Vol. 18, No. 9, March 17, 1989 NOTICES CHANGES IN THE NEW INDIVIDUAL FELLOWSHIP FORM .........(84/178).............. 1 National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH NOTICE - AVAILABILITY OF A MOUSE GENETIC MODEL FOR HUMAN NEURAL TUBE DEFECTS ..........................................(182/247)............. 2 National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT DATED ANNOUNCEMENTS (RFPs AND RFAs) ISOLATION, PURIFICATION, AND CHARACTERIZATION OF ANTIGENS FROM PURIFIED MYCOBACTERIUM LEPRAE OBTAINED FROM ARMADILLO TISSUE (RFP) .......... 3 National Institute of Allergy and Infectious Diseases (253/286) Index: ALLERGY, INFECTIOUS DISEASES DETAILED DRUG EVALUATION AND DEVELOPMENT OF TREATMENT STRATEGIES FOR CHEMOTHERAPEUTIC AGENTS (RFP) .......................(289/337)........... 3 National Cancer Institute Index: CANCER SPECIALIZED CENTERS OF RESEARCH (SCOR) IN THROMBOSIS (RFA) .................. 4 National Heart, Lung, and Blood Institute (340/373, 884/1337) Index: HEART, LUNG, BLOOD PROGRAMS OF EXCELLENCE IN ENDOCRINOLOGY RESEARCH (RFA) ..(376/542, 1340/1589) 4 National Institute of Diabetes and Digestive and Kidney Diseases Index: DIABETES, DIGESTIVE AND KIDNEY DISEASES NATIONAL RESEARCH SERVICE AWARD-INSTITUTIONAL GRANTS (T32) (RFA) ............ 6 National Institute of Dental Research (545/618, 1592/2056) Index: DENTAL RESEARCH ONGOING PROGRAM ANNOUNCEMENTS INDIVIDUAL MEDICAL INFORMATICS POSTDOCTORAL FELLOWSHIPS ...(624/755)......... 7 National Library of Medicine Index: LIBRARY OF MEDICINE NATIONAL RESEARCH SERVICE AWARDS FOR PREDOCTORAL M.D./PH.D. FELLOWS ......... 9 Alcohol, Drug Abuse, and Mental Health Administration (758/831) Index: ALCOHOL, DRUG ABUSE, MENTAL HEALTH NOTICES CHANGES IN THE NEW INDIVIDUAL FELLOWSHIP FORM P.T. 22; K.W. 1014006, 0720005 National Institutes of Health As announced in the NIH Guide for Grants and Contracts, Vol. 18, No. 5, February 17, 1989, the application form for competing Individual National Research Service Awards, PHS 416-1, has just been revised. This revision (7/88), which should be used for the May 10, 1989 receipt date and subsequent deadlines, has undergone major changes. The kit now reflects the expedited review of individual fellowships, including the submission of reference letters with the application. Reference letters in sealed envelopes must be attached to the front of the original copy of the application. Applications without at least three reference letters will be returned without review. The kit also reflects the following changes in PHS policy; a) Deletion of the invention reporting requirements for fellows (NIH Guide for Grants and Contracts, Vol. 17, No. 32, October 7, 1988); b) Addition to the application face page of Item No. 6, Certification of Non-Delinquency on Federal Debt. See NIH Guide for Grants and Contracts, Vol. 17, No. 35, October 28, 1988, or the Important Notice flier now being inserted in application kits; and c) Addition to the Checklist page of the Scientific Fraud (Misconduct) Assurance. As with research grant application (NIH Guide for Grants and Contracts, Vol. 17, No. 2, January 15, 1988), the Assurance is not required until the DHHS regulations are final. But the sponsoring institution can check the block on the Checklist page if it already has procedures in place to review reports of misconduct. The Notice of Proposed Rulemaking requesting public comment on the development of the regulations was published in the Federal Register on September 19, 1988 (NIH Guide for Grants and Contracts, Vol. 17, No. 31, September 30, 1988). A future announcement in the Guide will note the date of the final regulations. Additional recent policies include: a) Debarment and Suspension. See NIH Guide for Grants and Contracts, Vol. 17, No. 38, November 18, 1988, or the Important Notice flier on Debarment and Suspension now being inserted in application kits, for the required certifications by fellowship applicants and sponsoring institutions; and b) Requirements for a Drug-Free Workplace. See NIH Guide for Grants and Contracts, Vol. 18, No. 1, January 13, 1989, for certifications required from sponsoring organizations and individual applicants effective March 18, 1989. Such certifications are given by individuals when signing the application face page and by Officials Signing for Sponsoring Institutions when signing the Facilities and Commitment Statement. Notice and interim final rules regarding drug-free workplace requirements were published in the Federal Register, Vol. 54, No. 19, January 31, 1989. Many items on the application form have been consolidated and relocated. This is most evident on page 2, which serves as a summary of the entire application (applicant, sponsor and research project). Other changes include: a) Design of pages 1 and 2 for optical character recognition; b) Expansion of the Human Subjects and Vertebrate Animal items (Nos. 9 and 10) on page 1 to include the institutional assurance numbers and IRB and IACUC review dates. A separate HHS 596 form or letter giving this information is no longer necessary unless required for a follow-up certification; c) Relocation of the sponsoring institution's Entity Identification Number and Business Official items (Nos. 12 and 14) to page 1; d) Addition of a Table of Contents page; e) Deletion of the Institutional Allowance item from the Facilities and Commitment Statement. This allowance is automatic, at the maximum level specified in the program announcement; Vol. 18, No. 8, March 17, 1989 - Page 1 f) Inclusion on the Checklist page of the Senior Fellowship budget information; and g) Clarification and expansion of the instructions, including a table of contents page for the entire kit and a glossary. Direct any questions or comments on the new form to: Mr. Nicholas Moriarty Program Analyst Division of Research Grants Westwood Building, Room A-25 National Institutes of Health Bethesda, Maryland 20892 Telephone: (301) 496-7221 Consult the February 17, 1989, issue of the NIH Guide for Grants and Contracts for sources of application kits. NOTICE - AVAILABILITY OF A MOUSE GENETIC MODEL FOR HUMAN NEURAL TUBE DEFECTS P.T. 34; K.W. 0755020, 1002002 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development has long been interested in the normal process of neuroembryological development as well as the pathogensis of neural tube defects. This animal model is provided to stimulate interest in characterizing a mammalian model and to search for clues to etiologic mechanisms which could be applicable to the human condition. Mouse embryos homozygous for the curly tail mutation (ct/ct) develop spinal neural tube defects as a result of delay in neural fold closure at the posterior neuropore (Copp, 1985). The defects are similar in site, form and associated anomalies to those occurring in humans; 1-5 percent have defects resembling anencephaly, 55-60 percent have lower spine defects, ranging from all tail flexion defects (curly tails) to open lumbosacral meningomyelocoele, which can be associated with elevated amniotic fluid alpha fetoprotein and hydrocephalus; and the remaining 40 percent are morphologically normal. The mutation is inherited as an autosomal recessive trait with incomplete penetrance and results in viable homozygous individuals (Gruneberg, 1954). The ct/ct embryos developing in whole embryo culture produce defects that resemble those that develop in vivo in both type and frequency. The size of the posterior neuropore at 10 days gestation (25-30 somites), prior to the normal time when spinal neurulation is complete, can distinguish embryos destined to develop spinal defects from their normally developing littermates (Copp, 1985). This morphological marker is consistent, reliable and has been used to identify localized regions of reduced cell proliferation (Copp, et al, 1988) and hyaluronate accumulation (Copp & Bernfield, 1988) in affected ct/ct embryos. The ct/ct mouse is a suitable experimental model for spinal neural tube defects in humans because of the similar neurulation process in these species, the similarities of the morphologic and associated defects, the ability to distinguish affected mouse embryos from their normal littermates prior to completion of neurulation and the fidelity of the abnormal phenotype in culture. Further genetic, molecular genetic and biochemical characterization of the mutation could help delineate the etiology and pathogenesis of human neural tube defects. The ct/ct mice are on a CBA/Gr genetic background and are maintained as a closed random-bred colony. Breeding nuclei, produced in the laboratory of Dr. Merton Bernfield as part of contract NO1-HD-6-2926, together with information on how to detect future abnormal embryos are available, upon request, from: Danuta Krotoski, Ph.D. Health Scientist Administrator Genetics and Teratology Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development Building EPN, Room 643 Bethesda, Maryland 20892 Telephone: (301) 496-5541 Vol. 18, No. 9, March 17, 1989 - Page 2 REFERENCES Copp, A.J. (1985) J. Embryol. Exp. Morph. 88:39-54. Copp, A.J. and Bernfield, M. (1988) Devel. Biol. 130:583-590. Copp, A.J., Brook, F.A., and Roberts, J.J. (1988) Development 104:285-295. Gruneberg, J. (1954) J. Genet. 15:52-67. DATED ANNOUNCEMENTS (RFPs AND RFAs) ISOLATION, PURIFICATION, AND CHARACTERIZATION OF ANTIGENS FROM PURIFIED MYCOBACTERIUM LEPRAE OBTAINED FROM ARMADILLO TISSUE RFP AVAILABLE: RFP-NIH-NIAID-MIDP-90-14 P.T. 34; K.W. 0780005, 0710060 National Institute of Allergy and Infectious Diseases The Microbiology and Infectious Diseases Program of the National Institute of Allergy and Infectious Diseases has a requirement for Isolation, Purification, and Characterization of Antigens From Purified Mycobacterium Leprae Obtained from Armadillo Tissues. The successful offeror should have demonstrated adequacy of procedures and plans for maintaining and separation of M. Leprae bacilli from infected armadillo tissues. This NIAID-sponsored project will take approximately five years to complete. One cost-reimbursement contract is anticipated. RFP NIH-NIAID-90-14 will be issued on or about March 24, 1989, with a closing date for receipt of proposals tentatively set for May 15, 1989. To receive a copy of the RFP, please supply this office with two (2) self-addressed mailing labels. All responsible sources may submit a proposal which will be considered by NIAID. Request for the RFP shall be directed: Mr. William C. Roberts National Institute of Allergy and Infectious Diseases Westwood Building, Room 707 5333 Westbard Avenue Bethesda, Maryland 20892 Telephone: (301) 496-2508 This advertisement does not commit the Government to award a contract. DETAILED DRUG EVALUATION AND DEVELOPMENT OF TREATMENT STRATEGIES FOR CHEMOTHERAPEUTIC AGENTS RFP AVAILABLE: NCI-CM-07315-72 P.T. 34; K.W. 0740020, 0755060 National Cancer Institute The Developmental Therapeutics Program, Division of Cancer Treatment (DCT), National Cancer Institute (NCI), is seeking a contractor to evaluate compounds for anticancer activity in experimental in vivo tumor models. Studies will focus on agents identified by the program's disease-oriented, in vitro drug screen and will employ human tumors growing in immuno-deficient (athymic) mice. Experiments will be designed and conducted to optimize drug activity and evaluate the drug's therapeutic potential. Some in vivo studies may involve mouse tumors growing in pathogen-free immune-competent mice and some cell culture support will be required for use of the human tumors. Compounds to be studied will be selected and assigned by the Government. As compounds of a commerically confidential nature (discreet) may be evaluated, pharmaceutical and chemical firms will be excluded from the competition. Also, since structural formulas of discreet materials may be provided by the Government on occasion, the organization must be willing to sign a confidentiality of information sheet. Facilities for handling pathogen-free immune-competent and immune-deficient mice and utilize methods to protect the facilities from pathogenic organisms are required. Additionally, facilities/ equipment are required for: frozen storage of tumors, tumor transplantation, drug preparation, and treatment; the handling of potentially carcinogenic or hazardous materials; and the propagation and testing human tumor lines in vitro. Vol. 18, No. 9, March 17, 1989 - Page 3 One incrementally-funded contract will be awarded for a period of five (5) years, on a "level of effort" basis specifying approximately 95,000 labor hours over five years. The current effort is being performed by Southern Research Institute, Contract No N01-CM-73726. RFP No. NCI CM-07315-72 will be available on or about March 13, 1989. Responses will be due by April 25, 1989. All responsible sources may submit a proposal for consideration by the NCI. Copies of the RFP may be obtained by sending a request to: Ms. Jacqueline Ballard Contracting Officer Representative Treatment Contracts Section Research Contracts Branch, OAM, NCI Executive Plaza South, Room 603 Bethesda, Maryland 20892 Telephone: (301) 496-8620 SPECIALIZED CENTERS OF RESEARCH (SCOR) IN THROMBOSIS RFA AVAILABLE: NIH-89-HL-08-B P.T. 04; K.W. 0715040, 0745020, 0745027, 0745070 National Heart, Lung, and Blood Institute Application Receipt Date: January 22, 1990 The Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, announces the availability of a Request for Applications (RFA) for Specialized Centers of Research (SCOR) in Thrombosis. New applications and applications for renewal of existing programs are invited. Copies of the RFA and Instructions for the Preparation of Applications are currently available from NHLBI staff. The objective of this program is to expedite the development and application of new knowledge essential for improved prevention, diagnosis, and treatment of thrombosis and thromboembolic disorders by focusing resources, facilities, and manpower on the problems of thrombosis and other related derangements of hemostasis. Applications for this program are required to contain both basic and clinical research projects. The requirements and format for applications submitted in response to this announcement and copies of the RFA may be obtained from: Carol H. Letendre, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute National Institutes of Health Federal Building, Room 516 Bethesda, Maryland 20892 Telephone: (301) 496-8966 PROGRAMS OF EXCELLENCE IN ENDOCRINOLOGY RESEARCH RFA AVAILABLE: 89-DK-05 P.T. 34; K.W. 0785050, 0765033, 0745020, 0745070, 0760020, 0765010, 0790000 National Institute of Diabetes and Digestive and Kidney Diseases BACKGROUND Endocrinology represents one of the broadest areas of biomedical research endeavors. Through investigator-initiated research, acquisition of basic knowledge in endocrinology has progressed rapidly. New techniques in molecular and cell biology and immunology are directly relevant to research in endocrinology and will permit further growth of knowledge in this field. Research in endocrinology has led to fundamental new understandings of intra- and inter-cellular communication, of regulation of gene expression, cell growth and metabolism, and of the integration of the endocrine system with the immune and nervous systems. These advances in our understanding of fundamental endocrinology are relevant not only to diseases of the endocrine system but also to cancer, osteoporosis, and cardiovascular, neurologic, immunologic and psychiatric disorders. Vol. 18, No. 9, March 17, 1989 - Page 4 RESEARCH GOALS AND SCOPE The goal of this RFA is to solicit applications for the support of coordinated multi-disciplinary research programs in areas of particular importance to the Endocrinology Research Program of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The long range purpose is to enhance our fundamental knowledge of endocrine processes, and to facilitate application of that knowledge to the study of human physiology and disease. To achieve this goal, program project grants will be awarded for the support of multi-disciplinary research with a specific major objective. Areas of investigation of interest to NIDDK include, but are not limited to: (1) the pathogenesis, diagnosis and therapy of endocrine disorders; (2) thyroid, parathyroid, adrenal, pituitary, endocrine hypothalamic and pineal physiology and pathophysiology; (3) the regulation and integration of endocrine systems; (4) the biosynthesis, processing, secretion, transport and metabolism of hormones and hormone-like agents; (5) mechanisms of hormone action, including hormone binding to receptors, synthesis and regulation of receptors, second messengers, and hormonal regulation of gene expression; (6) growth factors, cytokines, neuropeptides, gastrointestinal peptides, vitamin D, hormones of the immune system, prostaglandins, paracrine and autocrine factors and other substances with hormone-like activity; (7) the structure and function of the hypothalamic releasing hormones as they affect endocrine function; (8) bone active hormones and cytokines and the endocrine control of bone metabolism; (9) endocrine aspects of osteoporosis and of the metabolic bone disease associated with renal failure; (10) endocrine regulation of human growth including the roles of growth factors, somatomedins, somatostatin and GHRH; (11) the regulation of the growth and proliferation of endocrine cells including benign endocrine neoplasia; (12) endocrine aspects of obesity, growth disorders, stress, atherosclerosis, hypertension, cancer and other diseases in which endocrinology plays a major role. MECHANISM OF SUPPORT The administrative and funding mechanism will be the program project award. A Program Project award is for the support of a broadly-based multidisciplinary or multifaceted research program which has a specific major objective or central theme. The regulations and the policies that govern the research grant programs of the Public Health Service will prevail. The award may support: (a) research projects, (b) core functions, and (c) feasibility studies. Collectively, these projects should demonstrate essential elements of unity and interdependence and result in a greater contribution to program goals than if each project were pursued individually. Although this solicitation is included in the funding plans for Fiscal Year 1990 for NIDDK, the award of grants pursuant to this RFA is contingent upon the receipt of appropriated funds for this purpose. The duration of proposed projects may be up to five years. Projects may be extended through competing continuation applications. A program project application may request up to $6.25 million in direct costs over a 5-year period. The NIDDK plans to designate a total of $3.0 million (direct and indirect costs) in FY 1990 contingent on the receipt of highly meritorious applications in response to this solicitation. However, the specific amount to be funded will depend upon the overall merit and scope of applications received. REVIEW PROCEDURES AND CRITERIA All applications responsive to the RFA will be reviewed for scientific and technical merit by an NIDDK initial review group (IRG), which will be convened solely to review these applications. It is not anticipated that site visits will be part of the review process; therefore, each proposal should be complete in itself and should be prepared as if no visit is expected. Following the IRG review, the applications will be reviewed by the National Diabetes and Digestive and Kidney Diseases Advisory Council. METHOD OF APPLYING Applicants should request NIDDK Administrative and Review Guidelines for Program Project Grant Applications. These guidelines contain important additional information on the format of applications and review criteria. Prospective applicants should request the complete text of this RFA and NIDDK's program project guidelines from one of the program administrators indicated below. Vol. 18, No. 9, March 17, 1989 - Page 5 Format for Application: Applications should be submitted on the standard PHS 398 application form available at most institutional business offices or from the Division of Research Grants, NIH, (301) 496-7441. On item 2 of the face page of the application, applicants should enter: RFA: Programs of Excellence in Endocrinology Research and the RFA number, 89-DK-05. The RFA label available in the 9/86 revision of Application Form 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application to the extent that it may not reach the review committee in time for review. Application Procedure: Applications must be received by September 20, 1989; the original and four copies of the application should be sent or delivered to: Application Receipt Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** Two additional copies of the application should be sent to: Review Branch National Institute of Diabetes and Digestive and Kidney Disease Westwood Building, Room 406 Bethesda, Maryland 20892 Timetable: A letter of intent should be submitted no later than June 30, 1989. Applications must be received by September 20, 1989. Any applications received after this date will be considered ineligible for this special solicitation. APPLICATION RECEIPT DATE INITIAL REVIEW COUNCIL REVIEW EARLIEST START Sept. 20, 1989 Feb./Mar. 1990 May 1990 July 1, 1990 Inquiries: Inquiries regarding this announcement, the guidelines for structuring a program project application and method of applying should be directed to the program administrators: Judith A. Fradkin, M.D. Robert A. Tolman, Ph.D. Chief, Endocrinology and Metabolic Director, Endocrinology Diseases Programs Branch Research Program NIDDK NIDDK Westwood Building, Room 603 Westwood Building, Room 605 Bethesda, Maryland 20892 Bethesda, Maryland 20892 Telephone: (301) 496-7791 Telephone: (301) 496-7504 Francisco O. Calvo, Ph.D. Associate Director, Endocrinology Research Program NIDDK Westwood Building, Room 603 Bethesda, Maryland 20892 Telephone: (301) 496-7341 NATIONAL RESEARCH SERVICE AWARD-INSTITUTIONAL GRANTS (T32) RFA AVAILABLE: 89-DE-7 P.T. 44; K.W. 0720005, 0715148, 0785040 National Institute of Dental Research Application Receipt Date: September 10, 1989 AUTHORITY AND PURPOSE Under authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288), the National Institute of Dental Research (NIDR) is Vol. 18, No. 9, March 17, 1989 - Page 6 awarding National Research Service Award (NRSA) institutional grants to eligible institutions to develop or enhance research training opportunties for individuals selected by them who wish to prepare themselves for careers in biomedical and behavioral oral health research. With this Request for Applications (RFA), the NIDR is announcing the next application receipt date for this program and the training areas of special interest to the Institute. The announcement in the July 15, 1988, issue of the NIH Guide for Grants and Contracts, Volume 17, No. 23, contained a complete and detailed description of the new structure and administration of our NRSA institutional grants program. A modified version of that document is available from the NIDR (please see below) and should be used in preparing a response to this RFA. APPLICANT ELIGIBILITY REQUIREMENTS Domestic nonprofit private or public institutions may apply for grants to support research training programs. The applicant institution must have the staff and facilities required for the proposed program. The training program director at the institution will be responsible for the selection and appointment of trainees and for the overall direction of the program. Clinical departments or programs should have a significant relationship with basic scientists that will assure trainees with clinical backgrounds the opportunity to acquire the necessary foundation for future investigative work. REVIEW SCHEDULE The schedule (indicated below) is designed to allow Program Directors time to recruit candidates during the fall of the academic year (1990) for appointments to begin the following summer. Application Initial Review Council Earliest Receipt Date Meeting Meeting Award Date September 10, 1989 February/ May/ August 1990 March 1990 June 1990 ADDITIONAL INFORMATION The NIDR supports training in all the areas of biomedical and behavioral oral health research. However, for this cycle NIDR is interested only in applications proposing training in the basic and clinical sciences pertaining to cariology and periodontology. Application(s) submitted in any other area(s), will be returned as non-responsive to this RFA. The NIDR expects to fund approximately five new and/or renewal institutional training program in response to this RFA. Complete details on the mechanism of the award, application procedure, review criteria, and copies of the RFA may be obtained from: Thomas M. Valega, Ph.D. Special Assistant for Manpower Development and Training National Institute of Dental Research National Institutes of Health Westwood Building, Room 510 Bethesda, Maryland 20892 Telephone: (301) 496-6324 ONGOING PROGRAM ANNOUNCEMENTS INDIVIDUAL MEDICAL INFORMATICS POSTDOCTORAL FELLOWSHIPS P.T. 22; K.W. 1004017, 1004000, 1004008, 1004015 National Library of Medicine Application Receipt Dates: January 10, May 10, September 10 BACKGROUND There is a growing need for qualified, talented investigators, well equipped to address fundamental issues in the use of computers and automated information systems in health care, health professions education, and biomedical research. These investigators will contribute to the growth of science by their studies of knowledge management and by advancing the Vol. 18, No. 9, March 17, 1989 - Page 7 frontiers of the computer sciences for organizing, retrieving, and utilizing health knowledge. Medical informatics, as a discipline with an integral role in academic medicine, will also be enhanced. It is expected that the fellows will become able, cross-disciplinary translators, taking the computer sciences to all of medicine. The recent designation of the National Library of Medicine (NLM) as the National Center for Biotechnology intensifies the Library's interest and responsibilities in a special area of informatics. The appearance of new experimental methods in the past several years has greatly increased the rate at which data are accumulating about the molecular control of life processes. Because of their size and complexity, the data that are generated by such undertakings must be analyzed and compared using computerized techniques for storage, searching, and analysis. The computer databases that hold this information, currently numbered in millions of nucleotide base pairs and thousands of amino acids, are expected to grow by three orders of magnitude to encompass sequences totaling billions of nucleotides. GOALS AND SCOPE The discipline of medical informatics goes beyond the use of the computer as a computational tool and extends into the process of knowledge representation, storage, retrieval, and manipulation largely to support inferential reasoning and to rationalize decision-making in the health sciences. To support these pursuits, the span of relevant disciplines is far ranging. Engineering, computational linguistics, computer science, information science, statistics and cognitive sciences must all be brought to bear in the context of the health sciences to achieve the desired goals. Appropriately trained individuals able to conduct these types of multidisciplinary informatics research are in very short supply. A fellowship program in medical informatics research training will assist in alleviating the shortages. The NLM's Long Range Plan counts medical informatics training and career development among its top priorities. There is a large and growing number of qualified individuals seeking training in this field - a number which exceeds the combined capabilities of currently active institutional training sites. Clearly, other institutions are providing, or can also provide, quality training in medical informatics and a number of these have the requisite institutional environment for training in the special informatics area of biotechnology; i.e., the representation and analysis of molecular biology data by computer. The scope of this announcement is intended to encompass research fellowship applications in medical informatics generally or in the biotechnology category of informatics. MECHANISM OF SUPPORT Individual postdoctoral fellowship applications in medical informatics are welcomed from persons trained in the physical or computer sciences who desire to bring such approaches to medical informatics research or from biologists and physicians who wish to acquire research training in biocomputation, knowledge representation, inferential reasoning or other areas related to informatics. Individuals must be, at the time of application, 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). Before submitting an application, an applicant must arrange for appointment to an appropriate institution and acceptance by a sponsor, who will supervise the training and research experience. The stipend level for the individual postdoctoral fellowship ranges from $17,000 to $31,500 depending on years of relevant experience subsequent to the award of the doctorate degree. In addition, the applicant's institution/organization may request an institutional allowance up to $3,000 per year for support of supplies, equipment, travel, tuition, fees, insurance and other training related costs. Individual postdoctoral fellowships are made for project periods of up to three years. APPLICATION AND REVIEW PROCEDURES Applications must be submitted on Form PHS 416-1 (Rev. 7/88). These forms, with appropriate descriptive information about NLM's Individual Medical Informatics Postdoctoral Fellowship program, may be obtained from: Vol. 18, No. 9, March 17, 1989 - Page 8 Roger W. Dahlen, Ph.D. Chief, Biomedical Information Support Branch Extramural Programs National Library of Medicine Bethesda, Maryland 20894 Telephone: (301) 496-4221 Applications will be accepted in accordance with the usual receipt dates for new fellowship applications: January 10, May 10, September 10. The review process will be completed approximately six months after the respective receipt dates. Applications received too late for one cycle of review will be held until the next receipt date. Applications will be received by the NIH's Division of Research Grants (DRG) and referred to the Biomedical Library Review Committee for scientific and technical merit review. The review criteria customarily employed by the NIH for fellowship applications will prevail. The original and two (2) copies of the application should be directed to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** NOTE: Please type the following information in Item 3, page 1, the face page of the application form: "Medical Informatics (NLM)." This program is described in the Catalog of Federal Domestic Assistance, Medical Library Assistance, 13.879. Grants will be awarded under the authority of the Public Health Act, Section 472 (42 USC 286b-3) and administered under PHS grant policies and Federal Regulations, most specifically at 42 CFR 61. NATIONAL RESEARCH SERVICE AWARDS FOR PREDOCTORAL M.D./PH.D. FELLOWS P.T. 22; K.W. 0404003, 0404009, 0715095, 0715129, 0404000 National Institute of Mental Health National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) provides National Research Service Awards (NRSAs) to individuals for research training in specified areas of biomedical and behavioral research. The purpose of the NRSA for Predoctoral M.D./Ph.D. Fellows is to help ensure that highly trained physicians/scientists will be available in adequate numbers and in appropriate research areas to meet the Nation's alcohol, drug abuse, and mental health needs. An applicant for an ADAMHA NRSA M.D./Ph.D. individual fellowship must show evidence of high academic performance and evidence of significant interest in research. He or she must be enrolled in an M.D./Ph.D. program at an approved medical school, accepted in a related scientific Ph.D. program, and supervised by a mentor in the scientific discipline when the application is submitted. The ADAMHA NRSA M.D./Ph.D. fellowship program provides combined medical school and predoctoral Ph.D. support for a maximum of 6 years. The annual stipend for predoctoral fellows at all levels is $8,500. ADAMHA expects to begin support of up to 15 of these fellowships in 1990, 20 in 1991, and 25 in 1992. Approximately $375,000 will be set aside for this purpose in 1990, $875,000 in 1991, and $1,500,000 in 1992. Applications in response to this announcement will be accepted and reviewed once each year according to the following schedule: Receipt Date--September 10 Initial Review Group Meeting--February Notification--March to June Earliest Possible Start Date--July 1 Potential applicants interested in obtaining further information should contact one of the following: Vol. 18, No. 9, March 17, 1989 - Page 9 National Institute of Mental Health Leonard Lash, Ph.D. Division of Clinical Research Room 10-99 Telephone: (301) 443-3264 National Institute on Alcohol Abuse and Alcoholism David B. Lozovsky, M.D., Ph.D. Division of Basic Research Room 14C-20 Telephone: (301) 443-4223 Elsie Taylor Division of Clinical and Prevention Research Room 16C-03 Telephone: (301) 443-1677 National Institute on Drug Abuse Charles Sharp Division of Preclinical Research Room 10A-31 Telephone: (301) 443-6300 The mailing address for all of the above is: Parklawn Building 5600 Fishers Lane Rockville, Maryland 20857 **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, Maryland 20816 Vol. 18, No. 9, March 17, 1989 - Page 10 FULL TEXT OF RFAs FOR ONLINE ACCESS REQUEST FOR RESEARCH GRANT APPLICATIONS (RFA) NIH-89-HL-08-B P.T. 04; K.W. 0715040, 0745020, 0745027, 0745070 SPECIALIZED CENTERS OF RESEARCH (SCOR) IN THROMBOSIS NATIONAL HEART, LUNG, AND BLOOD INSTITUTE Application Receipt Date: January 22, 1990 INTRODUCTION The Division of Blood Diseases and Resources (DBDR) of the National Heart, Lung, and Blood Institute (NHLBI) invites new and renewal applications for grant to support Specialized Centers of Research (SCORs) in Thrombosis. The objective of this SCOR program is to expedite the development and application of new knowledge essential for improved prevention, diagnosis, and treatment of thrombosis and thromboembolic disorders. This objective will be accomplished by focusing resources, facilities, and manpower on the problems of thrombosis and related hemostatic mechanisms. The SCORs to be established as a result of this solicitation are intended to create an environment in which basic and clinical investigators can collaborate to elucidate the pathophysiology of disease processes and to develop improved methods for the diagnosis, treatment and prevention of thrombosis and thromboembolic disorders. DISCIPLINES AND EXPERTISE This request for grant applications will be of interest to groups engaged in research in thrombosis and hemostasis. The multidisciplinary teams comprising a SCOR in thrombosis may include investigators with basic, clinical, or applied expertise in hematology, molecular and cellular biology, biochemistry, immunology, genetics, physiology, pathology and related disciplines. BACKGROUND It is now recognized that thromboembolic disorders are commonly associated with a wide variety of diseases. As such, their incidence is difficult to assess and may be grossly underestimated. It has been suggested that thrombosis is the leading cause of serious acute morbidity and mortality in the aging population of the nation. It has only been in the past decade that advances in angiography and imaging techniques have clarified the role of thrombosis in myocardial infarction. The contribution of thrombosis to sudden coronary death has been even more difficult to document; however, in 1984, careful studies by Davis and Thomas demonstrated the thrombotic origin of sudden coronary death. Studies such as these now leave little doubt that thrombogenesis contributes to nearly all sudden deaths that are due to coronary artery disease. The importance of thrombosis to these major diseases provides additional urgency to the need to foster basic and clinical research. In 1986, cardiovascular disease was directly responsible for 979,000 deaths in the United States, accounting for nearly one of every two deaths. The economic cost of cardiovascular disease in 1985 was an estimated $119 billion, including $57 billion in direct health expenditures, $14 billion in indirect cost of morbidity, and $48 billion in indirect cost of mortality. It has been estimated (NHLBI Fact Book, 1987) that 73 percent of cardiovascular disease is due to atherosclerosis in which thrombosis is usually the final event. In addition, 286,000 deaths in 1986 were directly attributable to blood clotting disorders. These include phlebitis and thrombophlebitis, pulmonary embolism, and other venous and arterial thromboses and emboli. Such disorders cost the Nation's economy $34 billion in 1985. As impressive as these figures are, it is important to acknowledge that our ability to prevent, detect, and treat these diseases has also improved dramatically. This is evidenced by the fact that 77 percent of the decline in total mortality between 1966 and 1986, was due to declines in the death rates for cardiovascular disease. These statistics, combined with the strong and consistent research productivity of the Thrombosis SCORs since their inception, as well as the new frontiers of research related to the role of thrombosis in coronary artery disease and sudden death, provide the background for this announcement of the renewal of the Thrombosis SCOR program. The investigators and institutions associated with the Thrombosis SCORs have participated in establishing a foundation of basic knowledge of the pathogenesis, diagnosis, and treatment of thrombosis as well as the hemostatic system overall and its relation to other biological processes. Continued major contributions to basic and clinical thrombosis research are anticipated through the SCOR program. OBJECTIVES AND SCOPE The overall objective of this program is to develop and maintain Specialized Centers of Research (SCOR) in Thrombosis. These Centers should have strong investigative programs, an interest in transferring results from fundamental research in the biological and engineering sciences into clinical evaluation and application activities, and the goal of increasing our understanding of hemostasis and the thrombotic process. In addition to their research productivity, SCOR programs have proven to be productive in terms of training investigators in advanced concepts of thrombosis research. It is, thus, expected that an applicant institution will be able to show evidence of an environment conducive to the attraction and development of young investigators and of investigators with expertise in other related areas. Such factors as other research programs complementary to the thrombosis area, availability of institutional training programs, and training history of the SCOR Director and scientific staff are important enrichments to the SCOR environment. SCOR programs at the NHLBI support a full range of research and development activities, from basic to clinical. The proposed program must include both fundamental and clinical research and provide for a mutually supportive interaction among basic scientists, statisticians, epidemiologists, bioengineers or other scientists, and clinicians. By creating an environment in which these various groups of scientists can interact, exchange ideas, and become aware of problems within the field of thrombosis, research in this important area can proceed expeditiously. This competition for SCORs is open to all interested investigators, those presently involved as well as new groups with the requisite capabilities. AREAS OF OPPORTUNITY Although the accomplishments have been significant, there remain many unresolved problems in thrombosis research. The following brief discussion is intended to offer a few examples of such research and to emphasize the importance of employing a wide spectrum of basic and clinical research approaches to the resolution of important problems. o Areas that need further attention and that would profit from study in a Thrombosis SCOR environment have been identified by members of the thrombosis community including Advisory Committee members, SCOR Directors and staff. These include a major focus on the platelet including the megakaryocyte, receptors, inhibition and regulation, cloning of platelet proteins, studies of contractile proteins, and qualitative platelet defects. Studies on proteases and their inhibitors would be important as would studies of cytoadhesins and such substances as endothelial derived relaxing factors and effect on platelet function. Awareness is increasing of the influence of rheologic factors upon the structure and localization of thrombi. Many questions concerning the effect of blood flow on the behavior of the platelet, and the ultimate progression to atherosclerosis and/or thrombosis remain to be addressed. o Widespread use of thrombolytic therapy has pinpointed our lack of knowledge of the thromboselectivity of thrombolytic agents, in-depth understanding of mechanisms of bleeding complications and restenosis. A growing need exists to understand the biochemistry of fibrinolysis and to apply this knowledge to the development of indicators of thrombotic disease and efficacy of thrombolytic therapy. The platelet is emerging as the focus in thromboresistance to lytic therapy. What is the role of platelet activation and antiplatelet therapy in improving the efficacy of thrombolytic agents? These would seem to be ideal topics for study under the SCOR mechanism which provides the bridge to clinical application in its structure. o The advances of molecular biology have allowed us to define the protein structure and the biochemistry of the coagulation and fibrinolytic systems in great detail. Techniques such as NMR and x-ray crystallography can now be applied to provide further information about structural biology of clotting proteins. The design of new families of thrombolytic agents through genetic engineering can now begin to be explored. o The explosion in cell biology, most notably cell biology of the endothelial surface, puts us at the threshold of the ability to modulate thrombotic and fibrinolytic pathways. The SCOR setting would be ideal for further research in this area and its immediate translation to increased clinical capabilities. A SCOR application should consist of a cluster of scientifically meritorious projects each focused on a central theme. It may include one or more CORE resource units which perform specialized services shared by several or all investigators, one such CORE resource unit being administrative through which the SCOR Director is responsible for the organization and operation of the SCOR and for all communication with NHLBI on scientific and operational matters. Staff of the NHLBI are in frequent communication with SCOR Directors and formally review progress at yearly intervals. Each SCOR must have a mechanism for both internal and external review of its existing and proposed programs. Each SCOR Director should encourage and support close collaboration between individual project investigators by means of frequent meetings and seminars. Informal collaboration and communication among SCOR Directors and research personnel are encouraged. Annual meetings of SCOR Directors and project directors are planned to provide a forum for the complete exchange of information. Applicants should plan for such an annual meeting to be held in Bethesda. ELIGIBILITY CRITERIA In addition to the standard criteria defining eligibility for Public Health Service grants, the applicant organization must be, or must be associated with a major medical institution. Applicants must provide evidence of an established and continuing base of peer-reviewed projects or activities relevant to thrombosis and hemostasis. All elements of a program must include and be subjected to stringent, critical evaluative procedures. Universities and medical schools, hospitals and public or private research institutions, alone or in combination, with appropriate research and clinical capabilities to meet the objectives of this SCOR program are encouraged to apply for SCOR grants. EXCLUSIONS No support will be provided under the SCOR funding mechanism for large clinical trials or for programs containing exclusively clinical or exclusively basic studies. While the development of new instrumentation may be part of the SCOR, support for development alone will not be provided. Institute staff should be consulted if an applicant plans to request funds to purchase and install expensive new equipment. The fourth competition for the Thrombosis SCOR program, announced in June 1984, provided the opportunity for the Thrombosis SCORs to extend the results of basic and clinical research to the community by integrating demonstration and education research and competing as National Demonstration and Research Centers (NRDC). This option will not be available for this present competition. Investigators interested in pursuing demonstration and education research in the research area of the SCOR are requested to telephone the program administrator listed below under "Inquiries" to discuss options. MECHANISM OF SUPPORT The mechanism of support will be the grant-in-aid for a period of five years commencing on May 1, 1991. However, it will differ from other research grants in the expected communication among SCORs and with the NHLBI. Applicants are expected to furnish their own estimates of the time required to achieve specific objectives of the proposed work, a schedule for completion of the work, and an outline of the segments into which the proposed program can be logically divided. The SCOR will plan, direct and execute its own research program, but any substantial modifications in the scope or objectives must be mutually agreed upon by the SCOR institution and the NHLBI. Although this solicitation is included in the plans for Fiscal Year 1991, support of grants pursuant to this request for applications is contingent upon ultimate receipt of appropriated funds for this purpose. The level of funding of the SCOR program will be influenced by the amount of funds available to the Division, by the overall merit of proposals, and by their relevance to the program objectives. The NHLBI plans to designate for Fiscal Year 1991 the sum of $7,000,000 in total costs annually for the SCOR program in Thrombosis. A variety of approaches will be responsive to this solicitation. It is anticipated that there will be a range of costs among individual grants awarded. Unless specifically stated otherwise, all policies and requirements that govern the grant programs of the Public Health Service will prevail. CHARACTERISTICS OF A SCOR Description A Specialized Center of Research is an identifiable unit within a sponsoring institution. Each SCOR conducts its own research program based on local interest and capabilities. The SCOR will circumscribe specific, identifiable research objectives, provided that the resultant combination can be shown to be related directly to the SCOR's primary theme. The relationship among research objectives and projects and the SCOR's theme will be given considerable attention during review of the applications. The participating staff must consist of scientists of recognized ability, capable of conducting independent research, and willing to make a long- term commitment to the goals of the SCOR. The Center staff should have access to facilities where sophisticated clinical investigations can be conducted. The SCOR program must include related experimental or basic research that is logically integrated into the SCOR program. Clinical projects relating to diagnosis, treatment, or prevention, or special laboratories capable of performing specialized assays or tests as they may be developed in more basic projects, are an essential part of the overall program. The SCOR grant may also include core resources, for which funds may be requested. Core resources include centralized administration and shared specialized equipment and services, such as tissue culture, protein purification, electron microscopy, or monoclonal antibody capabilities. Facilities must be available for the primary needs of the SCOR and should require no more than moderate modification since funds for new construction are not available. The applicant institution must be willing to make a long-term commitment of these physical resources and the staff necessary for development and operation of the SCOR. Facilities, resources, and enhancement of the environment to be provided by the applicant institution will be an important aspect of the review of the adequacy of facilities and environment. SCOR Director The SCOR director must provide strong, effective administrative and scientific leadership. The Director is responsible for the organization and operation of the center and for communications with the NHLBI on all scientific and operational matters. The SCOR Director is responsible for maintaining high quality research throughout the 5-year funding period. The SCOR Director must encourage and support close collaboration among individual SCOR investigators by means of frequent seminars and scientific meetings. A SCOR Director must establish both internal and external advisory committees which will periodically assess the overall program as well as progress of individual projects. The external advisory committee must consist of expert consultants from outside the grantee institution and must meet annually. The NHLBI program administrator may attend these meetings as an observer. Interactions Among SCORs An active collaboration among the SCORs is one of the most important concepts of the SCOR program. To accomplish this goal, directors of the Thrombosis SCORs will meet at least once a year to review progress, discuss common interests and problems, and plan collaborative efforts. In addition, periodic meetings dealing with specific research areas may be arranged for key SCOR staff, the program officer, other NHLBI representatives, and invited investigators having mutual scientific interests. To facilitate collaboration, the program administrator for the SCOR will serve to coordinate plans for any special activities of mutual interest to the Institute and the SCOR. The program administrator will make periodic visits to the Centers and will be responsible for evaluating progress, and will provide assistance in any administrative considerations. Interim evaluations may also be conducted by the Division of Blood Diseases and Resources using ad hoc reviewers to assist in making recommendations and long-term plans for the program. The SCORs will also be encouraged to hold workshops on topics of mutual interest to SCOR grantees. The workshops, although planned by the SCOR Staff, will provide an opportunity to invite other scientists performing research relevant to SCOR activities. The impetus for a workshop could come from either a SCOR or the NHLBI. REVIEW PROCEDURES AND CRITERIA Applications for the SCOR will be reviewed and evaluated in a single national competition. The initial phase of peer review will be conducted by a group of predominantly non-federal consultants and may involve a site visit. A second level of review will be performed by the National Heart, Lung and Blood Advisory Council. The major factors to be considered in the evaluation of applications will include: 1. the qualifications, experience, and commitment of the SCOR Director and the ability to devote adequate time and effort to provide effective leadership; 2. the scientific merit of each proposed project, including the originality, and feasibility of the approach and the adequacy of the experimental design; 3. the technical merit and justification of each core unit; 4. the competence of the investigators to accomplish the proposed research goals, their commitment, and the time they will devote to the program; 5. the integration of the various components into an effective SCOR and the adequacy of plans for interaction among investigators; 6. the adequacy of facilities to perform the proposed research including the laboratory and clinical facilities, access to subjects, instrumentation, and data management systems when needed; 7. the scientific and administrative structure of the program, including adequate internal and external arrangements and procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; 8. the institutional commitment to the program as evidenced by provision of resources, and the appropriateness of the institutional resources and policies for the administration of a research program of the type proposed; and 9. the appropriateness of the budget for the proposed program. METHOD OF APPLYING Letter of intent To facilitate Institute planning, applicants are requested to submit a letter of intent to the NHLBI on or before November 13, 1989. The letter should include a descriptive title, investigators who might be involved, and any participants outside the applicant institution. The Institute requests such letters only for planning purposes and to obtain an indication of the number and scope of applications to be received. A letter of intent is not binding, will not enter into the review of any proposal subsequently submitted, and is not a necessary requirement for application. The Letter of Intent should be addressed to: Dr. Charles L. Turbyfill Division of Extramural Affairs National Heart, Lung, and Blood Institute, NIH Westwood Building, Room 553 Bethesda, Maryland 20892 Format for Applications Submit applications on Form PHS 398 (revised 9/86), the same for used for the traditional research-project grant. This form is available in an applicant institution's office of sponsored research (or business office). On line 2 of the application face page, type in the title of this RFA, "Specialized Centers of Research (SCOR) in Thrombosis," and the RFA number 89-HL-08-B. SPECIAL INSTRUCTIONS FOR THE PREPARATION OF GRANT APPLICATIONS FOR A SPECIALIZED CENTER OF RESEARCH ARE AVAILABLE. PROSPECTIVE APPLICANTS SHOULD CONTACT THE OFFICE LISTED BELOW UNDER "INQUIRIES" TO OBTAIN A COPY OF THE GUIDELINES AND INSTRUCTIONS. Application Procedure Send or deliver the completed application and four (4) signed, exact photocopies of it on or before January 22, 1990 to: Division of Research Grants Westwood Building, Room 240 National Institutes of Health Bethesda, Maryland 20892** AT THE SAME TIME, SEND AN ADDITIONAL TWO (2) COPIES OF THE APPLICATION TO DR. CHARLES L. TURBYFILL AT THE ADDRESS UNDER LETTER OF INTENT. THE NHLBI CANNOT GUARANTEE THAT THE APPLICATION WILL BE REVIEWED IN COMPETITION FOR THIS RFA UNLESS THESE TWO COPIES ARE ALSO RECEIVED ON OR BEFORE JANUARY 22, 1990. THE RFA LABEL (AVAILABLE IN THE 9/86 REVISION OF APPLICATION FORM 398) MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE OF THE ORIGINAL COPY OF THE APPLICATION. FAILURE TO USE THIS LABEL COULD RESULT IN DELAYED PROCESSING OF YOUR APPLICATION. Timetable Letter of Intent November 13, 1989 Receipt of Applications January 22, 1990 Advisory Council Review October 1990 Awards May 1, 1991 Inquiries Prospective applicants may wish to discuss their potential programs or to seek clarification of this announcement and the special instructions for preparation of applications. Information may be obtained as listed below: Dr. Carol H. Letendre Associate Director for Scientific Programs Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute National Institutes of Health Federal Building, Room 516 Bethesda, Maryland 20892 Telephone: (301) 496-8966 PROGRAMS OF EXCELLENCE IN ENDOCRINOLOGY RESEARCH RFA AVAILABLE: RFA-89-DK-05 P.T. 34; K.W. 0785050, 0765033, 0745020, 0745070, 0760020, 0765010, 0790000 National Institute of Diabetes and Digestive and Kidney Diseases APPLICATION RECEIPT DATE: September 20, 1989 BACKGROUND The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications from interested institutions for Programs of Excellence in Endocrinology Research. Endocrinology represents one of the broadest areas of biomedical research endeavor. Through investigator-initiated research, acquisition of basic knowledge in endocrinology has progressed rapidly. New techniques in molecular and cell biology and immunology are directly relevant to research in endocrinology and will permit further growth of knowledge in this field. Research in endocrinology has led to fundamental new understandings of intra- and inter-cellular communication, of regulation of gene expression, cell growth and metabolism, and of the integration of the endocrine system with the immune and nervous systems. These advances in our understanding of fundamental endocrinology are relevant not only to diseases of the endocrine system but also to cancer, osteoporosis, and cardiovascular, neurologic, immunologic and psychiatric disorders. NIDDK seeks to complement the Institute's ongoing research program in endocrinology, comprised largely of individual research projects oriented toward fundamental research, with multi-disciplinary research projects directed at elucidating basic endocrine processes and their regulation and/or at applying advances in fundamental knowledge to understanding of human physiology and pathophysiology, and ultimately to clinical practice. RESEARCH GOALS AND SCOPE The goal of this RFA is to solicit applications for the support of coordinated multi-disciplinary research programs in areas of particular importance to the Endocrinology Research Program of NIDDK. The long range purpose is to enhance our fundamental knowledge of endocrine processes, and to facilitate application of that knowledge to the study of human physiology and disease. To achieve this goal, program project grants will be awarded for the support of multi-disciplinary research with a specific major objective. Areas of investigation of interest to NIDDK include, but are not limited to: (1) the pathogenesis, diagnosis and therapy of endocrine disorders; (2) thyroid, parathyroid, adrenal, pituitary, endocrine hypothalamic and pineal physiology and pathophysiology; (3) the regulation and integration of endocrine systems; (4) the biosynthesis, processing, secretion, transport and metabolism of hormones and hormone-like agents; (5) mechanisms of hormone action, including hormone binding to receptors, synthesis and regulation of receptors, second messengers, and hormonal regulation of gene expression; (6) growth factors, cytokines, neuropeptides, gastrointestinal peptides, vitamin D, hormones of the immune system, prostaglandins, paracrine and autocrine factors and other substances with hormone-like activity; (7) the structure and function of the hypothalamic releasing hormones as they affect endocrine function; (8) bone active hormones and cytokines and the endocrine control of bone metabolism; (9) endocrine aspects of osteoporosis and of the metabolic bone disease associated with renal failure; (10) endocrine regulation of human growth including the roles of growth factors, somatomedins, somatostatin and GHRH; (11) the regulation of the growth and proliferation of endocrine cells including benign endocrine neoplasia; (12) endocrine aspects of obesity, growth disorders, stress, atherosclerosis, hypertension, cancer and other diseases in which endocrinology plays a major role. MECHANISM OF SUPPORT The administrative and funding mechanism will be the program project award. The regulations and the policies that govern the research grant programs of the Public Health Service will prevail. The award may support: (a) research projects, (b) core functions, and (c) feasibility studies. A Research Program Project award is for the support of a broadly based multidisciplinary or multifaceted research program that has a specific major objective or central theme. It is directed toward a range of problems having a central research focus in contrast to the usually narrower thrust of the traditional research project. The Program Project generally involves the organized efforts of relatively large groups, whose members are conducting research projects designed to elucidate the various aspects or components of the central theme. Each research project is usually under the leadership of a different experienced investigator and should contribute or be directly related to the common theme of the total research effort. Collectively these projects should demonstrate essential elements of unity and interdependence and result in a greater contribution to program goals than if each project were pursued individually. It is expected that most of the collaborative scientists will be independent investigators. Thus, support of one senior investigator and several postdoctoral or research associate level scientists is not appropriate. The Program Project grant is not intended to be a vehicle for departmental research support, and in most cases, investigators from more than one department will be represented. A Program Project application must contain a minimum of three approved meritorious research projects. Each individual research project must both stand on its own scientific merit and complement other projects. Thus, a project regarded as highly meritorious in isolation might be recommended for deletion from the program if it is seen as being totally independent from the program as a whole. Separate cores are not a mandatory component, but prior experience has shown them to be useful and economical. A core is defined as a separately budgeted component of the program project that provides essential facilities or services to two or more of the proposed research projects. Examples of core functions include biostatistical, design and data processing support; central laboratory facilities; cell and tissue culture facilities; animal resources; recruiting and clinical screening of a research subject pool; and administration. Each application may propose to support up to three feasibility studies per year. Each feasibility study may not exceed $20,000 annually in cost and two years in duration. If the program project includes feasibility studies, a procedure for soliciting, reviewing and monitoring the feasibility studies must also be proposed. Applicants are strongly encouraged to provide research training opportunities for students and junior investigators. Institutions for which this is not possible should include an explanation for the inability to provide research training oportunities. Although this solicitation is included in the funding plans for Fiscal Year 1990 for NIDDK, the award of grants pursuant to this RFA is contingent upon the receipt of appropriated funds for this purpose. The duration of proposed projects may be up to five years. Projects may be extended through competing continuation applications. A program project application may request up to $6.25 million in direct costs over a 5- year period. The NIDDK plans to designate a total of $3.0 million (direct and indirect costs) in FY 1990 for support of applications submitted in response to this solicitation; however, the specific amount to be funded will depend upon the overall merit and scope of applications received. REVIEW PROCEDURES AND CRITERIA Upon receipt, applications will be reviewed by staff for their responsiveness to the objectives of this RFA. If an application is considered unresponsive, the applicant will be contacted and given an opportunity to withdraw the application or to have it considered for the regular grant program of the NIH. All applications responding to the RFA will be reviewed for scientific and technical merit by an NIDDK initial review group (IRG), which will be convened solely to review these applications. It is not anticipated that site visits will be part of the review process; therefore, each application should be complete in itself and should be prepared as if no visit is expected. Factors to be considered in the evaluation of the scientific merit of each application will be those used in the review of traditional research-project grant applications: the novelty, originality and feasibility of the approach; the training, experience and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; and the appropriateness of the requested budget to the work proposed. Following the IRG review, the applications will be reviewed by the National Diabetes and Digestive and Kidney Diseases Advisory Council for program relevance, significance and policy issues. METHOD OF APPLYING NIDDK Program Project Guidelines: Applicants should request NIDDK Administrative and Review Guidelines for Program Project Grant Applications. These guidelines contain important additional information on the format of applications and review criteria. Letter of Intent: Prospective applicants are encouraged to contact one of the program administrators indicated below. A letter of intent is not mandatory and does not influence the review or funding decisions, but it will enable the NIDDK to plan the review. It will also ensure that each potential applicant receives important supplemental information prior to expending considerable effort in application preparation. Format for Application: Applications should be submitted on the standard PHS 398 application form available at most institutional business offices or from the Division of Research Grants, NIH, 301/496-7441. On item 2 of the face page of the application, applicants should enter: RFA: Programs of Excellence in Endocrinology Research and the RFA number, 89-DK-05. The RFA label available in the 9/86 revision of Application Form 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application to the extent that it may not reach the review committee in time for review. Application Procedure: Applications must be received by September 20, 1989; the original and four copies of the application should be sent or delivered to: Application Receipt Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two additional copies of the application should be sent to: Review Branch National Institute of Diabetes and Digestive and Kidney Disease Westwood Building, Room 406 Bethesda, MD 20892 Timetable: A letter of intent should be submitted no later than June 30, 1989. Applications must be received by September 20, 1989. Any applications received after this date will be considered ineligible for this special solicitation. APPLICATION RECEIPT DATE INITIAL REVIEW COUNCIL REVIEW EARLIEST START DATE Sept. 20, 1989 Feb./Mar. 1990 May 1990 July 1, 1990 Inquiries: Inquiries regarding this announcement, the guidelines for structuring a program project application and method of applying should be directed to the program administrators: Judith A. Fradkin, M.D. Robert A. Tolman, Ph.D. Chief, Endocrinology and Metabolic Director, Endocrinology Diseases Programs Branch Research Program NIDDK NIDDK Westwood Building, Room 603 Westwood Building, Room 605 Bethesda, MD 20892 Bethesda, MD 20892 301/496-7791 301/496-7504 Francisco O. Calvo, Ph.D. Associate Director, Endocrinology Research Program NIDDK Westwood Building, Room 603 Bethesda, MD 20892 301/496-7341 NATIONAL RESEARCH SERVICE AWARD-INSTITUTIONAL GRANTS (T32) POLICY AND GUIDELINES RFA AVAILABLE: 89-DE-7 P.T. 44; K.W. 0720005, 0715148, 0785040 NATIONAL INSTITUTE OF DENTAL RESEARCH Application Receipt Date: September 10th of each year AUTHORITY AND PURPOSE Under authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288), the National Institute of Dental Research (NIDR) awards National Research Service Award (NRSA) institutional grants to eligible institutions to develop or enhance research training opportunities for individuals selected by them who wish to prepare themselves for careers in biomedical and behavioral oral health research. These Guidelines announce significant changes in both the structure and the administration of its NRSA institutional program. These changes have been endorsed by the National Advisory Dental Research Council and by the Dental Research Programs Advisory Committee. This publication contains a description of the new policies and procedures. Although the NIDR supports training in all areas of biomedical and behavioral oral health research, we intend to issue an RFA annually (each winter/spring) in the NIH Guide for Grants and Contracts to indicate the particular area(s) of emphasis. Application(s) submitted in any other program area(s) will be returned as non-responsive to that particular RFA in that particular year. The purpose of the NRSA program is to help ensure that highly trained scientific manpower will be available in adequate numbers and in the appropriate research areas and fields to maintain the nation's biomedical and behavioral oral health research agenda. Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program as are the following Catalog of Federal Domestic Assistance numbers: 13.840, 13.841, 13.842, 13.843, 13.844, 13.845, and 13.878. LEVELS OF TRAINING Applications will be accepted for research training at the predoctoral level and specialized basic science or clinical science training at the postdoctoral level. Research training grants are a desirable mechanism for the postdoctoral training of dentists whose doctoral training usually involves only limited research experience. Since recent NIDR data indicate that dentists with a Ph.D. degree are more successful in obtaining NIH research support than investigators with either degree alone, the NIDR is requesting that applicants for institutional grants propose training programs in which the training is part of a research degree program. Priority will be given to programs that offer dentists the opportunity of obtaining a Ph.D. degree. However, in certain cases, proposals offering training as part of a master's degree program will also be acceptable. Preapplication consultation with NIDR is highly desirable. APPLICANT ELIGIBILITY REQUIREMENTS Domestic nonprofit private or public institutions may apply for grants to support research training programs. The applicant institution must have the staff and facilities required for the proposed program. The training program director at the institution will be responsible for the selection and appointment of trainees and for the overall direction of the program. The training program must provide opportunities for individuals to carry out supervised biomedical or behavioral oral health research. Clinical departments or programs should have a significant relationship with basic scientists that will assure trainees with clinical backgrounds the opportunity to acquire the necessary foundation for future investigative work. GENERAL PROVISIONS NRSAs may not be used to support studies leading to the D.D.S. or other similar professional degrees, or to support residencies, which means postgraduate training for dentists providing health care directly to patients where the majority of their time is spent in non-research clinical training. However, if a specified period of full-time research training is creditable toward specialty board certification, the NRSA may support such research training if the trainee has shown a clear interest in a research career. Since dentists usually have had little or no prior research training, their training program must have, as a minimum, two years of basic research training. Research trainees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to such efforts. Research trainees in clinical areas are expected to devote their time to the proposed research training and to confine clinical duties to those which are a necessary part of the research training. TRAINEE ELIGIBILITY REQUIREMENTS The individual to be trained must be a citizen or a non- citizen national of the United States or have been lawfully admitted for permanent residence (i.e., in possession of the Alien Registration Receipt Card I-551 or I-151) at the time of appointment. Individuals on temporary or student visas are not eligible. Predoctoral trainees must have received a baccalaureate degree as of the beginning date of their NRSA appointment, and must be enrolled in a graduate program leading to the award of a doctor of philosophy of science or equivalent degree in biomedical or behavioral oral health research. Individuals who wish to interrupt their dental school studies for a year or more to engage in full-time research training before completing their professional degrees are eligible; however, prior approval by the NIDR is required before their NRSA appointment is offered. Postdoctoral individuals must have received, as of the beginning of the NRSA appointment, a D.D.S., D.M.D., or equivalent dental degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree granting institution that all degree requirements have been met is acceptable. Individuals with a research doctoral degree (Ph.D. or equivalent) are expected to apply for the individual postdoctoral NRSA fellowship award (F32). As a rule, they should not be appointed to the traditional institutional training grant (T32). RECRUITMENT AND APPOINTMENT OF MINORITY TRAINEES The primary objective of this NRSA program is the preparation of qualified individuals for careers in biomedical and behavioral oral health research. Within the framework of the program's longstanding commitment to excellence and projected needs for investigators in particular areas of dental research, it is important that attention be given to recruiting individuals from minority groups that now are underrepresented nationally in these sciences. Information on plans for the recruitment of trainees should include a description of steps to be taken for the recruitment of individuals from underrepresented minority groups. Renewal applications should include cumulative information on the subsequent career development of all trainees, including information about their minority status. PAYBACK PROVISIONS Trainees must sign an agreement that they will fulfill the NRSA payback requirements. Recipients must agree to engage in biomedical or health-related behavioral research and/or teaching for a period equal to the period of NRSA support in excess of 12 months. Recipients must undertake the obligated service on a continuous basis within 2 years after termination of NRSA support. Individuals who fail to fulfill their obligation through service must pay back the total amount of NRSA funds paid to the individual for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period for starting service or for repayment, permit breaks in service, or otherwise waive or suspend the payback obligation of an individual. Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the service requirements and explain them to prospective training candidates before an appointment at the institution is offered. PROGRAM STRUCTURE An applicant may request as many postdoctoral or predoctoral trainee positions as the proposed program can accommodate. However, training programs with fewer than five positions for postdoctoral trainees over the five year period will not be funded. The program should be structured in such a way that acceptance of new postdoctoral trainees be limited to the first three years of the five year award, i.e., as a minimum, two trainees the first year, another two the second year, and one the third year. A similar pattern is to be proposed by applicants requesting more than five positions. Ultimately, the number of positions awarded will be decided by the review process, program needs, and availability of funds. The NIDR will not fund more than one training grant from the same institution unless distinctly different training programs are proposed. STIPENDS AND OTHER TRAINING COSTS For predoctoral individuals at all levels of experience, the stipend level will be $8,500 per annum effective October 1, 1988. For postdoctorals, the stipend for the first year of support is determined by the number of years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical practice, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. The stipend for each additional year of NRSA support is the next level on the stipend scale. Postdoctoral stipends, effective October 1, 1988, will be as follows: Years of Relevant Experiences Stipend 0 $17,000 1 18,000 2 25,000 3 26,250 4 27,500 5 28,750 6 30,000 7 or more 31,500 NRSA stipends may be supplemented by an institution from non- Federal funds. 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 V.A. benefits when permitted by those programs. Under no circumstance may the condition of stipend supplementation detract from or prolong the training. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Degree candidates who, prior to the enactment of Public Law 99-514, were able to exclude all monies received under an NRSA award from their reported income, may now exclude only course tuition, fees, books, supplies and equipment required for attendance. Non-degree candidates, who formerly were able to exclude from stipends $300 a month for a period not to exceed 3 years, will now be required to report all stipends and any monies paid on their behalf for course tuition and fees required for attendance. These new statutory requirements went into force as of January 1, 1987. NIH is not in a position to advise students or institutions about their tax liability. In any event, changes in the taxability of stipends in no way alter the relationship between NRSA fellows, trainees and institutions. NRSA stipends are not now, and never have been, salaries. Trainees supported under the NRSA are not in any employer- employee relationship with NIH or the institution in which they are pursuing research training. Tuition and fees, including medical insurance, are allowable trainee costs if such charges are required of all persons in a similar training status at the institution, without regard to their source of support. Tuition at the postdoctoral level, if justifiable, is limited to that required for specific courses in support of the approved training program. Annual increments in tuition costs beyond the first year of a multi-year award (generally five years) may not exceed six percent. Trainee travel, including attendance at scientific meetings, which the institution determines to be necessary to the individual's training, is an allowable trainee cost. Institutional costs of $1,500 per year per predoctoral trainee and $2,500 per year per postdoctoral trainee may be requested to defray the cost of other training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Also, an indirect cost allowance based on 8 percent of total allowable direct costs, or actual indirect costs, whichever is less, may be requested. Applications from State and local government agencies may request full indirect cost reimbursement. PERIOD OF SUPPORT Institutional grants are made for competitive segments of five years and are renewable. No individual trainee may receive more than five years of total NRSA support at the predoctoral level and three years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards, except under certain circumstances. Any exception to this policy requires a waiver from the NIH. Dentists requiring additional time to complete training as a participant in a Ph.D. program may anticipate favorable consideration of a waiver request, contingent upon certification of the recipient's good academic standing. Subject to availability of funds, it is the intention of the NIDR to provide stipend support until the completion of training for dentists already enrolled and participating in a doctoral degree program, in the event that a competitive renewal application is not funded. REVIEW PROCESS Applications will be evaluated for merit by an NIDR initial review group (IRG). Site visits may be involved. The IRG will consider, among the criteria in its review, the following. a. The proposed research training and program design: core curriculum; prescribed set of courses or seminars; the manner in which individualized guided research activities will be selected; procedures for monitoring trainees progress; the existence of a true training program (as contrasted with fellowship training for individual trainees); the appropriateness of the proposed number of trainees; the unique and/or innovative nature of the training program; resources and facilities. b. Relevance to the goals of the NIDR, as described in the NIDR's long-range research plan, "Challenges for the Eighties". c. The program director and participating faculty: the roles of specific preceptors; demonstrated research and training competence; their time commitment; current research grant holdings, track record, pending activities; specific experience in graduate research training. d. Training environment: evidence of high level of ongoing fundamental and clinical research activity; availability of equipment, facilities and clinical resources. e. Selection of trainees: plans for recruitment and criteria for the selection of trainees, including minorities, must be described fully; how will trainees be allocated to preceptors. f. Past training record: it is critical to the review of both new and renewal applications that a detailed description of past performance in the training of scientists be provided; reviewers will look for demonstrated accomplishment, or potential, by the faculty in the training of scientists who will make major contributions to dental research (e.g., as indicated by success in achieving individual research grant support or recognition for outstanding scientific accomplishment); past trainee involvement in academic, clinically-oriented, and laboratory research; their ongoing productivity. For renewal applications, what is the record in filling the number of awarded trainee positions? What was the completion record of such trainee appointments? The IRG, following assessment of the quality of training grant applications and assignment of priority scores indicative of merit, will comment on each applicant's plans for attracting individuals from underrepresented minority groups to the research training program. When the application is a renewal of an award made under the new guidelines, these commentaries will cover accomplishments in recruiting individuals from underrepresented minority groups and in training them for research positions. Applications will then be reviewed by the National Advisory Dental Research Council. In addition to the recommendations made by the initial review group, the Council will include, among the information they consider, the IRG's comments on the plans for (and success in) recruitment of individuals from underrepresented minority groups into the training program. The NIDR will notify the applicant of the final Council action shortly after its meeting. Funding decisions will be made based on the review groups' recommendations, the need for research personnel in specified program areas, and the availability of funds. REVIEW SCHEDULE The NIDR has established a new policy instituting a single annual NRSA training grant receipt date and review cycle for all new and competitive renewal applications. The schedule is indicated below. It is designed to allow Program Directors time to recruit candidates during the fall of the academic year for appointments to begin the following summer. Application Initial Review Council Earliest Receipt Date Meeting Meeting Award Date September 10, 1989 February/ May/ August 1990 March 1990 June 1990 ADDITIONAL INFORMATION The NIDR expects to fund approximately five new and/or renewal institutional training programs in response to the annual RFA. For additional information, including the grounds for approving extensions of support and payback provisions, please refer to the announcement in the NIH Guide for Grants and Contracts, entitled, "National Research Service Awards - Guidelines for Individual Awards - Institutional Grants," Special Edition, Volume 13, (#1), dated January 6, 1984, and to that in the Guide of June 12, 1987, volume 16 (#20), entitled, "National Institutes of Health - National Research Service Awards, Institutional Grants". These are usually available at the applicant institution, or contact the following person: Mr. Nicholas C. Moriarty, Jr. Office of the Chief Referral and Review Branch Division of Research Grants National Institutes of Health Westwood Building, Room A27 Bethesda, Maryland 20892 Telephone: (301) 496-7221 APPLICATION PROCEDURES Application is to be made on Grant Application Form 398 (Rev. 9/86). This revision, which replaces Training Grant Application PHS 6025-1 (Rev. 1/83), contains special instructions for institutional NRSAs. Application forms are usually available at institutional offices of sponsored research or their equivalent. If not available locally, send a request accompanied by a self-addressed mailing label to: Samuel H. Joseloff, Ph.D. Chief, Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building - Room 449 Bethesda, Maryland 20892 Telephone: (301) 496-7441 An original and four copies of the application are to be mailed to the Division of Research Grants as per the instructions in the application kit. Insert on line 2 of the application face page: RFA-NIDR Institutional Training Grant (T32). Two information copies should be sent to: H. George Hausch, Ph.D. Chief, Scientific Review Branch National Institute of Dental Research National Institutes of Health Westwood Building - Room 519 Bethesda, MD 20892 (301) 496-7658 Please notify the following person of your intentions to submit an application and contact for additional information: Thomas M. Valega, Ph.D. Special Assistant for Manpower Development and Training National Institute of Dental Research National Institutes of Health Westwood Building, Room 510 Bethesda, Maryland 20892 Telephone: (301) 496-6324