Vol. 18, No. 23, July 7, 1989 NOTICES CONFERENCE ANNOUNCEMENT: DIABETES IN AMERICAN INDIANS AND ALASKA NATIVES .........................................(84/140)............. 1 Indian Health Service National Institute of Diabetes and Digestive and Kidney Diseases Index: INDIAN HEALTH SERVICE DIABETES, DIGESTIVE AND KIDNEY DISEASES NEW PROPHET WORKSTATION SOFTWARE AVAILABLE .............(143/192)............ 1 Division of Research Resources Index: RESEARCH RESOURCES DATED ANNOUNCEMENTS (RFPs AND RFAs) EVALUATION OF COMMONLY USED ORTHOGNATIC TREATMENT PROCEDURES (RFA) .......... 2 National Institute of Dental Research (198/233, 564/830) Index: DENTAL RESEARCH ANIMAL FACILITY IMPROVEMENTS FOR SMALL RESEARCH PROGRAMS (RFA) .............. 3 Division of Research Resources (241/334, 833/1393) Index: RESEARCH RESOURCES ONGOING PROGRAM ANNOUNCEMENTS DEVELOPMENT OF MEDICATION--MEDICINAL CHEMISTRY CONSIDERATIONS ..(340/518).... 4 National Institute on Drug Abuse Index: DRUG ABUSE NOTICES CONFERENCE ANNOUNCEMENT: DIABETES IN AMERICAN INDIANS AND ALASKA NATIVES P.T. 42, FA, FE; K.W. 0715075 Indian Health Service National Institute of Diabetes and Digestive and Kidney Diseases November 14-17, 1989, Mesa, Arizona Conference Goals: o to assess progress, needs, and opportunities in diabetes research and health care delivery in American Indians and Alaska Natives; o to encourage collaboration between scientists, health care professionals, and tribal/community leaders in developing new research proposals related to the diagnosis, treatment, and prevention of diabetes and its complications in these populations; o to facilitate the transfer of current research knowledge to medical practice, and to inform tribal and community leaders of opportunities for the reduction of diabetes-related morbidity and mortality. Conference Topics: o Biological Diversity Among American Indians and Alaska Natives o Diabetes in American Indians: Tribal and Regional Differences o Complications of Diabetes Among American Indians o Risk Factors and Pathogenesis of non-insulin dependent diabetes mellitus (NIDDM) Among American Indians o Research Opportunities: Prevention and Early Treatment Treatment of Complications We particularly encourage attendance by investigators who are interested in applying their knowledge and skills to emerging research opportunities associated with diabetes in Native Americans, either as independent investigators or potentially as participants in a cooperative, multicenter research program. Limited travel funds are available to assist both new and established investigators who might be expected to make important contributions to this area of research in the future and who have no other available source of support. Applications for travel funds should be submitted in the form of a curriculum vitae appended to a letter that summarizes the applicant's interest in this conference and the potential commitment/contribution that he/she might make to this area of research. Applications must be received by the Conference Coordinator no later than September 1, 1989. All conference participants should preregister by October 1, 1989, to ensure hotel accommodations. The conference program, registration materials, and additional information regarding the conference are available from: Raymond Kuehne, Conference Coordinator Diabetes in American Indians and Alaska Natives 1801 Rockville Pike, Suite 500 Rockville, Maryland 20852 Telephone: (301) 496-6045 NEW PROPHET WORKSTATION SOFTWARE AVAILABLE P.T. 34, 36; K.W. 0780018, 1003001, 0790010, 1002008, 1002034, 0710100, 0706000 Division of Research Resources The Biomedical Research Technology Program is now making its low-cost PROPHET data management, analysis and visualization package widely available. Increased research productivity is the goal through the appropriate and wide-spread use of powerful networked workstations and PROPHET's comprehensive capabilities. The package is fully documented, engineered and supported by scientific software professionals. It offers features for many biomedical scientists including: Vol. 18, No. 23, July 7, 1989 - Page 1 o Tabular data management and spread-sheet-like calculation o Color graphics and scientific visualization o Statistics and mathematical modeling o Molecular structure databases, modeling and display o Nucleic and amino acid sequence manipulation and databases o Advanced user interface and user customization o Network access for email, sharing data, and NSFnet supercomputers o Organized user group and electronic bboard PROPHET has been used in many disciplines including: o biochemistry o clinical research o molecular biology o physiology o pharmacology o biomedical engineering The software is available for a variety of Unix workstations currently Sun 3s and 4s and DEC Ultrix hosts, VaxStations and the DECStation 3100 and also supports the X11 and SunView window systems. Further ports and continuing enhancements are planned including interfaces to standard SQL databases, and SAS. For further information please contact: Dr. Richard DuBois Biomedical Research Technology Program Division of Research Resources Westwood Building, Room 8A-15 National Institutes of Health 5333 Westbard Ave. Bethesda, Maryland 20892 Telephone: (301) 496-5411 DATED ANNOUNCEMENTS (RFPs AND RFAs) EVALUATION OF COMMONLY USED ORTHOGNATHIC TREATMENT PROCEDURES RFA AVAILABLE: 89-DE-1 P.T. 34; K.W. 0755015, 0785040, 0710120, 0414000, 1010013 National Institute of Dental Research Application Receipt Date: January 15, 1990 The Craniofacial Anomalies, Pain Control And Behavioral Research Branch of the National Institute of Dental Research (NIDR) seeks research grant (R01) applications to conduct clinical trials evaluating commonly used orthognathic treatment procedures. In order to obtain sufficiently large samples, it is likely that such trials would involve consortium arrangements, directed from major treatment centers. Investigative teams might include specialists in oral, maxillofacial and plastic surgery, orthodontics, prosthodontics, psychology, speech pathology, clinical epidemiology and biostatistics. This RFA is for a single competition with a receipt date of January 15, 1990. It is anticipated that up to three awards will be made, if a sufficient number of high quality applications is received. The earliest funding date is July 1, 1990. Applications should be prepared and submitted in accordance with the objectives and requirements described in the full RFA, available from: John D. Townsley, Ph.D. Extramural Program Westwood Building, Room 506 National Institute of Dental Research National Institutes of Health Bethesda, Maryland 20892-4500 Telephone: (301) 496-7807 Vol. 18, No. 23, July 7, 1989 - Page 2 ANIMAL FACILITY IMPROVEMENTS FOR SMALL RESEARCH PROGRAMS RFA AVAILABLE: 89-RR-03 P.T. 34; K.W. 1002002, 0201011 Division of Research Resources Application Receipt Date: December 4, 1989 BACKGROUND The Division of Research Resources (DRR) is announcing a competitive grant program to help institutions with small research programs using animals to upgrade and develop their animal facilities. RESEARCH GOALS AND SCOPE Institutional animal resource improvement grants are awarded to assist biomedical research and educational institutions in upgrading their animal facilities and developing a centralized animal care program. A major objective is to enable institutions to comply with the USDA Animal Welfare Act and DHHS policies on the care and treatment of animals. These awards are limited to Alterations and Renovations (A&R) to improve laboratory animal facilities, and related major resource equipment, such as animal cages and cage washers. To gain approval and support, the need for resource improvement, as well as a sound plan to meet the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals, must be presented and described in the context of the biomedical research and research training program of the institution. ELIGIBILITY AND REVIEW Any domestic public, or private institution, organization or association, with one or more research projects that involves the use of laboratory animals and is supported by the Public Health Service (PHS) at the time of award, is eligible to apply. The total PHS support in the last fiscal year for projects using animals must have been less than $500,000. Institutions are expected to develop a single proposal for campus-wide service. Applications will be received by the Division of Research Grants. Applicants must use Form PHS 398 (rev. 10/88), "Application for Public Health Service Grant." There will be a single receipt date of December 4, 1989. Applications received after this date will be returned. The RFA label available in the Application Form PHS 398 must be affixed to the bottom of the face page. All applications submitted in response to this Request for Applications (RFA) will be reviewed by Special Review Committees managed by DRR for scientific merit, and the National Advisory Research Resources Council for program considerations. Earliest possible funding will be July, 1990. MECHANISM OF SUPPORT Awards will be made as competitive resource grants for a project period of one year. It is expected that six to eight awards will be made in Fiscal Year 1990. The number of grants and the specific amount of the awards will depend on the merit and scope of the applications received, as well as the availability of funds. All policies and requirements which govern the grant programs of the PHS apply. TERMS OF AWARD Institutions may request major equipment items for their animal resources as well as funds for A&R. Support for new construction is not authorized. The award is limited to $100,000 for A&R and $150,000 for equipment. Matching funds are not required. Funds awarded for A&R may not be obligated until final architectural drawings, specifications, and updated cost estimates are received and approved by the Division of Research Resources. INQUIRIES A copy of the complete RFA, which describes the research goals and scope, terms and conditions, review procedures and criteria, and method of applying, may be obtained by contacting the Animal Resources Program, DRR: Vol. 18, No. 23, July 7, 1989 - Page 3 Director Laboratory Animal Sciences Program Animal Resources Program Branch Division of Research Resources 5333 Westbard Avenue, Room 853 Bethesda, Maryland 20892 This program is described in the Catalog of Federal Domestic Assistance No. 13.306, Laboratory Animal Sciences Primate Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review of Executive Order 12372 or Health Systems Agency review. ONGOING PROGRAM ANNOUNCEMENTS DEVELOPMENT OF MEDICATION--MEDICINAL CHEMISTRY CONSIDERATIONS P.T. 34; K.W. 0710080, 0404009, 0755025 National Institute on Drug Abuse Purpose There is a need for new medications for the treatment of drug abuse and related disorders. New medications are needed which substitute for abused drugs in clinical treatment programs, block the psychotropic effects of abused drugs, reduce the craving for abused drugs, moderate and/or eliminate the process of withdrawal from abused drugs, and block and/or reverse the toxic effects of abused drugs. New grant applications are solicited from the design and synthesis of new drug moieties for all classes of drugs of abuse including cocaine and related compounds, opioids, PCP and related compounds, cannabinoids, and benzodiazepines. Research Objectives This program will support studies which involve rational design of new therapeutic entities by application of structure-activity relationship (SAR) studies, synthesis of analogs, screening for bioactivity, and preliminary studies to determine metabolism and bioavailability followed by dosage development/utilization of new techniques such as computer-aided drug design (CADD) are strongly encouraged for these efforts. In addition, there is a need for the design of affinity labels to reveal receptor populations using positron emission tomography (PET) and other imaging procedures as diagnostic tools in normal and addicted populations, the development of new computer-assisted techniques for receptor mapping and utilization of theoretical methods to design new drugs and molecular probes. Priority areas include the synthesis of drugs to treat the toxic side effects of drugs of abuse (such as drugs to treat cardiotoxicity of cocaine), synthesis of Mu-1 receptor specific opioids, synthesis of cannabinoid and cocaine antagonists, synthesis of sigma/PCP receptor specific analogs, and synthesis of PCP receptor ligands that antagonize N-methyl-D-aspartate receptors (NMDA). Research Support Mechanisms Support mechanisms include: (1) research projects (R01), (2) program projects (P01), (3) small grants (R03), and (4) first independent research support and transition awards (R29). For details on a particular support mechanism or program, please contact the member of the program or review staff listed at the end of the announcement. Eligibility Application for research grants may be made by any public or private non-profit or for-profit institution such as universities, colleges, hospitals, laboratories, units of state or local government, private industry and eligible agencies of the Federal government. The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) urges applicants for grants to give added attention (where feasible and appropriate), to the inclusion of women and minority populations. Vol. 18, No. 23, July 7, 1989 - Page 4 Investigators should include sufficient women and minority group participants to permit generalization of results to the referenced populations. If women and minorities are not included in a given study, a clear rationale for their exclusion must be provided. Application Process Applicants interested in submitting P01 applications are strongly urged to consult the program staff listed at the end of this announcement, prior to preparing an application. Additional information for the preparation of the application and review criteria may be obtained from the review staff listed at the end of this announcement. State and local government agencies may use Form PHS 5161-1 Rev. 11/88). All other applicants should use the grant application Form 398 (Rev. 10/88). The title of this program announcement, Development of Medications-- Medicinal Chemistry Considerations, should be typed in item number 2 on the face page of the PHS 398 application form or in item 9 in PHS 5161-1 term. Receipt and Review Schedule Receipt Dates Initial Advisory Council Earliest New/Renewal Review Review Start Date June 1/July 1* Oct/Nov Jan/Feb Apr 1 Oct. 1/Nov. 1* Feb/Mar May/June July 1 Feb. 1/Mar. 1* May/June Sept/Oct Dec 1 *Amended applications (new or renewal) are to be submitted on these dates. Other components of ADAMHA and the National Institutes of Health (NIH) share an interest in several of the research areas described above. Projects may be submitted under this announcement that address issues in common with Institutes from either of these agencies. Joint funding of such projects is possible; however, preapplication consultation is strongly encouraged. Applications are considered for acceptance and assigned according to standing referral guidelines. Referencing this announcement does not guarantee assignment to the National Institute on Drug Abuse (NIDA). Consequences of Late Submission Applications received after the above receipt date are subject to assignment to the next review cycle or may be returned to the applicant. Review and Review Criteria The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an initial review group (IRG) in accordance with established PHS Referral Guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate National Advisory Council. Only applications recommended for approval by the Council may be considered for funding. Applications submitted in response to this Announcement are not subject to the intergovernment review requirements of Executive Order 12372, as implemented through Department of Health and Human Services regulations at 45 CFR Part 100 and are not subject to Health Systems Agency review. Criteria for scientific/technical merit review of regular research grant applications will include the following: significance and originality from a scientific and technical standpoint of the goals of the proposed research; adequacy of the methodology proposed to carry out the research; qualifications of the Principal Investigator and other key research personnel; availability of adequate facilities, other resources, and collaborative arrangements necessary for the research, appropriateness of budget estimates for the proposed research activities, and adequacy of provisions for the protection of human subjects and welfare of animal subjects as applicable. Criteria for other support mechanisms are contained in separate program announcements available from NIDA staff. Vol. 18, No. 23, July 7, 1989 - Page 5 Inquiries Contact for Detailed Program Information: Dr. Rao Rapaka Research Technology Branch Division of Preclinical Research NIDA, Room 10A-13 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-5280 Contact for Review Procedures/Policies: Dr. Rita Liu Executive Secretary Office of Extramural Program Review NIDA, Room 10-42 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-1644 or 443-2620 Contact for a copy of the complete program announcement and for application kits, if not available from your business office: Grants Management Branch NIDA, Room 10-25 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-6710 FOOTNOTE: This program is described in the catalog of Federal Domestic Assistance No. 13.279. Grants will be awarded under the authority of Section 301 of the Public Health Service Act, as amended (42 USC 241) and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Vol. 18, No. 23, July 7, 1989 - Page 6 FULL TEXT OF RFAs FOR ONLINE ACCESS EVALUATION OF COMMONLY USED ORTHOGNATHIC TREATMENT PROCEDURES RFA AVAILABLE: 89-DE-1 P.T. 34; K.W. 0755015, 0785040, 0710120, 0414000, 1010013 National Institute of Dental Research Application Receipt Date: January 15, 1990 The Craniofacial Anomalies, Pain Control And Behavioral Research Branch of the National Institute of Dental Research (NIDR) seeks research grant applications to conduct clinical trials evaluating commonly used orthognathic treatment procedures. This RFA is for a single competition with a receipt date of January 15, 1990. The RFA may be reissued at a later date. BACKGROUND Dentofacial malrelations usually result from disproportionate growth of the jaws and have an adverse impact on the quality of life. Psychological well-being and functions such as eating and communicating may be compromised and oral-facial pain can occur. The interdependence of orthodontists and surgeons in orthognathic treatment has been increasingly recognized in the past three decades. Orthodontic treatment alone can compensate for minor interjaw malrelations. As more severe jaw relationship problems are encountered, orthodontic treatment becomes a less satisfactory form of treatment and the combined skills of the orthodontist and surgeon are essential. However, surgical treatment of orthodontically uncompensated patients reduces the magnitude of the surgical correction obtained and unnecessarily compromises the results. The collaboration of other professionals in diagnosis, treatment planning and execution and follow-up is often sought in major centers. These include psychologists, plastic surgeons and maxillofacial prosthodontists. The majority of patients are adults. Treatment of children or teenagers is limited to those with exceptionally severe jaw discrepancies, because of the unpredictable impact on subsequent growth. It is thought that between five and fifteen percent of the U.S. population could benefit from orthognathic treatment. The number of patients treated has increased significantly over the past two decades. Surgeons have developed increasingly sophisticated procedures to adjust jaws in three dimensions. Alternative procedures to address similar problems are being advocated. Technological improvements in surgery, wound management, anesthesiology, fixation methods and orthodontic appliances have improved the safety and patient acceptance of treatments. Surgical costs vary between $2,500 and $5,000 per jaw; both jaws may require treatment and multiple surgeries may be needed. Estimates of costs for other professionals involved are not readily available. Hospitalization costs generally exceed $6,000. In the past, evaluations of orthognathic treatments have typically been published as retrospective reports of small series of patients. There have been few published reports of relapse or treatment failures, although anecdotal reports suggest that treatment outcomes are not always optimal. A number of factors has deterred the conduct of systematic clinical trials. The field has undergone rapid technical advances. Modifications of standard procedures have been introduced in rapid succession. The small number of patients treated using a specific procedure by any single team demands consortium arrangements, in order to obtain statistically valid treatment results. The conduct of multisite trials presents organizational difficulties. The need to reduce or eliminate observer bias, the desirability of randomizing subjects in prospective trials, the requirement for widely acceptable diagnostic criteria and quantitative measures of success have complicated the design of trials. Nevertheless, the state of the art has advanced sufficiently that prospective or retrospective clinical trials to evaluate some of the more commonly used orthognathic treatment procedures could now be conducted. RESEARCH GOALS The objective of this RFA is to solicit applications for support of clinical trials of commonly used orthognathic treatments for the correction of dentofacial malrelations. It is not intended to support studies of treatments for major congenital or acquired craniofacial defects or for problems originating in the temporomandibular joint (TMJ). Evaluations will require precise characterization of the pretreatment condition, rigorous implementation or analysis of the treatment plan, and precise measurement of the outcomes. The application should establish that a suitable, defined, study population is available or that data from a treated population are accessible. Study designs must be statistically sound and ethically acceptable. Prospective trials, though more expensive, may permit better control and completeness of record collection. Provided the ethical problems can be solved, prospective designs would allow randomization, which permits isolation of treatment effects from selection effects. This is important where pretreatment differences between subjects may bias their assignment to particular treatment groups. Less expensive retrospective evaluations of established procedures offer advantages in allowing long-term follow-up. This may be important in determining the extent of muscle adaptation to changed skeletal position and in assessing long-term patient satisfaction, for example. Decisions regarding experimental designs are left to the discretion of the applicant. Projects should be designed so that some specific aims can be met during the initial period of support (3-5 years). The following are examples of the types of issues which might be addressed; the list is not intended to be inclusive and applicants should feel free to propose clinical trials concerning other issues in orthognathic treatment. 1 Comparison of orthodontic, surgical and combined orthodontic-surgical treatments in patients with moderate ranges of vertical and horizontal skeletal discrepancies. 2 Determination of the impact of growth stage on the efficacy of treatment of maxillary and mandibular asymmetries in children and adolescents. 3 Evaluation of various surgical techniques for treatment of particular orthognathic problems. 4 Comparison of post-operative osseous fixation methods. 5 Evaluation of various naturally occurring and synthetic bone grafting materials used adjunctively in orthognathic surgery. 6 Determination of the contribution of newer imaging techniques in treatment planning to treatment outcomes. In evaluating the efficacy of different procedures or techniques the following parameters might be considered: post-operative airway obstruction, hemorrhage, infection, and paresthesia; tooth viability and stability; dental occlusion and facial esthetics; short- and long-term stability, including the development of new malrelations; effects on mandibular motion, bite force and chewing efficiency; neurosensory, speech, hearing and nasal and oral airway disturbances. The short- and long-range consequences of orthognathic treatment on the health of the TMJ need to be assessed. Psychosocial factors may be particularly important in assessing outcomes. The emotional impact of sudden changes in facial appearance deserves study. Patients' adjustments to dentofacial deformity, their motivation in seeking treatment and compliance during treatment, their satisfaction with the results of treatment, and its impact on psychosocial functioning and the quality of their lives all need to be evaluated. In order to obtain sufficiently large samples, it is likely that such trials would involve consortium arrangements, directed from major treatment centers. This may also reduce the effects of differences in patient management. Investigative teams might include specialists in oral, maxillofacial and plastic surgery, orthodontics, prosthodontics, psychology, speech pathology, clinical epidemiology and biostatistics. Consideration might be given to archiving raw data and the physical records from which they are derived and making them accessible to qualified investigators, while assuring the privacy of patients and clinicians. The development of such a shared data base could be an important outcome. MECHANISM OF SUPPORT Support for this program will be through research project grants (R01). It is anticipated that up to three awards will be made, if a sufficient number of high quality applications is received. Although funds have been allocated for this program in NIDR's plans for fiscal years 1990 through 1994, award of grants resulting from this RFA is contingent upon receipt of appropriated funds for this purpose. Applicants may request up to five years of support. Subsequent support will be contingent upon program needs and grantees' performance, as determined by peer review. Policies that govern research grant programs of the National Institutes of Health will prevail. APPLICATION AND REVIEW PROCEDURES Applications in response to this RFA will be reviewed by a Special Review Committee convened by the NIDR's Scientific Review Branch. Secondary review will be by the National Advisory Dental Research Council in May 1990. Review criteria include the significance and originality of the research goals and approaches; feasibility of the research and the adequacy of the study design; availability and appropriateness of the study populations or clinical data; plans for data processing and analysis; training, experience and research competence of the investigator(s); adequacy of facilities; provisions for protection of human subjects; and the appropriateness of the requested budget for the work proposed. Funding decisions will be based on the initial review group's and the National Advisory Dental Research Council's recommendations concerning scientific merit and program relevance, and the availability of appropriated funds. The earliest funding date is July 1, 1990. Applications should be submitted on form PHS-398 (Rev. 10/88), available in the business or grants office of most academic or research institutions or from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health. Applications received after January 15, 1990, and those which are deemed nonresponsive to the RFA will be assigned to a Division of Research Grants Study Section for initial review and will be considered with other nonsolicited grant applications received during that review cycle. To identify the application as a response to this RFA, check "yes" on item 2 of page 1 of the application and enter RFA: 89-DE-1 "EVALUATION OF ORTHOGNATHIC TREATMENTS." The RFA label available in the 10/88 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 your application such that it may not reach the review committee in time for review. The original and four copies must be received by January 15, 1990, at: Grant Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** Two copies should be sent to: John D. Townsley, Ph.D. Chief, Craniofacial Anomalies, Pain Control and Behavioral Research Branch National Institute of Dental Research Westwood Building, Room 506 Bethesda, MD 20892-4500 Telephone: (301) 496-7807 Inquiries concerning this RFA may be addressed to Dr. Townsley. This program is described in the Catalog of Federal Assistance No. 13.122. Awards will be made under authorization of the Public Health Service Act, Title III. Section 301 (Public Law 78-410, as amended), and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. A N I M A L R E S O U R C E S P R O G R A M I N F O R M A T I O N F O R A P P L I C A N T S RFA 89-RR-03 ANIMAL FACILITY IMPROVEMENT FOR SMALL RESEARCH PROGRAMS P.T. 34; K.W. 1002002, 0201011 An Administrative Document Issued By: Animal Resources Program Division of Research Resources National Institutes of Health Department of Health and Human Services July 1989 INTRODUCTION The Animal Resources Program (ARP) of the Division of Research Resources (DRR), National Institutes of Health (NIH), assists institutions in developing and improving animal resources for biomedical research and research training through the award of research and resource grants. For the purpose of this program, animal resources are defined as all animals, their associated facilities, and staff which support biomedical research activities. The ARP supports various activities which assist in meeting the animal resource needs of investigators, the public demand, and legal requirements for proper care of laboratory animals. This document relates to institutional animal resource improvement projects which will be supported with funds made available to the Department of Health and Human Services (DHHS) in Fiscal Year 1990 for this activity. PROGRAM GOALS AND SCOPE Animal resource improvement grants are awarded to assist biomedical research and educational institutions in upgrading their animal facilities and in developing centralized programs of animal care. Another major objective is to enable institutions to comply with the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. Allowable requests include alterations and renovations (A&R) to improve laboratory animal facilities; major resource equipment related to the improvement, such as animal cage systems and cage washers; and large pieces of basic equipment for centralized surgeries or diagnostic laboratories. This improvement grant is not intended to provide operational support for the resource (e.g., funding for personnel, consumable supplies for routine animal care, or small equipment items costing less than $1,000 per manufacturer's unit). Equipment to monitor/provide animal facility security is also not acceptable. To gain approval and support, both the need for resource improvements and a sound plan to bring the entire animal resource up to required standards must be demonstrated and well-described in the context of the biomedical research programs of the institution. It is expected that an institution will take over complete financial responsibility for its basic animal resource as soon as full results from the development and improvement program are available for use by its investigators. ELIGIBILITY AND SUPPORT Any domestic public or private institution, organization, or association, with one or more research projects that involves the use of laboratory animals and is supported by the Public Health Service (PHS) at the time of award, is eligible to apply. However, the total PHS support in the last fiscal year for projects using animals must have been less than $500,000. An institution that applies to this program may not, within the same fiscal year, also apply for support under RFA 89-RR-02, Developing and Improving Institutional Animal Resources. The applicant institution is strongly encouraged to develop a single proposal for a campus-wide program with a single, centralized animal care program whenever possible. The total cost of the proposed project may be of any size. However, for the purposes of this program, the request to PHS for equipment is limited to $150,000, and for A&R is limited to $100,000. Matching funds are not required. Support for new construction, including completion of shell space, is not authorized. Following the actual award, funds for A&R will not be released until final architectural drawings, specifications, and updated cost estimates are received and approved by DRR. Awards will be made for a period of one year, and are not renewable. However, this does not preclude the submission of applications for additional improvements or support for other types of animal resource activities in subsequent fiscal years. DRR anticipates that approximately $1.0 million may be available to support these animal resource improvement grants in Fiscal Year 1990. It is anticipated that six to eight awards will be made. The number and specific amounts of these awards will depend on the merit and scope of the applications received and the availability of funds. All policies and requirements which govern PHS grant programs will apply. If this program is successful, it may be expanded in future years. A previous three-year program for facility improvement that also provided support for supplies and new personnel, will no longer be available. REVIEW PROCEDURES AND CRITERIA Applications will be received by the Division of Research Grants (DRG). Applicants must use Form PHS 398 (Rev. 10/88), "Application for Public Health Service Grant." There will be a single receipt date of December 4, 1989. Applications received after this date will be returned without further processing. All applications will be reviewed by Special Review Committees managed by DRR for scientific merit, and by the National Advisory Research Resources Council for program considerations. Review of animal resource improvement projects will be based on the request itself as well as on the entire animal resource program to which the specific improvement request relates. Factors entering into the appraisal of an animal resource improvement project include: A. The Improvement Request 1. Need - The extent to which the project will fill a need of the research and educational community to be served by the resource will be an important part of the evaluation. Evidence of the necessity of resource grant support for improvements in order for the institution to meet the standards of the Animal Welfare Act and DHHS policies on the care and use of animals should be demonstrated. The amount and source(s) of funding for animal related biomedical research utilizing the resource will also be evaluated. 2. Procedural Plans - Evidence of campus-wide planning to assure a comprehensive and acceptable research animal program will be evaluated. The specific methods proposed will be judged for scientific and technical soundness and their ability to meet the applicable standards. 3. Budget - The budget will be evaluated in relation to the program scope, institutional commitment, and the justification provided for the requested items. B. The Animal Resource Program 1. Animal Care - The quality of the proposed animal husbandry program will be considered, including training of the animal technical staff, housing, caging, feeding, record keeping, sanitation, and other animal care practices. Consideration of the animal health program will include clinical services, laboratory support, preventive medicine programs, and any relevant specialized procedures. 2. Personnel - The adequacy of the staff will be evaluated. There should be a sufficient number of professional staff with appropriate qualifications to operate the animal resource in a competent manner. Provisions should be made for an adequate number of appropriately trained non- professional staff and supporting services. An appropriate preventive health program should be in place. 3. Administrative Arrangements - An evaluation will be made of the administrative arrangements for planning and day-by- day management of the animal resource. There should be a sound plan for financial support of the resource, e.g., through a recharge system. Previous expenditures by the institution for capital improvements of the animal resource program should be described. 4. Resources and Environment - The suitability of the institutional setting for achieving the goals of the program will be considered. This will include an appraisal of the academic environment and the support for the animal resource by the administration and faculty. The adequacy of the physical environment, buildings, and equipment for the animal resource will be evaluated. APPLICATION PROCEDURES Applications must be submitted on Form PHS 398 (Rev. 10/88), the application form used for research grants. Application kits can be obtained from most institutional business offices, or from the Division of Research Grants, NIH, (see address below). The RFA label, which is included in Application Form PHS 398 (located at the end of the instruction pages and immediately before the additional instruction pages for RCDA applications), must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of your application such that it may not reach the review committee in time for review. The format and details applicable to regular research grant applications should be followed, except for the following: SECTION 1 A. Face Page of the Application - Item 2 - Check the box marked "Yes" and type in the number and title of this RFA (RFA #89-RR-03, "Animal Facility Improvement for Small Research Programs"). Item 5 - Check the box marked "No" at Item 5a. Item 5b - Not applicable. B. Key Personnel - Application Page 2 - All key personnel should be listed here with the percent effort to be devoted to the animal resource even though salary support is not requested. This must include the chief or consulting veterinarian. It may also include the principal investigator, director of the animal facility, or chief animal technician as appropriate. Biographical sketches must be provided for all people listed. C. Table of Contents - Indicate page numbers for all major headings outlined under Section 1 and Section 2, Research Plan. This is an important aid for the reviewers of the application. D. Detailed Budget - Application Page 4 - The requested budget should be limited to allowable items described under ELIGIBILITY AND SUPPORT (see above). Equipment should be classified as movable or fixed using the applicant's institutional classification guidelines. The request for the equipment should appear in the appropriate category, i.e., movable equipment in the equipment category and fixed equipment in the A&R category. Small equipment items costing less than $1,000 per manufacturer's unit should not be requested. This includes multiple polycarbonate rodent cages for replacement or change-out purposes. To avoid deletion during review, requests for items that may require the purchase of small component parts, such as a rack and cages, should be priced as a single unit, but the individual components must be described in the description (see below). Large pieces of basic surgical equipment, such as tables, lights, and gas anesthesia machines may be requested if the operating room is an integral part of the animal facility and is available to all investigators. Such a request must be justified by listing the number of investigators, case load, and types of surgeries involved. Similarly, basic diagnostic equipment to be used in support of the animal facility, but not for research, will be allowed if adequate justification is given. Office equipment (including data processing items), and research equipment should not be requested. Each major equipment item must be carefully described. The manufacturer, model number, size, capacity, or design criteria, total unit cost and facility where it will be used must be given. This information should be provided on a separate page immediately following the budget. It should not be in the Appendix. The total cost of the project may be of any value. However, the request for PHS support of A&R may not exceed $100,000, and for equipment may not exceed $150,000. These data should be summarized in tabular form (contact Animal Resources Program, address below, for directions). E. Budget for Entire Proposed Project Period - Application Page 5 - Not applicable. F. Justification - Application Page 5 - Justification should be provided for all equipment items requested in terms of the proposed improvement program. Failure to adequately justify each requested item will likely result in its deletion from the recommended budget. In this section, justification may be brief, e.g., "The cage washer is needed to wash cages in the Life Sciences Center because the current one frequently breaks down and new parts are no longer available." More extensive justification must be provided in the body of the narrative (SECTION 2, D.2.f.). Information, such as the species and number of animals, cages, tests or surgeries involved, should be provided as appropriate. The location and use of each piece of equipment should be clearly described. The failure to adequately justify budget items has been a major weakness of applications in the past. G. Summary Sheets - (contact Animal Resources Program at the address below for directions). These sheets have been developed to assist investigators in the preparation of the application as well as to assist the reviewers in their review of the application. They should be filled out as appropriate and placed between the Budget Justification and the Biographical Sketches section of the application. SECTION 2. - Research Plan The points identified under REVIEW PROCEDURES AND CRITERIA, should be kept in mind when this section is prepared. Please note the instructions on Page 20 of Form PHS 398 concerning the limitation of 20 pages for Sections A-D of the Research Plan. A. Specific Aims - (Limit to 1 page) Clearly present the aims of the animal resource improvement project and relate them to the short- and long-term goals of the institution's animal resource program. B. Background and Significance - (Limit to 2-3 pages) This part should demonstrate the institution's overall involvement in animal related research. In addition, the following information for the last fiscal year should be provided as shown on the sample Data Sheet (contact Animal Resources Program at the address below for directions): 1) the institution's total annual research budget that involves the use of animals; 2) the annual dollar level from PHS vs. non-PHS sources that make up this budget; and 3) the institution's total number of projects using laboratory animals. Failure to provide this data will weaken the application. This section should also be used to relate the significance of the proposed resource improvement project to the institution's overall biomedical research programs, as well as to the research projects that will be affected. If the resource will be used by a relatively small number of research projects, a brief description of those projects, including the source and amount of funding on an annual basis for each, must be indicated. At least one currently active, PHS-supported research project, which involves the use of animals in the facility to be supported, must be identified to be eligible for award. C. Progress Report/Preliminary Studies - Not applicable. D. Experimental Design and Methods - This section should provide an overall description of the institution's animal care and use program. It should also demonstrate how the facility improvement program will enhance the resource, and how it fits into the institution's overall plan to meet or maintain PHS standards for animal care and use. The equipment items requested should be justified as part of this narrative. The A&R request should be described/justified as indicated in Paragraph 2.g. below. 1. Introduction - Provide relevant background information and a description of the current status of the institution's animal resource facilities and program as they relate to biomedical research and research training. Include relevant information regarding deficiencies in the animal care program cited by the American Association for Accreditation of Laboratory Animal Care (AAALAC), the Institutional Animal Care and Use Committee (IACUC) facility review reports, and the institution's PHS Animal Welfare Assurance Statement. Any problems in meeting the provisions of the Animal Welfare Act should also be addressed. This information is an important means to document the need for facility improvement support. 2. Project Plan - This section should describe how the requested improvements will accomplish the Specific Aims presented in Item A. It is important to show how the requested improvements will correct the deficiencies and problems documented above. This part should also include a description of the following aspects of the animal resource and an explanation of how they would be affected by the project plan: a. Administrative arrangements and structure of the animal resource. The lines of authority and responsibility for administering the institution's program for the care and use of animals should be clearly presented. The role and composition of the IACUC and how compliance with relevant laws, policies, and guidelines is achieved should be included. The campus-wide planning process which resulted in this proposal should be described. b. Animal care procedures and the animal health program. This section should include information on veterinary oversight, vendor surveillance, conditioning programs, colony and environmental monitoring, and diagnostic capabilities in anatomic pathology, clinical chemistry, hematology, and microbiology. The general description of the animal care program should be supported by data which characterizes various activities, such as numbers of laboratory procedures for health monitoring and disease diagnosis, veterinary inspections for animal health, etc. If specialized equipment, such as microisolators, is requested, it should be part of an overall system, and the husbandry program to utilize this equipment should be carefully outlined. Failure to carefully describe the basic program of animal care, including veterinary care, has been a major weakness of many applications. c. Outline the total staff and functional organization of the animal resource, both current and planned following the requested improvements. Outline the qualifications of the animal care staff and the training opportunities available to them. d. List all financial support for the animal resource, including sources and amounts (e.g., recharge, core funding from the institution, etc.) and the operating budget (listed by major categories). Provide a copy of per diem and service charge schedules and indicate their method of determination. This latter information may be included in an Appendix. e. Expenditures for capital improvements (facilities and equipment) during the past five years and future plans for such needs should be described. Any previous support for improvement of the institution's animal facilities from the Animal Resources Program, DRR, NIH, should be noted. How the support was utilized and the effect on the animal care program should be described briefly. f. Provide a brief description of all on- and off-campus animal facilities, including sites where experimental surgery is performed. Indicate who is responsible for the direction and day-to-day management of each animal facility. It is in this section that the need for specific items of equipment should be justified as related to the various facilities where they will be located (See D.2.g. below for A&R). The reason for the need, the facility that will be affected, and the ultimate improvement of the overall animal care program should be clearly described. As shown on the sample Data Sheet (sample available from the Animal Resources Program at the addresss below), indicate the number of animals (by species) used or produced per year, and the average daily census for each major component of the animal resource. If equipment is requested for surgical or diagnostic facilities, the case load, species, and types and numbers of surgeries or diagnostic tests must be documented on the Data Sheet. These data are critical to the evaluation of the application, as well as for the justification of need. g. For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be supplied. (See sample format for cost estimates, which is available from the Animal Resources Program at the address below). The total PHS support for this category is limited to $100,000. If the total cost for A&R exceeds this amount, the source(s) of additional funds must be provided. If multiple sites are involved, the A&R, including the cost estimate proposed for each site, should be described separately. The following narrative format should be followed: Narrative Summary (1) Relate the proposed renovations to projected animal populations by the species and research projects that will utilize the facility. Daily and annual census data (by species) must be provided. The animal care and use program for the animal facility which is to be renovated must be well described in D.2.b., Animal care procedures and the animal health plan, above. (2) List the functional components and size and square footage of each component (room, alcove, cubicle, etc.) that will be directly affected by the renovation project. (3) List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, steam, etc. (4) List appropriate architectural criteria, such as width of corridors and doors, surface finishes, etc. (5) List all fixed equipment requested for the renovated area. (6) List all movable equipment requested for the renovated area. Line Drawings (On 8-1/2" x 11" paper only, DO NOT SUBMIT BLUEPRINTS) All floor plans must be legible, with the scale clearly indicated. (1) The plot plan should indicate the location of the proposed renovation area in the building. (2) Include the as-built drawings of the proposed renovation area and indicate any demolition. (3) Provide the architectural plan(s) of the proposed renovation at a scale adequate to explain the project. The plans should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given. (4) Changes or additions to existing mechanical and electrical systems should be clearly narrated in notes made directly on the plan or attached to the plan. (5) A Finish Schedule, indicating the type of new finishes to be applied to room surfaces, should be included in the plan. SECTION 3. Appendix Material All information critical for the review must be included in Sections 1 and 2 of the application. Be very selective and include only relevant supplementary information in the appendix. Do not include standard references or other generally available information. Six collated sets of the appendix material should be included in the application package. All appendix material must be identified with the name of the Principal Investigator and the institution. Do not mail this appendix material separately, but include it with the original grant application. APPLICATION PROCEDURE 1. The completed original application and four copies should be mailed or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** 2. An additional two copies of the application should be mailed to: Dr. Arthur Schaerdel, Executive Secretary Animal Resources Review Committee Division of Research Resources Westwood Building, Room 10A16 National Institutes of Health 5333 Westbard Avenue Bethesda, Maryland 20892 To ensure their timely review, applications must be received by December 4, 1989. Applications received after this date will be returned without further processing. This one time request for applications is based on the Fiscal Year 1990 President's budget. INQUIRIES ABOUT APPLICATION AND OTHER ASPECTS OF THE PROGRAM SHOULD BE DIRECTED TO: Animal Resources Program Division of Research Resources Westwood Building, Room 853 National Institutes of Health 5333 Westbard Avenue Bethesda, Maryland 20892 Telephone: (301) 496-5175 APPLICATION FORMS (PHS 398) MAY BE OBTAINED FROM: Office of Grants Inquiries National Institutes of Health Westwood Building, Room 440 5333 Westbard Avenue Bethesda, Maryland 20892 Telephone: (301) 496-7441