From owner-sci-resources@net.bio.net Mon May 02 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 - 1 May 1994 Date: 2 May 1994 18:50:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 7 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2q4am0$6sa@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ There were no new documents on STIS this week. ------------------------------------------------------------------------ From owner-sci-resources@net.bio.net Thu May 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Peter Arzberger Newsgroups: bionet.sci-resources Subject: Collaborative Research in Neuroscience Computer and Mathematical Sciences and Engineering (NSF 94-53) Date: 6 May 1994 05:19:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 107 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2qdclc$shg@net.bio.net> Reply-To: cri@nsf.gov NNTP-Posting-Host: net.bio.net Attached please find an portion of the program announcement on Collaborative Research in Neuroscience Computer and Mathematical Sciences and Engineering. Please note that: Preproposals are NOT REQUIRED this year. The proposal target date is June 3. You may get the complete announcement via the NSF gopher, STIS. For more information, send e-mail to cri@nsf.gov Title : NSF 94-53 - Collaborative Research in Neuroscience, Computer and Mathematical Sciences and Engineering File : nsf9453 COLLABORATIVE RESEARCH IN NEUROSCIENCE, COMPUTER AND MATHEMATICAL SCIENCES AND ENGINEERING Proposal Announcement INTEGRATING ENABLING TECHNOLOGIES INTO NEUROSCIENCE RESEARCH: An NSF contribution to The Decade of the Brain: Opportunities for Planning and Initiation of Collaborative Research in Neuroscience, Computer and Mathematical Sciences and Engineering Proposal target date: June 3, 1994 with anticipated awards in August 1994. INTRODUCTION: Some of the most exciting and challenging scientific research opportunities address the mapping of function onto the structure of the brain. This research demands a multidisciplinary approach, and provides unique opportunities for neuroscientists to collaborate with investigators in mathematical, computer and information sciences, and engineering. The National Science Foundation seeks proposals to develop more comprehensive and effective collaborative research related to neuroscience. The goal of this announcement is to invite proposals for the planning and initiation of collaborations to address problems of the design, development, and implementation of electronic and information technology resources for functional studies of the nervous system. The research must be collaborative in nature, creating teams of investigators able to use common languages and scientific concepts to attack problems with impact in more than one discipline. It is expected that this cross- disciplinary research will ultimately lead to the development of novel solutions to problems of neuroscience information modeling, storage, visualization, integration and communication. Research is encouraged on any organism that provides a good model system for neuroscience. The types of projects that might be supported include image processing, visualization and multiregistration algorithms; new computational and statistical approaches; the learning capabilities of biological neurons; novel database structure and search strategies; network systems; and associated tools that provide neuroscientists access to multimodal information. It is expected that funded collaborations will expand fundamental knowledge and identify important research directions for neuroscience, computer, mathematical sciences and engineering. WHO IS INVOLVED: Teams of two or more investigators, including at least one neuroscientist and one investigator from a relevant discipline such as: - Computer, Mathematical Sciences, and Engineering - Signal Processing - Database Design - Interfaces - Systems Integration/Interoperability - Networks - Simulation - Intelligent Control/Neuroengineering - Image Processing - Scientific Visualization - Mathematical and Statistical Modeling - Applied Mathematics - Sensor Design United States academic institutions and non-profit organizations with academically oriented engineering and science research programs are invited to submit proposals. Proposals from for- profit institutions are not eligible. Proposals involving clinical studies, technical assistance, pilot plant efforts, product development, market research, classified research, literature searches, or patent applications and/or litigation will not be supported. AWARD AMOUNT AND DURATION: Awards will generally be made for one to two years at levels up to $100,000. Higher awards will be considered for large group efforts. It is anticipated that eight to twelve awards will be made each year. These awards are not renewable. Subsequent collaborative research proposals will be handled as unsolicited interdisciplinary proposals. NSF programs in neuroscience, computer, engineering and mathematical sciences are participating in the support of this collaborative research activity. From owner-sci-resources@net.bio.net Thu May 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 17, pt. 1of1, 6 May 1994 Date: 6 May 1994 05:40:45 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1345 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2qddsd$dr@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940506 V23N17 P1O1 ************************************ X-comment: RFAs described: HL-94-014, CA-94-017, AI-94-018 NIH GUIDE - Vol. 23, No. 17 - May 6, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** AVAILABILITY OF DRUG USE DATA National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N2 ********************************************************** AMERICAN TYPE CULTURE COLLECTION - U-937 CELL LINE National Center for Research Resources INDEX: RESEARCH RESOURCES NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** PREPARATION/DELIVERY OF HOMOGENEOUS CERAMIDETRIHEXOSIDASE (RFP NIH-NINDS-94-09) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R2 ********************************************************** SAFE AND EFFECTIVE STIMULATION OF NEURAL TISSUE (RFP NIH-NINDS-94-10) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R3 ********************************************************** MICROSTIMULATORS AND MICROTRANSDUCERS FOR FUNCTIONAL NEUROMUSCULAR STIMULATION (RFP NIH-NINDS-94-11) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R4 09/13/94 ************************************************* ANGIOGENESIS IN BREAST CANCER (RFA HL-94-014) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R5 09/23/94 ************************************************* TRANSLATIONAL INVESTIGATOR GRANTS FOR CANCER PREVENTION AND CONTROL (RFA CA-94-017) National Cancer Institute INDEX: CANCER $$INDEX R6 11/16/94 ************************************************* MECHANISMS OF AIDS PATHOGENESIS (RFA AI-94-018) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** SHORT-TERM RESEARCH TRAINING FOR MINORITY STUDENTS (PAR-94-064) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES THIS PUBLICATION IS AVAILABLE ELECTRONICALLY TO INSTITUTIONS VIA BITNET OR INTERNET AND IS ALSO ON THE NIH GOPHER. ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221). CONTACT DR. JOHN JAMES AT 301/594-7270 FOR DETAILS. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** AVAILABILITY OF DRUG USE DATA NIH GUIDE, Volume 23, Number 17, May 6, 1994 P.T. 34; K.W. 0404009, 0755018 National Institute on Drug Abuse PURPOSE In the October 29, 1993 (Vol. 22,. No. 39) issue of the NIH Guide for Grants and Contracts, a new program announcement (PA-94-007) titled: "Survey Research on Drug Use and Associated Behaviors," was published. As an update to that program announcement, data from the 1985, 1988, 1990, and 1991 National Household Surveys on Drug Abuse are now available from the Substance Abuse and Mental Health Services Administration, Public Health Service. These data are public use files designed to be used for secondary data analysis. INQUIRIES Direct inquiries regarding access to these data files to: Joseph Gfroerer or Janet Greenblatt Office of Applied Studies Substance Abuse and Mental Health Services Administration Parklawn Building, Room 16C-06 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-7981 Direct inquiries regarding programmatic issues to: Arthur Hughes or Andrea Kopstein Division of Epidemiology and Prevention Branch National Institute on Drug Abuse Parklawn Building, Room 9A-53 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6637 AMERICAN TYPE CULTURE COLLECTION - U-937 CELL LINE $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIH GUIDE, Volume 23, Number 17, May 6, 1994 P.T. 34; K.W. 0780015 National Center for Research Resources The National Center for Research Resources supports the American Type Culture Collection (ATCC), which is an international resource to provide scientists with a variety of biological material. This is a notification sent to all recipients of the cell line ATCC-CRL 1593 (U-937) from Freeze lot F-11205. A cellular cross contamination has been discovered and confirmed by PCR and cytogenetic analyses at the ATCC. The inappropriate cell line has not yet been identified, but is human and has a chromosomal mode of 67 plus other properties different from those of U-937. DNA and cell progeny from additional stocks of U-937 are currently under scrutiny. Results will be made public in due course. The ATCC appreciates that this contamination will have caused considerable confusion plus wasted effort in recipients' laboratories and sincerely regrets the problem. The situation emphasizes the critical need for repeated testing of stocks of cells and organisms for purity. Upon request ATCC will provide replacements for all cultures of F-11205 with aliquots of a new lot of U-937 having authenticity confirmed. INQUIRIES Direct programmatic inquiries regarding this resource to: Elaine Young, Ph.D. ATCC Project Officer National Center for Research Resources Westwood Building, Room 854 Bethesda, MD 20892 Telephone: (301) 594-7906 Direct requests for updated information and replacement cultures to: Robert Hay, Ph.D., Head Cell Culture Department American Type Culture Collection 12301 Parklawn Drive Rockville, MD 20852-1776 Telephone: (301) 231-5529 FAX: (301) 770-1848 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIH-NINDS-94-09 ****************************************** PREPARATION/DELIVERY OF HOMOGENEOUS CERAMIDETRIHEXOSIDASE NIH GUIDE, Volume 23, Number 17, May 6, 1994 RFP AVAILABLE: NIH-NINDS-94-09 P.T. 34; K.W. 0780005, 0760013, 0760080 National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, has a requirement to develop a method of producing ceramidetrihexosidase by recombinant means, isolating the enzyme, and supplying it in a form suitable for intravenous injection into patients with Fabry's disease. The enzyme preparation shall consist of a single (homogeneous) protein. The purified enzyme will catalyze the hydrolysis of a minimum of 2.0 x 1,000,000 nanomoles of 4-methylumbelliferyl alpha-D-galactopyranoside per milligram of protein per hour at 37 degrees. The enzyme will also catalyze the hydrolytic cleavage of 800,000 nanomoles of the terminal molecule of galactose from ceramidetrihexoside per milligram of protein per hour. The Contractor shall be required to deliver 650 milligrams of recombinant ceramidetrihexosidase according to the following schedule: 150 milligrams by the end of contract year 1; 200 milligrams by the end of contract year 2; and 300 milligrams by the end of contract year 3. At the time of proposal submission, the offeror's facilities must meet Food and Drug Administration (FDA) standards in accordance with draft Guidelines on the Preparation of Investigational New Drug Products (Human and Animal)(March 1991) under current good manufacturing practices and/or the technical requirements under the Statement of Work of the forthcoming Request for Proposals (RFP). It is anticipated that a single award will be made for an initial contract period of one year in March 1995, with two subsequent one-year option periods. INQUIRIES This is not an RFP. An RFP will be issued on or about May 10, 1994 and proposals will be due by COB June 30, 1994. To receive a copy of the RFP, submit a written request with two self-addressed mailing labels to: Lynne M. Darby Contracts Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 ATTN: NIH-NINDS-94-09 All responsible sources will be considered by the agency. $$R1 END ************************************************************ $$R2 BEGIN NIH-NINDS-94-10 ****************************************** SAFE AND EFFECTIVE STIMULATION OF NEURAL TISSUE NIH GUIDE, Volume 23, Number 17, May 6, 1994 RFP AVAILABLE: NIH-NINDS-94-10 P.T. 34; K.W. 0745047, 0706000, 0706040, 0750005 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, is seeking a contract to develop neural stimulating microelectrodes and evaluate the effects of electrical stimulation on neural and surrounding tissue in non-human animals. Studies have established a safe level of intracortical stimulation with single penetrating microelectrodes, but essentially nothing is known about the safe limits for multiple, closely-spaced microelectrodes such as would be used in a visual prosthesis. Progress has been made on understanding the causes of tissue damage at the higher levels of stimulation. In order to minimize tissue damage, more information is needed on methods of preventing damage, the safety of new biomaterials, as well as better methods of physically stabilizing microelectrodes in neural tissue. The possibility of using multicontact integrated circuit microelectrodes with long shanks to access buried cortical tissue also needs to be investigated. Histopathological, neurochemical, and neurophysiological techniques must be applied to determine the effects of both acute and chronic activation of neural tissue. Electrodes to be used will include discrete wire intracortical microelectrodes as well as silicon microcircuit microelectrodes furnished by the Project Officer. Personnel with expertise in histological tissue examination and facilities are needed. It is anticipated that one award will be made for a period of three years in January 1995. INQUIRIES This is not a Request for Proposals (RFP). An RFP will be issued on or about April 26, 1994 with proposals due on June 27, 1994. All responsible sources will be considered by the agency. To receive a copy of the RFP, submit a written request along with two self- addressed mailing labels to: Laurie A. Leonard Contracts Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 ATTN: NIH-NINDS-94-10 $$R2 END ************************************************************ $$R3 BEGIN NIH-NINDS-94-11 ****************************************** MICROSTIMULATORS AND MICROTRANSDUCERS FOR FUNCTIONAL NEUROMUSCULAR STIMULATION NIH GUIDE, Volume 23, Number 17, May 6, 1994 RFP AVAILABLE: NIH-NINDS-94-11 P.T. 34; K.W. 0745047, 0706000, 0706040, 0715140, 0750005 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, is seeking a contract to develop and test a system for functional neuromuscular stimulation (FNS) consisting of implantable receiver-stimulators and transducers-telemeters and an easily donned extracorporeal transmitter. Multiple implantable microstimulators that selectively stimulate paralyzed muscles in a controlled fashion may permit an individual to use his or her own muscles as the motors to produce limb movement. Multiple implantable microtransducers that sense contact, grasp force, and limb position from either implanted transducers or intact sensory receptors may provide sensory feedback from an otherwise insensate limb. To produce a useful system, these sensory and motor prostheses are being developed together as standard and compatible building blocks of an integrated FNS system. Personnel with expertise in animal testing, telemetry, biomaterials, packaging, custom circuit design, and bioengineering are needed. It is anticipated that one award will be made in February 1995 for a period of three years. INQUIRIES This is not a Request for Proposals (RFP). An RFP will be issued on or about April 26, 1994 with proposals due on June 27, 1994. All responsible sources will be considered by the agency. To receive a copy of the RFP, submit a written request, along with two self- addressed mailing labels to: Laurie A. Leonard Contracts Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 ATTN: NIH-NINDS-94-11 $$R3 END ************************************************************ $$R4 BEGIN HL-94-014 FULL-TEXT ************************************** ANGIOGENESIS IN BREAST CANCER NIH GUIDE, Volume 23, Number 17, May 6, 1994 RFA AVAILABLE: HL-94-014 P.T. 34; K.W. 0715036, 0715040 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: August 1, 1994 Application Receipt Date: September 13, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "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 Heart and Vascular Diseases invites research grant applications for up to four years of support for research into breast cancer angiogenesis. The objective of this RFA is to encourage vascular biologists to apply their knowledge and skills to elucidate the mechanisms whereby breast tumor cells stimulate angiogenesis and control the structure and function of the tumor blood vessels. The ultimate goal is to identify strategies that offer possibilities for treating breast cancer by inhibiting the vascularization of tumors. Although recent progress has led to the accumulation of much knowledge on the subject of angiogenesis, that information has yet to be synthesized in a manner that would allow the rational consideration of new treatment modalities. Moreover, knowledge has been developed by study of normal tissues, bone marrow, and many different tumors. The purpose of this initiative is to focus on breast tumors and the specific mechanisms of stimulation and inhibition of angiogenesis in those tissues. The powerful tools of molecular biology and immunology combined with animal models and possibly cell lines provide the means to increase knowledge in this area. 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, Angiogenesis in Breast Cancer, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). Trans-NIH Breast Cancer Collaborative Effort This RFA is part of the activities to be initiated by the National Institutes of Health (NIH) to advance knowledge regarding the etiology, treatment, and prevention of breast cancer. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01). 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 four years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with other investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1.5 million in total costs will be provided for the first year of support for the entire program. It is anticipated that no more than eight grants will be awarded under this program. This level of support is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NHLBI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Administrative adjustments in project period and/or amount of support may be required at the time of the award. RESEARCH OBJECTIVES Background The average U.S. mortality rate for breast cancer is 27.5 per hundred thousand women. Approximately 46,000 women died of breast cancer in 1993. Thus, despite vigorous efforts to diagnose, treat and prevent this disease, it remains a leading cause of death among women. In order to develop new approaches to the treatment of this disease, further knowledge is needed of the basic biology underlying the etiology and progression of the disease. The orientation of this initiative is on the mechanisms whereby cancer tumor cells promote angiogenesis as a means of providing nutrients to the tumor cells and a conduit for escape of tumor cells into the circulation. Recent studies have shown that vascularization is significantly higher in node-positive breast tumors than it is in node-negative tumors, and that a high degree of vascularization is generally associated with a poorer prognosis. This finding has led to the conclusion that inhibition of angiogenesis offers a possible therapeutic modality for a subset of patients. Circulation in a tumor has both favorable and detrimental aspects. The existence of blood vessels provides for the delivery of antitumor therapeutic agents at the same time it provides an escape route for metastases. A fundamental question that remains unanswered is the process whereby angiogenesis is initiated in an avascular tumor. Tumors can remain avascular and survive by growth at the periphery and necrosis at the center for several years before angiogenesis begins. On the other hand, some breast tumors metastasize before they are clinically detectable, and it is not clear whether angiogenesis is a very early event in these cases. Investigations into the process by which tumor cells may switch to the angiogenic phenotype include the following mechanisms: (1) basic fibroblast growth factor (bFGF) normally confined within cells or bound in the extracellular matrix is reported to be released when tumor cells become angiogenic, and (2) angiogenic inhibitors secreted by cells decrease with the onset of angiogenesis presumably due to the loss of a tumor suppressor. The mechanism may be tumor specific. It is important to know whether these or other mechanisms stimulate angiogenesis in breast cancer. Also involved in the angiogenic process are circulating cells recruited to tumor sites, i.e., neutrophils, monocytes, macrophages, lymphocytes, eosinophils, basophils, and mast cells. Their specific roles are only partially understood. Of these cells, only macrophages appear to have the ability to stimulate angiogenesis alone. Whether mast cells play a role in the initiation of angiogenesis, remains to be elucidated. Heparin released from mast cells is thought to have a role in potentiating angiogenesis, but is not thought to be able to act alone. Moreover, in other circumstances, heparin appears to be antiangiogenic. Lastly, although the lymphatic system is known to play a critical role in the process of metastasis, it remains unclear whether there are lymphatics within the breast tumor and how the tumor vasculature relates to the host lymphatic system. 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 1, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel, and the number and title of this RFA. 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 selection of reviewers. The letter of intent is to be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 Telephone: (301) 594-7452 FAX: (301) 402-1660 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; and from the NIH Project Scientist listed under INQUIRIES. Applications must be received by September 13, 1994. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will contact the applicant to determine whether to return the application or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NHLBI 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 in accordance with the criteria stated below for scientific/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. The review criteria for this RFA are: the novelty, originality and feasibility of the approach and the adequacy of the experimental design; the competence of the principal investigator and collaborators to accomplish the proposed research, and the commitment and time they will devote to the project; the suitability of the facilities to perform the proposed research, including laboratories, instrumentation and data management systems; the appropriateness of the requested budget and duration for the proposed research; adequate plans for interaction and communication of information and concepts among investigators involved in collaborative studies. 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: Dr. Constance Weinstein Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 3C06 Bethesda, MD 20892 Telephone: (301) 496-1081 FAX: (301) 480-6282 Inquiries regarding fiscal and administrative matters may be directed to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 594-7458 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This project is described in the Catalog of Federal Domestic Assistance No. 93.837. 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 74. This project is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN CA-94-017 FULL-TEXT ************************************** TRANSLATIONAL INVESTIGATOR GRANTS FOR CANCER PREVENTION AND CONTROL NIH GUIDE, Volume 23, Number 17, May 6, 1994 RFA AVAILABLE: CA-94-017 P.T. 34; K.W. 0715035, 0785055, 0745027, 0795003 National Cancer Institute Letter of Intent Receipt Date: June 15, 1994 Application Receipt Date: September 23, 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 Prevention and Control (DCPC) of the National Cancer Institute (NCI), invites research grant applications from investigators new to this area of research, who are in the early stages of their career, to conduct studies translating phase I (hypothesis development) and II (methods development) basic, epidemiological, and clinical research into new approaches for the prevention and control of cancer. 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, Translational Investigator Grants for Cancer Prevention and Control, is related to the priority area of cancer. Potential applicants may obtain a copy of "Health People 2000" (Full Report: Stock No. 017-001-00474-0) or "Health 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, public and private organizations, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. The Principal Investigator (PI) must have a doctoral degree and be working independently, but at the beginning stages of his or her research career in the areas of translational prevention and control research. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01). 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 may not exceed $150,000. The anticipated award date is July 1, 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 FY 95. FUNDS AVAILABLE Approximately $1.5 million, per year, in total costs for four years will be committed to fund applications submitted in response to this RFA. It is anticipated that eight awards will be made. RESEARCH OBJECTIVES There is concern about the declining number of investigators entering and remaining in academic research related to cancer prevention and control. These investigators are a critical component in translating phase I and phase II prevention and control research from epidemiological studies, the laboratory, and the clinic to broader venues such as physician practices, Health Maintenance Organizations (HMOs), and communities. This translational investigator is considered distinct from the investigator who has a Ph.D. or equivalent training and concentrates on basic or epidemiological research, or the M.D. clinician who participates in cancer research by entering patients on clinical trials. The objective of this initiative is to encourage qualified cancer prevention and control investigators to develop grant applications to conduct interventions and trials that translate phase I and II research into new means of preventing particular cancers or improving survival from cancers. Grant applications must include trials and interventions involving human subjects and be designed to ultimately reduce the incidence of particular cancers or improve cancer survival. It is expected that at least 30 percent effort will be committed to the research project by the Principal 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 June 15, 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 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. Helen Meissner at the address listed under INQUIRIES. APPLICATION PROCEDURES Method of Applying Applications are to be submitted on the grant application form PHS 398 (rev. 9/91), which 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. 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: Mrs. Toby Friedberg Referral Office Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Applications must be received by September 23, 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 RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and 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 receive a preliminary scientific peer review (triage) by an NCI peer review group for relative competitiveness. The NIH will withdraw from further consideration those applications judged to be noncompetitive for award and will notify the Principal Investigator and institutional office. Those applications judged to be competitive will undergo further scientific merit review in accordance with the review criteria listed in the RFA, by an appropriate peer review group convened by the National Cancer Institute. The second level of review will be by the National Cancer Advisory Board. 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: Helen Meissner, Sc.M. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 330 Bethesda, MD 20892 Telephone: (301) 496-8520 Direct inquiries regarding fiscal matters to: Robert E. Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399. 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 HHS policies and grant regulations. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R5 END ************************************************************ $$R6 BEGIN AI-94-018 FULL-TEXT ************************************** MECHANISMS OF AIDS PATHOGENESIS NIH GUIDE, Volume 23, Number 17, May 6, 1994 RFA AVAILABLE: AI-94-018 P.T. 34; K.W. 0715008, 0765033, 0705048 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: September 16, 1994 Application Receipt Date: November 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 Institute of Allergy and Infectious Diseases (NIAID) invites applications from single institutions or consortia of institutions for research project grants focusing on a hypothesis for AIDS-related pathogenesis. This RFA specifically solicits applications for in vivo research of AIDS-related pathogenesis utilizing state-of-the-art methods and approaches. In vivo research includes studies of human clinical or epidemiologic cohorts, of animal models, or of appropriate specimens from humans or animals. Research supported by this RFA is limited to one or more of three scientific areas: (1) non-human primate models of Human Immunodeficiency Virus (HIV) immunopathogenesis, (2) sexual/mucosal transmission of HIV or Simian Immunodeficiency Virus (SIV), and (3) host factors that modulate HIV or SIV infection or disease. Although the research necessary to test a proposed pathogenesis hypothesis may be possible within a single laboratory, the NIAID anticipates that highly competitive applications may require separate components at the same or different institutions specializing in different scientific disciplines (e.g., molecular biology, biochemistry, cellular biology, cellular immunology, genetics, and biophysics). 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, Mechanisms of AIDS Pathogenesis, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "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 or local government, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards made under this RFA will use the National Institutes of Health (NIH) individual research project grant (R01) award 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 by domestic institutions may not exceed four years; the total project period for applications submitted by foreign institutions may not exceed three years. Applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant reagents and expertise in their use, demonstrated ability in a particular area of relevant research, or access to relevant animal or patient populations. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards made under this RFA will be $6 million. Foreign applications or components that may be funded under this RFA are not eligible for indirect costs. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will vary also. The NIAID anticipates 8 to 16 awards under this RFA. This RFA may be a one-time solicitation. It is the intent of the NIAID to fund applications in each of the three scientific areas described above. The number of awards and level of support depend upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the 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 and availability of funds. RESEARCH OBJECTIVES Research grant applications responsive to this RFA should provide innovative, focused approaches to test a hypothesis of HIV pathogenesis in non-human primate models, HIV or SIV sexual/mucosal transmission, or host factors that modulate HIV or SIV infection or disease. The NIAID anticipates that investigators will propose studies testing hypotheses using state-of-the-art methods on specimens from human and/or animal models. Although the research necessary to test a proposed pathogenesis hypothesis may be possible within a single laboratory, the NIAID anticipates that highly competitive applications may require separate components at the same or different institutions specializing in different scientific disciplines. Descriptive, non-hypothesis driven, research is not within the scope of this RFA. Drug and vaccine trials in animal models, and clinical trials and recruitment or retention of cohorts will not be supported under this RFA. SPECIAL REQUIREMENTS Principal Investigators and other key members will be requested to attend an annual NIAID AIDS Pathogenesis Meeting to include grantees of the Mechanisms of AIDS Pathogenesis RFA, to be held each year at a site designated by NIAID (Bethesda, Maryland is anticipated). To best utilize limited funds, applicants are encouraged NOT to include funds for travel to other scientific meetings in their budgets. 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 September 16, 1994, a letter of intent that includes the number and title of the RFA; a descriptive title of the proposed research; names, addresses, telephone numbers, and EMAIL addresses (if available) of the Principal Investigator, component leaders and other key personnel; and the name of the primary institution and component institutions (if different). Although a letter of intent is not required, is not binding, and does not enter into the review of the application, the information that it contains is helpful in planning for the review of expected applications. The letter of intent is to be addressed to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. 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 449, Bethesda, MD 20892, telephone 301/594-7248. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. REVIEW CONSIDERATIONS Applications will be reviewed by the Division of Research Grants (DRG) staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or nonresponsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group to determine their scientific competitiveness relative to the other applications submitted in response to this RFA. The NIAID will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will notify the Principal Investigator and the institutional business official. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. Peer reviewers will base their comments and recommendations solely on the written application, which must be complete and prepared according to the RFA guidelines. A second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Applicants are strongly encouraged to discuss research plans and organizational structure with DAIDS program staff in the early stages of preparation of the application. The factors considered in evaluating the scientific merit of each application are included 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 and inquiries regarding programmatic issues to: Dr. Gregory Milman Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B35 Bethesda, MD 20892 Telephone: (301) 496-8378 FAX: (301) 480-5703 Address the letter of intent and direct any questions regarding review procedures to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 Bethesda, MD 20892 Telephone: (301) 496-0818 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 The above individuals may also be addressed by EMAIL to: MAPS@EXEC.NIAID.PC.NIAID.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergy and Transplantation Research. 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 Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R6 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PAR-94-064 *********************************************** SHORT-TERM RESEARCH TRAINING FOR MINORITY STUDENTS NIH GUIDE, Volume 23, Number 17, May 6, 1994 PA NUMBER: PAR-94-064 P.T. 44, FF; K.W. 0720005, 0725000 National Institute of Environmental Health Sciences Application Receipt Dates: July 15, 1994 and May 10 each subsequent year. PURPOSE The National Institute of Environmental Health Sciences (NIEHS) announces a program to support short-term biomedical research training experiences for minority undergraduate students in areas related to defining and understanding the action of environmental agents on human health. The purpose of the award is to encourage institutions with a significant environmental health sciences research and training program to provide opportunities for underrepresented minority students who have expressed an interest in a career in biomedical research. The intent is to interest highly motivated and qualified minorities at the undergraduate level in developing both their interests and scientific capacity to pursue a professional career in biomedical research relevant to the environmental health sciences. 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, Short-Term Research Training for Minority Students, is related to the priority area of environmental health. Potential applicants may obtain a copy of Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "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 Awards under this program will be made to domestic institutions or organizations, including minority institutions, engaged in health related research in areas of environmental health sciences. These grants will support full-time, short-term research training experiences of one to three months duration for underrepresented minority undergraduate students. Trainees appointed to the program need not be from the grantee institution, but may include a number of minority students from other institutions, schools, colleges or universities. Trainees may be appointed for up to three separate short-term training periods. However, in no circumstance may a training period exceed three months in any year. The grantee institution will be responsible for the selection and appointment of trainees. In order to facilitate the training of minority students, the NIEHS has determined that this research training could be facilitated as a part of an ongoing research training program. Therefore, applications from existing NIEHS Institutional Training Grant (T32) programs are strongly encouraged. Also, only institutions with a significant, peer-reviewed NIEHS research grant are eligible to apply. For the purpose of this program, underrepresented minority students are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Awards will be limited to United States citizens or to individuals who have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. In awarding grants, the NIEHS will give priority to programs involving Black, Hispanic, Native American, and Pacific Islander or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Trainees should have successfully completed at least one undergraduate year at an accredited school or university prior to participating in the program. In addition, the student should be interested in a career in biomedical research in environmental health sciences. These grants are intended to introduce, foster, and develop the interest and capability of students in environmental health sciences research that would not otherwise be available through their regular course of studies. This program is intended to increase the number of qualified minorities for professional careers in environmental health sciences research by increasing the number of qualified applicants for graduate training programs. MECHANISM OF SUPPORT The mechanism of support is the institutional National Research Service Award for Short-Term Training of Students (T35). Institutions may request up to five years of support for short-term training programs for at least three and not more than six trainees per year. As indicated above, applications from existing NIEHS T32 awardees are strongly encouraged. The stipend level for trainees is $834 per month. Stipends may be supplemented from non-Federal funds. Training-related expenses up to $250 per month, per trainee, may be requested. In addition, up to $500 per trainee may be requested to cover domestic travel to and from the training site, and up to $400 per month, per trainee may be requested to cover the cost of housing and subsistence at the training site. Trainee tuition and fees, where necessary to the research training, must be covered by the training-related expenses. Indirect costs will be awarded based on eight percent of total direct costs, exclusive of tuition and fees. Supplementation of stipends when provided must not require an obligation from the fellow. Under no circumstances may Federal grant funds be used for supplementation unless specifically authorized under the terms of the program from which the funds are derived. RESEARCH OBJECTIVES In the NIH Revitalization Act of 1993, the NIH was encouraged to increase the number of underrepresented minorities participating in biomedical and behavioral research. However, an analysis of the NIEHS training pool revealed that less than five percent of these individuals were underrepresented minorities. Less than one percent of the principal investigators of NIEHS research grants are underrepresented minorities. In addition, the number of underrepresented minority applicants for research grants and training positions was very low. This program will establish a mechanism for universities and other eligible institutions that are involved in environmental health sciences research and training to identify and train qualified underrepresented minorities earlier in their academic careers. The intent of this program announcement is to significantly improve the number and quality of students interested in research careers in environmental health sciences. The Short-Term Research Training for Minority Students Program is designed to offer short-term training grant awards in environmental health sciences research to eligible institutions to enable qualified undergraduate students to become better prepared for a career in environmental health sciences research. It is expected to attract students in the developmental stages, to increase their awareness of environmental health sciences research, to improve their scientific skills and to acquaint them with career opportunities in research. It is expected that this program will increase in a direct and measurable way, the number and success of underrepresented minority students attracted to NIEHS training grants . 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 in the offices of sponsored research at most academic and research institutions and from the Grants Information Office, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Additional information and guidelines for the program are available from the NIEHS, and can be obtained by contacting Dr. Michael Galvin at the address listed under INQUIRIES. Except for the first year, which has a receipt date of July 10, there will be a single receipt date of May 10, each year. If an application is received after that date, it will be returned to the applicant. To identify the application as a response to this program announcement, check "YES" in Item 2a on the face page of the application and enter the program announcement title, "SHORT-TERM RESEARCH TRAINING FOR MINORITY STUDENTS," and program announcement number, PAR-94-064. A signed, typewritten original of the application, including the checklist, and five signed photocopies of the application must be sent 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 that do not meet the guidelines, including applications without a significant, peer-reviewed NIEHS research grant base, will be returned without review. Applications will be reviewed for scientific and technical merit by the Environmental Health Sciences Review Committee in accordance with the standard NIH peer review procedures for training grants. Factors that will be used in the review to evaluate applications are: o evidence of an organized program for training students in environmental health sciences topics. o the availability of opportunities for students to participate in a research environment. o access to an appropriate student population. o institutional facilities and commitment such as housing, tutors, faculty time or other substantive commitments by the institution. o criteria for selecting students. Following the initial review of scientific and training merit, the applications will receive a second-level review by the National Advisory Environmental Health Sciences Council. AWARD CRITERIA Applications will compete for available funds with all other training applications recommended for further consideration that have been assigned to the NIEHS. The following will be considered in making funding decisions. o Quality of the proposed training program, as determined by initial review. o Commitment of the institution to the program. o Availability of funds. o Program balance among the training areas supported by the NIEHS. 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: Dr. Michael Galvin, Jr. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 Direct inquiries regarding fiscal matters to: Ms. Jacqueline M. Russell Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, Building 2 Research Triangle Park, NC 27709 Telephone: (919) 541-7628 FAX: (919) 541-2860 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.894, Resource and Manpower Development in the Environmental Health Sciences. 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, 43 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Thu May 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-94-014 - V23(17) 05/06/94 Date: 6 May 1994 05:40:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 532 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2qddsj$ea@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL94014 HL-94-014 P1O1 *************************************** ANGIOGENESIS IN BREAST CANCER NIH GUIDE, Volume 23, Number 17, May 6, 1994 RFA: HL-94-014 P.T. 34; K.W. 0715036, 0715040 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: August 1, 1994 Application Receipt Date: September 13, 1994 PURPOSE The Division of Heart and Vascular Diseases invites research grant applications for up to four years of support for research into breast cancer angiogenesis. The objective of this Request for Application is to encourage vascular biologists to apply their knowledge and skills to elucidate the mechanisms where by breast tumor cells stimulate angiogenesis and control the structure and function of the tumor blood vessels. The ultimate goal is to identify strategies that offer possibilities for treating breast cancer by inhibiting the vascularization of tumors. 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, Angiogenesis in Breast Cancer, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (202-783-3238). Trans-NIH Breast Cancer Collaborative Effort This RFA is part of the activities to be initiated by the National Institutes of Health (NIH) to advance knowledge regarding the etiology, treatment, and prevention of breast cancer. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) mechanism of support. 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 four years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1.5 million in total costs will be provided for the first year of support for the entire program. It is anticipated that no more than eight grants will be awarded under this program. This level of support is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NHLBI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Administrative adjustments in project period and/or amount of support may be required at the time of the award. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. RESEARCH OBJECTIVES Background The average U.S. mortality rate for breast cancer is 27.5 per hundred thousand women. Approximately 46,000 women died of breast cancer in 1993. Thus, despite vigorous efforts to diagnose, treat and prevent this disease, it remains a leading cause of death among women. In order to develop new approaches to the treatment of this disease, further knowledge is needed of the basic biology underlying the etiology and progression of the disease. The orientation of this RFA is on the mechanisms whereby cancer tumor cells promote angiogenesis as a means of providing nutrients to the tumor cells and a conduit for escape of tumor cells into the circulation. Recent studies have shown that vascularization is significantly higher in node-positive breast tumors than in node-negative tumors, and that a high degree of vascularization is generally associated with a poorer prognosis. This finding has led to the conclusion that inhibition of angiogenesis offers a possible therapeutic modality for a subset of patients. Circulation in a tumor has both favorable and detrimental aspects. The existence of blood vessels provides for the delivery of antitumor therapeutic agents but at the same time it provides an escape route for metastases. In a growing tumor, pre-existing host blood vessels become incorporated into the tumor tissue. These vessels, however,are altered; venules are tortuous, elongated and dilated. New blood vessel growth occurs from these venules or from venules in the host tissue adjacent to the invasion front. Some of the original host vessels in the tumor disintegrate, are obstructed or are compressed. Of the remaining vessels, arteries seem to become permanently dilated and resistant to the invasive and destructive growth of tumor cells. The newly formed vessels randomly fuse either with arterioles or venules and create a microcirculation that has many characteristics not found in the microcirculation of normal tissues. These characteristics include abnormal morphology,absence of vasomotion, increased fragility, and increased permeability. Regions of a tumor may be avascular or poorly vascularized and it is unclear why angiogenesis fails in those regions. A fundamental question that remains unanswered is how angiogenesis is initiated in an avascular tumor. In the heart, the stimulus is thought to be ischemia and the vascular response is almost immediate. Animal models subjected to embolization showed evidence of angiogenesis in three days. Tumors can remain avascular and survive by growth at the periphery and necrosis at the center for several years before angiogenesis begins. On the other hand, some breast tumors metastasize before they are clinically detectable and it is not clear whether or not angiogenesis is a very early event in these cases. Investigations into the process by which tumor cells may switch to the angiogenic phenotype include the following mechanisms: (1) basic fibroblast growth factor (bFGF) normally confined within cells or bound in the extracellular matrix is reported to be released when tumor cells become angiogenic and (2) angiogenic inhibitors secreted by cells decrease with the onset of angiogenesis presumably due to a loss of a tumor suppressor. The mechanism may be tumor specific, and it is important to know whether these or other mechanisms stimulate angiogenesis in breast cancer. The first apparent response to an angiogenic stimulus from a tumor is thought to be dissolution of the basement membrane surrounding a pre-existing vessel, usually a post-capillary venule. Endothelial cells are then believed to migrate toward the tumor. The leading endothelial cells do not appear to divide, whereas those behind do. After elongation of immature vessels, lumen formation occurs along with branching and formation of vascular loops to produce a vascular network. Finally, capillaries become surrounded by basement membrane components and, in most cases, pericytes. However, as described in further detail below, these processes differ from those seen in vascularization of normal tissue. The question of how these events are effected is complex but it is clearly the result of interactions, either direct or indirect, between tumor cells and endothelial cells. Much progress has been made in identifying factors that contribute to tumor angiogenesis. In fact, more than a dozen purified molecules have been shown to be angiogenic; most of them are polypeptides, but lipids, nucleotides, copper, selenium, and one vitamin have also been shown to have angiogenic properties. The more difficult task is to now develop an understanding of the cascade of events that result in vascularization of a breast tumor and to identify specific factors and their precise roles in that process. Some of these factors are angiogenic in vivo but do not have measurable effects on cultured cells, probably because the effect requires the presence of other cells, such as macrophages that produce endothelial activating factors, or because the factor is normally stored in a cell or the extracellular matrix and is only released under certain conditions. Angiogenin is one factor that has no effect on endothelial cell cultures. Additionally, it is produced in adult rat liver and is found in normal bovine and human plasma. Thus, its activity as an angiogenic factor seems to be expressed only in special circumstances when a receptor is presented on the endothelial cell surface. Some factors such as angiotropin, fibrin, and tumor necrosis factor-alpha (TNF-alpha) stimulate endothelial cells to migrate, but not to proliferate. Others, such as basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) are both mitogenic and chemotactic. Mitogenic factors can be produced by macrophages, monocytes, platelets, and lymphocytes as well as tumor cells. Heparin-binding growth factors (HBGFs), including basic and acidic FGFs, do not have signal peptides, yet appear to be released into the subendothelial extracellular matrix and stored there bound to heparin sulfate. Degradation of the extracellular matrix is, in itself, a complex process involving T and B lymphocytes, platelets, granulocytes, macrophages, mast cells, and endothelial cells, as well as compounds such as thrombin, and plasminogen activator (PA). PA inhibitors (PAIs) are also present. Degradation appears to be under the control of tumor cells. A further step needed for the potent mitogens to interact with endothelial cells is the expression of receptors on those cells. How all of these steps are integrated is not well understood. Ischemia/hypoxia is reported to be a stimulus for angiogenesis. Recent studies have shown that VEGF is highly expressed in human gliomas around the periphery of necrotic cords and that the VEGF receptor is expressed only on endothelial cells. In culture, a glioma cell line was shown to express VEGF mRNA in response to hypoxia. Upon reoxygenation, mRNA levels returned to control levels. Since VEGF expression is also influenced by estrogen, there may be a particular relevance to breast cancer. Other participants in the angiogenic process are circulating cells recruited to tumor sites. These include neutrophils, monocytes, macrophages, lymphocytes, eosinophils, basophils, and mast cells. Their specific roles are only partially understood. Of these cells, only macrophages appear to have the ability to stimulate angiogenesis alone. Mast cells may play a role in the initiation of angiogenesis but this possibility remains to be elucidated. Heparin released from mast cells is thought to have a role in potentiating angiogenesis but not to be able act alone. Moreover, in other circumstances, heparin appears to be antiangiogenic. It is important to note that the roles of angiogenic factors in tumor vascularization may differ from those in wound healing. There are important distinctions between the structure and function of tumor versus normal endothelium. Thus, once the process of angiogenesis is initiated, tumor cell-endothelial cell interactions become determinants of the growth, morphology, and function of the developing vessels. For example, normal capillaries are often surrounded by pericytes, whereas these may be reduced in number or absent from tumor capillaries. Pericytes are thought to be involved in the maturation of vessels and the inhibition of endothelial proliferation. The combined activity of endothelial cells and pericytes is thought to result in the elaboration of TGF-beta, an inhibitor of endothelial cell proliferation. However, under certain circumstances, TGF-beta can also promote angiogenesis. Additionally, the extracellular matrix of tumor vessels is different. The basement membrane surrounding the vessels is reduced, there are higher concentrations of hyaluronic acid and lower concentrations of sulfated proteoglycans. The tumor vessels have increased permeability, which may be due in part to the reduced basement membrane, in part to increased fluid pressure in tumors and in part to the elaboration of permeability factors, as well as to modification or reduction of cell adhesion molecules. In addition, the increased permeability of the tumor vasculature may be due to stimulation of nitric oxide release by FGF. All of these features would facilitate entry of tumor cells into the lumen in a manner not possible for normal blood vessels. An alternative source of angiogenic factors is the stroma, which is specific to the breast and contains a variety of cells including fibroblasts, macrophages and adipocytes. The stroma functions as a source and storage site for cytokines and growth factors. The possibility that the stroma is abnormal in tumorogenesis has yet to be investigated. Although recent progress has led to the accumulation of much knowledge on the subject of angiogenesis, that information has yet to be synthesized in a manner that would allow the rational consideration of new treatment modalities. Moreover, that knowledge has been developed from studies of normal tissues, bone marrow, and many different tumors. The purpose of this initiative is to focus on breast tumors and on the specific mechanisms of stimulation and inhibition of angiogenesis in those tissues. The powerful tools of molecular biology and immunology combined with animal models and possibly cell lines provide the means to increase knowledge in this area. Lastly, although the lymphatic system is known to play a critical role in the process of metastasis, it remains unclear whether there are lymphatics within the breast tumor and how the tumor vasculature relates to the host lymphatic system. Research Topics The following suggestions are given only as examples. They are not intended to represent research directions to which the NHLBI would give special emphasis. Investigators are urged to utilize their own knowledge of the subject in preparing a response to this RFA. o changes in tumor cell gene expression that elicit angiogenesis in breast tumors o mechanisms underlying the expression of receptors for angiogenic factors on endothelial cells o interactions between tumor cells, circulating cells, and endothelium in breast tumors o role of the stroma in promotion of angiogenesis o mechanisms that direct endothelial cell migration into the tumor o molecular regulation of angiogenic factor production by breast cells o mechanisms of control of gene expression in endothelial cells residing in breast tumors o relative roles of tumor cells and altered endothelial cells in the modification of extracellular matrix associated with tumor capillaries o role of hormones in the angiogenic process in breast cancer o endogenous inhibitors of angiogenesis o the relative roles of specific oncogenes and tumor suppressor genes in modulating the process of metastasis o the relationship of the tumor vasculature and possible lymphatics to the host blood vessels and lymphatic system Investigators should be aware that NIH requires applicants to comply, where feasible and appropriate, to the inclusion of minorities and women in study populations. SPECIAL REQUIREMENTS Although multidisciplinary approaches are encouraged, it is not the intent of this RFA to solicit applications for large studies that would encompass a variety of independent projects, e.g., program projects. This program will not support clinical trials or large epidemiological studies. In general, funds will not be provided for the purchase and installation of expensive, equipment. Awards under this RFA to foreign institutions will be made only for research of very unusual merit, need and promise, and in accordance with PHS policy governing such awards. Upon initiation of the program, the Division of Heart and Vascular Diseases will sponsor periodic meetings to encourage the exchange of information among grantees and to stimulate collaboration. Applicants should include their budget request funds for travel to an annual one-day meeting, most likely to be held in Bethesda, Maryland, and should also include a statement indicating their willingness to participate in these meetings. STUDY POPULATION 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 August 1, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains 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: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application for 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 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 delay 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 "Angiogenesis in Breast Cancer", and the RFA number HL-94-014 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, Centers and Special Projects Section, at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants; otherwise, the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. Applications must be received by September 13, 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. Schedule Letter of Intent Receipt Date: August 1, 1994 Application Receipt Date: September 13, 1994 Review by NHLBI Advisory Council: February 1995 Anticipated Award Date: May 1995 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned without further consideration. If the application is complete but not responsive to the RFA, NHLBI staff will contact the applicant to determine whether to return the application or to submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NHLBI 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 NHLBI. The second level of review will be provided by the National Heart, Lung, Blood Advisory Council. Review Criteria The review criteria are: o the novelty, originality, and feasibility of the approach and the adequacy of the experimental design o the competence of the principal investigator and collaborators to accomplish the proposed research, and the commitment and time they will devote to the project o the suitability of the facilities to perform the proposed research, including laboratories, instrumentation, and data management systems o the appropriateness of the requested budget and duration for the proposed research o the adequacy of plans for interaction and communication of information and concepts among investigators involved in collaborative studies AWARD CRITERIA Applications must fulfill all the eligibility criteria in order to be considered for funding. The most important criterion in selecting awardees will be scientific merit, as reflected in the priority score. However, factors such as program balance and available funds may also enter into the selection of meritorious applications. The anticipated date of award is May 1995. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Dr. Constance Weinstein Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 3C06 Bethesda, MD 20892 Telephone: (301) 496-1081 FAX: (301) 480-6282 Inquiries regarding fiscal and administrative may be directed to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 594-7458 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance number 93.837, Heart and Vascular Diseases. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency Review. The 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 Thu May 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-017 - V23(17) 05/06/94 Date: 6 May 1994 05:40:54 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 387 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2qddsm$en@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94017 CA-94-017 P1O1 *************************************** TRANSLATIONAL INVESTIGATOR GRANTS FOR CANCER PREVENTION AND CONTROL NIH GUIDE, Volume 23, Number 17, May 6, 1994 RFA: CA-94-017 P.T. 34; K.W. 0715035, 0785055, 0745027, 0795003 National Cancer Institute Letter of Intent Receipt Date: June 15, 1994 Application Receipt Date: September 23, 1994 PURPOSE The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI), invites research grant applications from investigators new to this area of research, who are in the early stages of their career, to conduct studies translating phase I (hypothesis development) and II (methods development) basic, epidemiological, and clinical research into new approaches for the prevention and control of cancer. 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), Translational Investigator Grants for Cancer Prevention and Control, is related to the priority area of cancer. Potential applicants may obtain a copy of "Health People 2000" (Full Report: Stock No. 017-001-00474-0) or "Health 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. The principal investigator (PI) must have a doctoral degree and be working independently, but at the beginning stages of his or her research career in the areas of translational prevention and control research. An important principle to remember is that the more extensive the prior independent research experience, regardless of funding source, 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 project grant (R01). 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 may not exceed $150,000. The anticipated award date is July 1, 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 FY 95. However, the NCI has plans to re-issue this RFA for funding in FY 1996 and 1997. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to customary peer review procedures unless additional re-issuances are required. FUNDS AVAILABLE Approximately $1.5 million, per year, in total costs for four years will be committed to fund applications that are submitted in response to this RFA. It is anticipated that eight new individual awards will be made. RESEARCH OBJECTIVES Background and Rationale The DCPC supports research with an emphasis on studies to identify, evaluate, and implement techniques and approaches for the primary, secondary, and tertiary prevention of cancer. Those studies may focus on specific cancers, such as breast or prostate, or more general areas of prevention research such as studies to change current behaviors and/or develop new behaviors effective in reducing incidence, morbidity or mortality from cancer (e.g., smoking, diet, early detection), or studies to improve the application of patient management, pain, or symptom management and rehabilitation principles. There is concern about the declining number of investigators entering and remaining in academic research related to cancer prevention and control. These investigators are a critical component in translating phase I and phase II prevention and control research from epidemiological studies, the laboratory, and the clinic to broader venues such as physician practices, Health Maintenance Organizations (HMOs), and communities. These investigators must maintain a broad perspective and knowledge concerning epidemiology and clinical and basic sciences, while developing new delivery and intervention approaches that are hypothesis driven. They are highly interactive with basic, clinical, and epidemiological researchers in related disciplines. This translational investigator is considered distinct from the investigator who has a Ph.D. or equivalent training and concentrates on basic or epidemiological research, or the M.D. clinician who participates in cancer research by entering patients on clinical trials. Usually, investigators who do not have the publication or research track record in cancer prevention and control translational research are not competitive for R01 grant support. Thus, very few prevention and control research applications are submitted by these investigators. The DCPC would like to reverse this trend and encourage prevention and control investigators new to the area of the conduct of translational research. Objectives The objective of this initiative is to encourage qualified cancer prevention and control investigators to develop grant applications to conduct interventions and trials that translate phase I and II research into new means of preventing particular cancers or improving survival from cancers. Investigators are urged especially to address the more difficult prevention and control challenges, including the most common malignancies in adults (e.g., breast, lung, colon, prostate) and risk factors (e.g., tobacco use, diet and nutrition, early detection, environmental exposures). Project Description The DCPC encourages qualified prevention and control investigators to develop R01 research grant applications to conduct studies translating phase I and II epidemiological, basic, and clinical research into new approaches for the prevention and control of cancer. Examples of translational research include controlled feeding studies to improve understanding of the bioavailability of vitamins and minerals administered in different forms (e.g., tablets, fruits); controlled interventions to increase and improve smoking cessation counseling, or breast, cervical and colorectal screening by physicians; and studies to determine the relative effectiveness of behavioral interventions to reduce side effects of cancer treatments, such as anxiety or nausea. Research grant applications submitted in response to this RFA must include trials and interventions involving human subjects and be designed to ultimately reduce the incidence of particular cancers or improve cancer survival. The trials and interventions must have a strong rationale and be based upon phase I and II research that support the underlying hypotheses. New intervention trials employing such channels as appropriate dietary regimens, pharmacologic agents, or behavioral or psychosocial change mechanisms, whether used as a single agent/modality or in combination, are appropriate. The research plan should be focused on the trial or intervention proposed. Laboratory studies to monitor patients or to study the mechanism of action of agents may be included as appropriate. It is expected that at least 30 percent effort will be committed to the research project by the Principal Investigator. 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 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 June 15, 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 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. Helen Meissner at the address listed under INQUIRIES. APPLICATION PROCEDURES Method of Applying Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title and number of this RFA must be typed in Section 2a on the face page of the application form and the YES box must be marked All requirements including those with regard to type, size, page limitations, and appendix material must be followed or the application 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: Mrs. Toby Friedberg Referral Office Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Applications must be received by September 23, 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 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. Application Requirements The application must include the following documentation to be considered for review: o A letter or memorandum from a department head or dean must be included that addresses the eligibility of the proposed principal investigator to independently lead a research project at the applicant institution and a description of the institution's intended commitment to the project for the four year period. o A draft of any protocols involved must be included in the Appendix. Documentation of the status of Human Subjects and IRB approval must also be included. o Documentation of the gender and racial/ethnic group composition of the proposed study population, together with a rationale for its choice, must be included in the Human Subjects section. o Provision for one two-day meeting to Bethesda must be included in each year's budget. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If the application is complete but 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 receive a preliminary scientific peer review (triage) by an NCI peer review group for relative competitiveness. The NIH will withdraw from further consideration those applications judged to be noncompetitive for award and will notify the Principal Investigator and institutional office. Those applications judged to be competitive will undergo further scientific merit review in accordance with the criteria stated below by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be by the National Cancer Advisory Board. Review Criteria are: o scientific/technical significance and originality of proposed research; o extent to which the proposed research clearly translates basic, epidemiological and clinical research into cancer prevention and control applications; o appropriateness and adequacy of the experimental design and methodology proposed to carry out the research; o qualifications and relevant research experience of the Principal Investigator and collaborating scientists o availability of the resources necessary to perform the research; o evidence that appropriate steps have been taken to ensure the protection of human subjects; and o evidence of compliance with NIH policies regarding the inclusion of women and minorities in research study populations. The review group will examine the details of the proposed budget and recommend an appropriate budget and period of support for each application recommended for further consideration. AWARD CRITERIA The anticipated date of award is July 1, 1995 Applications found to have significant and substantial scientific merit will be considered for funding based on priority score, availability of funds, and programmatic priorities. In addition, preference will be given to clinical investigators who are new to cancer prevention and control translational research. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Helen Meissner, Sc.M. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 330 Bethesda, MD 20892 Telephone: (301) 496-8520 FAX: (301) 402-8520 Direct inquiries regarding fiscal matters to: Robert E. Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399. 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 HHS policies and grant regulations. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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 May 05 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-94-018 - V23(17) 05/06/94 Date: 6 May 1994 05:40:59 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 643 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2qddsr$f0@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI94018 AI-94-018 P1O1 *************************************** MECHANISMS OF AIDS PATHOGENESIS NIH GUIDE, Volume 23, Number 17, May 6, 1994 RFA: AI-94-018 P.T. 34; K.W. 0715008, 0765033, 0705048 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: September 16, 1994 Application Receipt Date: November 16, 1994 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications from single institutions or consortia of institutions for research project grants focusing on a hypothesis for AIDS-related pathogenesis. This Request for Applications (RFA) specifically solicits applications for in vivo research of AIDS-related pathogenesis utilizing state-of-the-art methods and approaches. In vivo research includes studies of human clinical or epidemiologic cohorts, of animal models, or of appropriate specimens from humans or animals. Research supported by this RFA is limited to one or more of three scientific areas: (1) non-human primate models of HIV immunopathogenesis, (2) sexual/mucosal transmission of HIV or SIV, and (3) host factors that modulate HIV or SIV infection or disease. Where scientifically justified, applicants are encouraged to include both human and animal studies. Although the research necessary to test a proposed pathogenesis hypothesis may be possible within a single laboratory, highly competitive applications may require separate components at the same or different institutions specializing in different scientific disciplines (e.g., molecular biology, biochemistry, cellular biology, cellular immunology, genetics and biophysics). 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, Mechanisms of Aids Pathogenesis, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "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, public and private organizations, such as universities, colleges, hospitals,laboratories, units of State or local government, and eligible agencies of the Federal government. Successful applications from foreign institutions are limited to three years of support for direct costs; domestic applications may include international components, but these components will receive no support for indirect costs. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards made under this RFA will use the National Institutes of Health (NIH) individual research project grant (R01) award 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 by domestic institutions may not exceed four years; the total project period for applications submitted by foreign institutions may not exceed three years. Applicants are strongly encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant reagents and expertise in their use, demonstrated ability in a particular area of relevant research, or access to relevant animal or patient populations. 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 in the application. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $6 million. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will vary also. The NIAID anticipates 8 to 16 awards under this RFA. It is the intent of the NIAID to fund applications in each of the three scientific areas described in RESEARCH OBJECTIVES below. The number of awards and the levels of support will depend upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Continued funding beyond the first and subsequent years of a grant will be contingent upon satisfactory progress and availability of funds. Applicants are encouraged to discuss budget requests with Division of AIDS (DAIDS) program staff (listed under INQUIRIES) prior to submission. Requests for expensive equipment are not encouraged. Investigators are encouraged to use animals efficiently and to minimize expenses for animal purchase and/or support. The purchase of animals must be strongly justified. This RFA is a one-time solicitation. Future competing continuation applications will compete with unsolicited investigator-initiated applications and be reviewed by an appropriate Study Section according to the customary NIH referral and peer review procedures. RESEARCH OBJECTIVES A. Background Non-Human Primate Models of HIV Immunopathogenesis Non-human primate models of HIV disease are vital tools for pathogenesis research. Where no single animal model satisfies all investigative requirements, comparison of data from multiple models may contribute to the understanding of the pathogenic aspects of HIV disease. The simian immunodeficiency virus (SIV) and chimeric SIV-HIV infections of macaques are well described. Clues to HIV pathogenesis also may be discovered from analyses of lentivirus-infected non-human primates in which there is little or no apparent disease, e.g., HIV-infected chimpanzees and African green monkeys infected with African Green Monkey (AGM) lentiviruses. Sexual/Mucosal Transmission The overwhelmingly predominant mode of transmission of HIV is through exposure of mucosal surfaces to infected sexual fluids (semen, cervical/vaginal, rectal) and during birth. However, epidemiological data suggest that sexual transmission, in general, is relatively inefficient, in that exposure does not always produce infection. Some individuals who are exposed to HIV via mucosal surfaces over prolonged periods remain seronegative. The likelihood of transmission is increased by factors that decrease the integrity of the mucosal epithelium. Epidemiologic studies have implicated sexually transmitted diseases that produce genital ulcerations or inflammation, use of intrauterine devices, and lack of male circumcision as cofactors facilitating HIV transmission. Studies in the SIV monkey model indicate that 100- to 1,000-fold more infectious virus is required to produce infection following application to intact genital mucosal surfaces than by intravenous injection. Studies of mucosal infection in the SIV model suggest that mucosal dendritic cells may be the first cells infected. Subsequently, infected dendritic cells may migrate to lymph nodes where they infect other cells. Host Resistance to Infection or Disease Genes that confer host resistance to retroviral infection in animals have been described and include both immune response genes and non-immune response genes. For example, the product of the Fv-1 allele prevents the development of leukemia in inbred mice infected with specific MuLV strains. Recent experimental evidence suggests that host genes may also modulate infection or disease caused by lentiviruses including HIV. In vitro evidence for the relative resistance of human T lymphocytes to HIV infection has been described. Resistance of PBMCs from individual monkeys to infection by SIV has also been observed and has been reported to be predictive of disease course. Investigation of these and other resistance mechanisms may reveal novel events in infection or replication of lentiviruses and could lead to novel prevention or therapeutic strategies. The NIAID Multicenter AIDS Cohort Study (MACS) has shown that the median time from infection with HIV to development of AIDS is approximately 10 years, although this time period is highly variable among different individuals. A small proportion of the cohort participants who seroconverted in the study developed AIDS and died within two or three years of HIV infection, while others have maintained stable, high CD4+ cell counts ten or more years following HIV infection. To date, no independent epidemiologic factor or set of host or viral factors has been identified that reliably predicts disease progression or a state of relative "immunologic non-progression" (as judged by CD4+ cell stability). Studies of host factors and other determinants of HIV infection and disease are needed to gain a better understanding of the pathogenesis of HIV. B. Goals The NIAID HIV/AIDS Research Agenda (October 1993) identified eight critical areas of research in HIV pathogenesis: o molecular biology of viral and cellular processes; o cellular biology and immunology related to the course and dynamics of HIV infection; o viral genetic and phenotypic correlation with disease; o host factors affecting infection and/or progression; o external factors affecting infection and/or progression; o mechanisms of HIV-related immunodeficiency; o animal models of HIV infection and/or pathogenesis; and o mechanisms of sexual transmission and mucosal immunity. Reviews of the DAIDS pathogenesis programs by an ad hoc committee and by the AIDS Research Advisory Committee (ARAC) concurred with these eight critical areas of research and recommended that three receive particular emphasis, specifically: non-human primate models of HIV immunopathogenesis, sexual/mucosal transmission of HIV or SIV, and host factors that modulate HIV or SIV infection or disease. The reviews strongly encouraged NIAID to promote studies of in vivo pathogenesis in these areas utilizing state-of-the-art in vitro approaches. This RFA is intended to foster applications for integrated, multi-disciplinary pathogenesis research linking in vitro studies to in vivo disease and focusing specifically on these three scientific areas. The most relevant studies are expected to examine molecular and cellular biology, virology, and immunology within the context of animal models and/or well-defined human cohorts or patient samples. C. Research Scope Research grant applications responsive to this RFA should provide innovative focused approaches to test a hypothesis of HIV pathogenesis in non-human primate models, HIV or SIV sexual/mucosal transmission, or host factors that modulate HIV or SIV infection or disease. The NIAID anticipates that investigators will propose studies testing hypotheses using state-of-the-art methods on specimens from human and/or animal models. Although the research necessary to test a proposed pathogenesis hypothesis may be possible within a single laboratory, highly competitive applications may require separate components at the same or different institutions specializing in different scientific disciplines (e.g., molecular biology, biochemistry, cellular biology, cellular immunology, genetics, and biophysics). If applicable, applicants are encouraged to select component leaders based on scientific excellence rather than proximity. If multiple components are proposed, the interactive role of each component in investigating the hypothesis should be described. The following are examples of major issues or gaps in knowledge in the three RFA scientific areas that were identified in the NIAID HIV/AIDS Research Agenda: Pathogenesis In Humans And Non-Human Primates o Course of infection (infected cells, non-productively infected cells, virus production, altered biology of infected and uninfected cells) in different organ systems (blood, thymus, lymph nodes, gastrointestinal tract, bone marrow, spleen, nervous system, etc.) from early to systemic disease. o Clinical course and mechanisms of disease following infection with viruses of differing tropisms (macrophage, T-cell, neurotropic), high/low replication properties, or syncytium /non-syncytium inducing abilities. o Role of accessory viral genes (vif, nef, vpu, vpr, etc.) in infection, cellular tropism, and disease progression in vivo. o Steps in T-cell development and/or regulation that are affected by lentivirus infection and the lentivirus genes or gene products that are responsible. o Mechanisms of defects in T-cell signalling in uninfected and SIV (SHIV or HIV) infected cells. o Differences in pathogenesis between control and treated infected non-human primates in ongoing (already funded) therapeutic and vaccine SIV or SHIV studies. HIV or SIV Sexual/Mucosal Transmission o Mechanisms of mucosal transmission by free virus, cell-associated virus, or both. o Genetic composition of HIV in the donor compared to HIV phenotype/genotype that is sexually transmitted to the recipient. o Types of cells initially infected (i.e., lymphocytes, macrophages, and dendritic cells). o Mechanisms, time course, and pathways of viral spread from site of initial infection. o Differences, if any, in the mechanisms of establishment of HIV infection by rectal, vaginal, oral, or other mucosal routes. o Host mechanisms operative at mucosal surfaces that protect exposed individuals from HIV infection. o Role of co-factors other than STDs in facilitating or hindering mucosal transmission in vivo. Host Factors that Modulate HIV or SIV Infection or Disease o Mechanisms for differences in susceptibility of cells from different hosts to HIV or SIV infection in vitro. o Identification of host genes (alleles) and/or factors that prevent or enhance infection, resistance to infection, and/or disease progression. Investigations of variations in normal immune response are not included under this topic. o Mechanisms by which host factors prevent or enhance infection, provide resistance to infection, and/or disease progression in vitro and in vivo. o Mechanisms by which primates are resistant to lentivirus disease; i.e., chimpanzees infected with HIV and African Green monkeys infected with AGM virus. o Mechanisms responsible for observed variations in susceptibility to HIV or SIV infection and/or rates of progression in different individuals. o Comparison of known mechanisms of resistance to retroviruses in non-primates (mice, chickens, etc.) with observations in primates. D. Restrictions and Exclusions Descriptive, non-hypothesis driven, research is not within the scope of this RFA. For example, natural history epidemiologic studies in many DAIDS-supported cohorts are critically important for collecting information on cause and course of disease. The information provided by such studies may provide a foundation for hypotheses that may be tested in research supported by this RFA. This RFA is intended to support the next step in research, the testing of these hypotheses. This initiative will not support drug or vaccine trials in animals or humans. Proposed studies should minimize expenses for animal support and maximize the use of animals in ongoing non-human primate research. For example, the applicant may be able to coordinate SIV pathogenesis projects with DAIDS-supported vaccine or drug development studies in macaques. The applicant is responsible for establishing components and/or collaborative arrangements. A list of Principal Investigators who have access to non-human primates in NIAID-sponsored research is available from DAIDS program staff (see INQUIRIES) upon request, but these investigators are under no obligation to collaborate with RFA applicants. Clinical trials involving the recruitment or retention of cohorts will not be supported under this RFA. However, costs for patient visits, sample storage, and handling specific to the applicant's proposed research are appropriate. Analyses of samples acquired from epidemiologic or clinical trials are also appropriate. Proposed studies should maximize the use of epidemiologic or clinical cohorts in ongoing research to minimize expenses. A list of Principal Investigators who have access to epidemiologic or clinical cohorts in NIAID-sponsored research will be available from DAIDS program staff (see INQUIRIES) upon request, but these investigators are under no obligation to collaborate with RFA applicants. Special Requirements A. Travel -- NIAID AIDS Pathogenesis Meeting Principal Investigators and other key members of the projects will be requested to attend an annual NIAID AIDS Pathogenesis Meeting, a grantees of the Mechanisms of AIDS Pathogenesis RFA, to be held each year at a site designated by NIAID (Bethesda, Maryland is anticipated). Principal Investigators and component leaders will be requested to present significant findings in symposium format. Data are to be selected by the individual presenters in consultation with their Principal Investigator thus affording appropriate protection of proprietary or commercially sensitive information. At the discretion of the DAIDS program staff, other investigators may also be invited to attend. Funds for the Principal Investigator and key scientific personnel to travel to these meetings should be included in the application budget. For budgetary purposes, applicants should anticipate lodging for three nights in the Bethesda, Maryland area (estimated food and lodging costs for 1994 = $158/night) and travel at economy airfares. B. No Initial Review Site Visit One important factor that should influence the care and detail with which applications in response to this RFA are prepared is a long-standing NIAID policy that there will be no site visits in the initial review of applications. Peer reviewers will base their comments and recommendations solely on the written application, which must be complete and prepared according to the RFA guidelines. Applicants are strongly encouraged to discuss research plans and organizational structure with DAIDS program staff in the early stages of preparation of the application. (See program contact list in INQUIRIES.) 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 of the policy from program staff listed in INQUIRIES, who may also provide additional information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 16, 1994, a letter of intent that includes a descriptive title of the project; the names, addresses, telephone numbers, and EMAIL addresses (if available) of the Principal Investigator, component leaders, and other key personnel; the names of the primary institution and component institutions (if different); 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 the application, the information that it contains is helpful in planning for the review of expected applications. It allows NIAID to estimate the potential workload for reviewers and to avoid possible conflict of interest in the review process. The letter of intent is to be sent to Dr. Diane Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may 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 must adhere to the format and requirements specified in the PHS 398 application kit. For purposes of identification and processing, mark "YES" in item 2a on the face page of the application and type in the RFA number AI-94-018 and the title "MECHANISMS OF AIDS PATHOGENESIS." The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original application. Failure to use this label could delay the processing of the application such that it may not reach the review committee in time for review. Questions regarding the format for submission of an R01 package may be directed to the staff person listed under INQUIRIES. Submit a signed, typewritten original of the application, including the Checklist, and three exact, signed, single-sided 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 and five sets of appendices and reprints must also be sent to Dr. Dianne Tingley at address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants (DRG) and Division of Extramural Activities by November 16, 1994. Applications not received by the receipt date will be considered non-responsive and will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to an application that has already been submitted to the NIH but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of essentially identical applications is not 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 A. Review Procedures Applications will be reviewed by DRG staff for completeness and by NIAID staff for administrative and programmatic responsiveness to this RFA. To be considered responsive, the application must be directed towards the attainment of the stated programmatic goals (see RESEARCH OBJECTIVES). Therefore, applicants are encouraged to discuss their research plans with program staff before completing their applications. Those applications judged to be incomplete or nonresponsive will be returned to the applicant without review. Those applications that are complete and responsive may be subjected to a triage to determine their scientific competitiveness relative to the other applications received in response to this RFA, based on the review initial described below. The NIAID will remove from further competition those applications judged to be noncompetitive for award and will notify the applicant and institutional business official. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Scientific Review Branch, Division of Extramural Activities, NIAID. A second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. In the event of multiple highly qualified applications, final funding recommendations will be based on program priorities. B. Review Criteria The factors, to be considered in evaluating the scientific merit of each application are: 1. Adequacy of preliminary data leading to the hypothesis of the proposed research including the adequacy of data for component studies. 2. Clarity and significance of the hypothesis to be tested. 3. Relationship of the Specific Aims to the hypothesis, e.g., o Will accomplishment of the Specific Aims provide significant proof or refutation of the hypothesis? o Does the application justify additional components to fulfill the Specific Aims? o Are necessary components included in the application? 4. Integration of in vitro and in vivo approaches and of components. 5. Innovativeness and technical merit of the experimental approach. 6. Availability and acquisition of clinical specimens (tissues/biological fluids), and cost savings achieved by utilization of resources not funded through this application. Documentation of the availability of the specimens. 7. Efficient use of animals, and utilization of animal resources not funded through this R01 application. Documentation of the availability of animals or animal specimens. 8. Adequacy of resources and environment including of biohazard containment facilities if relevant. 9. Documented research experience, accomplishments, and other qualifications of the principal Investigator, key personnel, and technical personnel in the proposed research areas. 10. Time commitment of the Principal Investigators (and Component Investigators) to conduct the proposed research; AWARD CRITERIA The number and specific amounts of awards to be made will depend upon the following: o Results of the initial scientific and technical merit review; o Potential contribution of the proposed research to the goals and objectives of the RFA; o Program balance within the three areas of research; and o Availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct written, telephone, or electronic mail (EMAIL) inquiries regarding scientific and responsiveness issues to: Dr. Gregory Milman Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B35 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8378 EMAIL: MAPS@EXEC.NIAID.PC.NIAID.NIH.GOV Direct letters of intent, inquiries regarding the scientific review process and format of applications, and two copies of the application including five sets of appendices and reprints, to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard Solar Building, Room 4C16 Bethesda, MD 20892 Telephone: (301) 496-0818 EMAIL: MAPS@EXEC.NIAID.PC.NIAID.NIH.GOV Direct inquiries regarding fiscal matters and budget format to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard Solar Building, Room 4B22 Bethesda, MD 20892 Telephone: (301) 496-7075 EMAIL: MAPS@EXEC.NIAID.PC.NIAID.NIH.GOV Schedule Letter of Intent Receipt Date: September 16, 1994 Application Receipt Date: November 16, 1994 Scientific Review Date: March 1995 Advisory Council Date: June 1995 Earliest Award Date: Sep 1995 and/or Nov - Dec 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergy and Transplantation Research. 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 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 Mon May 09 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 - 8 May 1994 Date: 9 May 1994 20:31:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 215 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2qmv7c$c68@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: General Publication Title: Publications of the National Science Foundation (NSF 9439) File size (bytes): 55165 STIS Filename: nsf9439 Document Type: News Title: Tip 40328 "BLOW-UP" DAMS MIGHT PROTECT CRITICAL STRUCTURES IN A FLOOD File size (bytes): 5186 STIS Filename: tip40325 Title: Tip 940408 CHANGE IN UNDERGRADUATE ENGINEERING EDUCATION File size (bytes): 5392 STIS Filename: tip40404 Document Type: Press Release Title: .SCIENTISTS SEARCH FOR CLUES TO AIRCRAFT ICING AT AND NEAR DENVER'S STAPLETON AIRPORT File size (bytes): 3570 STIS Filename: pr9417 Title: FIRST AWARDS MADE UNDER ADVANCED TECHNOLOGICAL EDUCATION (ATE) PROGRAM File size (bytes): 4085 STIS Filename: pr9426 Title: MATHEMATICIAN RECEIVES NSF'S WATERMAN AWARD File size (bytes): 6091 STIS Filename: pr9427 Title: NATIONAL SCIENCE BOARD'S VANNEVAR BUSH AWARD GIVEN TO FRANK PRESS File size (bytes): 5653 STIS Filename: pr9428 Title: NATIONAL SCIENCE & TECHNOLOGY WEEK 1994 CULMINATES YEAR FOCUS ON SCIENCE AWARENESS File size (bytes): 9413 STIS Filename: pr9429 Title: PRELIMINARY CLUES ABOUT ELECTRICAL FIELDS' IMPACT ON CELLS File size (bytes): 2744 STIS Filename: pr942 Title: U.S. INVESTMENTS IN R&D INCREASING TO MEET NATIONAL GOALS AND INTERNATIONAL COMPETITION,SAYS NEW NSB REPORT File size (bytes): 11121 STIS Filename: pr947 Title: ANTARCTIC ICE DRILL EXTRACTS NEW CORE FOR CLIMATE STUDIES File size (bytes): 4528 STIS Filename: pr949 Document Type: Program Guideline Title: NSF 94-61 National Chaallenge Groups File size (bytes): 30723 STIS Filename: nsf9461 Title: Rapid Prototype- Virtual & Physical (NSF 94-63) File size (bytes): 19780 STIS Filename: nsf9463 Document Type: Recruit Title: Secretary (Office Automation) File size (bytes): 5224 STIS Filename: vgs9464 Title: Secretary (Office Automation) File size (bytes): 5211 STIS Filename: vgs9465 Title: Senior Program Assistant (Office Automation) File size (bytes): 5098 STIS Filename: vgs9466 Document Type: SRS Data Brief Title: Annual Increases in Federal R&D Obligations No Longer the Pattern File size (bytes): 6080 STIS Filename: db93305 Document Type: SRS SE Indicators Title: NSB 93-1 Ch. 1 Elementary & Secondary Science & Mathematics education File size (bytes): 120470 STIS Filename: sei9301 Also available: sei9301.zip Title: NSB 93-1 Appendix tables, ch. 1 Elementary & Secondary Science & Math Education File size (bytes): 2786 STIS Filename: sei9302 Also available: sei9302.zip Title: NSB 93-1 Figures, ch. 1 Elementary & Secondary Sci & Math Educ'n File size (bytes): 1599 STIS Filename: sei9303 Also available: sei9303.zip Title: NSB 93-1 Ch. 2 Higher Education in Science and Engineering File size (bytes): 81531 STIS Filename: sei9304 Also available: sei9304.zip Title: NSB 93-1 App. tables, ch. 2 Higher Education in Science and Engineering File size (bytes): 2979 STIS Filename: sei9305 Also available: sei9305.zip Title: NSB 93-1 Figures, ch. 2 Higher Education in Science and Engineering File size (bytes): 1644 STIS Filename: sei9306 Also available: sei9306.zip Title: NSB 93-1 Figures, ch. 4, R&D- Financial Resources & Institut'l Linkages File size (bytes): 164435 STIS Filename: sei9312 Also available: sei9312.zip ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 2814 STIS Filename: cmpublic Document Type: Letter Title: Current List of REU Sites File size (bytes): 55134 STIS Filename: reulist Document Type: Press Release Title: ETHIOPIAN SKULL FIND HELPS PIECE TOGETHER PUZZLE OF HUMAN ORIGIN File size (bytes): 4287 STIS Filename: pr9424 Title: PRELIMINARY CLUES ABOUT ELECTRICAL FIELDS' IMPACT ON CELLS File size (bytes): 2744 STIS Filename: pr943 Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 37107 STIS Filename: sesvac Document Type: Report Title: NSF 94-19 Innovation and Change in the Chemistry Curriculum File size (bytes): 103091 STIS Filename: nsf9419 ------------------------------------------------------------------------ ** 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 nsf9419, the text of your message should be as follows: get nsf9419 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9419, you would enter: ftp> get nsf9419 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 Mon May 16 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 - 15 May 1994 Date: 16 May 1994 17:55:18 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 114 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2r94lm$314@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF Bulletin June/July/August 1994 Vol. 21; No. 10 File size (bytes): 37707 STIS Filename: bul9406 Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 2509 STIS Filename: cm-publi Document Type: Grant Conditions Title: Grant General Conditions File size (bytes): 49210 STIS Filename: nsfgc1 Document Type: Program Guideline Title: NSF 94-64 - Social, Behavioral, and Economic Research (SBER) File size (bytes): 46328 STIS Filename: nsf9464 Document Type: Recruit Title: Management Analyst File size (bytes): 5404 STIS Filename: vgs9468 Title: Supervisory Computer Specialist (Section Head) File size (bytes): 7228 STIS Filename: vgs9470 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Form Title: About NSF Forms File size (bytes): 2179 STIS Filename: fmsmart Document Type: Program Guideline Title: NSF 94-61 National Chaallenge Groups File size (bytes): 30723 STIS Filename: nsf9461 Title: NSF94-63 Rapid Prototype- Virtual & Physical File size (bytes): 19777 STIS Filename: nsf9463 Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 37107 STIS Filename: sesvac Title: Secretary (Office Automation) File size (bytes): 5210 STIS Filename: vgs9465 Title: Senior Program Assistant (Office Automation) File size (bytes): 5098 STIS Filename: vgs9466 ------------------------------------------------------------------------ ** 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 vgs9466, the text of your message should be as follows: get vgs9466 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vgs9466, you would enter: ftp> get vgs9466 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 Mon May 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-94-016 - V23(18) 05/13/94 Date: 16 May 1994 18:08:40 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 547 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2r95eo$3gm@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL94016 HL-94-016 P1O1 *************************************** TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA: HL-94-016 P.T. 34; K.W. 0715165, 0502024, 0403004, 0795003 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: July 13, 1994 Application Receipt Date: September 14, 1994 PURPOSE The primary objective of this Request for Applications (RFA) is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of Mycobacterial tuberculosis (TB) 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, Tuberculosis Academic Award, is related to the priority areas of immunization and 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 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. In this competition, there is an interest in a diversity of types of applications. These include, but are not limited to, applications from any of the following: o established researchers and/or faculty specializing in the field of tuberculosis; o minority faculty members interested in medical education; o minority medical institutions; o institutions serving a high proportion of minority medical students or minority patients; o institutions having other tuberculosis research projects to which this award would be complementary. Candidates A candidate for an award must: o be an established physician and a medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have the unqualified support of the Dean and the educational leadership at the institution and demonstrate knowledge and commitment to medical education for medical students, physicians, patients, and the public; o have sufficient clinical training, and experience in the control of TB to develop and implement a high quality curriculum in TB encompassing current knowledge and methods applicable to the control of tuberculosis in individuals of all ages and to provide leadership in applied research in control of TB; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; and o commit at least 30 percent effort for a five-year period. Individuals who have held another NIH career development award (K series) are eligible to apply for the Tuberculosis Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin April 1, 1995. (Applicants may request a July 1, 1995 start date.) FUNDS AVAILABLE The estimated funds (total costs) for fiscal year 1995 will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested for each year. RESEARCH OBJECTIVES Background Despite major advances in our understanding of the pathogenesis, detection and treatment of tuberculosis, nearly 28,000 cases have been reported in the United States since 1984, the year when the lowest number of cases were reported. Currently, TB is spreading rapidly, especially in some population groups. From 1985 through 1990, the number of TB cases increased by 44 percent in the 25-44 year old age group. There was a 12 percent increase among Asians, a 25 percent increase among non-Hispanic whites, a 55 percent increase among blacks, and a 77 percent increase among Hispanics. There is also a high prevalence of TB among HIV infected patients. It is estimated that about 12 percent of all AIDS cases develop TB. HIV-associated TB has occurred in virtually all age groups, both men and women, all race/ethnic groups and in all HIV-transmission categories, although the largest numbers of cases have occurred in intravenous drug users and homosexual/bisexual men. Other groups at high risk for TB include persons living or working in group or institutional settings such as hospitals and correctional facilities. More recently, there have been outbreaks of multi-drug resistant TB. These outbreaks are a dramatic manifestation of serious underlying problems in public and private efforts to control TB. Although considered "curable" since the development of effective chemotherapy in 1950, the TB problem has not been dealt with adequately. This has been attributed to a lack of sufficient awareness of the problem and inadequate resources, as well as clinical management errors and patient nonadherence to treatment regimens. The management errors include failing to diagnose and treat the cases in a timely manner, relying heavily on isoniazid (INH) therapy even in patients likely to have INH-resistant organisms, using a single drug therapy, prescribing inappropriate drug dosages, and failing to isolate patients appropriately with infectious TB thereby missing opportunities to prevent the spread of the disease. Surveillance has often been slow or incomplete. Noncompliance with treatment regimens for chronic diseases has been a major problem with approximately 50 percent not taking their medicine. A study in 1988 in New York City reported 89 percent of the patients at one hospital failed to complete therapy, more than half failed to keep their first clinic appointment, and within twelve months of discharge 27 percent of the patients had been readmitted at least once with confirmed active TB. The concept for this initiative originated with the Tuberculosis Education Planning Committee convened by the NHLBI in December 1991, which emphasized the need for increased efforts to educate health care workers, patients, and the public on tuberculosis, and recommended that public health officials identify populations and geographic areas in the community where tuberculosis screening programs should be intensified and conduct public education campaigns targeted to high risk populations to encourage symptomatic patients to seek prompt treatment. In addition, in 1987 the Department of Health and Human Services established an Advisory Committee (Council) for the Elimination of TB (ACET), and in 1992 a "National Action Plan to Combat Multidrug Resistant Tuberculosis" was published to complement and supplement the "Strategic Plan for the Elimination of Tuberculosis." These plans indicate the urgency to improve the control of TB in the United States. In summary, TB is spreading in the U.S., despite major advances in the ability to diagnose, treat, and prevent this disease, largely due to inadequate education of health professionals, patients and their families, and the community. Objectives The objectives of the Tuberculosis Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling TB; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote communication among primary care and other specialists to ensure appropriate control and treatment strategies; o encourage applied research in the control of TB; o promote the development of a faculty capable of providing appropriate instruction in diagnosis and management of TB, with special emphasis on minority faculty; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have TB; o provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high TB morbidity; o contribute to updating the knowledge and skills of practicing physicians and other health care providers in the community; o enhance the awareness of health care providers of the unique ethnic, cultural, socioeconomic, and medical dimensions of TB; o coordinate and collaborate with other community organizations to control TB in areas with high incidence of TB; o facilitate an interchange of ideas and methods among awardees and institutions; o contribute to public health efforts to control TB in the United States; and o enhance the teaching of tuberculosis in minority medical schools and promote TB education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about tuberculosis and among physicians who are or who will be caring for medically underserved populations. Since this is a medical education program, funds may be requested for technical support staff who have complementary expertise to the principal investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. SPECIAL REQUIREMENTS 1. Awardee Salary The salary requested for the awardee must not exceed the actual institutional salary rates for the effort devoted to the Academic Award, and must not exceed $50,000 plus fringe benefits. A candidate must spend at least 30 percent time on this award. An awardee may devote up to a total of 100 percent effort as an Academic Awardee and as principal or participating investigator on any other NIH-supported grant(s) or contract(s) and may receive remuneration from such grant(s) or contract(s) accordingly. An example of an investigator who receives the Academic Award at a level of effort of 30 percent, who wishes to devote 60 percent of effort to other Federally-sponsored research, and whose institutional salary is $130,000 is as follows: Academic Award 30 percent effort $ 37,500* Other Federally-supported 60 percent effort $ 75,000* grants and contracts Total salary from Federal sources $112,500 Salary contribution from grantee's institution $ 17,500 Total Salary $130,000 *(based on the current ceiling of $125,000) 2. Program Support Technical support will be provided up to a maximum of $20,000 per year for the following: o personnel other than the awardee if requested for the development, implementation, and evaluation of the program. Salaries will be allowable for technical and support staff and consultants, e.g. educational and evaluation specialists. Students stipends are allowable for students conducting projects directly related to the award; o consumable supplies essential to the proposed program; o funds for educational development to enable the awardee to develop educational skills; o funds for travel for the Principal Investigator to meet with other awardees and NHLBI staff to exchange ideas, to develop collaborative projects, and to provide for some needed technical support. (Awardees may be requested to meet as a group up to two times a year; $2,000 should be allocated for this purpose.) o equipment costs are not allowable; 3. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures of equipment. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases, it may be necessary for the applicant to be relieved of some responsibilities for the 5 years of the grant award in order to implement the proposed plan. An institution may apply for an award on behalf of a named individual meeting the criteria for this award. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a non-competitive basis depending upon progress being made in meeting the program's objectives. An annual report will be required that summarizes activities relevant to curriculum development at the institution and other elements of the program plan and outlines future plans. This report will serve as the principal basis for renewal of the grant. Awards may not be transferred from one institution to another. If an awardee moves to another institution, the award will continue at the original institution only upon acceptance by the Division of Lung Diseases of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. 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 July 13, 1994, a letter of intent that includes 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: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 Telephone: (301) 594-7478 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7428. 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, "RFA: HL-94-016, Tuberculosis Academic Award" 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: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 Applications must be received at both locations by September 14, 1994 to be assured of review in this competition. 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 by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will return the application to the applicant. The initial review may include a preliminary evaluation to determine scientific merit relative to the other applications received in response to this RFA (triage); the NIH will remove from further consideration applications judged to be noncompetitive and promptly notify the Principal Investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures, including, if deemed appropriate, an applicant interview in or near Bethesda at the applicant's expense. The initial review will be conducted by a Special Emphasis Panel, managed by the Division of Extramural Affairs, National Heart, Lung, and Blood Institute. The secondary review will be by the National Heart, Lung, and Blood Advisory Council. Applications for this Tuberculosis Academic Award will be evaluated in terms of the following criteria: o description of the magnitude of the tuberculosis problem and the need for the program in the area to be served; o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula in tuberculosis control; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and administration in a medical school, and planning and conduct of research; o the ability and commitment to work cooperatively with other awardees to make innovative tuberculosis curricula, materials, and programs available; o the institution's commitment to implement the proposed curriculum and to maintain a program in education about tuberculosis control after the termination of the award; o the significant involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with tuberculosis in areas with high incidence of TB; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, infections, and community medicine to ensure optimal treatment; o plans for collaborative projects with other organizations that have responsibility for and interest in tuberculosis control, for example, health departments, medical and nursing associations, and voluntary health agencies; o plans for and availability of expertise to implement and evaluate the proposed program, including strategies for both process and impact evaluation; o the potential of the program for making an impact on the control of tuberculosis among populations served; o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is April 1, 1995. Applicants may alternatively request a July 1, 1995 start date. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Tuberculosis Academic Award, the Division of Lung Diseases will provide funds for a project period up to five years. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, listed below, as soon as they receive approval from their institution to apply for this award. Direct inquiries regarding programmatic issues to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. The 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 Mon May 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 18, pt. 2of2, 13 May 1994 Date: 16 May 1994 18:08:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1383 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2r95ei$3g5@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940513 V23N18 P2O2 ************************************ dental degree (D.D.S. or equivalent) and must be, at the time of appointment, citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence. Dentists who have completed a Ph.D. or equivalent research degree and those who have undergone clinical knowledge and skills development in a recognized dental specialty or who have received two or more years of formal postdoctoral clinical development in a non-specialty recognized clinical field are not eligible. They should apply for an individual Dentist Scientist Award (K15). Dentists who have undergone clinical development in either an Advanced Program in General Dentistry or a General Practice Residency Program are eligible. MECHANISM OF SUPPORT Awards resulting from this RFA will be National Institutes of Health (NIH) Institutional Dentist Scientist Awards (K16). Responsibility for planning, direction, and execution of the proposed program will be solely that of the program director on behalf of the applicant institution. The project period must be five years. The earliest award date is July 1, 1996. FUNDS AVAILABLE The NIDR expects to make at least six new or competing renewal awards, in response to this RFA, at a total first year cost of approximately five million dollars. DSAs will receive salary and fringe benefits, research and development support for tuition, fees, research project expenses, travel and other purposes directly related to their training. The program director will receive partial salary support. RESEARCH OBJECTIVES Background This award prepares individuals for careers as highly skilled investigators and potential leaders in oral health research. It provides for five years of intensive study, involving three distinct phases that include basic and clinical science components integrated with a supervised research experience. The basic science component includes didactic and laboratory experiences and is comparable to a program leading to a Ph.D. The research program employs either basic or clinical science approaches to an oral health problem. The program provides advanced clinical knowledge and skills development of the caliber that the individual would be eligible to receive specialty certification. Throughout the entire program, the individuals are closely supervised by mentors who have basic science, research and clinical specialty career development experience. 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." LETTER OF INTENT Prospective applicants are asked to submit, by December 1, 1994, a letter of intent that includes a descriptive title of the proposed Dentist Scientist Award program, the name, address, and telephone number of the PD, the identities of other key personnel, participating institutions, and the number and title of the RFA (RFA: DE-94-005, Institutional Dentist Scientist Award) 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 early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this 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 Dr. Valega at the address listed under INQUIRIES. Applications must be received by January 18, 1995. 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 an initial review group, convened by the NIDR Scientific Review Section, 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 and institutional official. Applications judged to be competitive will receive further review for scientific and technical merit by the review committee. Secondary review will be by the National Advisory Dental Research Council. Additional review criteria are listed in the RFA. AWARD CRITERIA The earliest award date will be July 1, 1996. Funding decisions will be based on the initial review committee's and Council's recommendations, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone requests for the RFA and inquiries concerning this RFA are encouraged. The opportunity to clarify any issue or questions from potential applicants is welcome. Direct requests for the RFA, inquiries on 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 on fiscal matters to: Ms. Theresa Ringler Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 AUTHORITY AND REGULATIONS Institutional Dentist Scientist Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are 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. $$R9 END ************************************************************ ONGOING PR0GRAM ANNOUNCEMENTS $$P1 BEGIN PAR-94-065 *********************************************** INDIVIDUAL DENTIST SCIENTIST AWARD NIH GUIDE, Volume 23, Number 18, May 13, 1994 PA NUMBER: PAR-94-065 P.T. 34; K.W. 0715148, 0710030 National Institute of Dental Research PURPOSE The National Institute of Dental Research (NIDR) re-announces the availability of individual Dentist Scientist Awards in basic biomedical, behavioral and clinical oral health research, which were initiated nine years ago. Several changes have been introduced in the policies and provisions governing these awards, which are effective for applications for the June 1, 1994, and later receipt dates and will apply to all appointments made on or after March 1, 1995. Dentists previously eligible for Physician Scientist Awards for Dentists (K11), now are eligible for K15s. The NIDR will no longer accept K11 applications. Existing policies and provisions will remain in effect for current appointees until completion of their five years career development. This Program Announcement (PA) supersedes all previous K11 and K15 announcements. The purpose of the K15 is to develop outstanding clinician research scientists. It will provide doctoral (Ph.D.) basic science and research experiences to facilitate transition to a research career. Advanced clinical knowledge and skills development in a recognized clinical specialty or equivalent discipline, will be provided for Dentist Scientist appointees (DSAs) who have not undergone such development. It is anticipated that most graduates will undertake two or more years of post-Ph.D. research development to complete their preparation for an independent research career. Research career development 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 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, Individual Dentist Scientist Award, 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 Summary: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted on behalf of dentists, by domestic, public or private dental schools or institutions affiliated with a dental school. Minorities and women are encouraged to apply. Applicants must be U.S. citizens or noncitizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551). Noncitizen nationals, although not U.S. citizens, 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. Dentists on temporary or student visas are not eligible. Applicants holding a D.D.S. or equivalent degree are eligible. Preference will be given to applicants with advanced clinical knowledge and skills in a recognized dental specialty or who have received two or more years of formal post-D.D.S. clinical development in a non-specialty recognized field. Dentists without advanced clinical knowledge and skills are eligible but are encouraged to seek appointment to NIDR sponsored institutional Dentist Scientist Award (K16) programs. Dentists with advanced clinical knowledge and skills, but wishing to develop such competence in another clinical area, those without or not wishing to pursue clinical knowledge and skills development, and those with a Ph.D. in another area may request the NIDR to consider their eligibility. Former principal investigators on NIH research project (R01), FIRST (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible. MECHANISM OF SUPPORT Awards in response to this PA will use the NIH K15. Planning, direction, and execution of the program will be the responsibility of the DSA and mentor on behalf of the applicant institution. The project period must be five years. Awards are not renewable. RESEARCH OBJECTIVES A. Environment: The institution must have well-established research and clinical career development programs and qualified faculty in clinical and basic research to serve as mentors. The DSA, mentor and institution must develop innovative multidisciplinary programs to maximize the available research and educational resources. B. Program: The award provides five consecutive 12 month appointments. At least 80 percent of the DSA's effort must be devoted to the program and the remainder devoted to other clinical and teaching pursuits consonant with the objectives of the award. The program must meet the unique needs of the DSA and provide requisite competencies. There will be two or three distinct, integrated components: basic science, supervised research, and, for some, advanced clinical knowledge and skills development. No component can be offered in isolation from the other(s). The basic science component must develop knowledge and research skills in scientific areas relevant to oral health and include didactic and laboratory experiences consistent with the applicant institution's Ph.D. requirements and the objectives of the award. The research experience must use basic or clinical approaches to oral health problems, comparable to a doctoral program. The advanced clinical development must ensure acquisition of clinical knowledge and skills in either a recognized clinical specialty or equivalent dental clinical discipline. These are not limited to the eight dental specialties recognized by the American Dental Association. If specialty certification is possible, the certificate is not to be conferred until program completion. C. Mentor(s): The DSA must be closely supervised throughout the five year program by mentors with basic and clinical specialty research and career development experience. The primary mentor is usually the doctoral thesis advisor. Where feasible, women and minority mentors should be involved as role models. D. Duration, Effort, and Allowable Costs: 1. Salary: The NIDR will provide salary up to the amounts listed below, starting at $26,500 for 0 years relevant experience, with four percent annual increases thereafter, up to a maximum of $39,226. The salary must not exceed institutional salaries provided from its own funds to other staff or faculty with equivalent qualifications, rank, and responsibility in the department concerned. Fringe benefits will be provided. The scale extends up to 10 years to give credit for relevant postdoctoral experience including: research, including industrial; teaching; residency; clinical practice; or time spent in a health-related field beyond the doctoral degree. Number of Years Experience Salary (maximum provided by the NIDR) 0 $26,500 1 $27,560 2 $28,662 3 $29,808 4 $31,000 5 $32,240 6 $33,530 7 $34,871 8 $36,266 9 $37,717 10 or more $39,226 Salaries may be supplemented from non-Federal funds. Other NIH funds may not provide additional salary. Non-NIH Federal funds may not supplement salary unless authorized under terms of the program. An individual may use Federal educational loan funds or Department of Veterans' Affairs benefits when permitted by those programs. Under no circumstance may the condition of salary supplementation detract from or prolong the program. 2. Provisions must be made for support of a DSA choosing clinical specialties that require more than two years of clinical knowledge and skills development. 3. Research Development Support (RDS): $15,000 per year will be allowed for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) DSA travel to research meetings or training; (d) statistical services including personnel and computer time. Authorization to use RDS funds for other purposes may be requested from the NIDR. 4. Authorization may be requested from the NIDR to carry over unobligated funds from one budget period to the next; for example, for support of a DSA's salary and RDS for up to 12 months beyond the standard five years to permit completion of the program. 5. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 6. 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. E. Concurrent Awards: DSAs are encouraged to seek support for a post-Ph.D. experience after completion of the K15 program, ideally at another institution. During the final one to two years of their program, they may apply for a post-Ph.D., National Research Service Award (NRSA) individual fellowship (F32), apply for appointment to a NIDR sponsored NRSA institutional postdoctoral training program (T32), or arrange for other support from the NIH or from nongovernmental sources sufficient to ensure two or more years of post-Ph.D. training and career development. If such support becomes effective prior to completion of the K15 program, it may be used without reduction in the annual RDS from the award. F. Evaluation: For ten years after leaving the program, the DSA and mentor must update the NIDR annually of the DSA's employment history, publications, participation in research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. 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 It is strongly recommended that prospective applicants contact Dr. Valega at the address listed under INQUIRIES early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this PA. Applications are to be submitted on form PHS 398 (rev. 9/91) and will be accepted on or before the receipt deadlines indicated in the application kit (February 1, June 1, and October 1). Forms are available at most institutional offices of sponsored research; 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 Dr. Valega. Provide information establishing a serious commitment to oral health research and a high potential to develop into an independent investigator. Summarize immediate and long-term career objectives, explaining how the award would contribute to their attainment. Include three sealed letters of recommendation addressing the applicant's potential for a research career. Describe the basic science component, including didactic and laboratory experiences, and arrangements for acceptance in the graduate school doctoral program. The research experience may use a basic or clinical science approach to oral health problems. When appropriate, describe the advanced clinical component to acquire knowledge and skills in either a recognized clinical specialty or other equivalent dental clinical discipline. Indicate clinical disciplines and degree certifications to be pursued. Selections may not be changed without NIDR approval. The applicant and mentor together must describe the research plan as outlined on pages 19-24 of form PHS 398, Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Typically, it is what is required for a doctoral degree. The plan should be as detailed as possible, especially for applicants who will not be pursuing the advanced clinical component. Applicants who will be pursuing the clinical component, where it may be premature to provide detailed plans, must discuss the area, feasibility, relevance, and significance of the anticipated research. In this case, the DSA will be required to submit, for NIDR approval, a detailed description of the proposed research as soon as feasible after appointment but no later than the midpoint of the program. Applications must include plans for instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction; and the amount and nature of faculty participation. No award will be made if an application lacks this component. Budget requests must be provided according to the instructions in form PHS 398. The RDS requested for tuition and fees, books, travel, etc., must be specified by category. To identify the application as a response to this PA, check "YES" on item 2a of page 1 of the application and enter "PA-94-065, Individual Dentist Scientist Award." Submit a signed, typewritten original of the application with 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, together with three sealed letters of reference, 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 REVIEW CONSIDERATIONS Applications will be reviewed for completeness, and responsiveness to the PA, by NIDR 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 to determine their merit, relative to others received in response to the PA. The NIDR may withdraw applications judged to be noncompetitive and notify the applicant. Applications judged to be competitive will be evaluated for scientific and technical merit by the review committee. The following review criteria will be applied: o Applicant: Clinical and scientific knowledge and experience; potential and commitment to a career as an independent researcher. o Environment: Institutional commitment and ability to provide research development opportunities; collaboration between basic and clinical departments; availability of facilities, equipment, clinical resources and research support. o The Basic Science, Clinical and Research Career Development Program: Its structure and the quality of each component; integration of the components; relationships among clinical and basic science departments and the graduate school in the design and conduct of the program; degree requirements; types of specialty development; availability of prescribed and optional courses or seminars; procedures for selecting research activities and monitoring progress; and the unique and innovative aspects of the program. o Mentors: Experience in graduate research and clinical career development; accomplishments in research; and current and pending research grant holdings; time commitment for the duration of the program. o Responsible Conduct of Research: The quality of instruction. Secondary review will be by the National Advisory Research Council. AWARD CRITERIA The NIDR will notify the applicant of the Council's action shortly after its meeting. Funding decisions will be made based on the Special Grants Review Committee's and Council's recommendations, the need for research personnel in specific program areas, and the availability of funds. Preference will be given to otherwise equally qualified applicants with advanced clinical certification. The NIDR appreciates the value of complementary funding from other public, foundation and industry sources, for activities that will complement and expand those supported by the NIDR. 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 on programmatic issues 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 on fiscal matters to: Ms. Theresa Ringler Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 AUTHORITY AND REGULATIONS Individual Dentist Scientist Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is 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. $$P1 END ************************************************************ $$P2 BEGIN PA-94-066 ************************************************ MEDICAL TREATMENT EFFECTIVENESS RESEARCH -- PORT-II NIH GUIDE, Volume 23, Number 18, May 13, 1994 PA NUMBER: PA-94-066 P.T. 34; K.W. 0730050 Agency for Health Care Policy and Research PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for innovative and timely research that will provide convincing evidence for or against the effectiveness and/or cost effectiveness of alternative clinical interventions used to prevent, diagnose, treat, and manage common clinical conditions. "PORT-IIs" will extend the work of AHCPR's original Patient Outcomes Research Teams (PORTs) into more clinical areas and will make substantial new contributions to improved patient outcomes, clinical practice, and health care policy. Awards will be part of the new generation of research developed by AHCPR for the Medical Treatment Effectiveness Program (MEDTEP), as introduced in Request for Applications (RFA) HS-94-002. 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. The AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-004374-1) 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 organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This program announcement (PA) uses the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period may not exceed five years. Annual progress reviews by AHCPR and the availability of funds will determine the continuation of grants up to the five year limit. RESEARCH OBJECTIVES Background and Conceptual Framework Since 1989, AHCPR has made a major investment and major advances in medical effectiveness research, especially through the set of special projects known as PORTs. This PA describes a new generation of PORT research, introduced in July 1993 with RFA HS-94-002. Like the original PORTs, PORT-IIs are pragmatic, methodologically sophisticated, multidisciplinary projects that focus on patient outcomes for common clinical problems and emphasize the policy significance of understanding what health care services and procedures are most effective and for whom. PORT-IIs are expected to start with careful formulations of important research questions about the effectiveness and relative effectiveness of different clinical approaches to common conditions. The proposed research strategy must be tailored to the research question(s) and the population at risk; unlike the original PORT projects, PORT-IIs do not have a common research plan. PORT-IIs focus on the establishment of direct linkages between clinical practice and outcomes, and on research methods and data that facilitate direct comparisons of different clinical strategies available for use in routine practice. PORT-IIs do not test or evaluate the application of clinical practice guidelines or "appropriateness criteria;" rather, they are designed to obtain empirical evidence useful for constructing, specifying, and updating such guidelines. PORT-IIs incorporate fundamental concepts of all MEDTEP research, as defined below. "Effectiveness" refers to the outcomes experienced by, or observed in, typical patients receiving care in typical clinical situations. The intent of this emphasis is to ensure that the findings of all PORT-IIs can be widely generalized. "Patient outcomes" are the terms in which effectiveness and cost effectiveness are assessed. Outcomes of interest emphasize the patient's perspective. They include survival, symptom relief, patient-reported quality of life, functional status, satisfaction with care, and costs. In PORT-IIs, analysis of a broad set of outcomes is generally desirable. It is essential that the analysis include the most significant outcomes for the particular condition under study, both long- and short-term. "Cost effectiveness" is the comparison of the direct monetary costs of health care plus the indirect costs (e.g., lost work) associated with the outcomes of the intervention. PORT-IIs should address questions of cost effectiveness if or when the interventions to be compared are likely to be associated with significant differences in cost or outcome. In analyzing effectiveness and cost effectiveness, PORT-IIs take into account the many important clinical and non-clinical variables that influence practice and outcomes. This includes pertinent characteristics of patients (e.g., comorbidities; medical history; demographic, socioeconomic, and cultural characteristics; preferences and utilities); providers (e.g., training, skill, practice style); diseases (e.g., severity, course); and the health care system (e.g., setting, type of practice, liability issues). Topic Selection PORT-II studies will be condition-specific or technology-specific, and will conduct comparative analyses of the most important alternatives for prevention, diagnosis, treatment, and/or management. A well-defined disease (e.g., breast cancer, pediatric asthma) or a symptom or condition (e.g., headache, fatigue, obesity) may be selected. The topic must meet all of the following MEDTEP criteria: o high incidence or prevalence in the general population or in major population subgroups, as defined by age, gender, or ethnicity; o controversy or open questions over the effectiveness and relative effectiveness of available clinical strategies; and o high cost whether due to the number of people needing care, high unit cost of care, or high indirect cost. Applicants are expected to present a strong case for their selected topic in a critical literature review that: addresses the clinical, policy, and research significance of the topic; provides evidence of controversy or information gaps regarding current clinical strategies; and supports the formulation of the proposed research question(s). The formulation of the problem must reflect understanding of the issues regarding clinical decisionmaking and the translation of study findings into clinical practice. Further, the research questions must be answerable within the proposed grant period. PORT-IIs are expected to compare distinctly different clinical approaches to the prevention, diagnosis, treatment, or management (including rehabilitation) of common clinical conditions. Examples of responsive studies include comparisons of: medical vs. surgical treatment; treatment vs. watchful waiting; psychotherapy vs. pharmacotherapy; or invasive vs. non-invasive screening technologies. Other possible comparisons include care prescribed or provided by different kinds of health care professionals, or in different care settings. If it is not feasible to address all important treatment options in a single study, applicants must identify the specific interventions the study will address and justify the selections and exclusions. In general, the most comprehensive assessments of pertinent clinical strategies will be of greatest interest for PORT-IIs. Methods Investigators are encouraged to design new research strategies, use new combinations of methods, or tailor existing methods to their research questions so that convincing evidence will be obtained for or against the effectiveness of alternative clinical interventions. PORT-IIs may employ experimental, quasi-experimental, or observational designs; methods include, but are not limited to, case-control studies, cohort studies, clinical trials, meta-analyses, cost effectiveness analyses, decision modeling, and combinations of these methods. MEDTEP's emphasis on the generalizability of results precludes traditional randomized controlled trials (RCTs) whose findings of "efficacy" apply only to narrowly defined patient groups and circumstances. PORT-IIs do, however, include "effectiveness trials," designed to answer questions about the likely outcomes of health care in the "real world." Thus, randomized studies that include a broad range of patients and practitioners are encouraged. Types and sources of data may include clinical, patient-reported, and administrative data. The data may be obtained prospectively or retrospectively from registries or records of health care providers, or via new, established, or adapted surveys of patients and health care providers. Primary data will generally be required; however, these may be combined with, and occasionally replaced by, secondary data when the latter will provide adequate information and an efficient means to address the research questions. For example, administrative data, although they generally lack clinical detail, may be useful in identifying cases and controls, estimating costs, or measuring some outcomes. Applicants who propose to use Medicare or Medicaid data must specify the required data files and explore the availability and cost of obtaining these data with the Health Care Financing Administration (HCFA). The estimated cost must be presented along with documentation from HCFA, as part of the grant application. This cost should not be included in the total budget request for the project. For more information about data budgets, contact Ralph L. Sloat, AHCPR Grants Management Officer; at the address listed under INQUIRIES. The application must be explicit and detailed in justifying the proposed methods and data in terms of their potential for answering the research questions under study and the generalizability of results. Descriptions of the data collection and analysis plans, including strategies for case-finding, measuring outcomes, and comparing alternative treatments, must be specific. Adequate attention must be paid to relevant characteristics of: o the population at risk for the condition, o the condition, o the clinical interventions, o the outcomes, o the providers, o available data and measures, and o the sociocultural context of illness and health care. Project Organization To address the clinical and non-clinical dimensions of effectiveness research, PORT-IIs will require multidisciplinary research teams. The composition of the team and relative time commitments of each member should be well justified in terms of substantive knowledge, methodological expertise, and experience in conducting or managing related research projects. Each team should include at least one individual who is actively involved in patient care central to the study, and who contributes understanding of how and why clinical decisions are made in routine clinical practice. Applicants are encouraged to take full advantage of opportunities for efficient enhancements of available expertise, data, and other resources. This might include collaboration with researchers and practitioners outside applicants'/ grantees' own institutions, creative use of existing data, or "piggybacking" on other research activities. In addition, existing practice variations that are known to exist across health care settings, systems, or international borders can provide special opportunities for comparative analysis of outcomes. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups must be included in all AHCPR supported health services research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains some provisions that are substantially different from the 1990 policies. AHCPR plans to publish guidelines specific to AHCPR. In the interim, AHCPR will follow the NIH guidelines, as applicable. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," 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 NIH policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this 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 application deadlines as indicated in the application kit. State and local government agencies may use form PHS 5161 and follow those requirements for copy submission. Application kits 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 for AHCPR applications from Global Exchange Inc., 7910 Woodmont Ave Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX 301-652-5264). The completed, signed, 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** The Division of Research Grants (DRG) will not accept any application in response to this program 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. Incomplete applications will be returned to applicants without further consideration. General scientific review criteria are: significance and originality from a scientific and technical viewpoint; adequacy of the method(s); availability of data or adequacy of proposed plan to collect data; qualifications and experience of the principal investigator and proposed staff; adequacy of the plan for organizing and carrying out the project; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant. Each PORT-II application will be independently evaluated for scientific/technical merit in accordance with the general criteria stated above and the special scientific review criteria listed below, by an appropriate peer review group. Applications assigned to the AHCPR requesting direct costs, over the life of the project, exceeding $250,000 will be reviewed by AHCPR's National Advisory Council for Health Care Policy, Research, and Evaluation, as may applications requesting direct costs, over the life of the project, in excess of $50,000. Special Scientific Review Criteria The major scientific criterion for evaluating PORT-II applications assigned to the AHCPR is the potential for obtaining convincing, new evidence for the effectiveness or ineffectiveness of health care services and procedures. The topic must be compatible with the MEDTEP criteria listed under Topic Selection. Other special criteria are: o scientific importance and policy relevance of the clinical topic and the particular clinical interventions to be studied, as justified in a review of the literature; o generalizability of results; o feasibility of answering the proposed research question(s) within the project period; o attention to technical issues in case-definition, case-finding, data collection, and analysis; o quality and adequacy of the proposed data; o justification for focus on the outcomes specified; o adequacy of outcomes measures, including costs if applicable; o extent to which research design permits direct comparisons of treatment effectiveness and/or cost effectiveness; o evidence of understanding of the issues in clinical decisionmaking and the translation of research findings into clinical practice; o sensitivity to patient heterogeneity and individual preferences; o specification of useful findings or products and identification of constituency(ies) for these; o efficiency of the research plan; and o evidence of productive collaborations (e.g., with other institutions, appropriate professional groups, other sources of support). AWARD CRITERIA Applications will compete for available funds with all other investigator-initiated applications. In making funding decisions, AHCPR will consider: quality of the proposed project as determined by peer review, availability of funds, and program balance. The earliest anticipated date of award is nine months from the date of submission. INQUIRIES Those considering applying in response to this PA are strongly encouraged to discuss their project with AHCPR program administrators before formal submission. The AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women and minorities in study populations, to: Richard Greene, M.D., Ph.D. Center for Medical Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852 Telephone: (301) 594-1485 Direct inquiries regarding fiscal matters to: Ralph L. Sloat Grants Management Office Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.180. Awards are made under authorization of the Public Health Service Act, Title IX, and Section 1142 of the Social Security Act. Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. $$P2 END ************************************************************ $$P3 BEGIN PA-94-067 ************************************************ SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BEHAVIORAL RESEARCH CAREERS NIH GUIDE, Volume 23, Number 18, May 13, 1994 PA NUMBER: PA-94-067 P.T. 34; K.W. 0710030 National Institutes of Health PURPOSE The National Institutes of Health (NIH) announces a program for administrative supplements to research grants to support individuals with high potential to reenter an active research career after taking time off to care for children or parents or to attend to other family responsibilities. The aim of these supplements is to encourage fully trained individuals to reenter research careers within the missions of the program areas of the NIH. This program will provide administrative supplements to existing NIH research grants for the purpose of supporting full-time or part-time research by these individuals in a program geared to bring their existing research skills and knowledge up to date. The NIH recognizes the need to increase the number of women and minorities and people with disabilities in basic, behavioral, and clinical science research careers. Among the reasons for the low representation of women may be the fact that women bear a majority of the responsibilities surrounding child and family care. To address this issue, this program is designed to offer opportunities to women and men who have interrupted their research careers to care for children or parents or to attend to other family responsibilities. The objective of the program is for those who receive support to reestablish careers in biomedical or behavioral research. In 1992 and 1993, the Office of Research on Women's Health sponsored a research supplement program to promote reentry with a single application date each year. The present program announcement replaces that program with one with an open receipt date and with review and funding directly by participating Institutes and Centers (ICs). Participating ICs are the National Cancer Institute, National Eye Institute, National Heart, Lung and Blood Institute, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Institute of Dental Research, National Institute of Drug Abuse, National Institute of Environmental Health Sciences, National Institute of General Medical Sciences, National Institute on Deafness and Other Communication Disorders, National Center for Human Genome Research, and National Center for Research Resources. The National Institute of Mental Health (PA-94-043) recently announced a similar reentry supplement program. The National Institute of Neurological Disorders and Stroke previously announced a Research Career Development Award (K17) for scientists reentering the neurological sciences (NIH Guide, Vol. 21, No. 33, 1992). 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, Supplements to Promote Reentry into Biomedical and Behavioral Research Careers, is related to the priority area of women's health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Grants and Cooperative Agreements: Only the following active NIH award mechanisms at domestic institutions are eligible for Supplements to Promote Reentry into Biomedical and Behavioral Research Careers: R01, R10, R18, R24, R35, R37, P01, P40, P41, P50, P51, P60, U01, U10, and G12. Principal Investigators on such awards are invited to submit a request for an administrative supplement to the awarding component of the parent grant to support an eligible candidate interested in reestablishing a research career. The parent grant must have at least two years of support remaining at the time of the proposed beginning date of the supplemental funding. The rationale for this policy is to ensure ample opportunity for the candidate to develop further her or his research skills. A maximum of three years supplemental support can be awarded under this program. Usually, a parent grant would support only one administrative supplement (Research Supplements for Underrepresented Minorities, Research Supplements to Promote the Recruitment of Individuals with Disabilities into Biomedical Research Careers, or Research Supplements to Promote Reentry into Biomedical and Behavioral Research Careers). Grants most likely to support more than a single administrative supplement are multicomponent awards. Candidates Candidates must have a doctoral degree, such as M.D., D.D.S., Ph.D., O.D., D.V.M., or equivalent, and at least two years of post-doctoral research experience and must have had sufficient prior research experience to qualify for a faculty appointment at the assistant professor or equivalent level. Candidates who have begun the reentry process through a fellowship or similar mechanism are not eligible for this program. The following general guidelines will be applied by the individual ICs. In general, the duration of the career interruption should be for at least two years and no more than eight years. Examples of qualifying interruptions would include starting and/or raising a family, an incapacitating illness or injury of the candidate, the spouse, partner, or a member of the immediate family; relocation to accommodate a spouse, partner, or other close family member; pursuit of non-research endeavors that would permit earlier retirement of debt incurred in obtaining a doctoral degree; and military service. The program is not intended to support graduate or postdoctoral training and is not intended to support career changes from non- research to research careers for individuals without prior research training. Generally, at the time of application, a candidate may not be engaged in paid research activities for more than 25 percent effort. MECHANISM OF SUPPORT In all cases, the proposed research must be directly related to the funded approved ongoing research of the parent grant or cooperative agreement. The individual supported under this supplemental award, hereafter called the reentry candidate, must be afforded the opportunity to act as a full participant in the research project and must be given an opportunity to update and enhance her or his research capabilities. This will allow the candidate to begin the process of establishing or re-establishing a career as an independent, competitive research investigator. Supplemental awards will be consistent with the goals of strengthening the existing research program and with the overall programmatic balance and priorities of the funding program of the NIH. Awards will be made according to the policies and provisions stated in this announcement and in the PHS Grants Policy Statement (rev. 10/90). Administrative supplements (S1) provided under this program may be for either part-time or full-time support for the candidate, and all supported time is to be spent updating and enhancing research skills. Proposed part-time appointments may not be less than 50 percent effort per week. Supplemental awards may be made for up to three years and may not exceed $50,000 in direct costs per year. A maximum of $40,000 may be requested for the combination of full time salary and fringe benefits for the reentry candidate. The amount of salary requested must be consistent with the policies of the grantee institution for individuals occupying similar positions and must be related to the percent effort requested for the supplement and the number of months requested for the supplement. An additional amount up to $10,000 may be requested for supplies, domestic travel, and publication costs relevant to the proposed research. Equipment may not be purchased as a part of this supplement without justification and specific prior approval of the NIH. The decision to fund a supplement will take six to eight weeks from the time the necessary information is received by the awarding ICD. During the first budget period, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on funding of the parent grant and can not extend beyond the current competitive segment of the parent grant. A decision may be made to pay, but, in fact, at the end or beginning of a year, no funds may be available. APPLICATION PROCEDURES A request for a supplement may be made at any time during the funding year, providing there will be two full years of funding remaining for the parent grant at the time of funding. In making requests, the grantee institution, on behalf of the Principal Investigators, should submit the request for supplemental funds directly to awarding component that supports the parent grant. The request is NOT to be submitted to the NIH Division of Research Grants. Principal Investigators are encouraged to obtain the address for submission from the NIH program administrator on the parent grant. The request for a supplemental award must include the following: 1. A complete face page (with appropriate signatures) from grant application form PHS 398 (rev. 9/91), including the title and grant number of the parent grant and "Reentry Supplement" on line 1 2. A brief, three- or four-page description, prepared by the Principal Investigator of the parent grant, that includes: a. A summary or abstract of the funded grant or project b. A description of the research proposed for the candidate c. How the supplement will expand and foster the independent research capabilities of the candidate d. How the proposed research relates to the specific research goals and objectives of the parent grant e. A description of the scope and nature of the mentoring relationship between the Principal Investigator and the candidate 3. A brief description, prepared by the candidate, that includes: a. research objectives and career goals b. length of and reason for career hiatus c. description of how the candidate has kept current or attempted to keep current in her/his field d. identification of steps taken toward reentry, (if any, such as attending scientific meetings) 4. A biographical sketch of the candidate that includes: a. curriculum vitae b. social security number c. citizenship status d. publications e. other evidence of scientific achievement. 5. A proposed budget entered on budget pages from the grant application form PHS 398 (rev. 9/91), related to the percent effort for the research proposed for the reentry candidate during the first and future budget period(s) (The amount requested for the supplement must coincide with the current period of support. Thus, if the initial budget period requested is less than 12 months, the budget must be prorated accordingly.) 6. Documentation, if applicable, that the proposed research is approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) of the grantee institution 7. Under unusual circumstances in which the applicant and mentor would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted. The request must be signed by the Principal Investigator, the reentry candidate, and the appropriate institution business official. REVIEW CONSIDERATIONS The program staff of the individual ICDs will review requests for supplements using the following general criteria: o the qualifications of the reentry candidate, including career goals, prior research training, research potential, and any relevant experience o the plan for the proposed research experience in the supplemental request and its relationship to the parent grant o evidence from the Principal Investigator that the experience will enhance the research potential, knowledge, and/or skills of the reentry candidate o evidence from the Principal Investigator that the activities of the reentry candidate are an integral part of the project o evidence of effort by the reentry candidate to initiate the reentry process, such as attending scientific meetings, keeping current with journals o evidence that proposed research will achieve the stated objectives of the reentry supplements In noncompeting continuation applications, the progress report for the reentry supplement should be clearly delineated from the progress report for the parent grant. The progress report should include information about the research activities supported by the supplement, even if support for future years is not requested. Since these applications will undergo administrative review, summary statements will not be produced. This is consistent with NIH practice for other similar programs, such as those referenced in the ELIGIBILITY REQUIREMENTS section of this program announcement. INQUIRIES For general information about the reentry supplements, candidates and Principal Investigators should contact the program official of the appropriate awarding Institute or Center. Candidates who have not yet made contact with a Principal Investigator are encouraged to contact the program official whose institute or center is specific to the research interest. To discuss business aspects of the parent grant or the supplement, Principal Investigators should contact their grants management official. Program officials and grants management contacts and the respective awarding institutes or centers are listed below. Toby Friedberg National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Telephone: (301) 496-3428 FAX: (301) 402-0275 Ralph J. Helmsen, Ph.D. National Eye Institute Executive Plaza South, Suite 350 Bethesda, MD 20892 Telephone: (301) 496-5301 FAX: (301) 402-0528 Ronald S. Geller, Ph.D. National Heart, Lung, and Blood Institute Westwood Building, Room 7A17 Bethesda, MD 20892 Telephone: (301) 594-7454 FAX: (301) 594-7424 Robin Barr or D. Phil. or Joseph Ellis National Institute on Aging 7201 Wisconsin Avenue, Room 218 Bethesda, MD 20892 Telephone: (301) 496-9322 FAX: (301) 402-2945 Helen Chao, Ph.D. or Linda Hilley National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-2530 or (301) 443-4703 FAX: (301) 594-0673 Milton Hernandez, Ph.D. National Institute of Allergy and Infectious Disease Solar Building, Room 4C10 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Julia Freeman, Ph.D. National Institute of Arthritis and Musculoskeletal and Skin Disease Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 594-9961 FAX: (301) 594-9673 Hildegard Topper or Donald Clark National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892 Telephone: (301) 496-0104 or (301) 496-5001 FAX: (301) 402-1104 Patricia S. Bryant, Ph.D. or Theresa Ringler National Institute of Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 594-7641 or (301) 594-7629 FAX: (301) 594-9720 Eleanor Friedenberg, Program Official National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 FAX: (301) 443-0538 Anne P. Sassaman, Ph.D. or Dave Mineo National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7723 or (919) 541-7628 FAX: (919) 541-2843 Anthony A. Rene, Ph.D. or Carol Tippery National Institute of General Medical Sciences Westwood Building, Room 925 Bethesda, MD 20892 Telephone: (301) 594-7706 or (301) 594-7813 FAX: (301) 594-7701 Earleen F. Elkins, Ph.D. National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400C Rockville, MD 20892 Telephone: (301) 496-8693 FAX: (301) 402-6250 Jane Peterson, Ph.D. National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 Louise E. Ramm, Ph.D. or Lacey J. Durham National Center for Research Resources Westwood Building, Room 854 Bethesda, MD 20892 Telephone: (301) 594-7906 or (301) 594-7955 FAX: (301) 594-9121 AUTHORITY AND REGULATIONS Supplemental awards will be made under authorities applicable to the parent grant and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Mon May 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 18, pt. 1of2, 13 May 1994 Date: 16 May 1994 18:08:29 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2r95ed$3fu@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940513 V23N18 P1O2 ************************************ X-comment: RFAS described: HD-94-022, HL-94-016, HL-94-017, DK-94-021, AI-94- 016, DE-94-005 NIH GUIDE - Vol. 23, No. 18 - May 13, 1994 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** INTERVENTIONS TO IMPROVE ASTHMA MANAGEMENT AND PREVENTION AT SCHOOL (BAA NHLBI-HR-94-15) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 ********************************************************** CLINICAL TRIAL OF MANAGEMENT STRATEGIES OF ATRIAL FIBRILLATION IN AN ELDERLY POPULATION (RFP NHLBI-HC-94-22) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 ********************************************************** PROGRAM OF HEARING AID DEVICE DEVELOPMENT (RFP NIH-DC-94-02) National Institutes on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATIONS DISORDERS $$INDEX R4 08/19/94 ************************************************* UNINTENDED PREGNANCY IN THE UNITED STATES (RFA HD-94-022) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R5 09/14/94 ************************************************* TUBERCULOSIS ACADEMIC AWARD (RFA HL-94-016) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R6 09/14/94 ************************************************* ASTHMA ACADEMIC AWARD (RFA HL-94-017) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R7 11/15/94 ************************************************* SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS (RFA DK-94-021) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R8 11/17/94 ************************************************* SEXUALLY TRANSMITTED DISEASES COOPERATIVE RESEARCH CENTERS (RFA AI-94-016) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R9 01/18/95 ************************************************* INSTITUTIONAL DENTIST SCIENTIST AWARD (RFA DE-94-005) National Institute of Dental Research INDEX: DENTAL RESEARCH ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** INDIVIDUAL DENTIST SCIENTIST AWARD (PAR-94-065) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX P2 ********************************************************** MEDICAL TREATMENT EFFECTIVENESS RESEARCH -- PORT-II (PA-94-066) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX P3 ********************************************************** SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BEHAVIORAL RESEARCH CAREERS (PA-94-067) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH 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 NHLBI-HR-94-14 ******************************************* INTERVENTIONS TO IMPROVE ASTHMA MANAGEMENT AND PREVENTION AT SCHOOL NIH GUIDE, Volume 23, Number 18, May 13, 1994 BAA AVAILABLE: NHLBI-HR-94-15 P.T. 34; K.W. 0715013, 0745027 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) plans to use a Broad Agency Announcement (BAA) research and development contract program to develop and evaluate innovative programs to assure optimal asthma management and prevention at school. Program objectives include: identify cost-effective measures to increase identification and appropriate referral of children with uncontrolled asthma; reduce exposure to known allergens and irritants; increase participation of students with asthma in all school activities, including physical education and sports; improve support to the students for following their asthma management plans, especially assuring appropriate access to medications; and improve communication between the school and home. NHLBI hopes to make four awards. Offerors other than U.S. organizations will not be considered. INQUIRIES This is an announcement for Broad Agency Announcement (BAA). The BAA will be available on or about 20 April, 1994, with proposals due on or about 15 July, 1994. Written requests for the BAA must include three self-addressed mailing labels and cite BAA NHLBI-HR-94-15. Requests for copies of the BAA are to be directed to: Mr. Craig Miron Contracts Operations Branch National Heart, Lung and Blood Institute 7550 Wisconsin Avenue, Room 200 Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN NHLBI-HC-94-22 ******************************************* CLINICAL TRIAL OF MANAGEMENT STRATEGIES OF ATRIAL FIBRILLATION IN AN ELDERLY POPULATION NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFP AVAILABLE: NHLBI-HC-94-22 P.T. 34; K.W. 0715040, 0755015 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute is soliciting proposals for a clinical trial center to study two different strategies for the management of atrial fibrillation. The contractor will enroll approximately 5,300 patients to be randomized to one of the two management strategies. The first strategy will administer arrhythmia drugs to maintain normal sinus rhythm and the second group will be given a different group of drugs and/or catheter ablation for heart rate control only. The anticipated period of performance is seven years beginning on or about April 1, 1995. The Request for Proposal (RFP) NHLBI-HC-94-22 will be released on or about May 10, 1994 with proposals due on August 1, 1994. One award is anticipated from this RFP. INQUIRIES All requests must be in writing, cite RFP NHLBI-HC-94-22, and be addressed to: Ms. Lisa O'Neill Contracting Officer ECA Contract Section National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue, Room 200 Bethesda, MD 20892 $$R2 END ************************************************************ $$R3 BEGIN NIH-DC-94-02 ********************************************* PROGRAM OF HEARING AID DEVICE DEVELOPMENT NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFP AVAILABLE: NIH-DC-94-02 P.T. 34; K.W. 0740030, 0706000 National Institutes on Deafness and Other Communication Disorders The National Institute on Deafness and Other Communication Disorders, National Institutes of Health, has a requirement to design, develop, and evaluate in laboratory-based and field-trial studies, innovative speech processing strategies for hearing aids. The focus will be on new and creative approaches; although it may include the evaluation of recently developed strategies using existing technologies such as multiple microphone arrays, automatic signal processing technologies (e.g., fixed-frequency or level-dependent frequency response, compression amplification), and programmable hearing aids employing digital processing. Wearable speech processors will be developed for use in field trials. A four-year cost-reimbursement type contract is anticipated. The solicitation is scheduled to be issued on or about May 16, 1994. Proposals will be due 45 days after the date of issuance of the solicitation. All responsible sources may submit a proposal that will be considered by the Government. INQUIRIES Copies of the solicitation may be obtained by sending a written request to: John P. DeCenzo Research Contracts Branch, DCG/OD National Institutes of Health Building 31, Room 1B44 Bethesda, MD 20892 Telephone: (301) 496-4487 $$R3 END ************************************************************ $$R4 BEGIN HD-94-022 FULL-TEXT ************************************** UNINTENDED PREGNANCY IN THE UNITED STATES NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA AVAILABLE: HD-94-022 P.T. 34; K.W. 0775020, 0404000, 0417000 National Institute of Child Health and Human Development Application Receipt Date: August 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. APPLICATIONS IN RESPONSE TO THIS RFA WILL BE ASKED TO USE A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE APPLICATION PROCEDURES BELOW. PURPOSE The Center for Population Research (CPR) of the National Institute of Child Health and Human Development (NICHD) invites scientists to submit grant applications for the support of research on the definition of, the measurement of and the determinants of intended VS unintended pregnancies and births in the contemporary U.S. Research on various aspects of contraceptive use and non-use is an important part of the Demographic and Behavioral Sciences Branch's program, within the Center for Population 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, Unintended Pregnancy in the U.S., is related to the priority areas of family and child 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. 017-001-004734-1) 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 from minorities, women and disabled persons are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Applications in response to this RFA will be funded through individual research project grants (R01) and FIRST (R29) awards. 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 five years. This RFA is for a single competition with the application receipt date of August 19, 1994. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. For R29 applications, the budgetary conventions governing FIRST awards will apply. FUNDS AVAILABLE The NICHD has set aside $1,000,000 direct costs for the first year of support for the program. It is anticipated that four to six awards will be made depending on the nature and scope of the projects. 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 NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES This RFA invites applications to conduct research on the meaning, measurement, and determinants of unintended pregnancy and birth in the contemporary United States. Two sets of research questions are at issue and applications may address aspects of either or both. First, the RFA seeks to provide a richer understanding of the meaning of unintended pregnancy, as conventionally defined, as well as to build a scientific base for improved measures that may be used in demographic surveys. Second, the RFA seeks to improve and extend research on the determinants of unintended pregnancy and birth at the cultural, societal, couple, and individual levels. Sociological, psychological, social-structural, and contextual approaches are welcomed. Qualitative as well as quantitative methodologies would be appropriate. 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) that is available in most institutional 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. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applications must be identified by checking the "YES" box in Item 2a on the face page of the application and by typing "RFA HD-94-022." The RFA label in form PHS 398 must be affixed to the bottom of the face page of the original 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. Applications must be received by August 19, 1994. Late applications will not be accepted. The signed original and three copies of the applications must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Additional applications procedures are described in the RFA. REVIEW CONSIDERATIONS The applications will be reviewed for scientific merit by an initial review group convened solely for this purpose by the Division of Scientific Review, NICHD and the NICHD Advisory Council for program relevance and policy issues before awards for meritorious applications are made. AWARD CRITERIA The anticipated date of award is March 1995. Scientific merit and technical proficiency, as described in the application, will be the predominant criteria for determining funding. INQUIRIES Written and telephone requests for the RFA and inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Susan F. Newcomer, Ph.D. Demographic and Behavioral Science Branch National Institute of Child Health and Human Development Building 61E, Room 8B13 Bethesda MD 20892 Telephone: (301) 496-1174 FAX: (301) 496-0962 Electronic mail: NewcomeS@HD01.NICHD.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-5481 FAX: (301) 402-0915 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864 (Population Research). 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 Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN HL-94-016 FULL-TEXT ************************************** TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA AVAILABLE: HL-94-016 P.T. 34; K.W. 0715165, 0502024, 0403004, 0795003 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: July 13, 1994 Application Receipt Date: September 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 CONTACTS LISTED BELOW IN "INQUIRIES." 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 primary objective of this RFA is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of Mycobacterial tuberculosis (TB) 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, Tuberculosis Academic Award, is related to the priority areas of immunization and 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 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. In this competition, there is an interest in a diversity of types of applications. These include, but are not limited to, applications from any of the following: established researchers and/or faculty specializing in the field of tuberculosis, minority faculty members interested in medical education, minority medical institutions, institutions serving a high proportion of minority medical students or minority patients or institutions having other tuberculosis research projects to which this award would be complementary. Candidates A candidate for an award must: o be an established physician and a medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have the unqualified support of the Dean and the educational leadership at the institution and demonstrate knowledge and commitment to medical education for medical students, physicians, patients, and the public; o have sufficient clinical training, and experience in the control of TB to develop and implement a high quality curriculum in TB encompassing current knowledge and methods applicable to the control of tuberculosis in individuals of all ages and to provide leadership in applied research in control of TB; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; and o commit at least 30 percent effort for a five year period. Individuals who have held another NIH career development award (K series) are eligible to apply for the Tuberculosis Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin April 1, 1995. (Applicants may request a July 1, 1995 start date.) FUNDS AVAILABLE The estimated funds (total costs) for fiscal year 1995 will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested for each year. RESEARCH OBJECTIVES The objectives of the Tuberculosis Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling TB; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote communication among primary care and other specialists to ensure appropriate control and treatment strategies; o encourage applied research in the control of TB; o promote the development of a faculty capable of providing appropriate instruction in diagnosis and management of TB, with special emphasis on minority faculty; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have TB; o provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high TB morbidity; o contribute to updating the knowledge and skills of practicing physicians and other health care providers in the community; o enhance the awareness of health care providers of the unique ethnic, cultural, socioeconomic, and medical dimensions of TB; o coordinate and collaborate with other community organizations to control TB in areas with high incidence of TB; o facilitate an interchange of ideas and methods among awardees and institutions; o contribute to public health efforts to control TB in the United States; and o enhance the teaching of tuberculosis in minority medical schools and promote TB education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about tuberculosis and among physicians who are or who will be caring for medically underserved populations. Since this is a medical education program, funds may be requested for technical support staff who have complementary expertise to the principal investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. 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 July 13, 1994, a letter of intent that includes 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 Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7428. Applications must be received by September 14, 1994. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will return the application to the applicant. The initial review may include a preliminary evaluation to determine scientific merit relative to the other applications received in response to this program announcement (triage); the NIH will remove from further consideration applications judged to be noncompetitive and promptly notify the Principal Investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures, including, if deemed appropriate, an applicant interview in or near Bethesda at the applicant's expense. The initial review will be conducted by a Special Emphasis Panel, managed by the Division of Extramural Affairs, National Heart, Lung, and Blood Institute. The secondary review will be by the National Heart, Lung, and Blood Advisory Council. Applications for this Tuberculosis Academic Award will be evaluated in terms of the criteria listed in the RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, listed below, as soon as they receive approval from their institution to apply for this award. Direct requests for the RFA and inquiries regarding programmatic issues to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. $$R5 END ************************************************************ $$R6 BEGIN HL-94-017 FULL-TEXT ************************************** ASTHMA ACADEMIC AWARD NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA AVAILABLE: HL-94-017 P.T. 34; K.W. 0715013, 0502024, 0745027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: July 13, 1994 Application Receipt Date: September 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 CONTACTS LISTED BELOW IN "INQUIRIES." 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 primary objective of this RFA is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of asthma 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, Asthma Academic Award, is related to the priority areas of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "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 Institutions Applications may be submitted by domestic universities or schools of medicine. In this competition, there is an interest in a diversity of types of applications. These include, but are not limited to, applications from any of the following: established researchers and/or faculty specializing in the field of asthma, minority faculty members interested in medical education, institutions serving a high proportion of minority medical students or minority patients, institutions having other asthma research projects to which this award would be complementary. Candidates A candidate for an award must: o be an established physician and medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have demonstrated knowledge and commitment to medical education for medical students, physicians, and patients; o have sufficient clinical training and experience in asthma to develop and implement a high quality curriculum in asthma encompassing current knowledge and methods applicable to the control of asthma in individuals of all ages and to provide leadership in applied research in control of asthma; o have the support of the Dean and educational leadership at the institution; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; and o commit at least 30 percent effort for a period of five years. Individuals who have held another NIH career development award (K series) are eligible to apply for the Asthma Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute (NHLBI). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin April 1, 1995. (Applicants may request a July 1, 1995 start date.) FUNDS AVAILABLE The estimated funds (total costs) for fiscal year 1995 will be $300,000. It is anticipated that three to four grants will be awarded under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested for each year. RESEARCH OBJECTIVES The objectives of the Asthma Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling asthma; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote communication among specialists in primary care, allergy, and obstetrics and gynecology to ensure appropriate treatment of pregnant women with asthma; o encourage applied research in the control of asthma; o promote the development of a faculty capable of providing appropriate diagnosis and management instruction in asthma, with special emphasis on minority faculty; o promote an institutional environment that facilitates an interchange of information and educational evaluation techniques about new diagnostic, therapeutic, and prevention measures in asthma in both children and adults; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have asthma, such as minorities, young children, and the elderly; o provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high asthma morbidity, such as inner city minority communities; o facilitate an interchange of ideas among awardees and institutions; o evaluate the impact of the proposed program; o contribute to the public health efforts to control asthma in the United States; and o enhance the teaching of asthma in minority medical schools and promote community asthma education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about asthma and among physicians who are or who will be caring for medically underserved populations. Since this is a medical education program, funds may be requested for technical support staff who have complementary expertise to the Principal Investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. 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 July 13, 1994, a letter of intent that includes the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the RFA number and title 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 Application are to be submitted on the grant application form PHS 398 (rev. 9/91). 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, 5333 Westbard Avenue, Room 449, Bethesda MD 20892, telephone (301) 594-7428. Applications must be received by September 14, 1994. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will return the application to the applicant. The initial review may include a preliminary evaluation to determine scientific merit relative to the other applications received in response to this program announcement (triage); the NIH will remove from further consideration applications judged to be noncompetitive and promptly notify the Principal Investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures, including, if deemed appropriate, an applicant interview in or near Bethesda at the applicant's expense. The initial review will be conducted by a Special Emphasis Panel, managed by the Division of Extramural Affairs, National Heart, Lung, and Blood Institute. The secondary review will be by the National Heart, Lung, and Blood Advisory Council. Applications for this Asthma Academic Award will be evaluated in terms of the criteria listed in the RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, listed below, as soon as they receive approval from their institution to apply for this award. Direct requests for the RFA and inquiries regarding programmatic issues to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99- 158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CAR 52 and 45 CAR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. $$R6 END ************************************************************ $$R7 BEGIN DK-94-021 FULL-TEXT ************************************** SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA AVAILABLE: DK-94-021 P.T. 04; K.W. 0715085, 0755030, 0765035, 0745070 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 18, 1994 Application Receipt Date: November 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Silvio O. Conte Digestive Diseases Core Center grants. NIDDK anticipates the award of four competitive Silvio O. Conte Digestive Diseases Core Center Grants (P30s) in Fiscal Year 1996. 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, Silvio O. Conte Digestive Diseases Research Core Center grants, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (not 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. Minority individuals and women are encouraged to submit as principal investigators. Applicant institutions must have an adequate base of established programs of high quality in laboratory and/or clinical digestive diseases related research. MECHANISM OF SUPPORT Support of this program will be through the NIH grant in aid core center (P30) award. Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. This RFA is a one-time solicitation. The receipt of four competing continuation applications is anticipated. These applications will compete for four awards along with other applications received in response to this RFA. The total project period for each application submitted in response to the present RFA may not exceed five years. The earliest possible award dates will be December 1994 for three center grants and January 1995 for the other grant. 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 a Principal Investigator must be included with the application. FUNDS AVAILABLE For FY 1996, up to $3,265,000 in total costs will be committed to fund applications submitted in response to this RFA. It is anticipated that four awards will be made with an average size of approximately $750,000 per year, total costs; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Applicants must limit their requests to not more than $700,000 direct costs for the initial budget period. Included in this $700,000 are funds with a limit of $100,000 for the pilot and feasibility program. Future budget period escalations should not exceed a four percent increase over the previous budget period. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objective of the Digestive Diseases Core Centers is to bring together clinical and basic science investigators from relevant disciplines to enhance and extend the effectiveness of research related to digestive diseases and their complications. There must be an existing peer reviewed and funded program of excellence in this area. At least one half of the research must have a central theme or focus. Examples of a central theme or focus include, but are not restricted to, inflammatory bowel disease, peptic ulcer disease, liver disease, pancreatic disease, pediatric gastrointestinal disease, GI hormones, GI motility, AIDS in gastrointestinal disease, or gene therapy. Core facilities which enhance productivity or in other ways benefit a group of investigators working in digestive diseases centers to accomplish the stated goals of the center will be supported. Two other activities may also be supported with center funding: (1) a pilot and feasibility grant program which may include temporary salary support for one Named New Investigator and (2) an enrichment program including for example, seminars, visiting scientists, consultants, and workshops. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. SPECIAL REQUIREMENTS At least 50 percent of the already funded research base in a new application must be supported by NIDDK. In competing continuation applications the percent may be less than 50 percent due to, for example, a growing research base of investigators entering digestive diseases from other fields. The appropriateness of the research base will be determined by the initial review group. At least one of the Centers awarded in FY 96 will have a primary focus on studies related to inflammatory bowel disease. 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 October 18, 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 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 NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91), available in the office of sponsored research at most academic or research institutions and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Detailed instructions on submission procedures are described in the RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIDDK in accordance with the usual NIH peer review procedures. Following review, the applications will be given a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant. Review Criteria are given in the RFA. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential are welcome. It is imperative that the pamphlet "Administrative Guidelines for Silvio O. Conte Digestive Diseases Research Core Centers" be obtained before an application is prepared. Requests for the RFA and the pamphlet and inquiries regarding programmatic issues may be directed to: Dr. Judith M. Podskalny Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 594-7539 FAX: (301) 594-7504 Inquiries regarding fiscal matters may be directed to: Ms. Nancy Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637A Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7494 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R7 END ************************************************************ $$R8 BEGIN AI-94-016 FULL-TEXT ************************************** SEXUALLY TRANSMITTED DISEASES COOPERATIVE RESEARCH CENTERS NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA AVAILABLE: AI-94-016 P.T. 34; K.W. 0715182, 0710030, 0785055 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 5, 1994 Application Receipt Date: November 17, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The purpose of this RFA is to stimulate multidisciplinary, collaborative research to further understanding of sexually transmitted diseases (STDs) and effective approaches to their prevention and control. The Sexually Transmitted Diseases Branch of the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites research grant applications for recompetition of the Sexually Transmitted Diseases Cooperative Research Centers (STD CRCs). The NIAID recognizes that although each STD presents unique diagnostic, therapeutic, and prevention challenges, all STDs share a common mode of transmission, populations at risk for one STD are at risk for others, comorbidity is common, and the presence of one infection may influence the acquisition and natural history of another. Therefore, a research program that addresses these diseases as a group is likely to be highly productive. The CRCs provide a multi-disciplinary approach to STD research by bridging biomedical, clinical, behavioral, and epidemiological research areas; foster interaction among STD investigators; and facilitate intervention-oriented research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Sexually Transmitted Diseases Cooperative Research Centers (STD CRCs), is related to the priority areas of STDs and acquired immunodeficiency syndrome (AIDS). 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 be limited to domestic institutions, but may include an international component. Applications may be submitted by domestic for-profit and non-profit research institutions; public and private organizations, such as universities, colleges, hospitals, laboratories, units of State or local governments; and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U19). Details on the responsibilities, relationships, and governance of a study funded under a cooperative agreement are discussed in the RFA under the section Terms and Conditions of Award. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $6.2 million. In Fiscal Year 1995, the NIAID plans to fund five new and/or competing STD CRCs or more if additional money becomes available. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. The initial year's total costs, including direct and indirect costs, should not exceed $1.2 million for each award. Each award will be made for a project period of four years. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES The purpose of this RFA is to stimulate multidisciplinary, collaborative research to further the understanding of STDs and effective approaches to their prevention and control. This will be accomplished through collaborations of scientists from various disciplines of biomedical, clinical, behavioral, and epidemiological research areas. In addition to utilizing a multi-disciplinary approach, applications should include: o at least three projects, one of which should be in behavioral or epidemiologic research (behavioral/epidemiologic research must include both behavioral or epidemiologic outcomes and microbiologic/disease outcomes); o two projects that link disciplines within a single scientific area (e.g., molecular biology and immunology within the biomedical area) and at least one project that links disciplines in two different areas (e.g., microbiology from the biomedical area and psychology from the behavioral area); o a strong clinical capability with accessible patient populations to participate in the clinical and behavioral/epidemiologic research projects; o provisions for the Principal Investigator of each CRC to attend meetings with NIAID staff twice each year and for all CRC Project Leaders to attend CRC workshops twice during the program period. 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. Copies of these Guidelines may be obtained from Dr. Miller listed in INQUIRIES below. LETTER OF INTENT Prospective applicants are asked to submit, by August 5, 1994, a letter of intent that includes a descriptive title of the overall proposed research; the name, address, and telephone number of the Principal Investigator; the number and title of this RFA; and a list of the key investigators and their institution(s). The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "SEXUALLY TRANSMITTED DISEASES COOPERATIVE RESEARCH CENTERS (STD CRCs)" must be typed in. 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. These forms may be obtained from the institution's office of sponsored research or its equivalent and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applications must be received by November 17, 1994. All components, subparts and sections of the application must be collated into the application, and the packages sent to the DRG and to the NIAID must each be complete in themselves. Applications that do not conform to the instructions contained in PHS 398 (rev. 9/91) application kit will be judged nonresponsive and will be returned to the applicant. REVIEW CONSIDERATIONS Applications will be reviewed by the Division of Research Grants (DRG) for completeness and by NIAID for responsiveness to the RFA. Incomplete and non- responsive applications will be returned to the applicant without further consideration. The applications may be subjected to triage by a peer review group. The NIAID will remove from further competition those applications judged to be noncompetitive for award and will notify the applicant. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by a committee convened by NIAID. A second level of review will be provided by the NIAID Advisory Council. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities and balance, and 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 welcomed. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Heather Miller Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-26 Bethesda, MD 20892 Telephone: (301) 402-0443 Internet Address: heather@exec.niaid.pc.niaid.nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 Bethesda, MD 20892 Telephone: (301) 496-8208 Internet Address: op2t@nih.gov Direct inquiries regarding fiscal matters to: Ms. Katherine Phillips Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-33 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: August 5, 1994 Application Receipt Date: November 17, 1994 Scientific Review Date: February/March 1995 Advisory Council Date: June 1995 Earliest Award Date: July 1, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 Immunology, Allergic and Immunological Diseases Research and 93.856 Microbiology and Infectious Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. $$R8 END ************************************************************ $$R9 BEGIN DE-94-005 FULL-TEXT ************************************** INSTITUTIONAL DENTIST SCIENTIST AWARD NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA AVAILABLE: DE-94-005 P.T. 34; K.W. 0715148, 0710030 National Institute of Dental Research Letter of Intent Receipt Date: December 1, 1994 Application Receipt Date: January 18, 1995 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 applications proposing new and competing renewal Institutional Dentist Scientist Award programs in basic biomedical, behavioral and clinical oral health research. The purpose is the development of outstanding clinician research scientists. Programs must provide doctoral (Ph.D.) basic science and advanced clinical knowledge and skills development in either a recognized clinical specialty or other equivalent dental clinical discipline, and a supervised research experience designed to facilitate transition to an active research career. Programs must be relevant to the NIDR's goals. Several changes have been introduced in the policies and provisions governing these awards. Current policies and provisions will remain in effect for all programs through June 30, 1995, and will continue to apply to appointees accepted into programs prior to that date until completion of their five years career development. The new policies and provisions will apply to appointments made on or after July 1, 1995 and to all new and competing renewal awards made on or after July 1, 1996. 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, Institutional Dentist Scientist Award, 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 dental schools, or institutions with a dental school affiliation. Only one award will be made to an institution. Dentist Scientist Appointees (DSAs) to the programs must have a From owner-sci-resources@net.bio.net Mon May 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-94-017 - V23(18) 05/13/94 Date: 16 May 1994 18:08:44 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 531 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2r95es$3h3@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL94017 HL-94-017 P1O1 *************************************** ASTHMA ACADEMIC AWARD NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA: HL-94-017 P.T. 34; K.W. 0715013, 0502024, 0745027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: July 13, 1994 Application Receipt Date: September 14, 1994 PURPOSE The primary objective of this Request for Application (RFA) is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of asthma 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, Asthma Academic Award, is related to the priority areas of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "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 Institutions Applications may be submitted by domestic universities or schools of medicine. In this competition, there is an interest in a diversity of types of applications. These include, but are not limited to, applications from any of the following: o established researchers and/or faculty specializing in the field of asthma o minority faculty members interested in medical education o institutions serving a high proportion of minority medical students or minority patients o institutions having other asthma research projects to which this award would be complementary Candidates A candidate for an award must: o be an established physician and medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have demonstrated knowledge and commitment to medical education for medical students, physicians, and patients; o have sufficient clinical training and experience in asthma to develop and implement a high quality curriculum in asthma encompassing current knowledge and methods applicable to the control of asthma in individuals of all ages and to provide leadership in applied research in control of asthma; o have the support of the Dean and educational leadership at the institution; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; and o commit at least 30 percent effort for a period of five years. Individuals who have held another NIH career development award (K series) are eligible to apply for the Asthma Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin April 1, 1995. (Applicants may request a July 1, 1995 start date.) FUNDS AVAILABLE The estimated funds (total costs) for fiscal year 1995 will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested for each year. RESEARCH OBJECTIVES Background Asthma is a serious chronic condition, affecting approximately 10 million Americans. People with asthma experience over 100 million days of restricted activity annually, and costs for asthma care exceed $4 billion a year. Asthma morbidity and mortality rates are increasing. From 1980 to 1987, the prevalence of asthma in the U.S. increased 29 percent, and the number of asthma deaths increased by 31 percent. Recent reports indicate that mortality from asthma has been rising since about 1968 in all age groups. In 1987, the overall death rate from asthma was 1.9/100,000 people with females slightly higher than males. Many of these deaths were considered to be largely preventable. The largest increase in asthma-related mortality has been among blacks, women, and persons over 65 years of age. Additionally, since about 1950 there has been a widening gap in deaths from asthma between blacks and whites. Asthma mortality has been three times higher in black compared to white males and twice as high in black compared to white females. Reduction of asthma morbidity has been identified as a new objective in the U.S. Health Objectives for the Year 2000. Considerable national attention is being directed at this problem, including the following major efforts. Considerable behavioral and education research has been conducted in the area of patient/family self management to complement and enhance medical treatment regimens, and these have yielded several effective educational programs for patients and their families. With representation from 30 governmental, professional, and voluntary health organizations, a National Asthma Education Program has been initiated to educate patients, the public, and health care providers about the disease. A major early accomplishment of this Program was the preparation and dissemination of the "Guidelines for the Diagnosis and Management of Asthma" and the "Executive Summary: Management of Asthma During Pregnancy." Yet although asthma is a disease that generally can be controlled with expert medical treatment and self-management, many patients are not receiving state-of-the-art medical care and/or are not following the prescribed treatment plans. Special programs are needed to reach health care providers in areas remote from major medical centers and to reach minority and lower socioeconomic level patients in both inner city and rural areas. Multidimensional research conducted by multidisciplinary teams will be required to improve clinical practice and patient education. Therefore, the aim of this program is to stimulate the development and/or improvement of the quality of medical education, patient and community education, research programs, and clinical practice focused on the control of asthma. Objectives The objectives of the Asthma Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling asthma; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote communication among specialists in primary care, allergy, and obstetrics and gynecology to ensure appropriate treatment of pregnant women with asthma; o encourage applied research in the control of asthma; o promote the development of a faculty capable of providing appropriate diagnosis and management instruction in asthma, with special emphasis on minority faculty; o promote an institutional environment that facilitates an interchange of information and educational evaluation techniques about new diagnostic, therapeutic, and prevention measures in asthma in both children and adults; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have asthma, such as minorities, young children, and the elderly; o provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high asthma morbidity, such as inner city minority communities; o facilitate an interchange of ideas among awardees and institutions; o evaluate the impact of the proposed program; o contribute to the public health efforts to control asthma in the United States; and o enhance the teaching of asthma in minority medical schools and promote community asthma education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about asthma and among physicians who are or who will be caring for medically underserved populations. Since this is a medical education program, funds may be requested for technical support staff who have complementary expertise to the Principal Investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. SPECIAL REQUIREMENTS 1. Awardee Salary The salary requested for the awardee must not exceed the actual institutional salary rates for the effort devoted to the Academic Award, and must not exceed $50,000 plus fringe benefits. A candidate must spend at least 30 percent time on this award. An awardee may devote up to a total of 100 percent effort as an Academic Awardee and as principal or participating investigator on any other NIH-supported grant(s) or contract(s) and may receive remuneration from such grant(s) or contract(s) accordingly. An example of an investigator who receives the Academic Award at a level of effort of 30 percent, who wishes to devote 60 percent of effort to other Federally-sponsored research, and whose institutional salary is $130,000 is as follows: Academic Award 30 percent effort $ 37,500* Other Federally-supported 60 percent effort $ 75,000* grants and contracts Total salary from Federal sources $112,500 Salary contribution from grantee's institution $ 17,500 Total Salary $130,000 *(based on the current ceiling of $125,000) 2. Program Support Program support will be provided up to a maximum of $20,000 per year for the following: o personnel other than the awardee when requested for the development and evaluation of the educational program. Salaries will be allowable for technical and support personnel, e.g., educational and evaluation specialists. Student stipends are allowable for students conducting projects directly related to the award; o consumable supplies essential to the proposed program; o funds for educational development to enable the awardee to develop educational skills; o funds for travel for the Principal Investigator to meet with other awardees and NHLBI staff to exchange ideas, to develop collaborative projects, and to provide for some needed technical support. Awardees may be requested to meet as a group up to two times a year; $2,000 should be allocated for this purpose. o equipment costs are not allowable; 3. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures of equipment. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases it may be necessary for the applicant to be relieved of some responsibilities for the five years of the grant award in order to implement the proposed plan. An institution may apply for an award on behalf of a named individual meeting the criteria for this award. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a non-competitive basis depending upon progress being made in meeting the program's objectives. An annual report will be required that summarizes activities relevant to curriculum development at the institution and other elements of the program plan and outlines future plans. This report will serve as the principal basis for renewal of the grant. Awards may not be transferred from one institution to another. If an awardee moves to another institution, the award will continue at the original institution only upon acceptance by the Division of Lung Diseases of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. 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 July 13, 1994, a letter of intent that includes the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the RFA number and title 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 Telephone: (301) 594-7478 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. 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, "RFA: HL-94-017 Asthma Academic Award" 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: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 Applications must be received at both locations by September 14, 1994 to be assured of review in this competition. 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 by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will return the application to the applicant. The initial review may include a preliminary evaluation to determine scientific merit relative to the other applications received in response to this program announcement (triage); the NIH will remove from further consideration applications judged to be noncompetitive and promptly notify the Principal Investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures, including, if deemed appropriate, an applicant interview in or near Bethesda at the applicant's expense. The initial review will be conducted by a Special Emphasis Panel, managed by the Division of Extramural Affairs, National Heart, Lung, and Blood Institute. The secondary review will be by the National Heart, Lung, and Blood Advisory Council. Applications for this Asthma Academic Award will be evaluated in terms of the following criteria: o description of the magnitude of the asthma problem and the need for the program in the area to be served; o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula in asthma control; o access to a population with high incidence of asthma; o the qualifications and background of the candidate, including experience in teaching, curriculum development and administration within a medical school, and planning and conduct of clinical research; o the ability and commitment to working cooperatively with other awardees to make innovative asthma curricula and materials available; o the institution's commitment to implement the proposed curriculum and to continue a program in education about asthma control after the termination of the award; o the significant involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with asthma, especially in areas with high morbidity from asthma, such as inner city minority communities; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, family practice, internal medicine, community medicine, and other specialties; o plans for collaborative projects with other organizations that have responsibility for and interest in asthma control, for example, health departments, medical and nursing associations, and voluntary health agencies; o plans for and availability of expertise to implement and evaluate the proposed program, including strategies for both process and impact evaluation; o the potential for the program making an impact on the control of asthma among populations served; o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is April 1, 1995. Applicants may alternatively request a July 1, 1995 start date. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Asthma Academic Award, the Division of Lung Diseases will provide funds for a project period up to five years. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, listed below, as soon as they receive approval from their institution to apply for this award. Direct inquiries regarding programmatic issues to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. The 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 Mon May 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-94-022 - V23(18) 05/13/94 Date: 16 May 1994 18:08:49 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 567 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2r95f1$3hc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD94022 HD-94-022 P1O1 *************************************** UNINTENDED PREGNANCY IN THE UNITED STATES NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA: HD-94-022 P.T. 34; K.W. 0775020, 0404000, 0417000 National Institute for Child Health and Human Development Application Receipt Date: August 19, 1994 APPLICANTS RESPONDING TO THIS RFA WILL BE ASKED TO USE A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE APPLICATION PROCEDURES BELOW. PURPOSE This Request for Applications (RFA) invites applications for the support of research on the meaning, measurement, and determinants of unintended pregnancy and birth in the contemporary United States. Two sets of research questions are at issue and applications may address aspects of either or both. First, the RFA seeks to improve the research base for understanding the meaning of unintended pregnancy, as conventionally defined, as well as to build a scientific base for improved measures. Second, the RFA seeks to improve and extend research on the determinants of unintended pregnancy and birth at the cultural, societal, couple, and individual levels. 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, Unintended Pregnancy in the U.S., is related the priority areas of family planning and maternal and infant health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-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 individuals and women are encouraged. For-profit organizations should note that no profit or fees may be requested under financial assistance awards. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) and the FIRST (R29) awards. This RFA is for a single competition with the application receipt date of August 19, 1994. The earliest possible start date for these grants is March 1995. It is anticipated that four to six new and/or competing grants will be awarded under this program, contingent upon receipt of a sufficient number of meritorious applications and the availability of funds. $1,000,000 has been set aside to fund these awards for the first year. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will vary also. This RFA is a one-time solicitation. Further unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Applicants should state the amount of time required to conduct the proposed research. Ordinarily, grants are supported for one to five years. RESEARCH OBJECTIVES Background Information The Center for Population Research (CPR) of the National Institute of Child Health and Human Development (NICHD) invites scientists to submit grant applications for the support of research on unintended pregnancy in the contemporary United States. The CPR is composed of four branches that support research on all aspects of human reproduction. For more than two decades, the Demographic and Behavioral Sciences Branch has supported research on social, psychological, and behavioral aspects of pregnancy and childbearing, including sexual behavior, contraceptive decision-making and practice, and pregnancy outcome. Recent initiatives related to this program of research have included RFAs on childbearing motivation, the effect of sexually transmitted disease on fertility-related behavior, and the use of condoms to prevent HIV; a program announcement inviting research on fertility and fertility-related behavior, and a 1993 conference on "Negotiating the Paths to Parenthood". Despite the availability of safe, effective contraception, more than half of all pregnancies in the U.S. are reported by these pregnant women to be unintended. Furthermore, half of all unintended pregnancies end in abortion. The proportion of pregnancies reported as unintended is highest among unmarried women, women in their teens and 40s, and poor women. However, even among married women and women in their twenties, from 40 to 60 percent of pregnancies are unintended. U.S. rates of unintended pregnancy and abortion are among the highest in the industrialized world. According to the conventions established by a series of national fertility surveys conducted since the 1950s, "unintended pregnancy" is defined as a pregnancy that is reported to have been unwanted at any time ("unwanted") or to have occurred sooner than desired ("mistimed"). National estimates of unintended pregnancy and birth are based on retrospective survey reports of a woman's attitude toward pregnancy at the time she conceived. Partner attitudes have also been assessed, but rarely are included in the national estimates. Recently, the adequacy of these measures has come into question. This has resulted from research on childbearing motivation that points to a high degree of complexity in the motivational and intentional factors leading to pregnancy and birth, and evidence from qualitative research studies suggesting that the questions may not capture the appropriate dimensions of pregnancy timing and wantedness. Research Goals and Scope This RFA invites applications to conduct research on the meaning, measurement, and determinants of unintended pregnancy and birth in the contemporary United States. As noted above, two sets of research questions are at issue and applications may address aspects of either or both. First, the RFA seeks to provide a richer understanding of the meaning of unintended pregnancy, as conventionally defined, as well as to build a scientific base for improved measures that may be used in demographic surveys. Second, the RFA seeks to improve and extend research on the determinants of unintended pregnancy and birth at the cultural, societal, couple, and individual levels. An essential first step in interpreting data on unintended pregnancy is to improve our understanding of how individuals, couples and population groups differ in the extent to which pregnancy and childbearing are viewed as intentional and the value placed on planned childbearing. For some, values surrounding sexual behavior, contraception, and reproduction may emphasize aspects that are irrelevant to or even in conflict with the concept of planned childbearing. A better understanding of the variability in reproductive values within and across population subgroups is needed. It has been suggested that there are a "continuum of intention" and a "scale of wantedness" that underlie both conception and birth. Previous research supported by NICHD points to the complexity of fertility motivations and the possible presence of positive as well as negative dimensions of motivation (hence, the potential for ambivalent feelings about sexual behavior, contraception, and childbearing). Furthermore, changes may occur during and after pregnancy in the reported wantedness and intendedness of a particular birth. Studies of gender differences in motivation and intention regarding childbearing suggest that these concepts are equally salient for men and women, but that important differences in the nature of motivations exist. Research is needed to extend these insights to a variety of population groups and individuals at varying times in their lives and to explore their relevance to our understanding of the conventional measures of pregnancy intention. Some of the excess of actual pregnancies and births over wanted pregnancies and births may be accounted for by the measurement techniques conventionally used to assess whether a pregnancy is wanted, mistimed, or "on time." Variations in question wording and order, in time since the conception, and in emphasis placed on the individual rather than the couple, may be associated with differences in reported levels of intendedness. Social desirability bias in the responses to questions about pregnancy intentions may also distort estimates. Development and testing of improved measures of unintended pregnancy and related concepts for use in demographic surveys are within the scope of this RFA. Applications for such studies should reflect a solid grounding in previous research on fertility motivation, unintended pregnancy, and survey methodology. The second major goal of this RFA is to extend and improve scientific research on the determinants of unintended pregnancy. Even if current measures of unintended pregnancy are found to be flawed, the high rates of abortion in the U.S. compared with elsewhere suggest that some pregnancies are clearly unwanted. About half of the pregnancies aborted result from nonuse of contraception and the other half from method failure or inaccurate or inconsistent use of a method. This RFA invites applications to conduct research on the influence of cultural, societal, couple, and individual factors on the behaviors that result in unintended pregnancies and births. Among the most widely acknowledged, but least studied, influences on reproductive behavior are cultural norms and values. Research on these influences is difficult because they are pervasive and often inaccessible to the quantitative measures used in traditional demographic research. Ethnographic methods and comparisons with other industrialized nations could provide important insights. In addition, studies may examine specific mechanisms through which norms and values about reproductive behavior are shaped. For example, it is widely believed that media portrayals of sexual relationships and sexual behavior influence the behavior of media consumers. Well designed research to examine these purported linkages is within the scope of this RFA. The proportion of pregnancies that are unintended is greatest among poor women. Several factors may account for this: differences among socioeconomic groups in reproductive goals and values, differences in the personal resources individuals and couples are able to bring to achieving those goals, and differences in access to services and other social, economic, and community supports. Studies that propose to provide insight into the mechanisms contributing to socioeconomic differences in unintended pregnancy are appropriate for this RFA, including those that examine issues of access to services. Gender roles and male-female relationships are central to the behaviors that result in unintended pregnancy. Gender roles and ideologies give shape to and define what individuals view as appropriate sexual and reproductive behavior as well as the "scripts" for heterosexual relationships. A small research base exists linking gender roles to behaviors related to unintended pregnancy; studies to extend this base are needed. Unintended pregnancy invariably occurs within the context of a sexual relationship (however brief) between two individuals of opposite sex, each bringing their own characteristics, beliefs, values and attitudes to the relationship. The occurrence of an unintended pregnancy may be a function of each partner's characteristics, of the similarity or differences between partners, or of characteristics of the relationship that are independent of individual characteristics. The vast majority of studies of sexual and contraceptive behavior have taken the individual, not the couple, as the unit of analysis. Applicants are encouraged to develop dyadic research designs, taking into account the methodological challenges (such as selection bias) associated with such designs. Finally, this RFA encourages the expansion of research linking individual characteristics, psychology, and processes to unintended pregnancy. A large literature relevant to the determinants of unintended pregnancy has developed over recent decades. More recently, research on the determinants of STD/AIDS risk behaviors has also been supported, which may provide useful guidance for studies of pregnancy-related behavior. Applications submitted in response to this RFA should demonstrate clear and substantial advances relative to existing studies. This may involve significant extensions of existing approaches, the use of new models or methodologies, or the extension of research to previously understudied populations that may be expected, on substantive grounds, to differ from populations addressed in previous research. Applications may address any of the research goals described above. If appropriate to the scientific aims of the proposed research, applicants are encouraged to include qualitative as well as quantitative methods, men and couples, individuals in their twenties or older, and individuals belonging to ethnic or racial minorities. Although the focus of this RFA is on the contemporary U.S., cross-national studies may provide valuable insights into the conditions affecting unintended pregnancy among U.S. women. If such studies are proposed, the applicant must clearly demonstrate their relevance to the issues posed by this RFA. Studies proposing to examine the relationship between unintended pregnancy and subsequent outcomes for the mother or child will not be considered responsive to this RFA. Investigators seeking to study unintended pregnancy as an outcome should be aware of the underreporting of induced abortion typical of most interview settings. Applicants must effectively address potential bias in self-reported pregnancy data or choose alternative outcome measures. If clinic-based samples are proposed, selection bias in such groups should be addressed in relation to the research objectives. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS 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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreement that do not comply with these policies. APPLICATION PROCEDURES NOTE: See Special Instructions below for Completion of Grant Applications in response to this RFA. Applications are to be submitted on form PHS 398 (rev. 9/91), which is available in most 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. Applications must be identified by checking the "YES" box in Item 2a on the face page of the application and typing in the words, "In Response to RFA HD-94-022." The RFA label available in PHS 398 must be affixed to the bottom of the face page of the original 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. The signed original and three copies of the application must be received by August 19, 1994. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 9/91) application kit (as modified in, and superseded by, the special instructions below, for the purposes of this RFA), will be judged non-responsive and will be returned to the applicant. Applications must be received by close of business August 19, 1994. Late applications will not be accepted. Applications must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda MD 20892** It is extremely important for the timely review of an application that two additional copies of the application be sent under separate cover to: Susan Streufert Division of Scientific Review National Institute of Child Health and Human Development Building 61E, Room 5E03F Bethesda MD 20892 Telephone: (301) 496-1485 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. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA The NIH has recently been designated a "reinvention laboratory" by the Public Health Service. An experiment is being conducted to determine how to reduce the administrative burden in applying for an NIH grant without compromising the information needed by the initial scientific peer review group to assess the scientific merit of the application and the reasonableness of the proposed budget. The following are specific instructions for sections of the PHS 398 (rev. 9/91) application form that should be completed differently than usual. Some sections are modified and others in the application should not be completed for the submission of the application, but will be requested if the application receives a score in the fundable range. For all other items in the application, follow the usual instructions on pages 9-32 of the PHS 398 booklet. Form DD, Page 4. Detailed Budget Page for Initial Budget Period: Complete only selected portions of the Personnel section; do NOT complete balance of this page (see Form EE, page 5 below). o Personnel. Enter Names; and for each named person, enter Role on Project and percent effort on project. Do NOT complete remainder of columns for personnel. Form EE, Page 5. Budget and Justification: o Budget. Complete the budget section for all requested years of support for all budget categories including total direct costs by year and for all years. o Justification. For the INITIAL BUDGET PERIOD, provide brief justifications only for budget items that exceed the following dollar amounts and/or meet the following criteria: - Consultant Costs: Exceeds $10,000 and/or consultant(s) are key personnel. - Equipment: Exceeds $15,000 - Supplies: Exceeds $15,000 - Travel: Exceeds $5,000 - Other Expenses: Exceeds $5,000 - Consortium/Contractual: Exceeds $10,000 o For ADDITIONAL YEARS OF SUPPORT REQUESTED, briefly justify annual changes that are more than or less than four percent increases from the preceding years. Form FF - Page 6. Biographical Sketch: For each key investigator provide a biographical sketch that does not exceed TWO PAGES and includes the following information: o Name, Position Title, Education, as in the PHS 398 form. o Research and Professional Experience. This section should be used to highlight the investigator's scientific background and experience relevant to the research proposed in this application. Completing the section in the following sequence will facilitate review of this application: - Previous research position(s) relevant to this application - Honors, including: title and funding sources for all current and relevant completed research on which investigator was Principal Investigator, Co-Investigator, or Project Leader; and membership on NIH review groups, councils, or program advisory committees and length of service on each. - Complete references including titles and all authors for peer reviewed publications representative of the investigator's research career or pertinent to the research proposed in this application. Form GG - Page 7 - Other Support: Do not complete. Information on specific levels of support will be requested by the NICHD only from applicants being considered for funding. Form HH - Page 8 - Resources and Environment: Complete selected item(s) only if proposed research requires specialized unique resources for which availability must be documented. Research Plan (Booklet Pages 19-24): Note: Items 1 - 4 may not exceed 20 pages. o Item 1- Specific Aims (typically less than one page): List in priority order the broad, long range objectives of the proposed project and describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. o Item 2- Background and Significance (typically 1 page): The background and significance has been established by the NICHD in setting aside funds for the release of this RFA. Use this section to describe how the proposed research will contribute to meeting the goals and objectives of the RFA and explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. o Items 3 - 6: Complete as instructed on pages 21-23 of the PHS 398 booklet, noting the reduced page limit stated above. o Item 7 - Consultants/Collaborators: Biographical sketches should conform to the brief format described for Form FF, above. o Item 8 - Consortium, Contractual Arrangements (1 page only): Provide a brief explanation (not to exceed one page) of the scientific, fiscal, and administrative arrangements made with collaborating organizations. Appendix (PHS 398 Booklet - Page 24) A maximum of five publications, manuscripts, submitted or accepted for publication, patents, invention reports may be included. Other than this change, complete as instructed. Forms II and JJ - Checklist: Do not complete. Information will be requested by NICHD only from applicants being considered for funding. If you or your business office have any questions regarding these special instructions, call, FAX, or write Melinda Nelson at the address listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for responsiveness by the NICHD. Applications judged to be nonresponsive will be returned. The applicant may resubmit the application for review in competition with unsolicited grant applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Criteria for the initial review include: o the significance and originality of research goals and approaches; o the feasibility of research and adequacy of the experimental design; o the research experience and competence of the investigator(s) to conduct the project; and o the appropriateness of the project duration and cost relative to the work proposed. AWARD CRITERIA The anticipated date of award is March 1995. Scientific merit and technical proficiency, as described in the application, will be the predominant criteria for determining funding. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Susan F. Newcomer, Ph.D. Demographic and Behavioral Science Branch National Institute of Child Health and Human Development Building 61E, Room 8B13 Bethesda MD 20892 Telephone: (301) 496-1174 FAX: (301) 496-0962 Email: NewcomeS@HD1.NICHD.NIH.GOV Direct inquiries regarding fiscal matters to: Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: NelsonM@HD01.NICHD.NIH.GOV. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864 (Population Research). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 990158, 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 23472, or to 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 Mon May 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-94-016 - V23(18) 05/13/94 Date: 16 May 1994 18:09:05 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 787 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2r95fh$3ia@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI94016 AI-94-016 P1O1 *************************************** SEXUALLY TRANSMITTED DISEASES COOPERATIVE RESEARCH CENTERS NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA: AI-94-016 P.T. 34; K.W. 0715182, 0710030, 0785055 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 5, 1994 Application Receipt Date: November 17, 1994 PURPOSE The purpose of this Request for Applications (RFA) is to stimulate multidisciplinary, collaborative research to further understanding of sexually transmitted diseases (STDs) and effective approaches to their prevention and control. The Sexually Transmitted Diseases Branch of the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites research grant applications for recompetition of the Sexually Transmitted Diseases Cooperative Research Centers (STD CRCs). The NIAID recognizes that although each STD presents unique diagnostic, therapeutic, and prevention challenges, all STDs share a common mode of transmission, populations at risk for one STD are at risk for others, comorbidity is common, and the presence of one infection may influence the acquisition and natural history of another. Therefore, a research program that addresses these diseases as a group is likely to be highly productive. The CRCs (1) provide a multi-disciplinary approach to STD research by bridging biomedical, clinical, behavioral, and epidemiological research; (2) foster interaction among STD investigators; and (3) facilitate intervention-oriented research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Sexually Transmitted Diseases Cooperative Research Centers (STD CRCs), is related to the priority areas of STDs and acquired immunodeficiency syndrome (AIDS). 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 be limited to domestic institutions, but may include an international component. Applications may be submitted by domestic for-profit and non-profit research institutions; public and private organizations, such as universities, colleges, hospitals, laboratories, units of State or local governments; and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U19), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total project period for each application submitted in response to this RFA may not exceed five years. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. The anticipated award date is July 1, 1995. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $6.2 million. In Fiscal Year 1995, the NIAID plans to fund five STD CRCs or more if additional money becomes available. The final number of awards to be made is dependent upon the availability of funds. The initial year's total costs, including direct and indirect costs, should not exceed $1.2 million for each award. The usual PHS policies governing grants administration and management will apply. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background In 1993, an estimated 12 million cases of STDs occurred in the United States. Approximately 65 percent occurred in people under 24 years of age; three million occurred in teenagers. Associated health care costs exceeded $6 billion. Women and infants bear a disproportionate share of disease burden and sequelae of STDs, including infertility, ectopic pregnancy, cervical cancer, fetal wastage, low birth weight, and congenital/perinatal infection. Additionally, STDs disproportionately impact the health of some minority populations. Both the incidence of STDs and their long-term and potentially fatal sequelae are consistently higher among African and Hispanic Americans than among white Americans. o Chlamydial infection is the most prevalent bacterial STD in the U.S. and a major cause of pelvic inflammatory disease (PID); over four million cases are diagnosed annually. Due to delays in diagnosis or inadequate therapy, 10 to 40 percent of women with chlamydial cervicitis develop PID. o Gonorrhea, the other major cause of PID, occurs at an annual rate of approximately 1.4 million new cases, 25 percent of which occur in teenagers. Antibiotic resistance has increased within the last decade; up to 10 percent of isolates may be resistant to one or more antibiotics. o In the U.S., as many as 40 million people are believed to be infected with human papillomavirus (HPV). High risk HPV types are causally associated with cervical cancer. Globally, cervical cancer is the most common cause of cancer-related death in women. o In the 1990s, infectious syphilis reached the highest level in 40 years. Syphilis rates among African-Americans are reported to be 56 times higher than in whites. Increases in women were echoed by five-fold increases in congenital/perinatal cases. o Approximately 65 million Americans are afflicted with genital herpes (HSV). HSV is a painful, recurrent, incurable disease with annual costs estimated to exceed $96 million. o Both ulcerative and non-ulcerative STDs increase the risk of human immunodeficiency virus (HIV) transmission approximately three- to five-fold, independent of the effect of sexual behavior; and HIV infection, which decreases immune function, may alter the natural history and increase the prevalence of some STDs. Objectives and Scope In spite of decades of STD prevention and control programs and STD research, rates of infection continue to grow. This is now complicated by the emergence of a new fatal STD, HIV infection. The alarming dimensions of STDs and related health problems described above point to the need for more effective research approaches that will lead to essential tools for preventing and controlling STDs. The 1986 report of the NIAID Study Group on STDs and Congress have recommended a multidisciplinary approach to research programs seeking to prevent and control STDs. By contrast, STD research historically has not been conducted by multidisciplinary, collaborative teams of scientists. Each scientific area tended to build its own empirical base and report findings to peers. In response to both the dimension of the problem and advice provided to the NIAID, the STD CRCs were created to achieve the following goals: integrate clinical observations into basic biomedical research; apply the findings of basic research to the development of improved diagnostics, therapeutics, vaccines, and topical microbicides; and integrate behavioral and epidemiologic research needed to ensure the optimal utilization of these tools. The purpose of this RFA is to stimulate multidisciplinary, collaborative research to further understanding of STDs and effective approaches to their prevention and control. The scientific complexity of the STD problems is such that coordinated, multidisciplinary research is required to solve these problems. This will be accomplished through collaborations among scientists from various disciplines working in the scientific areas of biomedical, clinical, behavioral, and epidemiological research. In this RFA, the term scientific area refers to the four broad categories of investigation: (1) biomedical, (2) clinical, (3) behavioral, and (4) epidemiologic research. The term discipline refers to investigators' specialized areas of expertise or training. Some examples of disciplines associated with the four scientific areas include but are not limited to (1) immunology, virology, and molecular biology; (2) gynecology, infectious diseases, and adolescent medicine; (3) psychology, sociology, and anthropology; (4) epidemiology, biostatistics, and computer modeling. In order to attain these goals, applications should include: o at least three projects, one of which should be in behavioral or epidemiologic research (behavioral/epidemiologic research must include both behavioral or epidemiologic outcomes and microbiologic/disease outcomes as described in the next section); o two projects that link disciplines within a single scientific area and at least one project that links disciplines in two different areas (disciplines and scientific areas are defined above); o a strong clinical capability (described below) with accessible patient populations to participate the clinical and behavioral/epidemiologic research projects; and o provisions for the Principal Investigator of each CRC (also known as the CRC Director) to attend meetings with NIAID staff twice each year and for all CRC Project Leaders to attend CRC workshops twice during the program period. Diseases, Syndromes, and Areas of Interest In designing specific projects, applicants are encouraged to consider research proposals in the following areas of programmatic interest. Biomedical research projects are encouraged to use human material to address research questions. o Pathogens: C. trachomatis, N. gonorrhoeae, H. ducreyi, T. pallidum, T. vaginalis, herpes simplex virus 1 and 2, and human papillomavirus. o Adverse Outcomes of Pregnancy: Research is needed to define the epidemiology, pathogenesis, and immunology of STD-related adverse outcomes of pregnancy. o Human Papillomavirus Infection: The NIAID's priorities in HPV include research on the epidemiology, natural history, pathogenesis, and immunology of infection as well as the development of a culture system and improved diagnosis and treatment. o Pelvic Inflammatory Disease (PID): Additional research is needed in a number of areas, including diagnosis, epidemiology, pathogenesis, treatment, and long term sequelae. o Inter-Relatedness of Sexually Transmitted Infections: Because of the HIV epidemic, it is now recognized that infection with one sexually transmitted infection can alter susceptibility to and natural history of other STDs. Understanding the molecular bases of these interactions is needed. For example, research is needed to examine the role of classical STDs in the acquisition and progression of HIV infection and on the role of HIV in alterations of the natural history, diagnosis, or response to treatment of STDs. If this area is selected, the application should include only one project on STDs and HIV infection. o Immunology: Basic immunological research related to vaccine development for any of the pathogens or syndromes listed above is of programmatic interest. In order to make critical advances in this area, functional collaborations between immunologists and microbiologists focused on pathogenesis will be extremely important. o Behavioral/Epidemiologic Research: Much STD research to date has focused on diagnosis, treatment, and vaccine development without integrating approaches to modify the sexual and other behaviors associated with acquisition and transmission STDs or development of their sequelae. Behavioral research is needed to decrease risk-associated behaviors and to increase health behaviors, specifically those related to seeking early diagnosis, treatment, and immunization. STD CRCs, because of their multi-disciplinary approach, are in a unique position to assess behavioral measures and evaluate interventions because, as stated earlier, behavioral and epidemiologic research projects in the STD CRCs must include both behavioral and microbiologic and/or disease outcomes. (For more information on areas of programmatic interest, see Program Announcement Number PA-93-108, NIH Guide, Volume 22, Number 32, September 3, 1993.) o Topical Microbicides: Basic biomedical and clinical research leading to topical microbicide development to prevent sexually transmitted infections is needed. Topical microbicides are products for intravaginal use that are microbicidal (virucidal and/or bactericidal) but not necessarily spermicidal; they are used by women to prevent sexually transmitted infections (HIV and other STDs). Examples of such research include, but are not limited to, identifying early events in the infectious process, characterizing vaginal physiology and normal flora, developing methods to measure and assess clinical significance of vaginal/cervical inflammation. (See also RFA AI-94-013.) Clinical Capability As stated earlier, applications should have a strong clinical capability and access to patient populations to serve the clinical and behavioral/epidemiologic research projects. In describing the clinical and laboratory facilities, the application should include specific information on the institution's present patient load, projections for patient involvement in future clinical investigations, history of recruitment of subjects, and disease prevalence as well as on the availability of appropriate biohazard facilities and safety procedures. Optional Developmental Component Applications may include a Developmental Fund Core to provide support for new investigators or pilot projects. Eligible investigators are individuals in the early or mid stages of their career who have NOT held an NIH grant including an R29, R01, P01, U01, any research career or training grant (K or T awards), or any other type of grant or contract with annual direct costs in excess of $37,500 for research in STDs including HIV. Potential awardees and specific research projects to be pursued need not be identified in the CRC application. However, the application should include a one page description of the kind of project that might be funded under this mechanism and how it interdigitates with CRC research projects. Approval of the developmental funds portion of the application does not in any way commit the investigators to the execution of the sample project. In addition, the application must provide a description of the review process and selection criteria for proposed projects. Budget Issues Budget requests within each project may include research-related costs for supplies, patient involvement and medical care, funds for limited investigator travel, and costs of publication. Proposals for studies that do not receive the majority of funding through the CRC will not be counted as a project. There must be concordance between the science proposed and the budget requested. Furthermore, if additional sources of funding have been identified for a project, then letters documenting a funding commitment must be included in the application. STD CRC award funds may be utilized to support the following research-related activities: o PI Level of Effort: Each applicant Principal Investigator must allot at least 15 percent of time to the administration of the CRC. If less effort is indicated, justification must be provided, including a written plan explaining how the responsibilities demanded by these endeavors will be met fully and successfully. o Shared Research Resources (Cores): The STD CRCs may include funds for equipment, supplies, and services to expand and/or maintain clinical, laboratory, biostatistical, or behavioral facilities shared by research staff from at least two research projects. o Developmental Funds Core for New Investigators: This optional core sets aside and restricts funds solely to cover salaries and research costs for new investigator or pilot projects. There is no ceiling on the total dollar amount of the developmental funds pool, but once identified as developmental funds these monies constitute a restricted portion of the total CRC budget and will not be available for other CRC activities. The annual total amount for each developmental award may not exceed $40,000 and may be used for salary, technical support, laboratory supplies, and equipment. Supplies and equipment expenditures for each award may not exceed $20,000 annually. Projects and investigators funded under the developmental core may not receive subsequent awards from this pool. The duration of support is limited to three years. If the investigator achieves independent funding through a traditional research grant (R01) or a FIRST (R29) award prior to the end of the developmental award, the award must be terminated, and unexpended funds must be returned to the developmental funds pool. In general, the CRCs should try to advance learning experiences in STD research and to make medical students, house staff and postdoctoral candidates more aware of STD research opportunities in the clinical, biomedical, and behavioral sciences. It is permissible for projects to include post-residency personnel who spend a maximum of one third of their time in clinical activities related to the research focus of the project. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. STD CRCs can serve as important resources to increase awareness of the prevention, diagnosis, and treatment of STDs in the public health, the lay and the local medical communities. The NIAID has been involved with the Centers for Disease Control's (CDC) Accelerated Research Program in STDs. Several proposed projects for this CDC program involve collaborations between the existing STD CRCs and state and local health departments. Applicants with interest in this area should contact the Division of STDs/HIV, National Center for Prevention Services, CDC for information on support of outreach projects. SPECIAL REQUIREMENTS Collaborative Organization The application should include a plan to maintain close collaboration and communication among members of the STD CRC and an organizational chart showing the name, the organizational affiliation and the scientific discipline of the Principal Investigator, the Project Leaders, and the key personnel for the projects and cores. The application must also include a signed letter of agreement from each collaborator and/or consultant to the program indicating willingness to participate in the program and a description of the exact nature of the participation. Terms and Condition of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Awards will be made to an institution on behalf of a Principal Investigator who will be responsible for the coordination of STD CRC scientific and administrative activities. Support of all CRC activities will be coordinated through a Central Operations Office located within the applicant organization. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the details for the project within the guidelines of the RFA and for performing the scientific activity, and agree to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific and technical management of the project described in 2. below. Specifically, awardees have primary responsibilities as described below. Under the Cooperative Agreement, a partnership relationship exists between the recipient of the award and the NIAID in which successful applicants are responsive to the guidelines and conditions set forth in the RFA. At the same time, investigators are expected to define research objectives and approaches in accord with their own interests and perceptions of novel and exploitable approaches to the research which ultimately is likely to result in improved prevention and control of STDs. It is the primary responsibility of the Principal Investigator to clearly state the objectives and approaches of the research, plan and conduct the research stipulated in the application, and ensure that the results obtained are analyzed and published in a timely manner. The NIAID may periodically review and generate internal reports from data and progress reports developed under this cooperative agreement. The data obtained will, however, be the property of the awardee. The multi-disciplinary and collaborative nature of the STD CRCs creates an extraordinary opportunity for information exchange and scientific advancement in STD research. Principal Investigators are expected to take advantage of this opportunity by participation in both formal events established expressly for this purpose and informal investigator-initiated dialogues. 2. NIAID Staff Responsibilities The NIAID will have substantial scientific/programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The NIAID will work closely with the Principal Investigators and shall be represented by a Scientific Coordinator (Program Officer). The Scientific Coordinator will be a program officer in the STD Branch of the NIAID. During the award period, the NIAID Scientific Coordinator may provide appropriate assistance, advice, and guidance in: design of research activities; coordination and facilitation of information, technology, and reagent exchange between STD CRCs; data collection and analysis; assistance in review and selection of developmental fund applicants; and technical and administrative activities of CRCs. However, it is again emphasized that the role of the NIAID will be to facilitate and not to direct the activities of the STD CRC. It is anticipated that decisions in all activities outlined within this RFA will be reached by consensus of the investigators and that the NIAID Scientific Coordinator will be given the opportunity to offer input to this process. 3. Collaborative Responsibilities The CRC Principal Investigators and NIAID Scientific Coordinator will meet twice a year to review progress of the CRCs at the NIH in Bethesda, Maryland (or at a site designated by the NIAID). The first such meeting will be a Post Award Meeting. In addition, two workshops for the Principal Investigators and CRC Project Leaders will be convened during the project period to share STD research advances, discuss STD research needs and opportunities, and develop collaborations. It is likely that workshops will be convened in Year 1 and Year 3 of the project period at the NIH in Bethesda, Maryland (or at a site designated by the NIAID). Applicants should be aware that there are no additional travel monies available. Funds for travel to all meetings must be included in applicant's budget. A critical element of the STD CRCs' success is the degree of communication among its members. Therefore, additional informal meetings among participants from different CRCs as well as regular telephone and written communication will be encouraged. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Principal Investigator, a second member selected by the NIAID, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR part 50, subpart D, and HHS regulation at 45 CFR part 16. In the event that research supported by the Cooperative Agreement results in development of a therapeutic or other medical intervention, the NIAID will retain the option to cross-file or independently file an application for investigational clinical trial (i.e., an Investigational New Drug Application [INDA]) to the United States Food and Drug Administration. Reports of data generated by the CRC or any of its members that are required for inclusion in INDs and Clinical Brochures and for cross-filing purposes will be submitted by the Principal Investigator to the Scientific Coordinator upon request. Such reports will be in final draft form and include background information, methods, results, and conclusion. They will be subject to approval and revision by the NIAID and may be augmented with test results from other Government sponsored projects prior to submission to the appropriate regulatory agency. STUDY POPULATIONS A strong emphasis is placed on studying STDs in populations that are disproportionately affected. These populations include women, adolescents, and minorities. Subjects may be recruited or specimens obtained from domestic sites or through collaborations with foreign institutions in developing countries if the collaboration is beneficial to the foreign country and offers the potential for collection of STD data that are pertinent to U.S. populations and could not be generated as effectively in the United States. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The application should include a description of the proposed outreach for recruiting women and minorities as participants. 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 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from Dr. Miller (listed in INQUIRIES below), who may 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 overall proposed research; the name, address, and telephone number of the Principal Investigator; the number and title of this RFA; and a list of the key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Before preparing an application, the applicant should carefully read the information brochure, "NIAID Program Project Grants and Multiproject Cooperative Agreements." Instructions for formatting the application as outlined in the brochure should be followed carefully. Failure to follow the instructions may result in unnecessary delays in the review process. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). These application forms may be obtained from the institution's office of sponsored research or its equivalent and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "SEXUALLY TRANSMITTED DISEASES COOPERATIVE RESEARCH CENTERS (STD CRCs)" must be typed in. Applications from multi-component consortia must contain a single face page, an overall budget page, and separate budget pages for each institution involved. Each consortium institution is allowed 25 pages for the research plan if different plans are proposed by the different member institutions. For additional information, refer to page 8 of the PHS 398 application form. 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. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional exact copies of the grant application and five sets of appendix material must also be sent to Dr. Olivia Preble at the address listed under INQUIRIES. Applications must be received by November 17, 1994. All components, subparts and sections of the application must be collated into the application and the packages sent to the DRG and the NIAID must each be complete in themselves. Applications that do not conform to the instructions contained in PHS 398 (rev. 9/91) application kit will be judged nonresponsive and will be returned to the applicant. Current NIH policy permits a component research project of a multiproject grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multiproject application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multiproject grant. This is an NIH policy intended to preserve the scientific integrity of a multiproject grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multiproject grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. The three copies of the applications that are sent to the DRG must be received as a single package from the Principal Investigator and conform to the instructions contained in PHS 398 (rev. 9/91) application kit otherwise the application will be judged non-responsive and will be returned to the applicant. REVIEW CONSIDERATIONS Review Method Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and for completeness and for responsiveness by NIAID staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration or review. Those applications that are complete and responsive may be subjected to a triage by a peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID will remove from competition those applications judged to be non-competitive for award and will notify the Principal Investigators and institutional business officials. For applications found non-competitive, summary reports will be very brief and will only highlight the major reason(s) for the non-competitive rating. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The review criteria are stated in the NIAID Program Project Grants and Multiproject Cooperative Agreements brochure, which is available rom program staff listed under INQUIRIES. In addition, applicants are expected to address research priorities, objectives, and other requirements stated in this RFA, as well as the following: o the scientific and technical significance, merit, and originality of the research projects and anticipated contributions to the prevention and control of STDs; o the scientific expertise and experience of the Principal Investigator, the Project Leaders and key project and core personnel; o documentation of a strong clinical capability, adequate and appropriate patient populations, disease prevalence, and historical success of recruitment and retention of subjects; o documentation of the sponsoring institution's commitment to the cooperative program and willingness to accept the participation and assistance of NIAID staff; o adequacy of proposed plan for coordination and communication within the applicant STD CRC and with NIAID and other STD CRCs; and o adequacy of review plan and selection criteria for new investigators making application to the optional Developmental Funds. In addition, applications from existing STD CRCs must include a comprehensive progress report (as stated above under Objectives and Scope) and demonstrate successful collaborative activities supported through their CRC. Applicants who have not had an STD CRC should explain how they will establish successful collaborative efforts. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities and balance, and availability of funds. Program balance takes into account pathogen(s) proposed for study, the potential impact on health of women, minorities and adolescents, as well as geographic distribution of the CRCs. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Dr. Heather Miller Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-26 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 402-0443 Internet Address: heather@exec.niaid.pc.niaid.nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8208 Internet Address: op2t@nih.gov Direct inquiries regarding fiscal matters to: Ms. Katherine Phillips Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-33 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: August 5, 1994 Application Receipt Date: November 17, 1994 Scientific Review Date: February/March 1995 Advisory Council Date: June 1995 Earliest Award Date: July 1, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 Immunology, Allergic and Immunological Diseases Research and 93.856 Microbiology and Infectious Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon May 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-94-005 - V23(18) 05/13/94 Date: 16 May 1994 18:08:58 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 654 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2r95fa$3hu@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DE94005 DE-94-005 P1O1 *************************************** INSTITUTIONAL DENTIST SCIENTIST AWARD NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA: DE-94-005 P.T. 34; K.W. 0715148, 0710030 National Institute of Dental Research Letter of Intent Receipt Date: December 1, 1994 Application Receipt Date: January 18, 1995 PURPOSE The National Institute of Dental Research (NIDR) invites applications proposing new and competing renewal Institutional Dentist Scientist Award programs in basic biomedical, behavioral, and clinical oral health research. The ultimate purpose of these programs is the development of outstanding clinician research scientists. Programs must provide doctoral-level (Ph.D.) training in basic science and advanced clinical knowledge and skills development in either a recognized clinical specialty or other equivalent dental clinical discipline and a supervised research experience designed to facilitate transition to an active research career. It is anticipated that most graduates will undertake two or more years of post-Ph.D. research development to complete their preparation for an independent research career. 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. Several changes have been introduced in the policies and provisions governing these awards. Current policies and provisions will remain in effect for all programs through June 30, 1995, and will continue to apply to appointees accepted into programs prior to that date until completion of their five years career development. The new policies and provisions will apply to all new appointments made on or after July 1, 1995 and to all new and competitive renewal awards made after July 1, 1996. 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), Institutional Dentist Scientist Award Program, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public and private dental schools, or institutions with a dental school affiliation. Only one award will be made to an institution. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Institutional Dentist Scientist Award (K16). Responsibility for the planning, direction, and execution of the proposed program will be solely that of the program director (PD) on behalf of the applicant institution. The project period for applications submitted in response to this RFA must be five years. Awards may be renewable upon the submission of a successful competing application, depending on programmatic needs and the availability of funds. The earliest award date is July 1, 1996. FUNDS AVAILABLE The NIDR expects to make at least six new or competing renewal awards, in response to this RFA, at a total first year cost of approximately five million dollars. 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 for this purpose. RESEARCH OBJECTIVES Background Many studies have shown the need for post-D.D.S. career development, including exposure to basic biomedical and behavioral sciences and advanced clinical knowledge and skills development, for dentists who wish to pursue a career in oral health research. The NIDR has supported postdoctoral training of basic scientists and clinicians under the National Research Service Awards (NRSA) for many years. However, the declining numbers of clinician scientists called for additional opportunities tailored to the needs of promising clinician scientists. The Institutional Dentist Scientist Award program was initiated approximately nine years ago to help fill this need. This award prepares individuals for careers as highly skilled investigators and potential leaders in the full scope of oral health research. It enables individuals to undertake five years of intensive preparation in a course of study that involves three distinct phases that include basic and clinical science components integrated with a supervised research experience. The basic science component includes both didactic and laboratory experiences and typically is comparable to a doctoral-level program leading to a Ph.D. The research program can employ either a basic or clinical science approach to studying an oral health problem. The program also requires an advanced clinical knowledge and skills development component of a caliber that the individual would be eligible to receive specialty certification at the completion of the five year program. Throughout the course of the entire program, the individuals are closely supervised by mentors who have basic science and clinical specialty research experience. The first RFA appeared in June 1984 and the second in April 1988. The first group of programs are in their ninth year and the second group are in their fourth year. The current project period will end on June 30, 1995. However, the programs will be supported by administrative supplements through June 30, 1996. Approximately 85 individuals are being supported, with approximately 20 appointees graduating from the program and a similar number entering the program each year. Program Characteristics Opportunities will be provided for dentists pursuing advanced clinical knowledge and skills development and a Ph.D., or equivalent degree, in a basic biomedical or behavioral science. The program will have the following characteristics: A. The Environment: Applicant institutions must have well-established research, research career development, and clinical programs, and adequate numbers of highly qualified faculty in both clinical and basic science departments. The environment must stimulate interactions among basic scientists and clinical investigators. Collaboration with other institutions and organizations, such as other components of the NIH, the Department of Veterans Affairs, not-for-profit and private organizations, is encouraged. B. Program: The institutional award is intended to provide support for up to five consecutive twelve month appointments to each individual Dentist Scientist Appointee (DSA) selected by the program director (PD). There are to be three distinct but overlapping and integrated components to the program offered to each DSA: advanced basic science development, advanced clinical knowledge and skills development, and a supervised research experience. No component can be offered in isolation from the others. The basic science development component must develop knowledge and research skills in scientific areas relevant to oral health. It must include both didactic and laboratory experiences in a basic science. It must consist of a doctoral (Ph.D.) level program that is consistent with the applicant institution's degree requirements and with the objectives of the Dentist Scientist Award Program. The clinical development component must ensure that the DSA acquires requisite advanced clinical knowledge and skills in either a recognized clinical specialty or other equivalent dental clinical discipline. The research experience component uses a basic science or clinical science approach to problems in oral health research. Typically, it is what is required for a doctoral degree and it must facilitate transition to an active research career. The areas of clinical development are not limited to the eight dental specialties currently recognized by the American Dental Association. If specialty certification is possible in the clinical discipline proposed, the program of study is to be arranged so that conferring of the clinical specialty certificate does not occur until completion of the entire program by the DSA. The application must indicate the clinical disciplines and degree certifications to be offered to the DSAs. After an award is made, this offering may not be changed without the approval of the NIDR. A minimum of 80 percent of the DSA's effort must be devoted to this program. The remaining 20 percent effort may be devoted to other clinical and teaching pursuits only if they are consonant with the objectives of the Dentist Scientist Award Program. The PD and applicant institution are encouraged to develop innovative multidisciplinary programs that maximize the research and educational resources of the institution and any collaborating institutions. Applicant institutions must be able to provide programs individually tailored to meet the unique research and clinical development needs of each DSA and ensure that DSAs complete the program with requisite competencies. C. Program Director: The PD must possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary research and clinical career development program of this scope. The PD must have the commitment and capability to provide guidance to DSAs in their research career development. The PD is responsible for the selection of the DSAs, and the applicant must have developed a recruitment plan, which addresses the efforts to recruit women, minorities, and individuals from non-research intensive dental schools. Plans must be provided for the appointment of an advisory body to act as an overview committee and to assist in DSA selection. The PD will be expected to participate in at least one annual meeting with the staff of the NIDR. This meeting likely will be held in conjunction with the annual meeting of the American Association for Dental Research. The PD will be required to submit to the NIDR a detailed description of each DSA's planned supervised research experience as soon as feasible but no later than the midpoint of each DSA's program. Annually, the PD and advisory committee will assess the progress of each DSA and submit a detailed report on the progress of each DSA to the NIDR. Support for the DSA for the subsequent year in the program will be dependant on satisfactory performance. D. Mentors: Each DSA must have a mentor, who is an accomplished investigator active in the proposed area, to guide the DSA's development and research project. Usually, such a mentor will be the doctoral thesis advisor. The mentor must be committed to continue this involvement through the individual's total period of development under the award. A co-mentor, representing the clinical component, also may be named. Where feasible, women and minority mentors should be involved as role models. E. Dentist Scientist Appointees: DSAs must meet the following criteria: they must have completed a dental degree (D.D.S., D.M.D., or equivalent) and must be, at the time of appointment, citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551). Noncitizen nationals are persons who, although not citizens of the United States, owe permanent allegiance to the United States. They are generally persons born in lands which are not states but which are under United States sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible. Dentists who have completed a Ph.D., Sc.D., or equivalent research degree are not eligible for appointment. The NIDR will consider a written request from a PD for an exception on behalf of such an individual, if such a degree was awarded in an area unrelated to oral health. Individuals who have completed advanced clinical knowledge and skills development in a recognized dental specialty or who have undergone two or more years of formal postdoctoral clinical development in a non-specialty recognized clinical field are not eligible. Such individuals should apply for an individual Dentist Scientist Award (K15). However, applicants who have undergone clinical development in either an Advanced Program in General Dentistry or a General Practice Residency Program are eligible for appointment. Under special circumstances where an applicant already has significant clinical experience but wishes to pursue career development in another clinical area, the NIDR will consider a written request from a PD on behalf of the applicant. An individual who has been a principal investigator on an NIH- research grant, such as a research project grant (R01), FIRST award (R29), sub-project on a program project (P01) or center grant (P50), or the equivalent, is not eligible for appointment to this award. F. Duration, Effort, and Allowable Costs: The applicant must request support for two DSAs to enter the program in each year, giving a total of ten during the five year project period. In the case of competitive renewal applications, these positions are in addition to those required to allow completion of five years support for appointees already on the program. In planning DSA appointments beyond the first year of the award, the PD and the DSAs should be aware that continued NIDR support beyond the five-year project period is dependent upon the availability of appropriated funds and success in competition for renewed support. In the event that a competitive renewal application for the next five-year project period is unsuccessful, it is the intention of the NIDR to provide salary, and Research Development Support funds, until each DSA in that program has completed the five-year program. However, the applicant institution must have plans in place to provide such support in the event that funding from the NIDR is not available. 1. Appointments of new DSAs must occur within three months of the start of a new budget period, usually between July 1 and September 30. Unfilled positions resulting from either failure to make appointments within the prescribed period or due to termination of an appointee prior to completion of a five-year program, will be eliminated from the program. The associated funds will not be available for carry over and will be deleted from future years. A "Statement of Appointment" form (PHS 2271, rev. 3/92) must be completed and sent to the NIDR whenever an individual is appointed or reappointed to the program. 2. Salary - The NIDR will provide salary up to the amounts listed below, starting at $26,500 for 0 years relevant experience, with four percent annual increases thereafter, up to a maximum of $39,226. However, the salary must not exceed the established salary provided by the institution from its own funds to other staff or faculty members of equivalent qualifications, rank, and responsibility in the department concerned. Fringe benefits will be provided. Number of Years Experience Salary (maximum provided by the NIDR) 0 $26,500 1 $27,560 2 $28,662 3 $29,808 4 $31,000 5 $32,240 6 $33,530 7 $34,871 8 $36,266 9 $37,717 10 or more $39,226 The scale extends up to 10 years to give credit for relevant postdoctoral experience at the time of appointment. This may include research (including industrial); teaching; residency; clinical practice; or other time spent in a health-related field beyond that of the qualifying doctoral degree. Salaries may be supplemented by an institution from non-Federal funds. Other NIH funds may not be used to provide additional salary support. Non-NIH Federal funds may not be used for salary 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 program. 3. Plans must be provided for the support of DSAs choosing clinical specialties, such as oral-maxillofacial surgery, that require more than the usual two years of clinical knowledge and skills development. 4. Research Development Support (RDS) - $15,000 per year for each DSA will be allowed. The PD may allocate these funds among DSAs as deemed necessary. These funds may be used for the following expenses incurred by DSAs: (a) tuition, fees, and books directly related to their career development; (b) research project expenses, such as supplies, equipment and technical personnel costs; (c) travel; (d) core support, including maintenance, for common equipment for all DSAs; (e) biostatistical services including personnel and computer time; (f) invited seminar speakers; (g) PD travel to the annual meeting; (h) advisory committee. Authorization to use RDS funds for other purposes may be requested from the NIDR. 5. Authorization may be requested from the NIDR to carry over unobligated funds from one budget period to the next; for example, for support of a DSA's salary and RDS for up to twelve months beyond the standard five years to permit completion of the program. Funds attributable to unfilled positions, whether due to failure to make appointments within the prescribed period defined in paragraph 1 above or due to termination of appointees prior to completion of the five year program, will not be available for carry over. 6. Procedures and reporting forms used to track the expenditure of the funds attributable to each DSA must be provided. Annual reports of these expenditures will be required. 7. Program Director's Support - Up to ten percent of the PD's salary, with four percent annual increments thereafter, plus fringe benefits, will be allowed. A PD may serve as a mentor. 8. Ancillary Personnel Support - Salary for mentors, secretarial and administrative assistance, etc., is not allowed. The sponsoring institution is expected to provide these services. 9. 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 expenditures for equipment, is allowed. G. Concurrent Awards: DSAs are encouraged to seek support for a post-Ph.D. experience after completion of the K16 program, ideally at another institution. During the final one to two years of their program, they may apply for a post-Ph.D., NRSA individual fellowship (F32), apply for appointment to a NIDR sponsored NRSA institutional postdoctoral training program (T32), or arrange for other support from the NIH or from nongovernmental sources sufficient to ensure two or more years of post- Ph.D. career development. If such support becomes effective prior to completion of the K16 program, it may be used without reduction in the annual RDS from the Dentist Scientist Award. H. Evaluation: For purposes of evaluating the Dentist Scientist Award, the PD, on behalf of the applicant organization, and the DSAs must agree to inform the NIDR annually of the career of each DSA for a period of ten years after leaving the program. This information must include the employment history, including all professional activities, publications, participation in research grants and/or contracts, honors and awards, professional organizational activities, and any other information that may be of value in evaluating the impact of the Dentist Scientist Award program. 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 information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 1, 1994, a letter of intent that includes a descriptive title of the proposed Dentist Scientist Award program, the name, address, and telephone number of the PD, the identities of other key personnel, participating institutions, and the number and title of the RFA (RFA: DE-94-005, Institutional Dentist Scientist Award) 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 early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this RFA. Applications must 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 Dr. Valega at the address listed under INQUIRIES. Applications must include a description of formal and informal activities related to instruction in the responsible conduct of research. 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. Budget requests must be provided according to the instructions in form PHS 398. In addition, the salary level requested for "to be appointed" positions must be at the level of three years experience, $29,808. The RDS requested for tuition and fees, books, travel, etc., must be specified by category for each position. Competitive renewal applications must request support for current appointees at the levels specified under the existing policies, until completion of five years support. 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-94-005, Institutional Dentist Scientist Award. 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 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 January 18, 1995. If an application is received after that date or is deemed non-responsive to the RFA, it will be returned without review. 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 an initial review group, convened by the NIDR Scientific Review Section, 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 and institutional official. Applications judged to be competitive will receive further review for scientific and technical merit by the review committee. The following review criteria will be applied: o Environment: The institutional commitment and ability to provide opportunities for research career development; the quality of clinical knowledge and skills development; the level of ongoing basic and clinical research activity; the evidence of multidisciplinary, collaborative activities, especially between basic and clinical investigators and departments; the availability of facilities, equipment, clinical resources, and research support; and the plans to provide support for DSAs in the event that a competitive renewal application is unsuccessful and the NIDR is unable to continue support. o The clinical and research development program: The structure of a typical DSA's program; the integration of the didactic, clinical and research components; the relationships among clinical and basic science departments and the graduate school in the design and conduct of programs; degree requirements; types of specialty development offered; the availability of prescribed and optional courses or seminars; the manner in which individual guided research activities will be selected; procedures for monitoring DSAs' progress; the unique and innovative aspects of the program. o Program Director: Scientific and administrative expertise, or potential, for managing clinical and research career development programs and research grants; time commitment; other research support; the composition and role of the advisory committee in development of the program, recruitment and DSA selection, assignment of mentors and projects, and evaluation of progress. o Mentors: Their roles and time commitment now and for the duration of the program; accomplishments in basic or clinical research; current and pending research grant holdings; and experience in graduate research and clinical career development. o Recruitment: Plans for recruitment, including minorities, women and others who are underrepresented in oral health research, and individuals from non-research intensive institutions; selection criteria; the availability of high-quality candidates; and retention strategies. o Career development record: For competitive renewal applications, the performance of the program in developing clinician research scientists, as indicated by graduates' success in obtaining fellowships, career awards, and individual research grant support; the rate at which former appointees establish independent productive research careers; recognition for outstanding scientific accomplishments; involvement in clinically oriented and laboratory research; their ongoing productivity; and the record of the program in filling positions. o Recruitment and retention of women and minority appointees: After review of the application for scientific and technical merit and assignment of a priority score, the initial review committee will comment on the plans for recruiting women and individuals from underrepresented minority groups to the program. In the case of renewal applications, this will include the accomplishments in recruiting and retaining women and individuals from underrepresented minority groups and in preparing them for research positions. 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 initial review committee on the plans for, and success in, recruitment of women and individuals from underrepresented minority groups. Schedule Applications will be processed according to the following schedule: Letter of Intent Receipt Date: December 1, 1994 Application Receipt Date: January 18, 1995 Initial Review Group Meeting: May/June 1995 Council Meeting: September 1995 Earliest Date of Award: July 1995 AWARD CRITERIA Funding decisions will be based on the initial review committee's and Council's recommendations, the need for research personnel in specific program areas, and the availability of funds. The earliest award date will be July 1, 1996. 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 issue or questions from potential applicants is welcome. Direct inquiries on programmatic issues 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 on fiscal matters to: Ms. Theresa Ringler Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 AUTHORITY AND REGULATIONS Institutional Dentist Scientist Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are 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 Mon May 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-94-021 - V23(18) 05/13/94 Date: 16 May 1994 18:08:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 477 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2r95f5$3hl@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DK94021 DK-94-021 P1O1 *************************************** SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS NIH GUIDE, Volume 23, Number 18, May 13, 1994 RFA: DK-94-021 P.T. 04; K.W. 0715085, 0755030, 0765035, 0745070 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 18, 1994 Application Receipt Date: November 15, 1994 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Silvio O. Conte Digestive Diseases Core Center grants. The NIDDK anticipates the award of four competitive Digestive Diseases Core Center Grants (P30s) in Fiscal Year 1996. At least one of these awards will be to a center with a research emphasis on the etiology, pathology, and treatment of inflammatory bowel disease. The Silvio O. Conte Digestive Diseases Research Core Centers are part of an integrated program of digestive diseases-related research support provided by the NIDDK. The Centers currently funded in this program have provided a focus for increasing collaboration and improving the cost-effectiveness of supported research among groups of successful investigators at institutions with an established, comprehensive digestive diseases research base. 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), Digestive Diseases Research Core Centers, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (not 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. Minority individuals and women are encouraged to submit as Principal Investigators. Applicant institutions must have an adequate base of established programs of high quality in laboratory and/or clinical digestive diseases-related research. The quality of the programs must be evident from the fact that support has been awarded through peer reviewed competition, such as NIDDK research project grants (R01), program project grants (P01), First Independent Research Support and Transition (FIRST) (R29) awards, cooperative agreements, and contracts or through other Federal agencies or non-federal groups. It is required that at least fifty percent of the digestive diseases-related research being conducted at the applicant institution be supported by the NIDDK. MECHANISM OF SUPPORT Support of this program will be through the NIH core center (P30) award. Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. This RFA is a one-time solicitation. The receipt of four competing continuation applications is anticipated. These applications will compete for four awards along with other applications received in response to this RFA. The total project period for each application submitted in response to the present RFA may not exceed five years. The earliest possible award dates will be December 1995 for three center grants and January 1996 for the other grant. Applicants must limit their requests to not more than $700,000 direct costs for the initial budget period. Included in this $700,000 may be a maximum of $100,000 for a pilot and feasibility program. Future budget period escalations may not exceed a four percent increase over the previous budget period. 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 at the National Center for Research Resources or a Principal Investigator must be included with the application. FUNDS AVAILABLE For FY 1996, up to $3,265,000 in total costs will be committed to fund applications submitted in response to this RFA. It is anticipated that four awards will be made with an average size of approximately $750,000 per year, total costs; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objective of the Core Centers is to bring together investigators from relevant disciplines to enhance and extend the effectiveness of research related to digestive diseases and their complications. A Core Center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the Core Center is to bring together clinical and basic science investigators in a manner that will enrich the effectiveness of digestive diseases research. An existing program of excellence in biomedical research in the area of digestive diseases and disorders is required. This research must be in the form of NIH funded research projects, program projects, or other peer reviewed research that is already funded at the time of submission of a Center grant application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. The Core Center must have a central focus of research investigation. The central focus must be a digestive disease, group of diseases or functional studies relating to digestive diseases; at least half of the research must relate to this central focus. Examples of a gastrointestinal disease-related central focus of research investigation include (but are not restricted to) inflammatory bowel disease, peptic ulcer disease, pancreatic disease, liver disease, pediatric gastrointestinal disease, and AIDS in gastrointestinal disease. Examples of functional studies as the central focus include (but are not restricted to) gastrointestinal motility, gastrointestinal hormones, or gene therapy for digestive diseases. Applicants should consult with NIDDK staff concerning plans for the development of the Center and the organization of the application. Silvio O. Conte Digestive Diseases Research Core Centers are based on the core concept. Five or six cores are usually included in a Center. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in digestive diseases centers to accomplish the stated goals of the Center. Examples of such resources include electron microscope, tissue culture, and radioimmunoassay facilities. Centers are encouraged to include a clinical component or core that deals with patients. This clinical component can exist as a stand-alone core or part of another core such as the administrative core. Besides leading to a better understanding of disease etiology and natural history of disease, such cores might provide biostatistics support, enhance clinical study design, enhance collaboration among researchers and recruitment of subjects for clinical studies, provide for epidemiological studies in areas of digestive diseases or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical or epidemiology core may more effectively address NIH policies concerning issues of women and ethnic minority participation in clinical studies. Two other types of activities may also be supported with Center funding: a pilot and feasibility (P/F) program and an enrichment program. The P/F program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to digestive disease research, and, occasionally, at investigators already working in digestive diseases, but who wish to make a substantial change in the direction of their research. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P/F study may be requested for up to 24 months, with subsequent individuals to be named by the Center Director and approved by the Center's External Advisory Board and the NIDDK. The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. SPECIAL REQUIREMENTS At least 50 percent of the already funded research base in a new application must be supported by the NIDDK. In competing continuation applications the percent may be less than 50 percent due to, for example, a growing research base of investigators entering digestive diseases from other fields. The significance of the research base will be determined by the initial review group. 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 October 18, 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 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 NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), available in the office of sponsored research of most academic or research institutions and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Administrative Guidelines for Silvio O. Conte Digestive Diseases Research Core Centers may be requested from the NIDDK program staff listed under INQUIRIES below. The RFA label available in the application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by November 15, 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 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 previously reviewed. Such applications must not only include an introduction addressing the previous critique, but also be responsive to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. If the application is not responsive to the RFA, NIDDK staff will 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. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted to withdraw applications from further competition if they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Applications are unlikely to be reviewed by a site visit team; therefore, the written application must be complete to facilitate review without a site visit. Following this review, the applications will be given a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council unless not recommended for further consideration by the initial review group. The most important component of a DDRCC is an ongoing, strong base of digestive disease-related research. Specific review criteria for Digestive Diseases Core Centers are: o The scientific excellence of the Center's research base (its strengths, its breadth and depth) as well as the relevance and interrelation of these separately funded research projects to the central theme(s) or focus of the Center and the likelihood for meaningful collaboration among Center investigators. The existence of a base of established, independently supported biomedical research of high quality is a prerequisite for the establishment of a Digestive Diseases Core Center and is the most important component of the review. (The results of previous peer reviews of its content will weigh heavily in the application's overall strength as a potential recipient of an award.) o The qualifications, experience, and commitment of the Center investigators responsible for the individual research projects, and their willingness to interrelate with each other and contribute to the overall objectives of the Digestive Diseases Core Center. o The appropriateness and relevance of the proposed Cores and their modes of operation (such as how usage will be prioritized), facilities, and potential for contribution to ongoing research. Competing continuation applications must document the use, utility, quality control and cost effectiveness of each Core requested to continue as part of the Center. Progress will be judged in part on the list of publications arising from the cores. At least two users are required to establish a core. However, a greater number of users generally can be evaluated as more cost effective. o For all applications, four P/F studies should be submitted for evaluation as part of the review of the P/F program. In general for new applications, the proposed P/F projects will be examined to assess the eligibility of the P/F applicant and the adequacy of the selection process by which the individual studies were selected. Applicants should refer to the Administrative Guidelines for DDRCCs for specific details regarding the P/F program and its review by the IRG. o The Named New Investigator, if requested, will be considered separately. o The scientific and administrative leadership abilities of the proposed Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the program. o The administrative organization proposed for the following: (a) Coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring. (b) Establishment and maintenance of internal communication and cooperation among the Center investigators. (c) Mechanism for selecting and replacing professional or technical personnel within the Core Center. (d) Mechanism for reviewing the use of and administering funds for the P/F program. (e) Management capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities. o The institutional commitment to the program, including lines of accountability regarding management of the Center grant and the institution's contribution to the management capabilities of the Center. o The academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and institutions. o Efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center. o The appropriateness of the budgets for the proposed and approved work to be done in Core facilities, for P/F studies (these are restricted funds and are capped at $100,000), and for enrichment in relation to the total Center program. Total requested Direct Costs are limited to $700,000 (including the P/F program). For competing continuation application, total requested Direct Costs should not exceed the $700,000 cap or be 10% greater that the amount recommended in the last funding period, whichever is lower. Also in competing continuation applications, consideration must be taken for reductions instituted in FY 87 in accordance with NIDDK administrative policy. Ongoing Center grants incurred negotiated budget reductions averaging approximately 20 to 25 percent per year in addition to the Initial Review Group recommended reductions indicated in the summary statements. Applicants should address how these cuts affected their Center. AWARD CRITERIA The anticipated date of award is December 1995 for three center grants and January 1996 for one additional center grant. Applications recommended for further consideration by the National Diabetes and Digestive and Kidney Diseases Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, program needs and balance, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. It is strongly suggested that the pamphlet "Administrative Guidelines for Silvio O. Conte Digestive Diseases Research Core Centers" be obtained before an application is prepared. Inquiries regarding programmatic issues and requests for the Administrative Guidelines may be directed to: Dr. Judith M. Podskalny Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 594-7539 FAX: (301) 594-7504 Inquiries regarding fiscal matters may be directed to: Ms. Nancy Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637A Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 Schedule Letter of Intent Receipt Date: October 18, 1994 Application Receipt Date: November 15, 1994 Initial Review: March 1995 Second Level Review: May 1995 Anticipated Date of Awards: December 1995 and January 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The 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 Thu May 19 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 19, pt. 1of2, 20 May 1994 Date: 19 May 1994 21:55:20 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2rhfro$gra@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940520 V23N19 P1O2 ************************************ X-comment: RFAS described: AI-94-017, CA/DK-94-024, CA-94-019, CA-94-015, DK- 94-020 NIH GUIDE - Vol. 23, No. 19 - May 20, 1994 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 08/10/94 ************************************************* MOLECULAR AND STRUCTURAL APPROACHES TO ANTIVIRAL DRUG DESIGN (RFA AI-94-017) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 08/11/94 ************************************************* THE ROLE OF HELICOBACTER IN CANCER (RFA CA/DK-94-024) National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases INDEX: CANCER; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R3 08/19/94 ************************************************* CANCER PREVENTION AND RURAL HEALTH (RFA CA-94-019) National Cancer Institute INDEX: CANCER $$INDEX R4 09/22/94 ************************************************* RESEARCH IN INNOVATIVE STRATEGIES TO REDUCE TOBACCO USE (RFA CA-94-015) National Cancer Institute INDEX: CANCER $$INDEX R5 11/22/94 ************************************************* OBESITY/NUTRITION RESEARCH CENTERS (RFA DK-94-020) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** NATIONAL RESEARCH SERVICE AWARD INDIVIDUAL POSTDOCTORAL FELLOWSHIPS (PA-94-068) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES OF AVAILABILITYU (RFPs AND RFAs) $$R1 BEGIN AI-94-017 FULL-TEXT ************************************** MOLECULAR AND STRUCTURAL APPROACHES TO ANTIVIRAL DRUG DESIGN NIH GUIDE, Volume 23, Number 19, May 20, 1994 RFA AVAILABLE: AI-94-017 P.T. 34; K.W. 0740012, 1002019, 1002008, 0755025 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: June 22, 1994 Application Receipt Date: August 10, 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 Therapeutic and prophylactic agents (other than vaccines) for viral infections that specifically inhibit virus replicative functions without interfering with those of the host cell processes are likely to provide clinical benefit with minimal toxicity. The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research that applies an understanding of the genetics, structural biology, and molecular biology of virus replication and pathogenesis to the development of antiviral agents that are targeted to virus-specific or virus-induced functions. Research on any virus that is a human pathogen or that serves as a model for a human pathogen, except for human immunodeficiency virus (HIV) and/or other retroviruses, is an appropriate subject for an application. 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, Molecular and Structural Approaches to Antiviral Drug Design, is related to the priority area of therapy for viral diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). 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 from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U01). Details of the responsibilities, relationships, and governance of a study funded under a cooperative agreement are discussed in the RFA under the section Terms and Conditions of Award. The total project period for applications submitted in response to this RFA may not exceed five years. 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 NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This is a one-time RFA. At this time there are no plans to recompete this RFA. If the NIAID does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $2,600,000. In Fiscal Year 1995, the NIAID plans to make nine to twelve awards. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES The purpose of this RFA is to stimulate research in the development of novel molecularly targeted approaches to antiviral therapy. This includes strategies for both the design of novel specific agents and development of methods for selective drug delivery. The strategies proposed should involve a molecular rationale for anticipated antiviral activity without significant concomitant cellular and/or organism toxicity. These include, but are not limited to, the use of three dimensional structural knowledge for inhibitor design, receptor interference, substrate analogues for viral enzymes, antisense and ribozyme oligonucleotides, immune-based approaches such as bifunctional antibodies and T-cell reconstitution, peptides, peptidomimetics and rationally-based drug combinations. Targeted approaches to drug delivery are also encouraged since drug toxicity often results from effects on uninfected tissues. Collaborations between different scientific disciplines, such as chemistry and virology, as well as collaborations between industrial and academic investigators are encouraged. Virus systems may be any (except HIV and related lentiviruses) that provide a model for a clinically important human viral infection. Possible choices include, but are not limited to, hepatitis B, C, and D virus, papillomavirus, cytomegalovirus, herpes simplex virus, varicella zoster virus, influenza viruses, respiratory syncytial virus, parainfluenza, coxsackievirus, dengue, arenaviruses, bunyaviruses, and rhinovirus. It is possible that research applications will involve the use of clinical specimens. If so, the issues discussed below in the section STUDY POPULATIONS should be addressed regarding the populations from which the specimens are obtained. Applications to conduct clinical trials are not responsive to this RFA and will be returned to the applicant. 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 22, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the number and title of this RFA, and a list of any other key investigators and their institution(s). The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "MOLECULAR AND STRUCTURAL APPROACHES TO ANTIVIRAL DRUG DESIGN" must be typed in. 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. Application forms may be obtained from the institution's office of sponsored research or its equivalent and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applications must be received by August 10, 1994. REVIEW CONSIDERATIONS Applications will be reviewed by the Division of Research Grants (DRG) for completeness and by NIAID for responsiveness to this RFA. Incomplete and non-responsive applications will be returned to the applicant without further consideration. The NIAID will remove from further competition those applications judged to be noncompetitive for award and will notify the applicant. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by an appropriate review committee convened by the NIAID. A second level of review will be provided by the NIAID Advisory Council. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries, 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: Catherine Laughlin, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A22 Bethesda, MD 20892 Telephone: (301) 496-8285 FAX: (301) 402-1456 Questions regarding review procedures may be addressed to: Olivia Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C19 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Barbara Huffman Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B26 Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Schedule Letter of Intent Receipt Date: June 22, 1994 Application Receipt Date: August 10, 1994 Scientific Review Date: November 1994 Advisory Council Date: February 1995 Earliest Award Date: July 1995 AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Section 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assurance Citation is Sec. 93.856, Microbiology and Infectious Diseases Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R1 END ************************************************************ $$R2 BEGIN CA/DK-94-024 FULL-TEXT *********************************** THE ROLE OF HELICOBACTER IN CANCER NIH GUIDE, Volume 23, Number 19, May 20, 1994 RFA AVAILABLE: CA/DK-94-024 P.T. 34; K.W. 0715035, 0755030, 1002027 National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 17, 1994 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 Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite investigator-initiated research grant applications to support basic studies on defining the role of the bacteria Helicobacter in human cancer. 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, The Role of Helicobacter in Cancer, 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 for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for each application submitted in response to this RFA may not exceed four years. The anticipated Award date is April 1, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $2,000,000 ($1,500,000 from NCI and $500,000 from NIDDK) in total costs per year for up to four years will be committed to fund applications which are submitted in response to this RFA. It is anticipated that eight to nine awards will be made. RESEARCH OBJECTIVES Epidemiologic studies have consistently demonstrated an association between Helicobacter pylori and gastric cancer. A recent study of over 3000 subjects from 13 countries showed a six-fold risk of gastric cancer in populations with H. pylori infection compared to populations with no infections. A longitudinal study of patients with gastric adenocarcinoma showed that H. pylori infection was a risk factor, and while the relationship between H. pylori and gastric lymphoma of mucosa-associated lymphoid tissue (MALT) was only suggestive at that time, H. pylori has subsequently been confirmed as a risk factor for gastric lymphoma. These population studies indicate that H. pylori infections acquired in childhood lead to chronic gastritis that persists for decades, and in susceptible people progresses to atrophic gastritis, intestinal metaplasia and dysplasia. In underdeveloped countries, up to 50 percent of children are infected by the age of 10 years, and while the childhood prevalence is lower for most populations, up to 50 percent of adults are infected by age 60. While there are socioeconomic, dietary and other cofactors involved in gastric cancer, the lack of a basic understanding of the oncogenic mechanism of H. pylori and its role as a factor or co-factor in gastric cancer limits our understanding of this disease. On October 16, 1993, the Biological Carcinogenesis Branch, DCE, NCI sponsored a workshop entitled "Helicobacter and Cancer." Dr. Webster Cavenee, a member of the DCE Board of Scientific Counselors, chaired the workshop. The purpose of the workshop was to assess the current state of knowledge on the role of Helicobacter pylori in gastric cancer in humans. This RFA is issues in accordance with the workshop recommendations that extramural research be stimulated in this area with set-aside funds. SPECIAL REQUIREMENTS The principal investigator of an R01 application must spend a minimum of 20 percent time and effort on this project. 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 17, 1994, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the 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, it is requested in order to provide an indication of the number and scope of applications to be reviewed. It also allows Institute 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. Thomas E. Nightingale 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 August 11, 1994. An application received after that date will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is 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 Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Institutes in accordance with the review criteria listed below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score, and will also receive a second level of review by the appropriate ICD's National Advisory Council/Board. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The following review criteria will apply: 1. The scientific merit, technical and medical significance of the proposed research, including the appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. Familiarity with the proposed techniques should be demonstrated, e.g., by the presentation of preliminary data. 2. The research experience, expertise and qualifications of the principal investigator and proposed staff and/or collaborators to perform the proposed experiments. 3. Documentation of the adequacy of the facilities and resources necessary to perform the research. AWARD CRITERIA The earliest anticipated date of award is April 1, 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, inquiries regarding fiscal matters, and address the letter of intent to: Thomas E. Nightingale, Ph.D. Division of Cancer Etiology National Cancer Institute Executive Plaza North, Room 540 Bethesda, MD 20892 Telephone: (301) 496-1951 Frank A. Hamilton, M.D., M.P.H. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive Disease and Kidney Diseases Westwood Building, Room 3A15B Bethesda, MD 20892 Telephone: (301) 594-7571 Direct inquiries regarding fiscal matters to: Mr. Earl Bowman, Jr. Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 217 Mrs. Thelma Jones Grants Management Branch National Institute of Diabetes and Digestive Disease and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 594-7543 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.393, Cancer Cause and Prevention Research. Awards are made under the authorization of the Public Health Service (PHS) Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 U.S.C. 241 and 285) and administered under PHS and HHS grants policies and grant regulations 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. $$R2 END ************************************************************ $$R3 BEGIN CA-94-019 FULL-TEXT ************************************** CANCER PREVENTION AND RURAL HEALTH NIH GUIDE, Volume 23, Number 19, May 20, 1994 RFA AVAILABLE: CA-94-019 P.T. 34; K.W. 0715035, 0730075, 0745027, 0745020 National Cancer Institute Letter of Intent Receipt Date: June 20, 1994 Application Receipt Date: August 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 Public Health Applications Research Branch, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites research grant applications for research projects to develop, implement, and evaluate cancer prevention and early detection intervention strategies for rural 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, Cancer Prevention and Rural Health, is related to the priority area of cancer. Potential applicants may obtain a copy of "Health People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public and private, for-profit and non-profit, organizations such as universities, public health departments, voluntary organizations, research centers, hospitals, consortia of health providers, and units of state and local governments serving a substantial rural population. Collaborating applicant organizations and/or institutions with multidisciplinary expertise and access to rural populations are encouraged. Awards will not be made to foreign institutions and applicants from domestic organizations may not include international components. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT Support of this program will be through the NIH individual research grant (R01). Applicants will be responsible for the planning, direction, and execution of the proposed project. However, it is anticipated that grantees funded under this RFA, will meet regularly for purposes of sharing design and evaluation strategies, comparing results where possible, and distilling lessons learned from all grant projects (See SPECIAL REQUIREMENTS). The total project period for an application submitted in response to this RFA may not exceed four years. The anticipated award date is March 1, 1995. This RFA is a one-time solicitation. Generally, future unsolicited competitive continuation applications will compete with all investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, if the NCI determines that there is a sufficient continuing program need, a request for competitive continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. FUNDS AVAILABLE Approximately $1,000,000 in total costs per year for up to four years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that three to five awards will be made and that the average annual direct costs will be $175,000 per award. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for an application submitted in response to the present RFA may not exceed four years. The earliest feasible start-date for the initial awards will be March 1, 1994. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The NCI is interested in stimulating research to develop effective methods for increasing cancer prevention and early detection services in rural populations and settings. The primary goal of this project is to develop, implement, and evaluate cancer prevention and early detection intervention strategies for rural populations and settings. Definition of Rural - For purposes of this procurement, rural refers to areas of low population size and density that are categorized as 1) nonmetropolitan, using the designation of Metropolitan Statistical Areas by the U.S. Office of Management and Budget (OMB) or 2) rural, using the definition formulated by the U.S. Bureau of the Census (RHRP 1991). Intervention Approaches - Investigators are encouraged to submit applications that focus on the prevention and/or screening and early detection of cancer. Research projects should address the cancer concerns of special relevance to rural populations. Appropriate behavioral, educational and/or organizational scientific theories should provide the foundation for identification of barriers to cancer prevention and control in rural populations and settings, design of appropriate intervention approaches and evaluation of intervention outcomes. Interventions may be targeted to individuals within rural communities, health care providers serving rural communities, public health structures, community organizations, or other appropriate individuals and/or groups. Interventions may address individual, community and/or organizational level barriers to effective cancer prevention and control. Consideration must be given to the specific demographic, socioeconomic, cultural, and geographic factors that affect rural health-related behaviors and health provider practices. Evaluation - Evaluation of the effectiveness of interventions to improve the health status of rural residents is a critical component of this RFA. An adequate design must be employed to reliably demonstrate the effectiveness of interventions in reaching the target population and affecting cancer prevention and control practices. Randomization of the target population to intervention and nonintervention groups is the preferred study design, although other well justified study designs with appropriate comparisons, such as multiple time series designs, will be considered. Final outcome measures should reflect improvements in health status and/or health-related behaviors, and may include for example, changes in stage at diagnosis, proportion of unstaged cases at diagnosis, number of preventive care visits, number and frequency of screening tests performed, compliance with screening guidelines, case fatality, time from diagnosis to treatment. Interim measures such as improvements in knowledge, attitudes, beliefs and/or intentions may be included if relevant to the intervention being tested. Applications must include a clear plan for process evaluation. Process evaluation should provide information about implementation of the intervention and factors that both positively and negatively influenced implementation and any changes to the intervention as it was being implemented. Process information should be used to facilitate intervention design and implementation as well as interpretation of outcome results. High priority will be given to research projects that are applicable to rural communities nationwide and that can be easily replicated and disseminated. Successful interventions developed through this research will be used to assist health professionals working in rural areas around the country to address cancer prevention and early detection needs. Research results will be disseminated through appropriate NCI programs such as the Appalachia Leadership Initiative on Cancer (ALIC), the Cancer Information Service (CIS), the Cancer Centers, and the Community Clinical Oncology Programs (CCOPs). SPECIAL REQUIREMENTS Investigators will be expected to supply a final report in a specific format, which summarizes both successes and failures in order to contribute to the dissemination of community intervention research. In addition, grantees may be expected to participate in a joint summary of results of all grants. 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 20, 1994, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which an application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the final review of subsequent applications, the information it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in review. The letter of intent is to be sent to Dr. Marianne Haenlein Alciati at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications must be received by August 19, 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 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, Maryland 20892 (301-594-7248), and from the NCI Program Director listed under INQUIRIES. 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 applicant 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 the Program Director listed under INQUIRIES. 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: Marianne Haenlein Alciati, Ph.D. Public Health Agency Section National Cancer Institute Executive Plaza North, Room 233 Bethesda, MD 20892 Telephone: (301) 496-8584 Direct inquiries regarding fiscal matters to: Robert E. Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892-4200 Telephone: (301) 496-7800, ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under HHS policies and grant regulations. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN CA-94-015 FULL-TEXT ************************************** RESEARCH IN INNOVATIVE STRATEGIES TO REDUCE TOBACCO USE NIH GUIDE, Volume 21, Number 17, May 6, 1992 RFA AVAILABLE: CA-94-015 P.T. 34; K.W. 0404019, 0745027 National Cancer Institute Letter of Intent Receipt Date: June 29, 1994 Application Receipt Date: September 22, 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 Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites research grant applications to study strategies to develop, implement, and disseminate effective tobacco control interventions. Tobacco control interventions are those interventions that can influence large populations to reduce tobacco use. These interventions include, but are not necessarily limited to, restrictions on the sale of tobacco to minors, restrictions on indoor smoking, increases in tobacco excise taxes, and restrictions on tobacco advertising. The goal of this research is to assist policy makers and public health professionals in the enactment and enforcement of effective tobacco control policy interventions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Research in Innovative Strategies to Reduce Tobacco Use, is related to the priority area of tobacco. 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 institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) 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 anticipated award date is July 1, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will also vary. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Approximately $4,000,000 in total costs for four years ($1,000,000 per year for each of four years) will be committed specifically to fund applications submitted in response to this RFA. It is anticipated that three or more new awards will be made, dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Legislation and other policy interventions can decrease tobacco use. Effective policy interventions include increases in tobacco excise taxes, restrictions on indoor smoking, restrictions on tobacco advertising and promotion, and restrictions on minors' access to tobacco products. There remain many questions about the most effective strategies to develop, implement, enforce, and disseminate tobacco control policies. This program is intended to stimulate innovative behavioral, public health, and economic research on tobacco control policy interventions, including the analysis of their feasibility, effectiveness and consequences of implementation. The goal of this research is to assist policy makers and public health professionals in the enactment and enforcement of effective tobacco control policies. SPECIAL REQUIREMENTS It is expected that grantees will participate in a series of collaborative meetings at NCI. Although independence and originality are encouraged in the approaches of the various investigators, they are expected to share ideas, experiences, and information in attempting to reach their common goal. Funds should be budgeted to permit travel of senior staff to Bethesda, Maryland twice a year over the course of the grant. 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 29, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, 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. Marc Manley 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NIH program administrator listed under INQUIRIES. Applications must be received by September 22, 1994. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. 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 Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. Review criteria are provided in the RFA. AWARD CRITERIA The anticipated date of award is July 1, 1995. Awards will be made based on the following criteria: 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: Marc Manley, M.D., M.P.H. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 233 Bethesda, MD 20892 Telephone: (301) 496-8584 FAX: (301) 496-8675 Direct inquiries regarding fiscal matters to: Marci Bollt Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 AUTHORITIES AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.339. 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, 45 CFR Part 74, and 45 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN DK-94-020 FULL-TEXT ************************************** OBESITY/NUTRITION RESEARCH CENTERS NIH GUIDE, Volume 23, Number 19, May 20, 1994 RFA AVAILABLE: DK-94-020 P.T. 04; K.W. 0710095, 0715145, 0710030, 1002004, 0765020 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 21, 1994 Application Receipt Date: November 22, 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 Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Obesity/Nutrition Research Centers (ORNCs) to conduct basic and clinical research on obesity, and the related fields of energy metabolism, body composition, satiety, adipocyte metabolism, eating disorders and weight management. This center will be awarded as a core center in Fiscal Year 1996. The award of at least one ONRC by NIDDK is anticipated. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention goals of "Healthy People 2000," a PHS-lead national activity for setting priorities. This RFA, Obesity/Nutrition Research Centers, is related to the priority areas of nutrition, physical activity and fitness, heart disease and stroke, cancer, diabetes, and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No 017-001-00474-0, or Summary Report: Stock No 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as principal investigators. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT Support of this program will be through the NIH core center (P30) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. The earliest anticipated award date will be December 1, 1995. FUNDS AVAILABLE The NIDDK anticipates awarding one ONRC Grant in Fiscal Year 1996 on a competitive basis. The receipt of one competing continuation application is anticipated, which will be in competition with other applications received in response to this RFA. The anticipated award will be for five years and will be contingent upon the availability of appropriated funds. Each request for support must be limited to no more than $700,000 in direct costs per year. Any application exceeding this amount will be returned to the applicant. RESEARCH OBJECTIVES The objectives of the Core Center are to encourage a multidisciplinary approach to research in the nutritional sciences and to bring together, on a cooperative basis, clinical and basic science investigators in a manner that will enhance and extend the effectiveness of nutritional research being conducted in the field of obesity, eating disorders, and energy regulation. To accomplish the overall goal of these centers, there must be in existence at the applicant's institution an ongoing program of excellence in biomedical research related to the study of obesity. This research should be in the form of NIH-funded research projects (R01), FIRST Awards (R29), program projects (P01) or other peer-reviewed research from Federal and non-federal sources. The research base in the nutritional sciences need not be exclusively in obesity and can include a focus on eating disorders, energy metabolism, cell biology, or nutrient metabolism. It would be highly desirable that the Principal Investigator, as well as the applicant institution, have a commitment to the treatment and prevention of obesity. The availability of a clinic population with adequate representation of women and minorities that can be readily utilized by investigators will play a major role in attracting investigators to the field of obesity research and to serve as a resource in the design of pilot and feasibility projects. 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 a letter of intent, by October 21, 1994. The letter of intent should include 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 NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 603 Bethesda, MD 20892 APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91), available in the office of sponsored research at most academic or research institutions and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 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. Applications must be received by November 22, 1994, the original and three copies of the application must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two additional copies of the application, under separate cover, must be sent to: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 603 Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications for a ONRC grant will be evaluated in national competition by the NIH grant peer review process. Applications will be reviewed initially by an ad hoc review group convened by the NIDDK and subsequently by the National Diabetes and Digestive and Kidney Diseases Advisory Council. INQUIRIES Applicants should request a copy of the RFA as well as a copy of "Guidelines for Obesity/Nutrition Research Centers". These guidelines contain important additional information of the format, content and review criteria. Prospective applicants may obtain guidelines from and may address inquiries to: Van S. Hubbard, M.D., Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A18B Bethesda, MD 20892 Telephone: (301) 594-7573 FAX: (301) 594-7504 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 653 Bethesda, MD 20892 Telephone: (301) 594-7543 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R5 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-068 ************************************************ NATIONAL RESEARCH SERVICE AWARD INDIVIDUAL POSTDOCTORAL FELLOWSHIPS NIH GUIDE, Volume 23, Number 19, May 20, 1994 PA NUMBER: PA-94-068 P.T. 22; K.W. 0720005, 0730050 Agency for Health Care Policy and Research Application Receipt Dates: August 5, December 5, and April 5 PURPOSE The Agency for Health Care Policy and Research (AHCPR) announces the continuing availability of postdoctoral National Research Service Award (NRSA) individual fellowships (F32) in health services research. These postdoctoral research fellowships provide opportunities for one or more years of academic training and supervised experience in applying quantitative research methods to the systematic analysis and evaluation of health services. Women, minorities, and individuals with disabilities are encouraged to apply. 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. The AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-004374-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY Applicants for postdoctoral fellowships must, at the time they apply, be citizens of the United States, noncitizen nationals, or noncitizens who have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card I-551 or I-151 or other legal verification of such status at the time of application. Individuals on temporary or student visas are not eligible. Applicants must have received, by the activation date of the NRSA fellowship, a Ph.D., M.D., D.D.S., D.M.D., Sc.D., Dr.P.H., D.Pharm., or equivalent doctoral degree from an accredited domestic or foreign institution. Certification from an authorized official of the degree-granting institution that all degree requirements have been met is acceptable. (Persons possessing the J.D. degree as the sole advanced degree are not considered postdoctoral for NRSA purposes.) NRSA fellowships may not be used to support studies leading to the M.D., D.O., D.D.S., D.M.D., or equivalent health professional degree nor do they support residency training. MECHANISM OF SUPPORT This program announcement (PA) uses the National Research Service Award individual postdoctoral fellowship (F32) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant and the sponsoring institution. This program announcement replaces PA-92-08. RESEARCH OBJECTIVES AHCPR-sponsored NRSA fellowships emphasize multidisciplinary health services research training. This training should provide a rigorous conceptual and methodological foundation for investigating topics that include, but are not limited to, the following: o Determinants of successful health care market reform, including incentives for selection of efficient health plans by health care purchasers and effective management by health care providers; o Cost-effectiveness and cost-benefit analysis, including allocation of health care resources and its relationship to health status; o Analysis of service delivery, resource use, and costs of care for persons with HIV-related illnesses; o Primary care issues, including relationships between the structure and organization of service delivery, access to care, and costs and outcomes of care; o Evaluation of managed care and other approaches to organizing, financing, and reimbursing health care services; o Alternative delivery systems, providers, and practice patterns in long-term care including home and community- based care; o Medical treatment effectiveness issues, including evaluation of outcomes associated with the use of clinical practice guidelines; o Availability, accessibility, effectiveness, and quality of care for underserved populations such as low-income groups and minority populations; o Rural health issues, including primary care access, service delivery, technology diffusion, and supply of health professionals; o Medical malpractice and liability; o Appropriateness and effectiveness, including cost effectiveness, of alternative treatments and technologies; o Factors affecting dissemination and assimilation of health and clinical information to practitioners and patients; o Development of measures, methods, and technologies to support quality assurance and foster quality improvement in health care; and o Application of medical informatics to developing and improving expert systems for clinical diagnosis and treatment selection. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups must be included in all AHCPR supported health services research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains some provisions that are substantially different from the 1990 policies. AHCPR plans to publish guidelines specific to AHCPR. In the interim, AHCPR will follow the NIH guidelines, as applicable. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," 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 NIH policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this policy. APPLICATION PROCEDURES Prior to making formal application, an individual applicant must be accepted by an appropriate institution (private or public, for-profit or non-profit) and by a sponsor who will supervise the training and research experience. The applicant's research training plan should include a description of the proposed activities under the award and the aims, significance, and experimental design and methods of the research proposal. The sponsor must describe in detail the research training plan and the availability of suitable staff and facilities. Formal training is not necessarily limited to a single academic institution or discipline. The sponsor must be an established investigator who is active in health services research and who personally will supervise the applicant's training and research program. Fellowship applicants requesting continued training at the doctorate institution or under the same sponsor in an institution where they have been training for more than a year should describe those opportunities for new or additional training experiences that will broaden the scientific background and perspective. Applicants must submit the original and two copies of Public Health Service form PHS 416-1 (rev. 10/91), Individual National Research Service Award Application. If the applicant is lawfully admitted to the United States for permanent residence, a notarized statement documenting this status is required. NRSA fellowship material for AHCPR applications is available from Global Exchange Inc., 7910 Woodmont Ave. Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX 301-652-5264). Do not send applications to AHCPR. The completed, signed original application and two copies must be sent or delivered to: Fellowship Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The following is the schedule for individual NRSA application receipt and review: Application Receipt Date: Aug 5 Dec 5 Apr 5 Study Section Review: Oct Feb Jun Earliest Notification of Award: Dec Apr Aug Earliest Possible Start Date: Jan May Sep Applications for NRSA fellowships will be reviewed by a review committee that includes consultants from appropriate scientific fields. The committee will use the following criteria in evaluating applications: o Applicant's past academic and research accomplishments; o Applicant's research and training goals and potential for a health services research career; o Research training program proposed (including the training potential, as well as the scientific merit of the research project); o Qualifications and suitability of the proposed sponsor and appropriateness of the institutional environment; and o References and other relevant information. AWARD CRITERIA For applications assigned to the AHCPR, awards will be made based on the recommendations of the review committee, relevance of the application to AHCPR research priorities and training needs, and availability of funds in making the final selection of awardees. Stipends and Other Training Costs A stipend is provided to each NRSA fellow to help defray living expenses during the research training experience. The stipend amount is determined by the number of full years of relevant postdoctoral experience as of the date the award is issued. Relevant experience may include research experience, teaching, internship, residency, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. No departure from the standard stipend schedule may be negotiated between the institution and the fellow. Current postdoctoral stipend levels are listed below: Full years of relevant Annual experience stipend None $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 AHCPR will provide an allowance of $3,000 per 12-month period to non-Federal, non-profit sponsoring institutions to cover such awardee expenses as tuition and fees, self-only health insurance, research supplies, equipment, travel to scientific meetings, and related items. There is no institutional allowance for individuals sponsored by for-profit institutions; but AHCPR will provide up to $2,000 for the fellow's tuition and fees, self-only health insurance, scientific meeting travel expenses, and books. The $2,000 is paid to the for-profit institution for disbursement to the fellow, and any unexpended funds are to be returned to AHCPR. Additional funds may be requested by the institution for extraordinary costs for fellows who are disabled, as defined by the Americans with Disabilities Act. Such additional funds are provided only in exceptional circumstances and must be fully justified and explained by the institution. Supplementation: Institutions may use non-Federal funds to supplement NRSA stipends. Federal funds may be used for stipend supplementation only if 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 VA benefits when permitted by these programs. Supplementation, when provided, must be without obligation to the trainee. Compensation: Trainees may be permitted to receive compensation for work in some other position (for example, teaching or laboratory assistance) when the trainee is in an employee-employer relationship, the payments are for services rendered, and the situation otherwise meets conditions for student compensation as specified in the PHS Grants Policy Statement. Compensation may not be from a research grant that supports the same research that is part of the NRSA experience. Compensation for services must occur on a limited, part-time basis apart from the normal full-time training activities that require a minimum of 40 hours per week. Under no circumstances may the conditions of either stipend supplementation or student compensation for coincidental employment detract from or prolong the research training. Further information on stipend supplementation and compensation is available in "National Research Service Awards -- Guidelines for Individual Awards - Institutional Grants," NIH Guide for Grants and Contracts (special From owner-sci-resources@net.bio.net Thu May 19 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA/DK-94-024 - V23(19) 05/20/94 Date: 19 May 1994 21:55:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 354 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2rhfs6$gsc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA ADK94024 CA/DK-94-024 P1O1 *********************************** THE ROLE OF HELICOBACTER IN CANCER NIH GUIDE, Volume 23, Number 19, May 20, 1994 RFA: CA/DK-94-024 P.T. 34; K.W. 0715035, 0755030, 1002027 National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 17, 1994 Application Receipt Date: August 11, 1994 PURPOSE The National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite investigator-initiated research grant applications to support basic studies to define the etiologic role of Helicobacter in human cancer, thereby providing new insight into biological carcinogenesis and human tumorigenesis. 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), The Role of Helicobacter in Cancer, 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 for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority and women investigators are encouraged. 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. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) traditional research project grant (R01). 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 four years. The anticipated average amount of direct cost awards will vary from $200,000 to $250,000 per year. The anticipated award date is April 1, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all other investigator-initiated research grant applications and be peer reviewed by a study section in the Division of Research Grants (DRG), NIH. However, is it is determined that there is a sufficient continuing program need, a request for competing continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. FUNDS AVAILABLE Approximately $2,000,000 ($1,500,000 from NCI and $500,000 from NIDDK) in total costs per year for up to four years will be committed to fund applications that are submitted in response to this RFA. It is anticipated that eight to nine awards will be made. The level of funding is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for each application submitted in response to the present RFA may not exceed four years. The earliest feasible start date for the initial awards will be April 1, 1995. Although this program is provided for in the financial plans of the NCI and NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Epidemiologic studies have consistently demonstrated an association between Helicobacter pylori and gastric cancer. A recent study of over 3000 subjects from 13 countries showed a six-fold risk of gastric cancer in populations with H. pylori infection compared to populations with no infections. A longitudinal study of patients with gastric adenocarcinoma showed that H. pylori infection was a risk factor, and while the relationship between H. pylori and gastric lymphoma of mucosa-associated lymphoid tissue (MALT) was only suggestive at that time, H. pylori has subsequently been confirmed as a risk factor for gastric lymphoma. These population studies indicate that H. pylori infections acquired in childhood lead to chronic gastritis that persists for decades and in susceptible people progresses to atrophic gastritis, intestinal metaplasia, and dysplasia. In underdeveloped countries, up to 50 percent of children are infected by the age of 10 years, and while the childhood prevalence is lower for most populations, up to 50 percent of adults are infected by age 60. While there are socioeconomic, dietary and other cofactors involved in gastric cancer, the lack of a basic understanding of the oncogenic mechanism of H. pylori and its role as a factor or co-factor in gastric cancer limits our understanding of this disease. On October 16, 1993, the Biological Carcinogenesis Branch, DCE, NCI sponsored a workshop entitled "Helicobacter and Cancer." Dr. Webster Cavenee, a member of the DCE Board of Scientific Counselors, chaired the workshop. The purpose of the workshop was to assess the current state of knowledge on the role of Helicobacter pylori in gastric cancer in humans. This RFA is issued in accordance with the workshop recommendations that extramural research be stimulated in this area with set-aside funds. Research Goals and Scope The overall goal of this RFA is to stimulate research on defining the mechanistic role of Helicobacter species in the etiology of gastric cancer or MALT lymphoma. Examples of studies that may be supported by this RFA include, but are not limited to: (1) defining factors of the Helicobacter species that may contribute to carcinogenic potential; (2) characterizing relevant animal models that will reflect development of Helicobacter-related neoplastic changes seen in humans; (3) developing in vitro methods of culturing and propagating Helicobacter species without loss of animal pathogenicity; (4) developing reagents or markers for early detection of precancerous lesions, such as atrophic gastritis, in humans or animal models; (5) developing diagnostic tests and tools to isolate and identify Helicobacter serotypes and/or genotypes leading to or associated with cancer in humans. SPECIAL REQUIREMENTS The principal investigator of an R01 application must spend a minimum of 20 percent time and effort on this project. 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. LETTER OF INTENT Prospective applicants are asked to submit, by June 17, 1994, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the 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, it is requested in order to provide an indication of the number and scope of applications to be reviewed. It also allows NCI and NIDDK 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. Thomas E. Nightingale 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 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 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, 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, 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 August 11, 1994. An application received after that date 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 appropriate institute. Incomplete applications will be returned to the applicant without further consideration. If institute staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the institutes accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score, and will also receive a second level of review by the appropriate ICD's National Advisory Council/Board. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The following review criteria will apply: 1. The scientific merit, technical and medical significance of the proposed research, including the appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. Familiarity with the proposed techniques should be demonstrated, e.g., by the presentation of preliminary data. 2. The research experience, expertise and qualifications of the principal investigator and proposed staff and/or collaborators to perform the proposed experiments. 3. Documentation of the adequacy of the facilities and resources necessary to perform the research. The second level of review by t