Vol. 18, No. 11, March 31, 1989 NOTICES CANCER EDUCATION PROGRAM ...................................(84/98)......... 1 National Cancer Institute Index: CANCER STEVENS AMENDMENT TO THE DEPARTMENT OF DEFENSE APPROPRIATIONS ACT .......... 1 Public Health Service (101/123) Index: PUBLIC HEALTH SERVICE METHODS OF MOLECULAR MECHANICS AND DYNAMICS OF BIOPOLYMERS WORKSHOP, PITTSBURGH SUPERCOMPUTING CENTER ..................(126/182)....... 1 Division of Research Resources Index: RESEARCH RESOURCES NIH REGIONAL CONFERENCE IN GRANTS ADMINISTRATION ............(185/227)....... 2 National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH DATED ANNOUNCEMENTS (RFPs AND RFAs) DEVELOPMENT AND TESTING OF NEW MALE AND FEMALE CONDOMS (RFP) ..(244/276)..... 3 National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT HOUSING, MAINTENANCE AND ROUTINE TESTING OF AIDS INFECTED RESEARCH ANIMALS (RFP) ......................................(279/313)....... 3 National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES COMPUTATIONAL NEURONAL MODELING (RFP) .......................(321/382)....... 4 National Institute of Neurological Disorders and Stroke Index: NEUROLOGICAL DISORDERS, STROKE REDUCING FRAILTY AND INJURIES IN OLDER PERSONS (RFA) ....(385/532, 804/1585). 4 National Institute on Aging National Center for Nursing Research Index: AGING, NURSING RESEARCH MINORITY MENTAL HEALTH RESEARCH CENTERS (RFA) ..............(535/586)........ 6 National Institute of Mental Health Index: MENTAL HEALTH RESEARCH TRAINING AND CAREER DEVELOPMENT AWARDS FOR PHYSICIANS IN NUTRITION (RFA) ...................................(589/649, 1588/1740)... 7 National Institute of Diabetes and Digestive and Kidney Diseases Index: DIABETES, DIGESTIVE AND KIDNEY DISEASES ONGOING PROGRAM ANNOUNCEMENTS MINORITY RESEARCH PROGRAM ADMINISTRATIVE SUPPLEMENTAL AWARDS ..(655/715)..... 8 National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse Index: ALCOHOL ABUSE, ALCOHOLISM, DRUG ABUSE ERRATUM STUDIES OF DIABETES MELLITUS AND RELATED PROBLEMS (PA) ........(724/746)..... 9 National Institute of Diabetes and Digestive and Kidney Diseases Index: DIABETES, DIGESTIVE AND KIDNEY DISEASES SPECIAL EMPHASIS RESEARCH CAREER AWARD (SERCA) IN LABORATORY ANIMAL SCIENCE (PA) ............................................(749/772).... 9 Division of Research Resources Index: RESEARCH RESOURCES NOTICES CANCER EDUCATION PROGRAM (R25) P.T. 34; K.W. 0715035, 0403004, 0795003 National Cancer Institute The next application receipt dates for the Cancer Education Program (R25) will be October 1, 1989, for new applications and November 1, 1989, for renewal applications. The June and July 1989 receipt dates will be skipped; therefore, any applications received on those dates will be deferred to the next cycle. The timetable for all these applications will be as follows: initial review for scientific merit, February 1990; second level review by the National Cancer Advisory Board, May 1990. Please contact the Cancer Training Branch, (Dr. Robert Adams, (301) 496-8580), if you have any questions concerning this announcement. STEVENS AMENDMENT TO THE DEPARTMENT OF DEFENSE APPROPRIATIONS ACT P.T. 34; K.W. 1014002, 1014006 Public Health Service The Office of Management and Budget has advised the heads of all departments and agencies about a government-wide requirement set forth in Section 8136 of the Department of Defense (DOD) Appropriations Act for fiscal year 1989. Specifically, Section 8136 (The "Stevens Amendment") reads as follows: "When issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money, all grantees receiving Federal funds, including but not limited to State and local governments, shall clearly state (1) the percentage of the total cost of the program or project which will be financed with Federal money, and (2) the dollar amount of Federal funds for the project or program." All recipients of Public Health Service grants (and cooperative agreements) involving fiscal year 1989 appropriated funds must comply with the requirements of Section 8136. METHODS OF MOLECULAR MECHANICS AND DYNAMICS OF BIOPOLYMERS WORKSHOP, PITTSBURGH SUPERCOMPUTING CENTER P.T. 42; K.W. 0790010, 0760060, 1004000 Division of Research Resources The Pittsburgh Supercomputing Center (PSC) is conducting a three-day workshop on "Methods of Molecular Mechanics and Dynamics of Biopolymers," May 31, June 1-2, 1989, for biomedical researchers. This workshop is funded by a grant from the Division of Research Resources' Biomedical Research Technology (BRT) Program of the National Institutes of Health (NIH). The workshop will familiarize biomedical researchers with computational methods and provide practice in applying supercomputing resources to problems of concern in molecular mechanics. Previous programming or supercomputing experience is desirable but not necessary. Practical experience on the Pittsburgh Supercomputing Center's Cray Y-MP/832 will be gained in the application to: (1) the problem of conformational mapping and analysis of polypeptide structures; (2) the structural refinement of polypeptides, proteins, and nucleic acids using constraints from measured NMR data; and (3) computation of interaction energies and free energies for protein-drug interactions. The use of state-of-the-art macromolecular computational packages will be illustrated. The workshop will be led by Dr. Charles L. Brooks III, Carnegie Mellon University. This three-day workshop will include an optional half-day session the morning of May 31 led by PSC staff members. Topics to be covered during the optional session include VAX, VMS, and UNICOS, the Cray version of the AT&T System V Unix operating system. Vol. 18, No. 11, March 31, 1989 - Page 1 Travel, meals, and hotel accommodations are covered for U.S. academic participants under the grant. Enrollment is limited to 20 participants. THE DEADLINE FOR SUBMISSION OF APPLICATIONS IS APRIL 20, 1989. To apply for the workshop send a letter accompanied by a curriculum vitae to Cherolyn Brooks at the address below. The letter should outline your research background and current research activities and interests, together with a brief description (one paragraph) of a problem that may be addressed in this workshop. The applicant's level of FORTRAN programming experience and supercomputing experience, if any, should also be included. In addition, graduate students should submit a letter of recommendation written by a faculty member. For further information, call or write to: Cherolyn A. Brooks User Services Pittsburgh Supercomputing Center 4400 Fifth Avenue Pittsburgh, Pennsylvania 15213 Telephone: (412) 268-5206, 1-800-222-9310 (Pennsylvania) 1-800-221-1641 (outside Pennsylvania) NIH REGIONAL CONFERENCE IN GRANTS ADMINISTRATION P.T. 42; K.W. 1014006 National Institutes of Health A two-day conference covering topics related to both program funding and grants administration at the National Institutes of Health is planned for May 25-26, 1989, at Mississippi State University in Starkville. The conference is targeted for an audience of researchers and research administrators at institutions in the southern region which includes Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee. Those interested from Arkansas and Louisiana are also encouraged to attend. Investigators and staff from small and minority colleges, for-profit research organizations, hospitals, universities, and research institutes are invited. This two-day conference has a dual focus of interest to both researchers and grants administrators. Discussions of current issues that affect NIH funding and grants administration are included to give conference participants a comprehensive, up-to-date view of NIH-sponsored research. The first day of the conference is devoted to discussions of current interest to the research programs of the various institutes that comprise the NIH. Preparation of an NIH proposal and the NIH review process are included as agenda topics. Program representatives from three of the NIH institutes and the National Institute on Drug Abuse of the Alcohol, Drug Abuse and Mental Health Administration are featured speakers. Time will be available for conference participants to meet informally with the NIH representatives and discuss topics of special interest. The program for the second day covers topics associated with pre-award and post-award administration of NIH grants. Policy and procedural issues affecting NIH grants administration form the basis for the program. General discussions on current issues and the changes they precipitate are integrated with more specific discussions regarding special career development programs and lab safety. Mr. Geoffrey Grant, Grants Policy Officer in the Office of Extramural Research at NIH, and representatives from the Division of Research Grants and program and grants management staff of several institutes are featured speakers. Conference information will be mailed out in early April, and the deadline for conference registration is May 5th. Dr. Bev. R. Norment at Mississippi State University is in charge of conference arrangements. For more information, contact him or his assistant, Ms. Donna Echols, at (601) 325-3570. Vol. 18, No. 11, March 31, 1989 - Page 2 DATED ANNOUNCEMENTS (RFPs AND RFAs) DEVELOPMENT AND TESTING OF NEW MALE AND FEMALE CONDOMS RFP AVAILABLE: NICHD-BAA-89-16 P.T. 34; K.W. 0750020 National Institute of Child Health and Human Development The Contraceptive Development Branch of the Center for Population Research, National Institute of Child Health and Human Development, has a requirement to develop, design, and test new non-latex or modified latex condoms for male and female use possessing the following characteristics: (a) tensile and air burst strength greater than present latex condoms; (b) uniform wall thickness; (c) non-sensitizing, (d) pin-hole free, or porosity smaller than 40 microns; (e) spermicide compatibility; (f) extended shelf-life; (g) shipping stability. Proposals to develop new potential materials or to test or compare marketed products will not be accepted under this RFP. It is anticipated that three contract awards will be made for a maximum period of five years each depending upon the nature and complexity of the proposed research. This is not a Request for Proposals. RFP-NICHD-BAA-89-16 will be issued on or about April 11, 1989, as a Broad Agency Announcement as defined in FAR 6.102 (d)(2). Proposals will be due approximately 90 days thereafter. Copies of the RFP may be obtained by sending written requests to Mr. Paul J. Duska at the address listed below. Requests may also be made by FAX Telephone (301) 496-0962. Paul J. Duska, Contracting Officer Contracts Management Section, OGC National Institute of Child Health and Human Development Executive Plaza North, Room 610 9000 Rockville Pike Bethesda, Maryland 20892 HOUSING, MAINTENANCE AND ROUTINE TESTING OF AIDS INFECTED RESEARCH ANIMALS RFP AVAILABLE: RFP-NIH-NIAID-OSD-90-12 P.T. 34; K.W. 1002002, 0715008 National Institute of Allergy and Infectious Diseases The Intramural Research Program, Office of the Scientific Director of the National Institute of Allergy and Infectious Diseases, has a requirement for housing and maintenance of up to 12 adult chimpanzees while conducting directed research studies with human immunodeficiency viruses. Offerors must have facilities and trained personnel for working with infectious disease agents in chimpanzees. Any contract awarded will be subject to DHHS regulations regarding the use of animal subjects in research. The Institute plans to make one award from this solicitation. RFP-NIH-NIAID-OSD-90-12 will be issued on or about April 14, 1989, with a closing date for receipt of proposals tentatively set for June 2, 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 should be directed to: Ms. Joyce U. Sagami National Institute of Allergy and Infectious Diseases Westwood Building, Room 707 5333 Westbard Avenue Bethesda, Maryland 20892 Telephone: (301) 496-2509 This advertisement does not commit the Government to award a contract. Vol. 18, No. 11, March 31, 1989 - Page 3 COMPUTATIONAL NEURONAL MODELING RFP AVAILABLE: NIH-NINDS-89-06 P.T. 34; K.W. 0705055, 1004000 National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke (NINDS) has a new requirement for computational neuronal modeling. This contract is the first phase of a long-term effort to develop a sound functional mathematical description of the nature and behavior of learning, storage, and recall in vertebrate biological systems. Such a mathematical description, even in its early stages of development will serve two principal, mutually reinforcing functions. It will facilitate the design of further neurobiological experiments and it will serve as the basis for the development of numerical models that clearly demonstrate the pattern recognition and classification capabilities of animals and man. The work required of the Contractor shall consist of the following interrelated tasks: 1) develop a detailed, lumped-parameter model (that can be numerically emulated using a computer as a tool) of invertebrate and vertebrate neural systems exhibiting associate learning, storage, and recall that bears a one-to-one relationship to biological reality; 2) develop a mathematical model of the underlying input/output relations of the models; 3) demonstrate the validity of the mathematical model by numerical emulation of that model using the mathematical model rather than a one-to-one description of biological reality; and 4) utilizing the emulations, demonstrate as clearly as possible the ability of these algorithms to learn, store, recall, and associate inputs, using realistic test cases. Offerors must have: 1) experience in computer modeling and mathematical analysis of neural networks (artificial and natural), non-linear systems, and/or non-linear optimization theory and applications; 2) personnel qualified to perform interdisciplinary research spanning computer science/engineering/physics/systems science on the one hand and biomedical sciences on the other; and 3) computer hardware/software resources adequate to carry out the proposed work, including facilities to execute efficiently large neural network computer programs with consequent large data/program memory requirements. It is anticipated that one contract award will be made under this RFP, for a three-year period. This is not a Request for Proposals (RFP). RFP No. NIH-NINDS-89-06 will be issued on or about March 27, l989, with tentative date for receipt of proposals set at May l9, l989. To receive a copy of the RFP, please submit a written request to the following address and supply this office with two self-addressed mailing labels. All responsible sources may submit a proposal which will be considered by the Government. Contracting Officer Contracts Management Branch, DEA National Institute of Neurological Disorders and Stroke, NIH Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, Maryland 20892 Attn: RFP-NIH-NINDS-89-06 REDUCING FRAILTY AND INJURIES IN OLDER PERSONS RFA AVAILABLE: 89-AG/NR-04 P.T. 34; K.W. 0715027, 0745027, 0745030, 0710010, 0415003 National Institute on Aging National Center for Nursing Research Application Receipt Date: July 19, 1989 Vol. 18, No. 11, March 31, 1989 - Page 4 PURPOSE This announcement invites cooperative agreement applications for: i) Sites to carry out biomedical, behavioral or environmental intervention studies designed to reduce the loss of functional capacities and to prevent fall-related injuries in older persons; and ii) a Coordinating Center for these intervention studies. Two related investigative approaches are sought: o Studies aimed at increasing physical functional capacities and reducing injuries by improving mobility, strength, and balance. o Studies aimed at optimizing health behaviors and/or environmental conditions with the intent of reducing fear of falling, the actual occurrence of falls, consequent injuries, or other negative sequelae. BACKGROUND A major goal of research related to aging is to increase the period of time that older individuals are able to function independently and in relatively good health. The September 1988 "Workshop on Reducing Frailty and Fall-Related Injuries in Older Persons" sponsored by the National Institute on Aging (NIA), National Center for Nursing Research (NCNR) and the Centers for Disease Control, presented current knowledge on these subjects. Recommendations were for the need to: i) conduct initial studies to test the efficacy of different intervention approaches; ii) encourage interventions in populations with either low, intermediate or high functional impairment with the intervention well matched to the appropriate target population; iii) select outcome measures very carefully and with full awareness of required sample size; iv) emphasize functional capacities and health behaviors as critical outcome measures; and vi) evaluate factors which may affect compliance with the interventions in these populations. RESEARCH GOALS AND SCOPE Applications are invited which propose studies to test intervention strategies for the prevention, reduction or compensation of physical frailties or environmental hazards which place older persons at risk for injuries. It is anticipated that there will be 6-8 Sites and one Coordinating Center which must be independent of the Sites. A multidisciplinary approach is encouraged as appropriate to the proposed intervention. Examples of interventions to increase physical capacities include, but are not limited to: o Rehabilitation programs to restore functional deficits related to cardiovascular, musculoskeletal and other dysfunctions among older persons. o Exercise and/or nutritional interventions designed to improve muscular strength and/or bone strength. o Exercise regimens to improve postural stability and/or range of motion. o Interventions to increase mobility and strength in older individuals with arthritis. Examples of interventions to enhance health behaviors and/or environments include, but are not limited to: o Interventions to identify and eliminate risk-related environmental hazards in the home or institutional setting. o Behavioral strategies to increase older individuals' recognition of injury risk, avoidance of imprudent behaviors associated with injury risk, and adoption of appropriate behavioral responses to reduced functional capacities. o Psychosocial interventions to reduce incapacitating fear of falling and increase psychosocial functioning. o Development and testing of special falls reduction programs in institutional settings. Vol. 18, No. 11, March 31, 1989 - Page 5 MECHANISM OF SUPPORT The administrative and funding mechanism to be used to support these awards will be cooperative agreements between each awardee and NIH. This study will involve the cooperation of scientists from: 1) multiple research Sites, 2) a Coordinating Center, and 3) two NIH units (NIA and NCNR). A Steering Committee will serve as the study's primary governing body. The proposed start date is April 1, 1990. Support may be requested for up to 3 years for Sites but must be requested for the full 3 years by the Coordinating Center. REVIEW PROCEDURES AND CRITERIA Applications will be received by the NIH Division of Research Grants and will be dually assigned to NIA and NCNR. Applications judged by NIA or NCNR to be nonresponsive will not be accepted. Responsive applications may be subjected to triage by a peer review group to determine their scientific merit relative to the other applications received in response to this RFA. Applications will be reviewed in accord with the usual NIH peer review procedures. METHOD OF APPLYING The full version of this RFA should be requested and the instructions it contains for completing applications should be followed. Researchers considering an application in response to this RFA are strongly encouraged to discuss their project with NIA or NCNR program administrators in advance of formal submission. This can be done either through a telephone conversation or a brief letter giving the title of the proposed project, the principal investigator and, when known, other key participants. This letter should be sent to the appropriate staff contact listed below by June 14, 1989. INQUIRIES Presubmission inquiries and correspondence can be directed to these NIA and NCNR contact offices listed below. Geriatrics Branch National Institute on Aging Building 3l, Room 5C27 Bethesda, Maryland 20892 Telephone: (301) 496-1033 Behavioral and Social Research Program National Institute on Aging Building 3l, Room 5C32 Bethesda, Maryland 20892 Telephone: (301) 496-3136 Health Promotion and Disease Prevention Branch National Center for Nursing Research Building 31, Room 5B13 Bethesda, Maryland 20892 Telephone: (301) 496-0523 MINORITY MENTAL HEALTH RESEARCH CENTERS RFA AVAILABLE: MH-89-02 P.T. 04, FF; K.W. 0715095, 0710030 Application Receipt Date: November 15, 1989 National Institute of Mental Health The National Institute of Mental Health (NIMH) is requesting applications for Minority Mental Health Research Centers to support coordinated, multidisciplinary research on the mental health needs and issues of minority populations. Eligible applicant institutions include any non-profit or for-profit organization which has an established relevant research capacity or has a documented affiliation with an institution with such a research capacity. In fiscal year 1989, NIMH funded four centers for a total amount of about $2.3 million. In fiscal year 1990, NIMH hopes to fund up to four new centers under this RFA. The initial funding period of a new center will be for no more than 3 years, at which time a competing application for renewal will be considered for future funding. Vol. 18, No. 11, March 31, 1989 - Page 6 Potential applicants are requested to submit a one-page letter of intent by April 30, 1989. The letter should be sent to Mrs. Edna Hardy-Hill, with a copy to Dr. Freda K. Cheung at the following addresses: Mrs. Edna Hardy-Hill, Chief Research Development and Special Projects Review Branch Division of Extramural Activities Room 9C-15 Telephone: (301) 443-6470 Dr. Freda Cheung, Acting Chief Minority Research Resources Branch Division of Applied Biometry and Applied Sciences Room 18-101 Telephone: (301) 443-3724 The mailing address for both of the above is: NIMH 5600 Fishers Lane Rockville, Maryland 20857 NIMH will accept applications in response to this request for applications on November 15, 1989, and thereafter under the regular Public Health Service receipt dates for applications. For further information, potential applicants should contact Dr. Cheung as listed above. RESEARCH TRAINING AND CAREER DEVELOPMENT AWARDS FOR PHYSICIANS IN NUTRITION RFA AVAILABLE: 89-DK-06 P.T. 34; K.W. 0710095 National Institute of Diabetes and Digestive and Kidney Diseases Application Receipt Date: July 17, 1989 The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for nutrition research training and for career development for physicians. The Nutrition Program of the Division of Digestive Diseases and Nutrition (DDDN), NIDDK, supports research, research training, and career development programs on nutrient metabolism, obesity, eating disorders and energy regulation. The objective of this solicitation is to increase the number of physicians who can conduct high quality nutrition research. The award mechanisms offered to achieve this are: 1. The National Research Service Award Institutional Training Grant. 2. The National Research Service Award Individual Postdoctoral Fellowship. 3. The Physician Scientist Award 4. The Clinical Investigator Award. ELIGIBILITY REQUIREMENTS These requirements are in addition to the standard eligibility criteria for these Public Health Service award mechanisms and apply only to these awards under this RFA: 1. National Research Service Award Institutional Training Grant: the applicant organization must be or must be associated with a major medical institution, must have or be able to develop a potential basic science training staff who have NIH or other competitively awarded research support, and must evidence a capacity to attract and train physicians from under-represented minority groups. Trainees are to have completed a residency in internal medicine, surgery, or pediatrics. Consultation with DDDN staff is important to the potential applicant. 2. National Research Service Award Individual Postdoctoral Fellowship, Physician Scientist Award, and Clinical Investigator Award: the applicant is to have completed, by the time an award would be activated, a residency in internal medicine, surgery, or pediatrics. TERMS OF THE AWARDS AND AVAILABILITY OF FUNDS The NIDDK plans, under this RFA, assuming normal funding capacity and the receipt of meritorious applications, to award 1 Institutional Training Grant, a total of 2 Physician Scientist and/or Clinical Investigator Awards, and 4 Individual Postdoctoral Fellowship Awards. Vol. 18, No. 11, March 31, 1989 - Page 7 For the complete RFA document, which includes guidance for preparation of applications, please contact: Office of the Director Reseach Training and Career Development Program Division of Digestive Diseases and Nutrition, NIDDK Westwood Building, Room 3A15 Bethesda, Maryland 20892 Telephone: (301) 496-7455 ONGOING PROGRAM ANNOUNCEMENTS MINORITY RESEARCH PROGRAM ADMINISTRATIVE SUPPLEMENTAL AWARDS P.T. 34, FF; K.W. 0404003, 0404009, 0710030 National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse INTRODUCTION The National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA) are announcing an opportunity for administrative supplements to existing extramural research grants, including the traditional research projects (ROl), program project grants (POl), and specialized centers (P50) to support research by a minority researcher or other researchers with special expertise in alcohol and other drug abuse issues as they affect minority populations. This researcher will be referred to as the "proposed researcher" for the remainder of this announcement. PURPOSE The purpose of this program announcement is to increase research support to minority scientists and other researchers to expand their knowledge about alcohol and other drug abuse, to gain research experience, and to increase their commitment to examining problems of addiction and drug abuse among minority populations. Administrative supplements will be made for a period of up to three years on behalf of a proposed researcher, who will work in collaboration with the principal investigator of an ongoing NIAAA or NIDA grant. NIAAA and NIDA encourage applications for support of researchers at Historically Black Colleges and Universities and other minority institutions. The ongoing NIAAA or NIDA grant must have at least two years of remaining non-competitive support at the time of submission. The proposed research administrative supplemental application must be closely related to the currently funded research grant. An administrative supplemental application will not be accepted in the final year of the grant. It must examine some aspect of alcoholism and/or drug abuse among minority populations or support a minority researcher. It must represent an increased effort in an already approved objective of the research project or propose to enhance the effectiveness of the overall research project. The nature of the research should provide the proposed researcher with an opportunity to contribute intellectually to the program and to broaden his/her research potential. The scope of the project will generally be comprehensive enough to require two years for completion and the administrative supplemental application should include such a research plan and requested budget. APPLICATION RECEIPT AND REVIEW SCHEDULE Applications in response to this announcement may be made at any time during the fiscal year. Review of these applications for administrative supplements will be conducted by NIAAA and NIDA staff and other experts. Copies of the Program Announcement may be obtained by sending a written request to: NIDA NIAAA Catherine Bell-Bolek, M.S. Albert A. Pawlowski, Ph.D Program Director Associate Director Special Populations Research Division of Basic Research Program National Institute on National Institute on Drug Abuse Alcohol Abuse and Alcoholism Telephone: (301) 443-0441 Telephone: (301) 443-1273 Vol. 18, No. 11, March 31, 1989 - Page 8 ERRATUM STUDIES OF DIABETES MELLITUS AND RELATED PROBLEMS P.T. 34, FF; K.W. 0715075, 0710030, 0755030, 0765033, 0785055, 0745065, 0404000 National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Aging National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute of Dental Research National Institute of Environmental Health Sciences National Eye Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Center for Nursing Research This Program Announcement was published in the NIH Guide for Grants and Contracts, Vol. 18, No. 7, March 3, 1989, on page 7. A bullet was inadvertently omitted under I. PROGRAM SPECIFICATIONS, B. Research Scope. The additional area of research recommended includes: o Behavior and Psychosocial Risk Factors, Complications and Interventions SPECIAL EMPHASIS RESEARCH CAREER AWARD (SERCA) IN LABORATORY ANIMAL SCIENCE P.T. 34; K.W. 0201058, 0710030 Division of Research Resources Application Receipt Date: June 1, 1989 The ongoing program announcement titled as above, which was published in the NIH Guide for Grants and Contracts, Vol. 18, No. 7, March 3, 1989, incorrectly contained reference to an anticipated number of awards to be made under this announcement (refer to APPLICATION section of the announcement). The sentence, which reads, "Approximately 35-40 awards are expected to be made under this announcement" should be disregarded in its entirety. Questions regarding this correction should be addressed to: Director, Laboratory Animal Sciences Program, ARP Division of Research Resources National Institutes of Health Westwood Building, Room 853 5333 Westbard Avenue Bethesda, Maryland 20892 Telephone: (301) 496-5175 Vol. 18, No. 11, March 31, 1989 - Page 9 FULL TEXT OF RFAs FOR ONLINE ACCESS REDUCING FRAILTY AND INJURIES IN OLDER PERSONS RFA AVAILABLE: 89-AG/NR-04 P.T. 34; K.W. 0715027, 0745027, 0745030, 0710010, 0415003 NATIONAL INSTITUTE ON AGING (NIA) and the NATIONAL CENTER FOR NURSING RESEARCH (NCNR) APPLICATION RECEIPT DATE: July 19, 1989 PURPOSE This announcement invites cooperative agreement applications for: i) Sites to carry out biomedical, behavioral or environmental intervention studies designed to reduce the loss of functional capacities and to prevent fall-related injuries in older persons, and ii) a Coordinating Center for these intervention studies. Two related investigative approaches are sought: o Studies aimed at increasing physical functional capacities and reducing injuries by improving mobility, strength, and balance. o Studies aimed at optimizing health behaviors and/or environmental conditions with the intent of reducing fear of falling, the actual occurrence of falls, consequent injuries, or other negative sequelae. Given the multiple causes of functional impairments and injury risk in old age, individual applications addressing either one or both of these approaches will be accepted for the single competition review of proposals viewed as responsive to this RFA. SCIENTIFIC BACKGROUND Deficits in strength, mobility and balance pose prominent physical problems for many older individuals. The progression of these physical deficits can lead to the loss of independent living and increased risk of injury. Also, when these physical deficits are combined with undesirable social, behavioral or environmental conditions, the risk for injury rises. Falls are the most prevalent form of injury in older people. The greater severity of injuries in old age combined with longer recovery periods make falls and other mobility-related injuries a serious threat to the health and functioning of older persons. Also, falls and other mobility problems are often associated with loss of confidence in the ability to function independently, restriction of physical and social activities, and increased dependence. A major recommendation from the recent Surgeon General's Workshop on Health Promotion and Aging is the need for well-designed, controlled studies on the effects of preventive and rehabilitative strategies on physical functional capacities and injury risk and related sequelae in older persons (1). Contributions of Physical Deficits: A diverse group of physical deficits often develops in older individuals and contributes to frailty. These include, but are not limited to: o Deficits in skeletal muscle strength o Deficits in gait speed o Limitations in joint range of motion and musculoskeletal flexibility o Deficits in postural stability leading to falls o Deficits in cardiopulmonary fitness These conditions contribute to significant functional limitations. For example, survey data suggest that 15% of persons aged 75-84 are unable to climb stairs, 23% are unable to walk one-half mile, 7% are unable to walk across a small room, and 24% are unable to lift ten pounds (2). These dysfunctions are even more common among persons over 85 years old (3). A substantial proportion of otherwise healthy older persons have limitations in gait speed severe enough to prevent crossing street intersections quickly enough to comply with traffic signals (4). Over 200,000 hip fractures in the U.S. each year occur among older persons (3,5) primarily as a result of osteoporosis and an increased risk of falling. These functional deficits are in turn responsible for a large share of the needs for long-term care, and also contribute to significant morbidity from injury and other adverse consequences of activity limitation. Some evidence indicates that several of these physical deficits in older persons are to some extent preventable or reversible by rehabilitation strategies. For example, small-scale studies with old persons indicate that exercise regimens can improve strength and mobility (6). Other studies suggest that exercise programs may retard the rate of age-related bone loss, increase cardiac fitness and improve glucose tolerance in older adults (7). It is therefore important and timely to determine the extent to which physical frailty and its consequent functional impairments and risk of injury among older persons may be reduced by interventions to improve skeletal muscle strength, mobility, flexibility, balance and cardiopulmonary fitness. Contributions of Environmental and Behavioral Factors: Falls and the circumstances surrounding them present a complex intersection of factors involving the person, the family and household social support networks, design features of the environment and the settings in which falls occur (8,9). While the contribution of physical deficits to the risk of falling and related injuries must be recognized, this second approach emphasizes the role of environmental and behavioral factors in older persons' perceptions of fall risk and actual fall and injury events. Previous research suggests that a significant proportion of falls in older persons may involve environmental hazards which could have been avoided by simple preventive measures (e.g., loose rugs, unstable furniture, poorly lighted areas, unsafe stairways). Even if environments are relatively safe, lack of awareness of injury risks associated with reduced physical capacities and imprudent risk taking behavior can increase falling and injury risk in physically impaired older persons. Conversely, older people may often respond to changing physical capabilities with an incapacitating fear of falling which leads to restrictions in physical and social activities, increased dependence on others, and reduced quality of life. While there have been several fall and injury prevention programs suggesting the potential of environmental and behavioral interventions for reducing injury risk in older persons, empirical knowledge is lacking about the most effective intervention strategies. The major drawbacks have been the lack of clearly defined population groups, rigorous research designs, and standard definitions for fall events, fall-related injuries, and other related outcomes. PROGRAMMATIC BACKGROUND In 1984, NIA sponsored a workshop on "Falls in the Elderly: Biological and Behavioral Aspects". An RFA was issued entitled "Neurologic, Muscular, Perceptual and Cardiovascular Aspects of Falls and Gait Disorders in Elderly People" as one result of this workshop. Since that time the NIA has provided funding for a variety of studies relevant to the present initiative including investigations on the etiology, epidemiology and prevention of falls, physiologic effects of exercise in older persons, osteoporosis, and influences of the social and physical environment on health and functioning. This basic research is providing the data which are essential to launch systematic interventions into these problems. A September, 1988 "Workshop on Reducing Frailty and Fall-Related Injuries in Older Persons" sponsored by NIA, NCNR and the Centers for Disease Control (CDC), presented the state of current knowledge on these subjects. Widely shared recommendations were for the need to: i) conduct initial studies to test the efficacy of different intervention approaches, ii) encourage interventions in populations with either low, intermediate or high functional impairment with the intervention well matched to the appropriate target population so that the population is most likely to respond to the intervention, iii) select outcome measures very carefully and with full awareness of required sample sizes, iv) emphasize functional capacities and health behaviors as critical outcome measures, and vi) evaluate factors which may affect compliance to the interventions in these populations. References 1. Surgeon General's Workshop on Health Promotion and Aging, U.S. Dept. of Health and Human Services, pp. 63-69, 1988. 2. Jette, A.M. & Branch, L.G.: The Framingham disability study. II. Physical disability among the aging. Am J Publ Hlth 71:1211-1216, 1981. 3. National Center for Health Statistics: Health Statistics on Older Persons, United States, 1986. DHHS Publication No. (PHS) 87-1409, Washington, D.C., U.S. Government Printing Office, 1987. 4. Lundgren-Lindquist, B., Aniansson, A. & Rundgren, A.: Functional studies in 79-year-olds. III. Walking performance and climbing capacity. Scand J Rehab Med 15, 125-131, 1983. 5. U.S. Bureau of the Census, Current Population Reports, Series P-25, No. 965, Estimates of the Population of the United States, by Age, Sex, and Race: 1980 to 1984, U.S. Government Printing Office, Washington, D.C., 1985. 6. Vallbona, C. & Baker, S.B.: Physical fitness prospects in the elderly. Arch Phys Med Rehabil 65:194-200, 1984. 7. Smith, E.L., Smith, P.E. & Gilligan, C.: Diet, exercise and chronic disease patterns in older adults. Nutr Revs 46: 52- 61, 1988. 8. Radebaugh, T.S., Hadley, E. & Suzman, R. (eds.):Falls in the Elderly: Biologic and Behavioral Aspects. Clinics in Geriatric Medicine 1: August, 1985. 9. Gibson, M.J.: The prevention of falls in later life. Danish Med Bull 34 (Suppl. No. 4):1-24, 1987. RESEARCH GOALS AND SCOPE General Considerations: The NIA and NCNR seek studies of one or both types of intervention strategies for the prevention, reduction or compensation of physical frailties or environmental hazards which place older persons at risk for injuries. These approaches are: i) interventions to improve physical capacities, and ii) interventions to optimize living environs and/or the behavioral adaptations to declining physical capacities. It is anticipated that there will be 6-8 Sites and one Coordinating Center which must be independent of the Sites. A multidisciplinary approach is encouraged as appropriate to the proposed intervention. Applications for Sites will be judged primarily on the suitability of the intervention being proposed, and the appropriateness of the match between the intervention, the target population, outcome measures and experimental design. It is not sufficient to state that the specific protocol will be developed during the trial. Each Site will have its own unique intervention strategy. Sites will share certain common baseline and outcome measures (see below). Interventions can be conducted in either community or institutional settings and, where appropriate, should include males, females and members of minority groups so that possible gender, racial and ethnic differences in functioning, injury risk, and intervention response can be assessed. (NIH policy states that if women or minorities are not included in a given study, a clear rationale for this exclusion must be provided.) A focus on high risk, older (>70 years) people is encouraged. In addition, the study of older persons with caregiving responsibilities whose functional deficits and injury risk may jeopardize these responsibilities is also relevant to this initiative. All Sites must be able to conduct comprehensive, multidimensional assessments of medical, behavioral and environmental factors on subjects entering the study. It is understood that severely cognitively impaired individuals will be excluded. Applications should provide thorough information on the population to be studied and indicate specific inclusionary and exclusionary criteria as appropriate to the proposed intervention. Detailed justifications for sample sizes will be required as will assurances that projected sample sizes can be obtained. In addition, estimates should be provided of subject attrition during the course of the study. Each Site must be able to study sufficient numbers of individuals in order to obtain acceptable statistical power on the endpoints being measured by that Site. Sample sizes may be based on intermediary outcomes (e.g. changes in physiological and functional status, behavioral activities, or environmental conditions) and not solely on more distal outcomes (e.g. falls and injuries). Adequate details about the intervention should be provided in order to evaluate the feasibility and potential efficacy on the population being proposed for study. The intervention studies should provide information on: o The feasibility of conducting the intervention, including assessment of factors affecting compliance. o The efficacy of the intervention on pertinent outcomes. o The validation of baseline and endpoint measures of appropriate sensitivity and specificity so that the effects of the intervention can be assessed and replicated. o The predictors of responsiveness to the intervention. In addition to measures which are specific to individual Sites, all Sites must demonstrate the capacity to collect reliable data on: i) demographics of the study population, ii) measures of health, functional (physical, psychosocial and cognitive), and environmental status, iii) mobility and activity levels, iv) number of falls and, v) falls-related trauma. The Coordinating Center will develop standardized forms for the collection of these five types of data. Protocols for these shared measures and other common aspects of the trials will be developed by the investigators during the first year of the study. The maximum duration of the proposed research project should be no more than 3 years. The variation in project length will be due to differences in the time needed for recruitment, intervention and follow-up. Interventions may start early in the first year if protocol development is at an appropriate stage. Applications proposing to start an intervention at any time later than 12 months into the project period will be considered nonresponsive. The projected timetable is: Phase 1: Recruit and screen subjects, protocol refinement and standardization: up to 1 year Phase 2: Conduct intervention activities, continued recruitment and screening (if necessary), preliminary data analysis: 1 to 2 years Phase 3: Data analysis and reporting: about 9 months After the conclusion of these studies, NIA and NCNR may consider supporting a multi-center, randomized, clinical trial to test further the most promising interventions. A Steering Committee will have overall responsibility for decision-making on shared aspects of the study. It will be comprised of the Principal Investigator (PI) of each site and of the Coordinating Center along with the three NIH Program Administrators. During Phase 1, the Steering Committee will meet on at least a quarterly basis to: i) develop and finalize the shared portions of the study, ii) review each site's recruitment activities, and iii) openly discuss each site's activities to coordinate the overall project. The Steering Committee meeting will also be attended by 2-3 key staff from each Site and the Coordinating Center. Due to the interaction among biomedical, behavioral, and environmental factors, applicants are encouraged to address pertinent aspects of each of these three areas in their intervention designs. Specific considerations regarding interventions to increase physical capacities and interventions to enhance health behavior and/or environments are described in the following two sections. Interventions to Increase Physical Capacities: Because of the interrelatedness of physiologic capacity, level of activity, and risk of trauma, applications in response to this solicitation should be designed to determine the effect of specific interventions on both physiologic and functional endpoints, as well as trauma risk. For example, in a study of an intervention to improve muscle strength, functional parameters which tell of capacities to perform activities of daily living involving muscle strength should be determined. Falls and associated trauma should also be measured although sample sizes may be calculated on the basis of more intermediary outcomes. The populations involved in these studies should consist of persons either with existing limitations in mobility, strength, flexibility or balance or persons at very high risk of developing such limitations during the term of these studies. For example, individuals who are losing the capacity to perform such activities as carrying a grocery bag or walking across the street in an "acceptable" amount of time would be good candidates to test interventions aimed at functional restoration. All subjects must initially receive a comprehensive geriatric assessment followed by standard medical treatment with well-accepted protocols. This will serve as the pre-intervention baseline. Since many specific interventions such as exercise can affect multiple physiologic and functional endpoints, applicants are encouraged to determine effects of such interventions on as many pertinent endpoints as is feasible. Conversely, since many interventions are interrelated (e.g. an exercise program may alter nutritional requirements) applicants are encouraged to consider using a coordinated set of multidisciplinary interventions. For example, a team comprised of a geriatrician, nurse, physiatrist, physical therapist, exercise physiologist and nutritionist might be appropriate for one Site's intervention. Within these general guidelines, all innovative proposals on this topic are encouraged. Examples of interventions and endpoints include, but are not limited to: o Rehabilitation programs to restore functional deficits related to cardiovascular, musculoskeletal and other dysfunctions among older persons. o Exercise and/or nutritional interventions designed to improve muscular strength and/or bone strength. o Exercise regimens to improve postural stability and/or range of motion. o Interventions to increase mobility and strength in older individuals with arthritis. o Training programs to reduce risk of falls by improving postural responses to disequilibrium. o Effects of hormonal replacement therapy on muscle and/or bone strength in older men and women. Interventions to Enhance Health Behaviors and/or Environments: The nature of a fall event provides a basis for designing interventions. A fall occurs when there is a change in body position and a failure to compensate in a critical period of time, resulting in inadvertent contact with the ground or some intermediate lower surface. Injury risks are determined by a dynamic interplay between the person and the environment. This person/environment interaction implies that changes in either one may precipitate a fall event in situations where there had been previous adaptation or accommodation. Thus, interventions may be designed to enhance behavioral skills or modify the environment or both. Interventions in this section can be directed toward reducing a wide range of interrelated outcomes, including but not limited to: fear of falling, a fall-event, fall-related injuries, medical care utilization and cost. While fall-related outcomes are important dependent variables, investigators should also monitor psychosocial variables to determine whether there are benefits to a falls prevention program beyond reduction in falls. At the same time, it is important that investigators also monitor potential negative effects of intervention such as the loss of autonomy and restrictions in activity levels. It is important to recognize that a low incidence of falls does not mean the setting is "safe." Individuals at risk of falling may have adjusted to the setting by limiting their activity to minimize exposure to hazards. The populations involved should consist of persons experiencing some physical limitation or morbidity that makes them susceptible to fears of falling or the actual fall event itself. Within these general guidelines, all innovative proposals on this topic are encouraged. Examples of interventions include, but are not limited to: o Environmental interventions designed to reduce injury risk by enhancing functional abilities and mobility (e.g., improved lighting, visual or spatial designs). o Interventions to identify and eliminate risk-related environmental hazards in the home or institutional setting (e.g., tacking down rugs, installing bathroom grab bars, modifying poorly designed stairways). o Technological innovations to match older persons' reduced functional abilities with environmental demands associated with risk of injury (e.g., design and use of chairs that are safer and easier to get in and out of). o Design of monitoring systems to reduce fear of falling and/or consequences of unattended falls. o Behavioral strategies to increase older individuals' recognition of injury risk, avoidance of imprudent behaviors associated with injury risk, adoption of appropriate behavioral responses to reduced functional capacities, and positive actions in case a fall does occur. o Cognitive training programs in risk perception, decision- making, and other processes related to fall prevention. o Psychosocial interventions to reduce incapacitating fear of falling and increase psychosocial functioning. o Development and testing of special falls reduction programs in institutional settings (e.g., patient/staff education of falls hazards, increased staff awareness of high risk patients, special care protocols focusing on transferring). Organizational Components 1. Sites: A Site is the institution which receives the award for conducting the intervention under this RFA. As mentioned, the PI is encouraged (as appropriate) to form a multidisciplinary team. Applications for Sites should provide evidence of their ability to recruit and evaluate enough subjects to yield statistically sound results. There should be evidence of strong institutional support for the Site, and a stated willingness to follow shared aspects of experimental design, measures and analysis as advised by the Steering Committee. An organizational structure for the Site should be set forth in the application, showing lines of authority and responsibility. Within the page limits, the applicant should succinctly discuss prior relevant studies. The proposed protocol must include discussion of research design, intervention, outcome measures, and analysis along with perceived problems and solutions. 2. Coordinating Center: Applications also are requested for one Coordinating Center with responsibility for standardizing data collection, management and analysis of the common data set. The Coordinating Center will be responsible for writing an operations manual detailing the final shared aspects of these studies. The Coordinating Center, which will maintain strict independence from the Sites, will compile for the Steering Committee progress reports prepared by the Sites as well as accumulated common data at approximately 6 month intervals. Detailed reports will be given to the Monitoring Board at the same time. In order to insure the independence of the Coordinating Center from the Sites, these two organizational components will have distinct personnel, budgets and administrative units. The designated NIA and NCNR Program Administrators will serve as liaisons between the Coordinating Center and these two groups. Examples of specific functions of the Coordinating Center are: i) to coordinate, with the assistance of the designated NIA and NCNR Program Administrators, baseline and outcome measures common to the various Sites; ii) to provide standard forms to collect the raw data at the Sites; iii) to develop appropriate statistical analyses for the raw data; iv) to manage quality control aspects of the data (e.g. regular editing and prompt return of data forms); v) to coordinate information exchange among the sites including publication of a Newsletter twice yearly; vi) to arrange and prepare detailed reports for Steering Committee and other inter-Site meetings; and, vii) to provide criteria for suspension or discontinuation of study treatments. Applicants should describe prior experience in functioning as a Coordinating Center in a multi-Site intervention trial. A complete description of computer facilities and allied resources must be provided along with the availability of these resources for use in this project. The proposal should also discuss how the proposed timetable can be met. The budget should include all costs required to convene the Monitoring Board (6 members) once during Phase 1 and twice yearly during Phase 2. Two completely separate applications from different applicant-investigators must be filed if an institution seeks selection as both a Site and the Coordinating Center. 3. Steering Committee: The Steering Committee will serve as the main decision making body of the study. It will be comprised of the PI from each Site and from the Coordinating Center as well as the NIH Program Administrators. Each PI will have one vote. In addition, the NIH will have one vote. Except for quarterly meetings during the first year, the Steering Committee will meet every 6 months. At its first two meetings the Steering Committee will be convened by the NIA and NCNR Program Administrators and a chairperson (not from NIH) will be elected at the second meeting. The Steering Committee will select the members of the Monitoring Board at the first meeting. In view of their experience in the area of injury control, representatives of the Centers for Disease Control have agreed to provide advice to the Steering Committee, as requested. 4. Monitoring Board: A Monitoring Board will be formed to be advisory to the Sites by reviewing periodically the study's progress and safety for subjects as well as resolving any serious conflicts in opinion on how the study should proceed. The Monitoring Board will be comprised of experts in relevant medical, behavioral, statistical, and bioethical fields. The Board must approve each Site's protocol during the first year in order for that project to advance from Phase 1 to 2. The chairperson of the Steering Committee, the PI from the Coordinating Center, and the NIA and NCNR Program Administrators will all participate as non-voting members of this Board. MECHANISM OF SUPPORT Start Date and Financing: The proposed start date for funded projects is April 1, 1990. Up to $2,000,000 in total costs (contingent upon availability of funds) will be allocated for the first-year awards. If applications of sufficient quality are received it is anticipated that 6 to 8 Sites will be supported along with the Coordinating Center. Support may be requested for up to 3 years for Sites but must be requested for the full 3 years by the Coordinating Center. Applicants should include in their budgets sufficient funds to allow travel of the PI and 2-3 key personnel to Bethesda, MD for four meetings per year (3 days/meeting) in the first year and three meetings per year thereafter. Renewal applications may be submitted but no funds have been specifically reserved for renewals at this time. Cooperative Agreement: The administrative and funding mechanism to be used to support these awards will be cooperative agreements between each awardee and NIH. In a cooperative agreement there is substantial programmatic involvement of the designated NIA and NCNR Program Administrators above and beyond the levels characteristic for traditional program management of grants. The need for significant programmatic involvement results from the fact that this RFA has the scientific objective of determining the efficacy of diverse interventions on frailty and injuries in older people with varying physical deficits, pathologies, behaviors and environments. In an effort to maximize the information obtainable from the set of funded projects, the assistance of the designated NIA and NCNR Program Administrators will center on coordinating the: i) study design and protocol; ii) interventions being tested; and, iii) the outcomes being measured. After the scientific merit, personnel and resources of proposals have been assessed by peer review, modifications of individual awardees' protocols may be necessary to maximize achievement of the objectives of this RFA by the group of projects which are funded. Needs for such modifications may arise both before and during implementation of the protocols, and cannot always be foreseen before the intervention starts. Thus there will be a strong need during Phase 1 for program staff to work closely with the Sites and the Coordinating Center to assist at arriving at common aspects of the studies. Under the terms of the cooperative agreement, the awardee defines the details of the project within the guidelines of the RFA, retains primary responsibility for performance of the activity and for analyzing and publishing results, and agrees to accept assistance, close coordination, and participation of the designated NIA and NCNR Program Administrators in all aspects of the scientific and technical management of the project in accordance with the terms of this RFA. The NIH will have the option of halting the study or study components if program objectives are not being met, or have been met prior to the full 3 year period. The following lists the scope and nature of assistance by the designated NIA and NCNR Program Administrators: o Participate in the monitoring of issues relating to recruitment, treatment, follow-up, quality control, and adherence to protocol. o Suggest refinements and adjustments of study design and protocols. o Assist in re-establishing study objectives, if necessary. o Assist in analysis and reporting of results. The NIA and NCNR program administrators will be available to review publications and presentations. The designated NIA and NCNR Program Administrators will serve as a resource to provide information on treatment regimen and study design. These administrators will assist the group in protocol design by providing information on concurrent intervention studies so as to avoid duplication of effort. These administrators may also provide advice on the scientific rationale and priority of the proposed trial, the design, staffing and implementation of the trial, and statistical requirements, and will cooperate with the awardees in protocol adjustment. In instances where there has been significant involvement in study design and/or analysis by the designated NIA and NCNR Program Administrators, they may cooperate with awardees as co-authors in preparing manuscripts which report the results of the trials. The designated NIA and NCNR Program Administrators will maintain the options of approving or disapproving selections of key personnel or subcontractors by the awardees during the project period. These NIH administrators must approve design and progress being made in Phase 1 (implementation) in order for the award to be continued. If any decision made by the designated NIA and NCNR Program Administrators is unacceptable to the awardee, and a mutually acceptable compromise cannot be reached, the awardee may, within 30 days of notification of the program decision, request a review of the decision by the Monitoring Board which will make a recommendation within 30 days of the request. If the recommendation of the Monitoring Board is unacceptable to both program staff and the awardee, either party may request a review of the decision by an arbitration panel composed of one nominee chosen by the awardee, one chosen by the designated NIA and NCNR Program Administrators, and one with pertinent expertise chosen by the first two nominees. This panel will render a decision within 60 days of the request. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. Cooperative Agreements are subject to the same administrative requirements as grants. Projects will be supported by the Research Project (Cooperative Agreement) (UO1) mechanism. The regulations (Code of Federal Regulations, Title 42, Part 52 and Title 45, Part 74) and policies that govern the research grant programs of the PHS will prevail. The awarding of funds pursuant to this RFA is contingent on availability of funds. All pertinent DHHS, PHS and NIH grant regulations, policies and procedures are applicable. Business management aspects of these awards will be administered in accordance with DHHS and PHS grant administration requirements by the NIH. REVIEW PROCEDURES AND CRITERIA Review Method: Applications will be received by the NIH Division of Research Grants and will be dually assigned to NIA and NCNR. Applications judged by NIA or NCNR to be nonresponsive will not be accepted. Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. NIH will return those applications judged to be noncompetitive. Those applications judged to be competitive will be further reviewed for scientific and technical merit by a review group convened solely for this purpose by the Scientific Review Office, NIA. The next stage of the review will be by the National Advisory Councils of NIA and NCNR. The proposed start date for research supported by this RFA is April 1, 1990. If an application submitted in response to this RFA is similar to another research project already submitted to NIH for review by the same investigative team, the applicant will be asked to withdraw one of the applications. Simultaneous submission of identical proposals is likewise not allowed. Review Criteria: Applications will be reviewed in accord with the usual NIH peer review procedures. The review criteria for Site applications are the traditional considerations and include scientific excellence, qualifications and experience of the investigators, capability to perform the work, availability of suitable numbers of participants, ability of key personnel to devote the time required to carry out the project, adequacy of facilities and supporting environment, and appropriateness of budget for the work proposed. In addition, a definite willingness to collaborate with other Sites, the Coordinating Center, and the designated NIA and NCNR Program Administrators will be assessed. Applications will be judged primarily on the merit of plans for design, recruitment and implementation. It is important for Site applications to carefully consider procedures for identifying and screening candidates. If screening is dependent on organizations not at the Site, then letters of commitment should be submitted with the application. The review criteria for the Coordinating Center are the qualifications, experience and commitment of key personnel. These include scientific and administrative abilities of the PI and key others, experience in serving as a Coordinating Center for clinical trials, proposed data collection and monitoring system, understanding of the scientific objectives and design of this RFA, adequacy of available facilities, willingness to collaborate, mechanism for selecting and replacing key personnel, and appropriateness of the budget for the work proposed. Each application should include an adequately justified budget for the entire anticipated project period of up to 3 years. Estimates of personnel needs, including the PI, other investigators, and support staff should be submitted. The Year 1 period shall begin on April 1, 1990. Given the necessary fluctuations in staffing and phasing, and to assist reviewers in making final recommendations on budgets, it is strongly suggested that detailed budgets be prepared for Phases 1, 2 and 3. The final budgets will be negotiated with the designated NIA and NCNR Program Administrators based on the specific intervention protocol to be implemented. During Phase 1, staff should be hired and reach full staffing by the end of this period. The detailed budget for Phase 1 should include costs for travel by PI and 2-3 key staff to Bethesda to attend four Steering Committee meetings (3 days/meeting). Coordinating Center applications should estimate the time and effort of key personnel needed to participate in the development of forms, manual of operations, and data entry system. Coordinating Center staff must be available toward the end of the first year for a training meeting in Bethesda where the Site scientists will meet for instruction on data forms, collection, entry and access. METHOD OF APPLYING Researchers considering an application in response to this RFA are strongly encouraged to discuss their project with NIA or NCNR program administrators in advance of formal submission. This can be done either through a telephone conversation or a brief letter giving the title of the proposed project, the principal investigator and, when known, other key participants. This letter should be sent to the appropriate staff contact listed below by June 14, 1989. Applications should be submitted on the standard PHS 398 (rev. 9/86) application forms available at most institutional business offices or from the Division of Research Grants, NIH, telephone (301) 496-7441. On item 2 of the face page of the application, applicants should enter the RFA number 89-AG/NR-04 and: FRAILTY AND INJURIES IN OLDER PERSONS. The RFA label contained in the PHS 398 packet must be attached to the bottom of the face page of the original application. Applications must be received by July 19, 1989. The latest date of IRB approval of the human subjects protocol must be included on the face page. The completed application and 4 copies should be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In order to hasten the review process it is requested that applicants submit 2 copies of the proposal to: Chief, Scientific Review Office National Institute on Aging Building 31, Room 5C12 Bethesda, MD 20892 Presubmission inquiries and correspondence can be directed to these NIA and NCNR contact offices listed below. Please note that the Coordinating Center will be formally administered through the Geriatrics Branch Program Officer; however, both NIA units and the NCNR will be involved in Coordinating Center activities and any inquiries may be directed to any of the offices listed below. Geriatrics Branch National Institute on Aging Building 3l, Room 5C-27 Bethesda, MD 20892 (301) 496-1033 Behavioral and Social Research Program National Institute on Aging Building 3l, Room 5C-32 Bethesda, MD 20892 (301) 496-3136 Health Promotion and Disease Prevention Branch National Center for Nursing Research Building 31, Room 5B13 Bethesda, MD 20892 (301) 496-0523 Research Training and Career Development Awards for Physicians in Nutrition RFA AVAILABLE: 89-DK-06 P.T. 34; K.W. 0710095 National Institute of Diabetes and Digestive and Kidney Diseases Application Receipt Date: July 17, 1989 The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for nutrition research training and for career development for physicians. The intent of this RFA is to provide research training and career development support to physicians who have a commitment to and an aptitude for research in nutrient metabolism, obesity, eating disorders, and/or energy regulation. BACKGROUND The Nutrition Program of the Division of Digestive Diseases and Nutrition (DDDN), NIDDK, supports research, research training, and career development programs on nutrient metabolism, obesity, eating disorders and energy regulation. Nutrition research needs and opportunities in the early decades of the next century will require an increased number of physicians trained in basic science that can be related to clinical nutrition problems falling within the DDDN program areas. The number of awards that would provide this nutrition research training and career development have dropped markedly over the past decade. This RFA is directed to the basic science research training of physicians interested in nutrition research careers. OBJECTIVE AND SCOPE The objective of this solicitation is to increase the number of physicians who can conduct high quality nutrition research, compete for NIH grant support, and provide leadership in the areas of clinical nutrition research. The award mechanisms offered to achieve this are: 1. The National Research Service Award Institutional Training Grant. 2. The National Research Service Award Individual Postdoctoral Fellowship. 3. The Physician Scientist Award 4. The Clinical Investigator Award. Potential applicants are encouraged to read the guidelines* for each mechanism to identify the mechanism most appropriate to their needs. ELIGIBILITY REQUIREMENTS These requirements are in addition to the standard eligibility criteria* for these Public Health Service award mechanisms and apply only to these awards under this RFA. Persons receiving research training under any of the award mechanisms offered here may also be enrolled in a medical or surgical subspecialty training program that relates to the nutrition programs of DDDN. In addition, the following applies: 1. National Research Service Award Institutional Training Grant: the applicant organization must be or must be associated with a major medical institution, must have or be able to develop a potential basic science training staff who have NIH or other competitively awarded research support, and must evidence a capacity to attract and train physicians from under-represented minority groups. Trainees are to have completed a residency in internal medicine, surgery, or pediatrics. Consultation with DDDN staff is important to the potential applicant. 2. National Research Service Award Individual Postdoctoral Fellowship, Physician Scientist Award, and Clinical Investigator Award: the applicant is to have completed, by the time an award would be activated, a residency in internal medicine, surgery, or pediatrics. DURATION OF SUPPORT AND BUDGET 1. The NRSA Institutional Training Grant is a five year renewable award providing trainee stipends, tuition and fees (including medical insurance), travel allowances, and $2,500 per year per trainee for institutional costs. Trainees can be appointed for up to three years, with waivers of this restriction considered for persons needing four or five years of research training. 2. The NRSA Individual Postdoctoral Fellowship, permits initial requests for up to three years of support, with waivers of this limit possible for persons who find that a total of 4 or 5 years of research training support is needed. 3. The Physician Scientist Award and the Clinical Investigator Award each provides 5 years of research career development support. TERMS OF THE AWARDS AND AVAILABILITY OF FUNDS Trainees supported by the Institutional Training Grant and/or Individual Postdoctoral Fellows are expected to pursue a minimum of 3 contiguous years of research training, at least one of which is supported on the Institutional Training Grant. The grantee institution must have a commitment to each trainee for the support necessary to complete research training if resources other than the Institutional Training Grant are to be used. Preferably, trainees will be engaged in a Ph.D. or equivalent program. The NIDDK plans, under this RFA, assuming normal funding capacity and the receipt of meritorious applications, to award 1 Institutional Training Grant, a total of 2 Physician Scientist and/or Clinical Investigator Awards, and 4 Individual Postdoctoral Fellowship Awards. The earliest possible award date is December 1, 1989, for the Individual Postdoctoral Fellowship applications; and April 1, 1990, for the Institututional Training Grant, Physician Scientist Award, and Clinical Investigator Award applications. APPLICATION PROCEDURE Use the Public Health Service Grant/Award application kits (PHS 398 Rev. 9/86 for Institutional Training Grant, Physician Scientist Award, and Clinical Investigator Award applications; PHS 416-1 Rev. 7/88 for the Individual Postdoctoral Fellowship application). Write "NIDDK nutrition RFA 89-DK-06" on line 2 of the PHS 398 form, and on line 3 of the PHS 416-1 form. One copy of the RFA label available in the PHS 398 application kit must be stapled to bottom of the face page of the original application and a second copy of the RFA label must be placed on the top of the entire application package. Failure to use these identifying labels could result in delayed processing of your application such that it may not reach the review committee in time for review. Applicants for the Institutional Training Grant should follow special guidelines, "NIDDK Suggestions to National Research Service Award Institutional Training Grant Applicants" NIDDK, NIH, July 1986 (available from the Research Training and Career Development Program, DDDN, NIDDK: see below). REVIEW PROCEDURES Initial review for scientific and technical merit is conducted by a group of predominantly non-Federal scientists. A second level review is conducted by the National Diabetes and Digestive and Kidney Diseases Advisory Council, or in the case of the Individual Postdoctoral Fellowship, by an NIDDK inhouse committee. * General guidelines and eligibility requirements: for the Institutional Training Grant see the NIH Guide for Grants and Contracts 16(20), June 12, 1987; for the Individual Postdoctoral Fellowship see the NIH Guide for Grants and Contracts 17(3), January 22, 1988, and "NIH National Research Service Awards", DRG, NIH, November 1, 1988; for the Physician Scientist and Clinical Investigator Awards see "The K Awards", Division of Research Grants, NIH, April 15, 1988. If not available at your institution, all of these documents are available from the NIH Office of Grants Inquiries, Westwood Building, Room 449, National Institutes of Health, Bethesda, MD 20892 (phone 301 496-7441). INQUIRIES For further information please contact: Donald G. Murphy, Ph.D. Director, Research Training and Career Development Program Division of Digestive Diseases and Nutrition, NIDDK Westwood Bldg Rm 3A15 National Institutes of Health Bethesda, MD 20892 (301 496-7455) **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