From owner-sci-resources@net.bio.net Mon Apr 04 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 3 April 1994 Date: 4 Apr 1994 17:24:22 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 129 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2nqb3m$m8g@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: BUL 9404 -- NSF April Bulletin Vol. 21, No. 8 File size (bytes): 39771 STIS Filename: bul9404 Document Type: Form Title: FM CERT - GPG Certification Page File size (bytes): 747 STIS Filename: fmcert Also available: fmcert.ps Document Type: Letter Title: IAI/IC NEWSLETTER File size (bytes): 49381 STIS Filename: ltriaiic Title: NSF 94-54 ENGINEERING NEWSLETTER File size (bytes): 5143 STIS Filename: nsf9454 Document Type: Press Release Title: NSF-FUNDED COMPUTER SIMULATION REVEALS ALZHEIMER'S - GLAUCOMA ENZYME File size (bytes): 3739 STIS Filename: pr9418 Title: TOOTH OF LARGE FOSSIL MAMMAL DISCOVERED IN MADAGASCAR BY NSF-FUNDED SCIENTIST File size (bytes): 3692 STIS Filename: pr9419 Document Type: Program Guideline Title: NSF 94-34 - Rural Systemic Initiatives in Science, Mathematics and Technology Education File size (bytes): 38029 STIS Filename: nsf9434 Title: NSF 94-46 File size (bytes): 25378 STIS Filename: nsf9446 Title: NSF 94-50 -- National Earthquake Hazards Reduction Program An Investigation Into the Cause and Effects of the Northridge Earthquake of January 17, 1994 File size (bytes): 33920 STIS Filename: nsf9450 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Form Title: FM 1030 - GPG Summary Proposal Budget Form File size (bytes): 756 STIS Filename: fm1030 Also available: fm1030.ps Title: FM 1359 - GPG Table of Contents Form File size (bytes): 750 STIS Filename: fm1359 Also available: fm1359.ps Title: FM 1363 - GPG Facilities, Equipment & Other Resources Form File size (bytes): 772 STIS Filename: fm1363 Also available: fm1363.ps Title: NSF 94-3 - Grant Proposal Guide Forms Kit File size (bytes): 1278 STIS Filename: nsf943 Also available: nsf943.zip Document Type: Letter Title: Current List of REU Sites File size (bytes): 54806 STIS Filename: reulist ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve reulist, the text of your message should be as follows: get reulist Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve reulist, you would enter: ftp> get reulist WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Tue Apr 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 13, 1 April 1994 Date: 5 Apr 1994 17:01:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1564 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2nsu45$422@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940401 V23N13 P1O2 ************************************ X-comment: RFAS described: CA-94-011, CA-94-012, AR-94-005, HL-94-012, HL-94- 013 NIH GUIDE - Vol. 23, No. 13 - April 1, 1994 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** EVALUATION OF CHEMOPREVENTIVE AGENTS BY IN VIVO SCREENING ASSAYS (RFP NCI-CN-45000-46) National Cancer Institute INDEX: CANCER $$INDEX R2 ********************************************************** DETERMINATION OF SERUM ANTIBODIES TO PERIODONTAL PATHOGENS IN THE U.S. POPULATION (RFP NIH-NIDR-2-94-7R) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R3 06/16/94 ************************************************* BREAST CANCER EDUCATION INITIATIVES (RFA CA-94-011) National Cancer Institute INDEX: CANCER $$INDEX R4 06/16/94 ************************************************* HOSPICE AND PALLIATIVE CARE EDUCATION PROGRAMS (RFA CA-94-012) National Cancer Institute INDEX: CANCER $$INDEX R5 07/26/94 ************************************************* BASIC OSTEOPOROSIS NEW EXPERIMENTAL STRATEGIES (RFA AR-94-005) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Aging INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; DIABETES, DIGESTIVE, KIDNEY DISEASES; AGING $$INDEX R6 09/15/94 ************************************************* SPECIALIZED CENTERS OF RESEARCH: TRANSFUSION BIOLOGY AND MEDICINE (RFA HL-94-012) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R7 09/15/94 ************************************************* SPECIALIZED CENTERS OF RESEARCH: HEMOSTATIC AND THROMBOTIC DISEASES (RFA HL-94-013) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** AGING AND BONE QUALITY (PA-94-052) National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: AGING; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES ADDENDUM $$INDEX A1 ********************************************************** GRANT WRITING WORKSHOP FOR NUTRITION FOR PROGRAM ANNOUNCEMENT PA-94- 033 National Cancer Institute INDEX: CANCER This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NCI-CN-45000-46 ****************************************** EVALUATION OF CHEMOPREVENTIVE AGENTS BY IN VIVO SCREENING ASSAYS NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFP AVAILABLE: NCI-CN-45000-46 P.T. National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Prevention and Control, Chemoprevention Branch, wishes to award Master Agreement (MA) contracts for the evaluation of chemopreventive agents by in vivo screening assays. The required services will be defined by Master Agreement Orders (MAO) issued during the four year period of performance. This solicitation is the annual announcement to expand the current pool of MA Holders qualified to perform this type of work. All interested offerors must submit proposals to be eligible to compete for future MAO RFPs. Pursuant to the MAO the Contractor will conduct in vivo screening studies in small rodents using gavage and other routes of administration to administer the designated chemopreventive agents in animal models using any carcinogenic mechanism (that is consistent with the Evaluation Criteria), such as the administration of carcinogens, promoters, hormones, irradiation, cells or other carcinogenic agents. Agents to be tested are potentially hazardous. The animal model systems also involve the use of carcinogens. Laboratory practices that keep any element of risk to personnel at an absolute minimum will be employed. Where indicated, tissue and compound handling must be performed in (at least) Class I laminar flow agents. It is required that the animal facilities be maintained in accordance with the NIH Guide for the Care and Use of Laboratory Animals, the Animal Welfare Act as administered by the USDA, and the U.S. Government Principals for Utilization and Care of Vertebrate Animals Used for Testing Research and Training. This research will be performed under cost reimbursement and/or fixed price MAO's. The contractor must have all the equipment necessary to accomplish the studies including, but not limited to, animal racks and caging, hazardous chemical storage cabinets and refrigerators, pathology equipment such as microscopes and microtomes and miscellaneous laboratory equipment. The laboratory must have or have access to appropriate terminal and computer facilities and equipment for data collection and storage. It is estimated that four to five Task Orders per year will be issued pursuant to the Master Agreement contracts. The Master Agreement Announcement will be available on approximately March 25, 1994. Proposal due date will be approximately May 24, 1994. INQUIRIES Copies of the MAA/RFP NCI-CN-45000-46 may be obtained by sending a written request to: Mr. Schuyler T. Eldridge Research Contracts Branch National Cancer Institute Executive Plaza South, Suite 635, Bethesda, MD 20892 Telephone: (301) 496-8603 Collect calls will not be accepted. $$R1 END ************************************************************ $$R2 BEGIN NIH-NIDR-2-94-7R ***************************************** DETERMINATION OF SERUM ANTIBODIES TO PERIODONTAL PATHOGENS IN THE U.S. POPULATION NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFP AVAILABLE: NIH-NIDR-2-94-7R P.T. National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement for a state-licensed microbiology laboratory capable of processing thousands of serum samples for antibodies to periodontal pathogens, including the capability of receiving and transporting the samples. The objective of this study is to determine the occurrence of elevated serum antibodies to periodontal pathogens in a sample of persons examined in the Third National Health and Nutrition Examination Survey (NHANES III). Serum from the NHANES III subjects has already been collected, frozen, and stored for further analysis. The serum must be assayed by ELISA procedures. Request for Proposals (RFP) NIH-NIDR-2-94-7R will be available on or about April 12, 1994, with proposals due May 12, 1994. It is anticipated that one award will be made as a result of this solicitation. INQUIRIES The RFP package is available by written request to: Marilyn R. Zuckerman Contract Management Office National Institute of Dental Research Westwood Building, Room 533 Bethesda, MD 20892 $$R2 END ************************************************************ $$R3 BEGIN CA-94-011 FULL-TEXT ************************************** BREAST CANCER EDUCATION INITIATIVES NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA AVAILABLE: CA-94-011 P.T. National Cancer Institute Letter of Intent Receipt Date: May 2, 1994 Application Receipt Date: June 16, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Cancer Institute (NCI) invites grant applications to create new educational programs aimed at reducing the mortality and morbidity of breast cancer. These cancer education programs are intended to disseminate what is professionally known about the prevention, early detection, and treatment of breast cancer to primary care physicians, other health professionals, and the lay community with special attention to minority or underserved populations. 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, Breast Cancer Education Initiatives, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, Cancer Centers, hospitals, Laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support for this program will be through the NCI Cancer Education (R25) Award. This is a flexible, curriculum-driven program aimed at developing and sustaining innovative and, possibly, unique educational approaches that ultimately will have an impact on reducing cancer incidence, mortality, and morbidity, as well as on improving the quality-of-life of cancer patients. The current guidelines for the Cancer Education Program (R25) may be obtained from the program director listed under INQUIRIES. Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to this RFA may not exceed three years. It is anticipated that the average amount of direct costs awarded per grant will range from $50,000 to $130,000 depending upon the proposed program. Indirect costs will be allowed at the rate of eight percent of total direct costs (exclusive of equipment). The earliest feasible start date for the initial award will be September 1994. This RFA is a one-time solicitation. Future competitive continuation applications will compete with all other applications in the Cancer Education Grant Program (R25). However, if the NCI determines that there is a sufficient program need, a new request for competitive continuation and/or new applications will be announced. FUNDS AVAILABLE For FY 1994, $1,600,000 in total costs will be available for, it is estimated, some 15 to 20 awards. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. A greater or lesser amount of dollars and number of awards may be negotiated based on the quality of the applications and the availability of funds. RESEARCH OBJECTIVES The purpose of this RFA is to stimulate breast cancer educational programs among health professionals and the lay public. The NCI proposes that Cancer Centers and other organizations with appropriate breast cancer expertise collaborate with educational specialists and other professional and lay groups, particularly those with access to underserved populations, to design and implement programs dealing with one or more of the following target populations for this initiative: primary care physicians, health professional faculty, health professional students, women's groups, minority or underserved groups, employer-based groups, breast cancer patients and their families. The NCI also strongly encourages submission of applications from minority health professional schools and from other organizations that have traditionally served minority communities and geographically isolated populations. SPECIAL REQUIREMENTS If several institutions are jointly involved or if several departments within an institution are cooperating in this RFA, a special, central, interdisciplinary Cancer Education Committee consisting of members from the collaborating organizations should be in place. The functions of the Committee would be to provide effective monitoring and coordination of the program. LETTER OF INTENT Prospective applicants are asked to submit, by May 2, 1994, a letter of intent that includes a descriptive title of the proposed educational proposal, the name, address, and telephone number of the Principal Investigator/Educator, 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 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 Dr. Robert C. Adams at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI Program Director listed under INQUIRIES. Applications must be received by June 16, 1994. REVIEW CONSIDERATIONS Applications will be reviewed by an appropriate review group convened by the Division of Extramural Activities, NCI. Consult the RFA for additional details. AWARD CRITERIA The anticipated date of award is September, 1994. Awards will be made according to priority score, availability of funds, and programmatic priorities. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Dr. Robert C. Adams Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Direct inquiries regarding grants management issues to: Mr. Robert Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.398, Cancer Research Manpower. Awards are made under the 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 HHS regulations and PHS grant policies. $$R3 END ************************************************************ $$R4 BEGIN CA-94-012 FULL-TEXT ************************************** HOSPICE AND PALLIATIVE CARE EDUCATION PROGRAMS NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA AVAILABLE: CA-94-012 P.T. National Cancer Institute Letter of Intent Receipt Date: May 2, 1994 Application Receipt Date: June 16, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Cancer Institute (NCI) invites grant applications to create new educational programs to address health professional training in palliative patient care. The intent of this RFA is to emphasize NCI's concern for this neglected area with the expectation that any funded programs will act as catalysts to encourage further interest and development in the medical community. 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, Hospice and Palliative Care Education Programs, is related to the priority area of Educational and Community-based Programs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, cancer centers, hospitals, hospices, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support for this effort will be through the NCI Cancer Education (R25) Award. This is a flexible, curriculum-driven program aimed at developing and sustaining innovative and, possibly, unique educational approaches that ultimately will have an impact on reducing cancer incidence, mortality, and morbidity, as well as on improving the quality-of-life of cancer patients and their families. The current guidelines for the Cancer Education Program (R25) may be obtained from the program director listed under INQUIRIES. Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to this RFA may not exceed three years. The earliest feasible start date for the initial award will be September 1994. It is anticipated that the average amount of direct costs awarded per grant will range from $50,000 to $100,000 depending upon the proposed program. Indirect costs will be allowed at the rate of eight percent of total direct costs (exclusive of equipment). This RFA is a one-time solicitation. Future competitive continuation applications will compete with all other applications in the Cancer Education Grant Program (R25). However, if the NCI determines that there is a sufficient program need, a new request for competitive continuation and/or new applications will be announced. FUNDS AVAILABLE For FY 1994, $500,000 in total costs will be available for, it is estimated, some five to seven awards. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. A greater or lesser amount of dollars and number of awards may be negotiated based on the quality of the applications and the availability of funds. RESEARCH OBJECTIVES This RFA proposes to stimulate medical schools, schools of nursing, cancer centers, oncology divisions, and other health professional entities to design methodologies for the education and training of health care professionals in hospice and palliative care. Hospices, either individually or in regional settings in collaborative arrangements with other medical centers are particularly encouraged to submit applications in response to this RFA. The NCI hopes to stimulate multi-disciplinary, team approaches to palliative care by encouraging a variety of educational programs aimed at medical students, physicians, other health professionals, and hospice personnel. The ultimate goal is to benefit cancer patients and their families. SPECIAL REQUIREMENTS If several institutions are jointly involved or if several departments within an institution are cooperating in this RFA, a special, central, interdisciplinary Cancer Education Committee consisting of members from the collaborating organizations or units should be in place. The functions of the Committee would be to provide effective monitoring and coordination of the program. LETTER OF INTENT Prospective applicants are asked to submit, by May 2, 1994, a letter of intent that includes a descriptive title of the proposed educational proposal, the name, address, and telephone number of the Principal Investigator/Educator, 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 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 Dr. Robert C. Adams at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI Program Director listed under INQUIRIES. Applications must be received by June 16, 1994. REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. Consult the RFA for additional details. AWARD CRITERIA The anticipated date of award is September, 1994. Awards will be made according to priority score, availability of funds, and programmatic priorities. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Dr. Robert C. Adams Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Direct inquiries regarding grants management matters to: Mr. Robert Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.398, Cancer Research Manpower. Awards are made under the 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 HHS regulations and PHS grant policies. $$R4 END ************************************************************ $$R5 BEGIN AR-94-005 FULL-TEXT ************************************** BASIC OSTEOPOROSIS NEW EXPERIMENTAL STRATEGIES NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA AVAILABLE: AR-94-005 P.T. National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Aging Letter of Intent Receipt Date: June 28, 1994 Application Receipt Date: July 26, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Bone Biology and Bone Diseases Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the Bone and Mineral Research Program of the Endocrinology Research Section of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Geriatrics and Biology of Aging Programs of the National Institute on Aging (NIA) invite investigator-initiated research project grant applications to encourage and facilitate research projects designed to develop promising basic cellular, molecular, physiological, and genetic approaches to osteoporosis. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Basic Osteoporosis New Experimental Strategies, is related to the priority areas of diabetes and chronic disabling conditions and older adults and preventive services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from women and minority individuals are encouraged. MECHANISM OF SUPPORT Support for this program will be through investigator-initiated research grant applications (R01) and FIRST (R29) awards. This RFA is a one-time solicitation for fiscal year 1995. The total project period for applications submitted in response to the present RFA may not exceed four years. FIRST (R29) awards must be for five years. The anticipated award date is April 1, 1995. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year for four years will be committed by the NIAMS to fund applications submitted in response to this RFA. An additional $500,000 will be committed by the NIDDK, and an additional $600,000 by the NIA. The direct cost of each R01 project is limited to $160,000 for the first year and each R29 is --- . Thus it is anticipated that a total of 12 to 14 projects will be funded in FY 95. 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. RESEARCH OBJECTIVES Effective approaches to the treatment of established osteoporosis are urgently needed. Such new therapeutic approaches are most likely to arise from improved understanding of the basic biology of bone growth and maintenance. In order to capitalize on current scientific opportunities, it is necessary to integrate biological insights and methodologies from a broad range of specialties. The overall goal of the BONES initiative is to encourage and support new basic research in the areas of bone structure, formation, remodeling, and repair. This initiative is designed to (1) encourage established bone biology investigators to address osteoporosis-related problems with novel approaches and the most powerful methodologies available; (2) increase the pool of investigators working in osteoporosis-related basic science areas by drawing researchers from genetics, cell and molecular biology, and structural chemistry into bone research; and (3) foster the development of interactions between laboratories originating in different disciplines. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by June 28, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. The letter of intent is to be sent to Dr. William Sharrock at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/ 594-7248; and from the program staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Dr. Tommy Broadwater Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 406 Bethesda, MD 20892 Telephone: (301) 594-9979 FAX: (301) 594-9673 Applications must be received by July 26, 1994. REVIEW CONSIDERATIONS Applications may be triaged by an NIAMS peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAMS. The second level of review will be provided by the NIAMS, NIDDK, and NIA advisory councils. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. AWARD CRITERIA The anticipated date of award is April 1, 1995. In addition to the technical merit of the application as reflected in the priority score, the NIAMS, NIDDK, and NIA will consider how well the applicant institution meets the goals and objectives of the program as described in the RFA, availability of resources and/or study populations. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: William Sharrock, Ph.D. Bone Biology and Bone Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 594-9975 FAX: (301) 594-9673 Ronald Margolis, Ph.D. Endocrinology Research Section National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 621 Bethesda, MD 20892 Telephone: (301) 594-7549 FAX: (301) 594-9011 Sherry Sherman, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 2C218 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9322 FAX: (301) 402-2945 Direct inquiries regarding fiscal matters to: G. Carol Fitzpatrick Grants Management Office National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 722A Bethesda, MD 20892 Telephone: (301) 594-9974 FAX: (301) 594-9950 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.846, 93.847, and 93.866. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241 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. $$R5 END ************************************************************ $$R6 BEGIN HL-94-012 FULL-TEXT ************************************** SPECIALIZED CENTERS OF RESEARCH: TRANSFUSION BIOLOGY AND MEDICINE NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA AVAILABLE: HL-94-012 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: May 31, 1994 Application Receipt Date: September 15, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF THE APPLICATION, FROM THE CONTACT LISTED IN THE "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The objectives of the Specialized Centers of Research (SCOR) program in Transfusion Biology and Medicine are to improve the safety and efficacy of blood and blood components, define the indications for their use, evaluate and possibly modify immunological responsiveness following their administration, and develop and evaluate alternative treatment strategies that substitute for certain of their functions or stimulate their endogenous production so as to reduce transfusion needs. This initiative also encourages the use of new and innovative technologies to pursue fundamental research studies in transfusion biology and clinical investigations in transfusion medicine. The goals of this program are to understand better the basic biology of transfusion; make optimal use of blood, blood components, and plasma protein derivatives in specific replacement therapy; improve transfusion practice; and perform basic and applied research on blood substitutes. 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, Specialized Centers of Research in Transfusion Biology and Medicine, is related to the priority area of 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic institutions, public and private, such as universities, colleges, hospitals, and laboratories. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Heart, Lung, and Blood Institute (NHLBI) SCOR (P50) grant to support this research program. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Basic and Clinical Research It is essential that all applications include both basic and clinical research. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Applications that include only basic or only clinical research will not be responsive to this RFA. In addition, clinical research projects focused on large epidemiologic studies or large clinical trials will be considered unresponsive to this RFA. FUNDS AVAILABLE Up to $1,125,000 in direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year may be requested in each application. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that at least two SCOR grants will be funded. NHLBI's FY 1996 plans for this initiative include a maximum of $4.4 million. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. RESEARCH OBJECTIVES Background During the past decade, significant scientific advances have been made in transfusion medicine that have improved the safety and quality of blood, blood components and plasma derivatives and have changed transfusion practices. Advances have been made in detecting evidence of viral pathogens such as HIV-1, HIV-2, HTLV-I/HTLV-II and hepatitis C in donated blood, thus preventing such agents from entering the blood supply. Moreover, procedures have been developed to inactivate viruses in plasma derivatives and soon in plasma itself. Improved apheresis technologies have been developed that permit more efficient collection and manipulation of blood components and bone marrow. Investigators have described properties of newly developed plasma derivatives. Techniques have been developed that may lead to the use of stem cells from umbilical cord blood for bone marrow transplantation. As a result, the importance of blood transfusion has been greatly expanded through the use of components and derivatives in increasingly specialized and effective forms of therapy. The use of blood and blood components continues to increase. Improved patient care, including aggressive cancer chemotherapy programs, bone marrow transplantation and sophisticated cardiac surgery procedures have contributed heavily to this growth which is expected to continue into the future. Consequently, the implementation of research programs to determine the optimal use of this valuable resource is important and timely. Proposed Research The principal research aim of this RFA is to encourage basic and clinical research towards the optimal use and improvement of transfusion therapy. Recent progress in our understanding in such areas as immune regulation and hematopoiesis make this an opportune time to encourage research in the following areas of emphasis: (1) immunomodulatory aspects of transfusion; (2) development of novel cell therapies and cytokine therapies; (3) structure/function relationships of human blood cell surface antigens; (4) blood substitutes; and (5) indications for red cell or platelet transfusion. The topics may address one or more than one area of emphasis. For example, it would be appropriate for a SCOR applicant to propose projects that address research issues pertaining to one area of interest such as structure/function relationships of human blood cell surface antigens or a combination such as structure/function relationships of human blood cell surface antigens and immunomodulatory aspects of transfusion. Applicants should also note that a SCOR program must meet the following criteria: (1) address areas of significant national need and clinical importance; (2) attract talented investigators who foster the development of a multidisciplinary and collaborative synergistic approach; (3) include both basic and clinical components; and, most importantly; (4) have the potential to accelerate the transfer of basic research to clinical application. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by May 31, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the principal investigator; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It 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 sent to: Chief, Review Branch Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications will be judged on the basis of the scientific and technical merit of the proposed research; the qualifications and research experience of the investigators; the collaborative interaction among basic and clinical research components; the adequacy of the environment; and the appropriateness of the budget. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applications must be received by September 15, 1994 INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify issues or questions from potential applicants are welcome. Direct inquiries regarding scientific issues and requests for the RFA to: George J. Nemo, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 504 Bethesda, MD 20892 Telephone: (301) 496-1537 FAX: (301) 402-4843 Direct inquiries regarding fiscal and administrative matters to: Ms. Jane Davis Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 4A15C Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS The programs of the Division of Blood Diseases and Resources, NHLBI, are described in the Catalog of Federal Domestic Assistance No. 93.839. Awards will be made under the 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 requirement of Executive Order 12372 or Health Systems Agency review. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. $$R6 END ************************************************************ $$R7 BEGIN HL-94-013 FULL-TEXT ************************************** SPECIALIZED CENTERS OF RESEARCH: HEMOSTATIC AND THROMBOTIC DISEASES NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA AVAILABLE: HL-94-013 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: May 31, 1994 Application Receipt Date: September 15, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF THE APPLICATION, FROM THE CONTACT LISTED IN THE "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The objectives of the Specialized Centers of Research (SCOR) program in Hemostatic and Thrombotic Diseases are to improve the basic understanding of the processes involved in hemostasis and thrombosis and to encourage the application of this fundamental knowledge to clinical situations. This initiative emphasizes the use of new and innovative technology to provide better insight and develop treatment for thrombosis and related cardiovascular disorders that are the leading cause of death in the United States. 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, Specialized Centers of Research in Hemostatic and Thrombotic Diseases, is related to the priority area of blood diseases and resources. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic institutions, public and private, such as universities, colleges, hospitals, and laboratories. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Heart, Lung, and Blood Institute (NHLBI) SCOR (P50) grant to support this research program. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Basic and Clinical Research It is essential that all applications include both basic and clinical research projects. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Applications that include only basic or only clinical research will not be responsive to this RFA. In addition, clinical research projects focused on large epidemiologic studies or large clinical trials will be considered unresponsive to this RFA. FUNDS AVAILABLE Up to $1,125,000 in direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year may be requested in each application. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that at least two new SCOR grants will be funded. NHLBI's FY 1996 plans for this initiative include a maximum of $4.4 million. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. RESEARCH OBJECTIVES Background Thrombosis and related cardiovascular diseases are the leading cause of death in the US. The progress made in thrombosis research has revealed a complex and dynamic balance between the thrombotic and fibrinolytic systems. Major new advances have put us on the threshold of fundamental understanding of the cellular and surface processes involved in modulating thrombotic and fibrinolytic pathways. Understanding the biology of endothelial cells is still in its infancy and a deeper insight into this area may lead to major therapeutic advances. New understandings in molecular genetics is likely to make gene therapy of bleeding disorders a reality. Progress is being made in the knowledge of how megakaryocytes grow and differentiate and what controls platelet production. With identification of growth factors that control these processes, the day may not be too far away when circulating levels of platelets may be regulated and the devastating consequences of neonatal thrombocytopenia avoided. There is a need to continue this research progress and put special emphasis on applying these basic research accomplishments to clinical situations. The overall goal of this program is to support quality basic research, facilitate transfer of the basic knowledge to the bed side and stimulate clinical studies in hemostatic and thrombotic diseases. Such a program will require an intimate interface between basic and clinical research that cannot be accomplished by other means of support provided by NHLBI. It becomes essential then that all SCOR applications must contain major clinical components. Other factors such as research programs complementary to thrombosis area, institutional training programs, training experience of the SCOR director and other key staff will be considered important for the enrichment of the scientific environment under which mutual information exchange may flourish. Proposed Research The principal aim of this RFA is to encourage basic and clinical research towards the improvement of prevention/therapy of hemostatic and thrombotic diseases. Recent progress in the understanding of gene regulation and identification of anticoagulant factors make this an opportune time to encourage research in the following areas of emphasis: (1) risk factors for thrombosis; (2) influence of nutritional elements and environmental factors on hemostatic and thrombotic disease; (3) diagnosis, assay, and treatment for venous thrombosis; (4) regulation of adhesive proteins and processes: and (5) synthesis, catabolism and function of fibrinolytic proteins. The topics may address one or more than one area of emphasis. Applicants should also note that a SCOR program must meet the following criteria: (1) address areas of significant national need and clinical importance; (2) attract talented investigators who foster the development of a multidisciplinary and collaborative synergistic approach; (3) include both basic and clinical components; and, most importantly; (4) have the potential to accelerate the transfer of basic research to clinical application. Applicants may use their own imagination within the SCOR guidelines. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by May 31, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the principal investigator; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It 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 sent to: Chief, Review Branch Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications will be judged on the basis of the scientific and technical merit of the proposed research; the qualifications and research experience of the investigators; the collaborative interaction among basic and clinical research components; the adequacy of the environment; and the appropriateness of the budget. See RFA for additional information. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applications must be received by September 15, 1994. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify issues or questions from potential applicants are welcome. Direct inquiries regarding scientific issues and requests for the RFA to: Pankaj Ganguly, Ph.D. Division of Blood Diseases and Resources National Heart, Lung and Blood Institute Federal Building, Room 5C14 Bethesda, MD 20892 Telephone: (301) 402-2237 FAX: (301) 496-9940 Direct inquiries regarding fiscal and administrative matters to: Ms. Jane Davis Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 4A15C Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.839. Awards will be made under the 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 requirement of Executive Order 12372 or Health Systems Agency review. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. $$R7 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-052 ************************************************ AGING AND BONE QUALITY NIH GUIDE, Volume 23, Number 13, April 1, 1994 PA NUMBER: PA-94-052 P.T. National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases PURPOSE The National Institute on Aging (NIA) and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite research applications to elucidate the nature and consequences of age-related changes in bone quality and the relationship of these changes to enhanced bone fragility and susceptibility to osteoporotic fractures. Factors that contribute to bone quality include architecture, density and mechanical strength. 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), Aging and Bone Quality, addresses the priority area of osteoporosis. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, non-profit and for-profit organizations, private and public such as colleges, universities, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). Applications from minorities and women are encouraged. MECHANISM OF SUPPORT Support for this program will be by the research project grant (R01) and the FIRST (R29) award. RESEARCH OBJECTIVES Background The progressive loss of bone with age very commonly leads to osteoporosis, a condition characterized by increased skeletal fragility and susceptibility to fracture. Osteoporosis and its consequences are a significant cause of frailty, morbidity, and even mortality. However, while in older individuals reduced bone mass is important both in contributing to and predicting an enhanced risk of fracture, low bone mass alone is not a sufficient explanation for osteoporotic fractures. This is exemplified by the substantial overlap in bone density between normal individuals and patients who sustain hip and other osteoporotic fractures. A new perspective is needed that broadens the conceptual basis of skeletal integrity to include in addition to bone mass, qualitative factors that may impact on bone strength such as geometry, macro and micro-structural organization, distribution of material within bone, biochemical composition, and the burden of unrepaired microdamage. An NIA Workshop on Aging and Bone Quality, held September 3-4, 1992, underscored the need to study bone quality and identified promising new areas of research, which can be found in the workshop Proceedings in Calcified Tissue International, Supplement 1, (53), 1993. This PA reflects the priority areas that were identified at the workshop. This PA is directed towards: (1) stimulating research aimed at elucidating age-related mechanisms that influence the development and/or course of osteoporosis and (2) developing strategies aimed at preventing or lessening the burden of osteoporosis-related fractures in older individuals. Specifically, this PA seeks applications for basic and clinical research to identify and evaluate the effects of age on factors related to bone quality and/or strategies to modify the impact of these factors on skeletal fragility and increased fracture susceptibility. Topics of interest include, but are not limited to: o Age-related changes in architecture, mechanical properties, and strength of bone o Evaluation of changes in bone matrix and mineralization and their impact on strength and resistance to microdamage o Assessment of the consequences of age on the accumulation of cortical and trabecular microdamage and their relationship to bone strength and fracture biomechanics o Age-related changes in the detection of microdamage and activation, and initiation of the remodelling and repair processes in bone o Determination of age- and disease-related changes in biochemical, cellular, and structural factors affecting bone quality o Elucidation of the role and function of osteocytes and bone lining cells in bone metabolism o The nature of changes in osteocyte viability and function with age and the effect of these changes on the structural and mechanical properties of bone o Development of model systems that reflect normal physical and physiological aspects related to functional loading and responses to loading in aged bone o Development and application of techniques such as histomorphometry, ultrasound, NMR, and QCT to evaluate changes in architecture, bone strength and fracture susceptibility STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. APPLICATION PROCEDURES Applications are to be submitted on the application form PHS 398 (rev. 9/91) available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Applications will be accepted on the standard application receipt dates as indicated in the application kit. The program announcement title and number must be typed on line 2a of the face page. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. Following scientific-technical review, applications recommended for further consideration will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds on the basis of scientific merit, program balance among research areas of the announcement, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Chhanda Dutta, Ph.D. Geriatrics Program National Institute on Aging $$XID NIHGUIDE 19940401 V23N13 P2O2 ************************************ Gateway Building, Suite 3E327 Bethesda, MD 20892 Telephone: (301) 496-1033 Joan A. McGowan, Ph.D. Bone Biology and Bone Diseases Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 594-9957 Direct inquiries regarding fiscal matters to: Joanne Colbert Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. 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 Part 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to the Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the PHS Grants policy statement, DHHS Publication NO. (OASH) 90-50,000, revised October 1, 1990. $$P1 END ************************************************************ ADDENDUM $$A1 BEGIN ********************************************************** GRANT WRITING WORKSHOP FOR NUTRITION FOR PROGRAM ANNOUNCEMENT PA-94- 033 NIH GUIDE, Volume 23, Number 13, April 1, 1994 P.T. 34; K.W. 0710095, 1014006 National Cancer Institute The following addendum is added to the notice that appeared in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994: "For persons who are unable to attend, a transcript of the meeting will be made available, and may be obtained by contacting: Dr. Jacqueline Whitted Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 232 Bethesda, MD 20892 Telephone: (301) 496-8584 FAX: (301) 496-8675 $$A1 END ************************************************************ From owner-sci-resources@net.bio.net Tue Apr 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-94-012 - V23(13) 04/01/94 Date: 5 Apr 1994 17:02:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 699 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2nsu5q$42q@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL94012 HL-94-012 P1O1 *************************************** SPECIALIZED CENTERS OF RESEARCH: TRANSFUSION BIOLOGY AND MEDICINE NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA: HL-94-012 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: May 31, 1994 Application Receipt Date: September 15, 1994 PURPOSE The objectives of the Specialized Centers of Research (SCOR) program in Transfusion Biology and Medicine are to improve the safety and efficacy of blood and blood components, define the indications for their use, evaluate and possibly modify immunological responsiveness following their administration, and develop and evaluate alternative treatment strategies that substitute for certain of their functions or stimulate their endogenous production so as to reduce transfusion needs. This initiative also encourages the use of new and innovative technologies to pursue fundamental research studies in transfusion biology and clinical investigations in transfusion medicine. The goals of this program are to understand better the basic biology of transfusion; make optimal use of blood, blood components, and plasma protein derivatives in specific replacement therapy; improve transfusion practice; and perform basic and applied research on blood substitutes. 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 of Research in Transfusion Biology and Medicine, is related to the priority area of 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic institutions, public and private, such as universities, colleges, hospitals, and laboratories. This RFA is intended to support SCOR grants for basic and clinical investigations. Therefore, applications that include only basic or only clinical research will not be responsive to this RFA. In addition, clinical research projects focused on large epidemiologic studies or large clinical trials will be considered unresponsive to this RFA. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Heart, Lung, and Blood Institute (NHLBI) SCOR (P50) grant to support this research program. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to diseases and therapies relevant to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. Each SCOR grant application and award must include research involving human patients/subjects. Support may be provided for human biomedical and behavioral studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders, or conditions. Small population-based studies, where the research can be completed within five years, may also be proposed. In addition, basic research projects must be included that relate to the clinical focus. A SCOR may also contain one or more core units that support the research projects. 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 program. A minimum time commitment of 25 percent is expected for this individual. The Principal Investigator must also be the project leader of one of the component research projects. Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. 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 the proposed research. If so, a letter of agreement from the GCRC program director/principal investigator could be included with the application. Length of SCOR Programs Each NHLBI SCOR program is limited to 10 years of support. Exceptions to this policy will be made only if a thorough evaluation of needs and opportunities, conducted by a committee composed of non-federal experts, determines that there are extraordinarily important reasons to continue a specific SCOR program. Thus, under this policy, a given SCOR grant is awarded for a five-year project period following an open competition. If the one five-year competing renewal that is permitted is awarded, a total of no more than 10 years of support is possible, unless the SCOR program is recommended for extension. The NHLBI comprehensive evaluation of the Transfusion Biology and Medicine SCOR program will be conducted during the second project period according to the following timetable: Program Announced: FY 1994 Project Period (First Competition): FY 1996 to FY FY 2000 Program Reannounced: FY 1999 Project Period: FY 2001 to FY 2005 (Second Competition) Letter to SCOR Directors Regarding SCOR Evaluation: FY 2002 (midway in year 02 of 2nd project period) SCOR Evaluation Meeting: FY 2003 (late in year 02 of 2nd project period) Notification of SCOR Directors Regarding NHLBI Decision: FY 2003 (midway in year 03 of 2nd project period) Number of Applications The NHLBI does not limit the number of SCOR applications in a given SCOR program from one institution provided there is a different SCOR Principal Investigator for each application and each application is self-contained and independent of the other(s). This arrangement does not preclude cooperation planned or possible among participants of SCORs after awards are made. Scientific overlap among applications will not be accepted. If more than one application is envisioned from an institution, the institution is encouraged to discuss its plans in advance with the NHLBI SCOR program administrator. FUNDS AVAILABLE Applicants may request up to $1,125,000 in direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year requested in the application. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that at least two SCOR grants will be funded. NHLBI's FY 1996 plans for this initiative include a maximum of $4.4 million. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Equipment is included in the budget limitation. However, requests for expensive special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requires in-depth justification. Final decisions will depend on the nature of the justification and the fiscal situation of the NHLBI. Consortium Arrangements If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such activities may be included in a SCOR grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are fully explained. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact Ms. Jane Davis, Grants Operations Branch, NHLBI, 301-594-7436. Applicants of SCOR grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside of the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. RESEARCH OBJECTIVES Background During the past decade, significant scientific advances have been made in Transfusion Medicine that have improved the safety and quality of blood, blood components, and plasma derivatives and changed transfusion practices. Advances have been made in detecting evidence for viral pathogens such as HIV-1, HIV-2, HTLV-I/HTLV-II and hepatitis C in donated blood, thus preventing such agents from entering the blood supply. Moreover, procedures have been developed to inactivate viruses in plasma derivatives and soon in plasma itself. Improved apheresis technologies have been developed that permit more efficient collection and manipulation of blood components and bone marrow. Investigators have described properties of newly developed plasma derivatives. Techniques have been developed that may lead to the use of stem cells from umbilical cord blood for bone marrow transplantation. As a result, the importance of blood transfusion has been greatly expanded through the use of components and derivatives in increasingly specialized and effective forms of therapy. The use of blood and blood components continues to increase. Improved patient care, including aggressive cancer chemotherapy programs, bone marrow transplantation, and sophisticated cardiac surgery procedures have contributed heavily to this growth, which is expected to continue into the future. Consequently, the implementation of research programs to determine the optimal use of this valuable resource is important and timely. Blood centers, as well as medical centers with large transfusion services, provide an important environment for research in transfusion medicine. These centers also provide a variety of educational opportunities aimed at several groups, both within and outside the special blood bank community, including laboratory technicians, undergraduate and graduate students, and practicing physicians. The SCOR mechanism is a very important and vital approach to address issues and problems confronting transfusion medicine today. Some of the advantages of this mechanism are: o A SCOR brings together multidisciplinary groups of investigators with valuable expertise to transfusion medicine. o With its multidisciplinary mix of basic, applied, and clinical research, a SCOR offers investigators invaluable resources for research through coordinated interactions. o The information that emerges from the research program of a SCOR may be useful in addressing important national policy issues in transfusion medicine. In the past, the SCOR program made important contributions to the NHLBI and other federal agencies. This involvement was particularly important during the turbulent times brought about by the AIDS epidemic. o A SCOR also addresses difficult clinical questions and provides the research needed to address related policy questions. The Transfusion Medicine SCOR program, like the subspecialty that it serves, is in an early, but continually evolving, state of development. Nevertheless, in the brief history of the program there have been major accomplishments in basic and clinical research that include: o Discovery of gp120 in the envelope of HIV-1 and recognition of its importance for use as an antigen to detect HIV-1 antibody in blood. o Discovery of HIV-1 and HIV-2 specific regulatory proteins and demonstration that they provide a means of distinguishing between the two viruses. o Initial development of assays to detect HIV-2 by serological means. o Recognition of the importance of the Tax gene product of HTLV-I/HTLV-II for screening blood. o Discovery of a pronounced downturn in national rates of blood collection and transfusion of red blood cells following proof that HIV is transmissible by transfusion. o Discovery of significant differences across hospitals in transfusion practice in patients undergoing the same surgical procedures. o Recognition of the importance of type specific screening of HTLV-II for the blood supply. o Use of soluble HLA Class I antigens to induce tolerance. o Performance of some feasibility studies in unrelated bone marrow transplantation. o Characterization of transfusion-related tolerance induction for solid organ transplantation. o Development of practical management strategies for platelet transfusion therapy. Since inception of the Transfusion Medicine SCOR program eight years ago, a large proportion of studies in this program have dealt with transfusion-transmitted infectious diseases, particularly AIDS. This focus on infectious disease was in part a response to the recognition that HIV-1 could be transmitted by blood transfusion. The multidisciplinary configuration of the SCOR program was ideally suited to meet the challenge of transfusion-associated AIDS. As a consequence, significant contributions were made in the understanding of HIV-1, HIV-2 and other human retroviruses. The knowledge gained from the Transfusion Medicine SCOR program contributed significantly, for example, in the selection, design and development of specific assays to detect the presence of human retroviruses in blood donors. With implementation of donor screening procedures that virtually eliminate HIV-1 and significantly reduce the likelihood of other transfusion-transmitted viruses from entering the blood supply, the NHLBI is now redirecting its SCOR program to address other important areas of scientific need and opportunity in Transfusion Biology and Medicine. Proposed Research Five areas of special emphasis have been identified that are essential for the optimal use and improvement of transfusion therapy. Recent progress in the understanding in such areas as immune regulation and hematopoiesis make this an opportune time to encourage research in the following areas of emphasis. Immunomodulatory Aspects of Transfusion The immune system occupies a central role in the safety and efficacy of transfusion therapy. One of the major problems in transfusion therapy is alloimmunization. In some situations, the occurrence may be of little consequence, but as a general problem, alloimmunization is of great importance as it limits the effectiveness of transfusions and in some cases results in death of the patient. Investigators in this SCOR program are encouraged to pursue studies that focus on the mechanisms, prevention, and management of alloimmunization to transfused blood and blood components. One approach could include strategies for rendering transfused products such as platelets nonimmunogenic by removing, altering, or masking surface antigens or interfering with immune "trigger cells." More information is needed about factors that determine immune responses in different individuals and the ways of predicting patients' potential responses. It is also important to improve our understanding of possible deleterious immunologic effects of transfusions such as enhancement of tumor growth and tumor recurrence as well as increasing susceptibility to infections. Studies on potential therapeutic applications of immune modulation might be pursued such as the use of intravenous immune globulins, staph protein A columns, photopheresis, and soluble class I and class II HLA antigens. Development of Novel Cell Therapies and Cytokine Therapies Recent developments in the understanding of hematopoiesis and stem cell biology, the identification of hematopoietic growth factors and cytokines, and cell culture technology hold promise for the creation of novel cellular components and transfusion therapies. Studies are needed on the identification, collection, purification, and preservation of hematopoietic stem cells for use in transplantation. Studies on the in vitro expansion of hematopoietic stem cells for later use in vivo are also encouraged. Significant advances have been made that create realistic prospects for the establishment of in vitro culture systems for production of stem cells for transplantation and for the production of specific cell populations for transfusion therapy. Studies are encouraged to further the understanding of the in vitro requirements for such culture systems including the use of cytokines. In addition to the use of cytokines to support the in vitro expansion of cells, studies are also needed to determine the optimal use of cytokines in vivo to reduce transfusion needs. Studies might address the identification of those disease states where cytokine therapy might be of use. Studies are needed on the dose and timing of cytokine therapy. Research studies on the regulation of endogenous cytokine production are important and could eventually lead to clinical therapies. Structure/Function Relationships of Human Blood Cell Surface Antigens Studies are needed to better understand the relation of structure to function in human blood cells, particularly red blood cells and platelets. There is a need for studies on the characterization and biological significance of blood cell surface antigens, particularly as they relate to the structural integrity of the cells, to specific cell functions, and to specific disease processes. Until recently, the major reasons for identifying blood group antigens and antibodies has been their importance in assuring safe and effective blood transfusions. In recent years, however, clinical information regarding the relation of blood cell antigens to disease has accumulated, as has knowledge of blood cell membrane structure and function. Platelet antigens are known to be associated with functional glycoproteins on platelet membranes and platelet antibodies have been shown to affect platelet function. Similar studies are needed to determine what role antibodies may play in altering red blood cell function. Basic research studies might also be pursued into understanding membrane biology and signaling in blood cells. In the area of applied research, more studies are needed on the improvement in the quality of cellular products used in transfusion therapy. With the recent emergence of new technologies to study cellular membranes and other cellular elements, this is an opportune time to pursue studies to improve the quality of platelet concentrates used for transfusion. Blood Substitutes Research on oxygen-carrying red cell substitutes could lead to the development of products that provide short or even possibly long term support for anemic patients with the advantages of being universally compatible, pathogen free, and without the requirement for cross-matching. They would ideally have a long shelf-life and offer convenient storage. There are currently several Phase I human safety trials of artificial oxygen carriers in various stages of study. The results reported thus far, have been disappointing as unexpected toxicities have been observed. Studies are needed to understand the mechanisms of toxicity of hemoglobin-based oxygen carriers. Projects might address the apparent vasoactivity of these preparations. Animal models or in need to be delineated. Studies on the efficacy of artificial oxygen carriers also need to be conducted under the experimental conditions that reflect the intended clinical use. Of particular importance are the function of artificial oxygen carriers in the presence of red cells; the measurement of tissue and organ function as an indication of efficacy; and the comparison of the efficacy of artificial oxygen carriers with that of red cells. Indications for Red Blood Cell or Platelet Transfusion Despite the obvious advantages of blood transfusion, there is concern that blood components such as red blood cells and platelets are at times given to patients who do not really need them, are given too frequently to patients who do need them, and occasionally, either are not given or are given in insufficient quantities when treatment is urgently required. Clinical decisions regarding red blood cell and platelet transfusions are hampered by a general lack of well designed clinical studies, by imprecise methods of evaluating clinical need and by uncertain methods for measuring effects. The time-honored and useful measurements of hemoglobin concentration and hematocrit are clearly not sufficient, by themselves, for many patients much of the time. Research studies are clearly needed to improve knowledge in these areas. Studies might focus on the detection or development of predictors that better define the need for red blood cell transfusion. The identification of organs that are specifically at risk during acute anemia and the development of clinical monitors that measure the state of perfusion and the presence of cellular hypoxia in those organs that are specifically sensitive to low hemoglobin values or a combination of low Hb and low perfusion are promising approaches that could be pursued. Studies are also needed to determine the appropriate indications for platelet transfusions. The platelet levels that predispose thrombocytopenic patients to hemorrhage and the efficacy of therapeutic modalities other than transfusion are not well understood and require investigation. The development of a practical test that predicts the likelihood of clinically significant platelet-related bleeding would be extremely useful. An area of special interest to the NHLBI is neonatal transfusion therapy. Dramatic advances in the care of infants of low to extremely low birth weight have resulted in survival beyond the immediate intrapartum period. Current practice often includes transfusions with red blood cells as part of the therapy for most of these infants. However, adequacy of red blood cell transfusion in the premature infant is most often assessed by measuring hemoglobin and hematocrit, two parameters that, as in adults, have limited correlation with both the need to transfuse as well as transfusion outcome. Research is needed to establish quantitative, clinically useful criteria to be used in addition to or instead of hemoglobin and hematocrit measurements in determining when to begin and end blood transfusions in newborns. There is a need for new, innovative methods to assess oxygen delivery in the newborn. Furthermore, studies to determine transfusion outcomes in this population are also needed. The different research topics and approaches described in the five areas of emphasis are intended to provide potential applicants with examples of the types of topics that are of interest to the NHLBI and worthy of pursuit. These examples, however, are not meant to be all inclusive. Investigators are encouraged to consider pursuing other important and innovative scientific topics as well. It should be emphasized, however, that the topics chosen must relate directly to the five areas of emphasis identified in this initiative. Furthermore, the topics may address one or more than one area of emphasis. For example, it would be appropriate for a SCOR applicant to propose projects that address research issues pertaining to one area of interest such as structure/function relationships of human blood cell surface antigens or a combination such as structure/function relationships of human blood cell surface antigens and immunomodulatory aspects of transfusion. Applicants should also note that a SCOR program must meet the following criteria: (1) address areas of significant national need and clinical importance; (2) attract talented investigators who foster the development of a multidisciplinary and collaborative synergistic approach; (3) include both basic and clinical components; and, most importantly; (4) have the potential to accelerate the transfer of basic research to clinical application. Applicants are requested to contact the project officer of this initiative prior to preparing a SCOR application to make certain that their proposed program is compatible with the objectives of this solicitation. The major emphasis of this SCOR program is on basic, applied and clinical research in transfusion biology and medicine, the nature of which will depend upon the interests and areas of expertise of its investigators, as well as on the physical resources and population available. However, each institution requesting SCOR support should have a basic range of competence and potential that will enable it to develop a program addressing the objectives and goals of this initiative. SCORs should also provide a challenging environment for attracting talented young scientists into biomedical research and offering opportunities for career development. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, 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. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) LETTER OF INTENT Prospective applicants are asked to submit, by May 31, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the principal investigator; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It 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 sent to: Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page 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", enter the title "Specialized Centers of Research in Transfusion Biology and Medicine", and the RFA number HL-94-012 on line 2a of the face page of the application. Send or deliver 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 Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to the Chief, Review Branch at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants (DRG), otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by September 15, 1994. If an application is received after that date, it will be returned to the applicant. 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. 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 by National Institutes of Health (NIH) staff for completeness and responsiveness. Incomplete applications or applications deemed not responsive to the RFA will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI. Crucial to the initial scientific review will be a triage process that will eliminate all applications that are deemed not scientifically competitive within the goals and criteria of the RFA. The second level of review will be provided by the National Heart, Lung, and Blood Advisory Council. If, through peer review, this project is not recommended for further consideration, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. Factors to be considered in the evaluation of each application will be similar to those used in review of traditional research grant applications and, in addition, will include overall proposed interactions among basic and clinical research projects. Major factors to be considered in the evaluation of applications include: o Scientific merit of the proposed basic and clinical research projects including significance, importance, and appropriateness of the theme; innovation, originality, and feasibility of the approach; and adequacy of the experimental design. o Leadership, scientific stature, and commitment of the program director; competence of the investigators to accomplish the proposed research goals and their time commitment to the program; and the feasibility and strength of consortium arrangements. o Collaborative interaction among basic and clinical research components, the balance between them, and plans for transfer of potential findings from basic to clinical studies. o Adequacy of the environment for performance of the proposed research including clinical populations and/or specimens; laboratory facilities; proposed instrumentation; quality controls; administrative structure; institutional commitment; and, when needed, data management systems. o Appropriateness of the budget for the proposed program. 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 scientific issues to: George J. Nemo, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 504 Bethesda, MD 20892 Telephone: (301) 496-1537 FAX: (301) 402-4843 Direct inquiries regarding fiscal and administrative matters to: Ms. Jane Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A15C Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS The programs of the Division of Blood Diseases and Resources, NHLBI are described in the Catalog of Federal Domestic Assistance No. 93.839. Awards will be made under the 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 requirement of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Tue Apr 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AR-94-005 - V23(13) 04/01/94 Date: 5 Apr 1994 17:02:20 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 419 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2nsu6c$43t@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AR94005 AR-94-005 P1O1 *************************************** BASIC OSTEOPOROSIS NEW EXPERIMENTAL STRATEGIES NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA: AR-94-005 P.T. National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Aging Letter of Intent Receipt Date: June 28, 1994 Application Receipt Date: July 26, 1994 PURPOSE The Bone Biology and Bone Diseases Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the Bone and Mineral Research Program of the Endocrinology Research Section of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Geriatrics and Biology of Aging Programs of the National Institute on Aging (NIA) invite investigator-initiated research project grant applications to encourage and facilitate research projects designed to develop promising basic cellular, molecular, physiological, and genetic approaches to osteoporosis. 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), Basic Osteoporosis New Experimental Strategies, is related to the priority areas of diabetes and chronic disabling conditions and older adults and preventive services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may be submitted by single institutions and by a consortia of institutions. Foreign institutions are not eligible for First Independent Research and Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support for this program will be through investigator-initiated research grant applications (R01) and FIRST (R29) awards. This RFA is a one-time solicitation for fiscal year 1995. However, the NIAMS, NIDDK, and NIA may reissue the RFA in future years. If there is a continuing program need, the NIAMS, NIDDK, and NIA will invite recipients of awards under this RFA to submit competitive continuation applications. Responsibility for planning and implementation of the proposed project will be solely that of the applicant. The total project period for R01 applications submitted in response to the present RFA may not exceed four years. FIRST awards must be for five years. The anticipated award date is April 1, 1995. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year for four years will be committed by the NIAMS to fund applications submitted in response to this RFA. An additional $500,000 will be committed by the NIDDK, and an additional $600,000 by the NIA. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The direct cost of each R01 project is limited to $160,000 for the first year and R29s are limited to $70,000. Thus it is anticipated that a total of 12 to 14 projects will be funded in FY 95. Although this program is provided for in the financial plans of the NIAMS, NIDDK, and NIA, the award of grants, as well as the final amounts awarded, will be contingent upon the availability of funds for this purpose. 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. RESEARCH OBJECTIVES Background Much work remains to be done in order to counter the disabling, costly consequences of osteoporosis. Means of targeting nutritional and pharmacological preventive strategies to individuals most at risk for bone loss are needed in order to reduce the incidence of fractures and the attendant costs to society. Alternatives to the available preventive drug therapies are needed in order to extend their utility to the largest possible number of people. Effective approaches to the treatment of established osteoporosis are urgently needed. Such new therapeutic approaches are most likely to arise from improved understanding of the basic biology of bone growth and maintenance. Recent scientific and technological developments have markedly expanded opportunities for understanding the molecular and genetic basis of osteoporosis. Details are beginning to emerge of the complex network of signalling mechanisms that control bone growth and maintain skeletal integrity. Specific probes have made it possible to identify new molecules responsible for the local and systemic regulation of bone cell function, as well as the cell surface molecules and linked signal transduction pathways that mediate their effects. In particular, the complex relationship between the bone microenvironment and the immune system demands attention. The identification, mapping, and structural analysis of genes with crucial functions in the regulation of bone are increasingly feasible research goals. The use of genetically manipulated animals allows investigators to test the effects of specific gene inactivation or over-expression. The identification of genetic variations in the human population that underlie different vulnerabilities to bone loss is made possible by the increasing knowledge of the human genome and advancing molecular screening technology. In order to capitalize on these opportunities, it is necessary to integrate biological insights and methodologies from a broad range of specialties. The overall goal of the Basic Osteoporosis New Experimental Strategies (BONES) initiative is to encourage and support new basic research in the areas of bone structure, formation, remodeling, and repair. This initiative is designed to (1) encourage established bone biology investigators to address osteoporosis-related problems with novel approaches and the most powerful methodologies available; (2) increase the pool of investigators working in osteoporosis-related basic science areas by drawing researchers from genetics, cell and molecular biology, and structural chemistry into bone research; and (3) foster the development of interactions between laboratories originating in different disciplines. Research Goals and Scope Some examples of research areas in which applications would be considered responsive to this RFA include, but are not limited to: o Mechanisms of action of growth factors, cytokines, bone inductive factors, and other regulators of bone growth and remodeling; o Genes and gene products with critical roles in bone growth and remodeling; o Mechanisms of action of estrogens, androgens, and glucocorticoids on bone; o Origins and lineages of osteoblasts, osteoclasts, and osteocytes: nature of precursor cells; control of activation, proliferation, and differentiation; role of marrow stromal stem cells; o Mechanisms of regulation of bone growth and remodeling by physical forces: loading stress, exercise, immobilization, and microgravity; o Biochemical and genetic markers of osteoporosis; o Biomechanical and non-invasive assessment of bone quality and architecture; o Influence of extracellular matrix composition and architecture on bone; growth and remodeling in normal and pathologic conditions; o Relationship between bone formation and vascularization in normal bone growth and fracture repair; o Cell and animal models for osteoporosis; o Effects of age and age-related changes on the level and action of hormones, growth factors, cytokines, and other osteotropic/osteogenic factors, and the impact and underlying mechanisms of such changes on bone remodeling and repair; o Elucidation of the nature and underlying mechanisms of age-related changes in the activation, proliferation and differentiation of bone cells and bone cell precursors; and o Determination of the mechanisms and consequences of age-related changes in bone vascularization and extracellular matrix on bone remodeling and bone architecture. Investigators are not limited to the above examples of research areas, and are encouraged to propose other approaches that are appropriate to the R01 and R29 mechanisms and the requirements of this RFA. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, 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. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) LETTER OF INTENT Prospective applicants are asked to submit, by June 28, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIH 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. William Sharrock at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIH program staff listed under INQUIRIES. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Dr. Tommy Broadwater Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 406 Bethesda, MD 20892 Telephone: (301) 594-9979 FAX: (301) 594-9673 Applications must be received by July 26, 1994. 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 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 NIAMS. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAMS staff will 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 may be triaged by an NIAMS peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAMS. The second level of review will be provided by the NIAMS, NIDDK, and NIA advisory councils. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o extent to which the proposed research addresses the goals of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o adequacy of plans for overall collaboration; o availability of the resources necessary to perform the research; o adequacy of the mechanisms for quality control, study monitoring, data management and reporting and data analysis; o adequacy of provisions for the protection of human subjects; o adequacy of the plans for inclusion of females and minorities; and o appropriateness of the proposed budget and duration in relation to the proposed research; AWARD CRITERIA The anticipated date of award is April 1, 1995. In addition to the technical merit of the application as reflected in the priority score, the NIAMS, NIDDK, and NIA will consider how well the applicant institution meets the goals and objectives of the program as described in the RFA, availability of resources and/or study populations. 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: William Sharrock, Ph.D. Bone Biology and Bone Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 594-9975 FAX: (301) 594-9673 Ronald Margolis, Ph.D. Endocrinology Research Section National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 621 Bethesda, MD 20892 Telephone: (301) 594-7549 FAX: (301) 594-9011 Sherry Sherman, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 2C218 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-932 FAX: (301) 402-2945 Direct inquiries regarding fiscal matters to: G. Carol Fitzpatrick Grants Management Office National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 722A Bethesda, MD 20892 Telephone: (301) 594-9974 FAX: (301) 594-9950 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.846, 93.847, and 93.866. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241 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 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. From owner-sci-resources@net.bio.net Tue Apr 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-012 - V23(13) 04/01/94 Date: 5 Apr 1994 17:02:12 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 335 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2nsu64$43f@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94012 CA-94-012 P1O1 *************************************** HOSPICE AND PALLIATIVE CARE EDUCATION PROGRAMS NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA: CA-94-012 P.T. National Cancer Institute Letter of Intent Receipt Date: May 2, 1994 Application Receipt Date: June 16, 1994 PURPOSE The National Cancer Institute (NCI) invites grant applications to create new educational programs to address health professional training in palliative patient care. The intent of this Request for Applications (RFA) is to emphasize NCI's concern for this neglected area with the expectation that any funded programs will act as catalysts to encourage further interest and development in the medical community. 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 Application (RFA), Hospice and Palliative Care Education Programs, is related to the priority area of Educational and Community-based Programs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238) ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, hospices, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support for this effort will be through the NCI Cancer Education (R25) Award. This award is a flexible, curriculum-driven program aimed at developing and sustaining innovative and, possibly, unique educational approaches that ultimately will have an impact on reducing cancer incidence, mortality, and morbidity, as well as on improving the quality-of-life of cancer patients and their families. The current guidelines for the Cancer Education Program (R25) may be obtained from the program director listed under INQUIRIES. Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for each application submitted in response to this RFA may not exceed three years. The earliest feasible start date for the initial award will be September 1994. It is anticipated that the average amount of direct costs awarded per grant will range from $50,000 to $100,000 depending upon the proposed program. Indirect costs will be allowed at the rate of eight percent of total direct costs (exclusive of equipment). This RFA is a one-time solicitation. Future competitive continuation applications will compete with all other applications in the Cancer Education Grant Program (R25). Should the NCI, however, determine that there is a sufficient program need, a new request for competitive continuation and/or new applications will be announced. FUNDS AVAILABLE For FY 1994, $500,000 in total costs will be available for, it is estimated, some five to seven new awards. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. A greater or lesser amount of dollars and number of awards may be negotiated based on the quality of the applications and the availability of funds. RESEARCH OBJECTIVES Background There are few formally structured programs for training in palliative patient care available in the United States. There are far too few health care professionals who have been trained or have an interest in dealing with this phase of a patient's disease. The Hospice movement in this country, through its own efforts, has developed largely outside mainline, established treatment and educational centers. In September 1990, NCI sponsored a workshop on cancer pain. Although the focus of this meeting was on the need for state-of-the-art technology transfer for pain management, the conference did at that time specify an urgent need for additional educational and training programs in palliative care. At the National Cancer Advisory Board meeting on May 6, 1992, a mini-symposium, "Living with Cancer," once again emphasized the necessity for training and education in this area. In response to these concerns, at the end of FY 1992, the NCI funded at a level of almost $1.3 million 15 of 55 applications for its RFA CA-91-25 which was entitled: "Cancer Education Programs in Pain Management, Rehabilitation, and Psychosocial Issues." In addition, in FY 1993, RFA CA-93-35, "Cancer Pain Management in the Outpatient Setting" was announced. Other This RFA proposes to stimulate medical schools, schools of nursing, cancer centers, oncology divisions, and other health professional entities to design methodologies for the education and training of health care professionals in hospice and palliative care. Traditionally, the nursing profession has been more involved with this phase of patient care than physicians. Hospices have had to struggle with physician recruitment. A major challenge is to train more physicians in a team approach to palliation. An important target group for reaching this goal would be medical students during their clinical training years. At a minimum, what a hospice is, issues of hospice care, and the practical aspects of interaction with patients and their families should be considered. Hospices, either individually or in regional settings in collaborative arrangements with other medical centers are particularly encouraged to submit applications in response to this RFA. The development of hospices in academically oriented settings is definitely encouraged. The NCI hopes to stimulate multi-disciplinary, team approaches to palliative care by encouraging a variety of educational programs aimed at medical students, physicians, other health professionals, and hospice personnel. The ultimate goal is to benefit cancer patients and their families. Applicants can design curricula, short courses, interactions with patients and families, and other effective approaches for training one or more of the target groups mentioned above. For example, programs could involve medical students taking a one month elective or doing a one or two month rotation in a hospice or home health care setting. Residents or practicing physicians could have specifically constructed opportunities in their regular or continuing education to become more cognizant of palliative care including cancer pain management and related psychosocial issues in a hospice setting. These multi-disciplinary programs will require the integration of several elements that could include, but are not limited to, control of physical symptoms such as pain, nausea, and hiccups [all successful applications must deal with pain relief and the pharmacokinetics of pain medications]; psychological issues of dying, bereavement, and metaphysical beliefs; medical ethics; health economics; home health care plus family or social concerns and values. In addition to any didactic components, it will be essential to involve participants in practical demonstrations of care with patients and families in a hospice or home setting. It has been estimated that 80 percent of palliative care occurs in the home. The participation of home care nurses with oncology experience, therefore, will be a critical element in most of these education programs. SPECIAL REQUIREMENTS Applicants are requested to identify clearly in their application the following aspects of their proposed initiative: (1) the content and scope of the educational activities; (2) the specific populations to be educated and their availability; (3) the procedures to be used to announce these educational activities and to recruit participants; (4) the potential benefits to health professionals, the lay public or to cancer patients and their families likely to arise as the result of these educational programs; (5) the methods of evaluation of the program outcomes; and (6) the specific plans to disseminate aspects of these educational activities that prove to be effective. If several institutions are jointly involved or if several departments within an institution are cooperating in this RFA, a special, central, interdisciplinary Cancer Education Committee consisting of members from the collaborating organizations or units should be in place. The functions of the Committee would be to provide effective monitoring and coordination of the program. LETTER OF INTENT Prospective applicants are asked to submit, by May 2, 1994, a letter of intent that includes a descriptive title of the proposed educational activity, the name, address, and telephone number of the Principal Investigator/Educator, 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 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 Dr. Robert C. Adams at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI Program Director listed under INQUIRIES. The RFA label available in the application form PHS 398 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 number and title must be typed on line 2a of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist and three signed, exact, clear, and single-sided photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, also send two additional copies of the application to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Applications must be received by June 16, 1994. If an application is received after that date, it will be returned. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review but not yet reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. An application, therefore, cannot be submitted in response to this RFA that is essentially identical to one that has already been 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 Review Procedure Upon receipt, applications will be reviewed initially by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications subsequently will be evaluated by NCI scientific administration staff to determine how well they meet the objectives of the program as described in this RFA. Applications that are not primarily oriented to the goals of this RFA will be judged non-responsive and will be returned. Program staff listed under INQUIRIES will be happy to address questions concerning the relevance of any proposed educational or training activity to this RFA. If number of applications is quite large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review (triage) to eliminate those applications that are clearly not competitive and will notify the applicant and institutional business official of this action. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board will consider the special needs of the NCI and the priorities of the National Cancer Program. Review Criteria o The overall quality of the proposed education programs. o The responsiveness of the application to the SPECIAL REQUIREMENTS section described above. o Scientific, pedagogic, and administrative qualifications and experience of the principal investigator and staff. o The availability of appropriate resources and facilities for the proposed activities. The review committee will critically examine the proposed budget and recommend an appropriate budget for each approved application. AWARD CRITERIA The anticipated date of award is September, 1994. Awards will be made according to priority score, availability of funds, and programmatic priorities. 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. Robert C. Adams Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Direct inquiries regarding grants management issues to: Mr. Robert Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.398, Cancer Research Manpower. Awards are made under the 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 HHS regulations and PHS grant policies. 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. From owner-sci-resources@net.bio.net Tue Apr 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-94-013 - V23(13) 04/01/94 Date: 5 Apr 1994 17:02:07 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 522 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2nsu5v$436@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL94013 HL-94-013 P1O1 *************************************** SPECIALIZED CENTERS OF RESEARCH IN HEMOSTATIC AND THROMBOTIC DISEASE NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA: HL-94-013 National Heart, Lung, and Blood Institute P.T. Letter of Intent Receipt Date: May 31, 1994 Application Receipt Date: September 15, 1994 PURPOSE The objectives of the Specialized Centers of Research (SCOR) program in Hemostatic and Thrombotic Diseases are to improve the basic understanding of the processes involved in hemostasis and thrombosis and to encourage application of this fundamental knowledge to clinical situations. This initiative emphasizes the use of new and innovative technology to provide better insight and develop treatment for thrombosis and related cardiovascular disorders, which are the leading cause of death in the United States. 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 of Research in Hemostatic and Thrombotic Diseases, is related to the priority area of blood diseases and resources. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic institutions, public and private, such as universities, colleges, hospitals, and laboratories. This RFA is intended to support SCOR grants for basic and clinical investigations. Therefore, applications that include only basic or only clinical research will not be responsive to this RFA. In addition, clinical research projects focused on large epidemiologic studies or large clinical trials will be considered unresponsive to this RFA. Awards will not be made to foreign institutions; however, under exceptional circumstances, a foreign component critical to a project may be included as part of that project. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Heart, Lung, and Blood Institute (NHLBI) SCOR (P50) grant to support this research program. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to diseases and therapies relevant to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research projects. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. Each SCOR grant application and award must include research involving human patients/subjects. Support may be provided for human biomedical and behavioral studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders, or conditions. Small population-based studies, where the research can be completed within five years, may also be proposed. In addition, basic research projects must be included that relate to the clinical focus. A SCOR may also contain one or more core units that support the research projects. 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 program. A minimum time commitment of 25 percent is expected for this individual. The Principal Investigator must also be the project leader of one of the component research projects. Each project leader must agree to commit at least 20 percent effort to each project for which he/she is responsible. Applications from institutions that have a General Clinical Research Center (GCRC) funded by the National Center for Research Resources, NIH may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC program director/principal investigator could be included with the application. Length of SCOR Programs Each NHLBI SCOR program is limited to 10 years of support. Exceptions to this policy will be made only if a thorough evaluation of needs and opportunities, conducted by a committee composed of non-federal experts, determines that there are extraordinarily important reasons to continue a specific SCOR program. Thus, under this policy, a given SCOR grant is awarded for a five-year project period following an open competition. If the one five-year competing renewal that is permitted is awarded, a total of no more than 10 years of support is possible, unless the SCOR program is recommended for extension. The NHLBI comprehensive evaluation of the Hemostatic and Thrombotic Diseases SCOR will be conducted during the second project period according to the following timetable: Program Announced FY 1994 Project Period (First Competition) FY 1996 to FY 2000 Program Reannounced FY 1999 Project Period (Second Competition) FY 2001 to FY 2005 Letter to SCOR Directors Regarding FY 2002 SCOR Evaluation (midway in year 02 of 2nd project period) SCOR Evaluation Meeting FY 2003 (late in year 02 of 2nd project period) Notification of SCOR Directors FY 2003 Regarding NHLBI Decision (midway in year 03 of 2nd project period) Number of Applications The NHLBI does not limit the number of SCOR applications in a given SCOR program from one institution provided there is a different SCOR Principal Investigator for each application and each application is self-contained and independent of the other(s). This does not preclude cooperation planned or possible among participants of SCORs after awards are made. Scientific overlap among applications will not be accepted. If more than one application is envisioned from an institution, the institution is encouraged to discuss its plans with the NHLBI SCOR program administrator listed under INQUIRIES. FUNDS AVAILABLE Up to $1,125,000 in direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year may be requested in each application. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that at least two new SCOR grants will be funded. NHLBI's FY 1996 plans for this initiative include a maximum of $4.4 million. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Equipment is included in the budget limitation. However, requests for expensive special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requires in-depth justification. Final decisions will depend on the nature of the justification and the fiscal situation of the NHLBI. Consortium Arrangements If a grant application includes research activities that involve institutions other than the proposed grantee institution, the program is considered a consortium effort. Such activities may be included in a SCOR grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact Ms. Jane Davis, Grants Operations Branch, NHLBI, 301-594-7436. Applicants of SCOR grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside of the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. RESEARCH OBJECTIVES Background Nearly 50 percent of mortality in the United States is related to cardiovascular diseases and amounts to about one million deaths per year. Thrombotic events precipitate myocardial infarction, deep vein thrombosis and pulmonary embolism, and stroke. Unconstrained thrombosis is the scourge of the present time. The cost in lives lost, morbidity, and lost productivity is enormous. The economic cost of cardiovascular diseases was an estimated $151 billion in 1989. In spite of these alarming figures, it is important to note that there have been significant improvements in the ability to combat thrombotic disorders and cardiovascular diseases. The death rates for coronary heart disease and stroke have declined 50 and 58 percent respectively during the 20-year period from 1970 to 1990. Because of the rapid decline in mortality from heart attack since its peak in 1963, there were 491,000 fewer deaths from this cause in 1990. This remarkable improvement would not have been possible without major and consistent progress in research on thrombosis. However, the present risk of thrombosis, heart attack, and stroke remains high and is not acceptable. The rapid progress in genetics, molecular biology, and protein chemistry has opened up frontiers and led to the development of new tools that provide new opportunities to combat thrombosis and cardiovascular diseases. Also, the major research advances made by investigators in thrombosis have significantly contributed to basic understandings and clinical developments in other disease areas. Proposed Research Although significant progress has been made, there are many opportunities in hemostasis and thrombosis research and the application of the results to clinical situations. The following are intended to serve only as examples and to emphasize the need for employing a multidisciplinary research approach to important clinical problems. o Risk factors for thrombosis The pathogenesis of thrombosis is complex and its etiology is likely to be multi-factorial. Both hereditary and acquired conditions are involved; inherited predispositions are more clinically disturbing because they affect patients at an younger age. There are a number of genes - antithrombin, protein C, protein S, fibrinogen - in which a mutation may be prothrombotic. However, heterozygosity for a particular mutant allele can be clinically silent in some individuals but devastating in others. These differences could be due to intergene interactions, i.e., variant alleles of other genes may exacerbate or reduce the effect of the primary genetic trait. Since the gene structure of many candidate proteins involved in hemostasis and thrombosis are known, it may be possible with improved technologies to perform multigene analysis and provide a genetic basis of thrombotic disorders. Recent reports of resistance to prolongation in clotting time induced by activated protein C in majority of thrombophillic patients offer hope of identification of additional risk factors for thrombosis. Research on the natural inhibitors of coagulation/fibrinolysis including the development of animal models may allow genetic manipulations leading to the delineation of the role of these proteins in hemostasis and thrombosis. These studies may allow determination of the causative factors, provide an objective definition of thrombosis proneness and application of preventive approaches. o Influence of nutritional elements and environmental factors on thrombotic disease There is an emerging consensus that many human diseases are related to behavior, nutrition and environmental factors. Increasing emphasis is being placed on prevention by alterations in lifestyle. Recent data indicate that certain nutritional elements, such as vitamin E, wine, garlic, fish oil, may be beneficial in the prevention of thrombosis. Once the candidate genes that lead to proneness to thrombosis have been identified, then the effect of external factors may be studied. This area related to prevention requires further research. o Diagnosis, assays, and treatment for venous thrombosis Two million Americans a year develop deep vein thrombosis and approximately 50,000 will die. Venous thromboembolism usually occurs as a complication of a major illness or major surgical procedure in hospitalized patients. There are important issues involving diagnosis, optimal anticoagulation therapy, laboratory assays, and efficacy of thrombolytic therapy that need further studies. The advent of newer agents, such as low molecular weight heparin and analogues of hirudin, is likely to require systematic and controlled studies on their efficacy and standardization. There is a need for optimal therapy to prevent extensions of thrombosis at early stages and restore involved vessels to as normal a state as possible. o Regulation of adhesive proteins and processes A number of processes important in hemostasis and thrombosis are regulated by adhesive protein ligands and their receptors. The adhesion of platelets and other cells to the endothelium, and the aggregation of platelets to each other are thought to be mediated by this process. The role of platelet and endothelial (glyco)proteins including the selectins and integrins in inflammation, signal transduction and thrombosis need further study. A detailed understanding of the regulation of integrin structure-function, affinity modulation and the role of other environmental factors are important, not only to thrombosis/hemostasis, but also to other biological processes. It is necessary to develop markers of a dysfunctional endothelium that may be applicable to in vivo situations and better understand the leukocyte-endothelial interactions. The data generated may provide the foundation for the development of new antithrombotic and anti-inflammatory agents. o Genetic regulation of the synthesis, catabolism, and function of fibrinolytic proteins Widespread use of thrombolytic therapy has exposed gaps in the knowledge of the fibrinolytic system, role of platelets in thrombolysis, thromboselectivity of the lytic agents, and the mechanism of reocclusion. The success rate of thrombolytic therapy has stubbornly stuck around 70 percent. There is an opportunity here for collaborative basic research and clinical investigation. Structure-function relationships in coagulation and fibrinolytic proteins, studies of macromolecular assembly in the coagulation and fibrinolytic systems, the enzymology and kinetic analyses of these systems, although important and productive, are considered mature and may be supported by other NHLBI grant mechanisms. Similarly, qualitative studies on platelet function, for example by aggregometry, and classification of patient populations are not encouraged to form the main themes of SCOR applications. Quantitative studies that address important questions of platelet dysfunction in specific patient populations and may also contribute to the understanding of normal platelet biology may form a component of the application. There is a need for further education and research on the influence of behavior, gender, race, and age in hemostasis and thrombosis. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, 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. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) LETTER OF INTENT Prospective applicants are asked to submit, by May 31, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the principal investigator; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It 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 sent to: Chief, Review Branch Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page 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," enter the title "Specialized Centers of Research in Hemostatic and Thrombotic Diseases," and the RFA number HL-94-013 on line 2a of the face page of the application. Send or deliver 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 Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to the Chief, Review Branch at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants (DRG), otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by September 15, 1994. If an application is received after that date, it will be returned to the applicant. 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. 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 by National Institutes of Health (NIH) staff for completeness and responsiveness. Incomplete applications or applications deemed not responsive to the RFA will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI. Crucial to the initial scientific review will be a triage process that will eliminate all applications that are deemed not scientifically competitive within the goals and criteria of the RFA from further review. The second level of review will be provided by the National Heart, Lung, Blood Advisory Council. If, through peer review, this project is not recommended for further consideration, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. Factors to be considered in the evaluation of each application will be similar to those used in review of traditional research grant applications and, in addition, will include overall proposed interactions among basic and clinical research projects. Major factors to be considered in the evaluation of applications include: o Scientific merit of the proposed basic and clinical research projects including significance, importance, and appropriateness of the theme; innovation, originality, and feasibility of the approach; and adequacy of the experimental design. o Leadership, scientific stature, and commitment of the program director; competence of the investigators to accomplish the proposed research goals and their time commitment to the program; and the feasibility and strength of consortium arrangements. o Collaborative interaction among basic and clinical research components, the balance between them, and plans for transfer of potential findings from basic to clinical studies. o Adequacy of the environment for performance of the proposed research including clinical populations and/or specimens; laboratory facilities; proposed instrumentation; quality controls; administrative structure; institutional commitment; and, when needed, data management systems. o Appropriateness of the budget for the proposed program. 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 scientific issues to: Pankaj Ganguly, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5C14 Bethesda, MD 20892 Telephone: (301) 402-2237 FAX: (301) 496-9940 Direct inquiries regarding fiscal and administrative matters to: Ms. Jane Davis Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 4A15C Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.839. Awards will be made under the 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 requirement of Executive Order 12372 or Health Systems Agency review. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. 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. From owner-sci-resources@net.bio.net Tue Apr 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-011 - V23(13) 04/01/94 Date: 5 Apr 1994 17:02:25 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 365 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2nsu6h$44a@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94011 CA-94-011 P1O1 *************************************** BREAST CANCER EDUCATION INITIATIVES NIH GUIDE, Volume 23, Number 13, April 1, 1994 RFA: CA-94-011 P.T. National Cancer Institute Letter of Intent Receipt Date: May 2, 1994 Application Receipt Date: June 16, 1994 PURPOSE The National Cancer Institute (NCI) invites grant applications to create new educational programs aimed at reducing the mortality and morbidity of breast cancer. These cancer education programs are intended to disseminate what is professionally known about the prevention, early detection, and treatment of breast cancer to primary care physicians, other health professionals, and the lay community with special attention to minority or underserved populations. 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), Breast Cancer Education Initiatives, is related to the priority area of Educational and Community-based programs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, Cancer Centers, hospitals, Laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support for this program will be through the NCI Education (R25) Award. This award is a flexible, curriculum-driven program aimed at developing and sustaining innovative and, possibly, unique educational approaches that ultimately will have an impact on reducing cancer incidence, mortality, and morbidity, as well as on improving the quality-of-life of cancer patients. The current guidelines for the Cancer Education Program (R25) may be obtained from the program director listed under INQUIRIES. Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for each application submitted in response to this RFA may not exceed three years. It is anticipated that the average amount of direct costs awarded per grant will range from $50,000 to $130,000 depending upon the proposed program. Indirect costs will be allowed at the rate of eight percent of total direct costs (exclusive of equipment). The earliest feasible start date for the initial award will be September 1994. This RFA is a one-time solicitation. Future competitive continuation applications will compete with all other applications in the Cancer Education Grant Program (R25). However, if the NCI determines that there is a sufficient program need, a new request for competitive continuation and/or new applications will be announced. FUNDS AVAILABLE For FY 1994, $1,600,000 in total costs will be available for, it is estimated, some 15 to 20 new awards. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. A greater or lesser amount of dollars and number of awards may be negotiated based on the quality of the applications and the availability of funds. RESEARCH OBJECTIVES Background The American Cancer Society estimates that 46,000 women will die of breast cancer or its complications in 1993 and that 182,000 new cases will be diagnosed. In the face of these statistics, the NCI is committed to basic research, translational research, and educational programs to respond to this crisis. Even though important scientific questions still remain unanswered, it is the considered belief of the NCI that public and professional educational programs dealing with breast cancer can result in better health behavior and better health care delivery, which should have a positive public health benefit. Other The purpose of this RFA, then, is to stimulate breast cancer educational programs among health professionals and the lay public. The NCI already supports a spectrum of basic and clinical research efforts in breast cancer; in addition, it has allocated significant resources to the prevention and early detection of breast cancer. What it would like to encourage by this RFA is the translation of current research findings and intervention practices into widely diffused state-of-the-art information packages on breast cancer. Since it is essential that any educational strategies to accomplish these goals rest on a knowledge base derived from the best current research findings, the NCI proposes that Cancer Centers and other organizations with appropriate breast cancer expertise collaborate with educational specialists and other professional and lay groups, particularly those with access to underserved populations, to design and implement programs to achieve the objectives noted above. Some examples of target populations for this initiative, therefore, might include: primary care physicians, health professional faculty, health professional students, women's groups, minority or underserved groups, employer-based groups, and breast cancer patients and their families. Some of the reasoning involved in the choice of these target groups is as follows. Breast cancer patients, once diagnosed, will need data, perspectives, and risk/benefit analyses to enable them to communicate with physicians and to participate with health care providers in the series of choices that must be made about their treatment and the future course of their lives. Those free of cancer may need different information in regards to cancer in general, the importance of mammograms, issues of radiation risk, and ways of overcoming a general sense of unease in the face of this disease. Health care professionals who have contact with women in a health maintenance setting or who treat breast cancer patients along with other patients in a community setting may wish to have their knowledge and skills updated or expanded in order to provide better care and comfort to women. This target population might profit from current information concerning breast cancer risk evaluation for different age populations, the formal range of current breast cancer screening guidelines, how to conduct proper physical breast examinations, and how to follow up on an abnormal physical finding or mammogram. Health professional students could be given early in their career training a comprehensive orientation to the range of breast cancer issues, especially the importance and impact of clinical trials in the nation's effort against breast cancer. The NCI feels that these types of educational programs should focus on the knowledge and attitudes of both professional and lay audiences concerning the rationale, selection criteria, and procedures for any referral to treatment and prevention clinical trials dealing with breast cancer. Minority or underserved populations have special needs in regard to breast cancer education. Breast cancer is generally diagnosed at a later stage in these groups, resulting in a higher mortality rate compared to the general population. In addition, early onset breast cancer in younger members of these distinctive populations may present special problems in the diagnosis and treatment of their disease. The costs necessary to attract and involve underserved populations may be requested and supported if appropriately justified. The NCI strongly encourages submission of applications from minority health professional schools and other organizations that have traditionally served minority communities and geographically isolated populations. These schools and organizations are invited to provide structured, state-of-the-art breast cancer educational programs to address specifically the needs of their faculty, students, and members. The proposals should, where feasible, also include educational outreach activities involving civic, fraternal, and religious groups with access to minority or underserved women. Participation, therefore, in this cancer education initiative by these appropriate institutions will help to achieve the goals of the NCI Minority Health Professional Training Initiative. The latter is intended to strengthen the oncology faculty and infrastructure of minority health professional schools through the use of a variety of research training and career development grant awards. In summary, NCI seeks to support innovative programs using educational techniques and media that are most appropriate for specific target groups. It especially encourages educational programs that include segments that offer information on and practical guidance in the use of the NCI Physician Data Query (PDQ) system, Cancer FAX databases, and the network of the Cancer Information Service (CIS). SPECIAL REQUIREMENTS Applicants are requested to identify clearly in their application the following aspects of their proposed initiative: (1) the content and scope of the educational activities; (2) the specific population(s) to be educated and their availability; (3) the procedures to be used to announce these educational activities and to recruit participants; (4) the potential benefits to health professionals, the lay public, or cancer patients and their families likely to arise as the result of these educational programs; (5) the methods of evaluation of the program outcomes; and (6) the specific plans to disseminate aspects of the educational activities that prove to be effective. If several institutions are jointly involved or if several departments within an institution are cooperating in this RFA, a special, central, interdisciplinary Cancer Education Committee consisting of members from the collaborating organizations should be in place. The functions of the Committee would be to provide effective monitoring and coordination of the program. LETTER OF INTENT Prospective applicants are asked to submit, by May 2, 1994, a letter of intent that includes a descriptive title of the proposed educational activity, the name, address, and telephone number of the Principal Investigator/Educator, 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 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 Dr. Robert C. Adams at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI Program Director listed under INQUIRIES. The RFA label available in the application form PHS 398 must be affixed to the bottom of 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 number and title of this RFA must be typed on line 2a of the face page of the application form. Submit a signed, typewritten original of the application including the Checklist and three signed, exact, clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, also send two additional copies of the application to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Applications must be received by June 16, 1994. If an application is received after that date, it will be returned. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review but not yet reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. An application, therefore, cannot be submitted in response to this RFA that is essentially identical to one that has already been 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 Review Procedure Upon receipt, applications will be reviewed initially by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications subsequently will be evaluated by NCI scientific administration staff to determine how well they meet the objectives of the program as described in this RFA. Applications that are not primarily oriented to the goals of this RFA will be judged non-responsive and will be returned. All basic research applications on breast cancer, for example, should be submitted under a regular research project mechanism or in response to another RFA. Program staff listed under INQUIRIES will be happy to address questions concerning the relevance of any proposed educational or training activity to this RFA. If the number of applications is quite large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review (triage) to eliminate those applications that are clearly not competitive, and will notify the applicant and institutional business official of this action. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board will consider the special needs of the NCI and the priorities of the National Cancer Program. Review Criteria o The overall quality of the proposed education programs. o The responsiveness of the application to the SPECIAL REQUIREMENTS section described above. o Scientific, pedagogic, and administrative qualifications and experience of the principal investigator and staff. o The availability of appropriate resources and facilities for the proposed activities. The review committee will critically examine the proposed budget and recommend an appropriate budget for each approved application. AWARD CRITERIA The anticipated date of award is September 1994. Awards will be made according to priority score, availability of funds, and programmatic priorities. 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 and address the letter of intent to: Dr. Robert C. Adams Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Direct inquiries regarding grants management issues to: Mr. Robert Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.398, Cancer Research Manpower. Awards are made under the 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 HHS regulations and PHS grant policies. 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. From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-94-010 - V23(14) 04/08/94 Date: 11 Apr 1994 15:41:00 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 660 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjls$77f@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL94010 HL-94-010 P1O1 *************************************** SPECIALIZED CENTERS OF RESEARCH IN HEMATOPOIETIC STEM CELL BIOLOGY NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA: HL-94-010 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: May 31, 1994 Application Receipt Date: September 15, 1994 PURPOSE The objectives of this program are to advance our knowledge of basic stem cell biology in areas of stem cell isolation, quantitation by in vivo assay, in vitro and in vivo growth and replication, gene insertion, and engraftment. This basic knowledge will be applied clinically to enhance our ability to achieve successful hematopoietic stem cell therapy to cure both genetic and acquired diseases and to perform successful gene therapy using the hematopoietic stem cell as the target for gene transfection and for life-long expression of normal genes. 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 of Research (SCOR) in Hematopoietic Stem Cell Biology, is related to the priority areas of maternal and infant health, and cancer. Potential applicants may obtain a copy of "Healthy People 2000," (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-01) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic institutions, public and private, such as universities, colleges, hospitals, and laboratories. This RFA is intended to support SCOR grants for basic and clinical investigations. Therefore, applications that include only basic or only clinical research will not be responsive to this announcement. In addition, clinical research projects focused on large epidemiologic studies or large clinical trials will be considered unresponsive to this RFA. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. Women and minority investigators are encouraged to apply. 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 program. A minimum time commitment of 25 percent is expected for this individual. The Principal Investigator must also be the project leader of one of the component research projects. If, through peer review, this project is not recommended for further consideration, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. MECHANISM OF SUPPORT This RFA will use the National Heart, Lung, and Blood Institute (NHLBI) SCOR (P50) grant to support this research program. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. Each SCOR grant application and award must include research involving human patients/subjects. Support may be provided for human biomedical and behavioral studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders, or conditions. Small population-based studies, where the research can be completed within five years, may also be proposed. In addition, basic research projects must be included that relate to the clinical focus. A SCOR may also contain one or more core units that support the research projects. 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 the proposed research. If so, a letter of agreement from the GCRC program director/principal investigator could be included with the application. Duration of SCOR Programs Each NHLBI SCOR program is limited to 10 years of support. Exceptions to this policy will be made only if a thorough evaluation of needs and opportunities, conducted by a committee composed of non-federal experts, determines that there are extraordinarily important reasons to continue a specific SCOR program. Thus, under this policy, a given SCOR grant is awarded for a five-year project period following an open competition. Only one five-year competing renewal is permitted, for a total of 10 years of support, unless the SCOR program is recommended for extension. The NHLBI comprehensive evaluation of the HEMATOPOIETIC STEM CELL BIOLOGY SCOR program will be conducted during the second project period according to the following timetable: Program Announced FY 1994 Project Period (First Competition) FY 1996 to FY 2000 Program Reannounced FY 1999 Project Period (Second Competition) FY 2001 to FY 2005 Letter to SCOR Directors FY 2002 (midway through regarding SCOR evaluation plans year 02 of 2nd project period) SCOR Evaluation Meeting FY 2003 (late in year 02 of 2nd project period) Notification of SCOR Directors FY 2003 (midway through of NHLBI Decision year 03 of 2nd project period) Number of Applications The NHLBI does not limit the number of SCOR applications in a given SCOR program from one institution provided there is a different SCOR principal investigator for each application and each application is self-contained and independent of the other(s). This does not preclude cooperation planned or possible among participants of SCORs after awards are made. Scientific overlap among applications will not be accepted. If more than one application is envisioned from an institution, the institution is encouraged to discuss its plans with the NHLBI SCOR Program Administrator. FUNDS AVAILABLE Applicants may request up to $1,125,000 in direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year requested in the application. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that at least two SCOR grants will be funded. NHLBI's FY 1996 plans for this initiative include a maximum of $4.4 million. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Equipment is included in the budget limitation. However, requests for expensive special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requires in-depth justification. Final decisions will depend on the nature of the justification and the Institute's fiscal situation. Consortium Arrangements If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such activities may be included in a SCOR grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact Ms. Jane Davis, Grants Operations Branch, NHLBI, 301-594-7436. Applicants of SCOR grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside of the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. RESEARCH OBJECTIVES Background The production of blood cells, or hematopoiesis, takes place in the bone marrow. Hematopoiesis begins with the most primitive, pluripotent hematopoietic stem cell, which has a frequency of less than one per 10,000 nucleated bone marrow cells. The stem cell can either replicate and remain a stem cell or differentiate into myeloid or lymphoid stem cells, which in turn can further proliferate and mature, ultimately giving rise to all the circulating blood cells. Each of these complex hematopoietic pathways is under the influence of one or more hematopoietic growth factors or other cytokines that enhance cellular proliferation and maturation, as well as inhibitory activities that prevent proliferation. These activities are generated and act within the marrow microenvironment. Currently, allogeneic bone marrow transplants are recognized as a treatment of choice for chronic myelogenous leukemia, acute leukemias failing initial treatment, aplastic anemia, and several lethal disorders of the immune system and hematopoiesis. Allogeneic bone marrow transplantation has become increasingly used as a cure for a variety of genetic defects of the hematopoietic and immune systems, and for lipid storage diseases. Genetic diseases that have been successfully cured by bone marrow transplantation include Cooley's anemia, sickle cell anemia, severe combined immunodeficiency, Wiskott-Aldrich syndrome, Fanconi anemia, Blackfan-Diamond anemia, ataxia telangiectasia, infantile agranulocytosis, Chediak-Higashi disease, chronic mucocutaneous candidiasis, mucopolysaccharidosis, cartilage-hair hypoplasia, Gaucher's and other lipid storage diseases. Some of these diseases, such as Cooley's anemia (beta-thalassemia) and sickle cell anemia, are major worldwide public health problems. Others are devastating orphan diseases that are extremely costly to treat. Collectively, these genetic diseases occur in tens-of-thousands of births per year. It is also recognized that several malignant disorders are sensitive to agents that have, as their dose-limiting toxicity, myelo-ablation. This knowledge, along with the initial success of marrow and peripheral blood-derived autografts administered after myelo-ablative therapy, has clearly defined the rationale for the use of hematopoietic stem and progenitor cells in the treatment of several non-hematopoietic malignancies, including breast cancer, which occurs with alarming frequency. At present, over 5,000 HLA-matched marrow allografts are performed annually. Only about 35 percent of transplant candidates have a suitably matched sibling marrow donor. However, the development of a national registry of volunteer marrow donors (National Marrow Donor Program) and improvements in histocompatibility testing have provided the alternative of marrow transplants from unrelated donors. About 40 percent of patients who activate or formalize their searches for an unrelated donor are now able to be transplanted. Hence, about 60 percent of patients with transplantable disorders are able to get a transplant. The significant cost of the procedure, which could be as much as $200,000 not including the possible long-term care for chronic graft-versus-host disease, may preclude many from benefiting from this form of treatment. Recent Advances in Basic Science Over the past five years, research into the biology of hematopoiesis in animal models and in man have led to significant advances in the phenotypic and functional characterization of stem cells. We have recently seen improvements in stem cell purification and in vitro expansion (1,2). These observations have increased our appreciation of the complexity of the genetic and cellular events required for homing, engraftment, growth, and development of stem cells within an allogeneic or autologous microenvironment. The advent of new molecular technology that allows analysis of gene expression in small numbers of cells makes it possible finally to address molecular events associated with stem cell function. A multitude of cloned and purified hematopoietic growth factors and cytokines are now available to facilitate stem cell research. In most cases, receptors for these activities have also been cloned, and studies are underway to define intracellular signaling pathways. Additionally, interacting accessory cells have been identified that, in concert with cytokines, may regulate or promote stem cell growth, self-renewal, and differentiation. Progress in the ability to define and isolate functional subsets of these marrow stromal cells provides an opportunity to control regulatory events in the marrow. Advances in these areas have served to spark an interest in the application of modern cellular and molecular biological techniques to the study of stem cells. Many of these areas are now ready for investigation. Gene Therapy Progress in the gene therapy area may no longer be impeded for lack of purified populations of stem cells, which are the ideal target for gene transfer. They can be easily obtained, manipulated in vitro, reinfused into a patient, and are capable of repopulating the bone marrow. Theoretically, if appropriately manipulated, they will self-renew, differentiate, and express the inserted normal gene for the life of the patient. Precisely how to manipulate the stem cell to achieve efficient gene transfer without compromising the functional potential required for long-term hematopoiesis remains a critical area of research. Nevertheless, the success of whole marrow transplantation for the correction of several genetic disorders has focused attention on the hematopoietic stem cell as a target for gene therapy for the correction of several genetic disorders of hematopoiesis and metabolism. While encouraging results have already been achieved with infusions of genetically modified autologous lymphocytes for the correction of immune function in children with ADA-deficient SCID, there remain major obstacles to the achievement of efficient, stable, and long-term genetic correction of marrow stem and progenitor cells and their mature progeny. Nevertheless, these early results signal the potential of this approach for correction of a variety of genetic disorders, such as thalassemia, Fanconi anemia, Sickle cell anemia, lethal genetic disorders of immunity, and potentially severe autoimmune disorders and diseases of metabolism. Stem Cell Therapy Research in hematopoietic stem and progenitor cells has brought about a new and fascinating therapeutic opportunity. The advances described above should permit more widespread application of stem cell enriched transplants for genetic and acquired diseases in both children and adults. The congenital and acquired marrow failure and dysfunction syndromes may soon be swiftly and completely treated by the infusion of autologous stem cells rendered normal by gene insertion, homologous replacement with the cloned wild-type allele, or the transplantation of foreign normal stem cells rendered compatible by manipulations of surface antigens. This exciting prospect, which will massively reduce the overwhelming cost and inefficient efforts to maintain the lives of afflicted patients, will finally offer a definitive cure for patients with rare disorders of marrow function such as those with Fanconi's Anemia, Wiskott-Aldrich syndrome, and Kostmann syndrome. It will also offer real hope to patients with acquired aplastic anemia and the large numbers of patients with various forms of thalassemia and sickle cell anemia who must now struggle with incomplete therapies. Recent studies indicate that either allogeneic donors or genetically modified autologous marrow stem cell grafts may also be used to correct several disorders in utero, early in the course of embryonal development. In animal models (3) and in humans (4,5) donor fetal liver hematopoietic stem cells can also be transplanted with varying degrees of success into an unrelated pre-immune recipient fetus. These procedures have been performed without tissue matching, without marrow ablation, without immunosuppressive drugs, and without the development of graft-versus-host disease. This suggests that the fetus is both an ideal recipient and donor of hematopoietic stem cells. Other Areas We are now in an excellent position to make significant progress in other areas that are of importance to stem cell therapy. For example, the recent intriguing report (6) of a single cell capable of reconstituting the bone marrow stroma and multilineage hematopoiesis has potential major implications and is in need of extensive investigation. Additional areas include the interaction of stem cells with adhesive proteins in the marrow stroma, the manipulation and enhancement of the stem cell homing receptor (7), and research on alternate sources of hematopoietic stem cells such as fetal liver (3-5), cord blood (8), and peripheral blood (9). The SCOR as a Mechanism for Supporting Stem Cell Biology Research A spectrum of research, ranging from basic molecular and cellular biology through clinical applications of this newly acquired knowledge, is now feasible. Stem cell biology research is ideally suited to a multidisciplinary approach. The collaboration of molecular and cell biologists, hematologists, immunologists, transplantation biologists, and clinicians will not only enhance, but is probably required for, the transfer of landmark advances in basic research into clinical applications. The SCOR mechanism may facilitate the development of skilled multidisciplinary teams. The SCOR mechanism is uniquely designed to support this spectrum of multidisciplinary basic and clinical research in a synergistic fashion such that major therapeutic advances will be realized in the next decade in both gene therapy and stem cell transplantation. Areas to be Addressed by this Initiative include, but are not limited to: o Basic stem and progenitor cell biology, evaluating a variety of sources including marrow, peripheral blood, cord blood, fetal liver, and embryonic stem cells. o Stem cell identification, isolation, purification, and in vitro (ex vivo) expansion. o In vivo and in vitro assay systems for human stem cells. o Manipulation of stem cell self-renewal and commitment. o Role of growth factors, cytokines, receptors, transmembrane signaling, marrow stroma and microenvironment, and adhesive proteins in stem cell interactions and hematopoiesis. o Interaction of stem cells and stromal cells with viruses such as parvovirus, HIV, and CMV. o Stem cell transplantation and expression in animal models. o Histocompatibility and allo-interactions, mechanism of induction of transplant tolerance, minimizing the GVH effect and graft rejection, and maximizing the graft versus leukemia effect. o Enhancing stem cell engraftment through manipulation of stem and progenitor cell homing receptors in the marrow stroma and on stem cell surfaces. o Stem cell therapy to correct genetic diseases and congenital and acquired marrow dysfunction. o Gene therapy using hematopoietic stem cells as targets for gene insertion and long term expression of normal genes, using retroviral vectors, adeno-associated viral vectors, and other sources of gene transduction. The primary focus of the overall SCOR grant application should be on non-malignant hematologic diseases. Biennial Research Meetings Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program and to stimulate collaboration. Applicants should request additional travel funds for a two-day meeting every other year, most likely to be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, 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 May 31, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the principal investigator; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It 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 sent to: Chief, Review Branch Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page 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", enter the title "Specialized Centers of Research in Hematopoietic Stem Cell Biology" and the RFA number HL-94-010 on line 2a of the face page of the application. Send or deliver 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 Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to the Chief, Review Branch at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants (DRG), otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by September 15, 1994. If an application is received after that date, it will be returned to the applicant. 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. 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 by NIH staff for completeness and responsiveness. Incomplete applications or applications deemed not responsive to the RFA will be returned to the applicant without further consideration. Crucial to the initial scientific review will be a triage process that will eliminate all applications that are deemed not scientifically competitive within the goals and criteria of the RFA. Those applications that are complete, responsive, and competitive will be further evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI. The second level of review will be provided by the National Heart, Lung, Blood Advisory Council. Factors to be considered in the evaluation of each application will be similar to those used in review of traditional research grant applications and, in addition, will include overall proposed interactions among basic and clinical research projects. Major factors to be considered in the evaluation of applications include: o Scientific merit of the proposed basic and clinical research projects including significance, importance, and appropriateness of the theme; innovation, originality, and feasibility of the approach; and adequacy of the experimental design. o Leadership, scientific stature, and commitment of the program director; competence of the investigators to accomplish the proposed research goals and their time commitment to the program; and the feasibility and strength of consortium arrangements. o Collaborative interaction among basic and clinical research components, the balance between them, and plans for transfer of potential findings from basic to clinical studies. o Adequacy of the environment for performance of the proposed research including clinical populations and/or specimens; laboratory facilities; proposed instrumentation; quality controls; administrative structure; institutional commitment; and, when needed, data management systems. o Appropriateness of the budget for the proposed program. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balances, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Special supplemental instructions for the preparation of large, multi-project grant applications for the NHLBI can be obtained by contacting the Stem Cell Biology SCOR Program Administrator, as indicated below. Direct inquiries regarding scientific issues to: Alan S. Levine, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5A12 Bethesda, MD 20892 Telephone: (301) 496-5911 FAX: (301) 496-9940 Direct inquiries regarding fiscal and administrative matters to: Ms. Jane Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A15C Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.839, Blood Diseases and Resources. Awards will be made under the 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 requirement of Executive Order 12372 or Health Systems Agency review. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. 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. REFERENCES 1. Spangrude GJ, Heinifeld S, Weissman IL: Purification and characterization of mouse hematopoietic stem cells. Science 240:58, 1988. 2. Brandt J, Srour E, Besien K, Briddell RA, Hoffman R: Cytokine-dependent long term culture of highly purified precursors of hematopoietic progenitor cells from human bone marrow. J. Clin. Invest. 86:932, 1990. 3. Harrison MR, Slotnick RN, Crombleholm TM, et al: In utero transplantation of fetal liver haematopoietic stem cells in monkeys. Lancet 2:1425, 1989. 4. Raudrant D, Touraine JL, Rebaud A: In utero transplantation of stem cells in humans: technical aspects and clinical experience during pregnancy. Bone Marrow Transplantation 9(suppl 1):98, 1992. 5. Touraine JL, Raudrant D, Rebaud A, et al: In utero transplantation of stem cells in humans: immunological aspects and clinical follow-up of patients. Bone Marrow Transplantation 9(suppl 1):121, 1992. 6. Huang S, Terstappen LWMM: Formation of haematopoietic microenvironment and haematopoietic stem cells from single human bone marrow stem cells. Nature 360:745-749, 1992. 7. Tavassoli M, Hardy C: Molecular basis of homing of intravenously transplanted cells to the marrow. Blood 76:1059, 1990. 8. Gluckman E, Broxmeyer HE, Auerbach AD, et al. Hematopoietic reconstitution in a Fanconi's anemia patient by means of umbilical cord blood from an HLA-identical sibling. New Engl J Med 321:1174-1178, 1989. 9. Kessinger A, Armitage JO. The evolving role of autologous peripheral stem cell transplantation following high-dose therapy for malignancies (Editorial). Blood 77:211-212, 1991. From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-014 - V23(14) 04/08/94 Date: 11 Apr 1994 15:40:55 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 397 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjln$775@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94014 CA-94-014 P1O1 *************************************** INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA: CA-94-014 P.T. National Cancer Institute Letter of Intent Receipt Date: August 5, 1994 Application Receipt Date: September 21, 1994 PURPOSE The Cancer Therapy Evaluation Program (CTEP) and the Biological Response Modifiers Program (BRMP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) invites research grant applications for the conduct of therapeutic clinical trials research employing new agents, concepts, or strategies for the treatment of cancer. This initiative is aimed at drawing new clinical investigators into this area of research. HEALTHY PEOPLE 2000 The Public Health Service 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), Investigator Grants for Clinical Cancer Therapy Research, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. An important principle to remember is that the more extensive the prior independent research experiences, regardless of funding sources, the greater likelihood there will be diminished priority for award. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) as its funding mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years. The total direct cost for the four year period may not exceed $500,000. The direct cost in any budget period should not exceed $150,000. The anticipated award date is July 1995. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the continuing availability of funds for this purpose. This RFA is a one-time solicitation for new applications for award in FY 95. However, the NCI has plans to re-issue this RFA for funding in 1996 and 1997. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1,500,000 in total costs per year for four years will be committed to fund specifically applications submitted in response to this RFA. It is anticipated that eight new individual awards will be made. RESEARCH OBJECTIVES Background In the past year, a number of groups have expressed concern over the declining number of clinical investigators entering and remaining in academic research. Clinical investigators are a critical component in translating new therapeutic agents and modalities from the laboratory into the clinic. They must maintain a broad perspective and knowledge concerning clinical and basic sciences, while developing new cancer therapies that are hypothesis driven. They are highly interactive with basic and clinical researchers in related disciplines. This translational clinician is considered distinct from the clinician who also has a PhD or equivalent training and concentrates on basic research or the clinician who participates in cancer research solely by entering patients on clinical trials. The Clinical Investigations Task Force of the National Cancer Advisory Board and a sub-committee of the American Association of Clinical Oncology (ASCO) have both been addressing the problem of the decreasing number of academic clinical investigators. One of the problems identified is the lack of suitable mechanisms for the training and funding of clinical oriented investigators involved in translating basic research into new cancer treatments. There is no specific program available to train the clinical investigators in the design and conduct of clinical trials and translational research. The traditional grants mechanisms (R01, R29) are under-utilized and often do not fit the needs of young clinical investigators for the support of clinical trials research. The R29 grant mechanism requires the investigator to devote at least 50% effort to a five year project and the yearly budget is limited to approximately $70,000. Most clinicians have major clinical and teaching responsibilities and it is impossible to support both the clinical and laboratory components needed within the budget limitations of an R29 grant. New clinical investigators often do not have the publication or research track record to be competitive for R01 grant support. Thus, very few clinical trial research applications are submitted by new clinical investigators. DCT would like to reverse this trend and encourage new clinical investigators in the conduct of translational clinical trials research. Project Description The Cancer Therapy Evaluations Program and the Biological Response Modifiers Program encourage qualified clinical investigators to develop R01 grant applications for the conduct of cancer clinical trials research on new therapeutic agents and modalities. Grant applications must include clinical trials involving human subjects and designed to ultimately improve cancer survival. The clinical trials must have a strong rationale and be based upon preclinical data generated by the applicant or others that support the underlying hypotheses. New clinical therapeutic trials employing drugs (including differentiating agents), biologics (including cytokines, antibodies), vaccine strategies, radiation, or surgery whether used as a single agent/modality or in combination are appropriate. Investigators are urged especially to address the more difficult therapeutic challenges, including the most common malignancies (e.g., breast, ovarian, prostate). Laboratory studies to monitor patients or to study the mechanism of antitumor effect and resistance should be included. The laboratory studies should be in support of the clinical trial, such that their conduct leads to a greater understanding of the relationship of the therapy and biological changes in the patient or the mechanism of action of an anti-tumor response. Laboratory studies would include pharmacokinetic studies of cytotoxic, immune-modulating, differentiation-inducing, and/or targeted therapeutic agents or relevant pharmacodynamic correlative studies. Measurement of particular biological responses would also be desirable particularly when this information would be relevant to the interpretation of the success or failure of the therapy in individual patients on the clinical trial. It is expected that a significant level of effort, at least 25 percent, will be committed to the research project by the Principle Investigator. 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. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 20, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigator may obtain copies from these sources or from the program staff or contact person listed below. Program staff amy also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 5, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is be sent to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 APPLICATION PROCEDURES The research grant application form PHS 398, (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI program staff listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Applications must be received by September 21, 1994. If an application is received after that date, it will be returned. 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. B. Application Requirements The application must include the following documentation to be considered for review: o A draft of the clinical protocol must be included in the Appendix. Documentation of the status of Human Subjects and IRB approval should be included. o Documentation for the composition of the proposed study population in terms of gender and racial/ethnic group together with a rationale for its choice must be included in the Human Subjects section. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and for responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will 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 may be triaged by an NCI peer review group on the basis of relative competitiveness. The NCI will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated, using the review criteria stated below, for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies using the following review criteria: 1. Importance, timeliness, and clinical merit of the clinical trials. 2. Quality of data supporting the proposed clinical trial. 3. Scientific and technical merit of the proposed laboratory studies. 4. Relevance of the proposed laboratory studies to the clinical trials. 5. Research training and clinical qualifications of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research. 6. Availability of the resources necessary to perform research. 7. Evidence that appropriate steps have been taken to insure the protection of human subjects. 8. Evidence that the applicant is in compliance with NIH policies regarding the inclusion of women and minorities in clinical research study populations (STUDY POPULATIONS section of this RFA). The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. AWARD CRITERIA Applications considered by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) availability of funds; and (c) programmatic priorities. Preference will also be given to clinical investigators who are new to this research area. Letter of Intent Receipt Date: August 5, 1994 Application Receipt Date: September 21, 1994 Review by National Cancer Advisory Board: May 1995 Anticipated Award Date: July 1995 INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged. The program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding general programmatic issues to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Direct inquiries regarding programmatic issues using biologics to: Dr. Toby Hecht Division of Cancer Treatment National Cancer Institute FCRF 1052, Room 253 Bethesda, MD 20892 Telephone: (301) 846-1098 FAX: (301) 846-5429 Direct inquiries regarding fiscal matters to: Ms. Eileen M. Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 256 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) and administered under HHS grants policies. 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. From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-94-019 - V23(14) 04/08/94 Date: 11 Apr 1994 15:40:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 382 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjlj$76s@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD94019 HD-94-019 P1O1 *************************************** IN VIVO ACTIVITIES OF LACTOFERRIN NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA: HD-94-019 P.T. National Institute of Child Health and Human Development Application Receipt Date: July 19, 1994 PURPOSE The Endocrinology, Nutrition and Growth (ENG) Branch of the Center for Research for Mothers and Children, National Institute of Child Health and Human Development (NICHD) issues this Request for Applications (RFA) for support of investigations of in vivo activities of lactoferrin in human beings and animals. Lactoferrin is a 78,000-dalton metal-binding single-chain glycoprotein found in milk and other exocrine secretions. It is the major protein component of human colostral whey, with concentrations as high as 6 mg/ml. Since the human lactoferrin gene has been cloned, overexpression and large scale lactoferrin production are now possible. A great deal of structural information has been obtained about the lactoferrin molecule. It has been possible to relate this structural information to two striking in vitro properties of lactoferrin, its ability to bind a wide variety of metal ions with extremely high affinity, and its ability to bind to a number of different types of cells. Lactoferrin also has bacteriostatic properties in vitro, which have been thought to derive from its powerful sequestration of iron; but a small bacteriostatic peptide obtained from lactoferrin digestion is remote from the iron binding site in the intact molecule. Lactoferrin from mother's milk can be absorbed to some extent by the nursing infant and excreted in the infant's urine, but no reproducible published evidence has established any in vivo activity of lactoferrin. Nevertheless, there is an international trend toward the addition of lactoferrin to infant formula. Spiking of formula is already being done in Japan, and there is interest in doing so in Europe and the U.S. European formula manufacturers have produced a transgenic bull which carries the gene for human lactoferrin. This animal is being used to sire daughters and granddaughters who are expected to produce human milk containing human lactoferrin. The plan is to use this milk to manufacture infant formula. It is important to derive hypotheses about biological function from the extensive structural knowledge about the lactoferrin molecule and test them in vivo. This is needed in order to plan testing of the utility and advisability of feeding lactoferrin-containing formula to infants. The impending addition of lactoferrin to all infant formula may make future definitive trials seem unethical or impractical. 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, In Vivo Activities of Lactoferrin, is related to the priority area of childhood nutrition. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS 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. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Applications in response to this RFA will be funded through the research project grant (R01) and FIRST Award (R29) program of the NIH. This RFA is for a single competition with the application receipt deadline of July 19, 1994. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed by a Division of Research Grants (DRG) study section. However, if the NICHD determines that there is a sufficient continuing program need, the NICHD may announce a request for competitive continuation applications. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest anticipated award date is April 1, 1995. FUNDS AVAILABLE It is anticipated that three or more grants will be awarded under this program, contingent upon receipt of a sufficient number of meritorious applications and the availability of funds. To fund these awards the NICHD has set aside $750,000 for direct costs in the first year. RESEARCH OBJECTIVES Background Lactoferrin has been the focus of attention in numerous investigations of the nutrition and host defense of term and preterm infants, but no physiological role for it has been established. Since the human lactoferrin gene has now been cloned, overexpression and large scale production are imminent. Thus, there is increased urgency for the characterization of lactoferrin function. Three striking in vitro properties of lactoferrin may be of importance to its biological function: its ability to bind and release a wide variety of metal ions, especially ferric iron (Fe), its ability to bind cations, and its binding to a number of different types of cells. In milk, as in other secretions, lactoferrin is mostly iron-free, with a saturation level of about 8 to 10 percent. In iron-free form it has pronounced bacteriostatic properties in vitro, probably dependent on its ability to bind adventitious iron extremely tightly, so depriving bacteria of iron essential for growth. The bacteriostatic properties of human milk are thought to derive largely from the high concentrations of lactoferrin present. In addition, sequestration of iron by lactoferrin inhibits iron-catalyzed free radical damage to cells. For these reasons, and because of its widespread occurrence in an frequent association with species such as lysozyme and immunoglobulins, lactoferrin is regarded as a component of the body's defense mechanisms. Lactoferrin is also a component of neutrophil secretory granules. The lactoferrin molecules of different tissues and secretions appear to be identical in structure and function, and the cDNA sequence of leukocyte lactoferrin matches the amino acid sequence of milk lactoferrin. Lactoferrin is a member of the transferrin family of iron binding proteins, which includes serum transferrin, ovotransferrin, and the membrane-associated melanotransferrin. Lactoferrin also bears a striking relationship to a sulfate-binding protein of Salmonella typhimurium. Lactoferrin has the capacity to bind reversibly two Fe ions concomitantly with two carbonate (C03=) or bicarbonate (HC03-) anions. Three features of metal binding by lactoferrin are particularly remarkable: the synergistic relationship between cation and anion binding, the extremely tight binding of iron, and the existence of mechanisms for the release of tightly-bound iron. Other metals can be substituted for iron in the two specific sites; those of similar size and charge (Ga, A1, Cr, Mn, Co) bind with affinities close to that of Fe, but even much larger cations such as lanthanides and some actinides (Th, Pu) can be accommodated. Likewise, although CO3= is the anion of highest affinity, other anions with a carboxylate group, some quite bulky, can be substituted for it. The two lactoferrin structural cavities in which Fe and the anion are bound seem much larger than necessary for this function. To some this has suggested that lactoferrin may function to bind anionic toxins and xenobiotics. All the Mn in human milk is bound to lactoferrin, and lactoferrin has been suggested to have a role in Zn binding and heavy metal absorption. The physiological importance of transferrin in A1 binding and its proposed therapeutic use in detoxification may also apply to lactoferrin. The ability of lactoferrin to bind to a variety of normal and leukemic blood cells has led to a suggestion that the lactoferrin released by neutrophilic leukocytes plays a role in modulating the immune and inflammatory responses. Lactoferrin promotes the aggregation of neutrophils and their adhesion to epithelial cells, and may be the agent that causes neutrophils to accumulate at inflammatory sites. Lactoferrin in its iron- saturated form is a highly active inhibitor of myelopoiesis, leading to the suggestion that lactoferrin might be useful in the treatment of leukemia. Other observations that focus on the ability of lactoferrin to interact with cells include its activity as an essential growth factor for lymphocyte cell lines, its partial sequence homology with a group of lymphoma transforming proteins, its interference in the receptor-mediated uptake of chylomicron remnants into the liver, and the observation that some antibacterial activities of lactoferrin depend on actual contact with bacteria rather than simple sequestration of iron. Scope The purpose of this RFA is to solicit applications for in vivo studies of effects of lactoferrin in human beings or animals. The goal is to learn of the significance of human lactoferrin in human milk to human infants or nursing women, but it is understood that some kinds of direct experiments in humans are not advisable without promising preclinical studies. Animal model studies are therefore also of interest provided they involve species-specific lactoferrin or the use of heterologous lactoferrin that can be shown to mimic homologous lactoferrin in adherence to receptors or effects on cells in vitro. A focus on effects of lactoferrin that apply to milk rather than other external secretions is preferred. The scope of this RFA, therefore, includes animal and human studies of the biological effects of lactoferrin. It does not include in vitro bacterial or tissue culture investigations. It is recognized that some preliminary experiments in vitro may be required for certain in vivo projects. Nevertheless, the priority for funding of each application will be determined by reviewers on the basis of the relative merit of the in vivo studies proposed, and the likelihood that the research will proceed to the whole animal or human level within the terms of the recommended award. Funded applications that fail to demonstrate progress towards this stage may be phased out before the recommended term of the award is completed. The decision of the ENG Branch not to solicit applications for in vitro studies of lactoferrin is not a result of any perception that such studies are not important. However, work of this kind is being conducted widely; progress in the chemistry and cell biology of the compound has been striking; and productive studies of lactoferrin structure are being funded by the NICHD and others. Studies of direct relevance to infant nutrition are much more difficult to execute, however, and are likely to be more speculative and uncertain of success. Meritorious applications of that type have been rare. The Branch therefore seeks to encourage investigators to venture appropriate proposals by setting aside funds for biological studies in vivo. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of an application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box checked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Building, Room 5E01 Bethesda, MD 20892 Applications must be received by July 19, 1994. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, that has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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 Applications will be reviewed by NICHD staff for responsiveness to the RFA. Applications judged to be nonresponsive will be returned. The applicant may resubmit the application and have it assigned for review in the same manner as unsolicited grant applications. Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. The NIH will withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be competitive will be further evaluated for scientific/technical merit by a review group convened solely for this purpose by the Division of Scientific Review, NICHD. Criteria for the initial review will include the significance and originality of research goals and approaches; the feasibility of research and adequacy of the experimental design; the research experience and competence of the investigator(s) to conduct the proposed work; the adequacy of investigator effort devoted to the project; and the appropriateness of the project duration and cost relative to the work proposed. Following review by the Initial Review Group, applications will be evaluated by the National Advisory Child Health and Human Development Council for program relevance and policy issues before awards for meritorious proposals are made. AWARD CRITERIA The anticipated award date is April 1, 1995. Scientific merit and technical proficiency, based on the demonstrated and projected capabilities described in the application will be the predominant criteria for determining funding priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions for potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Ephraim Y. Levin, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Building, Room 4B11 Bethesda, MD 20892 Telephone: (301) 496-5593 Direct inquiries regarding fiscal matters to: Mr. E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 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 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. From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-94-053 - V23(14) 04/08/94 Date: 11 Apr 1994 15:40:29 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 597 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjkt$758@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR94053 PAR-94-053 P1O1 ************************************* MINORITY DISSERTATION RESEARCH GRANTS IN MENTAL HEALTH NIH GUIDE, Volume 23, Number 14, April 8, 1994 PA NUMBER: PAR-94-053 P.T. National Institute of Mental Health PURPOSE The purpose of this program announcement is to stimulate and encourage minority doctoral candidates to pursue research careers in any area relevant to mental health and/or mental disorders. A dissertation represents the most extensive research experience formulated and carried out by doctoral candidates, with the advice and guidance of mentors. Dissertation research involves a major investment of the doctoral student's time, energy, and interest and its substance is often the basis for launching a research career. The usual mechanisms used for the support of doctoral dissertation research have not attracted significant numbers of minority students. The intent of the dissertation research grants is to attract larger numbers of minority students as mental health investigators and to assist in providing a positive and constructive research experience that will stimulate them to pursue research careers in this field. 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, Minority Dissertation Research Grants 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 Healthy People 2000 (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY The applicant investigator applying for a dissertation research grant must be enrolled in an accredited doctoral degree program in the behavioral, biomedical, or social sciences and must have approval of the dissertation proposal by a named committee. A student applying for a Minority Dissertation Research Grant in Mental Health must be an individual from a minority group who is conducting or intends to conduct dissertation research on any problem related to mental health or mental disorder. Research topics should fit within one or more of the areas described in the Attachment to this program announcement, which is available from program staff listed under INQUIRIES. Minority groups qualifying for support under this program announcement include African Americans, Hispanic Americans, American Indians, Alaskan Natives, and Asian and Pacific Islanders. The applicant must be a registered doctoral candidate in resident or nonresident status. All requirements for the doctoral degree other than the dissertation (and for students requiring it, the clinical internship) must be completed by the time of the award. This information, and the approval of the dissertation topic by a named committee, must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see APPLICATION PROCEDURES). The applicant institution administering the grant on behalf of the proposed applicant must be domestic. Applications may be submitted by any public or private non-profit university, college, or professional school. The doctoral candidate must be a citizen or noncitizen national of the United States or hold a permanent residence visa. Academic institutions are encouraged to facilitate application from qualified doctoral candidates. MECHANISM OF SUPPORT The mechanism of support is the National Institutes of Health (NIH) small grant (R03). Grants to support dissertation research will provide no more than $25,000 per year in direct costs. Awards will depend on the availability of funds. FUNDS AVAILABLE Availability of funds is determined by annual congressional appropriations. The NIMH anticipates funding up to 25 minority dissertation research grants with a total program cost of $675,000 per year, including indirect costs. APPLICATION PROCEDURES The application is to be submitted on the grant application form PHS 398 (rev. 9/91), available from university offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The special instructions described below and in the application kit must be followed. "PAR-94-053, Minority Dissertation Research Grants in Mental Health" must appear under item 2a of the face page. The narrative portion of the application that describes the research plan of the dissertation (see pp. 20-22 of form PHS 398, items 1-4) may not exceed 10 pages of text in standard-size type. This does not include material on human subjects, vertebrate animals, consultants/collaborators, consortium/contractual arrangements, or literature cited. The information in the required narrative project description must be presented in a form suitable for detailed scientific and technical review. Applications exceeding the 10-page length for the research plan will be returned without review. Scope of Awards Applicant investigators may request support for the amount of time necessary to complete the dissertation. A dissertation research grant usually is awarded for a period of 12 months, but may be extended without additional funds for up to 24 months. Investigators who need additional time to complete the research project will be required to submit a request for an extension of the grant beyond the first 12 months. An extension may be awarded if satisfactory progress is being made, but no supplemental NIMH funds will be available. Allowable Costs Expenses usually allowed under PHS research grants will be covered by the NIMH dissertation research grant but may not exceed $25,000 in direct costs for the project. An application that exceeds this amount will be returned. Allowable costs include the investigator's salary (not to exceed $14,000 for 12 months full-time effort) and direct research project expenses such as data processing, payments to subjects, supplies, and dissertation costs (e.g., printing and binding of the dissertation). Travel funds up to $750 may be requested to attend one scientific meeting; additional travel costs in connection with research at a remote performance site must be fully justified. No tuition, alterations/renovations, contracting costs, or space rental are allowed on dissertation research grants. Small equipment items may be requested if special justification is provided for them. Indirect costs are limited to eight percent of requested direct costs, less equipment. Level of Effort Any level of effort that is less than full time (40 hours per week) must be fully justified, and the investigator's salary must be prorated accordingly. Human Subjects/Vertebrate Animals If human subjects and/or vertebrate animals will be involved in the research, evidence of the required institutional review must be given on the face page of the application. Furthermore, the instructions on pp. 22-23 of the application kit must be followed. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 9, 1994 (FR 59 11146- 11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Concurrent Support An applicant who receives support for dissertation research under a grant from the NIMH may not at the same time receive support under a predoctoral training grant or fellowship grant awarded by any Federal agency, nor be supported under any other research project grant. Letter of Certification A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. The letter must (a) fully identify the members of the dissertation committee and certify their approval of the dissertation proposal; (b) certify that all requirements for the doctoral degree, except the dissertation and, if necessary, the clinical internship, are completed or will be completed by the time the grant award starts; (c) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without NIMH support; (d) certify that the institution's facilities and general environment are adequate to conduct the proposed research; and (e) indicate the minority group of the doctoral candidate to establish the eligibility of the applicant for support under this program. Additional Material A transcript of the applicant's graduate school record should be included with the application. The Biographical Sketch Section of the Form PHS 398 (Form Page 6) must contain a scientific autobiography. Applicants must provide a statement of career goals, including reference to their interest in the specific area of mental health/mental disorders research, and a description of their intended career trajectory. The mentor's biographical data should not exceed two pages. The mentor should also include material on other support (Form Page 7) indicating active research support. Applications must be submitted for the receipt dates of April 11, August 10, or December 13. Applications received late will be returned to the applicant. An application that does not conform to the instructions, including the special instructions provided below, will be returned. The applicant must submit the original and five copies of the completed application, which includes a detailed narrative project description (not to exceed 10 pages) and letter of certification (also an original and five copies) to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Minority Dissertation Research Grant Additional Instructions Applications for dissertation research grants must follow the instructions contained in the application for PHS grant form PHS 398 (rev. 9/91), except as noted in this program announcement and in these special instructions. I. General a. Applications will be accepted on April 11, August 10, or December 13. It is the intent to announce funding decisions to the applicant no more than four months after the deadline. b. A letter of certification from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. An example of the letter of certification is shown at the end of this program announcement. The applicant should provide the names of the dissertation committee and their university affiliations. c. Applications found ineligible for consideration under the Dissertation Research Grant program will be returned to the applicant. II. Specific Instructions - Face Page Item Number 2a. Response to Specific Program Announcement: Check "YES" and enter "PAR 94-053 Minority Dissertation Research Grants in Mental Health." 2b. Type of Grant Program: Enter "R03". 3a. Principal Investigator: Designate by name the doctoral candidate who is to be directly involved in carrying out the proposed research. The doctoral candidate must be listed as principal investigator. 3d. Position Title: Enter "Doctoral Candidate." 3f. Department, Service Laboratory or Equivalent: Enter the name of the department or program in which the principal investigator is a candidate for a doctoral degree. 6. Dates of Entire Proposed Project Period: Most applicants are expected to propose a total project period of 12 months for the research project and its support. A grant may be extended without additional funds if more than a year is required, but the entire project period of the grant must not exceed 24 months. If an extension beyond 12 months is desired, the principal investigator must submit a report of progress no later than 10 months after the effective date of the award. An extension of the grant, without additional funds, may be provided if there is evidence of acceptable progress. 9. Performance Sites: Indicate where project will be conducted. If more than one performance site, list all of them. 10. Inventions: Enter N.A. 11-16. Follow the instruction sheet for PHS-398. 17. Principal Investigator/Program Director Assurance: The applicant must sign here. 18. Certification and Acceptance: The official signing for the applicant organization must sign here. III. Specific Instructions - Detailed Budget for Initial Budget Period. Follow the Instruction Sheet for PHS-398, pages 16 through 19. Allowable costs include the candidate's salary, not to exceed $14,000 for 12 months full-time effort; direct research project expenses, such as data processing, supplies, payments to subjects, and dissertation costs (e.g., printing and binding). Travel to one scientific meeting (requesting up to $750) is allowable; additional travel costs in connection with research at a remote performance site must be fully justified. This research may not be supported at the same time under any other research grant. Any level of effort less than full time for the candidate must be fully justified and the candidate's salary prorated accordingly. Permanent equipment, tuition, alterations/ renovations, contracting costs, and space rental are not allowed on dissertation research grants. Small equipment items require special justification. The applicant must provide detailed justification for each budget item requested. IV. Specific Instructions - Research Plan The principal investigator must provide a narrative project description that contains a detailed scientific and technical discussion of the following specific points. This must not exceed 10 pages (Item "E" addressing human subjects and Item "F" regarding vertebrate animals must be filled out if human subjects and/or vertebrate animals are to be involved.) Address the following points rather than those shown in the PHS-398 instructions: a. A description of the research project and what it is intended to accomplish; the relevance of the project to mental health/mental disorders b. A summary of related published research that addresses the identified problem(s) c. The questions to be answered or the hypotheses to be tested by the project d. The methodological procedures to be followed and, whenever applicable, information on such matters as sampling procedures, including the size and composition of the population to be studied and the size and composition of the sample and control groups, as well as a description of the types and sources of data to be gathered, methodological problems to be encountered, specific statistical analyses to be made, and steps that will be taken to protect human subjects or research animals as appropriate e. The management of the project, including a schedule of the main steps of the proposed investigation f. The facilities and resources that will be available in the project. REVIEW CONSIDERATIONS Dissertation research grants are competitive. These applications will be reviewed initially by non-Federal experts, and a second level of review will be conducted by senior NIMH staff members. Reviewers will be selected on the basis of their knowledge and accomplishments in research pertinent to the applications and their experience in research training and career development. An abbreviated summary statement will be provided for applications not recommended for further consideration. All elements of the application will be considered in the review process. Reviewers will take into account the applicant's stage of development and the importance of the dissertation as a learning experience that is part of the applicant's graduate education. Emphasis will be given to the scientific merit, feasibility, and relevance of the project to the mental health/mental disorders areas specified in the attachment to this announcement. The qualifications of the candidate will also be emphasized in the review. It is the intent to provide review results and announce funding decisions within four months after the receipt date. Review criteria, funding decisions, and continuation of support are described below. Review Criteria Review criteria include significance of problem; scientific quality of the proposal; relationship of proposed research to expanding the knowledge base in mental health areas mentioned in the Attachment to this program announcement (available from program listed under INQUIRIES); research design and research methods; personal qualifications of the candidate; supervision of the candidate; institutional facilities and support structure; and appropriateness of budget. Problem Significance o The project is focused primarily on a significant problem in mental health/mental disorders. o The potential generalizability, heuristic value, or usefulness of the results is considered. Research Design and Methods o The problem to be addressed by the research is clearly defined. o The proposal reflects an excellent grasp of scientific principles and adequate knowledge of other research related to the problem. o Questions to be answered or hypotheses to be tested are well formulated and clearly stated. o Research methodology is fully described including, where applicable, explanation of scientifically appropriate sampling procedures, description of control and experimental groups, description of types and sources of data to be gathered, discussion of methodological problems expected to be encountered, and description of specific analyses to be performed. o The proposal adequately describes the plans for managing the project, including a tentative schedule for the main steps of the investigation within the project period requested. o The proposal adequately plans to include women and minorities as subjects in research, if applicable. o The proposal adequately plans for the protection of human subjects and/or care of animals, if applicable. Qualifications of the Applicant and Support Structure o The applicant shows promise as a research investigator in areas relevant to the proposal. o The experience and training of the applicant are sufficient to carry out the research. o The proposed research project is consistent with the long-term research interests of the applicant. o Faculty advice, support, and necessary supervision are available and suitable. o The available facilities and organizational arrangements are appropriate to the research. Budget o The allocation of time and money reflects an understanding of the research tasks to be accomplished and of the problems likely to arise. AWARD CRITERIA Final funding decisions are based on the recommendations of the reviewers, the relevance of the project to NIMH program support areas, program balance, and the availability of appropriated funds. Continuation of Support Without Additional Funds Awardees who have been funded for 12 months of a project requiring up to 24 months must submit a progress report 10 months after the award begins accompanied by a letter singed by the principal investigator, the mentor, and an institutional business official requesting an extension of the grant beyond 12 months without additional funds. The total amount awarded cannot exceed $25,000 in total direct costs. Direct research project costs and/or salary not spent in the first year of the award can be used during the second year, if an extension is approved, but the candidate's salary may not exceed $14,000 per year. Grant Terms and Conditions o Work on the funded project must be initiated within 3 months after the date of the award. o The NIMH Grants Management Branch must be informed if there is a change of mentor. A biographical sketch and material on the new mentor's research support should be provided. o Dissertation Research Grants are not transferable to another applicant institution. o The dissertation constitutes the final report of the grant. As a part of the closeout process, two copies of the dissertation must be submitted to the NIMH within 90 days of the termination of the grant. The dissertation must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation, and it must be signed by the responsible official. o Awards will be administered in accordance with the Public Health Service Policy Statement (Rev. October 1, 1990). INQUIRIES Potential applicants are strongly encouraged to contact NIMH staff regarding current program priorities before applying for a grant. Persons applying for a Minority Dissertation Research Grant should request and carefully read the Attachment to this program announcement describing the programs in the three research divisions of NIMH and in the NIMH Office of AIDS. Inquiries may be directed to the program office relevant to your dissertation research topic: Stanley F. Schneider, Ph.D. Division of Neuroscience and Behavioral Science Room 11-103 Telephone: (301) 443-4347 FAX: (301) 443-4822 Harry E. Gwirtsman, M.D. Division of Clinical and Treatment Research Room 18C-26 Telephone: (301) 443-3264 FAX: (301) 443-6000 Kenneth Lutterman, Ph.D. Division of Epidemiology and Services Research Room 10-95 Telephone: (301) 443-3373 FAX: (301) 443-4045 Leonard Mitnick, Ph.D. Office of AIDS Room 10-75 Telephone: (301) 443-6100 FAX: (301) 443-9719 INTERNET: LMITNICK@AOAMH2.SSW.DHHS.GOV Inquiries related to fiscal matters or grants management issues may be directed to: Diana S. Trunnell Grants Management Branch Room 7C-08 Telephone: (301) 443-3065 The street address for the program staff listed above is: National Institute of Mental Health 5600 Fishers Lane Rockville, MD 20857 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under the authorization of the Public Health Services Act, Title IV, Part A, Public Law 78-410, as amended, and administered under PHS grants policies and regulations 42 CFR 52 and 45 CFR 74. Under the authority of Section 301 of the Public Health Service Act, P.L. 78-410, as amended, and subject to the availability of funds, the National Institute of Mental Health (NIMH) will accept applications under the receipt dates listed herein. Titles 45 CFR 52 and 45 CFR 74 are applicable to these awards. 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. SAMPLE: LETTER OF CERTIFICATION FROM UNIVERSITY OFFICIAL OR FACULTY ADVISORY COMMITTEE HEAD To Whom It May Concern: This letter is in reference to the Minority Dissertation Research Grant application submitted to NIMH by ------------------------------------------------------ for the ---------------------------- deadline. As the University official responsible for supervising the subject dissertation research, I and the University certify the following: a) The members of the applicant's dissertation committee are b) The project proposal has been approved by the applicant's faculty advisory committee (or approval is imminent and will occur before any possible NIMH funding; no significant changes in the proposed project are anticipated upon arrival). c) All requirements for the doctoral degree except the dissertation (and, where required, the clinical internship) are completed or will have been completed by the doctoral candidate before the time of the grant award. d) I, the faculty advisory committee, and the University expect the doctoral candidate to proceed with the approved project proposal with or without NIMH support. e) The facilities and general environment of the institution are adequate to conduct the proposed research. f) The doctoral candidate, a member of the minority group, is eligible for support under this program as defined under the eligibility requirements of this announcement. g) The doctoral candidate is a citizen or noncitizen national of the United States, or holds a permanent residence visa. From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 14, pt. 2of2, 8 April 1994 Date: 11 Apr 1994 15:40:23 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1140 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjkn$74v@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940408 V23N14 P2O2 ************************************ SPECIALIZED CENTERS OF RESEARCH IN HEMATOPOIETIC STEM CELL BIOLOGY NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA AVAILABLE: HL-94-010 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: May 31, 1994 Application Receipt Date: September 15, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The objectives of this program are to advance our knowledge of basic stem cell biology in areas of stem cell isolation, quantitation by in vivo assay, in vitro and in vivo growth and replication, gene insertion, and engraftment. This basic knowledge will be applied clinically to enhance our ability to achieve successful hematopoietic stem cell therapy to cure both genetic and acquired diseases and to perform successful gene therapy using the hematopoietic stem cell as the target for gene transfection and for life-long expression of normal genes. 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, Specialized Centers of Research (SCOR) in Hematopoietic Stem Cell Biology, is related to the priority areas of maternal and infant health, and cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-01) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic institutions, public and private, such as universities, colleges, hospitals, and laboratories. This RFA is intended to support SCOR grants for basic and clinical investigations. Therefore, applications that include only basic or only clinical research will not be responsive to this RFA. In addition, clinical research projects focused on large epidemiologic studies or large clinical trials will be considered unresponsive to this RFA. Awards will not be made to foreign institutions; however, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Heart, Lung, and Blood Institute (NHLBI) SCOR (P50) grant to support this research program. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. FUNDS AVAILABLE Applicants may request up to $1,125,000 in direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year requested in the application. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that at least two SCOR grants will be funded. NHLBI's FY 1996 plans for this initiative include a maximum of $4.4 million. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. RESEARCH OBJECTIVES Background The production of blood cells, or hematopoiesis, takes place in the bone marrow. Hematopoiesis begins with the most primitive, pluripotent hematopoietic stem cell, which has a frequency of less than one per 10,000 nucleated bone marrow cells. The stem cell can either replicate and remain a stem cell or differentiate into myeloid or lymphoid stem cells, which in turn can further proliferate and mature, ultimately giving rise to all the circulating blood cells. Each of these complex hematopoietic pathways is under the influence of one or more hematopoietic growth factors or other cytokines that enhance cellular proliferation and maturation, as well as inhibitory activities which prevent proliferation. These activities are generated and act within the marrow microenvironment. Currently, allogeneic bone marrow transplants are recognized as a treatment of choice for chronic myelogenous leukemia, acute leukemias failing initial treatment, aplastic anemia, and several lethal disorders of the immune system and of hematopoiesis. Allogeneic bone marrow transplantation has become increasingly used as a cure for a variety of genetic defects of the hematopoietic and immune systems, and for lipid storage diseases. Genetic diseases that have been successfully cured by bone marrow transplantation include Cooley's anemia, sickle cell anemia, severe combined immunodeficiency, Wiskott-Aldrich syndrome, Fanconi anemia, Blackfan-Diamond anemia, ataxia telangiectasia, infantile agranulocytosis, Chediak-Higashi disease, chronic mucocutaneous candidiasis, mucopolysaccharidosis, cartilage-hair hypoplasia, Gaucher's and other lipid storage diseases. Some of these diseases, such as Cooley's anemia (beta- thalassemia) and sickle cell anemia, are major worldwide public health problems. Others are devastating orphan diseases that are extremely costly to treat. Collectively, these genetic diseases occur in tens-of-thousands of births per year. It is also recognized that several malignant disorders are sensitive to agents that have, as their dose-limiting toxicity, myelo-ablation. This knowledge, along with the initial success of marrow and peripheral blood-derived autografts administered after myelo-ablative therapy, have clearly defined the rationale for the use of hematopoietic stem and progenitor cells in the treatment of several non-hematopoietic malignancies, including breast cancer, which occurs with alarming frequency. At present, over 5,000 HLA-matched marrow allografts are performed annually. Only about 35 percent of transplant candidates have a suitably matched sibling marrow donor. However, the development of a national registry of volunteer marrow donors (National Marrow Donor Program) and improvements in histocompatibility testing have provided the alternative of marrow transplants from unrelated donors. About 40 percent of patients who activate or formalize their searches for an unrelated donor are now able to be transplanted. Hence, about 60 percent of patients with transplantable disorders are able to get a transplant. The significant cost of the procedure, which could be as much as $200,000 not including the possible long-term care for chronic graft-versus-host disease, may preclude many from benefiting from this form of treatment. Proposed Research The proposed research should advance our knowledge of basic stem cell biology. This new knowledge should then be applied clinically to enhance our ability to (1) achieve successful hematopoietic stem cell therapy to cure both genetic and acquired diseases and/or (2) perform successful gene therapy using the hematopoietic stem cell as the target for gene transfection and for life-long expression of normal genes. The primary focus of the overall SCOR grant application should be on non-malignant hematologic diseases. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by May 31, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the principal investigator; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It 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 sent to: Chief, Review Branch Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Applications must be received by September 15, 1994. REVIEW CONSIDERATIONS Applications will be judged on the basis of the scientific and technical merit of the proposed research; the qualifications and research experience of the investigators; the collaborative interaction among basic and clinical research components; the adequacy of the environment; and the appropriateness of the budget. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Alan S. Levine, Ph.D. Division of Blood Diseases and Resources National Heart, Lung and Blood Institute Federal Building, Room 5A12 Bethesda, MD 20892 Telephone: (301) 496-5911 FAX: (301) 496-9940 Direct inquiries regarding fiscal and administrative matters to: Ms. Jane Davis Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 4A15C Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.839, Blood Diseases and Resources. Awards will be made under the 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 requirement of Executive Order 12372 or Health Systems Agency review. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. $$R9 END ************************************************************ $$R10 BEGIN CA-94-014 FULL-TEXT ************************************* INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA AVAILABLE: CA-94-014 P.T. National Cancer Institute Letter of Intent Receipt Date: August 5, 1994 Application Receipt Date: September 21, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Cancer Therapy Evaluation Program (CTEP) and the Biological Response Modifiers Program (BRMP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) invites research grant applications (R01) for the conduct of therapeutic clinical trials research employing new agents, concepts, or strategies for the treatment of cancer. This initiative is aimed at drawing new clinical investigators into this area of 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, Investigator Grants for Clinical Cancer Therapy Research, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. An important principle to remember is that the more extensive the prior independent research experiences, regardless of funding sources, the greater likelihood there will be diminished priority for award. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) as its funding mechanism. The total project period for applications submitted in response to the present RFA may not exceed four years. The total direct cost for the four year period may not exceed $500,000. The direct cost in any budget period should not exceed $150,000. The anticipated award date is July 1995. This RFA is a one-time solicitation for new applications for award in FY 95. However, the NCI has plans to re-issue this RFA for funding in 1996 and 1997. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1,500,000 in total costs per year for four years will be committed to fund specifically applications submitted in response to this RFA. It is anticipated that eight new individual awards will be made. 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. RESEARCH OBJECTIVES The goal of this initiative is to provide a suitable mechanism for the training and funding of clinically oriented physician investigators, especially those involved in translating basic research into new cancer treatments. Qualified clinical investigators are encouraged to develop R01 grant applications for the conduct of cancer clinical trials research on new therapeutic agents and modalities. Grant applications must include clinical trials involving human subjects and designed to ultimately improve cancer survival. The clinical trials must have a strong rationale and be based upon preclinical data generated by the applicant or others that support the underlying hypotheses. New clinical therapeutic trials employing drugs (including differentiating agents), biologics (including cytokines, antibodies), vaccine strategies, radiation, or surgery whether used as a single agent/modality or in combination are appropriate. Investigators are urged especially to address the more difficult therapeutic challenges, including the most common malignancies (e.g., breast, ovarian, prostate). Laboratory studies to monitor patients or to study the mechanism of antitumor effect and resistance should be included. The laboratory studies should be in support of the clinical trial, such that their conduct leads to a greater understanding of the relationship of the therapy and biological changes in the patient or the mechanism of action of an anti-tumor response. Laboratory studies would include pharmacokinetic studies of cytotoxic, immune-modulating, differentiation-inducing, and/or targeted therapeutic agents or relevant pharmacodynamic correlative studies. Measurement of particular biological responses would also be desirable particularly when this information would be relevant to the interpretation of the success or failure of the therapy in individual patients on the clinical trial. It is expected that a significant level of effort, at least 25 percent, will be committed to the research project by the Principle Investigator. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research". See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by August 5, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. This letter of intent is not required, is not binding, and does not enter into the review of subsequent applications. It is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is be sent to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 APPLICATION PROCEDURES Applications must be received by September 21, 1994. If an application is received after that date, it will be returned. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI program staff listed under INQUIRIES. The application must include the following documentation to be considered for review: o A draft of the clinical protocol must be included in the Appendix. Documentation of the status of Human Subjects and IRB approval should be included. o Documentation for the composition of the proposed study population in terms of gender and racial/ethnic group together with a rationale for its choice must be included in the Human Subjects section. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and for responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will 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. Questions concerning the responsiveness of proposed research to the RFA are to be directed to program staff listed under INQUIRIES. AWARD CRITERIA Applications considered by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) availability of funds; and (c) programmatic priorities. Preference will also be given to clinical investigators who are new to this research area. The anticipated date of award is July 1995. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic to: Dr. Toby Hecht Division of Cancer Treatment National Cancer Institute FCRF 1052, Room 253 Bethesda, MD 20892 Telephone: (301) 846-1098 FAX: (301) 846-5429 Direct inquiries regarding fiscal matters to: Ms. Eileen M. Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 256 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) and administered under HHS grants policies. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R10 END *********************************************************** ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PAR-94-053 FULL-TEXT ************************************* MINORITY DISSERTATION RESEARCH GRANTS IN MENTAL HEALTH NIH GUIDE, Volume 23, Number 14, April 8, 1994 PAR AVAILABLE: PAR-94-053 P.T. National Institute of Mental Health Application Receipt Dates: April 11, August 10, December 13 THIS IS A NOTICE OF AVAILABILITY OF A PROGRAM ANNOUNCEMENT (PA); IT IS ONLY AN ABSTRACT OF THE PA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE PROGRAM ANNOUNCEMENT, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE PA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The purpose of this program announcement (PA) is to stimulate and encourage minority doctoral candidates to pursue research careers in any area relevant to mental health and/or mental disorders. The intent of the dissertation research grants is to attract larger numbers of minority students as mental health investigators and to assist in providing a positive and constructive research experience that will stimulate them to pursue research careers in this field. 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, Minority Dissertation Research Grants 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY The applicant investigator applying for a dissertation research grant must be enrolled in an accredited doctoral degree program in the behavioral, biomedical, or social sciences and must have approval of the dissertation proposal by a named committee. A student applying for a Minority Dissertation Research Grant in Mental Health must be an individual from a minority group who is conducting or intends to conduct dissertation research on any problem related to mental health or mental disorder. Research topics must fit within one or more of the areas described in the Attachment to the PA, which is available from program staff listed under INQUIRIES. Minority groups qualifying for support under this program announcement include Black Americans, Hispanic Americans, American Indians, Alaskan Natives, and Asian and Pacific Islanders. The applicant must be a registered doctoral candidate in resident or nonresident status. All requirements for the doctoral degree other than the dissertation (and for students requiring it, the clinical internship) must be completed by the time of the award. This information and the approval of the dissertation topic by a named committee must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see Application Procedures). The applicant institution administering the grant on behalf of the proposed applicant must be domestic. Applications may be submitted by any public or private non-profit university, college, or professional school. The doctoral candidate must be a citizen or noncitizen national of the United States or hold a permanent residence visa. Academic institutions are encouraged to facilitate application from qualified doctoral candidates. MECHANISM OF SUPPORT The mechanism of support is the National Institutes of Health (NIH) small grant (R03). Grants to support dissertation research will provide no more than $25,000 in direct costs. Awards will depend on the availability of funds. RESEARCH OBJECTIVES Research objectives of the Minority Research Dissertation Grants in Mental Health include, but are not limited to, studies in the basic, clinical, and services research areas pertinent to mental health and mental disorders. In the basic neurosciences and behavioral sciences, studies are supported in molecular and cellular neuroscience, neurobiology, and in the biological aspects of behavior; in psychopharmacology and neuropharmacology; in cognitive and language processes; in the regulation and maintenance of behavior; in personality, emotion, and psychosocial and family processes and factors influencing neural, behavioral, psychological and sociocultural development. Studies of the biological, psychological, and psychosocial aspects of stress, including post-traumatic stress, are supported, as is research in behavioral medicine, psycho- and neuroimmunology, neurovirology, and Acquired Immunodeficiency Syndrome (AIDS). Studies of the epidemiology, etiology, diagnosis, treatment, and prevention of distinct mental disorders are supported. Specific clinical research programs emphasize studies in the psychopathology, mental, and behavioral disorders of children, adolescents, and the aging, as well as others devoted to schizophrenia, mood, anxiety, and personality disorders. In services research, studies are supported on service delivery within the mental health system and on the provision of mental health services in other types of health care settings. Studies are supported also on economic factors influencing supply, demand and costs of mental health services. In addition, the NIMH supports research on mental health factors related to antisocial, violent, and abusive behavior, and studies of law and mental health interactions. Scope of Awards Dissertation Research Grants usually are awarded for a period of 12 months but may be extended without additional funds for up to 24 months. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the PA for details. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91), which is available from university offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applications will be accepted for the receipt dates of April 11, August 10, or December 13. Special Instructions Special instructions included in the complete Program Announcement must be followed. The applicant must submit the original and five copies of the completed application, which includes a detailed narrative project description (not to exceed 10 pages) and letter of certification (also an original and five copies) to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS These application will be reviewed initially by non-Federal experts in the review groups of the NIMH, and a second level of review will be conducted by senior NIMH staff members. Reviewers will take into account the applicant's stage of development and the importance of the dissertation project as a learning experience that is part of the applicant's graduate education. Detailed review criteria are in the complete PA. General criteria in the review of these applications include: o The potential significance of the problem to be investigated o The relationship of the proposed research to expanding the knowledge base in area(s) related to mental health and/or mental disorders o The scientific quality of the proposal, including appropriateness of the research design and methodology o Personal qualifications of the candidate and promise as a research investigator in areas relevant to the proposal o Suitability and availability of faculty advice, support, and supervision and of facilities necessary to carry out the research. It is the intent to provide review results and announce funding decisions within 4 months after the submission date. AWARD CRITERIA Final funding decisions are based on recommendations of the reviewers; relevance of the project to NIMH program support areas; program balance; and availability of appropriated funds. INQUIRIES Written and telephone requests for the PA and the opportunity to clarify any issues or questions from potential applicants are welcome. Requests for the PA and attachments, and inquiries regarding programmatic issues may be directed to: Stanley F. Schneider, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-4347 FAX: (301) 443-4822 Inquiries related to fiscal matters or grants management issues may be directed to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A, Public Law 78-410, as amended, and administered under PHS grants policies and regulations 42 CFR 52 and 45 CFR 74. This program is not subject to the intergovernmental requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-94-054 ************************************************ STRATEGIES TO REDUCE HIV SEXUAL RISK PRACTICES OF DRUG USERS NIH GUIDE, Volume 23, Number 14, April 8, 1994 PA NUMBER: PA-94-054 P.T. National Institute on Drug Abuse PURPOSE The purpose of this Program Announcement is to introduce a major research effort to develop and evaluate the efficacy of multi-phase behavioral change interventions designed to reduce high-risk sexual practices among injection drug users (IDUs) and/or crack smokers. It is expected that by implementing strategies in different community settings that are commonly utilized by drug users (e.g., primarily neighborhood settings, but also drug treatment facilities, sexually transmitted disease (STD) clinics, storefronts, etc.) there can be a substantial decrease in the probability of HIV exposure by reducing drug-related sexual risk behaviors. As the AIDS epidemic enters the midyears of the second decade, 339,000 cases of AIDS have been reported to the Centers for Disease Control (CDC) as of September 30, 1993. Of the women infected with the virus via heterosexual intercourse, 60 percent reported their sexual partners to be men who injected drugs. Some of these male injectors were also at risk from sexual contact with other men -- creating a bisexual "bridge" population to women's infection. Additionally, with many women being infected through their own or their sexual partners' drug use, heterosexual transmission of the virus from women to men is now occurring more frequently than originally believed possible. The goal of this research is to gain knowledge about the social and behavioral factors related to sexual risk taking and to develop, implement, and evaluate strategies that reduce sexually and drug related risk behaviors. 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, Strategies to Reduce HIV Sexual Risk Practices of Drug Users, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit, public and private organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Women and minority investigators are encouraged to apply. Applications are encouraged from State and municipal governments with outreach units and/or State and municipal governments collaborating with university-based research units. MECHANISM OF SUPPORT This program announcement will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award. In addition, the Interactive Research Project Grant (IRPG) program encourages the coordinated submission of related research project grants and, to a limited extent, FIRST (R29) awards may be used (see PA-93-078, NIH Guide, Vol. 22, No. 16. April 23, 1993). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant(s). Support will be provided for a period of up to five years (renewable for subsequent periods) for R01s, subject to continued availability of funds and progress achieved. FIRST (R29) awards must be for five years. Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will vary also. R29 awards are capped at $350,000 over a five-year period. RESEARCH OBJECTIVES Summary Since initiating its Cooperative Agreement (U01) for AIDS Community-Based Outreach/Intervention Research Program in 1990, the National Institute on Drug Abuse (NIDA) has been monitoring the HIV/AIDS epidemic in a population of out-of-treatment drug users across the country. Concurrently, other high-risk populations (including drug users) across the country have been monitored by the CDC. Behavioral change interventions are still the most promising prevention strategies available. All participating sites in NIDA's Cooperative Agreement program are participating in the development, implementation, and assessment of the effectiveness of a variety of community-based outreach intervention strategies to decrease viral transmission among IDUs and users of crack cocaine. The programs at CDC extend these efforts by including other high-risk populations. Since these program began, many changes have occurred in community ecologies of risk (social and biological environments) related to HIV and drug use. A good deal of knowledge has accrued about preventing the spread of HIV through behavior change interventions (e.g., NIDA, 1993a, 1993b, 1993c; CDC, 1992, 1993). The focus of NIDA's behavioral interventions has been to facilitate IDUs to reduce their HIV risk behaviors (i.e., to reduce drug use and to increase use of sterile needles)--for which the interventions appear to have been met with success. There is less understanding about sexual risk taking and success in reducing risky sexual behaviors of injection drug users and crack smokers. For example, preliminary data from NIDA's Cooperative Agreement program (N=6161) show that approximately 75 percent of drug users interviewed reported they were sexually active in the last 30 days, with almost two-thirds reporting no condom use, and 50 percent reporting that they had engaged in more than 11 unprotected sexual acts with more than two partners. Because these practices did not change significantly, the risk of HIV continues to threaten the health and well-being of many drug-using persons and their sexual partners. Findings from NIDA-sponsored and other research programs have demonstrated that a range of risk reduction interventions have been effective in facilitating at-risk injection drug users to enter into treatment, to reduce drug use, not to share needles, and/or to disinfect needles prior to re-using them. There is a compelling need to improve behavior change strategies to promote HIV related risk-reduction behaviors and help drug users who have made positive changes to maintain them and not relapse into greater risk. The challenge is to encourage drug users and their sexual partners to adopt and practice sexual behaviors that reduce their own risks and their partners' risks for acquiring or transmitting HIV infection. It is NIDA's intention to support the development, refinement, and evaluation of innovative interventions which retain a focus on reducing HIV related drug risks but that are particularly aimed at eliminating or reducing high risk sexual behavior in the following high-risk groups: (1) individuals or networks of sexually active male and female heterosexual/bisexual/gay injection drug users (IDUs), crack cocaine users, and/or poly-drug users; and (2) individuals or networks of male and female IDUs, crack cocaine users and poly-drug users who exchange sex for money or drugs for sex. There is a need to improve behavior change strategies, particularly with respect to high-risk sexual practices, to reduce the further spread of HIV. NIDA wishes to expand current research efforts by phasing in and evaluating approaches that focus on reducing drug risks and are aimed at eliminating or reducing high risk sexual behavior. The complexity of sexual and drug-related risks should be acknowledged when developing appropriate interventions; that is, risks related to different drugs and multiple injection and disinfection practices in combination with a range of sexual behaviors including condom use, number of partners, and partners' HIV status. For strategies to be potentially effective and interpretable, they should be guided theoretically and should target sexual risks of drug users and/or their partners or networks of sexual and drug using companions or communities in which sexual behaviors or norms are enacted or maintained. Multiple level, multi-component intervention strategies are encouraged. Program Description It is important to understand the extent to which HIV prevention efforts are needed, already exist, or can be developed and can be effective for sexually active drug users at risk for HIV/AIDS. To this end, NIDA considers epidemiologic, ethnographic, and evaluation perspectives critical aspects of a multi-phase research effort. CDC also supports this approach. Baseline and longitudinal ethnographic, sociobehavioral and/or epidemiologic data are needed to identify and monitor the nature and extent of sexual and/or drug-related risk behaviors and their interactions, as well as the social settings or relationships that affect these behaviors. These data may be qualitative in nature, using ethnographic field observations and/or interviews, or they may derive from survey or other quantitative research. Baseline and longitudinal epidemiologic data are also needed on the serostatus of identifiable subgroups as a function of their risk characteristics. Investigators shall use these epidemiologic and ethnographic data to develop and refine appropriate sexual risk reduction interventions. Finally, controlled evaluation efforts are necessary to assess the effectiveness of prevention projects in eliminating or reducing sexual risk behavior and maintaining risk reduction behavior. Evaluation efforts may also be directed at modeling program effects on HIV serostatus. This program announcement can be viewed as complementing other Program Announcements, i.e., Drug Abuse Aspects of AIDS, PA-93-098; Partner Notification to HIV-Infected Drug Users, PA-93-111; and Research on Needle Hygiene and Needle Exchange Programs (NEP), PA-94-010 in which NIDA and CDC have collaborated. Many previous HIV prevention studies have relied on behavioral change models that focus on the individual to change high-risk behavior or utilize generalized approaches to behavior that is not specific to sexual practices, gender differences, or cultural differences that influence the social context of risk taking. Applicants are encouraged to pay attention to social factors that influence changes in sexual practices and involve not only individual drug users but can also involve couples, groups, or communities in which sexual behaviors or norms are practiced and maintained. Prevention behavior change strategies can include, but need not be limited to: cognitive-behavioral skills training models, community/social norm change models, community mobilization efforts, diffusion of innovation models, and/or social networks approaches. Multidisciplinary perspectives are highly encouraged as is collaboration between researchers, populations at risk, and community-based organizations. Phase I exploratory studies are sought to link macro (community, group, or network) and micro (individual) level factors influencing safer sex practices and reduce exposure to HIV by (1) identifying the nature and antecedents of sexual risk taking and change; (2) developing (or adapting) behavioral and/or social interaction models that are theoretically based and that are specifically designed to change high risk sexual practices (e.g., multiple partners, unprotected sex), antecedent cognitive and social conditions under which unsafe sex occurs (e.g., being high, lacking condoms), or relationship norms that maintain risky practices or affect negotiations over safe sex (e.g., casual versus steady partners, paying versus nonpaying partners); and (3) developing and pilot testing materials, interventions, strategies and methods of locating, engaging and retaining individuals or networks of crack smokers and injection drug users with elevated risk of transmitting HIV through unsafe sexual activities. Interventions must take into account gender, race/ethnicity, sexual orientation, and/or risk behaviors and the social context in which the individual behaviors occur. We anticipate that multiple intervention strategies will be needed to take into account the behavioral heterogeneity among subpopulations at risk for HIV as well as the varying HIV seroprevalence of different communities. Applications should address such issues as gender-based outreach strategies, culturally appropriate HIV prevention strategies, and for behaviorally and socially specific interventions. Phase II implementation and evaluation (quantitative and qualitative) will include interventions developed in Phase I. Evaluation will require research plans that include measurement of project implementation and compliance with protocol, estimates of sample size and periods of data collection, plans for minimizing attrition, strategies for client followup, specification of variables to be analyzed and measures to be used, statistical techniques to be employed, a discussion of the strengths and weaknesses of the analytic strategies, as well as a strategy for component analysis to identify the most and least effective parts of the intervention. In addition to measuring specific behaviors, norms, and other outcomes, the evaluation research must separately analyze intervention effects by specific subgroups who are at risk for HIV and must be sensitive to potential negative effects of the project. The final defining characteristic of Phase II research is the replicability of the selected intervention and the development of mechanisms for its operationalization at other sites. Attention must focus on the process of implementation and impact on the target populations to help us better understand the dynamics of behavior change. It is critical to address methodological restrictions that can limit the contributions of Phase I or Phase II research to understanding HIV prevention. Much information can be gained if the interventions are theoretically grounded, specific behaviors clearly identified and measured, design issues related to sampling, attrition, and followup specifically planned or controlled and intervention strategies are specific to the behaviors targeted for change. It should be noted that the NIDA has developed a valid and reliable questionnaire (Risk Behavior Assessment) that may be modified and used to obtain drug and/or sexual risk information in the proposed study. Attention to using the most advanced strategies (new technologies for identifying, accessing, recruiting hidden populations and for data collection and transfer) are encouraged. As well, CDC has additional questionnaires. If the applicant plans to modify any currently used instrument, s/he should include an explanation of how validity and reliability will be assessed on the revised instrument. Confidential voluntary HIV antibody testing must be made available to all study participants. The NIDA will work closely with each project to ensure the smooth operation of this requirement. PHS Policy requires that every effort be made to inform persons who are tested of their HIV results. Policy also requires that counseling and treatment be provided to all persons testing positive for HIV infection, and that retesting after six months be offered all persons testing negative. Detailed protocols for implementing HIV testing and pre- and post-test counseling have been previously described by NIDA and CDC and will be made available upon request. As noted in this section, NIDA and CDC have collaborated, and will continue to collaborate, in the development and implementation of this program announcement. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151), and reprinted in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard AIDS-related application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone 301-594-7248. The title and number of the program announcement must be typed in Item 2a on the face page of the application. The completed original and five permanent, legible copies of the PHS 398 form must be submitted to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications received under this program announcement will be assigned to an initial review group (IRG) in accordance with established PHS referral guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate National Advisory Council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended for further consideration by the Council may be considered for funding. AWARD CRITERIA Applications recommended for further consideration by an appropriate Advisory Council will be considered for funding on the basis of overall scientific, clinical and technical merit of the application as determined by peer review, program needs and 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. Direct inquiries regarding programmatic issues to: Richard Needle, Ph.D., M.P.H. Community Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-30 Rockville, MD 20857 Telephone: (301) 443-6720 Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301 and administered under PHS policies and Federal Regulations of Title 42 CFR 52 "Grants for Research Projects", Title 45 CFR Part 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects". Title 42 CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient Records" may be applicable to these awards. Title 42 Part 241(d) "Certificates of Confidentiality and Communicable Disease Reporting" will also apply. This program is not subject to the intergovernmental review requirements of Executive Order 12372. References National Institute on Drug Abuse 1993a The Behavioral Counseling Model for Injection Drug Users. Rockville, MD: The National Institute on Drug Abuse. National Institute on Drug Abuse 1993b The Indigenous Leader Outreach Model. Rockville, MD: The National Institute on Drug Abuse. National Institute on Drug Abuse 1993c The NIDA HIV Counseling and Education Intervention Model. Rockville, MD: The National Institute on Drug Abuse. $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 14, pt. 1of2, 8 April 1994 Date: 11 Apr 1994 15:40:16 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1498 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjkg$74k@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940408 V23N14 P1O2 ************************************ X-comment: RFAS described: MH-94-008, CA-94-021, HD-94-019, AA-94-007, DE-94- 004, HL-94-010, CA-94-014, PAR-94-053 NIH GUIDE - Vol. 23, No. 14 - April 8, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NICHD TRANSGENIC MOUSE DEVELOPMENT FACILITY National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX N2 ********************************************************** POLICY STATEMENT REGARDING SITE VISITS BY THE NIDR National Institute of Dental Research INDEX: DENTAL RESEARCH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** EVALUATION OF ISCHEMIC HEART DISEASE IN WOMEN - CLINICAL CENTERS (RFP NHLBI-HC-94-13) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 ********************************************************** PROSPECTIVE STUDY DRUG USE NETWORKS/HIV (RFP N01DA-4-6401) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R3 ********************************************************** CLINICAL SITE MONITORING (RFP NIH-NIAID-DAIDS-95-06) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 06/08/94 ************************************************* SERVICES RESEARCH COMPETITIVE SUPPLEMENTS TO CLINICAL THERAPEUTIC RESEARCH GRANTS (RFA MH-94-008) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R5 06/14/94 ************************************************* CLONING AND SEQUENCING THE BRCA1 GENE (RFA CA-94-021) National Cancer Institute INDEX: CANCER $$INDEX R6 07/19/94 ************************************************* IN VIVO ACTIVITIES OF LACTOFERRIN (RFA HD-94-019) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R7 08/11/94 ************************************************* SMALL GRANTS FOR NEW ALCOHOLISM TREATMENT RESEARCHERS (RFA AA-94-007) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R8 09/12/94 ************************************************* NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL TRAINING APPLICATIONS (RFA DE-94-004) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R9 09/15/94 ************************************************* SPECIALIZED CENTERS OF RESEARCH IN HEMATOPOIETIC STEM CELL BIOLOGY (RFA HL-94-010) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R10 09/21/94 ************************************************ INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH (RFA CA-94-014) National Cancer Institute INDEX: CANCER ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** MINORITY DISSERTATION RESEARCH GRANTS IN MENTAL HEALTH (PAR-94-053) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX P2 ********************************************************** STRATEGIES TO REDUCE HIV SEXUAL RISK PRACTICES OF DRUG USERS (PA-94- 054) National Institute on Drug Abuse INDEX: DRUG ABUSE This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details 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. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NICHD TRANSGENIC MOUSE DEVELOPMENT FACILITY NIH GUIDE, Volume 23, Number 14, April 8, 1994 P.T. National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) Transgenic Mouse Development Facility (NTDF) is a research resource that develops transgenic mice for investigators requiring these services. It was established to provide reliable and affordable transgenic mice primarily to biomedical research grantees. Specifically, the NTDF supports basic biomedical research by providing investigators with the following customized services: o Analyzing constructs for microinjection. o Microinjecting constructs into fertilized one-cell mouse eggs and reimplanting into pseudopregnant recipient females. o Testing potential founders for DNA integration. o Producing at least two integration-positive transgenic mice. o Fast turnaround time (12-14 weeks) Applications for services should be requested from the Director, NTDF. Completed applications may be submitted anytime to the NICHD Project Officer for review. Review is completed within two weeks of receipt. All applications are handled confidentially and those constructs approved are microinjected at the NTDF. The Investigator is charged a non-refundable fee of $500 per construct for initial analysis. An additional fee of $1500 per construct is assessed if two or more integration-positive transgenic mice are produced. The NTDF is supported by a contract award from the National Institute of Child Health and Human Development, NIH. INQUIRIES Direct programmatic inquiries regarding this research resource to: Allan Lock, D.V.M. NTDF Project Officer National Institute of Child Health and Human Development Building 6100, Room 4B01 Bethesda, MD 20892 Telephone: (301) 496-5541 Direct requests for applications and resource inquiries to: Mark Swanson, Ph.D. or Mr. Frederick Huntress NICHD Transgenic Mouse Development Facility 303B College Road East Princeton, NJ 08540 Telephone: (609) 520-0300, Ext. 183 FAX: (609) 520-9864 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** POLICY STATEMENT REGARDING SITE VISITS BY THE NIDR NIH GUIDE, Volume 23, Number 14, April 8, 1994 P.T. National Institute of Dental Research The National Institute of Dental Research (NIDR) announces a modification in review procedures used for program project (P01) applications and other large granting mechanisms such as Phase II Small Business Innovation Research (SBIR) applications (R44). The NIDR will eliminate site visits as a regular feature in the review of these applications. Until further notice P01 and R44 applications will be reviewed by ad hoc groups of subject matter experts by mechanisms other than site visit. The basis for the judgement of scientific merit in most instances will be solely the written application submitted by the applicant. However, in some instances the reviewers may request additional information in writing, by teleconference, or by means of an applicant interview. INQUIRIES Inquiries regarding this policy may be directed to: H. George Hausch, Ph.D. Extramural Programs National Institute of Dental Research Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 594-7632 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NHLBI-HC-94-13 ****************************************** EVALUATION OF ISCHEMIC HEART DISEASE IN WOMEN - CLINICAL CENTERS NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFP AVAILABLE: NHLBI-HC-94-13 P.T. National Heart, Lung, and Blood Institute This announcement revises the issue and response dates, the award date, and the number of anticipated awards for Request for Proposals (RFP) No. NHLBI-HC-94-13 published in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. RFP NHLBI-HC-94-13 is now available and proposals are due on June 30, 1994. Three to five awards are anticipated to be made in March 1995. The National Heart, Lung, and Blood Institute (NHLBI) requires three to five clinical centers to evaluate innovative diagnostic methods that will improve the diagnostic reliability of cardiovascular testing in evaluation of ischemic heart disease in women. Innovative approaches proposed in evaluation of myocardial ischemia should include physiologic or functional measurements such as impaired metabolism, perfusion, or endothelial function as well as assessment of epicardial coronary arteries by angiography. Each clinical center will be fully independent and expected to fulfill all the requirements outlined in this RFP. The clinical centers will evaluate diagnostic methods and perform common study protocols, including angiography, on 100 participants annually for three years. The anticipated period of performance is from March 1, 1994 through February 28, 1999. INQUIRIES For a copy of the RFP send a written request, citing RFP No. NHLBI-HC-94-13, to: Donna J. Neal Contracts Operations Branch National Heart, Lung, and Blood Institute Federal Building, Room 3C16 7550 Wisconsin Avenue Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN N01DA-4-6401 ********************************************* PROSPECTIVE STUDY DRUG USE NETWORKS/HIV NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFP AVAILABLE: N01DA-4-6401 P.T. National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations to conduct research related to HIV risk networks of drug injectors and their sexual and drug use partners. Such analysis will require prospective ethnographic and epidemiologic HIV-related research that includes field observations, interviews, behavioral surveys, and HIV testing in at least two communities. The objectives are to access and study networks of drug injectors and sexual partners whose members are at risk for HIV transmission due to their drug-based and/or sex-based contacts. This research will require university research teams, local health departments, and possibly community agencies to work collaboratively in the planning and implementation of the proposed project. It is estimated that a three-year, cost-reimbursement contract will result from this requirement. The estimated issuance date for RFP No. N01DA-4-6104 is April 7, 1994, and responses are due to be received in the Contracting Office forty-five calendar days thereafter. INQUIRIES Requests for copies of solicitations will be honored if received within 30 calendar days after issuance of the solicitation. Requests received after this period will be filled on a first-come, first-served basis until the supply is exhausted; however, there is no assurance that copies requested after the 30th day will reach the requestor before the due date for receipt of responses. This requirement represents a new effort. All reasonable sources may submit a proposal that will be considered by the Agency. Only written or FAX requests for this RFP will be accepted. Written requests are to be forwarded to: Patricia W. Mummaugh Contracts Management Branch National Institute on Drug Abuse Parklawn Building, Room 10-49 5600 Fishers Lane Rockville, MD 20857 FAX: (301) 443-7595) This announcement does not commit the Government to make an award. $$R2 END ************************************************************ $$R3 BEGIN NIH-NIAID-DAIDS-95-06 ************************************ CLINICAL SITE MONITORING NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFP AVAILABLE: NIH-NIAID-DAIDS-95-06 P.T. National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement to establish and maintain a Clinical Site Monitoring Group for on-site monitoring of the Division of AIDS-sponsored Adult and Pediatric AIDS Clinical Trials Group (ACTG) and the Community Programs for Clinical Research on AIDS (CPCRA) sites. This is a recompetition of an ongoing project awarded under contract N01-AI- 05081 to Pharmaceutical Product Development, Inc. The purpose of this five-year Clinical Site Monitoring Contract is to administer a system for monitoring of DAIDS-funded ACTG and CPCRA sites, and conduct educational and training activities for the site monitors and personnel at the clinical sites. This is an announcement for an anticipated Request for Proposal (RFP). RFP No. NIH-NIAID-DAIDS-95-06 will be issued on or about April 21, 1994 with a closing date tentatively set for June 21, 1994. INQUIRIES To receive a copy of the RFP, provide this office with three self- addressed mailing labels. A short version of the RFP will be provided first, which includes only the Work Statement and the Evaluation Criteria to be used for selection of the awardee. After examining this, a full text version of the RFP must be requested in writing for those offerors interested in responding. FAX requests are acceptable for the full text version only. All proposals from responsible sources will be considered by NIAID. This advertisement does not commit the Government to make an award. No collect calls will be accepted. Requests for the RFP are to be directed in writing to: Phil Hastings Contracts Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-0194 FAX: (301) 402-0972 $$R3 END ************************************************************ $$R4 BEGIN MH-94-008 FULL-TEXT ************************************** SERVICES RESEARCH COMPETITIVE SUPPLEMENTS TO CLINICAL THERAPEUTIC RESEARCH GRANTS NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA AVAILABLE: MH-94-008 P.T. National Institute of Mental Health Letter of Intent Receipt Date: May 8, 1994 Application Receipt Date: June 8, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE Competitive supplements to expand ongoing funded clinical therapeutic research grants into the area of service research will be available. Supplemental grant support is designed to help move mental health treatments more rapidly from the testing of efficacy (i.e., whether the treatment works under controlled conditions in a population with a well-defined mental disorder) into testing of effectiveness (i.e., whether the same treatment works in everyday practice and across settings). 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, Services Research Competitive Supplements to Clinical Therapeutic Research Grants, is related to the priority area of mental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications will only be considered for currently funded grants with at least one year remaining, ending no later than March 30, 1996. Such funding could be supplementary to a competitive renewal grant. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) competitive supplement (S01) mechanism and can supplement the following types of grants: R01, R10, R37, P01, P20, P30, P50. FUNDS AVAILABLE It is anticipated that at least $1,000,000 in direct costs will be made available so that a minimum of seven awards can be made. Each award will have a maximum yearly direct cost amount of $150,000, but not to exceed 40 percent of the annual direct cost of the parent grant. RESEARCH OBJECTIVES Following are examples of the types of clinical services research issues that would benefit from expansion of ongoing clinical therapeutic research grants. o Studies testing the effectiveness of proven mental health treatments when employed in everyday practice and settings (e.g., primary care settings, nursing homes, community mental health centers, outpatient clinics). o Studies testing proven treatments with new populations, such as racial or ethnic minorities, patients with co-occurring mental, substance abuse, or medical conditions. o Studies testing the effectiveness of proven mental health treatments when administered by providers who more fully represent the range and expertise of providers expected to deliver the treatment in everyday practice and settings. o Studies of the delivery of treatment, such as how to provide coordinated treatment and rehabilitation services and select modalities which best match the patient's/client's needs. o Studies that measure an expanded range of outcomes (beyond symptom reduction), such as functional capacity, quality of life, or cost in relation to outcome. o Research on improving accessibility of efficacious treatments for patients/clients in need of such treatments. o Financing and cost issues relating to therapeutic interventions, e.g., cost-effectiveness, cost-benefit, and cost-utility research. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by May 8, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows 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. Robert Prien at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are to use the grant applications form PHS 398 (rev. 9/91). Application kits containing the necessary forms and instructions for regular research grants may be obtained from the offices of sponsored research at most universities, colleges, medical schools, and other major research facilities; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the program office listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title (Services Research Competitive Supplements to Clinical Therapeutic Research Grants) and number (MH-94-008) must be typed on line 2a of the face page of the application form and the YES box must be marked. The signed original and five legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** AWARD CRITERIA Applications received in response to this announcement will compete with others submitted to NIMH for funding. In granting awards, the following criteria are consider: program relevance, quality of application as documented by IRG and Council recommendation, and program balance. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Robert F. Prien, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Direct inquiries regarding grants management issues to: Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 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, a amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants and Federal Regulations 42 CFR, Part 52 "Grants for Research Projects" and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Execute Order 12372. $$R4 END ************************************************************ $$R5 BEGIN CA-94-021 FULL-TEXT ************************************** CLONING AND SEQUENCING THE BRCA1 GENE NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA AVAILABLE: CA-94-021 P.T. National Cancer Institute Application Receipt Date: June 14, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Division of Cancer Biology, Diagnosis and Centers, National Cancer Institute (NCI) invites the submission of research project grant applications for support to clone and sequence the BRCA1 gene. The aim of this RFA is to foster and stimulate collaborations among investigators who can expedite the process of cloning and sequencing the BRCA1 gene. It is expected that the achievement of this goal will lead to new research opportunities for prevention, screening, early detection, and treatment of breast and ovarian cancer, and perhaps other malignancies. 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, Cloning and Sequencing the BRCA1 Gene, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications can be from single or multiple institutions (collaborating institutions, consortia). Foreign institutions may also participate in Laboratory or Clinical Programs through subcontract or consortium arrangements. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) as its funding mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed projects. The total proposed project period for each application submitted in response to this RFA must not exceed two years. Recognizing the complexity of this initiative, it is appropriate to include several specific aims within a single research project application. The total proposed direct costs for the first year may not exceed $1,400,000. This does not include indirect costs on a subcontract that appears as a direct cost by the applicant organization. The anticipated award date is August 15, 1994. The award and level of support depends on receipt of a sufficient number of applications of high scientific merit. 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. This RFA is a one-time solicitation. At this time, the NCI has not determined whether or how this solicitation will be continued beyond the present RFA period. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year will be committed specifically to fund applications submitted in response to this RFA. It is anticipated that at least one award will be made. RESEARCH OBJECTIVES Several families with high frequencies of early-onset breast cancer and ovarian cancer have been linked to a genetic marker, BRCA1, at chromosome 17q21. Mutational change at the BRCA1 locus may be a critical step in the pathway ultimately leading to breast cancer in at least some patients because there is an increased incidence of breast cancer in individuals who inherit mutations at that locus. The same reasoning applies to ovarian cancer. The epidemiologic pattern is compatible with the transmission of a dominant allele of a gene that predisposes women to breast and ovarian cancer. Characterization of DNA from familial breast cancers indicates that allelic loss occurs at the locus called BRCA1 on chromosome 17q21, consistent with the interpretation that this locus contains the functional equivalent of a tumor suppressor gene, the loss of which may lead to the development and maintenance of a neoplastic state. One of several ways to find and isolate the BRCA1 gene would be to determine the complete sequence of the 400-500 kilobase genomic region thought to contain BRCA1 using DNA from persons thought to inherit wild-type or mutant genes, and DNA from breast tumors. Isolation or identification of a gene or genes at chromosome 17q21 could, therefore, be an outcome of profound importance to understanding the etiology of certain cancers in women. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI program staff listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Applications must be received by June 14, 1994. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At 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 Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 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 application will be reviewed in competition for this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the DRG for completeness and for responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will 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 will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged. Direct requests for the RFA and inquiries regarding programmatic issues to: Dr. Cheryl Marks Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 505 Bethesda, MD 20892 Telephone: (301) 496-7028 FAX: (301) 402-1037 Direct inquiries regarding fiscal matters to: Ms. Sara Stone Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 266 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.396, Cancer Biology Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, 42 U.S.C. 241, as amended; Public Law 100-607, 42 USC 285 and 285a) and administered under HHS grants policies. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R5 END ************************************************************ $$R6 BEGIN HD-94-019 FULL-TEXT ************************************** IN VIVO ACTIVITIES OF LACTOFERRIN NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA AVAILABLE: HD-94-019 P.T. National Institute of Child Health and Human Development Application Receipt Date: July 19, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Endocrinology, Nutrition and Growth (ENG) Branch of the Center for Research for Mothers and Children, National Institute of Child Health and Human Development (NICHD) announces the availability of an RFA for support of investigations of in vivo activities of lactoferrin in human beings and animals. Lactoferrin is a 78,000-dalton metal-binding single-chain glycoprotein found in milk and other exocrine secretions. It is the major protein component of human colostral whey, with concentrations as high as 6 mg/ml. Since the human lactoferrin gene has been cloned, overexpression and large scale lactoferrin production are now possible. It is important to derive hypotheses about biological function from the extensive structural knowledge about the lactoferrin molecule and test them in vivo. This is needed in order to plan testing of the utility and advisability of feeding lactoferrin-containing formula to infants. The impending addition of lactoferrin to all infant formula may make future definitive trials seem unethical or impractical. 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, In Vivo Activities of Lactoferrin, is related to the priority area of childhood nutrition. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS 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. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Applications in response to this RFA will be funded through the research project grant (R01) and FIRST Award (R29) program of the NIH. This RFA is for a single competition. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed by a Division of Research Grants (DRG) study section. However, if it is determined that there is a sufficient continuing program need, the NICHD may announce a request for competitive continuation applications. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest anticipated award date is April 1, 1995. FUNDS AVAILABLE It is anticipated that three or more grants will be awarded under this program, contingent upon receipt of a sufficient number of meritorious applications and the availability of funds. To fund these awards, the NICHD has set aside $750,000 for direct costs in the first year. RESEARCH OBJECTIVES Background Three striking in vitro properties of lactoferrin may be of importance to its biological function: its ability to bind and release a wide variety of metal ions, especially ferric iron (Fe), its ability to bind cations, and its binding to a number of different types of cells. In iron-free form it has pronounced bacteriostatic properties in vitro, probably dependent on its ability to bind adventitious iron extremely tightly, so depriving bacteria of iron essential for growth. The bacteriostatic properties of human milk are thought to derive largely from the high concentrations of lactoferrin present. In addition, sequestration of iron by lactoferrin inhibits iron-catalyzed free radical damage to cells. For these reasons, and because of its widespread occurrence in an frequent association with species such as lysozyme and immunoglobulins, lactoferrin is regarded as a component of the body's defense mechanisms. Lactoferrin is also a component of neutrophil secretory granules. Lactoferrin has the capacity to bind reversibly two Fe ions concomitantly with two C03= or other anions. The two lactoferrin structural cavities in which Fe and the anion are bound seem much larger than necessary for this function. To some this has suggested that lactoferrin may function to bind anionic toxins and xenobiotics. All the Mn in human milk is bound to lactoferrin, and lactoferrin has been suggested to have a role in Zn binding and heavy metal absorption. The physiological importance of transferrin in A1 binding may also apply to lactoferrin. The ability of lactoferrin to bind to a variety of normal and leukemic blood cells suggests that the lactoferrin released by neutrophilic leukocytes may play a role in modulating the immune and inflammatory responses. Lactoferrin promotes the aggregation of neutrophils and their adhesion to epithelial cells, and may be the agent that causes neutrophils to accumulate at inflammatory sites. Iron-saturated lactoferrin is a highly active inhibitor of myelopoiesis. Other observations that focus on the ability of lactoferrin to interact with cells include its activity as an essential growth factor for lymphocyte cell lines, its partial sequence homology with a group of lymphoma transforming proteins, its interference in the receptor-mediated uptake of chylomicron remnants into the liver, and the observation that some antibacterial activities of lactoferrin depend on actual contact with bacteria rather than simple sequestration of iron. Scope This RFA solicits applications for in vivo studies of effects of lactoferrin in human beings or animals. The goal is to learn the significance of human milk lactoferrin to human infants or nursing women, but it is understood that some kinds of direct experiments in humans are not advisable without promising preclinical studies. Animal model studies are, therefore, also of interest provided they involve species-specific lactoferrin or the use of heterologous lactoferrin that can be shown to mimic homologous lactoferrin in adherence to receptors or effects on cells in vitro. A focus on effects of lactoferrin that apply to milk rather than other external secretions is preferred. The scope of this RFA, therefore, includes animal and human studies of the biological effects of lactoferrin. It does not include in vitro bacterial or tissue culture investigations. It is recognized that some preliminary experiments in vitro may be required for certain in vivo projects. Nevertheless, the priority for funding each application will be determined by reviewers on the basis of the relative merit of the in vivo studies proposed, and the likelihood that the research will proceed to the whole animal or human level within the terms of the recommended award. Funded applications that fail to demonstrate progress towards this stage may be phased out before the recommended term of the award is completed. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Applications must be received by July 19, 1994. Potential applicants must request the detailed information included in the RFA before preparing an application. REVIEW CONSIDERATIONS Applications will be reviewed by NICHD staff for responsiveness to the RFA. Applications judged to be nonresponsive will be returned. The applicant may resubmit the application and have it assigned for review in the same manner as unsolicited grant applications. Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. The NIH will withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be competitive will be further evaluated for scientific/technical merit by a review group convened solely for this purpose by the Division of Scientific Review, NICHD. Criteria for the initial review are described in the RFA. Following review by the Initial Review Group, applications will be evaluated by the National Advisory Child Health and Human Development Council for program relevance and policy issues before awards for meritorious proposals are made. AWARD CRITERIA The anticipated award date is April 1, 1995. Scientific merit and technical proficiency, based on the demonstrated and projected capabilities described in the application will be the predominant criteria for determining funding priorities. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Ephraim Y. Levin, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Building, Room 4B11 Bethesda, MD 20892 Telephone: (301) 496-5593 Direct inquiries regarding fiscal matters to: Mr. E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 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. $$R6 END ************************************************************ $$R7 BEGIN AA-94-007 FULL-TEXT ************************************** SMALL GRANTS FOR NEW ALCOHOLISM TREATMENT RESEARCHERS NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA AVAILABLE: AA-94-007 P.T. National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: August 11, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking Small Grants applications to stimulate and facilitate the entry of promising new investigators into the field of alcoholism treatment research. This pilot program is designed to provide rapid review and funding decisions for applications. The NIAAA encourages investigators at the beginning of their research careers to submit applications for small-scale research projects (up to $10,000 for direct costs for one year) related to issues surrounding assessment and treatment of alcoholism. 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, Small Grants for New Alcoholism Treatment Researchers, is related to the priority areas of alcohol abuse reduction and alcoholism 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 202-783-3238). ELIGIBILITY Applications may be submitted by public and private non-profit and for-profit organizations such as universities, colleges, hospitals, treatment facilities, research institutions, units of State or local government, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. To be eligible for this award, the proposed Principal Investigator must be at the beginning of her/his research career and be able to secure a meaningful mentoring relationship with a more experienced researcher. Such experience must be in some way relevant to the project, though it need not be specifically in the field of alcoholism treatment. Special target groups for this award include pre-doctoral graduate students, post-doctoral fellows, as well as clinicians now working in the field of alcoholism treatment. Investigators who have received a research project grant (R01), small grant (R03), exploratory/development grant (R21), First Independent Research Support and Transition (FIRST) award (R29), scientist development award for clinicians (K20), or a scientist development award (K21) are not eligible to apply. MECHANISMS OF SUPPORT These awards will use the small grant (R03) mechanism. Support may be requested for up to one year for up to $10,000 for direct costs. These awards are not renewable, but a one-year no cost extension may be requested. The award may not be used for salary support of either the Principal Investigator or mentor, but may be used to support the costs of technicians and for dissertation research. FUNDS AVAILABLE It is estimated that approximately $100,000 will be available for approximately seven to eight grants under this RFA, in FY 1995. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Additional applications may also be funded if their scientific and technical merit warrants it. Although this program is provided for in the financial plans of NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES With competition for NIAAA grant funds increasing, academic careers becoming more dependent on funded grants, and costs associated with preparation of grant applications escalating, investigators face numerous challenges in entering a new research arena. The objective of this RFA is to stimulate and encourage promising new researchers to enter the field of alcoholism treatment research. It is anticipated that the prospects for funding meritorious projects under this RFA will likely be more favorable than is the case with larger award requests. The Treatment Research Branch of the Division of Clinical and Prevention Research supports research on management of alcoholism, alcohol abuse, and alcohol-related disorders, including evaluation of new treatment methods, assessment of effectiveness of various kinds of behavioral and pharmacologic interventions, development of new diagnostic instruments, and elaboration and refinement of assessment/methodologies for research on effectiveness and costs of treatment. The Branch also supports health services research on the organization, financing, delivery, and effectiveness of alcoholism treatment. This award is designed as a rapid mechanism that provides "seed" funds for investigators who have not received research or career development grant funds from NIAAA in the past. It supports primarily: o Pilot projects on treatment issues and outcomes; o Psychometric analyses and instrument development; and o Secondary analyses of existing data sets. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. Applications must be received by August 11, 1994. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. 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 NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or request the applicant to revise and resubmit it as a regular small grant application for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant and institutional official. Those applications judged to be competitive will undergo further scientific merit review in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. Applications may also be reviewed by mail ballot. Review Criteria Criteria to be used in the scientific and technical merit review of Small Grants for New Alcoholism Treatment Researchers applications will include the following: 1. The scientific, technical, health, or medical significance and originality of the proposed research. 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the proposed research. 3. Ability to secure a mentoring relationship with an experienced researcher. 4. The adequacy of the qualifications and relevant research experience of the principal investigator and the principal investigator's mentor. 5. The availability of adequate data, facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 6. The reasonableness of budget estimates for the proposed research. 7. Where applicable, the adequacy of procedures to protect or minimize effects on human subjects and the environment. 8. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Joanne Fertig, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-0635 FAX: (301) 443-8774 Email: JFertig@WILLCO.NIAAA.NIH.GOV Direct inquiries regarding fiscal matters to: Joseph Weeda Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects;" Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R7 END ************************************************************ $$R8 BEGIN DE-94-004 FULL-TEXT ************************************** NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL TRAINING APPLICATIONS NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA AVAILABLE: DE-94-004 P.T. National Institute of Dental Research Letter of Intent Receipt Date: August 10, 1994 Application Receipt Date: September 12, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Dental Research (NIDR) invites new and competing applications proposing National Research Service Award (NRSA) Institutional Research Training Grant (T32) programs in basic biomedical, behavioral and clinical sciences pertaining to oral health research. The primary objective is to develop highly qualified, clinical investigators by supporting postdoctoral training of individuals with a D.D.S., D.M.D., or equivalent degree, who are committed to a career in oral health research. The secondary objective is training of pre- and post-Ph.D. biomedical and behavioral scientists in oral health research. Programs must be relevant to the goals of the NIDR. There is a need to increase the number of clinical investigators in order to take advantage of opportunities for transfer of fundamental knowledge to improve oral health care of the public. To address this need, applications must allocate not less than two postdoctoral positions to trainees with a declared interest in training to conduct patient-oriented or patient-related research. The remaining positions may be allocated to basic or clinical research training, in the array of biomedical and behavioral research areas pertaining to the NIDR's mission. 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, NRSA - Institutional Training Applications, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public, and private institutions such as dental schools and dental research institutions. Only one application may be submitted by an institution unless the training programs are in distinctly different areas of oral health research. Training is to be provided at one or more of the following levels: (1) dentists pursuing postdoctoral clinical research training; (2) dentists pursuing a Ph.D. or equivalent degree in basic biomedical or behavioral science; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree holders pursuing postdoctoral research training although, generally, they are expected to apply for an individual postdoctoral NRSA fellowship (F32). Postdoctoral trainees who have received, as of the beginning of an appointment, a D.D.S., D.M.D., or equivalent dental degree from an accredited domestic or foreign institution must be given preference. Predoctoral trainees must have received a baccalaureate degree as of the beginning of the appointment and be enrolled in a graduate program leading to the award of a Ph.D. or an equivalent degree in biomedical or behavioral oral health research. Trainees must be citizens or noncitizen nationals of the United States, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551). MECHANISM OF SUPPORT Awards resulting from this RFA will be the National Institutes of Health (NIH), NRSA Institutional Research Training Grants (T32). 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. Trainees may receive up to five years of NRSA support at the predoctoral level and three years of support at the postdoctoral level. The anticipated award date is July 1, 1995. FUNDS AVAILABLE In response to this RFA, the NIDR expects to make up to three new or competing awards, each with six postdoctoral positions over the five-year period, with two appointments in each of the first, second and third years. Three predoctoral positions may be requested over the five year period. The estimated total funding for the first year of support is $240,000. LETTER OF INTENT Prospective applicants are asked to submit, by August 10, 1994, a letter of intent that includes a descriptive title of the proposed research training program, the name, address, and telephone number of the program director, 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 is helpful in planning for the review of applications. It allows NIDR staff to estimate the potential review workload and to avoid conflicts of interest in the review. The letter of intent is to be sent to Dr. Thomas Valega at the address listed under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Valega early in the planning phase of application preparation. This will help ensure that applications are responsive to the RFA. Applications are to be submitted on form PHS 398 (rev. 9/91). Application forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the program staff listed under INQUIRIES. REVIEW CONSIDERATIONS Applications may be subjected to triage by the NIDR Special Grants Review Committee, a standing NIH initial review group, to determine their merit, relative to others received in response to the RFA. Applications judged to be competitive will be evaluated for scientific and technical merit by the review committee. The following factors will be considered in the review: The training program objectives, design and direction; the training environment; the program director; mentors; training record; recruitment and retention of appointees: and instruction on scientific integrity. Secondary review will be by the National Advisory Dental Research Council. The NIDR will notify the applicant of the Council's action shortly after its meeting. AWARD CRITERIA The earliest award date is July 1, 1995. Funding decisions will be based on the Special Grant Review Committee's and Council's recommendations; the need for research personnel in particular program areas, including the need to train clinical investigators; and the availability of funds. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Thomas M. Valega, Ph.D. Extramural Program National Institute of Dental Research Westwood Building, Room 503 Bethesda, MD 20892 Telephone: (301) 594-7617 FAX: (301) 594-7616 Direct inquiries regarding fiscal matters to: Theresa Ringler Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R8 END ************************************************************ $$R9 BEGIN HL-94-010 FULL-TEXT ************************************** From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 10 April 1994 Date: 11 Apr 1994 15:20:32 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 148 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocifg$6c0@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: Undergradueate Course and Curriculum Development Awards in FY 1993 File size (bytes): 39343 STIS Filename: nsf9443 Document Type: International Document Title: INT9403 Japan's Polar Research File size (bytes): 10954 STIS Filename: int9403 Also available: int9403.doc Document Type: News Title: Tip 40328 File size (bytes): 5126 STIS Filename: tip40328 Document Type: Press Release Title: NSF-FUNDED COMPUTER SIMULATION REVEALS ALZHEIMER'S - GLAUCOMA ENZYME File size (bytes): 3740 STIS Filename: pr94-18 Title: TOOTH OF LARGE FOSSIL MAMMAL DISCOVERED IN MADAGASCAR BY NSF-FUNDED SCIENTIST File size (bytes): 3693 STIS Filename: pr94-19 Title: HIGH-ABILITY COLLEGE STUDENTS OFFERED NSF GRADUATE RESEARCH FELLOWSHIPS. File size (bytes): 4648 STIS Filename: pr94-20 Title: OUTSTANDING SCIENCE STUDENTS AWARDED NSF MINORITY GRADUATE FELLOWSHIPS File size (bytes): 4788 STIS Filename: pr94-21 Title: DIVERSION OF RIVERS COULD CAUSE CLIMAT CHANGE IN DELTA AREA ECOSYSTEMS, PREDICTS NSF-FUNDED RESEARCHER File size (bytes): 4731 STIS Filename: pr94-22 Title: SCIENTISTS TO GET 'INDEPTH' LOOK AT CRUST BENEATH THE HIMALAYA-TIBET PLATEAU File size (bytes): 7419 STIS Filename: pr94-23 Document Type: Program Guideline Title: NSF 94-61 National Challenge Groups 1994 File size (bytes): 27774 STIS Filename: nsf9461a Title: NSF 94-61 National Challenge Groups 1994 File size (bytes): 27775 STIS Filename: nsf9461b Title: NSF 94-61 National Challenge Groups 1994 File size (bytes): 27774 STIS Filename: nsf9461c Document Type: Recruit Title: Mathematical Statistician (Program Director) File size (bytes): 4946 STIS Filename: vex9419 Document Type: SRS Report Title: NSF 93-309 -- Acandemic Science and Engineering- Graduate Enrollment and Support Fall -1991 File size (bytes): 37512 STIS Filename: nsf93309 Also available: nsf93309.zip ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 6503 STIS Filename: cmpublic Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 32059 STIS Filename: sesvac Document Type: SRS Data Brief Title: DB 93-324 Academic R&D Spending Increased in FY 1992 File size (bytes): 6035 STIS Filename: db93324 Also available: db93324.ps ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve db93324, the text of your message should be as follows: get db93324 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve db93324, you would enter: ftp> get db93324 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-94-004 - V23(14) 04/08/94 Date: 11 Apr 1994 15:40:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 536 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjlf$76g@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DE94004 DE-94-004 P1O1 *************************************** NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL TRAINING APPLICATIONS NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA: DE-94-004 P.T. National Institute of Dental Research Letter of Intent Receipt Date: August 10, 1994 Application Receipt Date: September 12, 1994 PURPOSE The National Institute of Dental Research (NIDR) invites new and competing applications proposing National Research Service Award (NRSA) Institutional Research Training Grant (T32) programs in basic biomedical, behavioral and clinical sciences pertaining to oral health research. The primary objective is to develop highly qualified, clinical investigators by supporting postdoctoral training of individuals with a D.D.S., D.M.D., or equivalent degree, who are committed to a career in oral health research. The secondary objective is training of pre- and post-Ph.D. biomedical and behavioral scientists in oral health research. Several advisory groups have called attention to the need to expand the pool of clinical investigators in order to take advantage of opportunities for transfer of fundamental knowledge to improve oral health care of the public. For this purpose, the term clinical research is defined as research in which patients serve as the research subjects, and is often referred to as patient-oriented or patient-related research. It includes characterization of normal and diseased human function, evaluation of new diagnostic and therapeutic techniques and devices, patient compliance and disease prevention regimens, drug trials, assessment of various health care practices by various population subgroups and epidemiological studies. In order to address this need, applications must allocate not less than two postdoctoral positions to trainees with a declared interest in receiving training to conduct this type of clinical research. The remaining positions may be allocated to basic or clinical research training, in the array of biomedical and behavioral research areas pertaining to the NIDR's mission. Programs must be relevant to the goals of the NIDR including: research on the causes, epidemiology, prevention, diagnosis and treatment of dental caries, periodontal and soft tissue diseases, oral cancer, oral manifestations of AIDS, and craniofacial anomalies; orofacial pain; temporomandibular disorders; structure and function of teeth, jaws, oral mucosa, bone, connective tissue, salivary glands; behavioral, social, economic and cultural factors related to oral diseases and disorders; biomaterials; fluoride and nutrition; and research on older Americans, gender differences, minorities, those with medical problems and handicaps, and individuals and groups at high-risk for oral health problems. 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), NRSA - Institutional Training Applications, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public, and private institutions such as dental schools and dental research institutions. Only one application may be submitted by an institution unless the training programs are in distinctly different areas of oral health research. Levels of Training and Trainee Eligibility Training is to be provided at one or more of the following levels: (1) dentists pursuing postdoctoral clinical research training; (2) dentists pursuing a Ph.D. or equivalent degree in basic biomedical or behavioral science; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree holders pursuing postdoctoral research training although, generally, they are expected to apply for an individual postdoctoral NRSA fellowship (F32). Postdoctoral trainees who have received, as of the beginning of an appointment, a D.D.S., D.M.D., or equivalent dental degree from an accredited domestic or foreign institution, must be given preference. If the degree has not yet been conferred, a statement, by an authorized official of the degree-granting institution, that all degree requirements have been met is acceptable. Predoctoral trainees must have received a baccalaureate degree as of the beginning of the appointment and be enrolled in a graduate program leading to the award of a Ph.D. or an equivalent degree in biomedical or behavioral oral health research. Individuals who wish to interrupt their dental school studies for one or more years to engage in full-time research training before completing their professional degrees are eligible; however, prior approval by the NIDR, as well as by the institution, is required before an appointment can be offered. Trainees must be citizens or noncitizen nationals of the United States, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551). Noncitizen nationals, although not citizens of the United States, owe permanent allegiance to the U.S. They are generally born in lands which are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT Awards resulting from this RFA will be the National Institutes of Health (NIH), NRSA Institutional Research Training Grants (T32). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years. Awards may be renewable upon submission of a successful competing application, depending on programmatic needs and the availability of funds. The anticipated award date is July 1, 1995. Trainees may receive up to five years of NRSA support at the predoctoral level and three years of support at the postdoctoral level, including any combination of support from institutional training awards and individual fellowship awards. Extensions beyond these periods require a waiver from the NIH. Dentists requiring additional time to complete training as a participant in a Ph.D. program may anticipate favorable consideration of a waiver request, contingent upon certification of the recipient's good academic standing. It is expected that postdoctoral trainees with Ph.D., D.D.S., or equivalent degrees will engage in not less than two years training. FUNDS AVAILABLE In response to this RFA, the NIDR expects to make up to three new or competing awards, each with two postdoctoral positions, in the first year. The estimated total funding for the first year of support is $240,000. This level of support is dependent on the receipt of a sufficient number of applications of high scientific and educational merit. Although this program is provided for in the financial plans of the NIDR, awards pursuant to this RFA are contingent upon the availability of funds. RESEARCH OBJECTIVES The training program must provide opportunities for individuals to carry out supervised biomedical or behavioral oral health research and develop research skills. Clinical programs must have strong relationships with basic scientists to ensure trainees the opportunity to acquire the necessary foundation for independent research. The training program director will be responsible for the selection and appointment of trainees and for the overall direction of the program. Applicants must request six postdoctoral positions over the five-year period, with two appointments in each of the first, second and third years. Applicants must allocate not less than two postdoctoral positions to trainees interested in receiving training to conduct the type of clinical research defined under PURPOSE. Such appointments must be made in the first and second years of the award. The remaining positions may be allocated to basic or clinical research trainees, in the array of research areas relevant to the NIDR's mission. Three predoctoral positions may be requested over the five- year period. The number and types of positions awarded will be determined by the initial review group's assessment of scientific and educational merit, program needs, and the availability of funds. Training grants may not be used to support studies leading to a D.D.S. or other similar professional degrees, or to support residencies, or other training for dentists providing care to patients where the majority of their time is spent in non-research clinical training. However, if a specified period of full-time research training is creditable toward specialty board certification, the training grant may support such research training if the trainee has shown a clear interest in a research career. Since recently graduated dentists usually have little or no prior research training, the training must include a minimum of two years of basic or clinical research training. Applicants are reminded of the importance the NIDR places on recruitment and retention of women and underrepresented minorities to sponsored training and career development programs. Where feasible, women and minority mentors should be involved as role models. Additional information regarding NRSA Institutional Research Training Grants is given in the NIH Guide for Grants and Contracts, Vol. 21, No. 11, March 20, 1992. Copies of the NIH Guide are usually available in the business or grants office of most academic institutions. This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. Stipends and Other Training Costs For predoctoral trainees, at all levels of experience, the stipend is $10,008 per year. For postdoctoral trainees, the stipend is determined by the number of years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research, including industrial; teaching; internship; residency; clinical practice; or other time spent in a health-related field beyond that of the qualifying doctoral degree. The postdoctoral stipends are as follows: Years of Relevant Experience Stipend 0 $19,608 1 20,700 2 25,600 3 26,900 4 28,200 5 29,500 6 30,800 7 or more 32,300 Stipends may be supplemented by an institution from non-Federal funds. Other NIH funds may not be used to supplement stipends. Non-NIH Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which the supplemental funds are derived. An individual may make use of Federal educational loan funds or Department of Veterans' Affairs benefits when permitted by those programs. Under no circumstance may the condition of stipend supplementation detract from or prolong the training. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Degree trainees may exclude only required course tuition, fees, books, supplies, and equipment. Non-degree trainees will be required to report stipends and all monies paid on their behalf for tuition and fees. The NIH is not in a position to advise students or institutions about their tax liability. In any event, changes in the taxability of stipends in no way alters the relationship between NRSA fellows, trainees, and institutions. NRSA stipends are not now, and never have been, salaries. Trainees supported under the NRSA are not in an employer-employee relationship with the NIH or the institution at which they are pursuing research training. Reimbursement of tuition and fees, including medical insurance, will be consistent with NIH policy. They are allowable trainee costs if such charges are required of all persons in a similar training status at the institution, without regard to their source of support. Tuition at the postdoctoral level, if justifiable, is limited to that required for specific courses in support of the approved training program. Annual increments in tuition costs beyond the first year of a five-year award will not be allowed. Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's training, is an allowable trainee cost. Institutional costs of $1,500 per year per predoctoral trainee and $2,500 per year per postdoctoral trainee may be requested to defray the cost of training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Indirect costs - reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs, exclusive of tuition, fees and equipment, is allowed. Payback Provisions Predoctoral trainees do not incur payback obligations. Postdoctoral trainees must sign an agreement to fulfill NRSA payback requirements. They incur payback obligation for the first twelve months of support. This obligation will be satisfied by continuing on the training grant for an additional 12 months. For payback obligations which are not satisfied in this way, trainees must engage in biomedical or health-related behavioral research and or teaching for a period equal to the period of support up to 12 months. The obligated service must be undertaken continuously within two years after termination of support. Individuals who fail to fulfill the obligation through service must pay back the total amount of funds paid to the individual for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years of the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period of service or repayment, or otherwise waive or suspend the payback obligation of an individual. Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the payback service requirement and explain them carefully to prospective trainees before an appointment to the training grant is offered. For additional information, including the grounds for approving extensions of support and payback provisions, refer to the announcements in the NIH Guide, "National Research Service Awards - Guidelines for Individual Awards - Institutional Grants," Special Edition, Volume 13, No. 1, January 6, 1984, and "Modification of the NRSA Service Payback Obligation," Volume 22, No. 27, July 30, 1993. LETTER OF INTENT Prospective applicants are asked to submit, by August 10, 1994, a letter of intent that includes a descriptive title of the proposed research training program, the name, address, and telephone number of the program director, 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 is helpful in planning for the review of applications. It allows NIDR staff to estimate the potential review workload and to avoid conflicts-of-interest in the review. The letter of intent is to be sent to Dr. Thomas M. Valega at the address listed under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Valega, at the address listed under INQUIRIES, early in the planning phase of application preparation. This will help ensure that applications are responsive to the RFA. Applications are to be submitted on form PHS 398 (rev. 9/91). Application forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248 and from the program staff listed under INQUIRIES. Applicants must request six postdoctoral positions over the five-year period, with two appointments in each of the first, second and third years. Applicants must allocate not less than two postdoctoral positions to trainees interested in receiving training to conduct the type of clinical research defined under PURPOSE. Such appointments must be made in the first and second years of the award. The remaining positions may be allocated to basic or clinical research trainees, in the array of research areas relevant to the NIDR's mission. Three predoctoral positions may be requested over the five year period. A plan must be included for the recruitment of women and individuals from minority groups that are nationally underrepresented in these sciences. No awards will be made to applications lacking this component. Where possible, women and minority preceptors should be included, to serve as role models. Cumulative information on the career development of all former trainees, including information about their minority and gender status must be included. Applications must include a description of formal and or informal activities related to instruction about the responsible conduct of research to be incorporated into the proposed research training program. Information must be provided on the rationale, subject matter, appropriateness, format, and the frequency and duration of instruction; and the amount and nature of faculty participation. Progress reports in continuation applications must include the type of instruction, topics covered, and other details, such as attendance by trainees and names of the instructors. No award will be made if an application lacks this component. Information regarding, "Modification of Existing Review Criteria for NRSA Institutional Research Training Grants," is given in the NIH Guide, Vol. 21, No. 11, March 20, 1992. To identify the application as a response to this RFA, check "YES" on item 2a of page 1 of the application and enter "RFA: DE-94-004, NRSA - Institutional Training Applications." The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. 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 Westwood Building, Room 240 Bethesda, MD 20892-4500** At the time of submission, two additional copies of the application also must be sent to: H. George Hausch, Ph.D. Extramural Program National Institute of Dental Research Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 594-7632 This RFA is for a single competition. Applications must be received by September 12, 1994. If an application is received after that date or deemed non-responsive to the RFA, it will be returned to the applicant without review. 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 Applications will be reviewed for completeness and responsiveness to the RFA by NIH staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Remaining applications may be subjected to triage by the NIDR Special Grants Review Committee, a standing NIH initial review group, to determine their merit, relative to others received in response to the RFA. The NIDR will withdraw applications judged to be noncompetitive and notify the applicant. Applications judged to be competitive will be evaluated for scientific and educational merit by the review committee. The following review criteria will be applied: o Research training program objectives, design and direction: Management structure; core curriculum and available courses or seminars; how guided research activities are selected and trainees are assigned to preceptors; procedures for monitoring progress; existence of a true training program, as contrasted with fellowship training for an individual; appropriateness of the number of trainees; unique and innovative aspects. o Program director, faculty and preceptors: Administrative and scientific qualifications, roles, time commitment, ability to compete for research support, and experience in graduate research training. o Training environment: Institutional commitment; evidence of ongoing fundamental and clinical research; availability of research support, equipment, facilities, and clinical resources. o Selection of trainees: Plans for recruitment and criteria for selection of trainees, availability of high-quality candidates, including minorities and women. o Past training record: For new and renewal applications, potential or performance in training scientists as indicated by former trainees' success in obtaining research grant support, establishing independent research careers, and involvement in clinical and basic oral health research. o Recruitment and retention of women and minority trainees: After review of the application for scientific and educational merit and assignment of a priority score, the Special Grants Review Committee will comment on plans for recruiting women and underrepresented minorities. For renewal applications, this will include accomplishments in recruiting and retaining women and underrepresented minorities and training them for research careers. o Responsible conduct of research: The quality of scientific integrity instruction. Secondary review will be by the National Advisory Dental Research Council. Among the information the Council considers will be the report of the Special Grants Review Committee on the plans for, and success in, recruitment and retention of women and individuals from underrepresented minority groups. The NIDR will notify the applicant of the Council's action shortly after its meeting. Review and Award Schedule Applications will be processed according to the following schedule: Application Initial Review Council Earliest Receipt Date Group Meeting Meeting Award Date Sep 12, 1994 Feb/Mar 1995 May/Jun 1995 Jul 1995 AWARD CRITERIA Funding decisions will be based on the Special Grant Review Committee's and Council's recommendations; the need for research personnel in particular program areas, including the need to train clinical investigators; and the availability of funds. The earliest award date is July 1, 1995. The NIDR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR. 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 and address the letter of intent to: Thomas M. Valega, Ph.D. Extramural Program National Institute of Dental Research Westwood Building, Room 503 Bethesda, MD 20892 Telephone: (301) 594-7617 FAX: (301) 594-7616 Direct inquiries pertaining to fiscal matters to: Theresa Ringler Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described in the Catalog of Federal Domestic Assistance No. 93.121. 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. From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-94-007 - V23(14) 04/08/94 Date: 11 Apr 1994 15:40:43 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 321 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjlb$767@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AA94007 AA-94-007 P1O1 *************************************** SMALL GRANTS FOR NEW ALCOHOLISM TREATMENT RESEARCHERS NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA: AA-94-007 P.T. National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: August 11, 1994 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking small grants applications to stimulate and facilitate the entry of promising investigators into the field of alcoholism treatment research. This pilot program is designed to provide rapid review and funding decisions for applications. The NIAAA encourages investigators at the beginning of their alcohol research careers to submit applications for small-scale research projects (up to $10,000 for direct costs for one year) related to issues surrounding assessment and treatment of alcoholism. 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), Small Grants for New Alcoholism Treatment Researchers, is related to the priority areas of alcohol abuse reduction and alcoholism 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 202-783-3238). ELIGIBILITY Applications may be submitted by public and private non-profit and for-profit organizations such as universities, colleges, hospitals, treatment facilities, research institutions, units of State or local government, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. To be eligible for this award, the proposed Principal Investigator must be at the beginning of her/his research career and be able to secure a meaningful mentoring relationship with a more experienced researcher. Such experience must be in some way relevant to the project, though it need not be specifically in the field of alcoholism treatment. Special target groups for this award include pre-doctoral graduate students, post-doctoral fellows, as well as clinicians now working in the field of alcoholism treatment. Investigators who have received a research project grant (R01), Small Grant (R03), Exploratory/Development Grant (R21), First Independent Research Support and Transition (FIRST) Award (R29), Scientist Development Award for Clinicians (K20), or a Scientist Development Award (K21) are not eligible to apply. MECHANISMS OF SUPPORT These awards will use the Small Grant Mechanism (RO3). Support may be requested for up to one year for up to $10,000 for direct costs. These awards are not renewable, but a one-year no cost extension may be requested. Replacement of the Principal Investigator on this award is not permitted. Transfer of the award, with the Principal Investigator, to another institution for the remainder of the grant period may be requested as long as the relationship with the mentor is maintained. Grant funds may be used for expenses clearly related and necessary to conduct the research projects, including both direct costs that can be specifically identified with the project and allowable indirect costs of the institution. The award may not be used for salary support of either the Principal Investigator or mentor, but may be used to support the costs of technicians and for dissertation research. FUNDS AVAILABLE It is estimated that approximately $100,000 will be available for approximately seven to eight grants under this RFA in FY 1995. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Additional applications may also be funded if their scientific and technical merit warrants it. Although this program is provided for in the financial plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES With competition for NIAAA grant funds increasing, academic careers becoming more dependent on funded grants, and costs associated with preparation of grant applications escalating, investigators face numerous challenges in entering a new research arena. The objective of this RFA is to stimulate and encourage promising new researchers to enter the field of alcoholism treatment research. It is anticipated that the prospects for funding meritorious projects under this RFA will likely be more favorable than is the case with larger award requests by more senior investigators. The Treatment Research Branch of the Division of Clinical and Prevention Research supports research on management of alcoholism, alcohol abuse, and alcohol-related disorders, including evaluation of new treatment methods, assessment of effectiveness of various kinds of behavioral and pharmacologic interventions, development of new diagnostic instruments, and elaboration and refinement of assessment/methodologies for research on effectiveness and costs of treatment. The Branch also supports health services research on the organization, financing, delivery, and effectiveness of alcoholism treatment. This award is designed as a rapid mechanism that provides "seed" funds for investigators who have not received research or career development grant funds from NIAAA in the past. It supports primarily: o Pilot projects on treatment issues and outcomes; o Psychometric analyses and instrument development; and o Secondary analyses of existing data sets. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NIAAA program administrator listed under INQUIRIES. The RFA label available in the PHS (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. The biographical sketch for both the applicant and mentor should be kept to a minimum (not to exceed 1 or 2 pages each). Sections 1-4 of the Research Plan must be brief (i.e., 2-3 pages); in no case should the Research Plan exceed 5 pages. Applications failing to meet these page limitations may be returned without review. Include sufficient but concise information to facilitate an effective evaluation. The following information should be included: a description of the objectives of the research and what the research is intended to accomplish; why the work is important; a brief description of the research design and the procedures to be used to accomplish the objectives of the project; and a description of the research mentor's qualification and experience. In all other respects, applications must meet the conditions set out in form PHS 398, including a standard cover page, a statement of current and pending research support, and a budget. The signed original, including the checklist, and three signed, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Chief, Extramural Project Review Branch ATTN: RFA AA-94-007 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard Rockville, MD 20852-7003* Telephone: 301-443-4375 FAX: 301-443-6077 Applications must be received by August 11, 1994. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. 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 for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAAA staff will contact the applicant to determine whether to return the application to the applicant or request the applicant to revise and resubmit it as a regular Small Grant application for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIAAA peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant and institutional official. Those applications judged to be competitive will undergo further scientific merit review in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAAA. Applications may also be reviewed by mail ballot. Review Criteria Criteria to be used in the scientific and technical merit review of Small Grants for New Alcoholism Treatment Researchers applications will include the following: 1. The scientific, technical, health, or medical significance and originality of the proposed research. 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the proposed research. 3. Ability to secure a mentoring relationship with an experienced researcher. 4. The adequacy of the qualifications and relevant research experience of the principal investigator and the principal investigator's mentor. 5. The availability of adequate data, facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 6. The reasonableness of budget estimates for the proposed research. 7. Where applicable, the adequacy of procedures to protect or minimize effects on human subjects and the environment. 8. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. AWARD CRITERIA Applications recommended for approval will be considered for funding on the basis of the overall scientific and technical merit of the proposal as determined by peer review, NIAAA programmatic needs and balance, and the availability of funds. INQUIRIES Potential applicants are encouraged to seek preapplication consultation and may contact the individual listed below for consultation in preparing an application under this RFA. Direct inquiries regarding programmatic issues to: Joanne Fertig, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-0635 FAX: (301) 443-8774 Email: JFertig@WILLCO.NIAAA.NIH.GOV Direct inquiries regarding fiscal matters to: Joseph Weeda Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects;" Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (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. From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA MH-94-008 - V23(14) 04/08/94 Date: 11 Apr 1994 15:40:38 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 366 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjl6$75u@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA MH94008 MH-94-008 P1O1 *************************************** SERVICES RESEARCH COMPETITIVE SUPPLEMENTS TO CLINICAL THERAPEUTIC RESEARCH GRANTS NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA: MH-94-008 P.T. National Institute of Mental Health Letter of Intent Receipt Date: May 8, 1994 Application Receipt Date: June 8, 1994 PURPOSE The National Institute of Mental Health (NIMH) announces the availability of support in the form of competitive supplements to expand ongoing funded clinical therapeutic research grants into the area of services research. The purpose of these supplements is to help move mental health treatments from the testing of efficacy (i.e., whether the treatment works under highly controlled conditions in a population with a well defined mental disorder) into testing of effectiveness (i.e., whether the same promising treatment works when applied to a wider and diverse range of settings, providers, populations, and outcome assessment). Services research is a major NIMH priority and is responsive to Public Law 102-321 (July 10, 1992), which requires the NIMH to obligate not less than 15 percent of its budget to health services 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 Request for Applications (RFA), Services Research Competitive Supplements to Clinical Therapeutic Research Grants, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY Applications will only be considered for currently funded grants with at least one year remaining, ending no later than March 30, 1996. Such funding could be supplementary to a competitive renewal grant. Women and minority investigators are encouraged to apply. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) competitive supplement mechanism (S01) and can supplement the following types of grants: R01, R10, R37, P01, P20, P30, P50. Supplemental request may not exceed the tenure left on the parent grant. Annual awards will be made, subject to continued availability of funds and progress achieved. FUNDS AVAILABLE It is anticipated that at least $1,000,000 in direct costs will be made available. Awards will have a maximum yearly direct cost amount of $200,000, but will not exceed the total costs of the prior year of the parent grant. RESEARCH OBJECTIVES Background Despite the upsurge of research on the treatment of mental illness, both within the NIMH and in the field, there are still critical needs that were highlighted in a recent report by the NIMH Treatment Research Initiative Task Force. The basic goal of the initiative is to take advantage of emerging knowledge and technology to develop and refine more efficient and effective treatment programs for individuals with mental illness. Specific recommendations include (1) development of more effective treatments for patients who fail to respond to standard therapies; (2) enhanced research on the treatment of chronic or recurrent mental illness; (3) strengthening research directed at populations that are not often the focus of treatment research; (4) improved criteria and instruments for assessing a wider range of treatment outcomes and; (5) development of more effective integrated interventions involving biological, psychosocial, and rehabilitative therapies. The report places special emphasis on strengthening the linkage between clinical therapeutic research and clinical services research in advancing the effective use of available treatments in clinical practice. The aim of this RFA is to encourage the transition from clinical therapeutic efficacy research into clinical services effectiveness research (NIMH Caring for People with Severe Mental Disorders: A National Plan of Research to Improve Services. DHHS Pub. No. (ADM 91-1762. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 1991), thereby expanding the generalizability of the intervention. Ultimately, this transition should result in improved outcomes and increased numbers of individuals benefiting from promising mental health treatments. Following are examples of the types of clinical services research issues that would benefit from expansion of ongoing clinical therapeutic research grants. The list is illustrative rather than comprehensive. It is expected that additional relevant and important research topics will be identified by investigators responding to this RFA. o Studies testing promising treatments with new populations, such as racial or ethnic minorities, patients with co-occurring mental, substance abuse, or medical conditions. o Studies testing the effectiveness of proven mental health treatments when employed in everyday practice and settings (e.g., primary care settings, nursing homes, community mental health centers, outpatient clinics) o Studies testing the effectiveness of proven mental health treatments when administered by providers who more fully represent the range and expertise of providers expected to deliver the treatment in everyday practice and settings o Studies of the delivery of treatment, such as how to provide coordinated treatment and rehabilitation services and select modalities that best match the patient's/client's needs. o Studies that measure an expanded range of outcomes (beyond symptom reduction), such as functional capacity, and quality of life, or cost. o Financing and cost issues relating to therapeutic interventions, e.g., cost-effectiveness, cost-benefit, and cost-utility research. Program Specifications Supplementary requests should address the need to establish the effectiveness of efficacious treatments, thereby increasing the generalizability of research findings. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF FEMALES AND MINORITIES IN RESEARCH STUDY POPULATIONS It is the policy of the NIH that women and member of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (concerning the Inclusion of Women in Study Populations) which have been in effect since 1990. the new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151), and reprinted in the NIH Guide For Grants and Contracts of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 8, 1994, a letter of intent. This should include the title and number of the parent grant to be supplemented 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 this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIMH 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. Robert Prien at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are to use the grant applications form PHS 398 (rev. 9/91). Application kits containing the necessary forms and instructions for regular research grants may be obtained from the office of sponsored research at most universities, colleges, medical schools, and other major research facilities; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the program office listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. The signed original and five legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Schedule Letter of Intent Receipt Date: May 8, 1994 Application Receipt Date: June 8, 1994 IRG Review: July/August 1994 Council Review: September 1994 Approximate Start Date: September 1994 Terms and Conditions of Support Supplemental funds may be used for expenses clearly related and necessary to conduct the proposed supplemental services research, including both direct and allowable indirect costs. Supplemental funds may not be used to operate a treatment, rehabilitation, or other service program, nor may such funds be used to fund research that is an integral part of the parent grant. Public-Academic Liaison As part of the NIMH Public-Academic Liaison (PAL) initiative, special encouragement is given to applications that involve active collaborations between academic researchers and public sector agencies in planning, undertaking, analyzing, and publishing research pertaining to people with severe mental disorders. The PAL initiative is based upon the premise that important new advances in the understanding and treatment of severe mental illness can result from improved linkages between the Nation's scientific resources and the public sector agencies and programs in which many people with severe mental disorders receive their care. The scope of the PAL initiative encompasses public sector agencies of all types that provide services for people with severe mental disorders. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by an NIMH Initial Review Group (IRG) composed primarily of non-Federal Scientific experts. Final review is by the appropriate National Advisory Council; review by Council may be based on policy considerations as well as scientific merit. By law, only applications recommended for consideration for funding by the Council may be supported. Summaries of IRG discussions are sent to applicants as soon as possible following IRG review. Review Criteria Criteria for scientific/technical merit review of applications will include the following: significance of the goals of the proposed research plan and its relationship to the parent grant; evidence of familiarity with relevant research literature; adequacy of the conceptual and theoretical framework for the research; adequacy of the methodology proposed to carry out the research; feasibility of the proposed research; qualifications and research experience of the principal investigator and other key research personnel; availability of adequate facilities, other resources, and collaborative arrangements necessary for the research; appropriateness of budget estimates for the proposed research activities; adequacy of plans to include women and minorities in study populations; and adequacy of provisions for the protection of human subjects and the welfare of animal subjects, as applicable. AWARD CRITERIA In granting awards, the following criteria are consider: program relevance, quality of application as documented by IRG and Council recommendation, and program balance. INQUIRES 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 is and address the letter of intent to: Robert F. Prien, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Matthew V. Rudorfer, M.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Barry E. Wolfe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 George Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-1185 FAX: (301) 594-6784 Peter S. Jensen, M.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-5944 FAX: (301) 443-6000 Thomas Lalley Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 FAX: (301) 443-4045 Direct inquiries regarding grants management issues to: Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 AUTHORITY AND REGULATION 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 PSC 241 and 285) and administered under PHS grants and Federal Regulations 42 CFR, Part 52 "Grants for Research Projects" and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Execute Order 12372. 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. From owner-sci-resources@net.bio.net Sun Apr 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-021 - V23(14) 04/08/94 Date: 11 Apr 1994 15:40:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 299 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2ocjl2$75l@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94021 CA-94-021 P1O1 *************************************** CLONING AND SEQUENCING THE BRCA1 GENE NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA: CA-94-021 P.T. National Cancer Institute Application Receipt Date: June 14, 1994 PURPOSE The Division of Cancer Biology, Diagnosis and Centers, National Cancer Institute (NCI) invites research project grant applications to clone and sequence the BRCA1 gene. Although the region of DNA that contains BRCA1 has been identified by physical and genetic mapping, the gene or genes of interest have not been cloned and sequenced. The aim of this Request for Applications (RFA) is to foster and stimulate collaborations among investigators who can expedite the process of cloning and sequencing the BRCA1 gene. Such collaborations may involve scientists from academia and industry. It is expected that the achievement of this goal will lead to new research opportunities for prevention, screening, early detection, and treatment of breast and ovarian cancer, and perhaps other malignancies. 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, Cloning and Sequencing the BRCA1 Gene, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign nonprofit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications can be from single or several institutions (collaborating institutions, consortia). Foreign institutions may also participate in Laboratory or Clinical Programs through subcontract or consortium arrangements. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) as its funding mechanism. Applicants will be responsible for the planning, direction and execution of the proposed projects. The total proposed project period for each application submitted in response to this RFA may not exceed two years. Recognizing the complexity of this initiative, it is appropriate to include multiple specific aims within a single research project application. The total proposed direct costs for the first year may not exceed $1,400,000. This does not include indirect costs on a subcontract that appears as a direct cost by the applicant organization. The anticipated award date is August 15, 1994. The award and level of support depends on receipt of a sufficient number of applications of high scientific merit. 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. This RFA is a one-time solicitation. At this time, the NCI has not determined whether or how this solicitation will be continued. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that one or more awards will be made. RESEARCH OBJECTIVES Background Despite important progress in the early diagnosis and treatment of breast cancer, mortality and morbidity due to this disease remain high. A detailed picture of the specific genetic changes and somatic mutation underlying the development of breast cancer is emerging, primarily from molecular genetic analysis of tumors. An important genetic component is indicated by demonstration of linkage in several families with high frequencies of early-onset breast cancer and ovarian cancer to a genetic marker, BRCA1, at chromosome 17q21. Mutational change at the BRCA1 locus may be a critical step in the pathway ultimately leading to breast cancer in at least some patients because there is an increased incidence of breast cancer in individuals who inherit mutations at that locus. The same reasoning applies to ovarian cancer. Isolation or identification of a gene or genes at chromosome 17q21 could, therefore, be an outcome of profound importance to understanding the etiology of certain cancers in women, with clear ramifications in prevention, diagnosis, and treatment. Objective and Scope In those families with very high frequencies of breast cancer (and ovarian cancer), the epidemiologic pattern is compatible with the transmission of a dominant allele of a gene that predisposes women to breast cancer. Characterization of DNA from familial breast cancers indicates that allelic loss occurs at the locus called BRCA1 on chromosome 17q21, consistent with the interpretation that this locus contains the functional equivalent of a tumor suppressor gene, the loss of which may lead to the development and maintenance of a neoplastic state. The goals of mapping the regions of 17q21 likely to contain the BRCA1 gene and the reconciliation of the large-scale genetic and physical maps have to a great extent been achieved. There may now be several ways to find and isolate the BRCA1 gene. For example, one unexplored method would be to determine the complete sequence of the 400-500 kilobase genomic region thought to contain BRCA1, using DNA from persons thought to inherit wild-type or mutant genes, and DNA from breast tumors. The secondary benefit from this approach would be the first sequencing of a large segment of the human genome containing many uncharacterized genes to allow comparison with the recently determined genomes of yeast and C. elegans. This approach could be in conjunction with the process of isolating, screening, and sequencing candidate cDNA clones that might be synthesized from RNAs transcribed from the BRCA1 locus. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI program staff listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 Applications must be received by June 14, 1994. If an application is received after that date, it will be returned. 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 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 by the DRG for completeness and for responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will 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 may be triaged by an NCI peer review group on the basis of relative competitiveness. The NCI will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated, using the review criteria stated below, for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies according to the following criteria: 1. Scientific, technical, or medical significance and originality of proposed research; 2. Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; 3. Qualifications and research experience of the Principal Investigator, staff, and collaborators, particularly in the areas of DNA sequencing and cloning; 4. Likelihood that the proposed research plan will achieve its stated goals within the available project period and budget; 5. Availability of the resources, such as relevant clones and appropriate mapping and sequencing power, necessary to perform the research; 6. Appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA Applications considered by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) availability of funds; and (c) programmatic priorities. Applications considered for award must include a significant DNA sequencing element. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged. Direct inquiries regarding programmatic issues to: Dr. Cheryl Marks Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 505 Bethesda, MD 20892 Telephone: (301) 496-7028 FAX: (301) 402-1037 Direct inquiries regarding fiscal matters to: Ms. Sara Stone Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 266 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.396, Cancer Biology Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, 42 U.S.C. 241, as amended; Public Law 100-607, 42 U.S.C. 285 and 285a) and administered under HHS grants policies. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Apr 14 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 15, pt. 1of3, 15 April 1994 Date: 14 Apr 1994 19:29:42 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1498 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2oku6m$6ci@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940415 V23N15 P1O3 ************************************ X-comment: RFAS described: OD-94-004, MH-94-009, AI-94-022, AI-94-015, DC-94- 002 NIH GUIDE - Vol. 23, No. 15 - April 15, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** PUBLIC CONVOCATION---THE RESPONSIBLE CONDUCT OF SCIENCE National Academy of Sciences INDEX: NATIONAL ACADEMY OF SCIENCES $$INDEX N3 ********************************************************** ADDITIONAL NIDA SUPPORT MECHANISM National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N4 ********************************************************** TERMS AND CONDITIONS OF AWARD FOR LARGE UNSOLICITED RESEARCH PROJECT APPLICATIONS FOR: CLINICAL TRIALS; PREVENTION, EDUCATION AND CONTROL INTERVENTIONS; AND EPIDEMIOLOGICAL STUDIES National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX N5 ********************************************************** SMALL BUSINESS INNOVATION RESEARCH PROGRAM National Institutes of Health Centers for Disease Control and Prevention Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; DISEASE CONTROL, PREVENTION; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** PRECLINICAL TOXICOLOGY OF CHEMOPREVENTIVE AGENTS (RFP NCI-CN-45001-05) National Cancer Institute INDEX: CANCER $$INDEX R2 06/15/94 ************************************************* EXPLORATORY CENTERS FOR ALTERNATIVE MEDICINE RESEARCH (RFA OD-94-004) Office of Alternative Medicine INDEX: ALTERNATIVE MEDICINE $$INDEX R3 07/12/94 ************************************************* MULTI-SITE STUDY OF MENTAL HEALTH SERVICE USE, NEED, OUTCOMES, AND COSTS IN CHILD AND ADOLESCENT POPULATIONS (RFA MH-94-009) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R4 07/14/94 ************************************************* BASIC RESEARCH IN HUMAN TUBERCULOSIS (RFA AI-94-022) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R5 08/19/94 ************************************************* NATIONAL COOPERATIVE VACCINE DEVELOPMENT GROUPS FOR AIDS (RFA AI-94-015) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R6 10/20/94 ************************************************* NATIONAL MULTIPURPOSE RESEARCH AND TRAINING CENTERS (RFA DC-94-002) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** NATIONAL RESEARCH SERVICE AWARDS FOR INDIVIDUAL POSTDOCTORAL FELLOWS (PA-94-055) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P2 ********************************************************** COMPREHENSIVE PREVENTION RESEARCH IN DRUG ABUSE (PA-94-056) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P3 ********************************************************** PHYSIOLOGY AND PATHOLOGY OF LOW CHOLESTEROL STATES (PA-94-057) National Heart, Lung, and Blood Institute National Institute on Aging INDEX: HEART, LUNG, BLOOD; AGING $$INDEX P4 ********************************************************** RESEARCH TRAINING: ENVIRONMENTAL HEALTH AND NURSING SCIENCES (PA-94- 058) National Institute of Environmental Health Sciences National Institute of Nursing Research INDEX: ENVIRONMENTAL HEALTH SCIENCES, NURSING RESEARCH ERRATA $$INDEX E1 ********************************************************** NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS AND TUBERCULOSIS IN AIDS (RFA AI-94-014) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX E2 ********************************************************** CLONING AND SEQUENCING THE BRCA1 GENE (RFA CA-94-021) National Cancer Institute INDEX: CANCER This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT BE PUBLISHED ON APRIL 22, 1994. THE NEXT ISSUE OF THE NIH GUIDE WILL BE ON APRIL 29, 1994. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** PUBLIC CONVOCATION---THE RESPONSIBLE CONDUCT OF SCIENCE NIH GUIDE, Volume 23, Number 15, April 15, 1994 P.T. National Academy of Sciences Meeting Date: June 6 and 7, 1994 The National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine are committed to bringing matters of responsible conduct to the full attention of participants in the scientific and engineering enterprise. In pursuit of that goal, the Academy complex will hold a major public convocation on the conduct of science on June 6 and 7, 1994. The meeting will review progress made by government, universities, and other institutions in addressing matters related to the conduct of science and engineering, including the handling of allegations of misconduct and the creation of educational programs for new and established investigators. The meeting will also examine next steps to ensure that the highest standards of conduct in science are maintained. Participants in the convocation will include scientists and engineers, leaders of professional societies, research and university administrators, science educators, the media, and decisionmakers in the Administration, Congress, and industry. Previous studies by panels formed by the Institute of Medicine and the Committee on Science, Engineering, and Public Policy have been supported by the National Institutes of Health and other Federal agencies, as well as private funds. The current requirement for instruction in the responsible conduct of research for trainees supported by NIH-funded institutional research training grants supports some of the recommendations from those panels. INQUIRIES To register or for more information, please contact: Scott Spaulding Commission on Life Sciences, NAS 351 National Academy of Sciences 2102 Constitution Avenue Washington, DC 20418 Telephone: (202) 334-2233 FAX: (202) 334-1687 email: sspauldi@nas.edu $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** ADDITIONAL NIDA SUPPORT MECHANISM NIH GUIDE, Volume 23, Number 15, April 15, 1994 P.T. 34; K.W. 1014006, 0785035, 0404009 National Institute on Drug Abuse Effective with the June 1, 1994, receipt date, the National Institute on Drug Abuse (NIDA) will accept applications utilizing the Cooperative Clinical Research (R10) mechanism. The R10 mechanism is used to support clinical evaluation of various methods of therapy and/or prevention in specific disease areas. These represent cooperative programs between participating institutions and principal investigators and are usually conducted under established protocols. INQUIRIES Further information may be obtained from: Ms. Eleanor Friedenberg Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2755 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** TERMS AND CONDITIONS OF AWARD FOR LARGE UNSOLICITED RESEARCH PROJECT APPLICATIONS FOR: CLINICAL TRIALS; PREVENTION, EDUCATION AND CONTROL INTERVENTIONS; AND EPIDEMIOLOGICAL STUDIES NIH GUIDE, Volume 23, Number 15, April 15, 1994 P.T. 34; K.W. 1014006, 0755015, 0785055, 0745027 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID) announces that any new or competing continuation investigator-initiated clinical trial, prevention, education, or control intervention, or epidemiological study in which direct costs exceed $500,000 in any year will usually be awarded as a cooperative agreement (U01). The $500,000 direct costs limit applies when either (1) a study is to be conducted at one institution or (2) a study proposing multi-institutional collaborative arrangements is submitted as either subcontracts to a single application or as separate applications. For single applications, the dollar limit excludes indirect costs of any subcontracts that are reported as a direct cost on the application budget page summary. Separate U01 awards usually will be made for individual applications submitted concurrently by institutions proposing a study involving a coordinated research effort. This policy is effective immediately with publication of this notice and covers all current pending unfunded applications as well as all future submissions. The cooperative agreement is an assistance instrument similar in most ways to a grant. It differs in that, in addition to the standard stewardship role, an Institute extramural program director is expected to have a continuing substantive role in one or more scientific aspects of the study, in an assisting, not directing, relationship. The type and degree of such involvement should be appropriate to the specific cooperative agreement. The awardee will have lead responsibilities in all aspects of study, including any modification of study design, conduct of study, quality control, and analysis of results. The Institute program director may have assistance roles in one or more of those areas and will have a shared lead responsibility in facilitating interim data and safety monitoring. In order to facilitate the above interactions, it will be necessary for awardees to plan for periodic (at least annual) meetings with NIAID staff in the Bethesda, MD area. Accordingly, applicants must request, and will be allowed, sufficient funds within the submitted budgets to accommodate expenses for participants at these meetings, as well as for expenses incurred in the conduct and monitoring of the study. All awards made as cooperative agreements under the above circumstances will be subject to the applicable terms of award. Specific terms, conditions, and arbitration procedures pertaining to the scope and nature of the interaction between the NIAID and its awardees will be incorporated in the Notices of Award. It is anticipated that these terms and conditions will enhance the relationship between the National Institute of Allergy and Infectious Diseases and the principal investigator(s) and will facilitate the successful conduct and completion of the study. Therefore, applications falling under these guidelines, but not accepting the stated conditions, will not be considered for funding. INQUIRIES Potential applicants for research with these characteristics are strongly encouraged to contact the NIAID prior to making detailed plans or submitting their application(s). Questions regarding this notice and requests for a generic sample of terms and conditions of award may be directed to: Director, Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 3C20 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Potential applicants will be referred for further consultation to the appropriate NIAID Program and Grants Administration staff. $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** SMALL BUSINESS INNOVATION RESEARCH PROGRAM NIH GUIDE, Volume 23, Number 15, April 15, 1994 P.T. National Institutes of Health Centers for Disease Control and Prevention Food and Drug Administration Application Receipt Date: August 15, December 15, 1994, April 15 Innovative technologies and methodologies fuel progress in biomedical and behavioral research and represent an increasingly important area of the economy. The Small Business Innovation Research (SBIR) program provides support for research and development (R&D) of new technologies and methodologies that have the potential to succeed as commercial products. The purpose of this notice is to inform the public about the opportunities that the SBIR program offers to small business concerns as well as to scientists at research institutions, including colleges and universities. The applicant organization must be a small business concern, and the primary employment of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In accord with the intent of the SBIR program to increase private sector commercialization of innovations derived from federal research and development, scientists at research institutions can play an important role in an SBIR project by serving as consultants and/or subcontractors to the small business concern. Normally, up to one-third of the Phase I budget may be spent on consultant and/or contractual costs, and up to one-half of the Phase II budget may be spent on such costs. In this manner, a small business concern with limited expertise and/or research facilities may benefit from teaming with a scientist at a research institution; for the scientist at a research institution, this team effort provides support for R&D not otherwise obtained. Public Law 102-564, signed by the President October 28, 1992, requires the National Institutes of Health (NIH), Public Health Service, Department of Health and Human Services, and certain other federal agencies to reserve a specified amount of their extramural research or R&D budgets for an SBIR program. In fiscal year 1994, 1.5 percent of the extramural budget is reserved for the SBIR program, amounting to over $125 million; in fiscal years 1995 and 1996, the allotment becomes 2.0 percent; and in fiscal years 1997 and beyond, the requirement will be 2.5 percent. The SBIR program consists of the following three phases: PHASE I: The objective of this phase is to determine the scientific and technical merit and feasibility and potential for commercialization of the proposed project and the quality of performance of the small business concern, before consideration of further federal support in Phase II. PHASE II: The objective of this phase is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II application. PHASE III: The objective of this phase, where appropriate, is for the small business concern to pursue with non-SBIR funds the commercialization of the results of the research or R&D funded in Phases I and II. The amount and period of support for SBIR awards are as follows: PHASE I: Awards may not exceed $100,000 for direct costs, indirect costs, and negotiated fixed fee for a period normally not to exceed six months. PHASE II: Awards may not exceed $750,000 for direct costs, indirect costs, and negotiated fixed fee for a period normally not to exceed two years, that is, generally, a two-year Phase II project may not cost more than $750,000 for that project. A Phase I award must have been issued in order to apply for a Phase II award. INQUIRIES Eligibility requirements, definitions, application procedures, review considerations, application forms and instructions, and other pertinent information are contained in the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) GRANT AND COOPERATIVE AGREEMENT APPLICATIONS, available from: MTL, Inc. 13687 Baltimore Avenue Laurel, MD 20707 Telephone: (301) 206-9385 FAX: (301) 206-9722 Following are contact points for discussion of program interests pertaining to awarding components participating in the SBIR grant program: Dr. Miriam F. Kelty National Institute on Aging 7201 Wisconsin Avenue, Room 2C-218 Bethesda, MD 20892 Telephone: (301) 496-9322 FAX: (301) 402-2945 Dr. Laurie Foudin National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 443-4224 FAX: (301) 594-0673 Mr. Allan Czarra National Institute of Allergy and Infectious Diseases Solar Building, Room 3C28 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Dr. Michael Lockshin National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 31, Room 4C32 Bethesda, MD 20892 Telephone: (301) 496-0802 FAX: (301) 480-6069 Dr. Steve Gordon National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 407A Bethesda, MD 20892 Telephone: (301) 594-9951 FAX: (301) 594-9673 Dr. Gladys M. Glenn Cancer Biology and Diagnosis National Cancer Institute Executive Plaza North, Room 500 Bethesda, MD 20892 Telephone: (301) 496-5307 FAX: (301) 496-8656 Dr. Jack Gruber Cancer Etiology National Cancer Institute Executive Plaza North, Room 540 Bethesda, MD 20892 Telephone: (301) 496-9740 FAX: (301) 496-2025 Dr. Ruthann M. Giusti Cancer Treatment National Cancer Institute Building 31, Room 3A49 Bethesda, MD 20892 Telephone: (301) 496-6404 FAX: (301) 496-0826 Dr. Barry Portnoy Cancer Prevention and Control National Cancer Institute Building 31, Room 10A49 Bethesda, MD 20892 Telephone: (301) 496-1071 FAX: (301) 496-9931 Ms. Connie Dresser Interactive Multimedia Technologies for Cancer Prevention National Cancer Institute Executive Plaza North, Room 241 Bethesda, MD 0892 Telephone: (301) 496-0273 FAX: (301) 496-8675 Ms. Hildegard Topper National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892 Telephone: (301) 496-0104 FAX: (301) 402-1104 Ms. Jacqueline P. Downing National Institute on Drug Abuse Parklawn Building, Room 10A-55 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1056 FAX: (301) 443-6277 Dr. Daniel A. Sklare Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South Building, Suite 400-C Bethesda, MD 20892 Telephone: (301) 496-1804 FAX: (301) 402-6251 Dr. Joyce A. Reese National Institute of Dental Research Westwood Building, Room 505 Bethesda, MD 20892 Telephone: (301) 594-7648 FAX: (301) 594-9720 Mr. John R. Garthune National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637 Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 Dr. Michael J. Galvin, Jr. National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-03 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 Dr. Ralph Helmsen National Eye Institute Executive Plaza South, Suite 350 Bethesda, MD 20892 Telephone: (301) 496-5301 FAX: (301) 402-0528 Dr. Michael R. Martin National Institute of General Medical Sciences Westwood Building, Room 936 Bethesda, MD 20892 Telephone: (301) 594-7753 FAX: (301) 594-7731 Dr. David Robinson Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 416 Bethesda, MD 20892 Telephone: (301) 496-5656 FAX: (301) 402-3508 Dr. John T. Watson Devices and Technology Branch Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 312A Bethesda, MD 20892 Telephone: (301) 496-1586 FAX: (301) 480-6282 Dr. Thomas Blaszkowski Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 208A Bethesda, MD 20892 Telephone: (301) 496-1841 FAX: (301) 496-0075 Dr. Carol Vreim Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 6A16 Bethesda, MD 20892 Telephone: (301) 594-7430 FAX: (301) 594-7408 Dr. George Nemo Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 504 Bethesda, MD 20892 Telephone: (301) 496-1537 FAX: (301) 496-4843 Dr. Paul Didisheim National Heart, Lung and Blood Institute Federal Building, Room 312 Bethesda, MD 20892 Telephone: (301) 496-1586 FAX: (301) 480-6282 Michael F. Huerta, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health Parklawn Building, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-5625 FAX: (301) 443-4822 Internet: HMI@CU.NIH.GOV Dr. Judith Laughlin National Institute of Nursing Research Westwood Building, Room 738 Bethesda, MD 20892 Telephone: (301) 594-7493 FAX: (301) 594-7603 Mr. Edward Donohue National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 Bethesda, MD 20892 Telephone: (301) 496~4188 FAX: (301) 402-4370 Dr. William Heetderks National Institute of Neurological Disorders and Stroke Federal Building, Room 9C02 Bethesda, MD 20892 Telephone: (301) 496-5745 FAX: (301) 402-1501 Dr. Mary Ann Markwell National Center for Research Resources Westwood Building, Room 8A15 Bethesda, MD 20892 Telephone: (301) 594-7934 FAX: (301) 594-9187 Dr. Cynthia L. Pond National Center for Research Resources Westwood Building, Room 857 Bethesda, MD 20892 Telephone: (301) 594-7933 FAX: (301) 594-9149 Dr. Louise E. Ramm National Center for Research Resources Westwood Building, Room 854 Bethesda, MD 20892 Telephone: (301) 594-7906 FAX: (301) 594-9121 Dr. Dorothy D. Sogn National Center for Research Resources Westwood Building, Room 10A07 Bethesda, MD 20892 Telephone: (301) 594-7945 FAX: (301) 594-7929 Dr. Abraham Levy National Center for Research Resources Westwood Building, Room 10A11 Bethesda, MD 20892 Telephone: (301) 594-7947 FAX: (301) 594-9153 Dr. Richard DuBois National Center for Research Resources Westwood Building, Room 8A15 Bethesda, MD 20892 Telephone: (301) 594-7934 FAX: (301) 594-9187 Dr. Bettie J. Graham Mapping Technology National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 E-Mail: Bettie_Graham@occshost.nlm.nih.gov Dr. Carol A. Dahl Sequencing Technology National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 E-Mail: Carol_Dahl@occshost.nlm.nih.gov Dr. David Benton Informatics National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 E-Mail: David_Benton@occshost.nlm.nih.gov Dr. Eric T. Juengst Ethical, Legal and Social Implications of Human Genome Research National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 E-Mail: Eric_Juengst@occshost.nlm.nih.gov Mr. Peter Clepper National Library of Medicine Building 38A, Room 5S518 Bethesda, MD 20894 Telephone: (301) 496-4221 FAX: (301) 402-0421 Dr. Roy Fleming National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, NE, Mail Stop D30 Atlanta, GA 30333 Telephone: (404) 639-3343 FAX: (404) 639-2196 Mr. Ted Jones National Center for Injury Prevention and Control Centers for Disease Control and Prevention 4770 Buford Highway, NE, Mailstop F-36 Atlanta, GA 30341-3724 Telephone: (404) 488-4824 FAX: (404) 488-4422 Mr. Greg Jones National Center for Infectious Diseases Centers for Disease Control and Prevention 1600 Clifton Road, NE, Mailstop C-19 Atlanta, GA 30333 Telephone: (404) 639-2434 FAX: (404) 639-1525 Victoria F. Westberg National Center for Prevention Services Center for Disease Control and Prevention 1600 Clifton Road, NE, Mailstop E07 Atlanta, GA 30333 Telephone: (404) 639-1823 FAX: (404) 639-8601 Dr. Tom Sinks Division of Environmental Hazards and Health Effects National Center for Environmental Health 4770 Buford Highway NE, Mailstop F-28 Atlanta GA 30341-3724 Telephone: (404) 488-7350 FAX: (404) 488-7335 Dr. Richard A. Lasco National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention 4770 Buford Highway NE, Mailstop K-46 Atlanta, GA 30341-3724 Telephone: (404) 488-5428 FAX: (404) 488-5964 David E. Adcock Public Health Practice Program Office Centers for Disease Control and Prevention 1600 Clifton Road, NE, Mailstop E20 Atlanta, GA 30333 Telephone: (404) 639-1960 FAX: (404) 639-1989 Ms. Olia Hopkins Division of Contracts and Grants Management Food and Drug Administration Parklawn Building, Room 320 Rockville, MD 20857 Telephone: (301) 443-6170 FAX: (301) 594-6577 $$N5 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NCI-CN-45001-05 ****************************************** PRECLINICAL TOXICOLOGY OF CHEMOPREVENTIVE AGENTS NIH GUIDE, Volume 23, Number 15, April 15, 1994 RFP AVAILABLE: NCI-CN-45001-05 P.T. National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Prevention and Control (DCPC), Chemoprevention Branch wishes to award Master Agreement contracts for the above study. The required services will be defined by Master Agreement Orders issued during the period of performance. It is estimated that four to five Master Agreement Orders will be issued per year pursuant to the Master Agreement contracts. This solicitation is the annual announcement to expand the current pool of MA Holders qualified to perform this type of work. A primary function of the chemoprevention program is the identification and evaluation of agents for possible utilization in clinical trials in humans. Candidate agents, whether from natural sources or synthesized, have been evaluated for anti-cancer efficacy in various screening tests. However, before a decision can be made as to their suitability for the Phases I clinical trials in humans, they must be evaluated for toxicity in animals. The basic objectives of this project will be to evaluate the acute, subacute/subchronic and chronic toxicity of designated agents. These studies will be performed in animals (rodents and dogs) and will include conventional multi-generation teratogenecity studies. The agents would be given primarily by the oral route. A summary of the tasks required in the project are as follows: TASK I - Perform acute toxicity, pilot dose range finding, and 13-week subchronic toxicity in rats and dogs by the oral route. Include where appropriate, complete gross necropsies, histopathological examinations, and clinical laboratory studies. TASK II - Develop a protocol for a pharmacokinetic profile for each investigational agents. The protocol and profile may build upon published data and data provided by the manufacturer of the agent or NCI staff, Additional studies necessary to complete the pharmacokinetic profiles for the rat and dog shall be performed by the Contractor. Pharmacokinetic studies will provide parameters of absorption blood concentration-time profiles, distribution, and excretion. Data on tissue concentration to the test agent, determined as part of the toxicology testing shall contribute to the pharmacokinetic profile, Information on major metabolites shall be included in order to provide as complete a picture as possible of the overall distribution and fate of the test agent. Appropriate modeling shall be applied to determine probable pattern of distribution and absorption and half-life information necessary to plan the 90-day rat and dog toxicology studies. TASK III - Develop and perform teratogenicity studies on chemopreventive agents that have the prospect of being administered to women of childbearing potential. These will be the standard segment I, II, and III studies as described in the Guidelines for Reproduction Studies for Safety Evaluation of Drugs for Human Use, available from the Contract Specialist, upon request. For efficiency, the male rats from the 3-month oral study may be used to initiate the male-related reproductive toxicity studies. TASK IV-Perform chronic one-year oral toxicity in rats and dogs. Clinical laboratory studies and gross and microscopic necropsy findings are to be included. Suitable facilities and equipment appropriate to accomplish tasks should be available. Animal-holding facilities for dogs must be provided with adequate environmental containment. Offerors are to comply with the NIH Guide for Care and Use of Laboratory Animals. Facility must have design and maintenance capability to meet chemical and biological control; must comply with NCI carcinogens and handling standards; must comply with federal and state occupational health and environmental laws and regulations. On-site data handling (computer), chemical, and pathological facilities and equipment should be available. Must comply with requirements set forth in the FDA Good Laboratory Practice Regulations. The period of performance of the Master Agreement pool will be approximately three years. The Master Agreement Announcement/Request for Proposal (MAA/RFP) will be available on approximately April 29, 1994. The due date for proposals is approximately June 30, 1994. INQUIRIES Copies of the MAA/RFP NCI-CN-45001-05 may be obtained by sending a written request to: Mr. Gary P. Topper Prevention and Control Contracts Section National Cancer Institute Executive Plaza South, Suite 635 Bethesda, MD 20892 Telephone: (301) 496-8603 No collect calls will be accepted $$R1 END ************************************************************ $$R2 BEGIN OD-94-004 FULL-TEXT ************************************** EXPLORATORY CENTERS FOR ALTERNATIVE MEDICINE RESEARCH NIH GUIDE, Volume 23, Number 15, April 15, 1994 RFA AVAILABLE: OD-94-004 P.T. Office of Alternative Medicine Letter of Intent Receipt Date: May 9,1994 Application Receipt Date: June 15, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Office of Alternative Medicine invites applications that describe a plan for providing technical, clinical/scientific/assistance to Alternative Medicine (AM) clinicians/researchers as they develop their clinical databases. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," an initiative for setting national health policy and priorities. Although "Healthy People 2000" does not currently specify an AM objective, this RFA includes priority areas within the "Healthy People 2000" objectives that involve alternative medical health care. Applicants may obtain a copy of "Health People 2000" (Full Report: Stock No. 017001-00474-0) or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and not-for-profit organizations, public and private organizations such as universities, colleges, hospitals, laboratories, units of State or local governments, Federally recognized Indian Tribal organizations, and eligible agencies of the Federal government. Applications may include foreign components, but foreign organizations are not eligible to apply. MECHANISM OF SUPPORT The mechanism of support is the Resource-Related Research Projects mechanism (U24). Under the cooperative agreement mechanism, OAM anticipates substantial programmatic involvement with the awardee in a partner role during performance of the project. In general, allowable costs must be consistent with PHS policy and recommended by peer reviewers. These costs can include, but are not limited to, personnel costs, supplies, consultant costs, equipment, travel, sub-contractual and other when appropriate. FUNDS AVAILABLE The estimated funds available (total costs) for this fiscal year will be approximately $1.8 million. It is anticipated that two or three awards will be made. Length of support will be four years. RESEARCH OBJECTIVES The Office of Alternative Medicine plans to accomplish its objective to investigate and validate alternative therapies by developing exploratory centers. Within these centers the potential will exist to support planning for new interdisciplinary programs involving experienced investigators from conventional medicine with clinicians and investigators from Alternative Medicine. These centers should be able to provide clinical/scientific/technical assistance to alternative medicine clinicians who may have potentially useful accumulations of patient data that could be evaluated for treatment outcome. It will be important that the research faculty at these centers have expertise in broad areas such as biostatistics, computer processing, data management, and protocol design. Assistance is to be provided to alternative medicine clinicians/researchers for the evaluation of their retrospective clinical data. Additionally, through a peer review process which will be established by the centers, small prospective pilot studies will be started. The ultimate goal is to establish if selected "alternative therapies" have potential for further evaluation through more extensive clinical trials research. Program areas that are to be developed and subsequently evaluated regarding treatment efficacy can include: (1) Nutrition, Diet and Lifestyle/Behavioral Health Changes; (2) Mind/Body Control Therapies; (3) Traditional and Ethnomedicine Therapies; (4) Structural Manipulations and Energetic Therapies; (5) Pharmacological and Biological Therapies; (6) Bioelectromagnetic Therapies; Each center should, during the entire cooperative agreement period, evaluate the application of three of the above program areas by integrating them into one of the following center themes: (a) cancer; or (b) pain; or (c) other (disease or symptom other than cancer or pain). APPLICATION PROCEDURES Applications must be received by June 15, 1994. To apply for an Exploratory Center Cooperative agreement award, applicants are to use the PHS research grant application form PHS 398 (rev. 9/91) available from the applicant institution's office of sponsored research. Application forms can also be obtained from the Office of Grants Information Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applicants are encouraged to submit a letter of intent by May 9, 1994 to the program person listed in the Inquires section. Completed application receipt date will be June 15, 1994. The title and number of the RFA must be typed in Section 2a on the face page of the application. The signed, typewritten original of the application and three signed, exact clear and single-sided photocopies, and the completed Checklist must be sent in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS o Scientific and technical merit of the proposed approaches for conducting the project. o Qualifications and clinical/research training and experience of the Principal Investigator and staff; o Demonstration that the appropriate AM community linkages exist. o Availability of resources necessary to perform research assistance activities. o Appropriateness of the proposed budget. AWARD CRITERIA The anticipated date of award is September 30, 1994. Factors that will be taken into consideration in making awards include the scientific merit of the proposed application as evidenced by the priority score and the availability of funds. INQUIRIES The above description of the RFA guidelines is an abbreviation of a more extensive RFA that must be requested from the program administrator listed below. Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, as soon as they receive approval from their institution to apply for this award. Direct inquires regarding programmatic issues to: John Spencer, Ph.D Office of Alternative Medicine National Institutes of Health 6120 Executive Boulevard, Suite 450 Rockville, MD 20892-9904 Telephone: (301) 402-2466 FAX: (301 402-4741 AUTHORITY AND REGULATIONS This Program is described in the Catalog of Federal Domestic Assistance No. 93.213, Research and Training in Alternative Medicine. 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 Part 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. $$R2 END ************************************************************ $$R3 BEGIN MH-94-009 FULL-TEXT ************************************** MULTI-SITE STUDY OF MENTAL HEALTH SERVICE USE, NEED, OUTCOMES, AND COSTS IN CHILD AND ADOLESCENT POPULATIONS NIH GUIDE, Volume 23, Number 15, April 15, 1994 RFA AVAILABLE: MH-94-009 P.T. 34, AA; K.W. 0730057 National Institute of Mental Health Letter of Intent Receipt Date: May 1, 1994 Application Receipt Date: July 12, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Mental Health (NIMH) invites cooperative agreement applications for a five-year study of child and adolescent mental health services. Applications are invited for two types of studies. One type involves multi-site, collaborative, longitudinal, community-level studies of the types and patterns of mental health service used by children and adolescents, ages 4 to 17, the extent of unmet need for services, and the ways in which the organization and financing of services influence access to, use of, and outcomes of mental health services. The major goal of this study is to encourage investigations of the following overarching types of questions: How do community factors (poverty levels, rates of unemployment, rural/urban), service system variables (range, degree of coordination, types of inter-relationships), economic constraints (methods of financing), cultural influences (degree of acculturation, contextual factors), and family factors (roles, structures, supports, functioning) influence the need, access, use, and outcomes of mental health services across several service sectors for children and adolescents? To what extent are children's mental health needs enduring or transient? What is the impact of services on the relative persistence of children's mental health needs? With these questions providing a broad conceptual framework, applications are invited for studies in community sites by independent teams of investigators who will work together to develop a common study protocol. The other type of study involves a national epidemiological survey to address issues related to the prevalence and incidence of specific mental disorders among children and adolescents, ages 4 to 17, rates of mental health service utilization across major service sectors, and costs and financing of care. In view of the scale and complexity of the research tasks involved, applications to conduct both types of studies concurrently are not encouraged. 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, Multi-site Study of Mental Health Service Use, Need, Outcomes, and Costs in Child and Adolescent Populations, is related to the priority areas of mental disorders and suicide in children and adolescents. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Application may be submitted by domestic public and private, for- profit and non-profit institution, such as a university, college, community agency, State and local governments, and eligible agencies of the Federal government. Eligibility under this program is limited to applications from institutions of the United States, its territories and commonwealths. Minority and women investigators are encouraged to apply. MECHANISM OF SUPPORT A cooperative agreement mechanism (U01) will be used for this study program. The NIMH will work jointly with the awardees in a partnership role, to support, coordinate, and facilitate the awardees' activities. Direction and principal responsibility for the conduct and implementation of the study will rest with the awardees. Details of the responsibilities, relationships, and governance of the study are discussed in the RFA under the section "Terms and Conditions of the Award." FUNDS AVAILABLE It is estimated that up to $7 million in total costs will be available for the first year of support. The exact amount of funding available will depend on the quality of applications and program priorities at the time of the award. It is anticipated that five to seven awards will be made in September 1994. The total project period is five years. RESEARCH OBJECTIVES Background. Research to date on service use by children and adolescents with mental health problems has shown that multiple service sectors are often involved: general health, education, child welfare, juvenile justice, substance abuse, and mental health. Community surveys have shown that between 6 and 16 percent of children and adolescents with diagnosable mental disorders have received some type of mental health service in the past year. However, much is unknown about both the children and adolescents who receive care and those who do not. For those who do receive mental health services, there is limited scientific knowledge about the care they are receiving; the patterns of their service use and pathways into services; the factors influencing access to and sources of care; and the costs and quality of care. For those who do not receive mental health services, there is little scientific understanding of the social, cultural, financial, or geographic barriers experienced by the children and their parents; the alternative sources of care used; and the consequences in either the short or long term of lack of specific types of care. To obtain a more precise scientific understanding of the scope of services available to children and adolescents and of the effectiveness of the services that exist, a multi-site community study is needed. In addition, to determine the level of unmet need for services across the United States, a prevalence study of mental disorders is necessary. The Community Study Objectives and Scope. This study program will be the first major multisite collaborative study to investigate the ways in which multiple factors influence child and adolescent use of mental health services and the outcomes associated with the use and non-use of mental health services. Through use of a common study protocol, to be developed and agreed upon by investigators participating in the research, the study will make it possible to pool data from different community sites and compare community and national data. The main questions in this study program concern the influence of multiple community, service system (including organizational and financial), cultural, and family variables on child and adolescent service use and outcomes of care. The National Survey The purpose of the National Survey is to provide estimates of the prevalence and incidence of specific mental disorders and behavioral problems among children and adolescents, degree of associated functioning impairment, rates of mental health service utilization, and costs of care for children and adolescents with mental disorders. It is anticipated that one site may be selected to conduct the national survey. The selected site will be expected to work with the community sites as part of the multisite collaborative research team. SPECIAL REQUIREMENTS To assist in the development of collaborative activities among the selected sites, applicants should consider several issues. These are discussed in the complete RFA. STUDY POPULATIONS INCLUSION OF FEMALES AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines on the Inclusion of Females and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are strongly encouraged to submit, by May 1, 1994, a letter of intent that includes a descriptive title of the proposed research, the study type (i.e., community study or national survey), the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. The letter of intent is to be sent to Dr. Kimberly Hoagwood at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). Application kits containing the necessary forms may be obtained from offices of sponsored research at most universities, colleges, medical schools, and other major research facilities and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The number and the title of this RFA must be typed in item 2a on the face page of the PHS 398 application form; the YES box must also be marked. Applicants must submit, in one package, a signed original of the application, including the Checklist, and four signed copies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications that are complete and responsive to this RFA may be subjected to a preliminary evaluation by a peer review group, convened by the NIMH, to determine their scientific merit (triage); the NIMH will withdraw from further consideration applications judged to be noncompetitive and notify the principal investigator or program director and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by an initial review group (IRG) consisting primarily of non-Federal experts, convened by the NIMH. Final review is by the Mental Health Advisory Council. Notification of the review outcome will be sent to the applicant by the NIMH. Only applications recommended by Council may be considered for funding. See RFA for a description of criteria that will be used in the review. AWARD CRITERIA Factors considered in determining which research applications will be funded are: scientific and technical merit, Council recommendations, responsiveness to the goals of this RFA, significance of the topic under study to NIMH priorities, program balance, public health significance, and availability of funds. Other criteria are indicated in the RFA. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Kimberly Hoagwood, Ph.D. Child and Adolescent Services Research Program National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-4233 FAX: (301) 443-4045 E mail: KHOAGWOO@AOAMH2.SSW.DHHS.GOV Direct inquiries regarding grants management issues to: Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 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 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 as implemented through Department of Health and Human Services regulations at 45 CFR part 100 or Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN AI-94-022 FULL-TEXT ************************************** BASIC RESEARCH IN HUMAN TUBERCULOSIS NIH GUIDE, Volume 23, Number 15, April 15, 1994 RFA AVAILABLE: AI-94-022 P.T. 34; K.W. 0715165, 0715125, 0765033, 0710070, 0785055 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: May 20, 1994 Application Receipt Date: July 14, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA). IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES" BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. APPLICATIONS IN RESPONSE TO THIS RFA MUST BE PREPARED USING A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS ARE IN THE COMPLETE RFA. PURPOSE The Respiratory Diseases Branch of the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications to conduct innovative basic research to elucidate the basic biology, immunology, epidemiology, and pathogenic mechanisms of infection with Mycobacterium tuberculosis. To better understand tuberculosis epidemiology, progression, treatment, and control, the NIAID wishes to expand research in these areas with the goals of developing rational strategies for vaccine and drug development, and improving the diagnosis, treatment, and prevention of this 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 RFA, Basic Research in Human Tuberculosis, is related to the priority areas of immunity, infectious diseases, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply for First Independent Research Support and Transition (FIRST) (R29) Awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms of support will be the individual research project (R01) grant and the FIRST (R29) award. The total project period may not exceed five years for R01s and is five years for R29s. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for all awards under this RFA will be $3,500,000. In Fiscal Year 1995, the NIAID plans to fund approximately 15 R01s/R29s. Applications may not request more than four percent annual inflationary increases for future years. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background On April 23, 1993, the World Health Organization declared tuberculosis a global public health emergency, an opprobrium never accorded another disease. Once believed by health officials to be contained, tuberculosis is now recognized as out of control in many parts of the world. In the United States an estimated 15 million people are currently infected with tuberculosis. Cases increased 20 percent during the period 1985 to 1992, and in 1992, 26,678 cases of active tuberculosis were reported to the CDC. This trend continues. Persons most likely to suffer the disease include HIV-infected persons, the homeless, chronic alcohol or drug-abusers, those living in long-term care facilities such as nursing homes and jails, and especially certain minorities. The increase of tuberculosis cases in developed countries is attributed to several causes. The most important of these include the link between tuberculosis and HIV infection and the emergence of drug-resistant strains of Mycobacterium tuberculosis. Tuberculosis is the only AIDS-associated infection readily transmitted to non-HIV-infected persons. The tuberculosis crisis is intensified by the emergence of disease caused by multidrug-resistant organisms. These strains may result in an essentially incurable form of the disease, capable of spread by casual contact. Treatment of MDR-TB infections is difficult, expensive, and often unsuccessful. The resurgence of tuberculosis poses special problems for health care workers, social workers, prison personnel, and other contacts at risk. The challenge for basic researchers, clinicians, and health officials interested in tuberculosis is to apply the advances in molecular biology, genetics, immunology, and epidemiology to those problems left unexplained when research interest in tuberculosis waned. The primary goals of these efforts include the development of an effective vaccine and progress toward improved antibiotic t