and scientific experts on studies of pooled data that promote generalizability. SPECIAL REQUIREMENTS Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grants administration regulations, 45 CFR Parts 74 and 92, and other HHS and PHS grants administration policies. 1. Cooperative Activities. The administrative and funding mechanism to be used for this program will be the cooperative agreement (U01), under which there will be substantial scientific and programmatic involvement by AHCPR and AAHPF with the awardees. Cooperative activities are intended to strengthen individual studies and at the same time generate generalizable results across multiple study sites, projects, disease conditions, and patient and physician groups. These goals present scientific and management challenges, requiring collaboration among Principal Investigators and mechanisms for both linking data and preserving the integrity and confidentiality of these data. The scientific and administrative management of the cooperative work will be organized through a joint planning and coordinating committee (the Collaborative Scientific Working Group) and a joint operational committee (the Research Coordinating Center). Two external groups will serve to assure timely progress of the research partnership (the Administrative Review Council) and to assure research and data integrity and protection of human subjects (the Oversight Committee). o The Collaborative Scientific Working Group (CSWG) will serve as the core mechanism for cooperative planning and coordination of research. The CSWG will meet as a group shortly after the award of the projects to begin the process of identifying cross-cutting research questions and common measures and methods to answer the questions. The group will make joint decisions to promote uniformity in research functions, sampling design for any surveys, study measures, analytic methods, and other methodologic and substantive issues that affect generalizability and scientific integrity across individual projects. The CSWG will be especially concerned with the subset of research activities in each project that involve cross-cutting issues and analyses of pooled data. In addition, the CSWG will develop and implement common policies on protection of the pooled data, including confidentiality of patients and institutions, and management and release of pooled data files. The CSWG will be chaired by Sheldon Greenfield, M.D., the Director of the Primary Care Outcomes Research Institute of New England Medical Center, or an equivalent expert designated by AHCPR and AAHPF, who will be a consultant to both sponsors. The CSWG will be co-chaired by a scientific advisor to be named by AHCPR, and Sherrie Kaplan, Ph.D., the co-director of the Primary Care Outcomes Research Institute, or equivalent expert designated by the sponsors. The other members of the CSWG will include each project's Principal Investigator, along with two representatives from AHCPR and two from AAHPF. o The Research Coordinating Center (RCC) will have day-to- day operational responsibilities for joint development of common measures and analyses of pooled data submitted by the individual projects on cross-cutting questions. It is estimated that approximately 25% of any survey data in each study will be pooled for cross-cutting analyses. The RCC members will provide assistance with data collection, survey methods, statistical and analytic methods for the cross- cutting studies, and serve as a repository for a uniform, aggregate database for cross-cutting studies. The RCC will be chaired by Sherrie Kaplan, Ph.D., co- director of the Primary Care Outcomes Research Institute, or an equivalent expert designated by AHCPR and AAHPF, and co- chaired by project officers of AHCPR and AAHPF; it will include the Principal Investigators or their designees. Additional experts, as needed, will be added with the concurrence of the CSWG. The RCC will be sponsored both by grant funds (see "BUDGET PREPARATION" below) and AAHPF. o An Administrative Review Council (ARC) will monitor the activities and progress of individual projects, the CSWG, and the RCC on an annual basis to ensure timely completion. The ARC will also provide an informal procedure for resolving issues brought to the Council's attention by AHCPR, AAHPF, or a Principal Investigator. In addition, the ARC will be consulted on non-competitive continuation awards. The Council will be composed of external experts independent of any project but qualified to review methodologies needed for this area of research. o An Oversight Committee that is completely external to the projects and the funding agencies will be created to assure protection of human subjects as well as research and data integrity. It will be composed of a small number of authorities in medical and scientific areas that include bioethics and scientific integrity. It will also include a patient advocate. This committee will be empowered to recommend interruption of studies or interruption of the use of study data, if warranted. 2. Awardee Responsibilities. - The awardee will conduct research in accordance with the terms and conditions of the Notice of Grant Award, and will engage, as necessary, in a process of refinement and revision of selected methodologic procedures in accord with plans developed collaboratively with the CSWG and the RCC. Specifically, the awardee will undertake or participate in collection of data on measures designed jointly with others in the RCC and CSWG (about 25% of any survey measures). - The awardee will contribute data on standardized measures for pooled analyses of cross-cutting issues by the RCC. The designs for this work will be reviewed by the CSWG. The Principal Investigator or other appropriate investigator may participate in analyses, co-author reports, or be acknowledged as a contributor, depending on mutual agreements. The awardee will later have access to the pooled data for additional analyses. - The Principal Investigator will participate in a combined total of up to six meetings per year of the RCC and the CSWG, in addition to telephone and electronic conferences. - The awardee will administer some of the costs of the joint work of the RCC. (see "BUDGET PREPARATION" below). 3. AHCPR/AAHPF Responsibilities. - The sponsoring agencies will establish the scientific and monitoring committees defined above to guide the cooperative work. Scientific consultants may be engaged by the CSWG as needed, with costs borne by the sponsors. - The progress of work by each awardee will be reviewed at least annually. Awards may be terminated in cases of documented underperformance where the awardee has been given adequate notification about performance and failed to take sufficient corrective actions. BUDGET PREPARATION The following guidance will supplement the standard requirements in form PHS 398 (rev. 5/95). o The costs of clinical care provided to participants in any project will not be paid out of grant funds. o Applicants should request funds to support the joint work of the RCC, such as joint development of common measures and analyses of pooled data. Two and one-half (2.5) percent of the requested direct costs should be budgeted for this purpose as a separate line item under Other Expenses, for each year of the project. o Budgets should reflect travel by the Principal Investigator to attend a combined total of 6 one-day meetings per year of the CSWG and the RCC. These meetings will generally take place in the Washington, DC area, or the Boston, MA area. It is anticipated that the business of the CSWG and the RCC can otherwise be conducted by teleconferencing and e-mail channels. Confidentiality of Data Information obtained in the course of this study that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act (42 U.S.C. 299a-1(c)). Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers will be safeguarded. Rights in Data Grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHCPR funds. Such copyrights and patents are subject to a Federal Government license to use these products and materials for AHCPR purposes. Such purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers. Final products may be made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish its broad dissemination mandate, AHCPR encourages and promotes publication of research findings, but generally relies on grantee efforts to market grant-supported products. To enable AHCPR to fulfill its statutory obligation to make both research results and developed data available, as well as to assure the statistics developed with its support are of high quality, copies of all products and materials developed under a grant supported in whole or in part by AHCPR funds are to be made available to AHCPR promptly upon request. Similarly, products shall be made available to AAHPF promptly upon its request, consistent with the applicable confidentiality statute cited above. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups be included in all AHCPR-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. AHCPR follows the NIH Guidelines, as applicable. Applicants may obtain copies from the above sources or from the AHCPR contractor, Global Exchange, Inc., listed under "INQUIRIES." AHCPR is also encouraging investigators to consider including children in study populations, as appropriate. AHCPR announced in the NIH Guide for Grants and Contracts, Volume 26, Number 15, May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research.