Vol. 18, No. 15, April 28, 1989 NOTICES CHANGE IN THE NUMBERS OF COPIES OF APPLICATIONS TO BE SUBMITTED FOR AIDS EXPEDITED REVIEW ........................(84/103)......... 1 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration Index: NATIONAL INSTITUTES OF HEALTH ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION HEALTH AND SAFETY GUIDELINES FOR GRANTEES AND CONTRACTORS ..(106/220)........ 1 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration Index: NATIONAL INSTITUTES OF HEALTH ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION REVISED GUIDELINES FOR CORE GRANTS .........................(223/258)........ 2 National Eye Institute Index: EYE REVISED GUIDELINES FOR CLINICAL VISION RESEARCH DEVELOPMENT AWARD ........... 3 National Eye Institute (261/291) Index: EYE IMPLEMENTATION OF EXPANDED AUTHORITIES FOR GRANTEE ORGANIZATIONS ............ 3 Alcohol, Drug Abuse, and Mental Health Administration (294/351) Index: ALCOHOL, DRUG ABUSE, MENTAL HEALTH DATED ANNOUNCEMENTS (RFPs AND RFAs) COORDINATING CENTER FOR AN ASSESSMENT OF THE EFFICACY OF MINOCYCLINE IN THE TREATMENT OF RHEUMATOID ARTHRITIS (RFP) .............(357/388)........ 4 National Institute of Arthritis and Musculoskeletal and Skin Diseases Index: ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES CLINICAL CENTERS FOR AN ASSESSMENT OF THE EFFICACY OF MINOCYCLINE IN THE TREATMENT OF RHEUMATOID ARTHRITIS (RFP) .............(401/433)........ 5 National Institute of Arthritis and Musculoskeletal and Skin Diseases Index: ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES CULTURED NEURON PROBE (RFP) ................................(436/469)........ 5 National Institute of Neurological Disorders and Stroke Index: NEUROLOGICAL DISORDERS, STROKE A FACILITY FOR ANIMAL MODELS FOR VIRAL HEPATITIS EXPERIMENTS (RFP) .......... 6 National Institute of Allergy and Infectious Diseases (481/526) Index: ALLERGY, INFECTIOUS DISEASES OPERATE CAENORHABDITIS GENETIC CENTER (RFP) ................(529/555)........ 6 Division of Research Resources Index: RESEARCH RESOURCES PRESOLICITATION: COLLABORATIVE STUDIES FOR METHODOLOGIC RESEARCH FOR MULTI-SITE EPIDEMIOLOGIC SURVEYS OF MENTAL DISORDERS IN CHILD AND ADOLESCENT POPULATIONS (RFA) ...............................(561/662)........ 7 National Institute of Mental Health Index: MENTAL HEALTH AIDS AND ITS BEHAVIORAL CAUSES: CHILDREN'S KNOWLEDGE AND EMOTIONS (RFA) .... 8 National Institute of Child Health and Human Development (665/853) National Institute of Mental Health (1124/1615) National Institute on Drug Abuse Index: CHILD HEALTH, HUMAN DEVELOPMENT, MENTAL HEALTH, DRUG ABUSE DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES (RFA) ..(856/951)....10 Division of Research Resources (1618/2190) Index: RESEARCH RESOURCES ONGOING PROGRAM ANNOUNCEMENTS EPIZOOTIOLOGY AND TRANSMISSION OF LYME BORRELIOSIS .............(964/1107)...12 National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES NOTICES CHANGE IN THE NUMBERS OF COPIES OF APPLICATIONS TO BE SUBMITTED FOR AIDS EXPEDITED REVIEW P.T. 34; K.W. 1014002, 1014006 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration The number of copies of applications required for investigator-initiated AIDS research project grant (R01) or First Independent Research Support and Transition (FIRST) award (R29) applications for expedited review has been changed. Beginning with the May 2, 1989, receipt date, applicants to NIH and ADAMHA will be required to submit the ORIGINAL APPLICATION PLUS 24 LEGIBLE COPIES instead of the presently required 32 copies. The number of copies of appendix materials remains at 6. This announcement supercedes the earlier notice published in the NIH Guide for Grants and Contracts, Vol. 17, No. 13, page 1, April 8, 1988. Applicants for other mechanisms of AIDS research, development, and training support should refer to the earlier notices from the NIH Guide (Vol. 17, No. 9, March 11, 1988) for the correct numbers of copies to be submitted and other relevant information. HEALTH AND SAFETY GUIDELINES FOR GRANTEES AND CONTRACTORS P.T. 34; K.W. 1014002, 0725010, 0725020 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration This notice is a republication, with minor modifications, of a November 1988 issuance on this subject. It is being reissued to emphasize its continuing importance. Organizations receiving grant or contract awards are responsible for protecting their personnel from hazardous conditions. The Government is not legally liable for accidents, illnesses, or claims arising out of research performed under its awards, but the National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) are nonetheless aware that a variety of hazards threaten the safety and health of both laboratory and clinical research personnel. Accordingly, the guidelines that follow are designed to (1) identify potential hazards, (2) advise awardee organizations and investigators of certain standards that should be considered in order to address particular health and/or safety concerns, and (3) emphasize that concerns about potentially hazardous conditions could result in grant or contract funding delays until those concerns have been resolved to the satisfaction of the awarding component. 1. Sources of potential danger to research personnel include the following classes of hazard: a. Biohazards (e.g., Human Immunodeficiency Virus, HIV; other infectious agents; oncogenic viruses). b. Chemical hazards (e.g., carcinogens; chemotherapeutic agents; other toxic chemicals; flammable or explosive materials). c. Radioactive materials. 2. The following guidelines and standards contain information designed to assist grantees and contractors in providing a safe work environment for research personnel. Therefore, depending upon the particular safety hazard at issue, grantees and contractors are expected to consult these standards. a. Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services, Centers for Disease Control and the National Institutes of Health. HHS Publication No. (CDC) 88-8395. b. Recommendations for Prevention of HIV Transmission in Health-Care Settings. Morbidity and Mortality Report, August 21, 1987, Vol. 35, No. 2S. c. Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Settings. Morbidity and Mortality Weekly Report, June 24, 1988, Vol. 37, No. 24. Vol. 18, No. 15, April 28, 1989 - Page 1 d. Agent Summary Statement for Human Immunodeficiency Viruses (HIV); Included are HTLV-III, LAV, HIV-1, and HIV-2. Morbidity and Mortality Weekly Report, April 1, 1988, Vol. 37, No. 24. e. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. f. NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH Publication NO. 81-2385. g. Guidelines for Research Involving Recombinant DNA Molecules (49 FR 46266 or latest revision) and Administrative Practices Supplement. h. Procedures for the Domestic Handling and Transport of Diagnostic Specimens and Etiologic Agents, National Committee for Clinical Laboratory Standards, July 17, 1985, Vol. 5, No. 1. i. Standards issued pursuant to the National Occupational Safety and Health Act of 1970 (29 CFR 1910). j. Standards issued pursuant to the Atomic Energy Act of 1954 (42 USC 2021). 3. Grant applications and contract proposals posing special hazards typically are identified during the initial review process, but such concerns can formally be expressed by agency staff or consultants at any time prior to award. Regardless of the timing of the described concern, grant or contract funding could be delayed until the matter has been resolved to the satisfaction of the awarding component. Special hazards that are identified after an award is made may lead to suspension of work under the grant or contract pending corrective action by the awardee. (See 45 CFR 74, Subpart M, concerning grant suspension and 48 CFR 12.5 concerning contract "stop work" orders.) 4. The materials identified in section 2 (a-h) of this notice may be obtained as follows. ITEMS a-f: Division of Safety Office of Research Services National Institutes of Health Building, 31, Room 1C02 Bethesda, Maryland 20892 ITEM g: Office of Recombinant DNA Activities Office of Science Policy and Legislation National Institutes of Health Building 31, Room 4B11 Bethesda, Maryland 20892 ITEM h: National Committee for Clinical Laboratory Standards 771 East Lancaster Avenue Villanova, Pennsylvania 19085 5. Grantee and contractor organizations are not required to submit documented assurance of their specific attention to the guidelines and standards identified in section 2 of this notice. However, where dictated by the circumstances, grantees and contractors should be able to provide evidence that pertinent health and safety standards have been considered and, where necessary, have been put in practice. Such evidence may be requested by appropriate NIH and ADAMHA staff; for example, during a site visit. REVISED GUIDELINES FOR CORE GRANTS P.T. 34; K.W. l002046, 07l0030, 07l5l00 National Eye Institute The National Eye Institute (NEI) has recently revised its application guidelines for Core Grants for Vision Research (P30). The objectives of the NEI Core Grant Program are: (l) to enhance an institution's environment and capability for conducting vision research; (2) to facilitate collaborative studies of the visual system and its disorders; and (3) to attract scientists of diverse disciplines to research on the visual system. To be eligible for Core Grants, institutions must have at least four NEI-supported investigators, each with at least two years of committed support remaining on a regular research grant (R0l), FIRST award (R29), or MERIT award Vol. 18, No. 15, April 28, 1989 - Page 2 (R37) at the time of submission of the application. The NEI currently provides up to $750,000 (direct costs) over a 5-year period in support of a Core Grant. An exception to this limit may be made for applications requesting a Biostatistics Module. Applications that specifically include such a module may request up to $l,050,000 (direct costs) over a 5-year period. The purpose of a Biostatistics Module would be the development of staff and other resources needed to enhance programs of clinical vision research through the application of epidemiologic and biostatistical methodology to clinical problems. The NEI has one receipt date for Core Grant applications: June l of each year. Copies of the new guidelines may be obtained by contacting: Ralph J. Helmsen, Ph.D. Research Training and Resources Officer National Eye Institute Building 3l, Room 6A48 Bethesda, Maryland 20892 Telephone: (30l) 496-5884 REVISED GUIDELINES FOR CLINICAL VISION RESEARCH DEVELOPMENT AWARD P.T. 34; K.W. l002046, 0785035 National Eye Institute The National Eye Institute (NEI) has recently revised its application guidelines for the Clinical Vision Research Development Award (R2l). The objective of the Clinical Vision Research Development Award is to encourage more clinical vision research groups to provide leadership in the design, coordination, and conduct of clinical trials and other epidemiologic research projects. The NEI will provide for this purpose up to $60,000 (direct costs) per year for up to five years. This award cannot be renewed. To be eligible for an R2l award, institutions must have at least two participating investigators with an active NEI grant, contract, or cooperative agreement award to conduct clinical research. Institutions that apply for or already receive NEI Core Grant support (P30) ARE NOT eligible for an R2l award. Support for the kinds of clinical research activities described above can be requested in a new, competing continuation, or supplemental Core Grant application, by including a Biostatistics Module. The NEI has one receipt date for Clinical Vision Research Development Award applications: June l of each year. Copies of the new guidelines may be obtained by contacting: Richard L. Mowery, Ph.D. Chief, Collaborative Clinical Research Branch National Eye Institute Building 3l, Room 6A5l Bethesda, Maryland 20892 Telephone: (30l) 496-5983 IMPLEMENTATION OF EXPANDED AUTHORITIES FOR GRANTEE ORGANIZATIONS P.T. 34; K.W. 1014002, 1014006 Alcohol, Drug Abuse, and Mental Health Administration In March 1986, five Federal agencies and ten universities in the State of Florida under the auspices of the Government/University/Industry Research Roundtable of the National Academy of Sciences, National Research Council, began a demonstration project (the "Florida Demonstration Project") designed to address ways in which unnecessary administrative burdens on sponsored research could be eliminated. Based on a review of the results of the Florida Demonstration Project, the Office of Management and Budget (OMB) authorized Federal agencies to make routine use of the most successful features of the project which were designed to reduce overhead costs and increase research productivity. Consequently, the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) implemented these expanded authorities for grantee organizations on applicable research awards beginning February 1, 1989. The ADAMHA implemented the expanded authorities for grantees consistent with the notice in the NIH Guide for Grants and Contracts, Vol. 17, No. 34, October 21, 1988 - Page 1. PHS plans to provide comprehensive policy guidance which will incorporate the expanded authorities in routine grants administration. The PHS-wide changes Vol. 18, No. 15, April 28, 1989 - Page 3 will be incorporated in the PHS Grants Policy Statement and the PHS Grants Administration Manual. Until the PHS policy is issued, the four expanded authorities (extension without additional funds, incurrence of preaward costs, carryover of unobligated balances, and cost related prior approvals) and all remaining cognizant awarding agency prior approval authorities will be implemented in accordance with the October 21, 1988 NIH Guide announcement. The expanded authorities apply to all the "R" series grant award mechanisms except: R10 Cooperative Clinical Research Grants R18 Research Demonstration and Dissemination Projects; and R43, R44 Small Business Innovation Research Grants. In addition, an awarding component may specifically exclude a grant award from those authorities when deemed necessary by programmatic and/or administrative considerations, for example, clinical trials supported by a regular research project (R01). In such cases, special conditions will be stated on the Notice of Grant Award. Further, because ADAMHA and NIH possess a common constituency of grantees, ADAMHA is making these expanded authorities retroactive to October 1, 1988, to provide for a uniform implementation and avoid possible grantee confusion. For covered research awards made between October 1, 1988 and January 31, 1989, ADAMHA will issue revised awards that indicate application of the expanded authorities. However, even though the policy is being made retroactive, grantee institutions are not authorized to override written grants management officer disapprovals of prior approval requests made during the period October 1, 1988 to January 31, 1989. DATED ANNOUNCEMENTS (RFPs AND RFAs) COORDINATING CENTER FOR AN ASSESSMENT OF THE EFFICACY OF MINOCYCLINE IN THE TREATMENT OF RHEUMATOID ARTHRITIS RFP AVAILABLE: RFP-NIH-NIAMS-89-2 P.T. 34; K.W. 0755015, 0755018, 0715010 National Institute of Arthritis and Musculoskeletal and Skin Diseases The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is seeking organizations to serve as the coordinating center for a multicenter, randomized, double-blind, placebo-controlled clinical trial that will assess the efficacy of minocycline hydrochloride in the treatment of rheumatoid arthritis. The coordinating center will participate with five clinical centers and the NIAMS in all phases of the clinical trial. This Request for Proposal, RFP No. NIH-NIAMS-89-2, will be issued on or about April 25, 1989, with a closing date set for July 25, 1989. To receive a copy of this RFP, please supply this office with two self-addressed mailing labels and cite the RFP number referenced above. Requests must be in writing and addressed to: Shirley A. Shores Contracts Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institutes of Health Westwood Building, Room 602 Bethesda, Maryland 20892 This advertisement does not commit the Government to make an award. Vol. 18, No. 15, April 28, 1989 - Page 4 CLINICAL CENTERS FOR AN ASSESSMENT OF THE EFFICACY OF MINOCYCLINE IN THE TREATMENT OF RHEUMATOID ARTHRITIS RFP AVAILABLE: RFP-NIH-NIAMS-89-3 P.T. 34; K.W. 0755015, 0715010, 0745070 National Institute of Arthritis and Musculoskeletal and Skin Diseases The National Institute of Arthritis and Musculoskeletal Skin Diseases (NIAMS) is seeking organizations to serve as the clinical centers for a multicenter, randomized, double-blind, placebo-controlled clinical trial that will assess the efficacy of minocycline hydrochloride in the treatment of rheumatoid arthritis. The clinical centers will participate with a coordinating center and the NIAMS in all phases of the clinical trial. This Request for Proposal, RFP No. NIH-NIAMS-89-3, will be issued on or about April 25, 1989, with a closing date set for July 25, 1989. The Institute expects to fund four to five centers for this study. To receive a copy of this RFP, please supply this office with two self-addressed mailing labels and cite the RFP number referenced above. Requests must be in writing and addressed to: Shirley A. Shores Contracts Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institutes of Health Westwood Building, Room 602 Bethesda, Maryland 20892 This advertisement does not commit the Government to make an award. CULTURED NEURON PROBE RFP AVAILABLE: RFP-NIH-NINDS-89-22 P.T. 34; K.W. 0710050, 0705055, 0780020 National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke (NINDS) has a requirement to investigate the feasibility of establishing connectors with specific target neuronal populations in the mammalian central nervous system (CNS) by developing and evaluating a cultured neuron probe. Offerors should have experience in culturing neurons and electrophysiological techniques for stimulating and recording from neurons. This is an announcement of an anticipated Request for Proposals. RFP-NIH-NINDS-89-22 will be issued on or about May 1, 1989, with a closing date of July 3, 1989, for receipt of proposals. It is anticipated that one contract award will be made. To receive a copy of the RFP, please supply this office with two self-addressed mailing labels. All responsible sources may submit a proposal which will be considered by the agency. The RFP will be available upon request to: Contracting Officer Contracts Management Branch National Institute of Neurological Disorders and Stroke, NIH Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, Maryland 20892 Vol. 18, No. 15, April 28, 1989 - Page 5 A FACILITY FOR ANIMAL MODELS FOR VIRAL HEPATITIS EXPERIMENTS RFP AVAILABLE: RFP-NIH-NIAID-OSD-90-18 P.T. 34; K.W. 1002002, 1002045, 0715125, 0755020 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 to house and maintain non-human primates and woodchucks for use in viral hepatitis experiments. Respondents must have facilities capable of housing approximately 85 non-human primates at all times (up to 25 infant and juvenile chimpanzees, and 60 marmosets or monkeys). Additionally, up to 25 other small animals (primarily woodchucks, but occasionally rabbits and guinea pigs) will be held. It is required that such facilities have the capacity to move air through isolation units at a rate of 12-15 air changes per hour. The facility must have a back-up generator to immediately compensate for any power failures that may occur. In addition, the facilities proposed by the offeror must include a waste disposal system capable of sterilizing all waste material prior to release into available sewage systems. Animals, caging, and isolation units will be provided by the Government. Any contract awarded will be subject to DHHS regulations regarding the use of animal subjects in research. One contract may be awarded as a result of this solicitation. It is expected that the contract will have a five-year period of performance. The issuance of the RFP will be on or about April 28, 1989, and proposals will be due by the close of business on June 12, 1989. Any responsible offeror may submit a proposal which will be considered by the Government. Requests for the RFP should be directed to: Mr. Thomas C. Porter, Contracting Officer Contract Management Branch National Institute of Allergy and Infectious Diseases National Institutes of Health Westwood Building, Room 707 Bethesda, Maryland 20892 To receive copies of the RFP please provide this office with two self-addressed mailing labels. This advertisement does not commit the Government to award a contract. OPERATE CAENORHABDITIS GENETIC CENTER RFP: NIH-RR-89-07 P.T. 34; K.W. 1002019, 1002027, 0780005 Division of Research Resources The Division of Research Resources requires the operation of a caenorhabditis genetic center to acquire, maintain, and distribute wild-type and mutant strains of C. elegans for biomedical research and to characterize these strains, stimulate research using C. elegans as a model system and to act as a resource of genetic information for investigators. The Government anticipates the award of one three-year cost reimbursement-type contract. This is an announcement of an anticipated request for proposals which will be issued on or about May 1, 1989. The closing date for receipt of proposals will be on or about June 15, 1989. The RFP will be available upon request from: Danielle Kaczensky, Contracting Officer Research Contracts Branch, DCG National Institutes of Health Building 31, Room 1B44 9000 Rockville Pike Bethesda, Maryland 20892 Vol. 18, No. 15, April 28, 1989 - Page 6 PRESOLICITATION: COLLABORATIVE STUDIES FOR METHODOLOGIC RESEARCH FOR MULTI-SITE EPIDEMIOLOGIC SURVEYS OF MENTAL DISORDERS IN CHILD AND ADOLESCENT POPULATIONS P.T. 34, AA; K.W. 0785055, 0715129, 0404021 RFA: MH-89-22 National Institute of Mental Health Anticipated RFA Availability Date: May 5, 1989 Anticipated Application Receipt Date: July 5, 1989 INTRODUCTION The purpose of this announcement is to alert researchers in the field of mental disorders to the proposed issuance of a Request for Applications (RFA) for a collaborative study to plan and conduct methodologic research to develop assessment instruments and procedures which could be used in a coordinated multi-site epidemiologic and services research study of mental disorders of children and adolescents. The reason for the presolicitation announcement is to enable interested sites to consider preparation of applications as the amount of time between the issuance of the RFA and the receipt date will be very short. PROJECT GOALS The goal of this project is to develop and validate survey instruments and procedures which could be used in a second phase, full-scale, multi-site epidemiologic and services research study of mental disorders of children and adolescents. The ultimate goal of this two-phase program is to obtain estimates of prevalence rates of major mental disorders in children and adolescents and data on the use of services by children for mental health problems and barriers to such care. Based on analyses of pilot studies conducted by each site in the first year of this study, the collaborators will develop a core survey questionnaire and other survey procedures for use in a standardized manner across sites in subsequent, community-based field trials, using a minimum sample size of 500 child/parent interviews. The core questionnaire may include a psychiatric diagnostic interview and an assessment of demographic, psychosocial, and behavioral risk factors; a measure of impairment; and a health care utilization section to determine the use of general medical, mental health and social services. The sample selection process should assure representation of minority groups appropriate for that site. MECHANISM OF SUPPORT This project will be supported by the cooperative agreement mechanism which differs from investigator-initiated research grants. Although the awardees are primarily responsible for the conduct of the study, there will be collaboration among the participating sites and NIMH staff will have substantial programmatic involvement above and beyond the levels regularly required for traditional program management of grants. Among the major criteria used to evaluate applications received in response to the RFA are the following: (1) adequacy of the conceptual and theoretical framework for the study of the complex measurement and sampling issues involved in studies of the epidemiology of mental disorders in children; (2) adequacy of the existing and proposed facilities, resources, and site staff, including access to a population size sufficient to provide the required number of respondents; (3) adequacy of the data analysis plan; and (4) ability to cooperate with other sites and with the NIMH in the development of survey assessment instruments and procedures to be used in a standardized manner across sites in the field trials. Up to six research applications may be funded under this program and applicants may request support for up to 3 years. Issuance of the RFA for this program is expected to be May 5 and is contingent on approval of the program concept paper and the availability of funds. It is anticipated that $3 million will be available for this project in FY 1989. A proposed receipt date for applications is July 5 with IRG review in August. It is expected that applications for a subsequent multi-site study based on the experiences of this methodologic research will be solicited by NIMH at the conclusion of this initial award period. Vol. 18, No. 15, April 28, 1989 - Page 7 ELIGIBILITY Eligibility for review and funding under this program is limited to applications for domestic-based research designed for U.S. populations. INQUIRIES For further information or to receive a copy of the RFA when it is available, please contact as soon as possible: Ben Z. Locke Chief, Epidemiology and Psychopathology Research Branch Division of Clinical Research National Institute of Mental Health 10C-05 Parklawn Building 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-3774 or Karen H. Bourdon Social Science Analyst at the same address and telephone number AIDS AND ITS BEHAVIORAL CAUSES: CHILDREN'S KNOWLEDGE AND EMOTIONS RFA AVAILABLE: 89-HD/MH/DA-07 P.T. 34, AA; K.W. 0715008, 0404000, 0715125, 0745027 National Institute of Child Health and Human Development National Institute of Mental Health National Institute on Drug Abuse Application Receipt Date: July 31, 1989 The Human Learning and Behavior Branch of the National Institute of Child Health and Human Development, the Health and Behavior Research Branch of the National Institute of Mental Health, and the Clinical Medicine Branch of the National Institute on Drug Abuse invite research grant applications for studies on six-to-twelve-year-old children's knowledge and feelings regarding: (a) Human Immunodeficiency Virus (HIV) infection and mechanisms of its transmission; (b) Acquired Immunodeficiency Syndrome (AIDS) as an illness and its health consequences; and (c) human sexuality and drug abuse. By requesting investigators to submit applications pertaining to one or more of the above areas of interest, the three Institutes seek to stimulate investigators' interest in an area of research that is important to their mission--AIDS prevention. BACKGROUND The Department of Health and Human Services has identified AIDS as the foremost public health problem in the United States. The Centers for Disease Control report that there have been over 85,000 cumulative cases of AIDS in the country, and the number is increasing. Many more individuals who do not manifest the defining characteristics of AIDS are thought to be infected with HIV, the precursor of AIDS. The number of children with AIDS is quite small. As of October 1988, 311 cases were reported for the age group between 13 and 16. However, 21 percent of all individuals diagnosed as having AIDS are between 20 and 29 years of age. Since the incubation period for AIDS may range from one to six years in adults, it is clear that some of the young men and women who are affected contracted the disease when they were adolescents. HIV infection is primarily transmitted by the exchange of bodily fluids during unprotected sexual intercourse or when intravenous drugs are injected by contaminated needles. Since inner city youth, especially Blacks and Hispanics, start experimenting with sex and with drugs at a relatively young age, they are at the highest risk for HIV infection. The Surgeon General has argued for the importance of initiating AIDS related education when children are as young as six years of age. As a consequence, AIDS education programs are being implemented in schools around the country. These programs are based on some general knowledge about child development but are not based on specific scientific knowledge regarding what children of different ages actually know or feel about AIDS. Likewise, these programs are not based on specific scientific knowledge about what AIDS-related information children of different ages can understand and integrate into their existing knowledge base. Vol. 18, No. 15, April 28, 1989 - Page 8 Since the transmission of AIDS is, to a large extent, dependent on human practices in the domain of sexuality and drug use, teachers are focusing on education pertaining to sexuality, sexual behavior, and substance abuse. As in the case of education about AIDS as a disease, the scientific base for the education is limited. It consists of general principles of cognitive development and extremely limited information on children's understanding of and feelings regarding sexual relations, the human need for intimacy and love, or the causes and consequences of drug abuse. Education-relevant scientific data are, therefore, needed to implement scientifically guided, age appropriate educational programs about AIDS and its behavioral causes. RESEARCH GOALS AND SCOPE This request for applications calls for developmental research about six-to-twelve year old children's knowledge, attitudes and feelings regarding AIDS, sexuality, sexual behavior and substance abuse. The results of this research are intended to inform and guide the planning of AIDS-related educational programs. Psychological-developmental and physiological-maturational variables are hypothesized to be important determinants of children's motivation to learn and ability to understand AIDS related information. Research is needed to examine the relationships among children's cognitive development; their physiological development; and their knowledge about HIV infection, AIDS, the behavioral causes of the infection and its consequences. In addition, research is needed to explore and explain the relationship between developmental/maturational variables and children's knowledge about sexuality and substance abuse. Environmental variables such as urban living or poverty and cultural variables such as minority status are hypothesized to be very important in determining children's feelings and knowledge regarding AIDS, sexuality and substance abuse. Research is needed to identify the environmental and cultural factors that are most influential and to specify some of the processes by which environment and culture impact on what children think and feel in the domains under inquiry. The distinction between what children know, believe and feel and what they are capable of understanding is an important one to make. When left to their own resources, children piece together fragments of information to build their knowledge and to form attitudes. This is particularly the case when societal taboos prevent them from finding out what "experts" know or believe. While educators should know what children of a given developmental and maturational level and of a specific sociocultural background know, believe and feel, they should also know what these children are capable of learning. The requested research may provide such information. Proposed research designs may include both cross-sectional and longitudinal methods. Applicants are invited to develop new methods and new tasks for studying the development of the above general areas of research. These may include interviews, questionnaires and problem-solving tasks. Since no one study can focus on all the above aspects of the needed research, investigators are encouraged to choose a subset of research problems that are closest to their interest and to study these in great depth. PHS urges applicants for grants to give added attention (where feasible and appropriate) to the inclusion of minorities in study populations for research in the behavioral and social sciences. If minorities are not included in a given study, a clear rationale for their exclusion should be provided. Investigators are reminded that merely including arbitrary numbers of minority group participants in a given study is insufficient to guarantee generalization of results. MECHANISMS OF SUPPORT Support for this program will be through the traditional research grant (R01), the first award (R29) and the small grant (R03) mechanisms. Policies that govern grant-in-aid award programs of the Public Health Service will prevail. The support of grants pursuant to this RFA is contingent upon ultimate receipt of appropriate funds for this purpose. It is anticipated that up to nine meritorious applications will be funded under this program. However, the number of awards will depend on the amount of funds available to the Institutes, the overall merit of the proposals, and their relevance to program goals. Vol. 18, No. 15, April 28, 1989 - Page 9 APPLICATION PROCEDURES Applications must be submitted on form PHS 398 (revised 9/86) which includes form HHS-596 dealing with protection of human subjects. The RFA label (found in the 9/86 revision of application form PHS 398) must be affixed to the bottom of the face page of the original copy of the application. Failure to use this label could result in delayed processing of your application such that it will not reach the review committee in time for review. The deadline for receipt of applications is July 31, 1989. Applications received after this date will not be considered. ADDITIONAL INFORMATION Potential applicants are encouraged to request the detailed Request for Application by writing to: Sarah L. Friedman, Ph.D. Health Scientist Administrator Human Learning and Behavior Branch National Institute of Child Health and Human Development 9000 Rockville Pike, EPN Room 633 Bethesda, Maryland 20892 OR Leonard Mitnick, Ph.D. Chief, Health and Behavior Research Branch National Institute of Mental Health Parklawn Building, Room 11C06 5600 Fishers Lane Rockville, Maryland 20857 OR Rodney R. Cocking, Ph.D. Chief, Cognition and Learning Program Behavioral Sciences Research Branch National Institute of Mental Health Parklawn Building, Room 11C10 5600 Fishers Lane Rockville, Maryland 20857 OR Zili Amsel, Sc.D. Clinical Medicine Branch National Institute on Drug Abuse Parklawn Building, Room 10A08 5600 Fishers Lane Rockville, Maryland 20857 DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES RFA AVAILABLE: 89-RR-02 P.T. 34; K.W. 1002002, 0201011 Division of Research Resources Application Receipt Dates: Aug. 7, 1989 and Dec. 4, 1989 BACKGROUND The Division of Research Resources (DRR) is continuing its competitive grant program to help institutions upgrade and develop their animal facilities. DRR anticipates that $10.931 million may be available to support 35 to 40 animal facility improvement grants in Fiscal Year 1990. 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 Vol. 18, No. 15, April 28, 1989 - Page 10 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. It is not the purpose of the improvement grant to provide general operating costs for the resource. The projects are supported for one year. To gain approval and support, both 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 supported by the Public Health Service and involving the use of animals is eligible to apply. Applicants are expected to develop a single proposal for campus-wide service. Applications will be received by the Division of Research Grants. Applicants must use PHS Form 398, "Application for Public Health Service Grant." The following receipt dates have been established: August 7, 1989 and December 4, 1989. Applications received after these dates will be returned. The RFA label available in the PHS Application Form 398 (revised 10/88) must be affixed to the bottom of the face page. All applications submitted in response to this RFA will be reviewed by the DRR Animal Resources Review Committee for scientific merit and the National Advisory Research Resources Council for program considerations. All applications will be pooled for funding in the summer, 1990. MECHANISM OF SUPPORT Awards will be made as competitive resource grants for a project period of one year. It is expected that from 35 to 40 awards will be made in Fiscal Year 1990. The number of grants and the specific amount of 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 total award is limited to a maximum of $700,000 from this grant program. Within this, there is no limit on the equipment request but the request for A&R is limited to $500,000. Equal matching funds from non-Federal sources are required for all A&R as well as equipment. 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: Leslie P. Bullock, D.V.M., Director Laboratory Animal Sciences Program Animal Resources Program Branch Division of Research Resources 5333 Westbard Avenue, Room 853 Bethesda, Maryland 20892 Telephone: (301) 496-5175 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 intergovern-mental review of Executive Order 12372 or Health Systems Agency review. Vol. 18, No. 15, April 28, 1989 - Page 11 ONGOING PROGRAM ANNOUNCEMENTS EPIZOOTIOLOGY AND TRANSMISSION OF LYME BORRELIOSIS P.T. 34; K.W. 0785055, 0715125, 0715010, 1002027 National Institute of Allergy and Infectious Diseases Application Receipt Dates: February 1, June 1 and October 1 I. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research grants to study epizootiology and transmission of Lyme borreliosis to advance the understanding of how the spread of this disease into non-endemic areas can be prevented and how prevalence and transmission in endemic areas can be controlled and reduced. II. DISCIPLINES AND EXPERTISE This is a complex problem that will require a multidisciplinary approach. Investigators responding to this announcement will be expected to possess expertise in at least one of the following disciplines: medical entomology, bacteriology, field biology, epidemiology, or molecular biology. III. BACKGROUND Lyme borreliosis is the most common vector-borne disease of bacterial etiology in the United States and Europe. In New York, over two thousand cases were reported in 1988. The incidence of Lyme borreliosis in the U.S. in 1988 can be conservatively estimated to be at least seven to ten thousand cases, occurring in at least thirty-five states. The etiologic agent of Lyme borreliosis is a spirochete, Borrelia burgdorferi. Although the etiologic agent has been isolated and cultured in the laboratory, and is exquisitely sensitive to antibiotics in vitro, Lyme borreliosis has proven to be a difficult bacterial infection to diagnose and treat. There is no one clinical presentation or progression of symptoms common to Lyme borreliosis as it occurs in the general patient population. The host response is highly variable. Some individuals respond to infection with strong immune responses whereas others may remain seronegative. The organism is very difficult to detect in infected individuals, if it can be detected at all. Published descriptions of the disease, indicating that the hallmark of the disease is erythema migrans followed by secondary and tertiary stages if untreated, often are misleading. The signs and symptoms presented by infected individuals actually are highly variable from one case to another. The symptoms may be easily confused with other diseases some of which may be more serious and have very poor prognoses. The disease is primarily transmitted to humans and other animals by one or more species of ticks. Transmission may also occur via other vectors or by direct contact with fluids from infected animals. Transplacental transmission with severe consequences to the fetus is known to occur. Many warm blooded animals apparently possess the potential to serve as reservoirs for the etiologic agent. Rodents appear to be the most important reservoir. However, other warm-blooded animals may contribute in significant ways to the spread of the disease to new locations or to increase of human disease in an endemic area. Ixodid ticks are recognized as the arthropod vectors for the disease. However, we know little concerning the potential for alternate vectors. IV. RESEARCH OBJECTIVES AND SCOPE Research project applications addressing the following problems are of particular interest to NIAID: o Define the vectors of B. burgdorferi. Presence of competent vectors in non-endemic areas. Identification of non-ixodid ticks, or insects such as fleas and mosquitos, that may act as potential vectors. o How B. burgdorferi interacts with the arthropod vector. Characterization of B. burgdorferi antigens expressed in vectors and the vector products associated with spirochete surface. o Define reservoirs for B. burgdorferi and assess their potential significance for spread of human infection. Vol. 18, No. 15, April 28, 1989 - Page 12 o Differences between B. burgdorferi isolates from different parts of the world. o Presence of B. burgdorferi in certain reservoir species as a sentinel to predict outbreak of human disease in previously non-endemic areas. o Factors that affect the major vector and reservoir populations and carriage of B. burgdorferi. o Control of vector and/or reservoir species and its effect on incidence of human disease. Several of the above areas may be included in applications. Applicants are also encouraged to consider other avenues of investigation that would be appropriate to the spirit of the goals of this announcement as well. V. MECHANISMS OF SUPPORT AND REVIEW PROCEDURE Applications considered appropriate responses to this announcement are the traditional research project grant (R01 and R29). Use the specific application kit (PHS Form 398 rev. 9/86) required in this connection which is available in the business or grants and contracts offices of most academic and research institutions or may be obtained from: Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building, Room 449 Bethesda, Maryland 20892 Telephone: (301) 496-7441 Applications in response to this announcement will be reviewed in competition with other applications and in accordance with the usual National Institutes of Health peer review procedures. The initial review for scientific and technical merit will be made by an appropriate study section of the Division of Research Grants, NIH; secondary review will be by an appropriate National Advisory Council. Funding decisions will be based upon relative scientific merit, program relevance, and the availability of appropriated funds. VI. APPLICATION PROCEDURE Application receipt dates are February 1, June 1 and October 1. On the first (face) page, item 2, of the application, the word "Yes" should be checked and the phrase "EPIZOOTIOLOGY AND TRANSMISSION OF LYME BORRELIOSIS" should be typed in the space provided. The original and six copies of the application should be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** VII. STAFF CONTACT Investigators are encouraged to contact: Robert L. Quackenbush, Ph.D. Vector-Borne Bacterial Diseases Program Officer Bacteriology and Virology Branch National Institutes of Health 9000 Rockville Pike Westwood Building, Room 736 Bethesda, Maryland 20892 Vol. 18, No. 15, April 28, 1989 - Page 13 FULL TEXT OF RFAs FOR ONLINE ACCESS AIDS AND ITS BEHAVIORAL CAUSES: CHILDREN'S KNOWLEDGE AND EMOTIONS RFA: 89-HD/MH/DA-07 P.T. 34, AA; K.W. 0715008, 0404000, 0715125, 0745027 National Institute of Child Health and Human Development National Institute of Mental Health National Institute on Drug Abuse Application Receipt Date: July 31, 1989 The Human Learning and Behavior Branch of the National Institute of Child Health and Human Development (NICHD), the Health and Behavior Research Branch of the National Institute of Mental Health (NIMH), and the Clinical Medicine Branch of the National Institute on Drug Abuse (NIDA) invite research grant applications for studies on six-to-twelve-year-old children's knowledge and feelings regarding: (a) Human Immunodeficiency Virus (HIV) infection and mechanisms of its transmission; (b) Acquired Immunodeficiency Syndrome (AIDS) as an illness and its health consequences; and (c) human sexuality and drug abuse. By requesting investigators to submit applications pertaining to one or more of the above areas of interest, the three Institutes seek to stimulate investigators' interest in an area of research that is important to their mission--AIDS prevention. BACKGROUND The Department of Health and Human Services has identified AIDS as the foremost public health problem in the United States. The Centers for Disease Control (CDC) report that there have been over 85,000 cumulative cases of AIDS in the country, and the number is increasing. Approximately 1,400 cases of AIDS have been reported among children; this number is also increasing. As of October 1988, 311 cases were reported for the age group between 13 and 16. However, 21 percent of all individuals diagnosed as having AIDS are between 20 and 29 years of age. Since the incubation period for AIDS may range from one to six years in adults, it is clear that some of the young men and women who are affected contracted the disease when they were adolescents. Among adolescents, those who are at highest risk for HIV infection and for AIDS are inner city youth, especially Blacks and Hispanics who start experimenting with sex and drugs at a relatively young age. In the United States, the average age of first intercourse for males is between 14 and 15 and for females it is 16. The 1985 National Household Survey on Drug Use indicated that 24% of respondents 12 through 17 were using marijuana and/or hashish and 6% were using cocaine. The 1987 High School Senior Survey showed that 57% of high school seniors responded as having used illicit substances. The distributions of the responses from the above-described surveys by gender, ethnic/racial background, and urban vs. rural residence show marked differences in the age of onset for the different behaviors, the specific substances used and the number of sexual partners. These distributions suggest that inner city youth and especially Blacks and Hispanics are particularly at high risk for AIDS. Figures presented in the 11-7-88 issue of the AIDS Weekly Report about the 16,150 AIDS cases between the ages of 20 and 29 further support this suggestion. More specifically, of these cases, 53% were White, 29% were Black, and 17% were Hispanic. Relative to their proportion in the U.S. population, the Blacks and Hispanics were, therefore, over-represented among cases diagnosed as having AIDS. The Surgeon General has argued for the importance of initiating AIDS related education when children are as young as six years of age. As a consequence, AIDS education programs are being implemented in schools. These programs are based on some general knowledge about child development but are not based on specific scientific knowledge regarding what children of different ages actually know or feel about AIDS. Likewise, these programs are not based on specific scientific knowledge about what AIDS-related information children of different ages can understand and integrate into their existing knowledge base. AIDS is unlike diseases that children learn about through first-hand experience (e.g., common cold, ear infection, diarrhea, influenza) or indirectly through experiences of their extended families (e.g., heart disease, cancer). This may mean that they could have a particularly difficult time understanding the transmission of HIV infection and its progression into AIDS. That this may be the case is suggested by the fact that even the knowledge that children have about diseases that they experience themselves is vague and distorted relative to adults' notions. The scientific literature which exists about children's understanding of disease and of health as general concepts shows that children between ages two and twelve undergo conceptual changes in terms of their understanding of disease. Recent scientific literature about children's understanding of biological systems and processes, points to significant conceptual change during childhood. Since the understanding of disease is conceptually related to one's understanding of normal biological function, it is evident that young children lack some important knowledge that will allow them to integrate what they learn about disease in general and AIDS in particular. The scientific literature indicates that, when children are not instructed about health and disease, they construct vague and distorted notions that may lead to fears. These, in turn, may interfere with the acquisition of information that is provided by teachers during a limited number of lessons about AIDS. The same literature, however, does not imply that young children are not capable of an accurate understanding of the functioning of biological systems or of disease when they are exposed to comprehensive instruction. Available scientific information about knowledge acquisition and the development of expertise in children suggests that, under appropriate conditions, children may acquire and master the necessary knowledge. Since the transmission of AIDS is, to a large extent, dependent on humans' practices in the domains of sexuality and drug use, teachers are focusing on education pertaining to sexuality, sexual behavior, and substance abuse. As in the case of education about AIDS as a disease, the scientific base for the education is limited. It consists of general principles of cognitive development and extremely limited information on children's understanding of and feelings regarding sexual relations, the human need for intimacy and love, and the causes and consequences of drug abuse. Relevant scientific data are, therefore, needed to implement scientifically guided, age-appropriate educational programs about AIDS and its behavioral causes. RESEARCH GOALS AND SCOPE This request for applications calls for developmental research about six-to-twelve year old children's knowledge, attitudes and feelings regarding AIDS, sexuality and substance abuse. The results of this research are intended to inform and guide the planning of AIDS-related educational programs. Psychological-developmental and physiological-maturational variables are hypothesized to be important determinants of children's capacity for understanding and of their motivation to learn. Research is needed to examine the relationships among children's cognitive development; their physiological development; and their knowledge about HIV infection, AIDS, the behavioral causes of the infection, and its consequences. In addition, research is needed to explore and explain the relationship between developmental/maturational variables and children's knowledge about sexuality and substance abuse. Environmental variables, such as living in an urban setting, or in poverty and cultural variables are hypothesized to shape children's emotions and knowledge regarding AIDS, sexuality and substance abuse. Research is needed to identify the environmental and cultural factors that are most influential and to specify some of the processes by which environment and culture impact on what children think and feel in the domains under inquiry. The distinction between what children know, believe and feel and what they are capable of understanding is an important one to make. When left to their own resources, children piece together fragments of information to build their knowledge and to form attitudes. This is particularly the case when societal taboos prevent them from finding out what "experts" know or believe. While educators should know what children of a given developmental and maturational level and of a specific sociocultural background know, believe and feel, they should also know what these children are capable of learning. The requested research can provide such information. Proposed research designs may include both cross-sectional and longitudinal methods. Applicants are invited to develop new methods and new tasks for studying the development of the above general areas of research. These may include interviews, questionnaires, and problem-solving tasks. Since no one study can focus on all the above aspects of the needed research, investigators are encouraged to choose a subset of research problems that are closest to their interest and to study these in great depth. Examples of research questions and research topics that investigators may choose to focus on are: --Children's understanding regarding the transmission of HIV infection, the relationship between the infection and AIDS, the course of AIDS and its effects on human function. --Children's conceptions regarding the effects of the short-term and long-term consumption of medication and of drugs on the physical and mental health of well and of sick individuals. --Developmental, familial and cultural variables influencing children's understanding of the effects of medications/drugs on the physical and mental health of users. --Children's conceptions regarding intimacy, love, and sexuality as factors influencing human behavior. --Children's concepts of behaviors responsible for HIV transmission and AIDS prevention. --The relationships between children's understanding of biological systems and their understanding of mechanisms of health and disease in general and of AIDS in particular. --The relationship between pubertal development and children's knowledge about sexuality, drug abuse, and AIDS. --The relationships between information that parents convey to children about AIDS, the feelings of parents about AIDS, and children's feelings and knowledge about AIDS. --The relationships between exposure to the media and children's feelings and knowledge about sexuality, drug abuse, and AIDS. --Comparisons of boys and girls in relation to any of the topics raised above. --Comparisons of children of different social and cultural background in terms of the topics mentioned above. ASSIGNMENT OF APPLICATIONS Program staff members of NICHD, NIMH, and NIDA will determine the assignment of the received applications prior to their review. The assignment will depend on the match between the content of specific applications and the mission and responsibilities of the three Institutes. MECHANISM OF SUPPORT Support for this program will be through the traditional research grant (R01), the first award (R29) and the small grant (R03) mechanisms. Policies that govern grant-in-aid award programs of the Public Health Service will prevail. It is anticipated that up to nine meritorious applications will be funded under this program. The number of awards will depend on the overall merit of the proposals, their relevance to program goals and on the availability of funds. REVIEW PROCEDURES AND CRITERIA Applications will be reviewed by the Public Health Service (PHS) staff for responsiveness to the RFA. Non-responsive applications will be returned to the applicant. The applicant then has the option to resubmit to PHS and have it assigned for review in the same manner as unsolicited grant applications during a subsequent review cycle. If an application submitted in response to this RFA is essentially the same as one already submitted to PHS, and pending review or funding, the pending application must be withdrawn before the new one can 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. PHS will withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be competitive will be further evaluated for scientific/technical merit by a review panel convened solely for this purpose by the Scientific Review Program, NICHD. Criteria for the initial review include: *significance and originality of the research goals and approaches *quality of the theoretical-conceptual framework *feasibility of the research *adequacy of the experimental design *appropriateness of data analysis techniques *appropriateness of the project duration and cost relative to the work proposed *the research experience and competence of the investigator(s) *effort devoted to the project. An additional criterion will be the responsiveness of the proposed project to this RFA. Following review by the Initial Review Group and before awards for meritorious proposals are made, applications will be evaluated by the appropriate Institute's Advisory Council for policy issues. PHS urges applicants for grants to give added attention (where feasible and appropriate) to the inclusion of minorities in study populations for research in the behavioral and social sciences. If minorities are not included in a given study, a clear rationale for their exclusion should be provided. Investigators are reminded that merely including arbitrary numbers of minority group participants in a given study is insufficient to guarantee generalization of results. APPLICATION PROCEDURE Applications should be submitted on Form PHS-398 (Rev. 9/86), which is available in the business or grants and contracts office at most academic and research institutions or from the Division of Research Grants, NIH. The receipt deadline for applications prepared in response to this RFA is July 31, 1989. The RFA label available in the 9/86 revision of Application Form 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of your application such that it may not reach the review committee in time for review. The phrase "AIDS AND ITS BEHAVIORAL CAUSES: CHILDREN'S KNOWLEDGE AND EMOTIONS" should be typed on line 2 of the face page of the application. The original and four copies of the application should be sent or delivered to: Application Receipt Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** In addition to applications and copies mailed to the Division of Research Grants, two copies of the application must be sent under separate cover to: Laurance Johnston, Ph.D. Deputy Director Scientific Review Program National Institute of Child Health and Human Development National Institutes of Health 6130 Executive Boulevard Executive Plaza North, Room 520 Bethesda, Maryland 20852 TIMETABLE Application receipt date July 31, 1989 Initial review date September/October 1989 Reviewed by Advisory Councils January 1990 Earliest start date February 1, 1990 INQUIRIES DIRECTED TO Sarah L. Friedman, Ph.D. Health Scientist Administrator Human Learning and Behavior Branch National Institute of Child Health and Human Development 9000 Rockville Pike, EPN Room 633 Bethesda, Maryland 20892 (301)496-6591 OR Leonard Mitnick, Ph.D. Chief, Health and Behavior Research Branch National Institute of Mental Health The Parklawn Building, Room 11C06 5600 Fishers Lane Rockville, Maryland 20857 (301)443-4337 OR Rodney R. Cocking, Ph.D. Chief, Cognition and Learning Program Behavioral Sciences Research Branch National Institute of Mental Health The Parklawn Building, Room 11C10 5600 Fishers Lane Rockville, Maryland 20857 (301)443-3566 OR Zili Amsel, Sc.D. Clinical Medicine Branch National Institute on Drug Abuse The Parklawn Building, Room 10A08 5600 Fishers Lane Rockville, Maryland 20857 (301)443-1801 This program is described in the Catalog of Federal Domestic Assistance No. 13.865, Research for Mothers and Children, No. 13.242 Mental Health Research and No. 13.279 Drug Abuse Research. It is also described in regulations at 42 CFR part 52, and 45, CFR part 75. SELECTED BIBLIOGRAPHY AIDS Weekly Surveillance Report - United States AIDS Program, Center for Infectious Diseases, Centers for Disease Control, November 7, 1988. Bernstein, A.C. and Cowan, P.A. (1981). Children's conceptions of birth and sexuality. In R. Bibace and M. Walsh (Eds). New directions in child development: Children's conceptions of health, illness and body functions. San Francisco: Jossey Bass. Bibace, R. and Walsh, M.E. (1980). Development of children's conceptions of illness. Pediatrics, 66, 912-917. Burbach, D.J. and Peterson, L. (1986). Children's conceptions of medical illness: A review and critique of the cognitive-developmental literature. Health Psychology, 5, 307-325. Bush, P.J. and Davidson, F.R. (1982). Medicines and "drugs": What do children think? Health Education Quarterly 92, 209-224. Bush, P.J. and Iannotti, R.J. (1985). The development of children's health orientations and behaviors: Lessons for substance use prevention. In Jones, C.L. and Battjes, R.J. (Eds.) Etiology of drug abuse: Implications for prevention. NIDA Research Monograph, 56, 45-74. Carey, S. (1985). Conceptual change in childhood. Cambridge, MA: The MIT Press. Centers for Disease Control (1988). Guidelines for effective school health education to prevent the spread of AIDS. In: Morbidity and mortality reports 37 (Supplement No. S-2). Goldman, R. and Goldman, J. (1982). Children's sexual thinking: A comparative study of children age 5 to 15 in Australia, North America, Britain and Sweden. New York: Methuen. Hofferth, S.L. and Hayes, C.D. (Eds.) (1987). Risking the future: Adolescent sexuality, pregnancy and childbearing. National Academy Press, Washington, D.C. National Institute on Drug Abuse (1987). National Household Survey on Drug Abuse. 1985 Population Estimates. DHHS Publication No. (ADM) 87-1539. National Institute on Drug Abuse (1987). The 1987 National High School Senior Survey. Press release. 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 P.T. 34; K.W. 1002002, 0201011 RFA 89-RR-02 DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES An Administrative Document Issued By: Animal Resources Program Division of Research Resources National Institutes of Health Department of Health and Human Services April 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 and 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. Other types of projects supported by ARP include developing and defining animal models, animal resource laboratories, and research related to laboratory animal science and medicine. Additional information on these latter grant programs may be requested from the Animal Resources Program, DRR (see address below). RESEARCH 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. Requests should be limited to alterations and renovations (A&R) to improve laboratory animal facilities and major resource equipment related to the improvement, such as animal cage systems and cage washers. Large pieces of basic equipment for centralized surgeries or diagnostic laboratories is allowable. This improvement grant is not intended to provide general 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). 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. ELIGIBILITY AND SUPPORT Any domestic public or private institution, organization, or association with one or more research projects supported by the Public Health Service (PHS) that involves the use of laboratory animals is eligible to apply. For the purposes of this program, an institution is defined as the organizational component covered under a single Biomedical Research Support Grant (BRSG) code. Multiple applications may be submitted from different colleges or schools on the same campus of a university within the same fiscal year. However, if this is done, documentation from an appropriate institutional official, stating that the applications are part of a coordinated, campus-wide plan to improve the animal facilities, must be provided. 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. Awards will be made for a project period of one year. DRR anticipates that $10.9 million may be available to support animal resource improvement grants in Fiscal Year 1990. It is anticipated that approximately 40 grant 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. The total request and the award are limited to $700,000. Matching funds, equal to the total award and from non-Federal sources, are required. This matching requirement cannot be met by citing other past, ongoing, or planned expenditures. Although, there is no limit to the equipment request, the A&R portion cannot exceed $500,000. A letter of assurance of matching and the projected source of funds, signed by an appropriate institutional official, must be included in the application. 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. 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." Either of the following receipt dates must be met: August 7, 1989 or December 4, 1989. Applications received after either of these deadlines will be returned without further processing. All applications submitted in response to this RFA will be reviewed by the DRR Animal Resources Review Committee 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 relationship to the responsiveness to the RFA, program scope, institutional commitment, and 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 instructions 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-02, "Developing and Improving Institutional Animal Resources"). Item 5 - Check the box marked "No" at Item 5a. Item 5b - Not applicable. Item 7 - This figure refers to the direct costs requested from the PHS only and should not include the required matching dollars. B. Key Personnel - Application Page 2 - Only key personnel should be listed here. This must include the chief or consulting veterinarian, and may include the principal investigator, director of the animal facility, or chief animal technician, as appropriate. Biographical sketches must be provided for all people listed. Salary support should not be requested. 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 items of major equipment for animal care or other aspects of facility function, and A&R. Equipment should be classified as movable or fixed using the institution's 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, requests for items that may require the purchase of small component parts, i.e., 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 request for PHS support may not exceed a total of $700,000. Of this, the request for A&R may not exceed $500,000. Matching funds, equal to the total award and from non-Federal sources, are required. Show the total cost of the equipment and A&R in the space under the appropriate headings on the left. The right hand column should reflect only the PHS request. The Total Direct Costs (bottom right hand column total) should be the total application request to the PHS, not including the required matching funds. These data should be summarized in tabular form (sample form may be obtained from the Animal Resources Program at the address below). of this document. E. Budget for Entire Proposed Project Period - Application, Page 5 - Not applicable (do not complete this section). 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 equipment items has been a major weakness of applications in the past. G. Summary Sheets - (Sample sheets may be obtained from the Animal Resources Program at the address below). 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, (see above), should 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 current information should be provided as shown on the sample Data Sheet (sample Data Sheet may be obtained from the Animal Resources Program at the address below): 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 individual 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 in order to be eligible for consideration. 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 monitoring and disease diagnosis, veterinary inspections for animal health, etc. If specialized equipment such as microisolators are requested, they 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 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 campus 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 evident. As shown on the sample Data Sheet (for sample data sheet, contact the Animal Resources Program at the address 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. Contact the Animal Resources Program for sample format (see address below). If multiple sites are involved, the A&R, including 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 animal health plan. (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. E. Letter of Assurance - Provide assurance of matching funds for the total PHS award and the projected source(s) and amount of these funds in a separate letter or memorandum signed by an appropriate institutional official. 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 no later than c.o.b. August 7, 1989 or December 4, 1989. Applications received after either of these dates 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 **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