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. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Vaccine Research and Development Branch (VRDB) of the Division of Acquired Immunodeficiency Syndrome (DAIDS) within The National Institute of Allergy and Infectious Diseases (NIAID) announces availability of an RFA for funding of new Collaborative Mucosal Immunology Groups (CMIGs) for AIDS vaccines. The purpose of this RFA is to invite research grant applications for collaborative projects from investigators pursuing research on mucosal immunity to Human Immunodeficiency Virus and/or Simian Immunodeficiency Virus (SIV) to participate in a network of CMIGs for AIDS vaccines. The urgent need to control the spread of AIDS has fueled efforts to develop safe and effective AIDS vaccines. Additional basic and preclinical research is needed in the area of vaccine induction of mucosal immunity to AIDS viruses (HIV and SIV). The NIAID wishes to encourage and expand research in the area of mucosal immunology to AIDS viruses, that will focus on: (1) design and development of novel recombinant vectors and/or AIDS vaccine formulations designed to induce regional mucosal immunity particularly in the female or male reproductive tracts and in the rectum (gut); (2) characterization of the components (T cells and antibodies) and their mechanism of action in the immune responses at mucosal surfaces, that are specific for HIV/SIV antigens; and (3) development of immunization strategies to prevent mucosal HIV infection and transmission. The special feature of the collaborative project program is the concurrent submission of research grant applications by investigators who wish to collaborate on a common theme related to mucosal immunity to AIDS viruses, but do not require extensive shared physical resources or core functions to conduct their research. In order to be responsive to this RFA, a minimum of two research projects are required for a Collaborative Project Group. The common theme for any group should reflect a multidisciplinary approach in the areas of immunology and virology. Investigators now participating in the National Cooperative Vaccine Development Group (NCVDG) that have pursued this area of research and new applicant groups are invited to apply. Applications from the private sector (e.g., vaccine, pharmaceutical, or biotechnological companies) are encouraged. Collaborative arrangements involving more than one institution are especially encouraged. Applications will be reviewed for scientific merit, relevance of projects to the chosen theme, and overall proposed collaboration. 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 RFA, Collaborative Mucosal Immunology Group for AIDS Vaccines, is related to the priority area of HIV infection. 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 20402-9325 (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. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The support mechanism for this program will be individual research grants (R01) that are organized around a common theme into a collaborative project group. Thus, it is the responsibility of the applicants to define their objectives in accord with their interests and perceptions of approaches to the study of mucosal immunity in AIDS vaccine development. This RFA is a one-time solicitation. If by the end of the third year, the NIAID has not announced its intent to readvertise this RFA, incumbents may prepare unsolicited competing continuation applications that will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Those who wish to continue collaborative effort are encouraged to contact NIAID staff listed under INQUIRIES before preparing an application. FUNDS AVAILABLE The NIAID anticipates making three to five new awards to Collaborative Groups (6 to 15 R01 awards). The NIAID has set-aside $1.4 million (total costs) for the initial year of funding for this RFA. RESEARCH OBJECTIVES The fundamental objective of the VRDB in the DAIDS is to develop safe and effective vaccines for the prevention of transmission of HIV-1, the causative agent of AIDS. The purpose of the CMIGs is to develop a network of focused, interdisciplinary, basic and preclinical research projects that will generate and evaluate novel strategies for eliciting protective immunity at mucosal sites of viral exposure. Applications are invited that seek to discover/design and develop vaccine strategies, animal models, methodologies, and assay reagents to study protective mucosal immunity to HIV (and SIV) in primates and/or humans. The following two general research areas are encouraged under this RFA: o Development and use of animal models to explore novel strategies for vaccination and mucosal challenge with AIDS viruses. o Development of assays, reagents and technology to evaluate specific, protective mucosal immune responses induced by AIDS vaccines in animals and human volunteers. Specific Objectives Examples of research areas of mucosal immunity for AIDS vaccines of high priority and that would be responsive to the RFA may include, but are not limited to, those listed below. These research topics are intended to provide a perspective on the scope of research. It is not required that all or any of them be included in a particular group of applications. o Development and analysis of novel AIDS vaccine strategies, vectors, delivery systems, or adjuvant formulations that would stimulate protective mucosal immunity, particularly in the genital tract in primate models. o Development of methods to evaluate mucosal immunity to lentiviruses in humans and primates. o Identification and evaluation of functional antibody responses that might be effective in preventing HIV or SIV mucosal transmission. Analysis of the mechanism of action of antiviral IgA antibodies. o Identification and characterization of mucosal cell-mediated immune responses (regional cytotoxic T lymphocytes (CTL) and helper T cells). SPECIAL CHARACTERISTICS Upon initiation of this program, several group and network meetings (three or four per year) will be sponsored to encourage the exchange of information and ideas among investigators who participate in this program. Applicants should provide plans for attending these meetings in their budget requests. Further details on special requirements are provided in the RFA. Because some investigators may not have adequate access to some specialized resources (such as: SIV or HIV and/or their proteins used as immunogens; evaluation for immunogenicity in primates; HIV or SIV vaccinee samples for evaluation) NIAID staff will be available as a source of information regarding these resources. Access to these resources should be discussed with NIAID Program Staff prior to submission of an application. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If woman and 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 April 15, 1993, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number (and FAX number, if available) of the Collaborative Project Coordinator, the names of other Principal Investigators who will submit as part of the collaborative group, other key personnel and their 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 allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review process. The letter of intent is to be sent to Dr. Bonnie J. Mathieson 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. This form is available in the applicant institution's office of sponsored research or business office 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. Additional instructions for preparation of collaborative project applications will be provided with the RFA. Applications must be received by May 21, 1993 or will otherwise be considered unresponsive. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants for completeness and by NIAID staff for responsiveness to the RFA. Incomplete and non-responsive applications will be returned to the applicant without further consideration or review. Those applications considered responsive to the RFA may be subjected to a triage review by an NIAID peer review group, to determine the scientific merit relative to the other applications submitted in response to this RFA. The NIAID will withdraw from further competition those applications judged to be non-competitive for award and will notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will be reviewed for scientific and technical merit by an appropriate peer review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the NIAID Council in September 1993. REVIEW CRITERIA Factors to be considered in the evaluation of each application will be similar to those used in review of traditional research grant applications and, in addition, will include those addressing overall proposed collaboration. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered for making funding decisions: o priority score o availability of funds o program balance among research areas INQUIRIES It is essential that prospective applicants obtain a copy of the RFA before preparing an application. Written and telephone inquiries from prospective applicants will provide NIAID staff the opportunity to clarify issues or questions about this RFA. Direct requests for the RFA, inquiries regarding programmatic or scientific issues, and address the letter of intent to: Dr. Bonnie J. Mathieson Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B04 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8200 FAX: (301) 402-1506 or (301) 480-5703 Direct inquiries regarding review matters to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 Bethesda, MD 20892 Telephone: (301) 496-0818 Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: April 15, 1993 Application Receipt Date: May 21, 1993 Council Date: September 1993 Anticipated Award Date: September 1993 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergy and Transplantation Research. Awards are made under the authority 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 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. $$R2 END ************************************************************ $$R3 BEGIN AI-93-09 FULL-TEXT *************************************** MOLECULAR AUGMENTATION OF HOST DEFENSE NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA AVAILABLE: AI-93-09 P.T. 34; K.W. 0710070, 0715125, 0740075, 0715015 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: July 15, 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 Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for basic and preclinical studies to increase knowledge of the host defense system in general and phagocytes in particular and especially the application of this information to the development of new therapies to kill infectious microorganisms. The information developed through this initiative would also be applicable to intracellular localization of therapeutic agents for autoimmune and allergic diseases. 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 RFA, Molecular Augmentation of Host Defense, is related to the priority areas of diabetes and chronic disabling diseases, and to immunization and infectious diseases. 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 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Only domestic organizations are eligible to apply for Program Project (P01) grants. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and the Program Project (P01) grant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. P01 applications should not request budgets in excess of $500,000, and R01 applications, $180,000, total direct costs in the first year; neither type of application should request more than 4 percent annual inflationary increases for future years. An application with a first year requested amount in excess of the above will require written approval by senior NIAID officials via the program officer for acceptance of the application for processing. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for this RFA will be $1,500,000. In fiscal year 1994, the NIAID plans to fund approximately 10 research projects, either as R01s or as components of P01s. 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 NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Drug-resistant infectious agents are an increasingly important medical problem. Examples of drug-resistant microorganisms include those which cause gonorrhea, tuberculosis, malaria and rheumatic fever. Infectious agents employ a variety of tactics to avoid the effects of antibiotics and the strategies of the host defense system. The objective of this RFA is to facilitate the application of advances in our understanding of such areas as membrane receptor trafficking, membrane fusion, and molecular transport between cellular compartments to the development of new types of therapeutics to combat infectious agents. An example of such an approach would be to deliver therapeutic agents to the intracellular compartments of phagocytes (endosomes) which contain microorganisms using targeting molecules which bind with high affinity to receptors which traffic between the surface membrane and endosomes. The ability to deliver therapeutic agents to the appropriate site confers enormous advantages by simultaneously increasing efficacy and diminishing toxicity, allowing the use of substances which might otherwise be too toxic. Research Objectives and Scope The goal of this initiative is increased knowledge of the cell and molecular biology of phagocytes and the use of this knowledge to develop new forms of anti-infective agents. Studies that involve human tissues and cells are especially encouraged. Examples of relevant research topics are given below; however, these examples are not intended to be inclusive or limiting. o Enhanced uptake of therapeutic agents into endosomal compartments by such means as modification of membrane receptors, selective regulation of expression of membrane receptors, or creation of targeting ligands. o Modification of membrane receptors or their expression in order to prevent or promote uptake of pathogens. o Characterization and modification of the molecules which regulate intracellular movement of microorganisms. o Promotion of selective accumulation of antibiotics in various cellular compartments including the cytosol. o Characterization of the intracellular fusion machine which operates in lysosome-phagosome fusion and the mechanism(s) used by certain organisms to disrupt this process. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES 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 research, 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 April 1, 1993, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. For P01 grant applications, prospective applicants are also asked to submit a list of the key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 09/91). For purposes of identification and processing, item 2a on the face page of the application must be marked "yes" and the RFA number and the words "MOLECULAR AUGMENTATION OF HOST DEFENSE" must be entered. These application forms may be obtained from the institution's office of sponsored research or its equivalent and 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. Applications must be received by the official receipt date as indicated in the RFA heading and in "SCHEDULE" below. Applicants interested in submitting a program project application may request, along with the RFA, a copy of the document entitled: SPECIAL INSTRUCTIONS FOR PREPARING THE GROUP APPLICATION FOR PROGRAM PROJECTS. The document provides detailed, updated instructions on how to prepare the P01 application and also contains Tables I-IV, which may be used in presenting the necessary budget and personnel information consistently. This document, particularly the tables, cannot be transmitted electronically, and must be requested from the contact listed under INQUIRIES. REVIEW CRITERIA The review criteria for R01 applications are those review criteria used for traditional research project grant applications; those for P01 grant applications are the review criteria for large, multicomponent, interdisciplinary program projects as outlined in the NIAID Brochure on Program Project and Center Grants. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the RFA,the NIAID Information Brochure on Program Project and Center Grants AND the document entitled "SPECIAL INSTRUCTIONS FOR PREPARING THE GROUP APPLICATION FOR PROGRAM PROJECTS," as well as inquiries regarding programmatic issues may be directed to: Howard B. Dickler, M.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A19 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and the five sets of appendices to: Olivia Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Jeffrey Carow Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: July 15, 1993 Scientific Review Date: October 1993 Advisory Council Date: February 1994 Earliest Date of Award: April 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN AI-93-10 FULL-TEXT *************************************** MECHANISMS OF ORAL TOLERIZATION AND IMMUNIZATION NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA AVAILABLE: AI-93-10 P.T. 34; K.W. 1002004, 1002008, 0740075, 0710070, 1002019 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: April 5, 1993 Application Receipt Date: July 21, 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 Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) and the Rheumatic Diseases Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite applications for studies focused on cellular and molecular mechanisms of oral immunization and oral tolerance. The goal of this initiative is to promote research that will increase our understanding of the mechanisms involved in the induction of protective immunity systemically and in the mucosal surfaces after oral immunization and improve our knowledge about the effects of oral administration of self-molecules as a means of inducing tolerance to prevent or reverse autoimmune and allergic diseases. 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 RFA, Mechanisms of Oral Tolerization and Immunization, is related to the priority areas of diabetes and chronic disabling conditions, and immunization and infectious diseases. 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 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by public and private, foreign and domestic, for-profit and non-profit organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Only domestic institutions are eligible to apply for Program Project (P01) grants. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The mechanisms of support for this program will be the research project grant (R01) and the Program Project (P01) grant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. P01 applications may not request budgets in excess of $500,000, and R01 applications, $180,000, total direct costs in the first year; neither type of application should request more than four percent annual inflationary increases for future years. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications with an annual budget request in excess of this amount will require written approval by senior NIAID or NIAMS officials via the program officer for acceptance of the application for processing. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for this RFA will be $1,500,000. In fiscal year 1994, the NIAID plans to fund approximately seven research projects, either as R01s or as components of P01s. In fiscal year 1994, the NIAMS plans to fund approximately three R01s. Although this program is provided for in the financial plans of the NIAID and the NIAMS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years, and availability of funds. RESEARCH OBJECTIVES Background Mucosal surfaces are the most common portals of entry of microorganisms and other environmental factors, and effective immune mechanisms exist that afford protection against some of the diseases caused by these organisms. In addition, protective immune responses can be induced in external secretions by oral administration of some attenuated or killed organisms. Although progress has been made in understanding the composition and some of the functions of the mucosal immune system in the induction of protective immunity, the basic mechanisms and molecular mediators involved in the development of immune responses remain largely unknown. Knowledge of the basic cellular and molecular immune mechanisms of the gastrointestinal tract will be the foundation for the development of successful multicomponent oral vaccines and oral tolerization protocols, and an understanding of inflammatory bowel disease. Experimental autoimmune diseases such as collagen-induced arthritis, experimental allergic encephalomyelitis and experimental uveitis have been successfully treated by the oral administration of the relevant antigen. Evidence suggests that a subpopulation of T cells and cytokines, such as TGF beta, are implicated in the induction of tolerance and prevention and/or delay of disease onset. However, the molecular basis for oral tolerance induction to autoantigens and the mechanisms that govern these processes are not understood. Although results obtained in experimental systems are encouraging, it is not clear whether oral tolerance regimens in established disease suppress or exacerbate autoimmune conditions. Carefully controlled studies using well defined self peptides and antigens in combination with advanced molecular and cellular immunology approaches are necessary before oral tolerance is considered as an effective form of therapy for human disease. Research Objectives and Scope Areas of interest include, but are not limited to: o Studies of the mechanisms involved in the induction and regulation of oral tolerance to self antigens, with emphasis on the identification of the cell types and cytokine cascades involved. o Analysis of the effect of oral administration of self peptides on ongoing autoimmune disease and the cellular and molecular mechanisms that mediate these effects. o Characterization of the molecular basis for the observed decrease in tissue damage in organ-specific autoimmune disease following the oral administration of appropriate antigens. o Studies to establish the immune parameters of induction of protective immune responses to orally administered antigens including attenuated or killed enteric pathogens, with emphasis on the characterization of cellular and molecular mediators involved in these processes. o Studies to analyze and determine peripheral and/or systemic correlates of protective immunity to orally administered antigens, including enteric pathogens and antigens delivered in carrier systems. o Studies of antigen processing and presentation by gut epithelial and lymphoid cells and design of methodologies to manipulate them to obtain stronger and/or long lasting protective immunity. New approaches to the study of mucosal immunity and approaches that combine cellular and molecular immunology and bacterial genetics are strongly encouraged as are studies that would yield information directly applicable to the human mucosal system/autoimmune disease interface. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES 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 research, 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 April 5, 1993, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator or Program Director (for P01s), and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 09/91). These application forms may be obtained from the institution's office of sponsored research and 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. Applicants interested in submitting a program project application must request, along with the RFA, a hard copy of the document entitled: SPECIAL INSTRUCTIONS FOR PREPARING THE GROUP APPLICATION FOR PROGRAM PROJECTS. The document provides detailed, updated instructions on how to prepare the P01 application and also contains Tables I-IV which may be used in presenting the necessary budget and personnel information consistently. This document, particularly the tables, cannot be transmitted electronically, and must be requested from the contact listed in under INQUIRIES. REVIEW CRITERIA The review criteria are those review criteria used for traditional research project grant applications and, in the case of P01 grant applications, those review criteria for large, multicomponent, interdisciplinary program projects as outlined in the NIAID Brochure on Program Project and Center Grants. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit, as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the RFA, the NIAID Information Brochure on Program Project and Center Grants,and the document entitled "SPECIAL INSTRUCTIONS FOR PREPARING THE GROUP APPLICATION FOR PROGRAM PROJECTS," as well as inquiries regarding programmatic issues may be directed to: Howard B. Dickler, M.D. Division of Allergy, Immunology, and Transplantation National institute of Allergy and Infectious Diseases Solar Building, Room 4A19 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Susan Serrate-Sztein, M.D. Rheumatic Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3340 FAX: (301) 480-7881 Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and the five sets of appendices to: Mark Rohrbaugh, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C22 Bethesda, MD 20892 Telephone: (301) 496-8424 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Jeffrey Carow Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: April 5, 1993 Application Receipt Date: July 21, 1993 Scientific Review Date: October 1993 Advisory Council Date: February 1994 Earliest Award Date: April 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research and No. 93.846 - Arthritis and Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN ES-93-01 FULL-TEXT *************************************** DEVELOPMENT GRANT: ENVIRONMENTAL HEALTH SCIENCES CENTERS NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA AVAILABLE: ES-93-01 P.T. 34; K.W. 0725005, 0710030 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: June 1, 1993 Application Receipt Date: July 28, 1993 THE REQUEST FOR APPLICATIONS 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 overall intent of this National Institute of Environmental Health Sciences (NIEHS) program is to establish multi-disciplinary research programs that utilize state-of-the-art science. The focus is on environmentally related health problems of economically disadvantaged and/or underserved populations. The first step in this process is the current RFA which requests developmental grant applications from institutions or consortia of institutions wishing to develop multi-disciplinary core center grants with this theme. 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 RFA, Developmental Grant: Environmental Health Sciences Centers, is related to the priority area of environmental health. 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 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) exploratory grant (P20). The requested amount of each application may not exceed $175,000 direct costs per year. The total project period may not exceed three years. It is estimated that approximately one to three awards will be made. It is important to note that the award of a developmental grant by the NIEHS does not imply a commitment to future funding of any resulting research or center grant applications. These must be submitted separately and will be evaluated on the basis of their own merit. The core center grant (P30) requires a research grant base of at least $1,000,000 of outside peer reviewed awards related to environmental health problems, particularly focusing on economically disadvantaged and/or underserved populations. Therefore, it will require a substantial effort during the award period of the P20 grant to achieve the level of research support base necessary to qualify and compete successfully for a core center grant. This RFA has a single receipt date. However, the NIEHS intends to announce additional receipt dates for developmental grants periodically. FUNDS AVAILABLE Approximately $800,000 has been set-aside for this program. The funding level for NIEHS developmental grants will be $175,000 direct costs per year for a maximum of three years. It is anticipated that one to three developmental grants will be awarded depending upon the appropriation of funds for this purpose and the quality of the applications received. The awards are not renewable and supplements are not allowed. RESEARCH OBJECTIVES Most Americans want to live long and healthy lives, and the majority achieve that goal. In general, however, economically disadvantaged and/or underserved populations are less likely to achieve this goal. At every stage of life, these populations suffer disproportionate levels of morbidity and mortality. The primary purpose of the NIEHS developmental grant will be to provide support for a group of investigators to develop interdisciplinary collaborations and strategies to obtain preliminary results to demonstrate feasibility and develop a research program addressing the above-cited PURPOSE of the NIEHS in this RFA. The resulting program will then be used as the basis for an application for other NIEHS project grants and ultimately a core center grant (P30). The objectives for an NIEHS developmental grant may include, but are not limited to: o Preliminary or feasibility studies to gather sufficient data to demonstrate the potential of an idea or the validity of an approach, to acquire or demonstrate technical competence, or to evaluate other technical factors involved in the development of a project that addresses the goal of this initiative; o Recruitment of new investigators whose expertise would strengthen the overall research project base in a subsequent core center grant application; o Inter- or intra-institutional planning to develop research strategies, including the establishment of a timetable or milestones, for the development of grant applications that are prerequisite for the NIEHS Core Center grant application. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES 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 June 1, 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 NIEHS staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Environmental Health Resources Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 104 Alexander Drive Research Triangle Park, NC 27709 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 and 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. Applications must be received at the NIH by July 28, 1993. The RFA label available in the application form must be affixed to the bottom of the face page of the application. In addition, the RFA title and number must be typed on Line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** To expedite review, two copies must also be sent to: Dr. Donald I. McRee Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7508 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Site visits as part of the initial review of applications are not planned. Therefore, it is imperative that the application be complete and stand on its own merits. If a large number of applications are received, the NIEHS will utilize a triage process whereby the applications are given a preliminary scientific review by scientific peers in order to identify the most meritorious applications. Those applications identified as highly meritorious will be given a full scientific review and a complete and detailed summary statement will be prepared. Those applications not achieving these qualifications will not be given a full review and an abbreviated summary statement listing the reasons for this decision will be prepared. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Thorsten A. Fjellstedt, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-0131 Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.894. 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, 43 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. $$R5 END ************************************************************ $$R6 BEGIN DE-93-04 FULL-TEXT *************************************** NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING APPLICATIONS NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA AVAILABLE: DE-93-04 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. 2, 12 March 1993 Message-ID: Date: 11 Mar 93 23:16:26 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1098 $$XID NIHGUIDE 19930312 V22N10 P2O2 ************************************ P.T. 44; K.W. 0720005, 0715148 National Institute of Dental Research Letter of Intent Receipt Date: August 10, 1993 Application Receipt Date: September 10, 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 of Dental Research (NIDR) invites applications proposing institutional training programs in basic and clinical sciences pertaining to oral health research. The NIDR supports research on the causes, epidemiology, prevention, diagnoses and treatment of dental caries, periodontal and soft tissue diseases, craniofacial anomalies and orofacial pain. This includes normal and abnormal craniofacial development; the structure and function of teeth, jaws, oral mucosa, bone, connective tissue, salivary glands and other organs and tissues of the craniofacial complex; trigeminal neurobiology; the relationship of behavioral, social, economic and cultural factors to oral diseases and conditions; dental biomaterials; and the role of fluoride and nutrition in oral health and disease. It also emphasizes the need for research on older Americans, minority groups, and individuals with medical and handicapping conditions or who are otherwise at high risk for oral health problems. The primary objective of these training programs is to develop highly qualified, clinical investigators by supporting postdoctoral training of individuals with D.D.S., D.M.D., or equivalent dental degree, who are committed to a career in oral health research. Applications also may include pre- and postdoctoral training for basic scientists and/or short-term training for dental students in the proposed programs. Proposed training must be relevant to the goals of the NIDR, as described in the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope." Availability of this publication is described under INQUIRIES. 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 RFA, NRSA - Institutional Training Applications, is related to the priority area of oral health. 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 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted from domestic non-profit, public, and private institutions and the applicant institution must have or be able to develop, the staff and facilities required for the proposed program. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) National Research Service Award (NRSA) Institutional Research Training Grant (T32). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years; awards are; however, renewable. FUNDS AVAILABLE The NIDR expects to make one or two institutional training awards in response to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific and educational merit. Although this program is provided for in the financial plans of the NIDR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The training program must provide opportunities for individuals to carry out supervised biomedical or behavioral oral health research and develop research skills. Clinical programs must have strong relationships with basic scientists that will assure trainees the opportunity to acquire the necessary foundation for future independent research. Training will be provided at one or more of the following levels: (1) dentists pursuing a Ph.D. or equivalent degree in basic science; (2) dentists pursuing postdoctoral research training; (3) baccalaureate degree-holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree-holders pursuing postdoctoral research training; (5) pre-dental degree students pursuing a short-term research experience, usually during, but not limited to, the summer months. Preference must be given to individuals who have received, as of the beginning of an appointment, a D.D.S., D.M.D., or equivalent dental degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is acceptable. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES 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 August 10, 1993, a letter of intent that includes a descriptive title of the proposed research training program, the name, address, and telephone number of the Program Director, 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 NIDR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Valega at the address listed under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Valega early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this RFA. Applications are to be submitted on form PHS 398 (rev. 9/91). Application 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 (301/594-7248 after 03/29/93), and from the NIDR program administrator listed under INQUIRIES. This RFA is for a single competition. Applications must be received by September 10, 1993. If an application is received after that date or deemed non-responsive to the RFA, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by the NIDR Special Grants Review Committee (DSR), a standing NIH initial review group. Applicant interviews or site visits may be involved. Secondary review will be by the National Advisory Dental Research Council. Among the information the Council considers will be the report of the DSR on the plans for, and success in, recruitment of women and individuals from underrepresented minority groups. Review and Award Schedule Applications will be processed according to the following schedule: Application Initial Review Council Earliest Receipt Date Group Meeting Meeting Award Date Sep 10, 1993 Feb/Mar 1994 May/Jun 1994 Jul 1994 AWARD CRITERIA The NIDR will notify the applicant of the Council's action shortly after its meeting. Funding decisions will be made based on the DSR and Council recommendation, the need for research personnel in specified program areas, and the availability of funds. Applicants are reminded that NIDR funding decisions will take into consideration those applications that offer training at the following levels in priority order: (1) dentists pursuing a Ph.D. or equivalent degree in a basic science; (2) dentists pursuing postdoctoral research training; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree holders pursuing postdoctoral research training; and (5) pre-dental degree students pursuing a short-term research experience. The NIDR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Thomas M. Valega, Ph.D. Special Assistant for Manpower Development and Training National Institute of Dental Research Westwood Building, Room 503 Bethesda, MD 20892 Telephone: (301) 496-6324 (301/594-7617 after 03/29/93) FAX: (301) 496-4180 (301/594-7616 after 03/29/93) Direct inquiries pertaining to fiscal and policy matters to: Theresa Ringler, Grants Management Officer Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 496-7437 (301/594-7629 after 03/29/93) Copies of the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope," are available by a written request to NIDR, P.O. Box 54793, Washington, DC 20032 AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288), Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R6 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-063 ************************************************ PRIMARY CARE AND HEALTH CARE REFORM NIH GUIDE, Volume 22, Number 10, March 12, 1993 PA NUMBER: PA-93-063 P.T. 34; K.W. 0730020, 0730050 Agency for Health Care Policy and Research PURPOSE The Agency for Health Care Policy and Research (AHCPR) supports and conducts research, demonstration projects, and evaluations of health care services and systems delivering such services. The AHCPR believes the current national policy interest in health care reform provides an important opportunity to enhance the understanding of the relationships between primary care and health care costs, access, and quality. This program announcement (PA) emphasizes a need for short term research (producing results within one to three years) to assess ways in which primary care services can contribute to health care reform. A major AHCPR responsibility is support for research that focusses on problems of immediate concern to policy makers at the Federal and State levels. Consistent with this charge, the AHCPR encourages research addressing questions raised in formulating policy changes to deal with significant problems in the health care sector, and specifically through this PA, in the primary care field. To generate the required analytical effort on primary care in health care reform, the AHCPR encourages investigators to use strategies that avoid primary data collection efforts, and focus instead on designs and methods that produce results quickly, such as the use of existing data, microsimulations, and rigorous syntheses. 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, Primary Care and Health Care Reform, is related to the objectives of broadening access to timely and effective preventive services. 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 domestic and foreign non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non- profit foundations. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This program announcement will use the research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. It is anticipated that projects will be accomplished in one to three years. This PA is in effect through July 1, 1994. RESEARCH OBJECTIVES Background. In response to continued growth in the cost of health care and the increasing numbers of persons without access to basic health care services, public attention is now focussed on major health care reform efforts. The experience of other developed countries that provide universal access to care for a substantially lower per capita cost than the U.S. argues strongly that careful consideration of the organization and delivery of primary care services will be an essential component of resolving the current health care dilemma. States and a number of regional coalitions have already initiated reform programs. These programs provide natural laboratories for assessing the effects of specific organizational, financial, and regulatory mechanisms on utilization, costs, and access to primary care services. Reform initiatives related to primary care that are in place or under development include: expanded Medicaid benefits for women and children, approaches that encourage or require Medicaid beneficiaries to enroll in managed care programs, the use of school based clinics to provide services to children and adolescents, and the establishment of primary care clinics in underserved areas. Analysis and evaluation of the relationship between the delivery of primary care services, and the overall effects of such programs on costs, quality, and access, are critical for informing further decisions regarding national health care reform. Policy Issues and Research Priorities Primary care includes: first contact care, care that is longitudinal, care that is person centered rather than disease or problem specific, and care that is comprehensive. It addresses the most common problems in the population by providing preventive, curative, or rehabilitative services to maximize health and well being. The U.S. does not have a clearly defined system of primary care delivery. Primary care services are provided by physicians in multiple specialties as well as nonphysician providers, predominately nurse practitioners, certified nurse midwives, and physician assistants, in a variety of settings. While the majority of persons identify one provider as their usual source of care, a substantial number obtain primary care services from multiple providers. Some individuals obtain specialized services when referred by a primary care provider, while others seek specialists' care directly. Studies have shown that access to primary care services is associated with improved health outcomes. Primary care providers also use fewer resources in the care of patients with chronic diseases than specialists, after adjusting for severity of illness. However, existing studies are limited, and additional studies that isolate the effects of distinct organizational and provider characteristics on overall costs and patient outcomes are essential to inform health care reform. A broad array of research questions are relevant to primary care and health care reform. Three research areas emerge as AHCPR priorities because of their relevance to the development of effective health care reform programs: (1) the effectiveness of primary care and overall costs; (2) the cost and quality implications of different modes of access to primary care; and (3) the organization of primary care providers. Effectiveness of Primary Care and Overall Costs In a health care system with a clearly defined primary care infrastructure, the decisions of primary care practitioners have important implications for the total expenditures for health care. Recent studies demonstrate that a lack of access to outpatient care can result in potentially avoidable hospital admissions. These studies suggest that improving the effectiveness of patient care may lead to substantial cost savings while improving the health status of the American people. Of particular interest are studies of referral to specialty services. Further research is needed to develop and test mechanisms by which consultation and referral can be accomplished without disrupting continuity or coordination of care. Illustrative research questions include: o Can the provision of primary care services decrease the incidence of avoidable hospitalizations? Which primary care services, providers, and organizational models are most effective in reducing avoidable hospitalizations? How is provider training related to the effectiveness of primary care services delivered to specific groups of patients, such as children, the elderly, and those residing in underserved areas? o What proportion of variations in costs and use of expensive technologies is attributable to variations in referral by primary care providers? Are observed variations attributable to provider training, availability of specialists, patient characteristics, or other factors? Can improved referral practices result in more appropriate use of expensive technologies? o How do nonphysician providers in a variety of settings refer patients to specialists, and what arrangement of physician backup is most effective? Cost and Quality Implications of Different Modes of Access to Primary Care Four general patterns of primary care include: episodic care from a hospital emergency room or urgent care center; longitudinal care from a "usual care" provider who may be a primary care provider or specialist; specialist provided primary care through direct (self) referral; and primary care from multiple providers. Most research confounds patient and practitioner characteristics, features of the organization, and reimbursement mechanisms. Studies that examine the quality and cost implications of receiving ongoing primary care from a specialist compared to a primary care provider are important. Of particular relevance to women's health care are the cost and quality implications of using one or two primary care providers. Studies are also needed that examine the cost and quality implications of restriction of self referral to specialty care. Isolating the confounding effects of cost sharing, provider training, and patient characteristics is essential. Research that uses existing data to develop or refine case mix measures for application to ambulatory problems is also needed. Illustrative research questions include: o What are the effects on cost and quality of care of receiving primary care from a primary care provider compared with multiple providers or specialists? o What are the effects on cost and quality of limiting direct access to specialists for continuity care? Are there differential effects on patient outcomes for patients with special needs, such as persons with disabilities and persons with chronic diseases? o Will recent changes in Medicare reimbursement that increase payment for some primary care services enhance the delivery of primary care services to all persons? Organization of Primary Care Providers Managed care organizations, particularly health maintenance organizations (HMOs), have a clearly defined system for delivering primary care services. Research on staff model HMOs, in which the ratio of primary care providers to specialists is higher than for the health care system as a whole, suggests that this type of organization provides more cost effective care than traditional fee for service practice. Studies that isolate the specific components of these arrangements that are most effective (e.g., type of primary care providers, staffing ratios, mechanisms for utilization review) could provide important guidance to policy makers. Recent State initiatives to enroll Medicaid recipients in managed care programs may offer the potential for studies using existing data to evaluate the effects of these programs on health outcomes, health costs, and utilization of services. In particular, information that links the effects of State regulations on the scope of practice of advanced practice nurses and physician assistants to the effective delivery of primary care services is urgently needed. Research is also needed on organizational characteristics that enhance the outcomes of primary care. Additional research that examines the relationship of continuity, accessibility, and comprehensiveness of primary care on cost, quality, and access in health care is critical for planning and organizing more effective and efficient services. Illustrative research questions include: o What organizational characteristics or administrative interventions enhance coordination and continuity of care across settings? How are continuity, coordination, and comprehensiveness best measured? o What are the effects of social, legal, and economic barriers to the scope of practice of advanced practice nurses and physician assistants, and the effects of these restrictions on patient outcomes? o How well do community based organizations, including public health departments and school based clinics, assure the integration of services? What are the effects of categorical programs, such as vaccination programs or family planning clinics, on continuity and coordination of care? STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDY POPULATIONS The AHCPR requires all applicants for research grants 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 to include minorities and women in studies of diseases, disorders, and conditions which 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 research, a clear and compelling rationale should be provided. This policy applies to all AHCPR research grants. The AHCPR will not award grants for applications which do not comply. If the required information is not contained in the application, the application will be returned without review. The compositions 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 should be included in the form PHS 398 in Sections 1 to 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, AHCPR 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., American Indians/Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics). Where appropriate, the applicant must provide the rationale for studies on single minority population groups. For foreign awards, the policy on inclusion of women applies fully; because 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. Peer reviewers will address specifically whether the applicant's research plan conforms to these policies. If the representation of women or minorities in a study design 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 09/91), and will be accepted at the standard application deadlines as indicated in the application kit. State and local governments may use form PHS 5161 and submit an original and two copies of the application. Application kits are available at most institutional offices of sponsored research; 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; and from the Office of Scientific Review, Agency for Health Care Policy and Research, 2101 East Jefferson Street, Suite 602, Rockville, MD 20852, telephone 301-227-8449. The title and number of the announcement must be typed in Section 2a on the face page of the application. The completed original application 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** 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 not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Applicants are encouraged to apply by the earliest possible submission date. The first due date is June 1, 1993. Thereafter, the due dates for application are October 1, 1993, February 1, 1994, and June 1, 1994. Applications for R01 grants must be received by the Division of Research Grants, NIH. An application received after the deadline may be acceptable if it carries a legible proof of mailing date assigned by the carrier and the proof of mailing date is not later than 1 week prior to the deadline data. REVIEW PROCEDURES Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. Review criteria for grant applications are significance and originality from a scientific and technical viewpoint; adequacy of the method to carry out the project; availability of data or the proposed plan to collect data required for the project; qualifications and experience of the principal investigator and proposed staff; adequacy of the plan for organizing and carrying out the project; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant. Applications will be evaluated in accordance with the criteria stated above for scientific/technical merit by an appropriate peer review group. Applications assigned to the AHCPR and requesting total direct costs in excess of $50,000 may be reviewed by the National Advisory Council for Health Care Policy, Research, and Evaluation Council for policy relevance and research value. Funding will be based on recommendations from the peer review and an appropriate Council. AWARD CRITERIA Applications will compete for available funds with all other applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review; availability of funds; and program balance among research areas of the announcement. The anticipated dates of award for applications are 10 months from the date of submission. INQUIRIES Those considering an application in response to this PA are strongly encouraged to discuss their project with AHCPR program administrators before formal submission. The AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Copies of a Grant Announcement based upon this PA will be available from the AHCPR Publications Clearinghouse, PO Box 8547, Silver Spring, MD 20907, (1-800-358-9295) after April 30, 1993. Direct inquiries regarding programmatic issues to: Carolyn Clancy, M.D. Center for General Health Services Extramural Research Agency for Health Care Policy and Research Executive Office Center, Suite 502 2101 East Jefferson Street Rockville, MD 20852-4908 Telephone: (301) 227-8357 Direct inquiries regarding fiscal matters to: Ralph Sloat Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 227-8447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.180 and 93.226. Awards are made under authorization of the Public Health Service Act, Title IX, as amended (Public Laws 101-239 and 102-410) and administered under PHS grants policies and Federal Regulations 42 CFR 67, Subpart A and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. $$P1 END ************************************************************ $$XID RFA AI9310 AI-93-10 P1O1 ***************************************** MECHANISMS OF ORAL TOLERIZATION AND IMMUNIZATION NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA: AI-93-10 P.T. 34; K.W. 1002004, 1002008, 0740075, 0710070, 1002019 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: April 5, 1993 Application Receipt Date: July 21, 1993 PURPOSE The Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) and the Rheumatic Diseases Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite applications for studies focused on cellular and molecular mechanisms of oral immunization and oral tolerance. The goal of this initiative is to promote research that will increase our understanding of the mechanisms involved in the induction of protective immunity systemically and in the mucosal surfaces after oral immunization and improve our knowledge about the effects of oral administration of self-molecules as a means of inducing tolerance to prevent or reverse autoimmune and allergic diseases. 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), Mechanisms of Oral Tolerization and Immunization, is related to the priority areas of diabetes and chronic disabling conditions, and immunization and infectious diseases. 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 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by public and private, foreign and domestic, for-profit and non-profit organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Only domestic institutions are eligible to apply for Program Project (P01) grants. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The mechanisms of support for this program will be the research project grant (R01) and the Program Project (P01) grant. The regulations and policies that govern the research grant programs of the National Institutes of Health will prevail. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years. At this time, the NIAID is administratively limiting the duration of P01 grants to four years; this administrative limitation may change in the future. P01 applications may not request budgets in excess of $500,000, and R01 applications, $180,000, total direct costs in the first year; neither type of application should request more than 4 percent annual inflationary increases for future years. An application with a first year requested amount in excess of the above will require written approval by senior NIAID or NIAMS officials via the program officers for acceptance of the application for processing. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for this RFA will be $1,500,000. In fiscal year 1994, the NIAID plans to fund approximately seven research projects, either as R01s or as components of P01s. In fiscal year 1994, the NIAMS plans to fund approximately three R01s. The usual PHS policies governing grants administration and management will apply. 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 NIAID and the NIAMS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years, and availability of funds. RESEARCH OBJECTIVES Background Mucosal surfaces are the most common portals of entry of microorganisms and other environmental factors, and effective immune mechanisms exist that afford protection against some of the diseases caused by these organisms. In addition, protective immune responses can be induced in external secretions by oral administration of some attenuated or killed organisms. Although progress has been made in understanding the composition and some of the functions of the mucosal immune system in the induction of protective immunity, the basic mechanisms and molecular mediators involved in the development of immune responses remain largely unknown. Knowledge of the basic cellular and molecular immune mechanisms of the gastrointestinal tract will be the foundation for the development of successful multicomponent oral vaccines and oral tolerization protocols, and an understanding of inflammatory bowel disease. Experimental autoimmune diseases such as collagen-induced arthritis, experimental allergic encephalomyelitis and experimental uveitis have been successfully treated by the oral administration of the relevant antigen. Evidence suggests that a subpopulation of T cells and cytokines, such as TGF beta, are implicated in the induction of tolerance and prevention and/or delay of disease onset. However, the molecular basis for oral tolerance induction to autoantigens and the mechanisms that govern these processes are not understood. Although results obtained in experimental systems are encouraging, it is not clear whether oral tolerance regimens in established disease suppress or exacerbate autoimmune conditions. Carefully controlled studies using well defined self peptides and antigens in combination with advanced molecular and cellular immunology approaches are necessary before oral tolerance is considered as an effective form of therapy for human disease. Research Objectives and Scope Areas of interest include, but are not limited to: o Studies of the mechanisms involved in the induction and regulation of oral tolerance to self antigens, with emphasis on the identification of the cell types and cytokine cascades involved. o Analysis of the effect of oral administration of self peptides on ongoing autoimmune disease and the cellular and molecular mechanisms that mediate these effects. o Characterization of the molecular basis for the observed decrease in tissue damage in organ-specific autoimmune disease following the oral administration of appropriate antigens. o Studies to establish the immune parameters of induction of protective immune responses to orally administered antigens including attenuated or killed enteric pathogens, with emphasis on the characterization of cellular and molecular mediators involved in these processes. o Studies to analyze and determine peripheral and/or systemic correlates of protective immunity to orally administered antigens, including enteric pathogens and antigens delivered in carrier systems. o Studies of antigen processing and presentation by gut epithelial and lymphoid cells and design of methodologies to manipulate them to obtain stronger and/or long lasting protective immunity. New approaches to the study of mucosal immunity and approaches that combine cellular and molecular immunology and bacterial genetics are strongly encouraged as are studies that would yield information directly applicable to the human mucosal system/autoimmune disease interface. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy requires that applicants for NIH clinical research grants and cooperative agreements 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 which 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, 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 must be included in the form PHS 398 in items 1-4 of the Research Plan AND summarized in item 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 U.S. racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian/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 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, clinical samples which may be coded for use by the applicant but could be identified by another source are not excluded. Every effort should be made and documented 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 U.S. populations, including minorities. If the required information is not contained within the application, the application will be returned. 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. Previous recruitment data for similar studies from the proposed sites should be provided. LETTER OF INTENT Prospective applicants are asked to submit, by April 5, 1993, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator or Program Director (for P01s), and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID and NIAMS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. APPLICATION PROCEDURES In preparing the application in response to this RFA, the applicant should bear in mind the research objectives of this RFA. An R01 application should be prepared according to the instructions in form PHS 398 (rev. 9/91). A P01 application should be prepared using the guidance and instructions provided in the NIAID document titled: "SPECIAL INSTRUCTIONS FOR PREPARING THE GROUP APPLICATION FOR PROGRAM PROJECTS." This document cannot be transmitted electronically, particularly Tables I-IV which may be used by the applicant for appropriate and consistent presentation of summary information on budgets and personnel. The P01 applicant should request and obtain a copy of such document and a copy of the NIAID Information Brochure for Program Projects and Grants, both of which may be sent along with this RFA. Failure to follow the instructions in the document may result in delays in the review or in an incomplete application. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 09/91). These application forms may be obtained from the institution's office of sponsored research and 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. For purposes of identification and processing, item 2a on the face page of the application must be marked "Yes" and the RFA number and the words "MECHANISMS OF ORAL TOLERIZATION AND IMMUNIZATION" must be entered. Applications must be received by July 21, 1993. Applications that are not received from the applicant organization by the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 09/91) application kit, will be judged to be non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 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. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, single-sided photocopies, in one package to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional exact copies of the grant application and all five sets of appendix material must also be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and by NIAID and NIAMS staff for responsiveness. Those judged to be incomplete will be returned to the applicant without review. Those considered to be non-responsive will be either returned without review or, if R01s, be referred to the DRG as unsolicited applications, to be scheduled for initial review at the next DRG review cycle. Those applications that are complete and responsive may be subjected to a triage by an NIAID peer review group to determine their scientific merit relative to the other applications received in response to this RFA. The NIAID and the NIAMS will withdraw from competition those applications judged to be non-competitive for award. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Scientific Review Branch, Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council or by the National Arthritis and Musculoskeletal and Skin Diseases Council. The factors to be considered in the evaluation of scientific merit of each application will be those used in the review of traditional research project grant applications, including: the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; and the adequacy and suitability of the facilities. For program project applications, additional review criteria are used, which are outlined in the NIAID Information Brochure on Program Project and Center Grants. Applicants planning a program project application must request and obtain the NIAID Information Brochure. While the following review factors do not usually influence the priority score, they are nonetheless carefully considered by the initial review group: the appropriateness of the requested budget to the work proposed; the adequacy of protection of human subjects and/or animals in research; and the adherence, whenever appropriate, to NIH guidelines concerning adequate representation of women and minorities in clinical research. Any documented concerns expressed by the initial review group about any of these factors on a given application may influence the recommendation of the Advisory Council concerning funding of that application. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit, as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct requests for the Information Brochure and the documents referred to under APPLICATION PROCEDURES, as well as inquiries regarding programmatic issues, to: Howard B. Dickler, M.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A19 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Susan Serrate-Sztein, M.D. Rheumatic Diseases Branch National Institute of Arthritis and Musculoskeletal Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3340 FAX: (301) 480-7881 Direct inquiries regarding review issues (including the preparation of a program project application if applicable); address the letter of intent to; and mail two copies of the application and all five sets of appendices to: Mark Rohrbaugh, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C22 Bethesda, MD 20892 Telephone: (301) 496-8424 FAX: (301) 402-2638 Direct inquiries regarding fiscal and administrative matters to: Mr. Jeffrey Carow Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 The mailing address given for NIAID staff in the Solar Building is the central mailing address for NIH. Applicants who use express mail or a courier service are advised to follow the carrier's requirements for showing a street address. The address for the Solar Building is: 6003 Executive Boulevard Rockville, MD 20852 Schedule Letter of Intent Receipt Date: April 5, 1993 Application Receipt Date: July 21, 1993 Scientific Review Date: October 1993 Advisory Council Date: February 1994 Earliest Award Date: April 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research and No. 93.846 - Arthritis and Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. 3, 12 March 1993 Message-ID: Date: 11 Mar 93 23:17:09 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1000 $$XID RFA DE9304 DE-93-04 P1O1 ***************************************** NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING APPLICATIONS NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA: DE-93-04 P.T. 44; K.W. 0720005, 0715148 National Institute of Dental Research Letter of Intent Receipt Date: August 10, 1993 Application Receipt Date: September 10, 1993 PURPOSE The National Institute of Dental Research (NIDR) invites applications proposing institutional training programs in basic and clinical sciences pertaining to oral health research. The NIDR supports research on the causes, epidemiology, prevention, diagnoses and treatment of dental caries, periodontal and soft tissue diseases, craniofacial anomalies and orofacial pain. This includes normal and abnormal craniofacial development; the structure and function of teeth, jaws, oral mucosa, bone, connective tissue, salivary glands and other organs and tissues of the craniofacial complex; trigeminal neurobiology; the relationship of behavioral, social, economic and cultural factors to oral diseases and conditions; dental biomaterials; and the role of fluoride and nutrition in oral health and disease. It also emphasizes the need for research on older Americans, minority groups, and individuals with medical and handicapping conditions or who are otherwise at high risk for oral health problems. The primary objective of these training programs is to develop highly qualified, clinical investigators by supporting postdoctoral training of individuals with D.D.S., D.M.D., or equivalent dental degree, who are committed to a career in oral health research. Applications also may include pre- and postdoctoral training for basic scientists and/or short-term training for dental students in the proposed programs. Proposed training must be relevant to the goals of the NIDR, as described in the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope." Availability of this publication is described under INQUIRIES. 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), NRSA - Institutional Training Applications, is related to the priority area of oral health. 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 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted from domestic non-profit, public, and private institutions and the applicant institution must have or be able to develop, the staff and facilities required for the proposed program. Levels of Training and Trainee Eligibility Several studies and advisory panels have emphasized the importance of graduate-level training leading to the Ph.D. degree in order to prepare dentists for productive careers in oral health research. However, training in oral health research is also appropriate for pre- and postdoctoral basic scientists and for dental students during their professional education. Training will be provided at one or more of the following levels: (1) dentists pursuing a Ph.D. or equivalent degree in basic science; (2) dentists pursuing postdoctoral research training; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree holders pursuing postdoctoral research training; and (5) pre-dental degree students pursuing a short-term research experience, usually during, but not limited to, the summer months. Preference for post-doctoral trainees must be given to individuals who have received, as of the beginning of an appointment, a D.D.S., D.M.D., or equivalent dental degree from an accredited domestic or foreign institution. If the degree has not yet been conferred, a statement, by an authorized official of the degree-granting institution, that all degree requirements have been met is acceptable. Predoctoral trainees must have received a baccalaureate degree as of the beginning date of the appointment and must be enrolled in a graduate program leading to the award of a Ph.D. or an equivalent degree in biomedical or behavioral oral health research. Trainees for short-term research experiences must be enrolled in a program leading to a D.D.S. or equivalent degree. Individuals who wish to interrupt their dental school studies for one or more years to engage in full-time research training before completing their professional degrees are eligible; however, prior approval by the NIDR is required before an appointment can be offered, as well as prior approval by the Institution. Individuals with a Ph.D. or equivalent degree may be appointed to the training grant. However, in general, they are expected to apply for an individual postdoctoral NRSA fellowship award (F32). Trainees must be citizens or non-citizen nationals of the United States or have been lawfully admitted for permanent residence (i.e., in possession of the Alien Registration Receipt Card I-551 or I-151) at the time of appointment. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) National Research Service Award (NRSA) Institutional Research Training Grant (T32). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years; however, awards are renewable. Trainees may receive up to five years of support at the predoctoral level and three years of support at the postdoctoral level, including any combination of support from institutional training awards and individual fellowship awards. Extensions beyond these periods require a waiver from the NIH. Dentists requiring additional time to complete training as a participant in a Ph.D. program may anticipate favorable consideration of a waiver request, contingent upon certification of the recipient's good academic standing. It is expected that postdoctoral trainees with the Ph.D., D.D.S., or equivalent degree will engage in at least two years of research training. FUNDS AVAILABLE Approximately $300,000 has been set-aside for this program. The NIDR expects to make one or two institutional training awards in response to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific and educational merit. Although this program is provided for in the financial plans of the NIDR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Only one training award will be made to any institution unless the training programs are in distinctly different areas of oral health research. RESEARCH OBJECTIVES The training program must provide opportunities for individuals to carry out supervised biomedical or behavioral oral health research and develop research skills. Clinical programs must have strong relationships with basic scientists that will assure trainees the opportunity to acquire the necessary foundation for future independent research. The training program director will be responsible for the selection and appointment of trainees and for the overall direction of the program. Applicants may request as many postdoctoral, predoctoral, and/or short-term trainee positions as can be justified. However, five or more positions for postdoctoral trainees over the five-year period must be proposed. Acceptance of postdoctoral trainees must be limited to the first three years of the five-year award, e.g,, two trainees the first year, two the second year, and one the third year. The number and types of positions awarded will be determined by peer review, program needs, and the availability of funds. Training grants may not be used to support studies leading to a D.D.S. or other similar professional degrees, or to support residencies, i.e., postgraduate training for dentists providing health care directly to patients where the majority of their time is spent in non-research clinical training. However, if a specified period of full-time research training is creditable toward specialty board certification, the training grant may support such research training if the trainee has shown a clear interest in a research career. Since recently graduated dentists usually have little or no prior research training, the training must include a minimum of two years of basic research training. Additional information regarding "Availability of Short-term Research Training Positions on Institutional National Research Service Awards for Students in Health-professional Degree Programs" and "National Research Service Award Institutional Research Training Grants" is given in the NIH Guide for Grants and Contracts, Vol. 21, No. 11, March 20, 1992. Stipends and Other Training Costs For predoctoral and the short-term trainees, at all levels of experience, the stipend is $8,800 per year ($734 per month). For postdoctoral trainees, the stipend is determined by the number of years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research (including industrial), teaching, internship, residency, clinical practice, or other time spent in a health-related field beyond that of the qualifying doctoral degree. The postdoctoral stipends are as follows: Years of Relevant Experience Stipend 0 $18,600 1 19,700 2 25,600 3 26,900 4 28,200 5 29,500 6 30,800 7 or more 32,300 Stipends may be supplemented by an institution from non-Federal funds. Federal funds may be used for stipend supplementation only if specifically authorized under the terms of the program from which the supplemental funds are derived. An individual may make use of Federal educational loan funds or Department of Veterans' Affairs benefits when permitted by those programs. Under no circumstance may the condition of stipend supplementation detract from or prolong the training. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Degree trainees may exclude only required course tuition, fees, books, supplies, and equipment. Non-degree trainees will be required to report stipends and all monies paid on their behalf for tuition and fees. These statutory requirements went into effect January 1, 1987. The NIH is not in a position to advise students or institutions about their tax liability. In any event, changes in the taxability of stipends in no way alters the relationship between NRSA fellows, trainees, and institutions. NRSA stipends are not now, and never have been, salaries. Trainees supported under the NRSA are not in an employer-employee relationship with the NIH or the institution at which they are pursuing research training. Tuition and fees, including medical insurance, are allowable trainee costs if such charges are required of all persons in a similar training status at the institution, without regard to their source of support. Tuition at the postdoctoral level, if justifiable, is limited to that required for specific courses in support of the approved training program. Annual increments in tuition costs beyond the first year of a five-year award may not exceed six percent. Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's training, is an allowable trainee cost. Institutional costs of $1,500 per year per predoctoral trainee and $2,500 per year per postdoctoral trainee and $125 per month per short-term trainee may be requested to defray the cost of training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Indirect costs based on eight percent of total allowable direct costs, or actual indirect costs, whichever is less, may be requested. Applications from State and local government agencies may request full indirect cost reimbursement. Payback Provisions Trainees, including short-term trainees, must sign an agreement that they will fulfill the payback requirements. Trainees agree to engage in biomedical or health-related behavioral research and/or teaching for a period equal to the period of support in excess of 12 months. Trainees must undertake the obligated service on a continuous basis within two years after termination of support. Individuals who fail to fulfill the obligation through service must pay back the total amount of funds paid to the individual for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years of the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period of service or repayment, or otherwise waive or suspend the payback obligation of an individual. Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the payback service requirement and explain them carefully to prospective trainees before an appointment to the training grant is offered. For additional information, including the grounds for approving extensions of support and payback provisions, refer to the announcement in the NIH Guide for Grants and Contracts, "National Research Service Awards - Guidelines for Individual Awards - Institutional Grants," Special Edition, Volume 13, No. 1, January 6, 1984. 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 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 must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which 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 must 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 item 4 on page 1, Human Subjects, and in Section B, number 5 of the Research Training Program Plan. 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 must 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 must be addressed by the applicants. If the required information is not contained within the application, the application will be returned. 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 that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by August 10, 1993, a letter of intent that includes a descriptive title of the proposed research training program, the name, address, and telephone number of the Program Director, 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 NIDR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Valega at the address listed under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Valega early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this RFA. Applications are to be submitted on form PHS 398 (rev. 9/91). Application 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 (594-7248 after 03/29/93); and from the NIDR program administrator listed under INQUIRIES. To identify the application as a response to this RFA, check "yes" on item 2a of page 1 of the application and enter "RFA: DE-93-04, NRSA - INSTITUTIONAL TRAINING APPLICATIONS." The RFA label available in the application form PHS 398 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. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** At the time of submission, two additional copies of the application must also be sent to: H. George Hausch, Ph.D. Scientific Review Section National Institute of Dental Research Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 496-7658 (301/594-7632 after 03/29/93) This RFA is for a single competition. Applications must be received by September 10, 1993. If an application is received after that date or deemed non-responsive to the RFA, 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 not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by the NIDR Special Grants Review Committee (DSR), a standing NIH initial review group. Applicant interviews or site visits may be involved. The following review criteria will be applied: o The proposed research training and program objectives, design and direction; core curriculum; prescribed set of courses or seminars; the manner in which individual guided research activities will be selected; procedures for monitoring trainee progress; the existence of a true training program, as contrasted with fellowship training for an individual trainee; the combination of different levels of training; the appropriateness of the proposed number of trainees; the unique and/or innovative nature of the training program; resources and facilities. o The qualifications of the program director and participating faculty including the roles of specific preceptors; time commitment; ability to compete successfully for research support; current research grant holdings and pending research grant activities; specific experience in graduate research training. o Training environment: institutional commitment, the quality of the facilities, and the availability of research support; evidence of a high level of ongoing fundamental and clinical research activity; availability of equipment, facilities, and clinical resources. o Selection of trainees: plans for recruitment and criteria for the selection of trainees, availability of high-quality candidates, including minorities and women; how trainees are assigned to preceptors. o Past training record: for both new and renewal applications the past performance of the program director and preceptors in training scientists; reviewers will look for accomplishments, or potential, of the faculty in the training of scientists who will make major contributions to oral health research, as indicated by success in obtaining awards, such as fellowships, career awards, and individual research grant support, the rate at which former trainees establish independent productive research careers, recognition for outstanding scientific accomplishment, and involvement of former trainees in academic, clinically oriented, and laboratory research and their ongoing productivity. For renewal applications, the record in filling trainee positions and the completion record of trainees will be considered. Cumulative information on the career development of all former trainees, including information about their minority status, will be evaluated. Attention must be given to recruiting women and individuals from minority groups that are underrepresented, nationally, in these sciences. A plan must be included for the recruitment of these individuals. After review of the training grant application for scientific and technical merit and assignment of a priority score, the DSR will comment on the plans for recruiting women and individuals from underrepresented minority groups to the training program. In the case of renewal applications, this will include the accomplishments in recruiting women and individuals from underrepresented minority groups and in training them for research positions. No awards will be made to applications lacking this component. Applications must include a description of formal and/or informal activities related to instruction about the responsible conduct of research to be incorporated into the proposed research training program. Information must be provided on the subject matter of the instruction, the appropriateness of the instruction, the format of the instruction, the amount and nature of faculty participation, and the frequency and duration of instruction. A rationale for the plan of instruction must be provided. Progress reports on the type of instruction provided, topics covered and other relevant details, such as attendance by trainees and who taught the material, must be included in the application. No awards will be made to applications lacking this component. The announcement of this requirement was published in the NIH Guide for Grants and Contracts, Vol. 21, No. 43, November 27, 1992. Additional information regarding, "Modification of Existing Review Criteria for NRSA Institutional Research Training Grants," is given the NIH Guide for Grants and Contracts, Vol. 21, No. 11, March 20, 1992. Copies of the NIH Guide are usually available in the business or grants office of most academic institutions and from the Office of Grants Inquiries, Division of Research Grants at the address listed under APPLICATION PROCEDURES. Secondary review will be by the National Advisory Dental Research Council. Among the information the Council considers will be the report of the DSR on the plans for, and success in, recruitment of women and individuals from underrepresented minority groups. Review and Award Schedule Applications will be processed according to the following schedule: Application Initial Review Council Earliest Receipt Date Group Meeting Meeting Award Date Sep 10, 1993 Feb/Mar 1994 May/Jun 1994 Jul 1994 AWARD CRITERIA The earliest award date will be July 1, 1994. The NIDR will notify the applicant of the Council's action shortly after its meeting. Funding decisions will be made based on the DSR and Council recommendation, the need for research personnel in specified program areas, and the availability of funds. Applicants are reminded that NIDR funding decisions will take into consideration those applications that offer training at the following levels in priority order: (1) dentists pursuing a Ph.D. or equivalent degree in a basic science; (2) dentists pursuing postdoctoral research training; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree holders pursuing postdoctoral research training; and (5) pre-dental degree students pursuing a short-term research experience. The NIDR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Thomas M. Valega, Ph.D. Special Assistant for Manpower Development and Training National Institute of Dental Research Westwood Building, Room 503 Bethesda, MD 20892 Telephone: (301) 496-6324 (301/594-7617 after 03/2993) FAX: (301) 496-4180 (301/594-7616 after 03/29/93) Direct inquiries pertaining to fiscal and policy matters to: Theresa Ringler, Grants Management Officer Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 496-7437 (301/594-7629 after 03/29/93) Copies of the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope," are available by written request to NIDR, P.O. Box 54793, Washington, DC 20032 AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288), Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA AI9309 AI-93-09 P1O1 ***************************************** MOLECULAR AUGMENTATION OF HOST DEFENSE NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA: AI-93-09 P.T. 34; K.W. 0710070, 0715125, 0740075, 0715015 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: July 15, 1993 PURPOSE The Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for basic and preclinical studies to increase knowledge of the host defense system in general and phagocytes in particular and especially the application of this information to the development of new therapies to kill infectious microorganisms. The information developed through this initiative would also be applicable to intracellular localization of therapeutic agents for autoimmune and allergic diseases. 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 RFA, Molecular Augmentation of Host Defense, is related to the priority areas of diabetes and chronic disabling diseases, and to immunization and infectious diseases. 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 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. However, only domestic organizations are eligible to apply for Program Project (P01) grants. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and the Program Project (P01) grant. Multidisciplinary approaches that involve collaborative efforts among investigators in the fields of basic immunology, molecular biology, cell biology, biochemistry, infectious disease and allergy are strongly encouraged. The total project period for applications submitted in response to this RFA may not exceed five years. At this time, the NIAID is administratively limiting the duration of P01 grants to four years; this administrative limitation may change in the future. P01 applications should not request budgets in excess of $500,000, and R01 applications, $180,000, total direct costs in the first year; neither type of application should request more than 4 percent annual inflationary increases for future years. An application with a first year requested amount in excess of the above will require written approval by senior NIAID officials via the program officer for acceptance of the application for processing. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for this RFA will be $1,500,000. In fiscal year 1994, the NIAID plans to fund approximately 10 research projects, either as R01s or as components of P01s. The usual PHS policies governing grants administration and management will apply. 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 NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Drug-resistant infectious agents are an increasingly important medical problem. Examples of drug-resistant microorganisms include those that cause gonorrhea, tuberculosis, malaria and rheumatic fever. Infectious agents employ a variety of tactics to avoid the effects of antibiotics and the strategies of the host defense system. The objective of this RFA is to facilitate the application of advances in our understanding of such areas as membrane receptor trafficking, membrane fusion, and molecular transport between cellular compartments to the development of new types of therapeutics to combat infectious agents. An example of such an approach would be to deliver therapeutic agents to the intracellular compartments of phagocytes (endosomes), that contain microorganisms using targeting molecules that bind with high affinity to receptors that traffic between the surface membrane and endosomes. The ability to deliver therapeutic agents to the appropriate site confers enormous advantages by simultaneously increasing efficacy and diminishing toxicity, allowing the use of substances that might otherwise be too toxic. Research Objectives and Scope The goal of this initiative is increased knowledge of the cell and molecular biology of phagocytes and the use of this knowledge to develop new forms of anti-infective agents. Studies that involve human tissues and cells are especially encouraged. Examples of relevant research topics are given below; however, these examples are not intended to be inclusive or limiting. o Enhanced uptake of therapeutic agents into endosomal compartments by such means as modification of membrane receptors, selective regulation of expression of membrane receptors, or creation of targeting ligands. o Modification of membrane receptors or their expression in order to prevent or promote uptake of pathogens. o Characterization and modification of the molecules which regulate intracellular movement of microorganisms. o Promotion of selective accumulation of antibiotics in various cellular compartments including the cytosol. o Characterization of the intracellular fusion machine which operates in lysosome-phagosome fusion and the mechanism(s) used by certain organisms to disrupt this process. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy requires that applicants for NIH clinical research grants and cooperative agreements 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 which 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, 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 items 1-4 of the Research Plan AND summarized in item 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 should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, (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, clinical samples which may be coded for use by the applicant but could be identified by another source are not excluded. Every effort should be made and documented 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 U.S. populations, including minorities. If the required information is not contained within the application, the application will be returned. 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. Previous recruitment data for similar studies from the proposed sites should be provided. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1993, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. For P01 grant applications, prospective applicants are also asked to submit a list of the key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES In preparing the application in response to this RFA, the applicant should bear in mind the research objectives of this RFA. An R01 application should be prepared according to the instructions in form PHS 398 (rev. 9/91). A P01 application should be prepared using the guidance and instructions provided in the NIAID document "SPECIAL INSTRUCTIONS FOR PREPARING THE GROUP APPLICATION FOR PROGRAM PROJECTS." This document cannot be transmitted electronically, particularly Tables I-IV which may be used by the applicant for appropriate and consistent presentation of summary information on budgets and personnel. The P01 applicant should request and obtain a copy of such document and a copy of the NIAID Information Brochure for Program Projects and Grants, both of which may be sent along with the RFA. Failure to follow the instructions in the document may result in delays in the review or in an incomplete application. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 09/91). For purposes of identification and processing, item 2a on the face page of the application must be marked "yes" and the RFA number and the words "MOLECULAR AUGMENTATION OF HOST DEFENSE" must be entered. These application forms may be obtained from the institution's office of sponsored research or its equivalent and 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. Applications must be received by July 15, 1993. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 09/91) application kit, will be judged non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 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. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional exact copies of the grant application must also be sent to Dr. Olivia Preble at the address listed under INQUIRIES. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID staff; those judged to be incomplete will be returned to the applicant without review. Those considered to be non-responsive will be either returned without review or, if R01s, be referred to the DRG as unsolicited applications, to be scheduled for initial review at the next DRG review cycle. Those applications that are complete and responsive may be subjected to a triage by an NIAID peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID will withdraw from competition those applications judged to be non-competitive for award and will notify the applicant and institutional business officials. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. The factors to be considered in the evaluation of scientific merit of each application will be those used in the review of traditional research project grant applications, including: the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; and the adequacy and suitability of the facilities. For program project applications, additional review criteria are used, which are outlined in the NIAID Information Brochure on Program Project and Center Grants. Applicants planning a program project application may request and obtain the NIAID Information Brochure from program staff listed under INQUIRIES. While the following review factors do not usually influence the priority score, they are nonetheless carefully considered by the initial review group: the appropriateness of the requested budget to the work proposed; the adequacy of protection of human subjects and/or animals in research; and the adherence, whenever appropriate, to NIH guidelines concerning adequate representation of women and minorities in clinical research. Any documented concerns expressed by the initial review group about any of these factors on an application may influence the recommendation of the Advisory Council concerning funding of that application. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. For P01 applicants, copies of the Information Brochure and the documents referred to in APPLICATION PROCEDURES must be requested.) Direct as inquiries regarding programmatic issues to: Howard B. Dickler, M.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A19 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Direct inquiries regarding review issues (including the preparation of a program project application if applicable); address the letter of intent to; and mail two copies of the application and all five sets of appendices to: Olivia Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Jeffrey Carow Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 The mailing address given for NIAID staff in the Solar Building is the central mailing address for NIH. Applicants who use express mail or a courier service are advised to follow the carrier's requirements for showing a street address. The address for the Solar Building is: 6003 Executive Boulevard Rockville, MD 20852 Schedule Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: July 15, 1993 Scientific Review Date: October 1993 Advisory Council Date: February 1994 Earliest Award Date: April 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. 4, 12 March 1993 Message-ID: Date: 11 Mar 93 23:18:00 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 662 $$XID RFA ES9301 ES-93-01 P1O1 ***************************************** DEVELOPMENT GRANT: ENVIRONMENTAL HEALTH SCIENCES CENTERS NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA: ES-93-01 P.T. 34; K.W. 0725005, 0710030 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: June 1, 1993 Application Receipt Date: July 28, 1993 PURPOSE The overall intent of this National Institute of Environmental Health Sciences (NIEHS) program is to establish multidisciplinary research programs that utilize state-of-the-art science and address as a primary focus environmentally-related health problems of economically disadvantaged and/or underserved populations. The first step in this process is the current request for applications (RFA) which requests Center Development Grant (P20) applications from institutions or consortia of institutions wishing to develop multi-disciplinary core center (P30) grants with this theme. 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 RFA, Developmental Grant: Environmental Health Sciences Centers, is related to the priority area of environmental health. 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 20402-9325 (telephone 202-783-3238). ELIGIBILITY Applications may be submitted by domestic for-profit and non- profit organizations, public and private including predominantly minority institutions, individually or as joint efforts of minority institutions and majority institutions. Usually, only one developmental grant will be funded at an institution. Although a single institution must be the applicant, a multi-institutional arrangement (consortium) is possible if there is a compelling reason for it and if there is clear evidence of close interaction among the participants. The NIEHS has a significant commitment to the support of programs designed to increase the number of underrepresented minority scientists participating in biomedical and behavioral research. Therefore, applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT It is important to stress that award of Developmental Grants (P20) will be highly competitive. These awards will be made to only those institutions able to demonstrate to the review committee a high likelihood of success in following the P20 grant period by a competitive core center grant application. Therefore, the requirements established by the NIEHS for its Core Center must be considered attainable by applicants for the P20 award. The NIEHS has available upon request the guidelines for these applications (P30) and potential applicants for the P20 award are encouraged to obtain a copy of them from the Chief, Environmental Health Resources Branch at the address listed below. Approximately $800,000 has been set-aside for this program. The funding level for NIEHS developmental grants will be $175,000 direct costs per year for a maximum of three years. It is important to note that to be eligible for a core center (P30) that would follow after the P20 award period, a minimum of $1,000,000 direct costs of NIH peer reviewed, investigator initiated research support (or its equivalent) must be in place. This research must be directly related to the theme proposed for the Core Center. FUNDS AVAILABLE It is anticipated that one to three developmental grants will be awarded depending upon the appropriation of funds for this purpose and the quality of the applications received. The awards are not renewable and supplements are not allowed. RESEARCH OBJECTIVES Background The Extent of the Problem Most Americans want to live long and healthy lives, and the majority of them achieve that goal. In general, however, members of economically disadvantaged and/or underserved populations are less likely to do so. At every stage of life, these populations suffer disproportionate levels of morbidity and mortality. The socioeconomically disadvantaged suffer the lowest life expectancy and highest adverse health consequences of inadequate access to high-quality health care. Additionally, they are most often the populations with the highest degree of exposure to environmental agents and are frequently the populations with the least information available as to the health consequences of exposure to these agents. Research efforts to identify the sources of hazardous environmental exposures and their effects among minority and underserved populations have been insufficient. Not much is known about the types of environmental agents to which socioeconomically disadvantaged groups within our population are exposed at home and on the job. There has been little research to see how exposure to these agents varies with socioeconomic status. It is reasonable to hypothesize that factors such as malnutrition, health status, socioeconomic status, in combination with behaviors such as smoking, alcohol consumption and drug use play important roles in the dose response, metabolism and health effects of these hazardous agents among these populations. Exposures to harmful environmental agents may be more extensive among the socioeconomically disadvantaged because of the jobs available to them and the conditions in which they work. Occupational exposures vary greatly with job responsibility. The lowest paying jobs in industrial plants are usually the most risky. A high percentage of certain jobs may be held by one racial group. Geographic location also plays an important role in environmental exposure of socioeconomically disadvantaged populations. Inner city poor often live in homes with high lead levels. These populations may also be exposed to higher levels of air pollution. Toxic wastes sites are more frequent in rural, low socioeconomic counties in the US. Nuclear facilities and chemical plants are often located in rural areas. Disadvantaged neighborhoods may rely on well water which may be polluted with toxic chemicals. Medical care is often inadequate or unavailable to a significant proportion of the socioeconomically disadvantaged and minority populations in America today. This is in conjunction with the fact that many chronic diseases and other medical problems associated with exposure to environmental agents are highly prevalent in segments of the population which are economically disadvantaged. Lead poisoning and the cognitive and developmental damage associated with exposure to lead occur disproportionately among minority populations. High blood pressure and prostate cancer are very common among Blacks. Low birth weight babies and other problems during pregnancy are common among groups of women who do not have access to good prenatal care. Some of these conditions or other disease may have an environmental component in their etiology. The lack of resources for early identification of the effects of toxic agents in these subgroups may lead to an increased disease burden in a population economically least able to cope with it. Recent progress and opportunities Some work has been done to investigate the effects of pesticides in agricultural workers, PCBs in children in rural areas, and lead exposure in socioeconomically disadvantaged urban children, usually looking at neurological outcomes. The effect of low versus high air pollutant exposure on pulmonary function has been extensively studied. Evidence from the NHANES study has shown that for comparable levels of exposure, different racial groups have different levels of blood lead. Some evidence is also available that suggests the toxic effects of some agents such as lead can be mitigated by good nutrition. Many of these studies have been of underserved populations, but none have focused on the problems from the perspective of identifying issues of highest impact on these populations. Thus, progress has been minimal in most areas due to the lack of well-developed studies targeting socioeconomically disadvantaged populations. More effort must be put into defining disadvantaged populations having high levels of exposure to types of environmental hazards in the home or occupational settings. Comprehensive outcomes to these exposures must be defined and measured. Prevention and treatment of these effects must also be generated. Prominent among the goals of the NIEHS is the achievement of "environmental equity" for all populations, as well as to bring minority populations into the mainstream of biomedical research as scientists. The achievement of both of these goals will benefit the health of the nation and provide a means of encouraging the needs of all populations. As one new aspect of this effort the NIEHS is requesting submission of Center Development Grant applications that focus on the environmentally-related health problems of socioeconomically disadvantaged populations. Objectives and Scope The primary purpose of the NIEHS Center Development Grant (P20) is to provide support for a group of investigators to develop interdisciplinary collaborations and strategies, to obtain preliminary results to demonstrate feasibility and develop a research program focused on the goals of this announcement. The resulting program will then be used as the basis for an application for an NIEHS core center grant (P30). Thus, the components of an NIEHS Center Development Grant may include, but are not limited to: 1. Preliminary or feasibility studies to gather sufficient data to demonstrate the potential of ideas or the validity of approaches, to acquire or demonstrate technical competence, or to evaluate other technical factors involved in the development of projects that addresses the goals of this announcement in conjunction with the goals of the NIEHS Centers Program; 2. Recruitment of new investigators whose expertise would strengthen the center grant application that will be submitted later; 3. Inter- or intra-institutional planning to develop research strategies, including the establishment of a timetable or milestones, for the subsequent center grant application. It is important to note that the award of a developmental grant by the NIEHS does not imply a commitment to future funding of any programs planned with the support of such a grant. Separate applications must be submitted for such programs and such applications will be evaluated on the basis of their own merits. SPECIAL REQUIREMENTS In order to ensure that developmental grants remain focused on appropriate goals and make sufficient progress towards establishing the interdisciplinary effort needed to apply for an NIEHS center, frequent programmatic assessments will be necessary. In addition to yearly staff review through progress reports, the directors of developmental grants will be asked to attend the periodic meetings of the Environmental Health Sciences Center Directors. Elements of a Planning and Development Effort The following elements are essential in the planning and subsequent development of an NIEHS center: 1. Planning grant director: A senior level person competent in administration should be assigned the responsibility for directing the planning and development effort. This person should devote a significant proportion of his/her time to this endeavor. The planning director will be the Principal Investigator of the P20 Center Development Grant application. It is both customary and desirable that the planning director be the proposed founding director of the new center. 2. Planning and advisory committees: An internal planning committee should assist the planning director. Committee members should be selected from within the Institution(s) developing the center. Additional members from the community should also be selected where appropriate. This committee should evaluate scientific, medical, institutional, and regional considerations and should make sure that all available resources are considered in the planning process. It may be advisable for all elements of the institution(s) affected by the center to be represented on this committee. In addition, an external advisory group, consisting of senior individuals who are familiar with the functions and organization of NIEHS designated centers, should be convened periodically to give the planning director knowledgeable advice on the development of a research center as well as unbiased and independent assessments of the center's progress to date and its objectives and plans for the future. 3. Research program definition and implementation: The research programs which are to comprise the center should be defined in terms of relevance to the problem, productiveness, membership in the center (present and future), peer reviewed grant/contract research base, space needs and utilization, availability of patient resources, etc. The research programs should be multidisciplinary in nature and may focus on basic, clinical or prevention investigations. They should build on the current strengths of the institution. This definition and its subsequent implementation should also include consideration of local, regional, and national needs. Shared resources that will support the peer reviewed research projects of the center programs will also need to be defined. 4. Definition of how research activities will be translated or linked to the patient care, educational and other outreach activities of the center: The relationship between the center's research activities and the patient care, educational (both professional and lay), community outreach and other activities of the center must be defined. Mechanisms should be developed so that the results of research performed at the center and elsewhere can impact quickly and positively on the populations served by the center in its geographic area. Such translational activities are a fundamental aspect of a NIEHS Center. Allowable Components of NIEHS Development Grant (P20) Applications Each applicant should consider the strengths and weaknesses of the planned research group plus the expertise and the preliminary data that would be required to demonstrate the technical competence necessary for a successful interdisciplinary center grant application. 1. Pilot projects/Feasibility studies. Research projects of limited scope to generate data needed to demonstrate technical feasibility such as access to study populations and to validate an experimental approach may be proposed. Costs required for carrying out individual projects may be requested. 2. Organizational development. The goal of the P20 grant is to bring together the individuals and organizational structure that will lead to a successful P30 application. Therefore, partial salary support as an incentive for the recruitment of faculty who will be part of the subsequent P30 application is acceptable. 3. Administrative/Planning core. Each developmental project must designate a director who will be the key figure in the scientific planning and subsequent administration of the proposed NIEHS project. Planning efforts should be described in terms of the necessary feasibility studies, recruitment of new investigators, establishment of new collaborations, development of plans for data release and outreach to the scientific community, and other components that will strengthen and broaden any existing programs in the research area of the proposed project. An internal steering committee is strongly recommended. Funds may be requested for the purpose of obtaining outside advice and for necessary administrative personnel. Costs are allowable in accordance with the cost principles outlined in OMB Circulars A-110, A-21, and A-122, and the provisions in DHHS Administration of Grants Federal Regulations Title 45 Part 74 and the PHS Grant Policy Statement, provided they fall into one of the categories below. It is important to recognize that, even though a cost may be allowable, it is the responsibility of the applicant to adequately justify the inclusion and amounts of all items for which funding is required. Non-allowable Costs for NIEHS Developmental Grants Funds from these grants may not be used to provide salary and support for central institutional administrative personnel usually paid from institutional overhead charges. Generally, funds for renovation of existing facilities or to purchase substantial amounts of equipment will not be allowed. If such requests are made, they must be justified in terms of the critical nature of the equipment for the success of the overall objectives of the developmental grant, rather than for the planned program project or center grant. 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 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 which disproportionately affect them. This policy in 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/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 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 population groups should be provided. For the purpose of this policy, clinical research includes 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. If the required information is not contained within the application, the application will be returned to the applicant. 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. LETTER OF INTENT Although not a prerequisite for applying, potential applicants are encouraged to submit to NIEHS staff a non-binding letter of intent to apply by June 1, 1993. The letter of intent should include 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 neither influences review nor funding decisions, but it enables NIEHS staff to plan the review and to ensure that each potential applicant receives relevant program information prior to preparation of the application. The letter of intent is to be sent to: Chief, Environmental Health Resources Branch National Institute of Environmental Health Sciences Division of Extramural Research and Training P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7634 INQUIRIES NIEHS staff welcomes the opportunity to clarify any issues or questions from potential applicants. Written and telephone inquiries concerning the objectives, scope and application procedures for this RFA, and inquiries about whether or not specific proposals would be responsive are encouraged and may be directed to: Thorsten A. Fjellstedt, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-0131 Questions regarding administrative or fiscal matters may be directed to: Mr. David Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7628 METHOD OF APPLYING Applicants are to use research grant application form PHS 398 (rev. 9/91) which is available from most institutional offices of sponsored research 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. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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 the YES box must be marked. As a guideline, it is suggested that approximately ten pages will be sufficient to describe the planned mission and structure of the proposed project and three to five pages to describe each feasibility study or other activity. Each project should be presented in the format used for NIH research grant (R01), but in greatly abbreviated form. Although not a prerequisite for applying, applicants are encouraged to consult with NIEHS staff concerning the technical and substantive aspects of preparing the applications is recommended. Applicants may contact NIEHS staff by phone early in the preparation of the application. However, applicants should understand that advice given by staff is independent from the review process. Schedule Letters of Intent Receipt Date: June 1, 1993 Application Receipt Date: July 28, 1993 Initial Scientific Review: Oct/Nov 1993 Advisory Council Review: January 1994 Anticipated Date of Award: April 1, 1994 Mail the complete original application and three copies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** To expedite review, two copies must also be sent to: Dr. Donald I. McRee Division of Extramural Research & Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7508 All human and animal welfare as well as misconduct assurances must be complete for an application to be reviewed. All follow-up assurances and approvals submitted as pending must be received within 60 days of the application receipt deadline or the application will not be reviewed. The written application is the basis for the merit review. Particular attention should be given to the format of the application. The standard instructions provided with form PHS 398 (rev. 9/91) are designed primarily for applications for single research projects. Developmental Center Grant applications require additional information as outlined below. Page limitations presented in the form PHS 398 (rev. 9/91) instructions should be followed closely. REVIEW CONSIDERATIONS Review will be carried out by the NIEHS Scientific Review Branch, Division of Extramural Research and Training. Applications will be screened by staff for responsiveness to the RFA. Those considered unresponsive will be returned to the applicant without review. Responsive applications will be reviewed by either the Environmental Health Sciences Review Committee or a review committee empaneled by the Scientific Review Branch staff. Site visits as part of the initial review of applications are not planned. Therefore, it is imperative that the application be complete and stand on its own merits. If a large number of applications are received, the NIEHS will utilize a triage process whereby the applications are given a preliminary scientific review by scientific peers in order to identify the most meritorious applications. Those applications identified as highly meritorious will be given a full scientific review and a complete and detailed summary statement will be prepared. Those applications not achieving these qualification will not be given a full review and an abbreviated summary statement listing the reasons for this decision will be prepared. Review Criteria A major review criterion is the likelihood of success in following the P20 grant period by a competitive core center grant application (P30). The following is not a complete listing of the Core Center requirements but, rather, is meant to highlight the major requirements for applicants for P30 programs. o A minimum of $1,000,000 direct costs of NIH peer reviewed, investigator initiated research support (or its equivalent) that is directly related to the Core Center and to the mission of the NIEHS. o A demonstrated institutional commitment to the core center. o A program cohesiveness that clearly indicates that the presence of the Core Center makes a significant difference to the individual research projects by providing and fostering a high degree of synergy among the various research projects. The major review factors listed below will be used in the evaluation of the applications for NIEHS Center Development Grants: I. Overall Program A. The ability to demonstrate a high likelihood of success in following the P20 grant period by a competitive core center grant application (P30). B. The scientific merit of the program as a whole and the development of a well-defined central focus of clear importance and relevance to the goals and mission of the NIEHS. C. The significance of the overall program goals and responsiveness to the goals of this initiative. D. The balance of administrative and planning expenses in comparison to those for conducting the small-scale studies. II. Administration and Planning Core A. The scientific and administrative leadership ability and experience of the Center Director and his/her commitment and ability to devote adequate time to the effective management of the Center. B. The proposed administrative organization to conduct the following: 1. Organize and maintain internal communication and cooperation among the investigators involved in the Center. 2. Establish a management structure that includes fiscal administration, procurement, property and personnel management, planning budgets, etc. 3. Develop mechanism for selecting or replacing professional or technical personnel within the Center. 4. Develop an appropriate and adequate review committee to assess the scientific merit of the proposed pilot project/feasibility studies. 5. Institute a mechanism for reviewing the use of and administration of funds for the proposed pilot project/feasibility studies. 6. Appropriateness and adequacy of the multidisciplinary teams constituting Center's members. 7. Adequacy of the initial research agenda and of the planning mechanism for elaborating a long-term research agenda for the institution. 8. The appropriateness of the budgets for the various components of the application. III. Pilot/Feasibility Studies A. The balance in coverage of the topics identified as the goals and scope of this initiative. B. The scientific and technical quality of the proposed pilot project/feasibility studies. (Note: Reviewers will not vote on the merit of each study. The overall quality of the proposed pilot project/feasibility studies will be taken into account in arriving at an evaluation of the application). IV. Institutional Commitment A. The institutional adequacy of the lines of responsibility for the Center and the institution's contribution to the management capabilities of the Center. B. The academic environment and resources in which the activities will be conducted, including the availability of space, equipment, and facilities, and the potential for interaction with scientists from other departments and schools. D. The institutional commitment to any newly recruited individuals responsible for conducting essential Center functions and activities. AWARD CRITERIA The following will be considered in making funding decisions: o Quality of the proposed applications as determined by peer review. o Responsiveness to the goals of this RFA and the mission of the NIEHS. o Availability of funds. Although this program is provided for in the financial plans of the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory progress during the preceding year and upon availability of funds. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.894. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 100-607) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Thu Mar 11 22:00:00 1993 Path: biosci!parc!decwrl!decwrl!wupost!zaphod.mps.ohio-state.edu!malgudi.oar.net!caen!kuhub.cc.ukans.edu!jimdb From: jimdb@kuhub.cc.ukans.edu Newsgroups: sci.bio,bionet.biology.tropical,bionet.population-bio,bionet.general,bionet.jobs,bionet.agroforestry,bionet.sci-resources,sci.environment,sci.research,talk.environment Subject: Summer Entomological Research Assistants Needed Message-ID: <1993Mar12.011937.48053@kuhub.cc.ukans.edu> Date: 12 Mar 93 07:19:37 GMT Organization: University of Kansas Academic Computing Services Lines: 53 Xref: biosci sci.bio:2446 bionet.biology.tropical:176 bionet.population-bio:390 bionet.general:4286 bionet.jobs:1582 bionet.agroforestry:274 bionet.sci-resources:639 sci.environment:4653 sci.research:530 talk.environment:2523 ENTOMOLOGICAL RESEARCH ASSISTANTS NEEDED Do you relish being in the desert in late spring? Does the idea of learning (not nearly) all there is to know about field entomology (the study of insects) appeal to you? How does the concept of spending an inordinate quantity of time digging through forest leaf litter on you hands and knees strike you? Well now you can realize these goals and many others in May and June of this year (including your secret fantasy of chasing obscure beetles through the desert)! Applications are currently being accepted for field assistants for the coming summer. Your responsibilities/opportunities will include helping in the search for five species of beetles, all of which are well-integrated guests in the nests of ants of the genus Liometopum in Arizona, Colorado, New Mexico, Texas, and California. Additionally, we will carry out a number of behavioral experiments primarily concerned with understanding the integration mechanisms that the beetles use to gain entry into the ants' nests. In return, I will supply gas, transportation, lodging (tents), and a bountiful storehouse of entomological knowledge, as well as sharing with you some of the most breathtaking areas of the United States (sorry, I am unable to provide research assistant stipends). I will be traveling from Lawrence, Kansas through these areas from May 6-20 and from June 6 - July 6. If you are interested in participating in some or all of this project, email me directly and I will give you the details of the study as well as answer any questions you may have. If you are unable to participate in the project, but know of others who may be, please pass this information on to them. Similarly, if you are on faculty at a university and wouldn't mind helping out, please print this out and post it on your departmental bulletin boards or make your students aware of this opportunity. Thanks a lot! James Danoff-Burg Snow Entomological Museum University of Kansas Lawrence, Kansas 66045 JIMDB@kuhub.cc.ukans.edu (internet) JIMDB@UKANVAX (bitnet) 913-749-1034 913-864-3309-- ---------------------------------------------------------------------- Jim Danoff-Burg (Snow Museum, Univ. of Kansas, Lawrence, KS 66045) Bitnet: JIMDB@UKANVAX Internet:jimdb@kuhub.cc.ukans.edu "Myrmecophiles-R-Us" From owner-sci-resources@net.bio.net Fri Mar 12 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. 5, 12 March 1993 Message-ID: Date: 13 Mar 93 00:17:13 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 903 $$XID RFA AI9308 AI-93-08 P1O1 ***************************************** COLLABORATIVE MUCOSAL IMMUNOLOGY GROUPS FOR AIDS VACCINES NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA: AI-93-08 P.T. 34; K.W. 0715008, 0710070, 0740075, 0755010, 0755020 The National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 15, 1993 Application Receipt Date: May 21, 1993 PURPOSE The Vaccine Research and Development Branch (VRDB) of the Division of Acquired Immunodeficiency Syndrome (DAIDS) within the National Institute of Allergy and Infectious Diseases (NIAID) announces availability of an RFA for funding of new Collaborative Mucosal Immunology Groups (CMIGs) for AIDS vaccines. The purpose of this RFA is to invite research grant applications for collaborative projects from investigators pursuing research on mucosal immunity to Human Immunodeficiency Virus and/or Simian Immunodeficiency Virus (SIV) to participate in a network of CMIGs for AIDS vaccines. The urgent need to control the spread of AIDS has fueled efforts to develop safe and effective AIDS vaccines. Additional basic and preclinical research is needed in the area of vaccine induction of mucosal immunity to AIDS viruses (HIV and SIV). The NIAID wishes to encourage and expand research in the area of mucosal immunology to AIDS viruses, that will focus on: (1) design and development of novel recombinant vectors and/or AIDS vaccine formulations designed to induce regional mucosal immunity particularly in the female or male reproductive tracts and in the rectum (gut); (2) characterization of the components (T cells and antibodies) and their mechanism of action in the immune responses at mucosal surfaces, that are specific for HIV/SIV antigens; and (3) development of immunization strategies to prevent mucosal HIV infection and transmission. The special feature of this program is the concurrent submission of research grant applications by investigators who wish to collaborate on a common theme related to mucosal immunity to AIDS viruses, but do not require extensive shared physical resources or core functions to conduct their research. In order to be responsive to this RFA, a minimum of two independent investigators with related research objectives should submit concurrent, collaborative, individual research grant applications that address a common theme. The common theme for any group should include a multidisciplinary approach, specifically in the areas of immunology and virology, since this likely to be essential to develop vaccines that will induce mucosal immunity and block sexual transmission of HIV. Investigators now participating in the National Cooperative Vaccine Development Group (NCVDG) that have pursued this area of research and new applicant groups are invited to apply. Applications from the private sector (e.g., vaccine, pharmaceutical, or biotechnological companies) are encouraged. Collaborative arrangements involving more than one institution are especially encouraged. 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), Collaborative Mucosal Immunology Group for AIDS Vaccines, is related to the priority area of HIV infection. 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 20402-9325 (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. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The support mechanism for this program will be the individual research grant (R01). Thus, it is the responsibility of the applicants to plan, direct and execute the proposed projects in accord with their interests and perceptions of approaches to the study of mucosal immunity in AIDS vaccine development. In order to be responsive to this RFA, a minimum of two independent investigators, representing diverse scientific disciplines with related research objectives should submit concurrent, collaborative, cross-referenced individual R01 applications that address a common theme. Each application must include a succinct description of the scientific relationship among the group of R01s and plans for collaboration, interaction, and communication among investigators in the group of applications. Collaborative arrangements involving more than one institution are especially encouraged. The Principal Investigator of one R01 within a collaborative group should be identified as the Collaborative Project Coordinator to be responsible for the coordination of collaborative efforts; that investigator may request funds, not to exceed 10 percent of direct costs, for an administrative core to include the time and effort contributed toward coordination of overall research. Scientific cores also are permitted to support core facilities which will benefit the Group as a whole. PIs proposing such cores may request funds up to 20 percent of direct costs of the total CMIG to support scientific core efforts and activities. In addition, for all investigators participating in a Collaborative Group, at least 30 percent of direct costs should be specified for shared resources and collaborative studies that are necessary for the shared research goals. Applicants are requested to furnish their own estimates of the time required to achieve the objectives of the proposed research project. Up to four years of support may be requested. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will vary also. The budget request for the initial year's total costs (direct and indirect) for any group may not exceed $500,000 and the total requested cost of each R01 application within a group must not exceed $180,000. Any budgets in excess of this amount must be approved by NIAID Program in advance of submission of the Group application. Requests for expensive pieces of equipment are not encouraged and any requests for equipment must be especially well-justified. In addition, groups using non-human primates should not budget for more than a limited number of animals under this mechanism. Access to additional animals may be provided through other NIAID-funded resources, such as the SIV Vaccine Evaluation Unit contracts and an Interagency Agreement with NCI for a chimpanzee unit for investigations on AIDS vaccines. This RFA is a one-time solicitation. If by the end of the third year, the NIAID has not announced its intent to readvertise this RFA, incumbents may prepare unsolicited competing continuation R01 applications that will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Those PIs who wish to continue collaborative efforts should consult NIAID staff before preparing an application. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded in connection with this RFA. FUNDS AVAILABLE The NIAID anticipates making three to five awards to Groups (6 to 15 R01 awards), based on highest program priorities, as a result of this RFA. The NIAID has set aside $1.4 million (total costs) for the initial year of funding applications received in response to the RFA. The final number and specific amounts of awards to be made will depend upon the scientific and technical merit, as reflected in the priority scores, relevance to programmatic priorities, and the availability of funds. RESEARCH OBJECTIVES Background As HIV continues its relentless spread into a wider population base, it is becoming apparent that the U.S. is now facing a second wave of infections. As has already been seen in Africa, this second wave is striking down almost equal numbers of young women and men in the young adult segment of the population. In our inner cities, it is already evident that young women in their early child-bearing years are becoming HIV-infected at alarming rates. Like several other sexually-transmitted diseases, HIV is transmitted from mother to infant. Because the primary mode of transmission is exposure to virus (or potentially to virus-infected cells) delivered to mucosal surfaces during sexual intercourse, it is essential that efforts to develop successful AIDS vaccines must be directed to strategies that will protect individuals against transmission across the mucosal surfaces of the female and male reproductive tracts and mucosal surfaces. Although great strides have been made in our understanding of HIV and of the immunologic responses to HIV antigens, the development of a safe and effective vaccine against HIV remains a formidable challenge. Research initiatives to develop both novel vaccine strategies and effective adjuvants have been launched to help achieve this goal. The VRDB, in the DAIDS, within the NIAID has undertaken a leading role in AIDS vaccine research and has organized the National Cooperative Vaccine Development Group (NCVDG), whose purpose is to spearhead investigator-initiated basic research in AIDS vaccine development. In the preclinical research area, the VRDB has also supported other preclinical studies that complement NCVDG studies, including the AIDS Cooperative Adjuvant Group, several SIV Vaccine Evaluation Unit contracts and an Interagency Agreement with NCI for a chimpanzee unit for investigations on AIDS vaccines. Clinical trials of AIDS vaccines in the AIDS Vaccine Evaluation Group funded by the NIAID, have tested a series of HIV-1 envelope vaccine candidates with different compositions, formulations and delivery systems. These trials continue to expand with plans to evaluate new candidate vaccines in additional groups of volunteers. To date, extensive efforts using animal models have been directed almost exclusively toward understanding the mechanism of protection against intravenous (IV) viral challenge induced by parenteral administration of AIDS vaccines. In addition, specific efforts have been directed toward evaluating the serological and cellular immune responses to HIV induced by vaccination of human volunteers in Phase I/II clinical trials. However, studies of mucosal immunity to HIV/SIV in humans and animals lag far behind those of systemic immunity to HIV, particularly in vaccine studies. Although the primary route of exposure for HIV in this worldwide epidemic is through mucosal surfaces, vaccines currently available have not been specifically targeted to induce immune responses that would effectively block mucosal transmission. Induction of virus-specific mucosal immunity capable of preventing or minimizing infectious events may provide the greatest opportunity to avert HIV disease in an individual and block HIV transmission to sexual partners or to infants. Thus, potent, efficacious AIDS vaccines must be designed to elicit comprehensive and long-lasting immune responses to HIV, both systemically and at mucosal surfaces. Objectives and Goals The fundamental objective of the VRDB in the DAIDS is to develop safe and effective vaccines for the prevention of transmission of HIV-1, the causative agent of AIDS. Because HIV infection occurs primarily as a result of exposure during sexual intercourse, the development of vaccine strategies to protect individuals from infection at mucosal surfaces is imperative. The goals of the network of the Collaborative Mucosal Immunology Groups for AIDS Vaccines (CMIGs) are several. First, the groups aim to conceptualize, design, and develop (evaluate immunogenicity) of AIDS vaccines that might protect against HIV transmission across mucosal surfaces. In addition, the effort will require the development of assays and technology to evaluate humoral and cellular mucosal immunity induced by candidate AIDS vaccines in primates and humans. Data from these studies will contribute to our understanding of what component(s) of the immune response correlate with protection against sexual transmission of HIV. Research Scope Applications are invited that seek to discover/design and develop vaccine strategies, animal models, methodologies, and assay reagents to study mucosal immunity to HIV (and SIV) in primates and/or humans. Applications for this RFA should stress creative approaches to the discovery, development and evaluation of candidate AIDS vaccines that might be effective. The following two general research areas are specifically encouraged under this RFA o Development and use of animal models to explore novel strategies (vectors or formulations) for vaccination and protection against mucosal challenge with AIDS viruses. o Development of assays, reagents and technology to evaluate specific, protective mucosal immune responses induced by AIDS vaccines in animals and human volunteers. Of particular interest is the integration of immunology and virology projects leading to productive interdisciplinary approaches that elucidate the basis of protective mucosal immunity to sexually-transmitted HIV infections. The objectives and goals of the application should be relevant and compatible with the missions and directions of the DAIDS and the NIAID, as stated in this RFA. While it is anticipated that complete development of new mucosal AIDS vaccines will not occur within the project period for all Groups, a rationale for the most likely utility of discoveries made or an outline of a plan for eventual clinical trials should be included. Specific Objectives Examples of research areas of mucosal immunity for AIDS vaccines of high priority and that would be responsive to RFA may include, but are not limited to those listed below. These research topics are intended to provide a perspective on the scope of research that would meet the objective of this program. It is not required that all or any of them be included in a particular group of applications. o Development and analysis novel AIDS vaccine strategies, vectors, delivery systems, or adjuvant formulations that would stimulate protective mucosal immunity, particularly in the genital tract in primate models. These strategies might include studies to provide improved antigen presentation that would induce long-lasting cellular immunity, or effective priming of T-cell responses to AIDS viruses potentially in humans. o Development of methods to evaluate mucosal immunity to lentiviruses in humans and primates. For example, development of assays for detection of HIV-specific immune cells or IgA and IgG in dilute or complex fluids (vaginal washings or seminal plasma) and specimens from mucosal sites (e.g., biopsy tissue from cervical mucosa or rectal/intestinal mucosa, swabs or scrapings from cervix and other tissue smears). o Identification and evaluation of functional antibody responses that might be effective in preventing HIV or SIV mucosal transmission. Analysis of the mechanism of action of antiviral polyclonal or monoclonal IgA antibodies by evaluation of their ability to neutralize or inactivate HIV or facilitate killing of virus-infected cells. o Identification and characterization of mucosal cell-mediated immune responses (regional cytotoxic T lymphocytes (CTL) and helper T cells); e.g., specific T-cell immune responses against HIV, that might be a front-line defense in the reproductive tract or the gut. Studies of vaccines that facilitate antigen presentation and increase T-cell help; e.g., by inducing cytokines, at mucosal surfaces. Restrictions and Exclusions No clinical trials will be supported under this RFA. However, proposed analysis of samples acquired from vaccinees in NIAID-sponsored AIDS Vaccine Clinical Trials is appropriate and should be discussed in detail with NIAID Program Staff. Access of existing samples from ongoing trials can be obtained for specific experiments by individual request. If samples, other than serum or peripheral blood cells, that are needed for specific research be dies could be obtained in future or already planned trials, early discussion with NIAID Program Staff is essential to ensure their availability. Research efforts in animal model systems should be focused on the basic research and preclinical immunological evaluation of new vaccines or vaccine strategies to protect against mucosal challenge. If an application includes plans for extensive use of primates, this should be discussed with Program Staff before submission of the application. Budgetary limitations will prohibit extensive use of primates in these projects (See MECHANISM OF SUPPORT). Definitions COLLABORATIVE PROJECTS. An assistance mechanism for research collaboration among at least two independent investigators utilizing traditional research grants (R01s). The special feature of this program is the concurrent submission of research grant applications by investigators who wish to collaborate on a common theme related to mucosal immunity to AIDS viruses, but do not require extensive shared physical resources or core functions to conduct their research. COLLABORATIVE MUCOSAL IMMUNOLOGY GROUP FOR AIDS VACCINES (CMIGs). In this RFA the terms COLLABORATIVE MUCOSAL IMMUNOLOGY GROUP FOR AIDS VACCINES and "Group" are synonymous. A Group is composed of a minimum of two independent investigators with related research projects representing diverse scientific disciplines, but with objectives that address a common theme: the conceptualization, development and application of new technology for the evaluation of new vaccines and strategies for protective mucosal immunity to AIDS viruses. (See MECHANISM OF SUPPORT) NETWORK OF COLLABORATIVE MUCOSAL IMMUNOLOGY GROUP FOR AIDS VACCINES - (CMIG Network): Awardees from this RFA, which include all of the PIs, and NIAID staff will comprise the Network of Collaborative Mucosal Immunology Groups for AIDS Vaccines (CMIG Network). PRINCIPAL INVESTIGATOR (PI) - The investigator who submits each R01 and is responsible for the conduct of the research. Limited funds may be requested for scientific cores by one or more PIs. Each PI is also responsible for collaborative efforts within the group (See SPECIAL CHARACTERISTICS and the additional instructions available from the program staff listed under INQUIRIES for preparation of a collaborative project application). COLLABORATIVE PROJECT COORDINATOR (CPC) - The PI who is responsible for organizing and maintaining effective collaboration and for submitting the application package containing all the collaborative projects. This PI may request funds for an administrative core to support these coordination efforts (See Section VIII "SPECIAL CHARACTERISTICS" and the additional instructions provided with the RFA for preparation of a collaborative project application). NIAID COLLABORATIVE PROGRAM OFFICER (NIAID CPO) - A Senior or Associate Scientist of the NIAID extramural staff and the immediate contact person for the PIs in the individual Groups. The Collaborative Program Officer is responsible for the program administration of the CMIGs and will be available to facilitate the communication among the Groups and between NIAID and the individual Groups and to serve as a source of information on resources. The responsibilities of the NIAID CPO are outlined under Special Characteristics. INVENTION - A new vaccine or diagnostic technique that is or may be patentable under Title 35 of the United States Code. o Working Relationships Within Collaborative Projects The special feature of this program is the concurrent award of research grant support to investigators to collaborate on a common theme related to mucosal immunity to AIDS viruses. We anticipate that at least 30 percent of funds within each grant will be designated for collaborative studies. In addition, one Principal Investigator must be identified as the Collaborative Project Coordinator, responsible for coordination of the collaborative efforts of the Group. The efforts of the CMIGs will be facilitated by the NIAID Collaborative Program Officer as outlined below (Special Characteristics - NIAID Staff Involvement"). o Intragroup Communications and Meetings (Each applicant should include travel funds for these meetings when they prepare their budgets.) Applicants should include a statement in their applications indicating their willingness to participate in such meetings. A critical determinant of Group success will be the degree of effective communication among its members. Therefore, it is suggested that the group also hold regular conference calls if long distances are a concern. Regular telephone and written communication among Group members will be important and is encouraged. These expenses should be included in the budget for the Administrative Core and, where appropriate, within the budget for each project. In addition, written updates on progress from the individual projects (no more than 5 pages) should be submitted to the NIAID Collaborative Program Officer in conjunction with the Group meetings. Each Group should plan for two meetings of the Principal Investigators each year (or more often if warranted) to review progress, plan and design research activities, and establish priorities; the NIAID Collaborative Program Officer may also attend these meetings. The Collaborative Project Coordinator will be responsible for scheduling the time and place (generally at one of the performance sites) and for notifying the NIAID Collaborative Program Officer at least thirty days prior to the meeting date. Funds for attending the two intra-Group meetings should be included in each PIs budget. The application for the Administrative Core (from the Collaborative Project Coordinator) should also include plans for scheduling the intra-Group meetings, notifying Group members and the NIAID Collaborative Program Officer, and documenting and disseminating Group meeting proceedings. This investigator may request funds, not to exceed 10 percent of direct costs, for the time and effort contributed toward coordination of overall research. o CMIG Network Meetings (Each applicant should include travel funds for these meetings when they prepare their budgets.) Applicants should include a statement in their applications indicating their willingness to participate in such meetings. o Annual meeting of the CMIG Network: In addition to the two Group meetings, one meeting each year will be held at a site designated by the NIAID during which the Principal Investigators from each Group will be invited to present significant findings in a symposium format. Whenever possible, this Network meeting will coincide with meetings of investigators from the National Cooperative Vaccine Development Groups (NCVDGs), the Primate Vaccine Evaluation Units, the AIDS Cooperative Adjuvant Group, and/or the AIDS Vaccine Clinical Trials Network. This collaboration and coordination is critically important to the success of the AIDS vaccine program and will be facilitated by the NIAID Collaborative Program Officer. o Annual NCVDG meeting: In addition, at least one representative from each CMIG will be invited to attend the annual National Cooperative Vaccine Development Group Meeting (NCVDG) meeting. o NIAID Staff Participation The NIAID Collaborative Program Officer will be a member of the professional (Senior Scientist or Section Chief) within the Vaccine Research and Development Branch of the Division of AIDS, which is an extramural program of the NIAID. The Collaborative Program Officer is assigned by the Vaccine Research and Development Branch Chief based on his/her scientific expertise, interests and compatibility with the Group's areas of research. Because of the limited number of awards anticipated under this RFA, there will be one individual assigned to all of the CMIGs initially. The Collaborative Program Officer will also oversee the entire mucosal immunology program (including the CMIG Network). Through the NIAID Collaborative Program Officer, the NIAID will exercise the usual stewardship responsibilities inherent in the role of an NIH Health Science Administrator. The Collaborative Program Officer will serve as a resource for information, access to laboratory testing, and biological reagents, when such resources are not a usual requirement of the Group's day-to-day research activities, but may be required on an occasional basis. A brief description of the resources available through the Division of AIDS and the Vaccine Research and Development Branch is enclosed with this RFA. These resources are intended for qualified studies and may not be available on a continual basis. It is the policy that, for any materials/samples that are received through the Collaborative Program Officer, written approval must be obtained before redistribution of any material/samples or dissemination of data gathered from these materials/samples. The following is a partial list of some resources available from the NIAID that might be of particular use to investigators: o Information and some resources for SIV and/or HIV antigens (proteins) that may be used as immunogens in these studies for investigators who may not have adequate access to SIV or HIV antigens, subunits or peptide immunogens. o Expanded access to evaluate immunogenicity in primates for those approaches that merit further study through contracts monitored by the Vaccine Research & Development Branch. o Access to HIV or SIV vaccinee samples for evaluation where investigators have demonstrated appropriate development of technology and methods for characterization of mucosal immunity. The principal end product of the research sponsored by the RFA will be the development and analysis of promising AIDS vaccines and methods for evaluating these in clinical trials. For further development beyond this award, collaboration and work through private resources are encouraged. Alternatively, the Group may request, through the Collaborative Program Officer, that development be assisted or sponsored by NIAID. In the latter case the NIAID Collaborative Program Officer will be available to facilitate or work with the PI(s) on the analysis, summarization, preparation and presentation of data to the appropriate NIAID staff and NIH advisory committees (including the AIDS Research Advisory Committee) and other working groups (such as the Animal Model Operating Committee or the AIDS Vaccine Selection Committee). o Patent Coverage Inasmuch as the development of effective AIDS vaccines is the objective of this effort and since the active involvement by industrial laboratories is facilitated by the existence of adequate patent coverage, it is essential that applicants provide plans to assure such coverage. Each applicant Group that represents more than one institution must, therefore, provide a detailed description of the approach to be used for obtaining patent coverage and for licensing where appropriate. Applicants are encouraged to develop an arrangement that is most suitable for their own particular circumstances. The NIAID will not be a partner in any patents or royalties ensuing from this research. Your attention is drawn to P.L. 96-517 as amended by P.L. 98-620 and instructions published by the Office of Management and Budget in the Federal Register (OMB Circular A-124), Volume 47, Number 34, Friday, February 19, 1982, pp. 7556-7566. Note that non-profit organizations (including universities) and small business firms retain the rights to any patent resulting from Government contracts, grants, or Cooperative Agreements. Also a Presidential memorandum of February 18, 1983 extended to all business concerns, regardless of size, the first option to the ownership of rights to inventions as provided in P.L. 96-517. For those groups where it is appropriate (more than one institution), the patent agreement, signed and dated by the organizational officials authorized to enter into patent arrangements for each Group member and member institution, should be submitted with the applications and, prior to peer review, to Dr. Bonnie J. Mathieson at the address listed under INQUIRIES). Federal regulation clause 37 CFR 401 and HHS Inventions regulations at 45 CFR Parts 6 and 8 require that NIH be informed of inventions and licensing occurring under NIH funded research. Invention and licensing reports must be submitted to Extramural Invention Reports office, Office of Extramural Research, Building 31, Room 5B41, NIH, with a copy to Dr. Bonnie J. Mathieson at the address listed under INQUIRIES. It is standard policy that NIAID will retain the option to cross-file or independently file an application for investigational clinical trial; i.e., an Investigational New Drug Application (INDA) to the United States Food and Drug Administration of any invention resulting from these NIAID-supported Collaborative Projects. Reports of data generated by the Group or any of its investigators required for inclusion in INDAs and Clinical Brochures and for cross-filing purposes should be submitted by the Principal Investigator(s) to the Collaborative Program Officer upon request. Such reports will be in final draft form and include background information, methods, results, and conclusions. They will be subject to approval and revision by NIAID and may be augmented with test results from other Government sponsored projects prior to submission to the appropriate regulatory agency. 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 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 which 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/ethnic group, 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 Native Islanders, Blacks, Hispanics). The rational for studies on single minority populations groups should 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 studies. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissue 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 application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in the 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. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. LETTER OF INTENT Prospective applicants are asked to submit, by April 15, 1993, a letter of intent that includes a descriptive title, brief description of the proposed research, the name, address, including institution, telephone number (and FAX number, if available) of the Collaborative Project Coordinator, the identities of the PIs and other key personnel (with their institutions) participating in the Collaborative Group, and the number and title of this RFA. 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 expected applications. It allows NIAID staff to estimate the potential workload for reviewers and to avoid possible conflict of interest in the review process. Since applications that do not address the objectives of the RFA will be considered nonresponsive, potential applicants are strongly encouraged to discuss their research plans with program staff before completing their applications. The letter of intent is to be sent to Dr. Bonnie J. Mathieson 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 NIH program administrator named below. Detailed instructions for preparing the application are found in the document "Preparation and Organization of a Collaborative Project Application" that is included with the RFA. Failure to follow these instructions may result in an incomplete application which will be returned to the Principal Investigator without review. The R01 applications from a proposed Group that are sent to the Division of Research Grants (DRG) must be submitted in one package. In preparing the application, it is important that the points identified under REVIEW CONSIDERATIONS are fulfilled. The page limitation requirements must be observed. The collaborative nature of the work should be discussed in the areas outlined in the instructions for preparation of the application. Additional NIAID instructions for preparation of collaborative project applications will be provided with the RFA. Applicants may contact one of the program administrators listed under INQUIRIES to seek clarification and to discuss any questions related to this announcement. The RFA label available in the application form must be affixed to the bottom of the face page of the application. 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, To assure the identification of the application with this RFA the "Yes" box must be marked in item 2a of the face page of the application form and "COLLABORATIVE MUCOSAL IMMUNOLOGY GROUPS FOR AIDS VACCINES" (RFA 93-AI-08) typed. Submit a written original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission to DRG, also submit two exact complete copies of your application directly to Dr. Diane Tingley at the address listed under INQUIRIES. It is important to send these copies at the same time as the original and three copies are sent to DRG. Applications must be received by May 21, 1993. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications that have not followed the instructions for preparation of the application or that do not conform to the instructions contained in the PHS 398 (rev. 9/91) application kit will be judged incomplete and will be returned to the applicant. Applications will be reviewed by DRG staff for completeness and by NIAID staff to determine responsiveness to this RFA; those individual or group applications judged to be incomplete or non-responsive will be returned to the applicant without review. A Group application with a budget in excess of $500,000 total (direct and indirect) first year costs will be returned without review unless the proposed amount has been approved in advance by NIAID. The application must be directed towards the attainment of the stated programmatic goals (see RESEARCH OBJECTIVES). If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allow nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions on applications already reviewed, but such applications must include an introduction addressing the previous critique. Those applications that are complete and responsive may be subjected to a triage by a peer review group convened by DEA, NIAID to determine their scientific merit relative to the other applications received in response to this RFA. The NIAID will remove from further competition those applications judged to be noncompetitive for award and will notify the applicant and institutional business official. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Scientific Review Branch, DEA, NIAID. A second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council during September 1993. In the event of multiple highly qualified applications, final funding recommendations will be based on highest Program priorities. Review Criteria The following criteria will be used in the scientific review of applications submitted in response to this RFA. o Scientific merit of the proposed individual projects including innovation, originality, and feasibility of the approach; o The significance of the overall group goals and the development of well-defined central research focus; o Evidence of collaboration, including the proportion of resources devoted to collaborative studies (at least 30 percent); o Integration of the component R01s into a coherent, multidisciplinary enterprise with adequate plans for collaboration, interaction, and communication of information among participating investigators. The relationship of each project to the central focus of the overall group; o Competence of the investigators to accomplish the proposed research goals, their commitment, and the time they will devote to the program. While there is no maximum percent effort set, it is anticipated that, due to the complexity and time required to maintain a well-coordinated and productive collaborative research effort, a minimum 15 percent (time) effort by each PI should be devoted to the study, unless there is compelling evidence to the contrary that this is not essential. o Accomplishments of the group to date (for investigators currently involved in AIDS vaccine development research). o Environment in which the research will be conducted, including the availability of space, equipment, animal facilities, and the potential for interaction with active scientists in infectious diseases, reproductive biology, virology and/or immunology from other departments and/or institutions. o Arrangements for internal quality control of on-going research, day-to-day management, internal communications and collaboration among the investigators involved in the Group, contractual agreements, and replacement of PIs, if required, on an interim or permanent basis. o The appropriateness of the period of support and budget requested in relation to the proposed program. In addition the following criteria specific for this RFA will also be considered by the review group: o Likelihood that new potential AIDS vaccines or vaccine strategies, or that novel technical or methodological advances for vaccine evaluation, will be identified during the course of the proposed study; o Technical merit and appropriateness of proposed methods. o AWARD CRITERIA Anticipated date of award is September 1993. Awards will be made based on: o Results of the initial scientific and technical merit review. o Significance and relevance to NIAID program goals in microbiology, infectious diseases, allergy, immunologic diseases, and AIDS. o National needs and program balance. o Evidence and degree of collaboration in proposed work. o Policy and budgetary considerations, including availability of funds. INQUIRIES It is essential that prospective applicants carefully review the RFA and accompanying instructions on preparation of the application before preparing an application. The contacts listed below welcome the opportunity to clarify issues or questions from potential applicants. Direct inquiries regarding programmatic issues and address the letter of intent to: Dr. Bonnie J. Mathieson Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B04 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8200 Direct inquiries regarding scientific review matters to: Dr. Diane Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-0818 Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: April 15, 1993 Applications Receipt Date: May 21, 1993 Council Date: September 1993 Earliest Award Date: September 1993 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergy and Transplantation Research. Awards are made under the authority 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 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. From owner-sci-resources@net.bio.net Sun Mar 14 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 - 14 March 1993 Message-ID: Date: 15 Mar 93 19:14:17 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 117 ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF Bulletin Vol.20; No. 8 April 1993 File size (bytes): 29763 STIS Filename: bul9304 Document Type: Press Release Title: GROUP OF BACTERIA RESPOND TO EARTH'S GEOMAGNETIC FIELD File size (bytes): 4217 STIS Filename: pr9315 Title: SEA LEVEL VARIATIONS USED TO PREDICT SPINY LOBSTER CATCH File size (bytes): 3055 STIS Filename: pr9317 Title: VOLCANIC FIRE MAY FUEL ANTARCTIC ICE STREAMS File size (bytes): 6212 STIS Filename: pr9322 Title: NEW STUDY PROBES HOW FULLERENE MOLECULE FORMS File size (bytes): 4289 STIS Filename: pr9323 Title: RESEARCHERS UNCOVER "ETHICALLY SUSPECT" TECHNOLOGICAL MANIPULATIONS IN POLITICAL ADVERTISING File size (bytes): 4751 STIS Filename: pr9324 Document Type: Program Guideline Title: Joint NSF/Private Sector Research Opportunities Initiative Announcement (NSF 92-136) File size (bytes): 17169 STIS Filename: nsf92136 Title: NSF 93-25 - Combined Research Curriculum Development in Technological Areas of National Importance File size (bytes): 11494 STIS Filename: nsf9325 Document Type: SRS National Patterns 1992 Title: Table of Contents National Patterns of R&D Resources- 1992 File size (bytes): 6830 STIS Filename: np92atoc ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 3267 STIS Filename: cmpublic Document Type: EPS Title: Electronic Proposal Submission (EPS) Unix Binaries File size (bytes): 1295 STIS Filename: epsbin Also available: epsbin.sun epsbin.nxt epsbin.sgi epsbin.aix Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 90971 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 92031 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 Sun Mar 14 22:00:00 1993 Path: biosci!agate!howland.reston.ans.net!gatech!europa.eng.gtefsd.com!news.ans.net!cmcl2!mcclb0.med.nyu.edu!smith From: smith@mcclb0.med.nyu.edu Newsgroups: bionet.sci-resources Subject: Gordon Conference Application form question. Message-ID: <1993Mar15.155744.7198@mcclb0.med.nyu.edu> Date: 15 Mar 93 20:57:44 GMT Organization: NYU Medical Center, New York, NY 10016, USA Lines: 13 We made a ratty 300dpi scan of the Gordon Conference application form that is published in 'Science' of Feb 19th. Someone suggested that I should make this generally available, since the copy of Science is one of the most stolen (for the form). It is not clear to me if making such a file available in this way violates someones copyright. Anyone offer any hints on this? +----------------------------------------------------------------------------+ |Ross Smith, Research Computing Resource, Department of Cell Biology, NYU-MC| |E-Mail: SMITH@NYUMED.BITNET (BITNET), SMITH@MCCLB0.MED.NYU.EDU (Internet)| +----------------------------------------------------------------------------+ From owner-sci-resources@net.bio.net Tue Mar 16 22:00:00 1993 Path: biosci!uwm.edu!cs.utexas.edu!uunet!utcsri!newsflash.concordia.ca!mizar.cc.umanitoba.ca!mrc-mac1.cc.umanitoba.ca!user From: insmath@ccm.umanitoba.ca (P.N. Shivakumar) Newsgroups: bionet.sci-resources,sci.engr.chem,sci.engr.civil,sci.engr,sci.environment,sci.geo.fluids,sci.geo.geology,sci.math.num-analysis,sci.physics,comp.theory.dynamic-sys,comp.theory.self-org-sys Subject: Porous Media Conference Message-ID: Date: 17 Mar 93 19:21:04 GMT Sender: news@ccu.umanitoba.ca Organization: Institute of Industrial Math Sciences Lines: 267 Xref: biosci bionet.sci-resources:643 sci.engr.chem:424 sci.engr.civil:392 sci.engr:892 sci.environment:4721 sci.geo.fluids:210 sci.geo.geology:1503 sci.math.num-analysis:1830 sci.physics:12053 comp.theory.dynamic-sys:269 comp.theory.self-org-sys:43 Nntp-Posting-Host: mrc-mac1.cc.umanitoba.ca CONFERENCE ON POROUS MEDIA AND THE ENVIRONMENT Organized by Institute of Industrial Mathematical Sciences University of Manitoba and Department of Mathematics, Statistics and Computer Science University of New Brunswick Held at 343 Drake Centre The University of Manitoba Winnipeg, Manitoba Canada May 7 - 8, 1993 Conference Objectives This decade is characterized by the greater awareness of environmental problems and the movement towards applied scientific topics dealing with the current state of our physical environment. The increasing levels of pollution, the need for new energy resources, and the need for advanced technology that is capable of disposing of, and storing, solid and chemical waste safely and permanently, together with the increasing demand for soil sustainability and water and air decontamination, call for an escalation and advancement of porous media models and technology. The state-of-the-art of this technology is concerned with both the processes of the largest porous reservoir (the Earth) and a wide variety of industrial and biomedical applications. The Conference on Porous Media and the Environment is therefore timely, and is aimed at bringing together researchers in the field of porous media from the environmental, physical, mathematical and biological fields both nationally and internationally. The conference setting is aimed at providing an atmosphere that allows a greater exchange of ideas of workers in this multifaceted field. Organizing Committee P. N. Shivakumar (Chair) IIMS and Applied Mathematics, University of Manitoba M. H. Hamdan (Co-Chair) Mathematics, Statistics and Computer Science, University of New Brunswick D. Ruth (Co-Chair) Mechanical and Industrial Engineering, University of Manitoba D. Jayas Agricultural Engineering, University of Manitoba R. Sri Ranjan Agricultural Engineering, University of Manitoba A. Woodbury Geological Engineering, University of Manitoba F. Render Water Resources Branch, Province of Manitoba Participation, Call for Papers The conference aims at attracting participants from the various research groups working on the different types of flow through porous media; heat and mass transfer; environmental flows; flow in biological systems; percoluation theory; structure, modelling, field theory and properties of porous media; simulation and percolation theory. Unsolved problems of industrial or of theoretical nature are particularly encouraged. The program will consist of invited talks and contributed papers. Contributed talks dealing with the above, or related topics, are solicited. Prospective authors are invited to submit abstracts of up to 500 words before April 8, 1993. Program Confirmed One-Hour Invited Speakers Include W. Gray Notre Dame D. Oldham Trent N. Rudraiah Gulbarga M. Sahimi Southern California E. Sudicky Waterloo K. Vafai Ohio S. Whitaker California, Davis Confirmed Half-Hour Invited Speakers Include S. Barton R.M.C. B. Boudreau Dalhousie A. J. Desbarats Energy, Mines & Resources P. Forsyth Waterloo D. Jayas Manitoba R. Knight U.B.C. H. Rasmussen Western Ontario M. Reeves Saskatchewan D. Ruth Manitoba D. Taylor Ottawa A. Woodbury Manitoba Accommodation and Parking The Conference will be held in Room 343 Drake Centre on the University of Manitoba Campus. The following accommodation is available. 1. On Campus Residence: $33.63 (single), $25.00 each (double). (Please ask for application form from the Institute. Last date for application is April 9, 1993). 2. Travelodge/Astoria Hotel, 2935 Pembina Highway: $45.00 (single or double occupancy). Call collect (204) 275-7711 for reservations. Limited accommodations. Public transport available to campus. 3. Holiday Inn Winnipeg South, 1330 Pembina Highway: $60.00 (single or double occupancy). Call collect (204) 452-4747 for reservations. Fax (204) 284-2751. The hotel provides complimentary airport shuttle service and transport to and from the campus. Advance information is required re date of arrival, flight time and flight number. Free parking is available in U lot on campus. Institute of Mathematics and its Applications (University of Minnesota) Interested participants from Participating Institutions of the IMA should contact the heads of the mathematics departments of the PIs for possible financial support. Participating Institutions include: Consiglio Nazionale delle Ricerche, Georgia Inst. of Technology, Universities of Indiana, Iowa State, Kent State, Michigan State, Northern Illinois, Northwestern, Ohio State, Pennsylvania State, Purdue, Chicago, Cincinnati, Houston, Illinois (Chicago), Illinois (Urbana), Iowa, Kentucky, Manitoba, Maryland, Michigan, Minnesota, Notre Dame, Pittsburgh and Wayne State. Institute of Industrial Mathematical Sciences (IIMS) The Institute of Industrial Mathematical Sciences in the Faculty of Science came into being in the spring of 1991. The purpose of the Institute is to promote interaction between scientists from industry and government and the mathematicians, applied mathematicians, statisticians and computer scientists in the Faculty of Science. The Institute has held the following four Workshops/Conferences since 1991. (a) Workshop on Matrix Computations and Applications (Dec. 9-10, 1991). (b) Workshop on Applied Expert Systems (May 7-8, 1992). (c) Workshop on Parallel Processing: Architecture and Algorithms (June 26, 1992). (d) Workshop on Models, Mathematics and Numerics of Excitable Media and Mini-Conference on Mathematical Biology (October 1-4, 1992). The Institute is a Participating Institution of the Institute of Mathematics and its Applications (IMA) of the University of Minnesota. IMA has sponsored the Workshop/Mini-Conference on Mathematical Biology and the Workshop on Matrix Computation and its Applications. The IIMS is also an associate affiliate of the Fields Institute of Canada. The City of Winnipeg Winnipeg is a city with a population of more than 600,000, and is served by several airlines including Air Canada, Canadian Airlines International and North West. During May, the weather is pleasant with the temperatures usually averaging 18!C (65!F) during the day. Winnipeg is the home of the world famous Royal Winnipeg Ballet and has its own Symphony Orchestra. Winnipeg also has an IMAX Theatre, an Art Gallery, a Planetarium, a Theatre Center and many museums. Other attractions include the Royal Canadian Mint, Assiniboia Downs (race track), a European style casino and many attractive parks. Registration Form Name (Prof/Dr/Mr/Ms) Affiliatrion Address Postal Code: Tel:(Bus): ( ) Tel:(Home): ( ) Electronic Mail: Fax: If you are planning to attend, please mail, fax or e-mail a copy of the Registration Form before April 10, 1993. Fees: (including GST) Registration Fee - $350* $ Participating Institution $ Member - $200* Faculty - $200* $ Postdoctoral Fellows and $ Students - $150* Guest for Banquet $50 $ TOTAL PAYMENT $ (payable to: IIMS-Porous Media) *includes Banquet and Luncheon Please note all fees are in Canadian funds. GST Registration #R119260669 Registration Fee includes: % Banquet on Friday, May 7, 1993 % Luncheon on Saturday, May 8, 1993 Funds will be available to assist a limited number of students to partially defray their expenses. Completed registration form, together with payment, may be sent to: Mrs. Sharon Henderson Conference Co-Ordinator and all enquiries regarding the meeting, including those on contributed papers and support, should be addressed to P. N. Shivakumar, Director Institute of Industrial Mathematical Sciences University of Manitoba Winnipeg, Manitoba R3T 2N2 Canada Tel: (204) 474-6724 Fax: (204) 275-0019 E-Mail: insmath@ccm.umanitoba.ca Registration Times The meetings will begin at 8:30 a.m. on Friday, May 7th, 1993. Registration will be as follows: May 6, 1993 Antelope Room, Holiday Inn South 7:00- 9:00 p.m. May 7, 1993 343 Drake Centre, University of Manitoba 8:00-10:00 a.m. Participating Institutions Participating Institutions of the Institute of Industtrial Mathematical Sciences are: Manitoba Hydro, Atomic Energy of Canada Ltd. and Red River Community College. --------------------------------------------- P. N. Shivakumar Institute of Industrial Mathematical Sciences insmath@ccm.umanitoba.ca From owner-sci-resources@net.bio.net Wed Mar 17 22:00:00 1993 Path: biosci!parc!decwrl!ames!agate!howland.reston.ans.net!newsserver.jvnc.net!newsserver.technet.sg!nuscc!nusunix2.nus.sg!ccewwm From: ccewwm@nusunix1.nus.sg (Wong Wui Ming) Newsgroups: bionet.sci-resources Subject: Biotech Job in Singapore Message-ID: <1993Mar18.074843.3763@nuscc.nus.sg> Date: 18 Mar 93 07:48:43 GMT Sender: usenet@nuscc.nus.sg Organization: National University of Singapore Lines: 45 X-Newsreader: TIN [version 1.1 PL6] Calling all CLONAL DESIGNERS and GENE MAPPERS!!! The Bioprocessing Technology Unit is looking for an INNOVATIVE and INVENTIVE post-doctoral molecular biologist who has had experience in identifying, isolating, mutating and cloning recombinant genes (using a variety of novel and conventional promoters) into Chinese Hamster Ovary (especially), insect, yeast or E. coli cells. Initially, s/he may be cloning snake venom or marine toxins into one of the above hosts for expression, structural and biological studies. S/he will also help the Cell Culture Group to understand the molecular basis of increased antibody production in hybridoma cells under stress conditions; the Fermentation Group to overexpress a cytokine in a soluble form, which currently exists as inclusion bodies; as well as undertaking other tasks such as developing PCR methods for diagnostic kits for the DNA/Peptide Synthesis Group.....etc. [Suffice to say, it will be a very challenging position and much will be learnt from our open interaction within our multi-disciplinary groups.] A 3 year contract will be offered and remuneration will be subject to work experience and equivalent to similar positions in academia in the U.S.A. Accommodation will be provided for to non-Singaporeans. Please send your applications with full resume and certificates to:- Dr. Miranda Yap or Dr. Steve Oh Director Project Leader, The Bioprocessing Technology Unit, National University of Singapore, 10 Kent Ridge Crescent, SINGAPORE 0511 FAX: 65 775 4933 Preferred e-mails of Dr. Steve Oh:1) engohkw@nusvm.nus.sg 2) engohkw@nuscc.nus.sg Thank you for your interest. Yours Biotechnologically, Dr. Steve Oh From owner-sci-resources@net.bio.net Thu Mar 18 22:00:00 1993 Path: biosci!daresbury!daresbury!news From: ydf@spek.siobc.msk.su (Yuri Fonarev) Newsgroups: bionet.sci-resources Subject: help Message-ID: <1993Mar19.192709.26925@gserv1.dl.ac.uk> Date: 19 Mar 93 14:55:40 GMT Sender: spek.siobc.msk.su!ydf@su.kiae.sequent Distribution: bionet Lines: 1 Original-To: sci-res@uk.ac.daresbury help From owner-sci-resources@net.bio.net Mon Mar 22 22:00:00 1993 Path: biosci!enterpoop.mit.edu!gatech!howland.reston.ans.net!zaphod.mps.ohio-state.edu!sdd.hp.com!apollo.hp.com!lf.hp.com!rowland From: rowland@lf.hp.com (Fred Rowland) Newsgroups: comp.org.isoc.interest,alt.pub.havens-rest,sci.image.processing,alt.tasteless,soc.culture.esperanto,bionet.sci-resources,comp.text.desktop Subject: Re: DidYouKnow... Message-ID: <1omvp4$3nc@hpavla.lf.hp.com> Date: 23 Mar 93 12:28:20 GMT References: <1993Mar22.225404.16775@midway.uchicago.edu> Followup-To: comp.org.isoc.interest,alt.pub.havens-rest,sci.image.processing,alt.tasteless,soc.culture.esperanto,bionet.sci-resources,comp.text.desktop Distribution: usa Organization: Hewlett-Packard Little Falls Site Lines: 16 Xref: biosci comp.org.isoc.interest:3 alt.pub.havens-rest:590 sci.image.processing:1882 alt.tasteless:8799 soc.culture.esperanto:1244 bionet.sci-resources:649 comp.text.desktop:628 NNTP-Posting-Host: hpavla.lf.hp.com X-Newsreader: TIN [version 1.1 PL8.8] Len Buzyna (buzy@quads.uchicago.edu) wrote: : Today Japan owns the 7/11 store chain, Dunlop, Universal Pictures, Columbia : Pictures, Loews Theaters, MCA Home Entertainment, Tri-Star Pictures, CBS : Records, Columbia Records, Spencers stores, Ciniplex Odeon (a big part), : Firestone Tires and many many more very large US companies while Americans : are prevented from owning any important Japanese concerns. Japan (the country) or a variety of Japanese companies? And what does this have to do with desktop publishing? Please don't clutter up this discussion with irrelevant obsessions. Fred Rowland Little Falls Site - Hewlett-Packard From owner-sci-resources@net.bio.net Mon Mar 22 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. 11, pt. 3, 19 March 1993 Message-ID: Date: 23 Mar 93 23:30:38 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1249 $$XID RFA HD94003 HD-94-003 P1O1 *************************************** MENTAL RETARDATION RESEARCH CENTERS NIH GUIDE, Volume 22, Number 11, March 19, 1993 RFA: HD-94-003 P.T. 04; K.W. 0715130, 0745027, 0745070, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 16, 1993 Application Receipt Date: July 16, 1993 PURPOSE The National Institute of Child Health and Human Development (NICHD), through the Mental Retardation and Developmental Disabilities Branch (MRDD), Center for Research for Mothers and Children (CRMC), invites research center core grant applications (P30) as part of the Institute's Mental Retardation Research Program to develop new knowledge in the field of diagnosis, prevention, treatment, and amelioration of mental retardation and developmental disabilities. Three centers may be supported in response to this announcement. A Mental Retardation Research Center (MRRC) is a center to facilitate, through organization and operation, a program of biomedical and/or behavioral research related to mental retardation. Mental Retardation Research Center core grants support multidisciplinary research in areas that may lead to diagnosis, prevention, treatment, and/or amelioration of mental retardation and developmental disabilities. These grants fund core support services, administration, and development of a limited number of new research programs. The primary objective of the NICHD Mental Retardation Research Centers is to provide support and facilities for a cohesive, interdisciplinary program of research and research training in mental retardation and related aspects of human development. Public Law 88-164, Title I, Part A authorized construction of mental retardation research centers. The NICHD has provided partial support for a limited number of these centers through the provision of core grants (P30), that facilitate program coordination and support central research facilities. Funds for the research projects using these core facilities come from independent sources including Federal, State and private organizations. This announcement seeks applications not only from these constructed centers, but also from other comparable institutions that meet the qualifications for a program of mental retardation research. A major goal of the MRDD Branch's Mental Retardation Research Centers is to prevent and/or ameliorate mental retardation. The degree of impairment associated with mental retardation varies in relation to the cause. Moderate and more severe mental retardation often results from problems that produce profound alterations in brain development and/or function. Diminished intellectual and adaptive capacity can often be traced to defective genes, teratogenic agents, toxic substances, infections, nutritional deficits, accidents, diseases and other disorders causing brain damage. A larger proportion of cases of mental retardation is related to environmental conditions and disorders of unknown etiology. These complex problems require integrated, multidisciplinary approaches involving biomedical and behavioral sciences in a variety of settings. More than 400 mental retardation syndromes have been identified, and new ones are being discovered. Each requires fundamental research into the underlying processes, as well as studies designed to meet the unique needs of the afflicted children. Therefore, one of the missions of the MRDD Branch is to support research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention or amelioration of mental retardation. The purpose of a Mental Retardation Research Center is to provide a research environment that facilitates interdisciplinary collaboration among investigators who are working in areas of relevance to the prevention and amelioration of mental retardation. Such research will cover a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development, to clinical and behavioral research in which persons with mental retardation are studied. It is thought that major solutions to the problems of mental retardation may be found as a result of multidisciplinary collaboration involving a variety of approaches in the Mental Retardation Research Centers. As a result of the administrative and scientific organization within an MRRC and across the network of MRRCs, opportunities for breakthroughs will be enhanced. 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 Application (RFA), Mental Retardation Research Centers, is related to several priority areas including nutrition, alcohol and other drugs, mental health and mental disorders, environmental health, maternal and fetal health, HIV infection, immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-011-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State and local governments. As stated in the NICHD Center Guidelines, the NICHD will not support more than one center grant (P30 or P50) in a given department or specialty unit. MECHANISM OF SUPPORT Mental Retardation Research Center grants will be supported through the customary grant-in-aid mechanism. The application should be prepared in a manner consistent with the general guidelines presented in the publication, P30 CENTER CORE GRANT GUIDELINES, which is available from the MRDD Branch office listed below. Awards will be made for a period of five years. To be eligible for award as an MRRC, the center must provide core support for a minimum of 10 projects funded from non-university sources. The cost of a center will be a material consideration in the selection of applications for funding. The total direct costs requested for the first year of a new Center Core Grant (P30) should not exceed $500,000. Renewal applications from existing P30 Centers may request, but not exceed, initial year direct costs of up to 120 percent of the Notice of Grant Award level of direct costs for the final year of the preceding project period, or $500,000 direct costs, whichever is greater. Budget increments for subsequent years generally will be limited to four percent. Budgets of new and renewal applications will be stringently reviewed within these guidelines. Applications with budget requests exceeding these guidelines will be administratively withdrawn by the NICHD and returned to the applicant. FUNDS AVAILABLE This is the sixth in a series of annual announcements. Plans are to make three awards in fiscal year 1994. The estimated funds available for the first year of support for the entire program is $2.4 million total costs. 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 NICHD, awards pursuant to this RFA are also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES MRRC core grants (P30) are intended to bring together in a center scientists from a variety of disciplines to work on the common problems of mental retardation. Consequently, applications for MRRC core grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. Applicants are encouraged, but are not required, to include both biomedical and behavioral components among the topics addressed within their center. Center grant applications must include among these topics at least five of the following: 1. Developmental neurobiological studies relevant to MRDD: neurophysiological, neuroanatomical, neurochemical, neuropharmacological. 2. Inborn errors of metabolism relevant to MRDD, including mitochondrial disorders: pathophysiology, recombinant DNA technology, screening, applied clinical and experimental studies, including treatment. 3. Genetic/cytogenetic disorders associated with MRDD: research on prenatal diagnosis, particularly non-invasive methods during the early stages of pregnancy on prevalent genetic causes of mental retardation such as Down syndrome or Fragile X syndrome; research on rare genetic disorders associated with mental retardation; genomic imprinting. 4. Molecular biology: gene localization, structure, function and organization; gene mapping; gene therapy; and development of animal models. 5. Toxicology and physical environmental factors in the etiology, treatment and prevention of MRDD including lead, mercury, and alcohol; developmental and behavioral teratology; subclinical levels of toxic agents and their effects on morphological and behavioral changes associated with mental retardation. 6. Effects of malnutrition (protein, calorie, micronutrients) on intellectual, behavioral, social and physical development and the intergenerational effects of malnutrition. 7. Developmental pharmacology and psychopharmacology: medication used with MRDD populations. 8. Infectious diseases in the etiology, prevention and treatment of MRDD; neurological, neuropathological, behavioral and intellectual consequences of AIDS in children. 9. Diagnosis: development and application of biomedical and behavioral methods and measures; identification of children and infants at risk for MRDD. Early interventions for infants at risk to develop MRDD: research into the process of early intervention strategies. 10. Predictive and developmental studies of perinatal problems associated with MRDD: developmental studies of low birth weight, small for gestational age, preterm and neonatally sick infants; hypoxic or ischemic insults. 11. Psychobiological processes in MRDD of conditions such as autism and Rett syndrome using methods of behavioral genetics, embryology and teratology, developmental neuroscience and psychophysiology. 12. Psychological processes in MRDD: studies of cognitive and information processing; attention and perception; sensory and motor development; family, social and affective behavior; and motivation and personality. 13. Behavioral analyses: manipulations of interaction between behavior and environments of individuals with MRDD to reduce problem behaviors, facilitate vocational training, improve social and self-help skills, and increase acquisition of adaptive behaviors. 14. Family and community studies: parent-child and family interactions; sexual behaviors; family structure and demographic variables, including ethnic minority families with members with MRDD; family and community factors influencing developmental outcomes and adjustment; community resources; caregiver behavior; and social support networks. 15. Language and communication of MRDD populations: studies on development of alternative communication systems; ontogeny of linguistic processes. 16. Learning disabilities, dyslexia, and attention deficit disorder. 17. Residential, educational, and occupational settings throughout the life-span: effects on behavior and adjustment of MRDD individuals; learning and social behavior in educational settings; adaptation to residential environments; aberrant behavior, including stereotypies, destructive behavior, and self-injury. 18. Socioeconomic status, ethnicity, and ecological processes: interaction of MRDD individuals in multiple settings (naturalistic observation); ethnographic research; life history reporting; systematic observation of specific activities. 19. Epidemiology of MRDD: analytic and case-control studies of etiology; prevalence; follow-up of outcomes. 20. Behavior and life-styles that could affect mortality and morbidity. STUDY POPULATIONS NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy requires applicants for NIH grants that include clinical research 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 which 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 and 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 must 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 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). In that case, the rationale for studies on single minority population groups should 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 the applicants. If the required information is not contained within the application, the application will be returned. 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 reflected in assigning the priority score to the application. In addition, NIH funding components will not award grants or cooperative agreements that do not comply with these policies. Because P30 funds in general do not directly support research projects, the issue of minority/gender representation will need to be addressed at the individual project level (i.e., R01 level). However, the application will specifically need to address these issues for any New Program Development projects or core units that focus on subject recruitment. LETTER OF INTENT If an investigator is satisfied that his/her institution meets the qualifications prescribed and elects to apply for a Mental Retardation Research Center (P30), a letter of intent may be submitted to the MRDD Branch at the address given below by April 16, 1993. The letter of intent should include a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of other key personnel and participating institutions, the core unit directors and Principal Investigators of the research projects that would use the core units, 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 evaluating relevance to MRDD and in planning for the review of applications. The letter of intent is to be sent to: Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 APPLICATION PROCEDURES The applicant is to submit the application using PHS 398 (rev. 9/91). Application kits containing this form and the necessary instructions are available from most institutional offices of sponsored research; 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 NIH program administrator named below. The NICHD recommends that the application be developed in consultation with the MRDD Program staff, who will provide whatever guidance is possible and appropriate in relation to both scientific and administrative issues. Applicants for P30 Mental Retardation Research Center grants must propose a program with a theme relevant to the mission of the MRDD Branch as outlined above. The program should consist of at least 10 externally funded research projects grouped according to relevant topics. These projects must be of high quality, providing a multidisciplinary approach to the problem(s) being investigated. Each project is to be summarized in accordance with the NICHD P30 Center Core Grant Guidelines. The MRRC Director should be a scientist or science administrator who can provide effective administrative and scientific leadership. The Director will be responsible for the organization and operation of the MRRC and for communication with the NICHD on scientific and operational matters. Scientific personnel and institutional resources capable of providing a strong research base in the fields specified must be available. In addition, the institution and pertinent departments have to show a strong commitment to the center's support. Such commitment may be provided as dedicated space, salary support for investigators, dedicated equipment, or other financial support for the proposed MRRC. Each core unit proposed for funding under the MRRC grant must be utilized by at least three federally funded research projects, at least one of which is funded by the MRDD Branch of the NICHD, exclusive of research contracts, training grants, interagency agreements, and NIH-supplemental projects funded by other agencies. Program staff will make exceptions to this requirement in instances where research relevant to MRDD is assigned elsewhere within the NICHD. Subprojects within a program project (POl) will be considered as individual projects comparable to an ROl. A detailed description of each core unit proposed as part of the center must be provided with detailed budget and budget justification. A scientist must be named as responsible for each core unit proposed. The description of the core units proposed should include a rationale to show how they will support the research effort in a cost effective manner. Facilities must be available for the primary needs of the MRRC Program and require no more than modest alteration and/or renovation. Funds for new construction will not be provided. Promoting interdisciplinary collaboration among scientists working within a Center is a major goal of the MRRC Program. Each MRRC applicant should submit a plan, as part of the application, to assure continuing interaction among participating scientists from different disciplines. Another goal of the MRRC Program is to attract scientists to the field of mental retardation research. Therefore, where appropriate, the applicant may request "New Program Development" funds for direct research support of one or more projects, not to exceed a total of $50,000 per year or 10 percent of total direct cost, whichever is less. Such funds might serve to attract new investigators to the Center, to develop a new area or program of research, or to facilitate the development of newly trained investigators' research programs. New Program Development projects should be comparable to ROl research applications in their detail and development. Each such project can provide support for only two years for any one investigator. It is a major goal of the NICHD to promote active collaboration among MRRCs. To accomplish this goal, the successful applicants will be encouraged to participate in the collaborative efforts of established MRRC programs. Some consideration should be given, in planning the program, to potential collaborative studies and projects that might be proposed for the MRRC network. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. 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. Applications must be identified by checking the YES box in item 2a on the face page of the application and entering the words "In response to RFA HD-94-03, Mental Retardation Research Centers," and then insert P30 in Item 2b. In addition, a brief cover letter may accompany the application indicating that it is in response to this RFA. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, a copy of the cover letter and two additional copies of the application must also be sent to: Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E-03 Bethesda, MD 20892 Applications must be received by July 16, 1993. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness to the RFA. Incomplete applications will be returned to the applicant without further consideration. Under certain circumstances, applications may be triaged by a peer review group on the basis of relative competitiveness. In that case, the NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Applications judged to be competitive will undergo further scientific merit review. Applications that are complete and responsive will then be evaluated for scientific and technical merit by the NICHD Mental Retardation Research Committee at its March 1994 meeting, in accordance with the criteria stated below. Because a site visit is not a prerequisite for MRRC consideration, each application should be thorough and complete enough to stand on its own. The second-level review will be made by the National Advisory Child Health and Human Development Council at its June 1994 meeting. The anticipated date of award is August 1, 1994. REVIEW CRITERIA Criteria for the initial review of applications include: o scientific, technical, or medical significance of the application; o qualifications and research experience of the Principal Investigator and scientific collaborators; o scientific and administrative leadership of the Principal Investigator; o quality of proposed core facilities; o availability and quality of resources and research environment; o quality and relevance to mental retardation of research projects that will be using the core facilities; o plans for interdisciplinary/multidisciplinary collaboration; o cost-effectiveness of the proposed MRRC; o institutional commitment; o appropriateness of the proposed budget; o adequacy of plans for the protection of human subjects; o adequacy of plans to protect against or minimize adverse effects on animals; o inclusion of women and minority subjects in research. AWARD CRITERIA In addition to the scientific and technical merit of the application, other factors will be considered in making the awards. Among these are: o centers addressing research areas of high programmatic interest to the MRDD Branch, the CRMC, and NICHD; and research areas targeted by Congress; o availability and quality of resources, especially institutional commitment and support; o access to unique populations; o potential to increase productivity and quality of research within the center, and stimulate interdisciplinary/multidisciplinary collaborations; o providing unique resources for the use of other Centers and the greater research community; and o cost-effectiveness of the core facilities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues may be directed to: Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 Inquiries regarding fiscal matters may be directed to: Mr. Edgar D. Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A-17 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865 Research for Mothers and Children. Awards will be made under the authority 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. $$XID RFA HD93013 HD-93-013 P1O1 *************************************** TRANSGENIC MOUSE SPERM CRYOPRESERVATION NIH Guide, Volume 22, Number 11, March 19, 1993 RFA: HD-93-013 P.T. 34; K.W. 0755050, 0780005 National Institute of Child Health and Human Development Letter of Intent Receipt Date: July 1, 1993 Application Receipt Date: August 19, 1993 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites research grant applications for the support of investigations into the basic cryobiology of mouse sperm, which may lead to improved methods of cryopreservation of transgenic material in mouse sperm. Two NIH conferences have recommended that cryopreserved mouse sperm be explored as a repository for transgenic material. 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), Transgenic Mouse Sperm Cryopreservation, is related to the priority area of family planning. 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 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private. Minority individuals, persons with disabilities, and women are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the NIH individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest expected award date is April 1, 1994. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FUNDS AVAILABLE It is expected that up to four new applications will be funded, within the total cost limit of $400,000 available for the first year. 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 NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background In recent years it has become possible to make specific additions or alterations to the genetic material of organisms in order to study the effect of the change on development, function, or evolution of disease processes. These changes can be maintained in vivo by propagating the altered, so-called "transgenic," organisms. The use of transgenic animals to detect and manipulate key genes in mammalian development, as well as those relevant to human diseases, has grown explosively with the refinement and wide availability of the technology. The mouse has been the premier species, because of its well-characterized genetic makeup and ease of use in the laboratory. To date, the preservation of most transgenic lines of mice has been done with cryopreserved mouse embryos, or by maintaining breeding colonies of living transgenic mice. However, these methods are expensive, labor-intensive, and/or technically demanding. An NICHD conference on "Transgenic Technology in Medicine and Agriculture" was held in December 1988. A related conference was held in November 1990 by the National Center for Research Resources (NCRR) on "Development of Transgenic Animal Model Resources." Both of these conferences recommended the development of alternative strategies for a repository of transgenic material. Improved preservation of animal genetic resources through cryopreservation was also recommended in the 1990 Report of the Committee on Preservation of Laboratory Animal Resources, Institute of Laboratory Animal Resources, Commission of Life Sciences, National Research Council. A scientifically attractive and cost effective strategy is use of cryopreserved sperm. However, while cryopreservation techniques for sperm have been used with some success for other mammalian species, for example, the bovine, and to a degree, the human, the viability of mouse sperm after cryopreservation is poor. Some preliminary attempts using empirical methods to cryopreserve mouse sperm have been made, but the literature to date is contradictory. Thus, this RFA is intended to stimulate research in the basic cryobiology of mouse sperm, with consequent development of cryopreservation methodology having a rigorous scientific foundation. The eventual benefit to the field and to the public is anticipated to be the optimization of the procedures necessary to generate a mouse sperm repository for preservation of transgenic material. Objecives The long-term goal of this initiative is to support and encourage research on improving the success and reliability of mouse sperm cryopreservation. It is generally agreed that an important approach to this goal is to gain a better understanding of mouse sperm physiology as it pertains to resistance to cryodamage. Thus, it is the intent of this RFA to support research on the basic cryobiology of mouse sperm, with particular emphasis upon those physiological aspects that are substantially related to the cryobiological properties of these cells. Since there is a practical overall goal of this initiative, however, it is expected that responsive applications would not only conduct cryobiological experiments on mouse sperm but also conduct assessments of viability and/or biological function. For the purpose of this RFA, basic physiology of mouse sperm related to cryobiology would include, but not be limited to, the following topics: o Osmotic and hydrologic properties o Membrane physiology o Organelle physiology o Intracellular biochemistry as they apply to cryopreservation research. Assessments of potentially enhanced viability and biological function of thawed, cryopreserved, mouse sperm would include, but not be limited to, the following monitoring parameters: o Acrosome reaction o Motility o Fertilizing ability o Pregnancy outcome o Chromosomal or genetic integrity LETTER OF INTENT Prospective applicants are strongly encouraged, but not required, to submit, by July 1, 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 allows NICHD staff to estimate the potential review workload and to avoid conflict of interest circumstances in the review process. The letter of intent is to be sent to Dr. Donna L. Vogel at the address listed under INQURIES. 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 business offices; 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. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. 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 the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03 Bethesda, MD 20892 Applications must be received by August 19, 1993. If an application is received after that date, it will be returned to the applicant. 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 not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NICHD 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, it will be returned to the applicant, who may then submit it to DRG for review in competition with unsolicited applications at the next available review cycle. Responsive applications may be triaged by a peer review group to determine their relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further evaluation for scientific merit. 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 NICHD. The second level of review will be provided by the National Advisory Child Health and Human Development (NACHHD) Council. Review criteria for RFAs are generally the same as those for unsolicited research grant applications, including: 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, and of collaborators, if applicable; o adequacy of time and effort dedicated to the project; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; AWARD CRITERIA The earliest anticipated date of award is April 1, 1994. Funding decision will be based on peer review and NACHHD Council recommendations, program relevance, and availability of funds. In some cases, if the proposed research has relevance to the research program of the National Center for Research Resources (NCRR) as well as that of the NICHD, the application may be dually assigned to, and considered for funding by, the NCRR. Any such assignment will be made independently of peer review procedures. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding scientific issues and address the letter of intent to: Donna L. Vogel, M.D., Ph.D Center for Population Research National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Direct inquiries regarding fiscal matters to: Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8B17 Bethesda, MD 20892 Telephone: (301) 496-5481 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. 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 12374 or Health Systems Agency review. $$XID RFA AES93024 CA/ES-93-024 P1O1 *********************************** ENVIRONMENTAL FACTORS AND BREAST CANCER IN HIGH-RISK AREAS NIH GUIDE, Volume 22, Number 11, March 19, 1993 RFA: CA/ES-93-024 P.T. 34; K.W. 0715035, 0725000, 0785055, 0411005, 0725020 National Cancer Institute National Institute of Environmental Health Sciences Letter of Intent Receipt Date: April 16, 1993 Application Receipt Date: May 20, 1993 PURPOSE The Extramural Programs Branch, Division of Cancer Etiology, National Cancer Institute (NCI) and the Division of Extramural Research and Training, National Institute of Environmental Health Sciences (NIEHS) invite grant applications for innovative epidemiologic studies to better understand the etiology of breast cancer in high risk areas including Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington, DC. These studies are to be designed to take known risk factors into consideration and must focus on markers or indicators of environmental exposures that may influence geographic differences in rates and temporal changes in incidence and mortality. 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), Environmental Factors and Breast Cancer In High-Risk Areas, is related to the priority area of cancer. Potential applicants may obtain a copy of a "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 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit institutions, public and private, such as colleges, universities, hospitals, research laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from or involving minority institutions, individuals, and women are encouraged. MECHANISM OF SUPPORT This RFA will be supported through the NIH research project grants (R01). Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. It is anticipated that the average award will be approximately $250,000 total costs. This RFA is a one-time solicitation. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years. Competitive continuation applications will compete with all other unsolicited applications and be reviewed by a Division of Research Grants study section. If the NCI and the NIEHS determine that there is a sufficient continuing program need, they may announce a request for new and renewal applications. FUNDS AVAILABLE Approximately $1.0 million per year in total costs for four years will be committed by the NCI to specifically fund applications which are submitted in response to this RFA. In addition, $250,000 will be committed by the NIEHS to fund at least one application. The expected number of awards is three to five. This funding level 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 NCI and the NIEHS, the award of grants pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Geographic variation in breast cancer incidence and mortality rates has been well documented, both internationally and within the United States. In particular, higher rates of breast cancer have been described for much of the northeastern and middle Atlantic parts of the United States as compared to other regions of the country. At least some of this variation may be explained by differences in the population distribution of known breast cancer risk factors, especially menstrual and reproductive variables, and possibly dietary, nutritional and other lifestyle factors. However, there are concerns that environmental hazards may influence the geographic distribution of breast cancer. In particular, questions have been raised about the possible effect of pesticides, automobile exhausts, water contaminants, landfills, electromagnetic fields, heterocyclic amines in cooked foods, other dietary factors and other environmental and occupational exposures on breast cancer risk. Biologic data relating environmental pollutants to breast cancer risk from studies in humans or animals are sparse. One recent study, for example, reported higher levels of dichlorodiphenyldichloroethylene (DDE) in specimens of breast cancer than in breast tissue from women with benign breast disease. Questions on possible environmental hazards might be resolved by epidemiologic studies incorporating biologic probes. Results of such studies could address public concerns, and provide new insights into the environmental determinants of breast cancer and the means of prevention. This RFA responds to the FY 1993 Senate Appropriations Subcommittee Report for NIH which specifies that "NCI is directed to conduct a study with four years of follow-up to determine the factors contributing to the high breast cancer mortality rates in Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington, DC. NCI is to develop a plan for conducting the study and provide it to the House and Senate Appropriations Committees, the House Committee on Energy and Human Resources and the Senate Committee on Labor and Human Resources by July 1, 1993. $1 million is provided to fund this study." In addition, this RFA relates to the NIH Strategic Plan in the areas of Women's Health and Population-Based Studies. Research Goals and Scope This RFA encourages applications for epidemiologic studies of breast cancer that include assessment of markers or indicators of environmental or occupational exposures, and include persons residing in the high-risk areas of Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington, DC. These studies are to be designed to take known risk factors into consideration while focusing on exposures that may account for geographic differences in rates, as well as temporal changes in incidence and mortality. Investigators must include innovative approaches to the quantitation of environmental and/or occupational exposures and the evaluation of biologic levels in exposed persons. The purpose of this initiative is to stimulate innovative epidemiologic research into the origins of breast cancer. Collaborations of multiple disciplines and research institutions are particularly encouraged. Whenever possible, research designs should make use of existing resources, such as specimen repositories. Investigators may propose studies for evaluating the mechanisms by which environmental, nutritional, or occupational exposures could act in the initiation or promotion of breast cancer, such as through effects on hormonal or metabolic pathways. Projects should be proposed as traditional R01s. Proposals may build upon ongoing research projects, utilizing already collected specimens or epidemiologic data. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF FEMALES 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 which 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/ethnic group, 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 application form PHS-398 in the Research Plan, 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 should be provided. For the purpose of this policy, clinical research includes 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. If the required information is not contained within the application, the application will be returned. 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. LETTER OF INTENT Prospective applicants are requested to submit, by April 16, 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 names 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 NCI staff to estimate the potential review workload and to avoid conflict of interest in review. The letter of intent is to be sent to Dr. A.R. Patel at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91) available at most institutional offices of sponsored research 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. The format and instructions applicable to regular research grant applications must be followed. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, case, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. The RFA label available in application form PHS 398 (rev. 9/91) 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 be not reach the review committee in time for review. In addition, the number and title of the RFA must be typed on line 2a of the face page of the application and YES must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to the Division of Research Grants at the address below. The photocopies must be clear and single sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, applicants must send two additional copies of the application to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard Executive Plaza North, Room 636 Rockville, MD 20892 Failure to submit these copies may delay the review and subsequent possible consideration of an application for award in FY 1993. Applications must be received by May 20, 1993. If an application is received after that date, it will be returned without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA which is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Preliminary evaluation for responsiveness to the RFA is an NCI/NIEHS program staff function. If an application is judged to be nonresponsive, the applicant will be contacted and given an opportunity to have it considered along with other unsolicited grant applications received by NIH at the next review cycle. Those applications judged to be responsive to this solicitation will be reviewed by an appropriate review group convened by the Division of Extramural Activities, NCI. The initial review will be for scientific merit. The second level of review by the National Cancer Advisory Board and the National Advisory Environmental Health Sciences Council will consider the special needs of the Institute and the priorities of the Institutes. Review criteria for RFAs 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. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each scored application. AWARD CRITERIA The earliest anticipated date of award is September 30, 1993. Applications will compete for available funds with all other approved applications. The following will be considered for making funding decisions: o quality of the proposed project as determined by peer review; o reasonableness of the budget in comparison with other applications; o program balance among research areas. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: A.R. Patel, Ph.D. or Kumiko Iwamoto, M.D. Division of Cancer Etiology National Cancer Institute 6130 Executive Boulevard Executive Plaza North, Suite 535 Rockville, MD 20892 Telephone: (301) 496-9600 Dr. William A. Suk Division of Extramural Research and Training National Institute of Environmental health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-0797 Direct inquiries regarding fiscal matters to: Ms. Katherine Schulze Grants Administration Branch National Cancer Institute 6120 Executive Boulevard Executive Plaza South, Suite 243 Rockville, MD 20892 Telephone: (301) 496-7800, ext. 16 Mr. David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.393 and 93.894. 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 Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health System Agency review. From owner-sci-resources@net.bio.net Mon Mar 22 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: subj NIH Guide, vol. 22, no. 11, pt. 2, 19 March 1993 Message-ID: Date: 23 Mar 93 23:28:09 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1246 $$XID NIHGUIDE 19930319 V22N11 P2O2 ************************************ psychosocial risk factors (e.g., psychosocial epidemiology), (2) the development, maintenance, and change of health-related behaviors, (3) the basic biobehavioral mechanisms, (4) the behavioral and social interventions to prevent and treat illness or to promote health, and (5) the effects of health upon behavior. Psychosocial geriatrics research addresses these issues by undertaking the development and integration of social/behavioral and biomedical science knowledge relevant to health promotion and the prevention and treatment of disease in the middle and later years. The pathways linking health and behavior are of special concern, including the sociocultural environment (e.g., health and social policies), psychosocial mediators (e.g., reactions to illness, sense of control, stress, coping) and physiological mediators (e.g, neuroendocrine or immune functioning). Research on the full range of health and illness behaviors are relevant to this announcement. Health behaviors include self care, informal or lay care, and formal care taken to improve health and functioning of people as they grow older. Illness behaviors are concerned with how older individuals monitor their bodily functioning; how they define and interpret symptoms perceived as abnormal; whether they consult with non-professionals, relatives, and friends; whether they take or fail to take remedial action, utilize formal health-care systems, or comply with prescribed regimens; and how they approach death. The following are offered as illustrations of appropriate topics for research. Accepted referral guidelines will be followed in assigning applications to NIA or to other Institutes. Applications need not, however, be limited to these issues. o Nature and Distribution of Health Behaviors and Attitudes How do attitudes and behavior change as people age? How and under what specific conditions do the health behaviors, attitudes, beliefs, and knowledge of older people vary by sex, education, race, or ethnic background? How do they vary from one type of society to another? Or from one cohort to another as society changes? How are particular health behaviors and attitudes of older people derived from cultural explanations of symptoms? From popular stereotypes of inevitable aging decline? From their earlier illness experience? From their intuitive models of their own bodily functioning? From the mass media? How do social conditions and social relationships at work, in the family, and in the community influence the development and maintenance of health behaviors and attitudes as people grow older? o Relation between Health Attitudes and Behaviors How do older people's beliefs about the nature of particular illnesses affect the preventive behaviors in which they engage? How do self assessments of their health affect their behavioral functioning in activities of daily life? How and to what extent can awareness of healthful practices be converted into sustained health behaviors? How do older people's use of self care and reliance on family or significant others increase or reduce their demand for formal health care services? o Linkages between Health Behaviors and Attitudes and Health-related Outcomes What psychological mechanisms (e.g., self-esteem, sense of personal control, forms of coping) link particular health behaviors and attitudes to functional health or disease outcomes in old age? What biological mechanisms and age-related changes (e.g., in neural, immunological, endocrine, and other physiological systems) link particular health behaviors and attitudes to functioning health or disease outcomes in old age? What social and behavioral interventions can increase older people's health promoting attitudes and behaviors and improve their health and functioning? o Methodological issues What measures of health behaviors and attitudes can be devised to improve predictions of health outcomes of older patients? How well do behavioral measures, as compared with conventional biological indicators, predict health outcomes? How can measures of health quality of life be adapted for use in cognitively or physically ill older populations? How can multivariate methods of longitudinal and cohort analysis be used to study age-related changes and stabilities in health attitudes and behaviors as they relate to health outcomes? How can methods currently used in other areas of behavioral research (e.g., in communications research or operant conditioning) be adapted for modifying older people's health behaviors and attitudes? 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 which 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 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 Applicants are to use the research grant application form PHS 398 (rev. 9/91) for research project grants and PHS 416-1 (rev. 10/91) for Individual Fellowships. Applications are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone 301-496-7441. Complete item 2a on the face page of the application indicating that the application is in response to this announcement and print (next to the checked box) Psychosocial Geriatrics Research: Health Behaviors and Aging. Five legible copies and the original must be mailed when using the PHS 398 application. The original and two legible copies must be mailed when using the PHS 416-1 application. The original and all copies must be mailed to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned to the appropriate group for initial review in accordance with the usual PHS peer review procedures. The review criteria are the traditional considerations underlying scientific merit. Applications will be reviewed for scientific and technical merit by an appropriate initial review group; second-level review will be by the appropriate national advisory council. Second-level review of individual fellowship applications will be conducted by the appropriate Institute Executive Group. Applications compete on the basis of scientific merit. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NIA. 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 INQUIRIES The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Marcia G. Ory Behavioral And Social Research Program National Institute on Aging Gateway Building, Room 2C234 Bethesda, MD 20892 Telephone: (301) 496-3136 Other Interests in This Research Area Other PHS institutes and agencies are also interested in research dealing with health-related behaviors and attitudes of older adults, their families, and significant others, that can affect health and functioning as people grow older, including the Agency for Health Care Policy Research, the National Center for Nursing Research, the National Institute of Mental Health, and the General Clinical Research Centers Program (GCRC). The GCRC Program supports inpatient and outpatient research facilities, along with specially trained research nurses, research dietitians and other paraprofessionals to host medical research, including research on behavioral aspects of aging. Additionally, most GCRCs are equipped with computerized data management capabilities, as well as with biostatisticians. Applicants from institutions that have a GCRC funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. Direct inquiries regarding fiscal matters to: Ms. Linda Whipp Grants 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, Aging Research. 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 Background readings useful for exploring this area of psychosocial geriatrics research include the following: Ory, MG, Abeles, RP, and Lipman, PD. (Eds.) 1992. Aging, Health, and Behavior. Newbury Park, CA: Sage Publication, Inc. Riley, MW, Matarazzo, JD, and Baum, A. (Eds.) 1987. Perspectives in Behavioral Medicine: The Aging Dimension. Hillandale, NJ: Lawrence Erlbaum. U. S. Department of Health and Human Services. 1990. Promoting Health/Preventing Disease: Year 2000 Objectives for the Nation. Washington, DC: Government Printing Office. $$P1 END ************************************************************ $$P2 BEGIN PA-93-065 ************************************************ NUTRIENT ANTIOXIDANTS, CELLULAR METABOLISM AND FUNCTION NIH GUIDE, Volume 22, Number 11, March 19, 1993 PA NUMBER: PA-93-065 P.T. 34; K.W. 0710095, 1002004, 0765020 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The purpose of this Program Announcement (PA) is to encourage research grant applications related to nutrient antioxidants, their roles and interactions in cellular mechanisms, and their protection against cellular damage. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieve the health promotion and disease prevention objectives of "Healthy People 2000," a PHS led national activity for setting priority areas. This PA, Nutrient Antioxidants, Cellular Metabolism and Function, is related to the priority area of diabetes and other chronic disorders. 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 20402-9325 (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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISMS OF SUPPORT Support of this program will be primarily by research project grants (R01) and FIRST awards (R29). Deadlines for new grants are February 1, June 1, and October 1, and for competing and revised grants are March 1, July 1, and November 1. Because the nature and scope of the research applications submitted in response to this Program Announcement may vary, it is anticipated that the size of award will vary also; however, the average size is estimated to be approximately $200,000, total costs. RESEARCH OBJECTIVES The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) supports basic and clinical studies related to the requirements, bioavailability, and metabolism of nutrients and other dietary components at the organ, cellular and subcellular levels in normal and diseased states. Areas of research interest include the understanding of the physiological, biochemical, and molecular factors and mechanisms of action/interaction of nutrients, including nutrient antioxidants, within the body. Nutrient antioxidants are now believed to protect against free radical cellular damage caused by excessive oxidative reactions. Examples of damage caused by excessive concentration of various forms of oxygen and of free-radical activity include polysaccharide depolymerization (carbohydrate damage), oxidation and inactivation of sulfhydryl-containing enzymes (protein damage), and separation of DNA strands, cross-linkage, or base hydroxylation leading to mutations and inhibition of genes that are responsible for protein, nucleotide, and fatty acid synthesis (nucleic acid damage). Perhaps the best understood mechanism of free radical-induced cell injury relates to peroxidation of polyunsaturated fatty acids in organelles and plasma membranes (lipid damage). The effects of several nutrient antioxidants at various steps in lipid peroxidation have been well-studied. Nevertheless, the overall role of antioxidants in cellular regulation and the balance between antioxidative and oxidative processes in cells under various states need further study. Oxidized and peroxidized compounds may be causally related to a variety of chronic diseases. For example, free radicals appear to play a role in the promotion and/or initiation of some cancers (such as breast, cervical, lung, and gastrointestinal cancers), cardiovascular diseases, cataracts, and degenerative diseases of the central nervous system. In addition, there is substantial evidence that indicates a role of free radical-induced cell injury in the aging process itself. While the list of chronic diseases believed to have free radical or oxidant involvement is growing, in most cases it remains unclear whether this involvement is a cause or a result of the disease. However, epidemiological and clinical studies have suggested that nutrient antioxidants may reduce the risk of these diseases. Vitamin C, vitamin E and/or beta-carotene and other carotenoids appear to be most effective. Other nutrients (zinc, copper, manganese, and selenium) associated with antioxidant enzymes may also be involved in protection against degenerative and chronic diseases since dietary deficiencies of minerals needed for synthesis of antioxidant enzymes can have a deleterious effect on enzyme formation. Relevant mechanisms focusing on the metabolism of nutrient antioxidants as well as their effect on cellular functions and metabolic processes need further study. In addition, it now appears that the status of nutrient antioxidants may be influenced by other nutrient factors. For example, increased levels of omega-3 fatty acids in the diet appear to result in a decrease in vitamin E (alpha-tocopherol) levels. Such interactions and their metabolic consequences need to be delineated at the cellular and subcellular levels. The mechanisms, location, and interactive metabolic effects of supplemental nutrient antioxidants on gastrointestinal absorption and transport, and other cellular processes need further study, for individual nutrients as well as for their complementary and synergistic roles. Other Institutes that have significant interests in nutrient metabolism and antioxidant research include the National Institute on Aging (NIA), the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI), the National Eye Institute (NEI), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Neurological Diseases and Stroke (NINDS), the National Institute of General Medical Sciences (NIGMS), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and the National Institute of Child Health and Human Development (NICHD). Areas of research of particular interest to the NIDDK focus on the normal and abnormal metabolism of nutrient antioxidants and resultant effects on oxidative processes (as well as other metabolic activities) within the cell. Complementary functions and the synergistic interactions between nutrient antioxidants are also of special interest, especially at those levels which may exceed normal nutritional requirements. Also of great importance are studies that focus on determination of proper balances between nutrient antioxidants and beneficial and deleterious levels of free radicals. Other specific examples of research objectives appropriate for inclusion in applications responsive to this program announcement include, but are not limited to, studies on: o nutrient antioxidant effects on impaired cellular energy systems including effects on the mechanisms surrounding glycolytic synthesis of ATP and on oxidative phosphorylation after free radical impairment; o nutrient antioxidant prevention of oxidant damage to cellular DNA, including effects on participation of the hydroxyl radical, DNA base hydroxylation by various oxidants, DNA damage by products of lipid peroxidation, and ultimate effects on mutagenesis and cell death; o nutrient antioxidant influence on peroxidation of polyunsaturated fatty acids in cellular organelles and plasma membranes; o nutrient antioxidant role in prevention of oxidation of sulfhydryl-containing enzymes and in prevention of polysaccharide depolymerization; o influence of nutrient antioxidants, including interaction with other dietary factors, on gastrointestinal absorption, transport and other cellular functions. While the major emphases in this effort will be on vitamins C and E, and on beta-carotene and other carotenoids, research support will not be limited to these antioxidants. Studies on nutritional co-factors of antioxidant enzymes are also important because dietary deficiencies of minerals needed for enzyme synthesis can have a deleterious effect on proper oxidant/antioxidant balance and subsequent extent of free-radical activity. Furthermore, the interactive and synergistic effects of all nutrient antioxidants will be a critical area of research. 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 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 as indicated in the application kit. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. 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 449, Bethesda, MD 20892, telephone 301/496-7441. The title and number of this announcement must be typed in line 2a on the face page of the application. The completed original application 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** Applications for R29 awards must include at least three letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW PROCEDURES Applications will be assigned to initial review groups and Institutes/Centers on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council or board. Applications for supplements to ongoing awards will be reviewed according to procedures applicable to the mechanism of the ongoing award. AWARD CRITERIA Applications will compete for available funds with all other approved applications. 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 INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael K. May, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A18A Bethesda, MD 20892 Telephone: (301) 496-7121 (594-7520 after 3/26/93) FAX: (301) 402-1278 Direct inquiries regarding fiscal matters to: Ms. Paulette Badman Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 496-7467 (594-7543 after 3/26/93) FAX: (301) 496-9721 (594-7594 after 3/26/93) AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. 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. $$P2 END ************************************************************ $$P3 BEGIN PA-93-066 ************************************************ VESTIBULAR REFLEXES DURING NATURAL MOTION NIH GUIDE, Volume 22, Number 11, March 19, 1993 PA NUMBER: PA-93-066 P.T. 34; K.W. 0710050, 1002061, 0705070 National Institute on Deafness and Other Communication Disorders National Eye Institute PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Eye Institute (NEI) invite applications for the support of basic and applied studies seeking to characterize the vestibular reflexes that maintain binocular fixation on visual targets during locomotion and other volitional movements of the head and body. The NIDCD and the NEI share an interest in this area. The vestibulo-ocular reflex (VOR) is, at present, the most direct and accessible probe of vestibular function. This initiative seeks to establish the fundamental knowledge base that will lead to the development of clinical test protocols for assessing the vestibular system in vivo during natural motion. 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 (PA), Vestibular Reflexes During Natural Motion, is related to the priority area of physical activity fitness, unintentional injuries, occupational health and safety and clinical prevention services. 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 20402-9325 (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. Domestic applications may include international components. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanism of support for this program will be the National Institutes of Health (NIH) individual research project grant (R01). RESEARCH OBJECTIVES Background The VOR is driven by two types of head accelerations, angular, sensed by the labyrinthine semicircular canals, and linear, sensed by the otolithic organs. It is a rapid and robust reflex system that usually operates synergistically with the slower visual following reflexes to maintain a stable image on the retina over the broad range of trajectories, velocities and frequencies of head motion performed during daily living. By illustration, when subjects fixate on a target while walking, their VORs must produce compensatory eye movements to stabilize gaze in the face of linear and rotational (pitch) head motion in the vertical plane. The predominant frequencies of these natural head movements greatly exceed the frequencies assessed during conventional tests of vestibular function. Oscillopsia, the illusory movement of the stationary world caused by slippage of images on the retina during head movement, results from an inability of the vestibular gaze-stabilizing reflexes to compensate for head movement. It is a well-recognized symptom of low VOR gain associated with marked bilateral vestibular disease. Patients with oscillopsia are typically symptomatic during the head motion that accompanies locomotion. The face validity of assessing the vestibular reflexes during locomotion with vision fixed or during combined eye and head movements is apparent, since the vestibular system stabilizes gaze during active movement of the head, eyes, and body. Yet, most studies of the VOR have been performed with passive stimuli, by rotating subjects in the horizontal plane with both the head and body fixed. Furthermore, it has been estimated that as many as 50 percent of patients whose complaints suggest a high likelihood of vestibular pathology have normal vestibular test findings. Some of these undiagnosed patients would likely be identified by testing the system under its operational state of free motion. Study of the vestibular system in its operational state will enhance the understanding of this system in both health and disease. Scope This initiative seeks to establish the fundamental knowledge base that will ultimately lead to the development and expansion of much-needed clinical test protocols for assessing the image-stabilizing vestibular reflexes during locomotion and other volitional movements, such as gait transitions. Specifically, the goal of this project is to determine how the VOR generates compensatory eye movements to maintain binocular fixation on visual targets during the linear, angular and complex head motion associated with daily living. Such an approach to the evaluation of the balance-disordered patient will likely enhance the diagnostic efficiency of vestibular testing. Human and/or animal studies of the biophysical dynamics and underlying neural mechanisms of the VOR are sought. Research studies may include, but are not limited to, the topics listed below: o role of the vestibular system in the control of gaze stability during stance versus gait; o development of animal models for the study of the VOR during natural motion; o development of computational models relating the VOR during natural motion to its neural substrates; o role of the vestibulo-collic reflexes and head stabilization in gaze stability during motion; o coding and integration of vestibular, visual and proprioceptive signals in response to coacting linear and angular acceleration forces; o effects of vestibular system abnormalities on the VOR during natural motion. 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 which 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 must 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 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 should 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 application will be returned. 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 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 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 as indicated in the application kit. The receipt dates for applications 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 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. The completed original application 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** Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources (NCRR) may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator should be included with the application. REVIEW PROCEDURES Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. 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 INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Daniel A. Sklare, Ph.D. Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-3461 FAX: (301) 402-6251 Michael D. Oberdorfer, Ph.D. Strabismus, Amblyopia and Visual Processing Branch National Eye Institute Building 31, Room 6A-47 Bethesda, MD 20892 Telephone: (301) 496-5301 FAX: (301) 402-0528 Direct inquiries regarding fiscal matters to: Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-0909 Carolyn E. Grimes Extramural and Collaborative Program National Eye Institute Building 31, Room 6A48 Bethesda, MD 20892 Telephone: (301) 496-5884 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173 and No. 93.867. 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. $$P3 END ************************************************************ $$XID RFA NR93004 NR-93-004 P1O1 *************************************** TUBERCULOSIS: PREVENTION AND ADHERENCE INTERVENTIONS NIH GUIDE, Volume 22, Number 11, March 19, 1993 RFA: NR-93-004 P.T. 34; K.W. 0715165, 0755030, 0745027, 0745070 National Center for Nursing Research Letter of Intent Receipt Date: May 3, 1993 Application Receipt Date: June 22, 1993 PURPOSE The National Center for Nursing Research (NCNR) invites submissions of research grant applications to investigate strategies to help persons with or at risk of tuberculosis (TB) to understand the disease and its etiology, methods of transmission and control, and the importance of early and complete treatment. The purpose of this request for applications (RFA) is to develop and test interventions with a goal of (1) minimizing TB exposure, (2) increasing awareness of signs and symptoms of TB infection, or (3) promoting the correct use of prophylaxis, treatment and respiratory precautions. 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 RFA, Tuberculosis: Prevention and Adherence Interventions, is related to the priority areas of immunization and infectious disease. Potential applicants may obtain a copy of the "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 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. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to the present RFA may not exceed three years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Because the nature and scope of the research proposed may vary, it is anticipated that the size of the award will vary also. The anticipated average direct cost award per year will range from $150,000 to $180,000. The anticipated award date will be September 30, 1993. FUNDS AVAILABLE Approximately $500,000 in total costs for the first year will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that two to three applications will be funded for a three year period. 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 NCNR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Despite major advances in the understanding of the pathogenesis, detection and treatment of tuberculosis, the number of reported cases in the United States is increasing. Mutation of the tubercle bacillus resulting in multi-drug-resistant disease has created an alarming dimension to this public health problem. Social circumstances, including increases in poverty, homelessness, substance abuse, and the number of immunosuppressed HIV-infected individuals, have contributed to the epidemic. However, non-adherence with prescribed therapy and inadequate education of health professionals, patients, and the community also play an important role and are potentially amenable to nursing intervention. The goal of this initiative is to stimulate research testing nursing interventions designed to increase awareness of tuberculosis risk, prevention of transmission, and compliance with therapeutic regimens. Examples of studies that would meet this objective include, but are not limited to: o the development of innovative educational strategies using biological and behavioral outcome measures to reach populations with high disease prevalence o the development and testing of strategies that enable health professionals to target efforts to address personal, social, or cultural barriers to adherence o the testing of adherence interventions such as incentives, enablers, or regimen strategies that promote correct use of prevention precautions or treatment medications. Of special concern with this initiative are the populations highly vulnerable to tuberculosis: HIV infected, institutionalized, immigrant, economically disadvantaged, and homeless persons. The design and implementation of the intervention strategies must address the unique characteristics of the target population. Data collection instruments should be adapted to yield accurate and meaningful information tht will enhance the understanding of the constraints and opportunities among these vulnerable groups. Nursing practice offers many opportunities for interaction with persons at high risk for or infected with tuberculosis. Nursing investigations benefit from collaboration across disciplines, blending expertise from the biological, clinical and social sciences. Applications submitted in response to this initiative should reflect the multidisciplinary nature appropriate to the intervention being tested. 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 should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which 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/ethnic group. In addition, gender and racial/ethnic issues must 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 should 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 disease, 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 application will be returned. 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 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. LETTER OF INTENT Prospective applicants are asked to submit, by May 1, 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 consultants, the 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 NCNR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ethel B. Jackson, D.D.S. Office of Scientific Review National Center for Nursing Research Building 31, Room 5B25 Bethesda, MD 20892 Telephone: (301) 496-0472 FAX: (301) 480-4969 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 and 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. The RFA label available in the application form must be affixed to the bottom of the face page of the application. 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 the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to Dr. Ethel B. Jackson at the address listed under LETTER OF INTENT. If the applicant has an approved assurance covering the research, the applicant should provide it with the application. Certification of Institutional Review Board (IRB) approval is required, if humans are involved. These reviews and approvals should occur prior to submission of the application for award and the certifications should be submitted with the application. There is no 60 day grace period for RFAs. If humans will be subjects of the research at performance sites other than the applicant organization, the applicant must identify, in the application, the assurance status of each participant. Failure to provide required certifications in the application could result in delay of an award. Instructions regarding inclusion of human subjects are given on pages 22-23 and 25-28 of PHS 398 (rev. 9/91). Applications must be received by June 22, 1993. If an application is received after that date, it will be returned to the applicant. 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 not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. 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, NCNR 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 at the next review cycle. Applications may be triaged by an NCNR peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged 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. 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 NCNR. The second level of review will be provided by the NCNR advisory council. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o scientific and technical 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. AWARD CRITERIA The anticipated date of award is September 30, 1993. Decisions to make awards are based on the scientific merit of the application reflected in the priority score, availability of funds within the NCNR for this purpose, and NCNR research program priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. NCNR program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: June R. Lunney, Ph.D., R.N. Acute and Chronic Illness Branch National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 402-3290 (301/594-9606 after 03/25/93) Direct inquiries regarding fiscal and administrative matters to: Sally A. Nichols Grants Management Officer National Center for Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 496-0237 (301/594-9615 after 03/25/93) AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361 Nursing Research. 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. From owner-sci-resources@net.bio.net Mon Mar 22 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. 11, pt. 1, 19 March 1993 Message-ID: Date: 23 Mar 93 23:25:08 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1506 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 19930319 V22N11 P1O2 ************************************ X-comment: RFAs described: CA/ES-93-024, NR-93-004, HD-94-003, HD-93-013 NIH GUIDE - Vol. 22, No. 11 - March 19, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH INTERIM GUIDELINES FOR THE SUPPORT AND CONDUCT OF THERAPEUTIC HUMAN FETAL TISSUE TRANSPLANTATION RESEARCH National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** REVISING THE PHS 398, PHS 2590, PHS 416-1, AND PHS 416-9 GRANT APPLICATIONS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** INVESTIGATIVE GROUP FOR HEPATITIS MOLECULAR PATHOGENESIS, IMMUNOLOGY, AND VIROLOGY (RFP NIAID-DMID-94-04) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 ********************************************************** DATOS PSYCHIATRIC COMORBIDITY STUDY (RFP NIH-N01DA-3-6201) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R3 ********************************************************** ANALYTICAL CHEMISTRY AND STABILITY TESTING OF TREATMENT DRUGS (RFP NO1DA-3-8301) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R4 ********************************************************** IN VITRO BIOGENIC AMINE RECEPTOR TESTING FOR POTENTIAL COCAINE TREATMENT MEDICATIONS (RFP NO1DA-3-8302) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R5 05/20/93 ************************************************* ENVIRONMENTAL FACTORS AND BREAST CANCER IN HIGH-RISK AREAS (RFA CA/ES-93-024) National Cancer Institute National Institute of Environmental Health Sciences INDEX: CANCER; ENVIRONMENTAL HEALTH SCIENCES $$INDEX R6 06/22/93 ************************************************* TUBERCULOSIS: PREVENTION AND ADHERENCE INTERVENTIONS (RFA NR-93-004) National Center for Nursing Research INDEX: NURSING RESEARCH $$INDEX R7 07/17/93 ************************************************* MENTAL RETARDATION RESEARCH CENTERS (RFA HD-94-003) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R8 08/19/93 ************************************************* TRANSGENIC MOUSE SPERM CRYOPRESERVATION (RFA HD-93-013) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** PSYCHOSOCIAL GERIATRICS RESEARCH: HEALTH BEHAVIORS AND AGING (PA-93- 064) National Institute on Aging INDEX: AGING $$INDEX P2 ********************************************************** NUTRIENT ANTIOXIDANTS, CELLULAR METABOLISM AND FUNCTION (PA-93-065) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY $$INDEX P3 ********************************************************** VESTIBULAR REFLEXES DURING NATURAL MOTION (PA-93-066) National Institute on Deafness and Other Communication Disorders National Eye Institute INDEX: DEAFNESS, COMMUNICATIONS DISORDERS; EYE 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 ********************************************************** NIH INTERIM GUIDELINES FOR THE SUPPORT AND CONDUCT OF THERAPEUTIC HUMAN FETAL TISSUE TRANSPLANTATION RESEARCH NIH GUIDE, Volume 22, Number 11, March 19, 1993 P.T. 34; K.W. 0783005, 0755055, 0780005 National Institutes of Health The National Institutes of Health (NIH), in implementing the directive set forth in the following memorandum, announces interim guidelines for the support and conduct of therapeutic human fetal tissue transplantation research. quote: THE WHITE HOUSE WASHINGTON January 22, 1993 MEMORANDUM FOR THE SECRETARY OF HEALTH AND HUMAN SERVICES SUBJECT: Federal Funding of Fetal Tissue Transplantation Research On March 22, 1988, the Assistant Secretary for Health of Health and Human Services ("HHS") imposed a temporary moratorium on Federal funding of research involving transplantation of fetal tissue from induced abortions. Contrary to the recommendations of a National Institutes of Health advisory panel, on November 2, 1989, the Secretary of Health and Human Services extended the moratorium indefinitely. This moratorium has significantly hampered the development of possible treatments for individuals afflicted with serious diseases and disorders, such as Parkinson's disease, Alzheimer's disease, diabetes, and leukemia. Accordingly, I hereby direct that you immediately lift the moratorium. You are hereby authorized and directed to publish this memorandum in the Federal Register. (signed) William J. Clinton endquote On February 1, 1993, the Secretary of Health and Human Services carried out the President's directive ending the moratorium. The Secretary further directed the NIH to develop interim guidelines, based on the recommendations of the 1988 Human Fetal Tissue Transplantation Research Panel, to ensure that Federal funding of therapeutic human fetal tissue transplantation research does not encourage the choice of abortion. Accordingly, the National Institutes of Health has developed the following interim policy guidance to ensure that therapeutic human fetal tissue transplantation research projects supported or conducted by the NIH are carried out in accordance with the guidance provided by the Human Fetal Tissue Transplantation Research Panel and the Advisory Committee to the Director. Relevant citations of Federal regulations governing the protection of human subjects in research (45 CFR 46) are in parentheses. INTERIM GUIDELINES FOR THE CONDUCT OF THERAPEUTIC HUMAN FETAL TISSUE TRANSPLANTATION RESEARCH Separating Abortion from Research. o The decision to terminate a pregnancy and the abortion procedures should be kept independent from the retrieval and use of fetal tissue. (45 CFR 46 Subpart B) o The timing and method of abortion should not be influenced by the potential uses of fetal tissue for transplantation or medical research. (45 CFR 46 Subpart B) Prohibiting Payments and Other Inducements. o Payments and any other forms of remuneration, compensation or benefit associated with the procurement of fetal tissue should be prohibited, except payment for reasonable expenses occasioned by the actual retrieval, storage, preparation, and transportation of the tissues. (45 CFR 46 Subpart B; Also addressed in the National Organ Transplant Act). Informed Consent. o Potential recipients of such tissues, as well as research and health care participants, should be properly informed about the source of the tissues in question. o The decision and consent to abort must precede discussion of the possible use of the fetal tissue and any request for such consent that might be required for that use. o Fetal tissue from induced abortions should not be used in medical research without the prior consent of the pregnant woman. Her decision to donate fetal material is sufficient for the use of tissue, unless the father objects (except in the cases of incest or rape). (Uniform Anatomical Gift Act; also 45 CFR 46 Subparts A and B contain general requirements for informed consent, which may be relevant) o Consent should be obtained in compliance with State law and with the Uniform Anatomical Gift Act. (45 CFR 46 Subpart B) Prohibiting Directed Donations. o The pregnant woman should be prohibited from designating the transplant-recipient of the fetal tissue. o Anonymity between donor and recipient should be maintained, so that the donor does not know who will receive the tissue, and the identity of the donor is concealed from the recipient and transplant team. o Experimental transplants performed with fetal tissue from induced abortions provided by a family member, friend or acquaintance should be prohibited. Abiding by State Laws. o Researchers in States with statutes appearing to ban fetal tissue transplants should seek clarification of the law. (45 CFR 46 Subpart B, which also requires adherence to local laws) Ethical Review of Research. o Customary review procedures should apply to research involving transplantation of tissue from induced abortions. (45 CFR 46) Determining When Progress to Clinical Studies Is Justified. o Sufficient evidence from animal experimentation is needed to justify proceeding to human clinical trials. Acceptable preliminary data must be presented to an appropriate Institutional Review Board, NIH Initial Review Group, and National Advisory Council before Public Health Service funds would be available. (45 CFR 46 and current peer review process) DEVELOPMENT OF FINAL GUIDELINES The NIH is beginning to develop formal guidelines for this area of research. Until final guidelines are issued, the provisions outlined above will constitute the NIH's interim policy guidance for the support and conduct of therapeutic human fetal tissue transplantation research. Comments on this interim policy will be considered in the preparation of the final guidelines. This interim policy will be published in the Federal Register in the near future with a request for public comment. If the NIH reauthorization legislation now pending before Congress is enacted in its present form, additions to this interim policy would be necessary. INQUIRIES Comments and questions about the interim guidelines may be directed to: F. William Dommel, Jr., J.D. Senior Policy Advisor Office for Protection from Research Risks Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-7005 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** REVISING THE PHS 398, PHS 2590, PHS 416-1, AND PHS 416-9 GRANT APPLICATIONS NIH GUIDE, Volume 22, Number 11, March 19, 1993 P.T. 34; K.W. 1014006 National Institutes of Health A National Institutes of Health (NIH) committee, with representatives from within the Public Health Service, has begun work on revising the PHS 398 Research Grant Application (which includes the Institutional National Research Service Award), the PHS 2590 Noncompeting Continuation Research Grant Application, the PHS 416-1 Individual National Research Service Award, and the PHS 416-9 Noncompeting Continuation Individual National Research Service Award. The Committee welcomes any suggestions or comments from the scientific community or from other interested persons regarding ways to improve the application kits. Suggestions could concern items such as the clarity of the instructions, other support, structure of the scientific proposal, biographical sketch, and personnel information. INQUIRIES Send suggestions or comments by April 9, 1993, to: Ms. Barbara Wassell Project Clearance Liaison Division of Research Grants National Institutes of Health Westwood Building, Room 5 Bethesda, MD 20892 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIAID-DMID-94-04 ***************************************** INVESTIGATIVE GROUP FOR HEPATITIS MOLECULAR PATHOGENESIS, IMMUNOLOGY, AND VIROLOGY NIH GUIDE, Volume 22, Number 11, March 19, 1993 P.T. 34; K.W. 0710070, 1002045, 0765033, 0715125, 0755010 RFP AVAILABLE: NIAID-DMID-94-04 National Institute of Allergy and Infectious Diseases The Enteric Diseases Branch of the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), has a requirement for a group to perform independent and collaborative work on hepatitis viruses in model systems such as the woodchuck. The specific focus is on understanding infection and chronic disease, identifying parameters that determine the outcome of infection, i.e., recovery and chronicity, and developing/evaluating preventions and therapies. This contract is to perform the molecular and viral/host assays for both the independent and collaborative work in the woodchuck animal model for hepatitis B and D. The Division of Intramural Research has a requirement for a contractor to determine the presence and quantities of markers of human hepatitis viruses on samples generated by separate activities using primarily commercially available kits. The DMID part of this effort is Part I, and the DIR Portion is Part II. RFP No. NIAID-DMID-94-04 is now available. Responses are due by 4:30 pm on April 26, 1993. It is estimated that one contract for Parts I and II together or two separate contracts for Parts I and II separately will be awarded incrementally for a period of five years. Due to increased emphasis in vaccine programs, the Government reserves the right to make more than one award for Part I. Any responsible offeror may submit a proposal that will be considered by the Government. INQUIRIES To receive a copy of this RFP, supply this office with two self-addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing and addressed to: Mr. Carl Henn, Contracting Officer National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard Solar Building, Room 3C07 Bethesda, MD 20892 Interested organizations may request either a streamlined or full RFP package. If no selection is made, a streamlined version of the RFP will be provided. This includes only the Statement of Work, deliverable and reporting requirements, special requirements and mandatory qualifications, if any, and technical evaluation criteria. After examination of these documents, any organization interested in responding to this RFP must request the entire RFP in writing, by telephone or by FAX. These numbers will be provided with the streamlined version of the RFP. This advertisement does not commit the Government to award a contract. $$R1 END ************************************************************ $$R2 BEGIN NIH-N01DA-3-6201 ***************************************** DATOS PSYCHIATRIC COMORBIDITY STUDY NIH GUIDE, Volume 22, Number 11, March 19, 1993 RFP AVAILABLE: NIH-N01DA-3-6201 P.T. 34; K.W. 0404009 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations to conduct a large scale, complex multi-year study of comorbidity and impairment among drug abuse clients. In conducting this study, the contractor will initiate and complete a large and complex program, involving assessment of subjects participating in the Drug Abuse Treatment Outcome Study (DATOS), a NIDA-funded prospective multi-year study conducted under a contract with the Research Triangle Institute (RTI). The study will involve large-scale data collection of diagnostic information from clients/patients entering currently available drug abuse treatments. Major goals of the study are (1) to study the prevalence of comorbid disorders to determine the stability of psychiatric diagnoses in a drug addict population, and (2) to determine the reliability and validity of the psychiatric subscales included in the Drug Abuse Treatment Outcome Study (DATOS) instruments. It is anticipated that a three year cost-reimbursement type contract will be awarded. Estimated issuance date of RFP No. N01DA-3-6201 is March 22, 1993, and responses are due to be received in the Contracting Office approximately 45 calendar days thereafter. All responsible sources may submit a proposal that will be considered by the agency. Only written or facsimile requests for this RFP will be accepted. INQUIRIES Forward all requests to: Ms. Johnnie L. Rice, Contract Specialist National Institute on Drug Abuse 5600 Fishers Lane, Room 10-49 Rockville, MD 20857 FAX: (301) 443-7595 This advertisement does not commit the Government to make an award. $$R2 END ************************************************************ $$R3 BEGIN N01DA-3-8301 ********************************************* ANALYTICAL CHEMISTRY AND STABILITY TESTING OF TREATMENT DRUGS NIH GUIDE, Volume 22, Number 11, March 19, 1993 RFP AVAILABLE: NO1DA-3-8301 P.T. 34; K.W. 1003008, 0404009, 0755060 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having the capability to develop analytical methods, carry out quality control tests, and perform stability studies for the compounds and dosage forms to be used in the medications development program. The development of medications for the treatment of drug addiction is a major mission of NIDA. The NIDA has been providing potential treatment drugs to investigators for use in preclinical toxicology evaluation, pharmacological studies, and clinical trials. The treatment drugs include both bulk drug substances (e.g., ibogaine, buprenorphine, naltrindole) and dosage forms (e.g., buprenorphine alcoholic solution, 1-alpha-acetylmethadol concentrate, naltrexone sustained-release preparations). These drugs are acquired by the Government from private industry, Government contractors/grantees, or independent investigators. In order to ensure the identity, strength, quality and purity of these materials, the Government has been performing quality control tests before distributing them to the research community. The purpose of this procurement is to solicit a contractor to develop analytical methods, carry out quality control tests, dosage form preparation, and perform stability studies for the compounds and dosage forms to be used in the medications development program. The offeror is required to submit documentation of possession of a DEA research registration for Schedule I and II-V controlled substances with their response to the Request for Proposal (RFP). It is estimated that the RFP will result in a four-year incrementally funded completion-type contract with an option for a fifth year, as well as options for additional compound analysis and testing. Estimated issuance date of RFP No. NO1DA-3-8301 is March 22, 1993, and responses are due to be received in the Contracting Officer 45 calendar days thereafter. Written requests for copies of solicitations will be honored if received within twenty calendar days after issuance of the solicitation. 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 Requests are to be forwarded to: Brenda Brooks, Contract Specialist National Institute on Drug Abuse Parklawn Building, Room 10-49 5600 Fishers Lane Rockville, MD 20857 $$R3 END ************************************************************ $$R4 BEGIN N01DA-3-8302 ********************************************* IN VITRO BIOGENIC AMINE RECEPTOR TESTING FOR POTENTIAL COCAINE TREATMENT MEDICATIONS NIH GUIDE, Volume 22, Number 11, March 19, 1993 RFP AVAILABLE: NO1DA-3-8302 P.T. 34; K.W. 0760075, 0755010, 0404009 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 receptor assays to systematically define biochemical activities of compounds at these targets. These assays will be utilized to characterize potential cocaine abuse treatment agents. The ability of these compounds to bind in vitro to dopaminergic, serotoninergic, phencyclidine (PCP) and sigma binding sites will be investigated. The in vitro functional activity (i.e. agonist, antagonist, partial agonist) of these compounds at dopamine and serotonin sites will also be determined. The offeror is required to submit documentation of possession of a DEA Registration for Schedules II-V controlled substances with their response to the Request for Proposal (RFP). In addition, the contractor must be able to obtain a Schedule I DEA license. It is estimated that the RFP will result in a three and one-half year incrementally funded completion-type contract for a specific number of compounds, with options for additional compound testing. Estimated issuance date of RFP No. NO1DA-3-8302 is March 22, 1993, and responses are due to be received in the Contracting Office 45 calendar days thereafter. Requests for copies of solicitations will be honored if received within twenty calendar days after issuance of the solicitation. 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 Written requests are to be forwarded to: Brenda Brooks, Contract Specialist National Institute on Drug Abuse Parklawn Building, Room 10-49 5600 Fishers Lane Rockville, MD 20857 $$R4 END ************************************************************ $$R5 BEGIN CA/ES-93-024 FULL-TEXT *********************************** ENVIRONMENTAL FACTORS AND BREAST CANCER IN HIGH-RISK AREAS NIH GUIDE, Volume 22, Number 11, March 19, 1993 RFA AVAILABLE: CA/ES-93-024 P.T. 34; K.W. 0715035, 0725000, 0785055, 0411005, 0725020 National Cancer Institute National Institute of Environmental Health Sciences Letter of Intent Receipt Date: April 16, 1993 Application Receipt Date: May 20, 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 Extramural Programs Branch, Division of Cancer Etiology, National Cancer Institute (NCI) and the Division of Extramural Research and Training, National Institute of Environmental Health Sciences (NIEHS) invites grant applications for innovative epidemiologic studies to better understand the etiology of breast cancer in high risk areas including Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington, DC. These studies are to be designed to take known risk factors into consideration and must focus on markers or indicators of environmental exposures that may influence geographic differences in rates and temporal changes in incidence and mortality. 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 RFA, Environmental Factors and Breast Cancer in High-Risk Areas, is related to the priority area of cancer. Potential applicants may obtain a copy of a "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 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit institutions, public and private, such as colleges, universities, hospitals, research laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from or involving minority institutions, individuals, and women are encouraged. MECHANISM OF SUPPORT This RFA will be supported through the NIH research project grants (R01). Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. It is anticipated that the average award will be approximately $250,000 total costs. This RFA is a one-time solicitation. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years. Competitive continuation applications will compete with cited applications and be reviewed by a Division of Research Grants study section. If the NCI and the NIEHS determine that there is a sufficient continuing program need, they may announce a request for renewal applications. FUNDS AVAILABLE Approximately $1.0 million per year in total costs for four years will be committed by the NCI to specifically fund applications which are submitted in response to this RFA. In addition, $250,000 will be committed by the NIEHS to fund at least one application. The expected range of number of awards is three to five. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NCI and the NIEHS, the award of grants pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES This RFA responds to the FY 1993 Senate Appropriations Subcommittee Report for NIH which specifies that "NCI is directed to conduct a study with four years of follow-up to determine the factors contributing to the high breast cancer mortality rates in Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington, DC. NCI is to develop a plan for conducting the study and provide it to the House and Senate Appropriations Committees, the House Committee on Energy and Human Resources and the Senate Committee on Labor and Human Resources by July 1, 1993. $1 million is provided to fund this study." This RFA encourages applications for epidemiologic studies of breast cancer that include assessment of markers or indicators of environmental or occupational exposures, and include persons residing in the high-risk areas of Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington, DC. These studies are to be designed to take known risk factors into consideration while focusing on environmental exposures that may account for geographic differences in rates, as well as temporal changes in incidence and mortality.Investigators must include innovative approaches to the quantitation of environmental and/or occupational exposures and the evaluation of biologic levels in exposed persons. Collaborations of multiple disciplines and research institutions are particularly encouraged. Whenever possible, research designs should make use of existing resources, such as specimen repositories. Investigators may propose studies for evaluating the mechanisms by which environmental, nutritional, or occupational exposures could act in the initiation or promotion of breast cancer, such as through effects on hormonal or metabolic pathways. Projects should be proposed as traditional R01s. Proposals may build upon ongoing research projects, utilizing already collected specimens or epidemiologic data. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF FEMALES AND MINORITIES IN CLINICAL RESEARCH STUDIES 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 requested to submit by April 16, 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 names 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 NCI staff to estimate the potential review workload and to avoid conflict of interest in review. The letter of intent is to be sent to Dr. A.R. Patel at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91) available at most institutional offices of sponsored research 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. The format and instructions applicable to regular research grant applications must be followed. Applications must be received by May 20, 1993. If an application is received after that date, it will be returned without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review criteria for