From owner-sci-resources@net.bio.net Wed Mar 03 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 9, pt. 1, 5 March 1993 Message-ID: Date: 4 Mar 93 00:32:35 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1505 NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930305 V22N09 P1O2 ************************************ X-comment: RFAs described: AG-93-005 NIH GUIDE - Vol. 22, No. 9 - March 5, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N2 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** SMALL GRANTS PROGRAM - REVISED GUIDELINES National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX N4 ********************************************************** EDUCATING FOR THE RESPONSIBLE CONDUCT OF RESEARCH National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** ASSESSMENT OF POTENTIAL COCAINE MEDICATIONS USING THE RAT SELF- ADMINISTRATION MODEL (RFP NIH-N01DA-3-8201) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R2 ********************************************************** PREPARATION OF IMMUNOCONJUGATES (MAA NCI-CM-37843-37) National Cancer Institute INDEX: CANCER $$INDEX R3 07/14/93 ************************************************* PATHOPHYSIOLOGIC EFFECTS OF IMPAIRED MYOCARDIAL FUNCTION IN OLDER PERSONS (RFA AG-93-005) National Institute on Aging INDEX: AGING ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** ETIOLOGY, CONSEQUENCES, AND BEHAVIORAL PHARMACOLOGY OF FEMALE DRUG ABUSE (PA-93-059) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** BIOMEDICAL FACTORS IN DRUG ABUSE ETIOLOGY AND CONSEQUENCES (PA-93- 060) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P3 ********************************************************** CONGENITAL CYTOMEGALOVIRUS: UNDERSTANDING INFECTION AND SEQUELAE (PA-93-061) National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders INDEX: ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; DEAFNESS, OTHER COMMUNICATION DISORDERS $$INDEX P4 ********************************************************** RESEARCH GRANTS RELATED TO GENETICS OF THE EPILEPSIES (PA-93-062) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer. Contact Dr. John James at 301/496-7554 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS NIH GUIDE, Volume 22, Number 9, March 5, 1993 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human persons and those currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes: NORTHWESTERN WORKSHOP DATES: May 19, 20, 21, 1993 LOCATION Sheraton Hotel, Anchorage, AK SPONSORS University of Alaska - Anchorage, Anchorage, AK Northwest Indian College, Bellingham, WA Indian Health Services, Tucson, AZ REGISTRATION Ms. Ann Howell Coordinator of Conferences and Institutes University of Alaska - Anchorage 2221 East Northern Lights, Suite 205 Anchorage, AK 99508 Telephone: (907) 278-8821 TITLE: Basic Training Session - Research Benefits and Risks to Individuals and Communities: Legal and Ethical Perspectives DESCRIPTION: This conference will explore the legal and ethical perspectives of social and biomedical research. Protecting the individual rights of human research subjects is of prime concern, but so is protecting the rights of communities of individuals. This is especially true for indigenous peoples. The conference is designed to be of interest to social and biomedical researchers, IRB members, students, agency personnel, indigenous peoples, and others interested in the rights of individuals and communities. Opportunities for informal discussion and exchange will supplement the panel and breakout group format. Reports from the simultaneous group sessions will be made. Participants will learn how regulations and community participation can protect human subjects in research, explore the notion of protecting communities from research risks, examine the impact of recent court rulings on research risks, interact with others interested in research risk issues, and make recommendations to agency and other personnel. For information regarding these workshops and future NIH/FDA National Human Subjects Protection Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 22, Number 9, March 5, 1993 P.T. 42; K.W. 0783005 National Institutes of Health The Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH), is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for FY 1993 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators, and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. NORTHEASTERN WORKSHOP DATES: June 21-22, 1993 LOCATION The Warwick Hotel 1701 Locust Street Philadelphia, PA 19103-6179 Telephone: 1-800-523-4210 or (215) 735-6000 FAX: (215) 790-7766 SPONSORS Hahnemann University - Drexel University REGISTRATION Ms. Lyla Haggard Vice President for Planning and Marketing Hahnemann University Broad and Vine - Mail Stop 609 Philadelphia, PA 19102-1192 Telephone: (215) 762-1661 FAX: (215) 762-4419 Dr. Kenneth Geller Assistant Vice President for Research and Technology Management Office of Sponsored Projects Drexel University - Building 1-102 Philadelphia, PA 19104 Telephone: (215) 895-2499 FAX: (215) 895-1619 TOPIC: ETHICAL ISSUES OF ANIMAL USE IN ACADEME AND INDUSTRY o Investigator Training o Animal Use in Teaching o Assessment of Morbidity and Endpoints o Allegations of Noncompliance For information concerning this workshop and future NIH/OPRR Animal Welfare Education workshops, contact: Mrs. Roberta Sonneborn Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-7163 FAX: (301) 402-2803 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** SMALL GRANTS PROGRAM - REVISED GUIDELINES NIH GUIDE, Volume 22, Number 9, March 5, 1993 P.T. 34; K.W. 1014006 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) announces the availability of the latest guidelines revised February 1993 for the NHLBI Small Grants Program originally announced in the NIH Guide for Grants and Contracts, Vol. 19, No. 7, February 16, 1990. These guidelines may be obtained from: Director, Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 7A17 Bethesda, MD 20892 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** EDUCATING FOR THE RESPONSIBLE CONDUCT OF RESEARCH NIH GUIDE, Volume 22, Number 9, March 5, 1993 P.T. 42; K.W. 1014004 National Institutes of Health On April 1 and 2, 1993, in Boston, Massachusetts, Public Responsibility in Medicine and Research (PRIM&R), in cooperation with the Association of American Medical Colleges, the Office of Extramural Research/NIH, and Tufts University School of Medicine will host a conference entitled, "Educating For the Responsible Conduct of Research: NIH Policy and Other Mandates." The meeting will focus on the training grants of the NIH and the National Science Foundation, which require instruction in the responsible conduct of research for both pre- and post-doctoral trainees. Panels will address the following topics: the need for teaching ethics, the goals of academic and/or institutional ethics programs, demonstrations of specific teaching methods and materials, and techniques for both individual and program evaluation. PRIM&R has set aside a limited number of scholarships for fulltime students and others demonstrating need, as well as a limited number of spaces for members of the press. INQUIRIES Claudia Blair, Ph.D. National Institutes of Health Building 31, Room 5B31 Bethesda, MD 20892 Telephone: (301) 496-5366 For a complete program, additional information, and registration, address inquires to: Public Responsibility in Medicine and Research 132 Boylston Street, Fourth Floor Boston, MA 02116 Telephone: (617) 423-4112 $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIH-N01DA-3-8201 ***************************************** ASSESSMENT OF POTENTIAL COCAINE MEDICATIONS USING THE RAT SELF- ADMINISTRATION MODEL NIH GUIDE, Volume 22, Number 9, March 5, 1993 RFP AVAILABLE: NIH-N01DA-3-8201 P.T. 34; K.W. 0404009, 0740020, 0755060 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having inhouse capability to perform experiments in rats to preclinically evaluate test compounds that may be of use in the treatment of cocaine abuse. The effects of these test compounds on cocaine self administration in rats will be investigated. The offeror must also indicate possession of current DEA registration for Schedule II-V substances prior to award and apply for Schedule I registration, if necessary. It is anticipated that two contracts, each being four and one half years in duration, will result from this requirement. Estimated issuance data of RFP No. N01DA-3-8201 is March 10, 1993 and responses are due to be received in the Contracting Office 45 calendar days thereafter. Written requests for copies of the solicitation will be honored if received within twenty calendar days after issuance of the solicitation. Written requests received after this period will be filled on a first-come, first-served basis until the supply is exhausted; however, there is no assurance that copies requested after the twentieth day will reach the requestor before the due date for receipt of responses. INQUIRIES All inquiries must be in writing and addressed to: Kenneth E. Goodling Contract Specialist National Institute on Drug Abuse Parklawn Building, Room 10-49 5600 Fishers Lane Rockville, MD 20857 This advertisement does not commit the Government to make an award. $$R1 END ************************************************************ $$R2 BEGIN NCI-CM-37843-37 ****************************************** PREPARATION OF IMMUNOCONJUGATES NIH GUIDE, Volume 22, Number 9, March 5, 1993 MAA AVAILABLE: NCI-CM-37843-37 P.T. 34; K.W. 0715035 National Cancer Institute Master Agreement Announcement (MAA) No. NCI-CM-37843-37, as published in the NIH Guide for Grants and Contracts, Vol. 22, No. 7, February 19, 1993, is amended to read as follows. This project was originally synopsized as a MAA No. NCI-CM-27731. The purpose of this procurement is to prepare preclinical and clinical grade monoclonal antibodies, antibody fragments, peptides, and/or other genetically engineered targeting molecules that are linked to chelating agents. The NCI will provide purified targeting molecules to the contractor for chemical conjugation to chelating agents using procedures that have either appeared in the peer reviewed literature or have been developed by the NCI. Proprietary technology developed by the offeror to prepare the desired immunoconjugates would prepare radioimmunoconjugates for both preclinical and clinical applications. All synthetic and purification procedures will be performed under Good Laboratory Procedures (GLP) and/or Good Manufacturing Practice (GMP). It is anticipated that the offeror will be required to prepare approximately 10-1000 mg of each immunoconjugate. The offeror will evaluate these immunoconjugates for purity, stability, immunoreactivity, and other criteria specified by the NCI. One or more awards may be made to qualified offerors responding to the RFP. INQUIRIES The amended MAA No. NCI-CM-37843-37 is now available and responses will be due on or about April 15, 1993. To obtain a copy of the Master Agreement Announcement, call or write: Patricia Lightner or Dorothy M. Coleman Treatment Contracts Section, Research Contracts Branch National Cancer Institute Executive Plaza South, Room 603 Bethesda, MD 20892 Telephone: (301) 496-8620 No collect calls will be accepted. $$R2 END ************************************************************ $$R3 BEGIN AG-93-005 FULL-TEXT ************************************** PATHOPHYSIOLOGIC EFFECTS OF IMPAIRED MYOCARDIAL FUNCTION IN OLDER PERSONS NIH GUIDE, Volume 22, Number 8, February 26, 1993 RFA AVAILABLE: AG-93-005 P.T. 34, CC; K.W. 0715040, 0765035, 0710010 National Institute on Aging Letter of Intent Receipt Date: May 15, 1993 Application Receipt Date: July 14, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute on Aging (NIA) invites applications for research projects to study the pathophysiologic effects of impaired myocardial systolic and/or diastolic function in persons with or without conventionally-defined heart failure. The purpose of this program is to define the major pathophysiologic links between impaired myocardial contractile function and resulting frailty or disability. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Pathologic Effects of Impaired Myocardial Function in Older Persons, is related to the priority areas of heart disease and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-1) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by any domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT Support of this program will be through the research project grant (R01). Awards will be administered under PHS grants policy as stated in the Public Health Service Grants policy statement, DHHS Publication No. (OASH) 90-50,000, revised 9/91. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed by a Division of Research Grants (DRG) study section. However, if it is determined that there is a sufficient continuing program need, the NIA may announce a request for competitive continuation applications. The total project period for applications submitted in response to the present RFA may not exceed four years. The requested total funding (direct and indirect costs) for individual grant applications for the first-year may not exceed $200,000, with increases of no more than 4 percent for subsequent years. The anticipated award date will be July 1, 1994. FUNDS AVAILABLE It is estimated that $1.2 million will be available to fund grants under this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Myocardial contractile dysfunction is an important cause of disability in older people. As a clinical syndrome, heart failure is associated with reduced exercise tolerance, dyspnea, and fatigue. It is now recognized that pumping action, at least as measured as left ventricular systolic function, is poorly related to exercise capacity. A number of other potential determinants of symptoms need to be considered. These include: diastolic dysfunction, pulmonary changes or disease, skeletal muscle changes, physical fitness, neuroendocrine and other hormones, nutritional changes, and other variables such as medications and depression. The purpose of this research program is to further define the relationship among these variables associated with heart failure and resultant symptoms, especially symptoms that contribute to frailty or disability in older people. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES It is NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them. The study design must seek to identify any pertinent gender or minority population differences. For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. The letter of intent is to be sent to Dr. Cooper at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. Receipt date: July 14, 1993. Further information about application procedures is available in the RFA and from staff contacts listed below. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIA. Applications may be subjected to triage by an NIA peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIH will withdraw from further competition those applications judged by triage to be noncompetitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. The second level of review will be provided by the National Aging Advisory Council. Review criteria for this RFA are the same as those for unsolicited research grant applications. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James K. Cooper, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E327 Bethesda, MD 20892 Telephone: (301) 496-6761 Direct inquiries regarding fiscal matters to: Barbara Cunningham Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-059 ************************************************ ETIOLOGY, CONSEQUENCES, AND BEHAVIORAL PHARMACOLOGY OF FEMALE DRUG ABUSE NIH GUIDE, Volume 22, Number 9, March 5, 1993 PA NUMBER: PA-93-059 P.T. 34; II; K.W. 0404009, 0710100, 0755030, 0785055, 0414014 National Institute on Drug Abuse PURPOSE This program announcement seeks to stimulate research on (a) the etiology and consequences of drug abuse by women of all ages and reproductive status and (b) gender differences in the behavioral effects of abused drugs. Studies on the etiology, natural history, and consequences of drug abuse unique to women include health risk, psychosocial, psychiatric, physiological, and neuroendocrine factors and clinical, social, economic, and legal issues related to the multiple roles and status of women (i.e., the role of drug use in female sexual activity, pregnancy, parenting, transmission of AIDS, stress and coping strategies, self identity and self esteem, health beliefs and practices and methods to reach, identify, and predict at risk individuals). Behavioral pharmacology studies include animal studies and human laboratory studies on all phases of drug abuse (acquisition, maintenance, withdrawal, and relapse) and are to examine gender differences in the behavioral effects of abused drugs. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Etiology, Consequences, and Behavioral Pharmacology of Female Drug Abuse, is related to the priority area of alcohol and other drug abuse. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applicants from minority individuals and women are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISM OF SUPPORT Support mechanisms include research projects (RO1), small grants (RO3), and FIRST awards (R29). Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Studies are needed on (a) the etiology, nature, concomitants, and consequences of drug abuse by women of all ages and reproductive status and (b) basic research involving laboratory studies on gender differences in the behavioral effects of abused drugs. One goal is to seek a scientific basis for decision making regarding drug abuse and women in recognition of the social, economic, political, marital, familial, and caretaker roles of women and their special vulnerabilities with regard to drug abuse. Another goal is to bring meaning to the efforts to assess gender differences in research on the behavioral effects of drug abuse. Etiology and Consequences of Drug Abuse Among Women: Conceptual models and theoretical constructs in drug abuse research based on research with male subjects do not recognize factors unique to females and the multiple etiologies, vulnerabilities, and special problems of women. Although the number of male drug abusers and addicts exceeds the identified number of female drug abusers and addicts, the clinical picture and consequences of drug abuse by women are more severe although little is known about why this occurs or how to intervene. The changing role of women in society creates a need to track how this may affect present and future substance abuse patterns. Existing studies of gender differences in drug metabolism, endocrine functioning, and reproductive biology and the natural history of drug abuse among subgroups of women--women with drug abusing partners, adult children of alcoholics and drug addicts, prostitutes, women having undergone traumatic life events--highlight the urgency of research in this area. Sex hormones interact at critical life stages to produce profound differences. Metabolites of illicit drugs are differentially stored and recirculated based on complex factors including age, gender, and physiologic reactions to stress. Research questions need to address clinically and socially relevant problems and follow the axiom of picking the most appropriate design, units of measure, and levels of analysis which fit the research question. In depth descriptive and ethnographic studies are needed to address fundamental issues on which future work can be based. Because of the realities of women in hidden, underserved populations, a combination of insight building studies and meticulous longitudinal studies need to be initiated. Studies also need to consider possible vulnerabilities due to drug effects on the female's developing central nervous system, metabolism, or endocrine functioning and their psychosocial development. Studies are needed which have promise of producing clinically significant information and tools for risk assessment, intervention, treatment, and prevention strategies. Areas of Special Interest: Drugs of abuse include illicit drugs and alcohol, tobacco, and medications within the context of polydrug abuse. Areas include, but are not limited to, studies of the natural history, etiology, consequences, concomitants, incidence and prevalence of drug use, abuse, dependence, and addiction among women, specifically: o The role of drug use in female sexual activity, pregnancy, parenting, and high risk sexual behaviors; o Differences in drugs of abuse, patterns of abuse, routes of administration, different physiologic and therapeutic responses, and abuse of prescription drugs by females; o The role of factors which increase risk for early onset and severity of drug abuse, such as stress and coping strategies, self identity and self esteem, sexual identity, psychosexual and social role, psychopathology, socioeconomics, metabolic and neuroendocrine functioning, reproductive and health status, health beliefs and practices, drug abuse by significant others, victimization, interrelationships between drug abuse and problem behaviors (delinquency, prostitution, high risk sexual activity, unwanted pregnancy); o Differential consequences of female drug abuse: morbidity, co- morbidity; psychological, social, economic, health and reproductive outcomes mediated by immune, endocrine, and other systems (differential physiologic, neurologic, psychiatric, psychologic, metabolic factors), and the clinical neuroscience interface with behavior; o Etiology of drug abuse among subgroups of women; o Special factors affecting subgroups of women (incarcerated, homeless, victims of violence, single head of household); o Impact of age at onset in developing drug and other disorders; o Victimization, rape, trauma, child abuse and neglect, and post traumatic stress disorder with women as victim or perpetrator; o Natural history of transmission of HIV among drug abusing women, especially women in minority and homeless populations; o Intergenerational studies of factors that transmit risk for drug abuse including role of females who model behaviors for daughters and influence how sons will relate to females; o Legal, health, and social policy issues; o Barriers to identification, diagnosis and treatment for women; o Incidence and prevalence of drug abuse among women and methods to reach, identify, and predict individuals at risk for drug abuse and misuse of prescriptive drugs; o Animal models to look at factors which are difficult or can not be examined in human studies. Laboratory Studies on Gender Differences in the Behavioral Effects of Abused Drugs: The PHS has explicit requirements for the inclusion of women in clinical research grants. This requirement grew out of concern that research findings benefit both men and women. The requirement, however, does not demand inclusion of an adequate sample of both genders so that separate conclusions can be drawn about men and women. Recent studies, however, showing gender differences in the behavioral responses to abused drugs indicate the need for further research in this area to achieve the objective of obtaining research findings that are of benefit to both men and women. Converging evidence from human and animal research stresses the need for further basic laboratory research on gender differences in the behavioral responses to abused drugs. Preliminary data suggesting that women may more rapidly proceed to addiction after casual drug use than men, as well as evidence that effects of marijuana and alcohol use in women is associated with the menstrual cycle, raise questions about possible fundamental gender differences in the reinforcing and stimulus properties of abused drugs. Such differences have been reported in animal studies with rodents. On several measures of stimulant-induced activity females exhibit more responsiveness than males, and this responsiveness varies with the estrus cycle. Further, gender differences in self-administration of cocaine have been reported. When cocaine infusions were made contingent upon increasingly higher numbers of bar presses, female rats made substantially more presses than males and their level of cocaine self-administration varied as function of the estrus cycle. Research findings from laboratory studies on gender differences in the behavioral responses to abused drugs should have implications for the development of prevention, intervention, and treatment procedures that are gender specific. The high rate of drug use by women of child-bearing age, thus potential prenatal drug exposure, underscores the importance of this research. Areas of Special Interest: This announcement seeks to stimulate behavioral pharmacology studies, in humans and animals, on gender differences in the behavioral response to abused drugs. Animal studies focusing on all phases of drug abuse--acquisition, maintenance, withdrawal, and relapse--are needed. Within these phases, studies of gender differences in (a) reinforcing and stimulus properties of abused drugs, (b) behavioral and pharmacotherapeutic interventions, and (c) behavioral history variables that may modulate gender differences are of particular interest. The existing literature on the effects of gonadal hormones on learning and memory and on neurotransmitter systems should serve to guide research in these areas, where applicable. Human laboratory studies examining gender differences in the behavioral effects of abused drugs in non- use and low-use subjects, as well as subjects who are in maintenance, withdrawal, and relapse phases of drug abuse are needed. Study of a variety of factors that may modulate gender differences is encouraged, including (a) hormonal and other biologic factors, (b) behavioral history variables, such as dieting and drug use pattern, (c) family history of drug abuse. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for including minorities and women in studies of disease, disorders and conditions which disproportionately affect them. Although the applicability of women to this program announcement is obvious, the requirement to address minorities must be addressed. If minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. AIDS IRB Guidelines Applicants are advised to obtain a copy of the "Guidance for Institutional Review Boards for AIDS Studies (December 16, 1984)" from the Office for Protection from Research Risks (OPRR), Building 31, Room 4B09, National Institutes of Health, Bethesda, MD 20892 (telephone: 301/496-7005). This office may be consulted on how to deal with difficult human subjects protection issues in AIDS research. Guidelines emphasize special considerations which must be taken into account in AIDS research and stipulate important protection that must be considered in design of AIDS research projects, including the requirement that subjects be informed of the result of AIDS antibody testing, if any such testing is done. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines indicated in the application kit. Receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional business offices or offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441). The title and number of this announcement must be typed in Item 2a on the face page of the application form PHS 398. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five legible copies of the application form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications. Applications will be assigned in accordance with established PHS referral guidelines. Applications will be reviewed by an initial review group (IRG) for scientific and technical merit in accordance with the standard NIH review procedures. AWARD CRITERIA Applications recommended for further consideration will compete for available funds with all other applications assigned to the that Institute. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; and o Program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Coryl Jones, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse Rockwall II, Suite 615 Rockville, MD 20857 Telephone: (301) 443-2974 Cora Lee Wetherington, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A20 Rockville, MD 20857 Telephone: (301) 443-1263 Direct inquiries regarding fiscal matters to: Mrs. Shirley A. Denney Grants Management Branch National Institute on Drug Abuse Parklawn Building, 8A54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Public Health Service Act, Sections 301 and 405 (42 USC 241 and 284). Title 42 Code of Federal Regulations (CFR) Part 52, "Grants for Research Projects," Title 45 CFR Part 74, "Administration of Grants," and 45 CFR Part 92 are applicable to these awards. Grants must be administered in accordance with the PHS Grants Policy Statement, (rev. 10/90). This program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-93-060 ************************************************ BIOMEDICAL FACTORS IN DRUG ABUSE ETIOLOGY AND CONSEQUENCES NIH GUIDE, Volume 22, Number 9, March 5, 1993 PA NUMBER: PA-93-060 P.T. 34; K.W. 0404009, 0755030, 0785055 National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) is soliciting applications for exploratory/developmental grants for research on the Biomedical Factors in Drug Abuse Etiology and Consequences. The purpose is to encourage investigations into biomedical factors in the etiology, escalation, consequences, and epidemiology of drug abuse. Exploratory/Developmental grants (R21) are intended to encourage new research activities which will be building blocks in the development of future, more intensive and larger research studies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Biomedical Factors in Drug Abuse Etiology and Consequences, is related to the priority area of alcohol and other drug abuse. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, non-profit and for-profit organizations, public and private, such as colleges, universities, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Woman and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The research support mechanism is limited to Exploratory/Developmental grants (R21). This mechanism is intended to encourage new research projects in undeveloped subject areas. It is expected that applicants will be experienced investigators whose previous research may be in related areas (of substance abuse including alcohol) or more distantly related areas (e.g., mental health), but whose expertise is applicable to research objectives for this announcement. Grants supported under this mechanism are limited to a two-year effort and a maximum of $90,000 in direct costs per year. However, well-justified costs exceeding $90,000 may be considered only in exceptional cases (e.g., PET imaging technology). (New investigators or investigators with established research in related areas should apply under other appropriate mechanisms.) A no-cost extension of up to one year may be effected by the grantee institution prior to expiration of the project period. Annual awards will be made subject to continued availability of funds and progress achieved. It is estimated that funds will be available for approximately four to five exploratory/developmental awards each year under this announcement. The final number of applications will depend on appropriated funds and program priorities at the time of award. RESEARCH OBJECTIVES The objectives of the exploratory/developmental grants (P21) are to explore, discover, and document relationships with biomedical factors that are possible causes or consequences of substance abuse. Biomedical, in this sense, refers to biologically based factors (which are separate from, but may be influenced by, environmental factors) that may be related to a medically relevant condition. These objectives are to: (1) Plan and conduct research that will assess the prevalence, distribution, and epidemiology of biomedical risk factors underlying the vulnerability to abuse drugs, following the initial exposure. (2) Plan and conduct research that will assess the type and distribution of the biomedical consequences of abusing drugs. (3) Conduct pilot studies leading to new programs that would enhance the prediction of factors contributing to the biomedical etiology of drug abuse. (4) Modify and further develop existing technologies and methodologies for studying the biomedical risk factors of drug abuse. In addition, NIDA is interested in projects that focus on biomedical aspects of drug abuse that might be unique to special groups such as women, neonates and infants, adolescents and youth, the elderly, and minority or ethnic populations. Applications solicited by this announcement are pertinent to a broad range of measurement and methodological issues, including the creation, development, modification, or enhancement of instruments, techniques and analytic strategies to assist in research on the epidemiology, etiology, vulnerability, or consequences of drug abuse. Basic research projects should develop new information about how individual differences for biomedical profiles are predictive of drug abuse or, alternatively, protection from drug abuse. Specific goals may include, but are not limited to: 1. Identifying concomitants for drug craving to determine if individuals may be distinguished on this basis, thereby improving chances for prevention and treatment. 2. Modifying technologies that have been traditionally used in other applications (e.g., alcohol) so that they may be applied to the biomedical aspects of drug abuse. 3. Analyzing appropriate variables collected in large data sets that would provide preliminary information on the epidemiology, etiology, and consequences of drug use. 4. Developing promising avenues of inquiry for understanding the multiple consequences of drug abuse for several variables including biological, physiological, and other biomedical factors. 5. Determining individuals at risk for vulnerability to drug-induced organ and tissue damage which lead to neurological, psychopathological, neurophysiological, hormonal, metabolic, immunological, or physiological dysfunction. Studies may include genetic susceptibilities as well as developmental or degenerative mechanisms. 6. Determining whether maternal drug use potentiates abnormalities in offspring for physiological, development, and cognitive conditions. 7. Determining whether psychological or neuropsychological function or dysfunction, or psychopathological disorders are associated with physiological conditions predictive of drug abuse. 8. Determining whether familial or environmental factors contribute to physiological changes that influence drug abuse. Examples include (but are not limited to) stress factors, dietary practices, preventive health care, and environmental toxins or teratogens. 9. Determining whether individual differences in brain metabolism, neuroanatomical structures, or patterns of neurophysiological function (e.g., neuronal firing, neurotransmitter efficiency) are predictive of escalation of drug use, or protection from drug abuse. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both sexes in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of disease, disorders and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one sex and/or minorities are excluded, or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of sex and racial/ethnic group, together with a rationale for its choice. In addition, sex and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all clinical research projects to include representation of the full array of United States racial\ethnic minority populations (i.e., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or sex representation (by age distribution, risk factors, incidence/prevalence, etc.), appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these sex and minority group differences in the proposed study. If adequate inclusion of one sex and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one sex or minority/majority group, the rationale for the study population must be well explained and justified. The NIH funding components will not make awards of grants, cooperative agreements or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of the subjects. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipts dates for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 249, Bethesda, MD 20892, telephone (301) 496-7441. The title and number of the announcement must be typed in Item 2a on the face page of the application. The completed original application and five legible copies of the research application) must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES The Division of Research Grants (DRG) serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by an Initial Review Group (IRG) in accordance with the review criteria described below. 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, whose review may be based on policy considerations as well as scientific merit. The following criteria will be considered when assessing the merit of an exploratory/developmental application: 1. The expected significance of the proposed research to provide a basis for future development of the research area. 2. The cogency of the hypotheses on which the proposed research is based. 3. The appropriateness and adequacy of the experimental design, including the adequacy of the methodology for selection of subjects and/or collection of data, overall research scheme, instrumentation, and statistical analysis. 4. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 5. The availability of adequate facilities, general environment or the conduct of proposed research, other resources, and collaborative arrangements necessary for the research. 6. The appropriateness of budget estimates for the proposed research activities. AWARD CRITERIA Applications will compete for available funds with all other applications recommended for further consideration assigned to the Institute. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement Terms and Conditions of Support Grant funds may be used for expenses clearly related and necessary to conduct research projects, including both direct costs that can be specifically identified with the project and allowable indirect costs of the institution. Funds may not be used to establish, add a component to, or operate a treatment, rehabilitation, or prevention intervention service program. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs which promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. These awards are not renewable. Grantees are expected to submit to their project officer three copies of the final reports of their research within 90 days of the project's termination. The final report should contain at least the following: a literature review, a clear statement of methodology employed, and a clear exposition of the practical implications for further research. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries on programmatic issues to: Harold Gordon, Ph.D. or Meyer D. Glantz, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2974 The National Institute of Neurological Disorders and Stroke (NINDS) supports research focusing on the determinants of normal and pathological development of the nervous system from the genetic to the environmental. Direct inquiries to: Giovanna M. Spinella, M.D. Division of Convulsive Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 8C10 Bethesda, MD 20892 Telephone: (301) 496-5821 Direct inquiries regarding fiscal matters to: Shirley A. Denney Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room 8A-54 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301 (42 USC 241). Federal regulations at 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to these awards. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$P3 BEGIN PA-93-061 ************************************************ CONGENITAL CYTOMEGALOVIRUS: UNDERSTANDING INFECTION AND SEQUELAE NIH GUIDE, Volume 22, Number 9, March 5, 1993 PA NUMBER: PA-93-061 P.T. 34; K.W. 0715125, 0765033, 1002045 National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), and the National Institute on Deafness and Other Communication Disorders (NIDCD) invite investigator-initiated research applications for support of basic studies needed to establish the knowledge base for the development of prototype vaccines to prevent symptomatic congenital cytomegalovirus (CMV) infection and/or reduce the associated severe sequelae. Emphasis is on the role of host and virus factors in determining disease pathogenesis and outcome of congenital CMV infections. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, Congenital CMV: Understanding Infection and Sequelae, is related to the priority areas of immunization and infectious diseases, maternal and infant health, and diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are ineligible for the First Independent Research Support and Transition (FIRST) (R29) award. Applications from minority individuals and women are encouraged. MECHANISMS OF SUPPORT Applications considered appropriate responses to this announcement are the research project grants (R01) and the FIRST award (R29). RESEARCH OBJECTIVES AND SCOPE Background In utero CMV infection affects 40,000 children annually in the US, with 7,500 to 10,000 children having severe sequelae including progressive and profound deafness, mental retardation and learning disabilities. In the US, congenital CMV infection may be the cause of 20 to 40 percent of congenital deafness and is as frequent a cause of mental retardation as the fragile X-chromosome. CNS damage from congenital CMV infection exceeds that due to any other infectious cause. CMV is the most common intrauterine infection in humans, occurring in 0.4 to 2.3 percent of all infants born alive. Of the 40,000 congenital CMV infections, ten percent are symptomatic; 90 percent of symptomatic children suffer severe CNS sequelae and many of them require lifetime custodial care at an annual cost of $1.86 billion. Annually, congenital CMV infection results in 7,500 severely impaired children. Of the asymptomatically infected children, 15 percent have sequelae that while less severe, impact substantially on their lives. The highest risk for symptomatic congenital CMV infection is among infants born to mothers who have had primary infection during pregnancy. Although transmission patterns may differ, infants born to seronegative women of both high and low socioeconomic status are at risk, with infants of disadvantaged adolescent women being at greatest risk. On March 12-13, 1992, the NICHD and the NIAID co-sponsored a workshop on congenital CMV infection. While substantial progress has been made in defining congenital CMV infection, there are still significant gaps in knowledge of the host and viral factors that determine viral transmission, disease pathogenesis and outcome, and severity of sequelae. Based on the severity of symptomatic congenital CMV disease, a vaccine that prevented symptomatic disease and/or moderated sequelae, even if not preventing infection, would be of significant benefit. (Copies of the workshop summary are available from the program officials listed below. Other references include: Morbidity and Mortality Weekly Reports, vol. 41, No. SS-2, April 24, 1992, pps 35-44 and Yow MD and Demmler GJ, New England Journal of Medicine, vol. 326, 1992, pps 702-3.) Additionally, CMV is the single most important infectious agent affecting recipients of organ transplants, with at least two or three of these patients developing CMV infection/reactivation one to four months after transplantation. CMV retinitis occurs in 6-15 percent of AIDS patients; the minimum prevalence of CMV enterocolitis is estimated as 2.5 percent of AIDS patients. Although antiviral therapy has reduced the morbidity and mortality from CMV in immunocompromised individuals, knowledge gained from research in response to this program announcement may facilitate the development of vaccine or other immunological strategies to help these patient groups as well. o Research Objectives and Experimental Approaches The focus of applications submitted in response to this program announcement should be the definition of the factors disposing to or preventing the development of congenital CMV infection, disease, and sequelae. The long term goal of this research is accrual of knowledge for the development of vaccines to prevent congenital CMV disease and/or reduce the associated severe sequelae. Examples of issues that need to be addressed include, but are not limited to: o determination of serological and cellular correlates of protective human immunity. Assessment of these correlates does not necessarily require study of pregnant women. Because CMV disease manifestations vary with the nature and degree of immunodeficiency, studies of defined groups of moderately immunocompromised individuals could provide an opportunity to correlate immune profile with disease pathogenesis. Studies measuring mucosal immunity, correlating specific cellular and humoral responses with level of virus excretion, or comparing primary infection with reactivation/persistent infection are also very relevant to this issue; o development of animal models of congenital infection. Such models should have infection outcomes that parallel human disease and could be used to study host factors, including the effect on outcome of gestational age of infection, maternal immune status, and reactivation vs primary infection; o determination of factors that impact on disease transmission and outcome such as: age of gestation, maternal protective immunity, role of primary infection vs. secondary infection vs reactivation; o determination of the effect of CMV strain variation on host response, disease or outcome; o determination of the virus site of latency and CMV trafficking in the lymphoid system; o assessment of the occurrence of deficits in asymptomatically infected children; and of host and viral factors which predispose to mental retardation; o assessment of the occurrence of early- and late-onset hearing loss and of vestibular dysfunction; o assessment of the prevalence in seropositive individuals of B-cells and/or T-cells reactive with vaccine prototype antigens or assessment of immune response or efficacy in animal models. The purpose of such studies would be to determine whether a prototype was an appropriate vaccine candidate. Vaccine trials are not within the scope of this announcement. Applications may address one or several issues, but should retain a common theme and focus in addressing those issues. Because issues of virology, immunology, epidemiology, neurology, neurology, audiology, and pathology may need to be addressed in a coordinated manner, collaboration among investigators having expertise in these and other appropriate disciplines is encouraged. When individuals are at different institutions, individual R01 applications may include consortium arrangements. Collaborative arrangements with on-going clinical studies or trials that provide patient material at little or no-cost to the proposed grant application are encouraged. Such arrangements should be clearly delineated in the application. The description should include sufficient information to permit scientific evaluation of the studies proposed. Among issues to include are the number and type of specimens/patients, patient population characteristics (including gender and minority composition; see STUDY POPULATIONS below), overall goals of the collaborative project, remaining term of the project and IRB approval of the project. If substantial interactions and costs with ongoing projects are proposed, a consortium agreement can be developed and submitted to support this additional research aspect. From owner-sci-resources@net.bio.net Wed Mar 03 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 9, pt. 2, 5 March 1993 Message-ID: Date: 4 Mar 93 00:34:12 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1016 $$XID NIHGUIDE 19930305 V22N09 P2O2 ************************************ If statistical analysis is anticipated, the methodologies and personnel involved should be described in the application and evident in the study design. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines: February 1, June 1, and October 1. The receipt dates for applications for AIDS-related research are: January 2, May 1, and September 1. Application kits are available at most institutional offices for sponsored research or business offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The title and number of the announcement must be typed in Section 2a on the face page of the application and the "YES" box marked. The completed original and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center of Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. Special Instructions In order to facilitate interaction among the investigators who successfully respond to this program announcement, program staff plans to hold workshops in the Bethesda/Rockville area in calendar years 1995 and 1997. Applicants may request travel funds for this purpose in the application. REVIEW PROCEDURES Applications will be assigned on the basis of established Public Health Service Referral Guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, and in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive secondary review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that ICD. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, and availability of funds. Generally, the interval between receipt of applications and earliest award is 10 months for non-AIDS applications and six months for AIDS-related applications. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Susan B. Spring, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-14 Bethesda, MD 20892 Telephone: (301) 496-7453 FAX: (301) 402-0804 Charlotte Catz, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Building 6100, Room 4B-03 Bethesda, MD 20892 Telephone: (301) 496-5575 FAX: (301) 402-2085 Kenneth Gruber, Ph.D. Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400B Rockville, MD 20892 Telephone: (301) 402-3458 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 Bethesda, MD 20892 Telephone: (301) 496-7075 Mr. Edgar D. Shawver Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100, Room 8A-17 Bethesda, MD 20892 Telephone: (301) 496-1303 Ms. Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400B Rockville, MD 20892 Telephone: (301) 402-0909 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research; 93.865, Research for Mothers and Children; 93.173 NIDCD. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies 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. $$P3 END ************************************************************ $$P4 BEGIN PA-93-062 ************************************************ RESEARCH GRANTS RELATED TO GENETICS OF THE EPILEPSIES NIH GUIDE, Volume 22, Number 9, March 5, 1993 PA NUMBER: PA-93-062 P.T. 34; K.W. 0715060, 1002019, 1002030 National Institute of Neurological Disorders and Stroke PURPOSE The Division of Convulsive, Developmental, and Neuromuscular Disorders, National Institute of Neurological Disorders and Stroke (NINDS) encourages the submission of research grant applications related to genetics of the epilepsies. The NINDS solicits submission of research project grants to stimulate research in both basic and clinical aspects of genetics of the epilepsies. The scope of this program encompasses both animal and human studies which would utilize a variety of experimental approaches and methods. In 1980, the NINDS cosponsored a conference for discussion of the epidemiologic, genetic, clinical and molecular strategies that could be used to study the pathogenesis of epilepsy. In the intervening decade human genetics, and neurogenetics in particular, have evolved at a remarkable pace. In 1991, a second conference on genetics and epilepsy critically reviewed a diversity of research strategies and pointed the way for future research. At the international conference, a number of areas that could profit from research, including applications of new technologies to epilepsy research, were identified. The NINDS seeks to encourage cross- communication among diverse scientific disciplines so that the potential of all of the relevant neurosciences can be brought to bear on the research problem of genetics of the epilepsies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priorities. This program announcement, Research Grants Related to Genetics of the Epilepsies, is related to the priority areas of the epilepsies. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-0) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are eligible for research project grants (R01) only. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the investigator-initiated research project grant (R01), the First Independent Research Support and Transition (FIRST) award (R29), the program project grant (P01), and the center grant (P50). As consistent with the aforementioned mechanisms, the Principal Investigator or program director, as well as any participating investigators, will plan, direct, and perform the research. Applicants for program project grants should contact the NINDS representatives listed below as early as possible in the planning stages. RESEARCH OBJECTIVES The intent of this program announcement is to increase understanding of the role of genetic factors in human epilepsy. Some examples of areas of research interest are given below. However, applications in other areas related to the genetics of epilepsy are welcome. Collaborative Studies. Collaboration between molecular geneticists and clinicians who have access to informative pedigrees is encouraged. Additional research to localize more precisely genetic abnormalities associated with specific epilepsy syndromes is encouraged. Such studies may permit the identification of abnormal gene products whose defect can be related to seizure activity. Electrophysiological Studies. There is some evidence that genetic mutations, for reasons that are unclear, may affect the excitability of individual neurons or neuronal nets. Therefore, research on genetic influences on neural synchronization is appropriate. Animal Models. Genetic non-human animal models of epilepsy can be particularly informative. At the present time there is no model that correlates with human temporal lobe epilepsy. The development of appropriate animal models may permit the identification of a genetic defect responsible for reduced seizure threshold, not only in idiopathic epilepsy, but those seizures associated with febrile episodes or seizures after head trauma. Genetic Susceptibility to Neuronal Damage Caused by Seizures. There is evidence that an initial seizure may predispose to subsequent seizures in certain individuals by producing some alteration or damage in structures controlling cortical excitability. This susceptibility may have a genetic basis, and highlights the need for identification of particular genes whose products affect control of excitability, leading some individuals to have recurrent seizures after the initial one. STUDY POPULATIONS POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups; however, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of Unites States racial or ethnic minority populations: Native Americans (including American Indians or Alaska Natives), Asian or Pacific Islanders, Blacks, and Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and prevention strategies), diagnosis, or treatment of diseases, disorders, or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded; however, every effort should be made to include human tissues from women and racial or ethnic minorities when it is important to apply the results of the study broadly. This directive should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully. Since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' population, including minorities. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. If the required information is not contained within the application, the review will be deferred until the information is provided. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) according to the instructions included in the application package. These application packages are available from the office of sponsored research at most institutions eligible to receive Federal grants and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. Applicants for program project grants should request, from the address below, a copy of the NINDS Guidelines: Program Project and Research Center Grants (rev. 06/92). Receipt dates for new research project grant applications and FIRST Awards (R01 and R29, respectively) and for program project and center grant applications (P01 and P50, respectively) are February 1, June 1, and October 1. FIRST applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. On page 1 of form PHS 398, check "yes" in Item 2a, enter the number of this Program Announcement in the space provided, and provide the name of this Program Announcement ("Genetics of the Epilepsies") in the blank space labeled "Title." Submit a signed, typewritten original of the application, including the Checklist and five exact photocopies for research project grant and FIRST Award (R01, R29) applications or the original and three photocopies if the application is for a program project or center grant (P01, P50) to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** If the application is for a program project or center grant (P01, P50) an additional two copies of the form PHS 398 must be sent to the address listed under INQUIRIES. REVIEW CONSIDERATIONS Research project grant applications and FIRST applications (R01 and R29, respectively) will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Program project grant and center grant applications (P01 and P50, respectively) will be reviewed according to the practice of the Institute to which the application is assigned. The second level of review will be by the appropriate National Advisory Council. AWARD CRITERIA The standard review criteria will be used to assess the scientific merit of applications. Applications will compete for available funds with all other applications. The following will be considered when making funding decisions: o quality of the proposed projects as determined by peer review, o availability of funds, and o program balance among research areas. INQUIRIES Questions concerning scientific aspects of this Program Announcement may be addressed to: Charlotte B. McCutchen, M.D. Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders Federal Building, Room 114 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1917 FAX: (301) 496-9916 Questions concerning fiscal aspects of this Program Announcement may be addressed to: Patricia Driscoll Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93.853, Clinical Research Related to Neurological Disorders, and 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Services Agency review. $$P4 END ************************************************************ $$XID RFA AG93005 AG-93-005 P1O1 *************************************** PATHOPHYSIOLOGIC EFFECTS OF IMPAIRED MYOCARDIAL FUNCTION IN OLDER PERSONS NIH GUIDE, Volume 22, Number 8, February 26, 1993 RFA: AG-93-005 P.T. 34, CC; K.W. 0715040, 0765035, 0710010 National Institute on Aging Letter of Intent Receipt Date: May 15, 1993 Application Receipt Date: July 1, 1993 PURPOSE The National Institute on Aging (NIA) invites applications for research projects to study the pathophysiologic effects of impaired myocardial systolic and/or diastolic function in persons with or without conventionally-defined heart failure. The purpose of this program is to define the major pathophysiologic links between impaired myocardial contractile function and resulting frailty or disability. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Pathologic Effects of Impaired Myocardial Function in Older Persons, is related to the priority areas of heart disease and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-1) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT Support of this program will be through the research project grant (R01). Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, rev. 10/91. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed by a DRG study section. If it is determined that there is a sufficient continuing program need, the NIA may announce a request for competitive continuation applications. The requested total funding (direct and indirect costs) for individual grant applications for the first-year may not exceed $200,000, with increases of no more than 4 percent for subsequent years. The total project period for applications submitted in response to the present RFA may not exceed four years. The anticipated award date will be July 1, 1994. FUNDS AVAILABLE It is estimated that $1.2 million will be available to fund grants under this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Total support may not exceed four years. RESEARCH OBJECTIVES Background Myocardial contractile dysfunction is an important cause of disability in older people. Heart failure is the most common hospital discharge diagnosis in persons over age 65 years. It was the first listed diagnosis in 533,000 admissions of people over 65 in 1988. The U.S. prevalence of heart failure among over-65 persons is estimated at over 2.5 million people (1). The prevalence of heart failure is expected to rise as population trends reflect the increase in proportion of people over age 65 years. Heart failure may be defined in various ways. As a clinical syndrome, heart failure is associated with reduced exercise tolerance, dyspnea, and fatigue, as well as shortened life span. Most definitions include diminished heart pumping capacity and inadequate cardiac output. There may be elements of systolic and/or diastolic dysfunction. Myocardial contractile dysfunction of varying degrees can occur without clinical heart failure. Impaired cardiac pumping capacity may cause inadequate blood supply to peripheral muscles, and inadequate muscle blood supply may be an important contributor to decreased exercise capacity. It may also contribute to subjective feelings of fatigue and shortness of breath in persons with heart failure. However, although it was once felt to be a sufficient explanation for decreased overall functional capacity in people with heart failure, it is now recognized that pumping action, at least as measured as left ventricular systolic function, is poorly related to exercise capacity (2). For example, subjects with moderately decreased ejection fractions may or may not have symptoms of heart failure. In the project, "Studies of Left Ventricular Dysfunction" (SOLVD), 40 subjects were studied who were totally free of symptoms even though they had ejection fractions less than 35 (mean 29 q 5%). None had symptoms of exertional fatigue or dyspnea, nor did they limit their normal physical activity, and all were New York Heart Association functional class I. They did, however, have a reduced peak aerobic capacity (3). Several studies support the concept that systolic pumping efficiency, at least as measured by left ventricular ejection fraction, is an inadequate single predictor of symptoms of heart failure, and symptoms may improve without an improvement in ejection fraction. A number of other potential determinants of symptoms need to be considered. (1) Diastolic dysfunction. Individuals with normal left ventricular function may have congestive heart failure from diastolic dysfunction (4,5). Diastolic dysfunction is often defined as a decrease in the volume rate of change in diastole (dV/dt) or filling rate integral, changes that may occur with age alone. Diastolic dysfunction may be associated with or cause an elevation in pulmonary wedge pressure, which may be the source of most symptoms in heart failure (6). Other pulmonary changes or disease may contribute to symptoms in other cases. Confounding the problem, subjects with other heart disease, but with preserved left ventricle function, also may have heart failure symptoms. In one study, heart failure symptoms were associated with chronic obstructive pulmonary disease and age (7). (2) Skeletal muscle changes. Changes in skeletal muscle typically occur with aging, and may result in a decline in physical capacity. Such changes may result from altered glycogenolysis, changes in adrenergic stimulation, or loss of type II skeletal muscle fibers (8). Heart failure has also been associated with skeletal muscle changes (9). Atrophy in Type I muscle fibers occurs in subjects with heart failure, along with other metabolic changes (10,11). Muscle inorganic phosphate to phosphocreatine ratio, a measure of bioenergetic efficiency, may be abnormal in persons with heart failure, but may improve with local muscle training without an overall training effect (12). Myopathy of heart failure may be the result of muscle disuse secondary to fatigue, or may result from another mechanism. Muscles such as the quadriceps may be used less because the subject has decreased exercise tolerance; however, the diaphragm is unlikely to be less used in subjects with heart failure, and may be used at a higher rate due to shortness of breath. Diaphragm muscle biopsies from human subjects with heart failure also show changes suggestive of myopathy (13). The myopathy possibly may be due to circulating elements or to central nervous system changes. Muscle vascular reactivity is decreased in heart failure, limiting blood flow during exercise (14). Decreased reactivity may be due to alterations in central nervous system sympathetic outflow (15). (3) Physical fitness. Cardiopulmonary function may be affected by age, but physical fitness contributes significantly to physiologic function (16). Exercise, pre-morbid fitness, and conditioning activities may modify the impact of heart failure in ways other than through myopathic changes in skeletal muscle. Physical training can increase peak aerobic capacity, even in subjects with severe systolic dysfunction. In one study, subjects with mean LV ejection fraction of 19 percent were able to significantly improve peak oxygen consumption with a program of home-based bicycle exercise (17). (4) Neuroendocrine and other hormones. Sympathetic activity increases in heart failure, but reactive beta receptor downregulation is variable (18). Exercise-provoked catecholamine response is greater in subjects with heart failure (19). Variable "resistance" to catecholamines may explain differences in exercise capacity. The renin-aldosterone-angiotensin system is also activated in heart failure, and possibly is interactive with the catecholamine system. Hyponatremia, presumably related to aldosterone, vasopressin and baroreceptor function, is significantly predictive of death in severe heart failure (20), but has apparently not been related to exercise capacity or other symptoms. Such relationships are difficult to study in humans due to the confounding effect of pharmacologic treatment. Tumor necrosis factor (TNF) may be produced with reperfusion following myocardial ischemia (21). TNF may be a mediator of adverse systemic consequences in ischemic-related heart failure. (5) Nutritional changes in subjects with myocardial impairment may contribute to muscle changes and symptoms of weakness. Protein malnutrition may contribute to "myopathy of failure." Obesity may contribute to fatigue and dyspnea. (6) Other variables. Medication. Digitalis, widely used to treat heart failure, is known to produce dysphoria even at less than "toxic" levels. Diuretics may cause magnesium deficiency, which in turn may cause weakness and fatigue. Depression prevalence increases with age over 50. The association of depression, heart failure, and functional capacity and symptoms has not been adequately studied. Psychological factors such as locus of control may affect an individual's response to a chronic illness such as heart failure. Abnormal pulmonary function (with or without diastolic dysfunction) may be a major determinant of symptoms in many persons with impaired myocardial contractility. Research Goals Research funded under this RFA should increase the understanding of the pathophysiologic mechanisms by which impaired myocardial contractile function produces symptoms and impaired functional capacity. A large variety of diverse and possibly related factors should be considered. Examples of parameters for study include, but are not limited to: o Effects on exercise tolerance and functional abilities in activities such as walking and stair climbing, of various myocardial contractile impairments o Effects on and interactions with pulmonary physiology, function, and pathology o Effects on skeletal muscle physiology, function, and pathology, including "myopathy of heart failure;" interactions with nutrition o Symptomatic effects such as dyspnea and fatigue o Effects of endocrine and neuroendocrine systems leading to secondary pathophysiologic changes in other organs, mood, and other effects o Secondary effects of impaired myocardial function on the myocardium, cardiac conduction system, or coronary circulation leading to progressive myocardial dysfunction o Relationship of different types of myocardial dysfunction to mortality rates, hospitalization rates, nursing home admissions, other care needs, and health costs These examples are illustrative, but not restrictive. Investigators are expected to use an integrated collaborative approach, enlisting the assistance of expertise in appropriate disciplines as necessary. Because of co-morbidity in the older population, the design of proposed projects should permit a separation of the potentially confounding effects of these conditions from the effects of impaired myocardial function per se. Analytic methods to compensate for variable interactions and confounding must be considered. Elucidation of specific effects of interactions of impaired myocardial function with other pathologies is encouraged. The focus of these studies should be subjects over age 65 with myocardial dysfunction, including men and women. Subjects of younger age groups may be necessary to make age-related comparisons. Because of the great population differences between the "young old" (under age 80) and "old old" (over age 80), designs that include adequate numbers in the latter age category for analyses specific to that group are strongly encouraged. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULAITONS It is NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them. The study design must seek to identify any pertinent gender or minority population differences. The composition of the proposed study population must be described in terms of gender and racial/ethnic groups, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority populations should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are exempt. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned without review. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study is inadequate to answer the scientific questions(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIA staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent should be sent to Dr. Cooper at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-496-7441; and from the program administrator named below. The RFA label available in the application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent to: Michael A. Oxman, Ph.D. National Institute on Aging Gateway Building, Room 2C212 7201 Wisconsin Avenue Bethesda, MD 20892 Applications must be received by July 14, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does snot preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Relationship to Existing Programs The National Heart, Lung, and Blood Institute (NHLBI) sponsors research on heart failure and mechanisms of myocardial dysfunction. This RFA is aimed at older populations and the mechanisms that produce frailty. The NHLBI will receive assignment on appropriate applications. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIA staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIA. Applications may be subjected to triage by an NIA peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIH will withdraw from further competition those applications judged by triage to be noncompetitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. The second level of review will be provided by the National Aging Advisory Council. Review criteria for this RFA are the same as those for unsolicited research grant applications. o Scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o Involvement of women and minorities in subject populations will also be considered when reviewers assign a priority score INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James K. Cooper, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E327 Bethesda, MD 20892 Telephone: (301) 496-6761 Direct inquiries regarding fiscal matters to: Barbara Cunningham Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. References 1. Thom T. 1991 Personal communication 2. Myers J, Froelicher VF. Hemodynamic determinants of exercise capacity in chronic heart failure. Annals Internal Med 1991; 115:377-86 3. LeJemtel TH, et al. Depressed peak aerobic capacity in asymptomatic patients with moderate to severe left ventricular dysfunction at rest: a substudy of the studies of left ventricular dysfunction (SOLVD). Presented at the Amer. Heart Assoc mtg, Nov 3, 1990 4. Grossman W. Diastolic dysfunction in congestive heart failure. New Engl J Med 1991; 325:1557-64 5. Gaasch WH. Congestive heart failure in patients with normal left ventricular systolic function: a manifestation of diastolic dysfunction. Herz 1991; 16:22-32 6. Packer M. Abnormalities of diastolic function as a potential cause of exercise intolerance in chronic heart failure. Circulation 1990; 81 (Suppl III):III-78-III-86 7. Judge KW. Congestive heart failure symptoms in patients with preserved left ventricular systolic function: analysis of the CASS registry. J Am Coll Cardiol 1991; 18:377-82 8. Chick TW, et al. The effect of aging on submaximal exercise performance and recovery. J Gerontology: Bio Sci 1991; 46: B34-38 9. Mancini DM, et al. Contribution of skeletal muscle atrophy to exercise intolerance and altered muscle metabolism in heart failure. Circulation 1992; 85: 1364-73 10. Sullivan MJ, Green HJ, Cobb FR. Skeletal muscle biochemistry and histology in ambulatory patients with long-term heart failure. Circ 1990; 81: 518-27 11. Drexler H, et al. Alterations of skeletal muscle in chronic heart failure. Circulation 1992; 85:1751-59 12. Minottie JR, et al. Skeletal muscle response to exercise training in congestive heart failure. J Clin Invest 1990; 86: 751-8 13. Lindsay D. Personal communication, 1991 14. Solal AC, Gourgon R. Assessment of exercise tolerance in chronic congestive heart failure. Am J Cardiology 1991; 67: 36C-40C 15. Ferguson D. Sympathetic mechanisms in heart failure: pathophysiological and pharmacological implications. Scientific conference on heart failure, Am Heart Assoc, Aug 4, 1991 16. Neyers DA et al. Relationship of obesity and physical fitness to cardiopulmonary and metabolic function in healthy older men. J. Gerontology: Med Sci 1991; 46: M57-65 17. Coats AJS, et al. Effects of physical training in chronic heart failure. Lancet 1990; 335: 63-6 18. Forfar JC. Neuroendocrine activation in congestive heart failure. Am J Cardiology 1991; 67: 3C-5C 19. Chidsey CA, Harrison DC, Braunwald E. Augmentation of plasma norepinephrine response to exercise in patients with congestive heart failure. N Engl J Med 1962;267: 650-54 20. Parameshwar J, Keegan J, Sparrow J, et al. Predictors of prognosis in severe chronic heart failure. Am Heart J 1992; 123:421-26 21. Lefer AM, Tsao P, Aoki N, Palladino MA. Mediation of cardioprotection by transforming growth factor-beta. Science 1990; 249: 61-64 From owner-sci-resources@net.bio.net Sun Mar 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 7 March 1993 Message-ID: Date: 8 Mar 93 21:54:27 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 89 ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF Bulletin Vol. 20; No. 7 (March 1993) File size (bytes): 26239 STIS Filename: bul9303 Document Type: Program Guideline Title: NSF 93-19 RESEARCH ON HUMAN LANGUAGE TECHNOLOGY File size (bytes): 10933 STIS Filename: nsf9319 Document Type: Report Title: MINUTES OF THE ADVISORY COMMITTEE FOR ASTRONOMICAL SCIENCES (ACAST) File size (bytes): 57824 STIS Filename: rast931 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 2837 STIS Filename: cmpublic Document Type: EPS Title: Electronic Proposal Submission (EPS) Unix Binaries File size (bytes): 1369 STIS Filename: epsbin Also available: epsbin.sun epsbin.nxt epsbin.sgi Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 91237 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 92094 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Wed Mar 10 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 10, pt. 1, 12 March 1993 Message-ID: Date: 11 Mar 93 23:10:28 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1505 NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930312 V22N10 P1O2 ************************************ X-comment: RFAs described: AI-93-08, AI-93-09, AI-93-10, ES-93-01, DE-93-04 NIH GUIDE - Vol. 22, No. 10 - March 12, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N2 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** LATE FINANCIAL STATUS REPORTS National Institutes of Health NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** IN VITRO BIOGENIC AMINE TRANSPORTER TESTING FOR POTENTIAL COCAINE TREATMENT MEDICATIONS (RFP NO1DA-3-8303) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R2 05/21/93 ************************************************* COLLABORATIVE MUCOSAL IMMUNOLOGY GROUPS FOR AIDS VACCINES (RFA AI-93-08) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 07/15/93 ************************************************* MOLECULAR AUGMENTATION OF HOST DEFENSE (RFA AI-93-09) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 07/21/93 ************************************************* MECHANISMS OF ORAL TOLERIZATION AND IMMUNIZATION (RFA AI-93-10) National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX R5 07/28/93 ************************************************* DEVELOPMENT GRANT: ENVIRONMENTAL HEALTH SCIENCES CENTERS (RFA ES-93-01) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX R6 09/10/93 ************************************************* NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING APPLICATIONS (RFA DE-93-04) National Institute of Dental Research INDEX: DENTAL RESEARCH ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** PRIMARY CARE AND HEALTH CARE REFORM (PA-93-063) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer. Contact Dr. John James at 301/496-7554 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS NIH GUIDE, Volume 22, Number 10, March 12, 1993 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human persons and those currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes: NORTHWESTERN WORKSHOP DATES: May 19, 20, 21, 1993 LOCATION Sheraton Hotel, Anchorage, AK SPONSORS University of Alaska - Anchorage, Anchorage, AK Northwest Indian College, Bellingham, WA Indian Health Services, Tucson, AZ REGISTRATION Ms. Ann Howell Coordinator of Conferences and Institutes University of Alaska - Anchorage 2221 East Northern Lights, Suite 205 Anchorage, AK 99508 Telephone: (907) 278-8821 TITLE: Basic Training Session - Research Benefits and Risks to Individuals and Communities: Legal and Ethical Perspectives DESCRIPTION: This conference will explore the legal and ethical perspectives of social and biomedical research. Protecting the individual rights of human research subjects is of prime concern, but so is protecting the rights of communities of individuals. This is especially true for indigenous peoples. The conference is designed to be of interest to social and biomedical researchers, IRB members, students, agency personnel, indigenous peoples, and others interested in the rights of individuals and communities. Opportunities for informal discussion and exchange will supplement the panel and breakout group format. Reports from the simultaneous group sessions will be made. Participants will learn how regulations and community participation can protect human subjects in research, explore the notion of protecting communities from research risks, examine the impact of recent court rulings on research risks, interact with others interested in research risk issues, and make recommendations to agency and other personnel. For information regarding these workshops and future NIH/FDA National Human Subjects Protection Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 22, Number 10, March 12, 1993 P.T. 42; K.W. 0783005 National Institutes of Health The Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH), is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for FY 1993 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators, and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. NORTHEASTERN WORKSHOP DATES: June 21-22, 1993 LOCATION The Warwick Hotel 1701 Locust Street Philadelphia, PA 19103-6179 Telephone: 1-800-523-4210 or (215) 735-6000 FAX: (215) 790-7766 SPONSORS Hahnemann University - Drexel University REGISTRATION Ms. Eleanore Hersh Director of Continuing Education Hahnemann University Broad and Vine - Mail Stop 623 Philadelphia, PA 19102-1192 Telephone: (215) 762-8263 FAX: (215) 762-8848 Dr. Kenneth Geller Assistant Vice President for Research and Technology Management Office of Sponsored Projects Drexel University - Building 1-102 Philadelphia, PA 19104 Telephone: (215) 895-2499 FAX: (215) 895-1619 TOPIC: ETHICAL ISSUES OF ANIMAL USE IN ACADEME AND INDUSTRY o Investigator Training o Animal Use in Teaching o Assessment of Morbidity and Endpoints o Allegations of Noncompliance For information concerning this workshop and future NIH/OPRR Animal Welfare Education workshops, contact: Mrs. Roberta Sonneborn Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-7163 FAX: (301) 402-2803 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** LATE FINANCIAL STATUS REPORTS NIH GUIDE, Volume 22, Number 10, March 12, 1993 P.T. 34; K.W. 1014006 National Institutes of Health Recipients of Public Health Service (PHS) nonconstruction grants are required to submit the Financial Status Report (SF 269 or 269A) as documentation of the financial status of grants according to the official accounting records of the grantee organization. Department of Health and Human Services (HHS) regulations at 45 CFR Part 74.73(d) and Part 92.41(b) dictate that the FSR, when required on an annual basis, must be submitted for each budget period no later than 90 days after the close of the budget period. The late submission of the FSR is a continuing problem for the PHS and the National Institutes of Health (NIH). While some grantees are in full compliance with this requirement, many are not. In fact, NIH data show that 45 percent of the FSRs submitted during fiscal year 1992 arrived after the 90 day period. Late submission of FSRs is not only a violation of HHS regulations, but also may be an indication that grantee accounting systems are deficient in meeting the federal accounting standards required by the Office of Management and Budget. The subsequent effort and follow-up on the part of the Division of Financial Management (DFM) and the NIH awarding components to obtain delinquent FSRs is time-consuming and labor-intensive for all parties. DFM regularly sends out a listing of past due financial status reports to all grantee institutions, informing them of their current status. The latest report was mailed out in early January. Staff at the NIH strongly believe that submission of timely FSRs is critical. Therefore, we want to work with you to identify the reasons for poor performance in the past and the steps that can be taken now to improve future performance. The NIH is beginning specific reviews of organizations that have been severely delinquent or overdue in the submission of FSRs. These institutions will be requested to review their systems with a critical eye to recognize the causes for late or delinquent FSRs, whether due to insufficient staffing, inadequate computer systems, or problems with accounting or organizational structure. These institutions will have to develop and submit a plan that identifies the problems experienced by the institution that have prevented timely submission of FSRs in the past; outlines the steps that will permit the institution to develop the capability for submitting future FSRs on time, including a timeline with milestones for improvement; and details the steps that will be taken in order to submit currently delinquent reports. If performance is not improved, these institutions may be in jeopardy of having sanctions imposed upon them until the problems are corrected. It is extremely important that grant recipients submit financial reports within the required time period. Failure to comply with this requirement may lead to delays or withholding of awards, loss of automatic carryover authority, loss of advanced payments, loss of expanded authorities, removal from participation in NIH-funded awards under the Federal Demonstration Project, and designation as a high- risk grantee. Grantees should evaluate their record for submitting FSRs as well as their current status. If FSRs are being submitted late, prompt corrective steps must be taken. If necessary, outside technical assistance should be obtained. It is important to reiterate that delinquency and lateness are serious concerns for all institutions and administrative authorities may be withdrawn from any institution that exhibits systemic problems or chronic lateness. In an effort to assist the grantee community, the NIH has developed a system for the Electronic Transmittal of Financial Status Reports, an interactive computer-based communications system. It enables the electronic transmission of FSRs from the grantee organization to the NIH mainframe computer. The electronic process eliminates the manual preparation, mailing, and handling of the hard-copy FSR, as well as manual processing once it arrives at NIH. There are several advantages derived from the use of this system: FSRs transmitted via this system are processed within 72 hours; the system gives users immediate feedback because it can detect errors; electronically submitted FSRs cannot be lost in the mail or sent to the wrong address; and users of the system can access current listings of grants for which FSRs are past due or for which FSRs will become due as of a specified period of time (terminating grants). INQUIRIES Additional information about the electronic system may be obtained by contacting Richard Rhoads or Priscilla Irick NIH Division of Financial Management Telephone: (301) 496-5287 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN RFP NO1DA-3-8303 ***************************************** IN VITRO BIOGENIC AMINE TRANSPORTER TESTING FOR POTENTIAL COCAINE TREATMENT MEDICATIONS NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFP AVAILABLE: NO1DA-3-8303 P.T. 34; K.W. 0404009, 0755060 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having in-house capacity to perform in vitro biogenic amine transporter assays to systematically define biochemical activities of compounds at these targets. These assays will be utilized to evaluate these compounds for potential use as cocaine abuse treatment agents. The ability of these compounds to bind to the biogenic amine transporters and affect uptake and release at these sites will be investigated. The offeror must also indicate possession of current DEA registration for Schedule II-V substances prior to award and apply for Schedule I registration, if necessary. It is estimated that a three and one-half year contract, that will include options for additional compound screens and profiles, will result from this procurement. Estimated issuance date of RFP No. NO1DA-3-8303 is March 16, 1993 and responses are due to be received in the Contracting Office 45 calendar days thereafter. Written requests for copies of the solicitation will be honored if received within twenty calendar days after issuance of the solicitation. Written requests received after this period will be filled on a first come, first served basis until the supply is exhausted; however, there is no assurance that copies requested after the twentieth day will reach the requester before the due date for receipt of responses. INQUIRIES Written requests are to be forwarded to: Contract Specialist National Institute on Drug Abuse Parklawn Building, Room 10-49 5600 Fishers Lane Rockville, MD 20857 $$R1 END ************************************************************ $$R2 BEGIN AI-93-08 FULL-TEXT *************************************** COLLABORATIVE MUCOSAL IMMUNOLOGY GROUPS FOR AIDS VACCINES NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA AVAILABLE: AI-93-08 P.T. 34; K.W. 0715 338, 0710070, 0740075, 0755010, 0755020 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 15, 1993 Application Receipt Date: May 21, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTE